CDAR2 Implementation Guide 2012JUL

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CDAR2_IG_IHE_CONSOL_DSTU_R1.1_2012JUL

HL7 Implementation Guide for CDA® Release 2:
IHE Health Story Consolidation, DSTU Release 1.1
(US Realm)
Draft Standard for Trial Use
July 2012

Publication of this draft standard for trial use and comment has been approved by
Health Level Seven International (HL7). This draft standard is not an accredited
American National Standard. The comment period for use of this draft standard shall
end 24 months from the date of publication. Suggestions for revision should be
submitted at http://www.hl7.org/dstucomments/index.cfm.
Following this 24 month evaluation period, this draft standard, revised as necessary,
will be submitted to a normative ballot in preparation for approval by ANSI as an
American National Standard. Implementations of this draft standard shall be viable
throughout the normative ballot process and for up to six months after publication of
the relevant normative standard.

Copyright © 2012 Health Level Seven International ® ALL RIGHTS RESERVED. The reproduction
of this material in any form is strictly forbidden without the written permission of the publisher.
HL7 International and Health Level Seven are registered trademarks of Health Level Seven
International. Reg. U.S. Pat & TM Off.

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Following is a non-exhaustive list of third-party terminologies that may require a separate license:
Terminology
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SNOMED CT
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Regenstrief Institute
World Health Organization (WHO)

Page 2
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

Primary
Editor/
Co-Chair:

Brett Marquard
Lantana Consulting Group
brett.marquard@lantanagroup.com

Co-Editor:

Kanwarpreet (KP) Sethi
Deloitte Consulting LLP
ksethi@deloitte.com

Co-Chair:

Calvin Beebe
Mayo Clinic
cbeebe@mayo.edu

Co-Editor:

George Benny Varghese
Deloitte Consulting LLP
gvarghese@deloitte.com

Co-Chair:

Austin Kreisler
SAIC Consultant to CDC/NHSN
duz1@cdc.gov

Co-Editor:

Corey Spears
McKesson
Corey.Spears@McKesson.com

Primary
Editor/
Co-Chair:

Robert H. Dolin, MD
Lantana Consulting Group
bob.dolin@lantanagroup.com

Co-Editor:

Michael Tyburski
Social Security Administration
michael.tyburski@ssa.gov

Co-Chair:

Grahame Grieve
Kestral Computing Pty Ltd
grahame@kestral.com.au

Co-Editor:

Kevin Coonan, MD
Deloitte Consulting LLP
kcoonan@deloitte.com

Co-Editor:

Liora Alschuler
Lantana Consulting Group
liora.alschuler@lantanagroup.com

Co-Editor:

Ryan Murphy
Tenino Tek
teninotek@gmail.com

Co-Editor:

Dave Carlson
U.S. Department of Veterans Affairs
David.Carlson@va.gov

Co-Editor:

Bob Yencha
Lantana Consulting Group
bob.yencha@lantanagroup.com

Co-Editor:

Keith W. Boone
GE Healthcare
keith.boone@ge.com

Co-Editor:

Zabrina Gonzaga
Lantana Consulting Group
zabrina.gonzaga@lantanagroup.com

Co-Editor:

Pete Gilbert
Covisint
peterngilbert@gmail.com

Co-Editor:

Jingdong Li
Lantana Consulting Group
jingdong.li@lantanagroup.com

Co-Editor:

Gaye Dolin
Lantana Consulting Group
gaye.dolin@lantanagroup.com

Co-Editor:

Rick Geimer
Lantana Consulting Group
rick.geimer@lantanagroup.com

Co-Editor:

Rich Kernan
Deloitte Consulting LLP
rkernan@deloitte.com

Co-Editor:

Sean McIlvenna
Lantana Consulting Group
sean.mcilvenna@lantanagroup.com

Co-Editor:

David Parker
Evolvent Technologies, Inc.
david.parker@evolvent.com

Co-Editor:

Sean Muir
U.S. Department of Veterans Affairs
Sean.Muir@va.gov

Co-Editor:

Jas Singh
Deloitte Consulting LLP
jassingh3@deloitte.com

Technical
Editor:

Susan Hardy
Lantana Consulting Group
susan.hardy@lantanagroup.com

Technical
Editor:

Diana Wright
Lantana Consulting Group
diana.wright@lantanagroup.com

Current Work Group also includes all those who participated in the ONC S&I Framework
See the full list of participants (approximately 140) here:
http://wiki.siframework.org/CDA+Harmonization+WG

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
Page 3
July 2012
© 2012 Health Level Seven, Inc. All rights reserved.

Acknowledgments
This guide was produced and developed through the joint efforts of Health Level
Seven (HL7), Integrating the Healthcare Environment (IHE), the Health Story
Project, and the Office of the National Coordinator (ONC) within the US
Department of Health and Human Services (HSS).
The project was carried out within the ONC’s Standards and Interoperability
(S&I) Framework as the Clinical Document Architecture (CDA) Consolidation
Project with a number of goals, one of which is providing a set of harmonized
CDA templates for the US Realm.
The co-editors appreciate the support and sponsorship of the HL7 Structured
Documents Working Group (SDWG) and all the volunteers, staff and contractors
participating in the S&I Framework.
The conformance requirements included here for review were generated from two
model-driven tools: the Model-Driven Health Tools (MDHT)—developed as on
open source tool under the auspices of the Veterans Administration, IBM, and
the ONC—and the Trifolia Template Database (Tdb)—developed initially for the
Centers for Disease Control and Prevention (CDC) and released by Lantana
Consulting Group under an open source license.
This material contains content from SNOMED CT®
(http://www.ihtsdo.org/snomed-ct/). SNOMED CT is a registered trademark of
the International Health Terminology Standard Development Organisation
(IHTSDO).
This material contains content from LOINC® (http://loinc.org). The LOINC table,
LOINC codes, and LOINC panels and forms file are copyright © 1995-2012,
Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and
Codes (LOINC) Committee and available at no cost under the license at
http://loinc.org/terms-of-use.

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HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

Table of Contents
1

INTRODUCTION ........................................................................................................... 30
1.1

Audience .............................................................................................................. 30

1.2

Purpose ................................................................................................................ 30

1.3

Scope ................................................................................................................... 31

1.4

Approach ............................................................................................................. 31

1.5

Organization of This Guide ................................................................................... 32

1.6

Use of Templates .................................................................................................. 32

1.6.1

Originator Responsibilities: General Case.......................................................... 33

1.6.2

Recipient Responsibilities: General Case ........................................................... 33

1.7

Levels of Constraint .............................................................................................. 33

1.8

Conformance Conventions Used in This Guide ...................................................... 34

1.8.1

Templates and Conformance Statements .......................................................... 34

1.8.2

Open and Closed Templates ............................................................................. 36

1.8.3

Conformance Verbs (Keywords) ......................................................................... 36

1.8.4

Cardinality ....................................................................................................... 37

1.8.5

Optional and Required with Cardinality ............................................................ 38

1.8.6

Vocabulary Conformance.................................................................................. 38

1.8.7

Containment Relationships .............................................................................. 39

1.8.8

Null Flavor ....................................................................................................... 40

1.8.9

Unknown Information ...................................................................................... 42

1.8.10

Data Types ....................................................................................................... 43

1.9

2

XML Conventions Used in This Guide ................................................................... 44

1.9.1

XPath Notation ................................................................................................. 44

1.9.2

XML Examples and Sample Documents ............................................................ 44

1.10

UML Diagrams ..................................................................................................... 45

1.11

Content of the Package ......................................................................................... 45

GENERAL HEADER TEMPLATE .................................................................................... 46
2.1

Document Type Codes .......................................................................................... 46

2.2

US Realm Header ................................................................................................. 46

2.2.1

RecordTarget .................................................................................................... 48

2.2.2

Author ............................................................................................................. 58

2.2.3

DataEnterer ..................................................................................................... 60

2.2.4

Informant......................................................................................................... 62

2.2.5

Custodian ........................................................................................................ 63

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2.2.6

InformationRecipient ........................................................................................ 64

2.2.7

LegalAuthenticator ........................................................................................... 65

2.2.8

Authenticator ................................................................................................... 67

2.2.9

Participant (Support) ........................................................................................ 69

2.2.10

InFulfillmentOf ................................................................................................. 70

2.2.11

DocumentationOf/serviceEvent ........................................................................ 70

2.2.12

Authorization/consent...................................................................................... 72

2.2.13

ComponentOf ................................................................................................... 73

2.3

US Realm Address (AD.US.FIELDED) .................................................................... 73

2.4

US Realm Date and Time (DT.US.FIELDED) .......................................................... 74

2.5

US Realm Date and Time (DTM.US.FIELDED) ....................................................... 75

2.6

US Realm Patient Name (PTN.US.FIELDED) .......................................................... 75

2.7

US Realm Person Name (PN.US.FIELDED) ............................................................. 77

2.8

Rendering Header Information for Human Presentation ......................................... 77

DOCUMENT-LEVEL TEMPLATES .................................................................................. 79
3.1

Continuity of Care Document (CCD)/HITSP C32 ................................................... 84

3.1.1

Header Constraints Specific to CCD .................................................................. 84

3.1.2

CCD Body Constraints ..................................................................................... 86

3.2

Consultation Note ................................................................................................. 96

3.2.1

Consultation Note Header Constraints .............................................................. 96

3.2.2

Consultation Note Body Constraints ............................................................... 103

3.3

Diagnostic Imaging Report .................................................................................. 112

3.3.1

DIR Header Constraints .................................................................................. 113

3.3.2

DIR Body Constraints ..................................................................................... 124

3.4

Discharge Summary ........................................................................................... 130

3.4.1

Discharge Summary Header Constraints ........................................................ 130

3.4.2

Discharge Summary Body Constraints ............................................................ 134

3.5

History and Physical (H&P) Note ......................................................................... 146

3.5.1

H&P Note Header Constraints ......................................................................... 147

3.5.2

H&P Note Body Constraints ............................................................................ 150

3.6

Operative Note .................................................................................................... 160

3.6.1

Operative Note Header Constraints ................................................................. 160

3.6.2

Operative Note Body Constraints .................................................................... 165

3.7

Procedure Note ................................................................................................... 169

3.7.1

Procedure Note Header Constraints ................................................................ 169

3.7.2

Procedure Note Body Constraints ................................................................... 177

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3.8
3.8.1

Progress Note Header Constraints ....................................................................188

3.8.2

Progress Note Body Constraints .......................................................................192

3.9

4

Progress Note ......................................................................................................188

Unstructured Document ......................................................................................197

3.9.1

Unstructured Document Header Constraints ...................................................198

3.9.2

Unstructured Document Body Constraints ......................................................199

SECTION-LEVEL TEMPLATES......................................................................................203
4.1

Advance Directives Section 42348-3.....................................................................210

4.2

Allergies Section 48765-2 ....................................................................................212

4.3

Anesthesia Section 59774-0 .................................................................................214

4.4

Assessment and Plan Section 51847-2 .................................................................215

4.5

Assessment Section 51848-0 ...............................................................................216

4.6

Chief Complaint and Reason for Visit Section 46239-0 .........................................217

4.7

Chief Complaint Section 10154-3 .........................................................................218

4.8

Complications Section 55109-3............................................................................219

4.9

DICOM Object Catalog Section - DCM 121181 .....................................................220

4.10

Discharge Diet Section 42344-2 ...........................................................................222

4.11

Encounters Section 46240-8 ................................................................................222

4.12

Family History Section 10157-6 ...........................................................................224

4.13

Findings Section (DIR) 18782-3 ...........................................................................226

4.14

Functional Status Section 47420-5 ......................................................................227

4.15

General Status Section 10210-3 ..........................................................................232

4.16

History of Past Illness Section 11348-0 ................................................................233

4.17

History of Present Illness Section 10164-2 ...........................................................234

4.18

Hospital Admission Diagnosis Section 46241-6 ....................................................235

4.19

Hospital Admission Medications Section 42346-7 (entries optional) ......................236

4.20

Hospital Consultations Section 18841-7 ..............................................................237

4.21

Hospital Course Section 8648-8 ...........................................................................237

4.22

Hospital Discharge Diagnosis Section 11535-2 .....................................................238

4.23

Hospital Discharge Instructions Section 8653-8 ...................................................239

4.24

Hospital Discharge Medications Section 10183-2 .................................................240

4.25

Hospital Discharge Physical Section 10184-0 .......................................................242

4.26

Hospital Discharge Studies Summary Section 11493-4 ........................................243

4.27

Immunizations Section 11369-6 ..........................................................................244

4.28

Instructions Section 69730-0 ...............................................................................247

4.29

Interventions Section 62387-6 .............................................................................248

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5

4.30

Medical Equipment Section 46264-8 ................................................................... 249

4.31

Medical (General) History Section 11329-0 .......................................................... 250

4.32

Medications Administered Section 29549-3 ......................................................... 251

4.33

Medications Section 10160-0 .............................................................................. 252

4.34

Objective Section 61149-1 .................................................................................. 254

4.35

Operative Note Fluid Section 10216-0 ................................................................. 255

4.36

Operative Note Surgical Procedure Section 10223-6 ............................................ 256

4.37

Payers Section 48768-6 ...................................................................................... 257

4.38

Physical Exam Section 29545-1 .......................................................................... 259

4.39

Plan of Care Section 18776-5 .............................................................................. 260

4.40

Planned Procedure Section 59772-4 .................................................................... 262

4.41

Postoperative Diagnosis Section 10218-6 ............................................................ 263

4.42

Postprocedure Diagnosis Section 59769-0 ........................................................... 264

4.43

Preoperative Diagnosis Section 10219-4 .............................................................. 265

4.44

Problem Section 11450-4 .................................................................................... 266

4.45

Procedure Description Section 29554-3 ............................................................... 269

4.46

Procedure Disposition Section 59775-7 ............................................................... 270

4.47

Procedure Estimated Blood Loss Section 59770-8 ............................................... 270

4.48

Procedure Findings Section 59776-5 ................................................................... 271

4.49

Procedure Implants Section 59771-6 ................................................................... 272

4.50

Procedure Indications Section 59768-2 ............................................................... 273

4.51

Procedure Specimens Taken Section 59773-2...................................................... 274

4.52

Procedures Section 47519-4 ............................................................................... 275

4.53

Reason for Referral Section 42349-1 ................................................................... 278

4.54

Reason for Visit Section 29299-5 ........................................................................ 279

4.55

Results Section 30954-2 ..................................................................................... 280

4.56

Review of Systems Section 10187-3..................................................................... 282

4.57

Social History Section 29762-2 ........................................................................... 283

4.58

Subjective Section 61150-9 ................................................................................. 285

4.59

Surgical Drains Section 11537-8 ......................................................................... 286

4.60

Vital Signs Section 8716-3 .................................................................................. 287

ENTRY-LEVEL TEMPLATES ........................................................................................ 289
5.1

Admission Medication ......................................................................................... 289

5.2

Advance Directive Observation ............................................................................ 291

5.3

Age Observation ................................................................................................. 296

5.4

Allergy - Intolerance Observation ........................................................................ 298

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July 2012

5.5

Allergy Problem Act .............................................................................................306

5.6

Allergy Status Observation ...................................................................................309

5.7

Assessment Scale Observation .............................................................................310

5.8

Assessment Scale Supporting Observation ...........................................................314

5.9

Authorization Activity ..........................................................................................315

5.10

Boundary Observation .........................................................................................317

5.11

Caregiver Characteristics .....................................................................................318

5.12

Code Observations ...............................................................................................321

5.13

Cognitive Status Problem Observation..................................................................323

5.14

Cognitive Status Result Observation ....................................................................328

5.15

Cognitive Status Result Organizer ........................................................................331

5.16

Comment Activity ................................................................................................333

5.17

Coverage Activity .................................................................................................336

5.18

Deceased Observation .........................................................................................337

5.19

Discharge Medication ..........................................................................................339

5.20

Drug Vehicle .......................................................................................................341

5.21

Encounter Activities ............................................................................................343

5.22

Encounter Diagnosis ...........................................................................................346

5.23

Estimated Date of Delivery ...................................................................................348

5.24

Family History Death Observation ........................................................................349

5.25

Family History Observation ..................................................................................351

5.26

Family History Organizer .....................................................................................356

5.27

Functional Status Problem Observation ...............................................................360

5.28

Functional Status Result Observation ..................................................................363

5.29

Functional Status Result Organizer .....................................................................366

5.30

Health Status Observation ...................................................................................368

5.31

Highest Pressure Ulcer Stage ...............................................................................371

5.32

Hospital Admission Diagnosis ..............................................................................372

5.33

Hospital Discharge Diagnosis ...............................................................................373

5.34

Immunization Activity ..........................................................................................375

5.35

Immunization Medication Information ..................................................................381

5.36

Immunization Refusal Reason ..............................................................................384

5.37

Indication ............................................................................................................386

5.38

Instructions ........................................................................................................388

5.39

Medication Activity ..............................................................................................390

5.40

Medication Dispense ............................................................................................399

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5.41

Medication Information ....................................................................................... 402

5.42

Medication Supply Order .................................................................................... 404

5.43

Medication Use – None Known (deprecated) ......................................................... 407

5.44

Non-Medicinal Supply Activity ............................................................................ 408

5.45

Number of Pressure Ulcers Observation .............................................................. 410

5.46

Plan of Care Activity Act ...................................................................................... 412

5.47

Plan of Care Activity Encounter ........................................................................... 413

5.48

Plan of Care Activity Observation ........................................................................ 414

5.49

Plan of Care Activity Procedure ........................................................................... 416

5.50

Plan of Care Activity Substance Administration ................................................... 417

5.51

Plan of Care Activity Supply ................................................................................ 418

5.52

Policy Activity ..................................................................................................... 419

5.53

Postprocedure Diagnosis ..................................................................................... 430

5.54

Precondition for Substance Administration .......................................................... 431

5.55

Pregnancy Observation ....................................................................................... 432

5.56

Preoperative Diagnosis ........................................................................................ 434

5.57

Pressure Ulcer Observation ................................................................................. 436

5.58

Problem Concern Act (Condition) ......................................................................... 444

5.59

Problem Observation .......................................................................................... 446

5.60

Problem Status ................................................................................................... 451

5.61

Procedure Activity Act ......................................................................................... 452

5.62

Procedure Activity Observation ........................................................................... 460

5.63

Procedure Activity Procedure .............................................................................. 466

5.64

Procedure Context .............................................................................................. 472

5.65

Product Instance ................................................................................................ 473

5.66

Purpose of Reference Observation ....................................................................... 475

5.67

Quantity Measurement Observation .................................................................... 476

5.68

Reaction Observation .......................................................................................... 480

5.69

Referenced Frames Observation .......................................................................... 483

5.70

Result Observation ............................................................................................. 484

5.71

Result Organizer ................................................................................................. 488

5.72

Series Act ........................................................................................................... 490

5.73

Service Delivery Location .................................................................................... 493

5.74

Severity Observation ........................................................................................... 495

5.75

Smoking Status Observation ............................................................................... 497

5.76

Social History Observation .................................................................................. 500

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6

5.77

SOP Instance Observation ...................................................................................502

5.78

Study Act ............................................................................................................505

5.79

Text Observation .................................................................................................507

5.80

Tobacco Use ........................................................................................................510

5.81

Vital Sign Observation .........................................................................................512

5.82

Vital Signs Organizer ...........................................................................................515

REFERENCES .............................................................................................................518

APPENDIX A —

ACRONYMS AND ABBREVIATIONS ..........................................................520

APPENDIX B —

CHANGES FROM PREVIOUS GUIDES ......................................................522

New and Updated Templates ............................................................................................522
Cardinality Changes ........................................................................................................523
Section Code Changes .....................................................................................................524
Conformance Verbs .........................................................................................................525
Template ID Changes .......................................................................................................527
Consolidated Entries........................................................................................................535
Changes Within Sections .................................................................................................539
APPENDIX C —

TEMPLATE IDS IN THIS GUIDE ...............................................................557

APPENDIX D —

CODE SYSTEMS IN THIS GUIDE .............................................................563

APPENDIX E —

VALUE SETS IN THIS GUIDE ...................................................................565

APPENDIX F —

SINGLE-VALUE BINDINGS IN THIS GUIDE ..............................................568

APPENDIX G —

EXTENSIONS TO CDA R2 ........................................................................569

APPENDIX H — XDS-SD AND US REALM CLINICAL DOCUMENT HEADER
COMPARISON ..............................................................................................................571
APPENDIX I —

MIME MULTIPART/RELATED MESSAGES ...............................................573

MIME Multipart/Related Messages ...................................................................................573
RFC-2557 MIME Encapsulation of Aggregate Documents, Such as HTML (MHTML) ..........573
Referencing Supporting Files in Multipart/Related Messages ............................................573
Referencing Documents from Other Multiparts within the Same X12 Transactions ............574
APPENDIX J —

ADDITIONAL PHYSICAL EXAMINATION SUBSECTIONS ...........................575

APPENDIX K —

ADDITIONAL EXAMPLES .........................................................................577

Names Examples .............................................................................................................577
Addresses Examples ........................................................................................................577
Time Examples ................................................................................................................578
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
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CD Examples .................................................................................................................. 578
APPENDIX L —

LARGE UML DIAGRAMS ......................................................................... 580

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Table of Figures
Figure 1: Constraints format example ........................................................................ 35
Figure 2: Constraints format – only one allowed......................................................... 37
Figure 3: Constraints format – only one like this allowed ........................................... 37
Figure 4: Binding to a single code .............................................................................. 38
Figure 5: XML expression of a single-code binding ..................................................... 39
Figure 6: Translation code example ........................................................................... 39
Figure 7: nullFlavor example ..................................................................................... 40
Figure 8: Attribute required....................................................................................... 41
Figure 9: Allowed nullFlavors when element is required (with xml examples) .............. 41
Figure 10: nullFlavor explicitly disallowed ................................................................. 41
Figure 11: Unknown medication example .................................................................. 42
Figure 12: Unknown medication use of anticoagulant drug example .......................... 43
Figure 13: No known medications example ................................................................ 43
Figure 14: XML document example ........................................................................... 44
Figure 15: XPath expression example ........................................................................ 44
Figure 16: ClinicalDocument example ....................................................................... 44
Figure 17: US Realm header example ........................................................................ 48
Figure 18: effectiveTime with time zone example ........................................................ 48
Figure 19: recordTarget example ............................................................................... 56
Figure 20: Person author example ............................................................................. 60
Figure 21: Device author example ............................................................................. 60
Figure 22: dataEnterer example ................................................................................ 62
Figure 23: Informant with assignedEntity example .................................................... 63
Figure 24: Custodian example ................................................................................... 64
Figure 25: informationRecipient example ................................................................... 65
Figure 26: legalAuthenticator example ....................................................................... 67
Figure 27: Authenticator example.............................................................................. 68
Figure 28: Participant example for a supporting person ............................................. 70
Figure 29: DocumentationOf example ........................................................................ 72
Figure 30: Procedure note consent example ............................................................... 73
Figure 31: CCD ClinicalDocument/templateId example ............................................. 84
Figure 32: CCD code example ................................................................................... 85
Figure 33: Consultation note ClinicalDocument/templateId example ......................... 97
Figure 34: Consultation note ClinicalDocument/code example ................................. 100

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Figure 35: Consultation note translation of local code example ................................ 100
Figure 36: Consultation note uncoordinated document type codes example .............. 101
Figure 37: Consultation note inFulfillmentOf example ............................................. 101
Figure 38: Consultation note componentOf example ................................................ 103
Figure 39: DIR ClinicalDocument/templateId example ............................................. 113
Figure 40: DIR ClinicalDocument/code example ...................................................... 115
Figure 41: DIR use of the translation element to include local codes for document type
....................................................................................................................... 115
Figure 42: DIR participant example ......................................................................... 116
Figure 43: DIR inFulfillmentOf example ................................................................... 117
Figure 44: DIR procedure context (CDA Header) illustration (non-normative) ............ 117
Figure 45: DIR documentationOf example................................................................ 118
Figure 46: DIR relatedDocument example ................................................................ 119
Figure 47: DIR componentOf example...................................................................... 121
Figure 48: Physician reading study performer example ............................................ 122
Figure 49: Physician of record participant example .................................................. 123
Figure 50: WADO reference using linkHtml example ................................................ 127
Figure 51: Fetus subject context example ................................................................ 128
Figure 52: Observer context example ....................................................................... 129
Figure 53: Discharge summary ClinicalDocument/templateId example .................... 130
Figure 54: Discharge summary ClinicalDocument/code example ............................ 131
Figure 55: Discharge summary componentOf example ............................................. 133
Figure 56: H&P ClinicalDocument/templateId example ............................................ 147
Figure 57: H&P ClinicalDocument/code example ................................................... 148
Figure 58: H&P use of translation to include local equivalents for document type ..... 148
Figure 59: H&P componentOf example .................................................................... 150
Figure 60: Operative note ClinicalDocument/templateId example ............................. 160
Figure 61: Operative note ClinicalDocument/code example ..................................... 162
Figure 62: Operative note serviceEvent example....................................................... 164
Figure 63: Operative note performer example ........................................................... 165
Figure 64: Procedure note ClinicalDocument/templateId category I example ............ 170
Figure 65: Procedure note ClinicalDocument/code example ..................................... 171
Figure 66: Procedure note serviceEvent example ...................................................... 176
Figure 67: Procedure note serviceEvent example with null value in width element .... 176
Figure 68: Procedure note performer example .......................................................... 177
Figure 69: Progress note ClinicalDocument/templateId example .............................. 188
Figure 70: Progress note ClinicalDocument/code example ...................................... 190
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Figure 71: Progress note serviceEvent example ........................................................ 191
Figure 72: Progress note componentOf example ....................................................... 192
Figure 73: nonXMLBody example with embedded content ........................................ 200
Figure 74: nonXMLBody example with referenced content ....................................... 200
Figure 75: nonXMLBody example with compressed content ..................................... 200
Figure 76: Unique file reference example ................................................................. 202
Figure 77: Advance directives section UML diagram ................................................. 210
Figure 78: Advance directives section example ......................................................... 211
Figure 79: Allergies section UML diagram ................................................................ 212
Figure 80: Allergies section example ........................................................................ 213
Figure 81: Anesthesia section example .................................................................... 215
Figure 82: Assessment and plan section example .................................................... 216
Figure 83: Assessment section example ................................................................... 217
Figure 84: Chief complaint and reason for visit section example ............................... 218
Figure 85: Chief complaint section example ............................................................. 218
Figure 86: Complications section example ............................................................... 219
Figure 87: DICOM object catalog section example .................................................... 221
Figure 88: Discharge diet section example ............................................................... 222
Figure 89: Encounters section UML diagram ........................................................... 223
Figure 90: Encounters section example ................................................................... 224
Figure 91: Family history section UML diagram ....................................................... 225
Figure 92: Family history section example ............................................................... 225
Figure 93: Findings section example ........................................................................ 226
Figure 94: Functional status section UML diagram .................................................. 227
Figure 95: Functional status section example .......................................................... 230
Figure 96: General status section example .............................................................. 232
Figure 97: History of past illness section example .................................................... 233
Figure 98: History of present illness section example ............................................... 234
Figure 99: Hospital admission diagnosis section example......................................... 235
Figure 100: Hospital admission medications section example ................................... 236
Figure 101: Hospital consultations section example ................................................. 237
Figure 102: Hospital course section example ........................................................... 238
Figure 103: Hospital discharge diagnosis section example ........................................ 239
Figure 104: Hospital discharge instructions section example ................................... 240
Figure 105: Hospital discharge medications section example.................................... 242
Figure 106: Hospital discharge physical section example ......................................... 243

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Figure 107: Hospital discharge studies summary section example ............................ 244
Figure 108: Immunization section* UML diagram .................................................... 244
Figure 109: Immunization section example .............................................................. 246
Figure 110: Instructions section example ................................................................ 248
Figure 111: Interventions section example ............................................................... 249
Figure 112: Medical equipment section UML diagram .............................................. 249
Figure 113: Medical equipment section example ...................................................... 250
Figure 114: Medical (general) history section example .............................................. 251
Figure 115: Medications administered section example ............................................ 252
Figure 116: Medications section UML diagram ......................................................... 252
Figure 117: Medications section entries example ..................................................... 254
Figure 118: Objective section example ..................................................................... 255
Figure 119: Operative Note fluid section example ..................................................... 256
Figure 120: Operative Note surgical procedure section example ............................... 256
Figure 121: Payers section UML diagram ................................................................. 257
Figure 122: Payers section example ......................................................................... 258
Figure 123: Physical exam section example ............................................................. 260
Figure 124: Plan of care section UML diagram ......................................................... 260
Figure 125: Plan of care section example ................................................................. 261
Figure 126: Planned procedure section example ...................................................... 263
Figure 127: Postoperative diagnosis section example................................................ 264
Figure 128: Postprocedure diagnosis section example .............................................. 265
Figure 129: Preoperative diagnosis section example ................................................. 266
Figure 130: Problem section UML diagram............................................................... 266
Figure 131: Problem section example ...................................................................... 268
Figure 132: Pressure ulcer on a problem list example .............................................. 268
Figure 133: Procedure description section example .................................................. 269
Figure 134: Procedure disposition section example .................................................. 270
Figure 135: Procedure estimated blood loss section example .................................... 271
Figure 136: Procedure findings section example ....................................................... 272
Figure 137: Procedure implants section example ..................................................... 273
Figure 138: Procedure indications section example .................................................. 274
Figure 139: Procedure specimens taken section example ......................................... 275
Figure 140: Procedures section UML diagram .......................................................... 275
Figure 141: Procedures section example .................................................................. 277
Figure 142: Reason for referral section example ....................................................... 278

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Figure 143: Reason for visit section example ........................................................... 279
Figure 144: Results section UML diagram................................................................ 280
Figure 145: Results section example ....................................................................... 282
Figure 146: Review of systems section example........................................................ 283
Figure 147: Social history section UML diagram ...................................................... 283
Figure 148: Social history section example .............................................................. 284
Figure 149: Subjective section example ................................................................... 285
Figure 150: Surgical drains section example ............................................................ 286
Figure 151: Vital signs section UML diagram ........................................................... 287
Figure 152: Vital signs section example ................................................................... 288
Figure 153: Admission medication entry example .................................................... 291
Figure 154: Advance directive observation example .................................................. 295
Figure 155: Age observation example ....................................................................... 298
Figure 156: Allergy - intolerance observation example .............................................. 305
Figure 157: Allergy problem act example ................................................................. 308
Figure 158: Allergy status observation example ....................................................... 310
Figure 159: Assessment scale observation example .................................................. 313
Figure 160: Assessment scale supporting observation example ................................ 315
Figure 161: Authorization activity example .............................................................. 317
Figure 162: Boundary observation example ............................................................. 318
Figure 163: Caregiver characteristics example with assertion ................................... 320
Figure 164: Caregiver characteristics example without assertion .............................. 320
Figure 165: Code observation example .................................................................... 323
Figure 166:Cognitive status problem observation example ....................................... 327
Figure 167: Cognitive status result observation example .......................................... 331
Figure 168 Cognitive status result organizer example .............................................. 333
Figure 169: Comment act example .......................................................................... 335
Figure 170: Coverage activity example ..................................................................... 337
Figure 171: Deceased observation example .............................................................. 339
Figure 172: Discharge medication entry example ..................................................... 341
Figure 173: Drug vehicle entry example ................................................................... 342
Figure 174: Encounter activities example ................................................................ 346
Figure 175: Encounter diagnosis act example .......................................................... 348
Figure 176: Estimated date of delivery example ....................................................... 349
Figure 177: Family history death observation example ............................................. 350
Figure 178: Family history observation scenario ...................................................... 353

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Figure 179: Family history observation example ...................................................... 354
Figure 180: Family history organizer example .......................................................... 359
Figure 181: Functional status problem observation example .................................... 363
Figure 182: Functional status result observation example ........................................ 366
Figure 183: Functional status result organizer example ........................................... 368
Figure 184: Health status observation example ........................................................ 370
Figure 185: Hospital admission diagnosis example .................................................. 373
Figure 186: Hospital discharge diagnosis act example .............................................. 375
Figure 187: Immunization activity example .............................................................. 381
Figure 188: Immunization medication information example ..................................... 384
Figure 189: Immunization refusal reason ................................................................ 385
Figure 190: Indication entry example ...................................................................... 387
Figure 191: Instructions entry example ................................................................... 389
Figure 192: Medication activity example .................................................................. 397
Figure 193: Medication dispense example ................................................................ 402
Figure 194: Medication information example ........................................................... 404
Figure 195: Medication supply order example .......................................................... 407
Figure 196: Medication use – none known example .................................................. 408
Figure 197: Non-medicinal supply activity example .................................................. 410
Figure 198: Number of pressure ulcers example ...................................................... 412
Figure 199: Plan of care activity act example ........................................................... 413
Figure 200: Plan of care activity encounter example ................................................. 414
Figure 201: Plan of care activity observation example .............................................. 416
Figure 202: Plan of care activity procedure example ................................................. 417
Figure 203: Plan of care activity substance administration example ......................... 418
Figure 204: Plan of care activity supply example ...................................................... 419
Figure 205: Policy activity example .......................................................................... 427
Figure 206: Postprocedure diagnosis example .......................................................... 431
Figure 207: Precondition for substance administration example ............................... 432
Figure 208: Pregnancy observation example ............................................................ 434
Figure 209: Preoperative diagnosis example ............................................................. 436
Figure 210: Pressure ulcer observation example ...................................................... 443
Figure 211: Problem concern act (condition) example ............................................... 445
Figure 212: Problem observation example ................................................................ 449
Figure 213: Problem observation with specific problem not observed ........................ 450
Figure 214: Problem observation for no known problems ......................................... 450

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Figure 215: NullFlavor example ............................................................................... 450
Figure 216: Problem status example ........................................................................ 452
Figure 217: Procedure activity act example .............................................................. 459
Figure 218: Procedure activity observation example ................................................. 465
Figure 219: Procedure activity procedure example ................................................... 471
Figure 220: Procedure context template example ..................................................... 473
Figure 221: Product instance example ..................................................................... 474
Figure 222: Purpose of reference example ................................................................ 476
Figure 223: Quantity measurement observation example ......................................... 479
Figure 224: Reaction observation example ............................................................... 483
Figure 225: Referenced frames observation example ................................................ 484
Figure 226: Result observation example .................................................................. 487
Figure 227: No evaluation procedures (e.g., labs/x-rays) performed example ............ 488
Figure 228: Local code example ............................................................................... 488
Figure 229: Result organizer example ...................................................................... 490
Figure 230: Series act example ................................................................................ 492
Figure 231: Service delivery location example .......................................................... 494
Figure 232: Severity observation example ................................................................ 497
Figure 233: Smoking status observation example .................................................... 499
Figure 234: Unknown if ever smoked ....................................................................... 499
Figure 235: Social history observation template example ......................................... 502
Figure 236: SOP instance observation example ........................................................ 504
Figure 237: Study act example ................................................................................ 507
Figure 238: Text observation example...................................................................... 510
Figure 239: Tobacco use entry example ................................................................... 512
Figure 240: Vital sign observation example .............................................................. 515
Figure 241: Vital signs organizer example ................................................................ 517
Figure 242: Correct use of name example 1 ............................................................. 577
Figure 243: Incorrect use of name example 1 - whitespace ....................................... 577
Figure 244: Incorrect use of Patient name example 2 - no tags ................................. 577
Figure 245: Correct use telecom address example .................................................... 577
Figure 246: Correct use postal address example ...................................................... 577
Figure 247: Correct use of IVL_TS example .............................................................. 578
Figure 248: Correct use of TS with precision to minute example .............................. 578
Figure 249: Correct use of TS with time zone offset example .................................... 578
Figure 250: Incorrect use of IVL_TS example ........................................................... 578

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Figure 251: Incorrect use of TS - insufficient precision example ............................... 578
Figure 252: Incorrect use of TS when time zone offset required example ................... 578
Figure 253: Incorrect use of time zone offset - not enough precision example ........... 578
Figure 254: Correct use of CD with no code example................................................ 578
Figure 255: Incorrect use of CD with no code - missing nullFlavor attribute example 579
Figure 256: Immunizations section UML diagram (larger copy) ................................. 580
Figure 257: Functional Status section UML diagram (larger copy) ............................ 580
Figure 258: Medications section UML diagram (larger copy) ..................................... 580
Figure 259: Plan of care section UML diagram (larger copy) ...................................... 580

Table of Tables
Table 1: Content of the Package ................................................................................ 45
Table 2: Basic Confidentiality Kind Value Set............................................................. 47
Table 3: Language Value Set (excerpt) ........................................................................ 47
Table 4: Telecom Use (US Realm Header) Value Set .................................................... 52
Table 5: Administrative Gender (HL7) Value Set ......................................................... 52
Table 6: Marital Status Value Set .............................................................................. 53
Table 7: Religious Affiliation Value Set (excerpt) ......................................................... 53
Table 8: Race Value Set (excerpt) ............................................................................... 54
Table 9: Ethnicity Value Set ...................................................................................... 54
Table 10: Personal Relationship Role Type Value Set (excerpt) .................................... 54
Table 11: State Value Set (excerpt) ............................................................................ 55
Table 12: Postal Code Value Set (excerpt)................................................................... 55
Table 13: Country Value Set (excerpt) ........................................................................ 55
Table 14: Language Ability Value Set ......................................................................... 56
Table 15: Language Ability Proficiency Value Set........................................................ 56
Table 16: IND Role classCode Value Set ..................................................................... 69
Table 17: PostalAddressUse Value Set ....................................................................... 74
Table 18: EntityNameUse Value Set ........................................................................... 76
Table 19: EntityPersonNamePartQualifier Value Set ................................................... 77
Table 20: Document Types and Required/Optional Sections with Structured Body ..... 80
Table 21: Template Containment for a CCD ............................................................... 88
Table 22: Consultation Note LOINC Document Codes ................................................ 98
Table 23: Invalid Codes for Consultation Note .......................................................... 100
Table 24: Template Containment for a Consultation Note ......................................... 105
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Table 25: DIR LOINC Document Type Codes ............................................................ 114
Table 26: Template Containment for Constrained DIR Sections ................................ 124
Table 27: DIR Section Type Codes ........................................................................... 125
Table 28: Discharge summary LOINC Document Codes ........................................... 131
Table 29: HL7 Discharge Disposition Codes ............................................................. 133
Table 30: Template Containment for a Discharge Summary ..................................... 137
Table 31: H&P LOINC Document Type Codes ........................................................... 148
Table 32: Template Containment for an H&P Note ................................................... 152
Table 33: Surgical Operation Note LOINC Document Codes ..................................... 161
Table 34: Provider Type Value Set (excerpt) .............................................................. 164
Table 35: Procedure Codes from SNOMED CT ......................................................... 164
Table 36: Template Containment for an Operative Note ............................................ 167
Table 37: Procedure Note LOINC Document Type Codes ........................................... 171
Table 38: Participant Scenario................................................................................. 172
Table 39: Healthcare Provider Taxonomy Value Set .................................................. 175
Table 40: Template Containment for a Procedure Note ............................................. 180
Table 41: Progress Note LOINC Document Codes ..................................................... 190
Table 42: Template Containment for a Progress Note ............................................... 194
Table 43: Supported File Formats Value Set (Unstructured Documents) ................... 200
Table 44: Sections and Required/Optional Document Types with Structured Body ... 204
Table 45: Advance Directives Section Contexts ........................................................ 210
Table 46: Allergies Section Contexts ........................................................................ 212
Table 47: Anesthesia Section Contexts .................................................................... 214
Table 48: Assessment and Plan Section Contexts ..................................................... 215
Table 49: Assessment Section Contexts ................................................................... 216
Table 50: Chief Complaint and Reason for Visit Section Contexts ............................. 217
Table 51: Chief Complaint Section Contexts ............................................................ 218
Table 52: Complications Section Contexts ............................................................... 219
Table 53: DICOM Object Catalog Section - DCM 121181 Contexts ........................... 220
Table 54: Discharge Diet Section Contexts ............................................................... 222
Table 55: Encounters Section Contexts ................................................................... 222
Table 56: Family History Section Contexts ............................................................... 224
Table 57: Findings Section Contexts ........................................................................ 226
Table 58: Functional Status Section Contexts .......................................................... 227
Table 59: Functional and Cognitive Status Problem Observation Examples .............. 228
Table 60: Functional and Cognitive Status Result Observation Examples ................. 229

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Table 61: General Status Section Contexts .............................................................. 232
Table 62: History of Past Illness Section Contexts .................................................... 233
Table 63: History of Present Illness Section Contexts ............................................... 234
Table 64: Hospital Admission Diagnosis Section Contexts ........................................ 235
Table 65: Hospital Admission Medications Section Contexts ..................................... 236
Table 66: Hospital Consultations Section Contexts .................................................. 237
Table 67: Hospital Course Section Contexts ............................................................. 237
Table 68: Hospital Discharge Diagnosis Section Contexts ......................................... 238
Table 69: Hospital Discharge Instructions Section Contexts ..................................... 239
Table 70: Hospital Discharge Medications Section Contexts ..................................... 240
Table 71: Hospital Discharge Physical Section Contexts ........................................... 242
Table 72: Hospital Discharge Studies Summary Section Contexts ............................ 243
Table 73: Immunizations Section Contexts .............................................................. 244
Table 74: Interventions Section Contexts ................................................................. 247
Table 75: Interventions Section Contexts ................................................................. 248
Table 76: Medical Equipment Section Contexts ........................................................ 249
Table 77: Medical (General) History Section Contexts ............................................... 250
Table 78: Medications Administered Section Contexts .............................................. 251
Table 79: Medications Section Contexts ................................................................... 252
Table 80: Objective Section Contexts ....................................................................... 254
Table 81: Operative Note Fluids Section Contexts .................................................... 255
Table 82: Operative Note Surgical Procedure Section Contexts ................................. 256
Table 83: Payers Section Contexts ........................................................................... 257
Table 84: Physical Exam Section Contexts ............................................................... 259
Table 86: Plan of Care Section Contexts................................................................... 260
Table 87: Planned Procedure Section Contexts......................................................... 262
Table 88: Postoperative Diagnosis Section Contexts ................................................. 263
Table 89: Postprocedure Diagnosis Section Contexts ................................................ 264
Table 90: Preoperative Diagnosis Section Contexts ................................................... 265
Table 91: Problem Section Contexts ......................................................................... 266
Table 92: Procedure Description Section Contexts ................................................... 269
Table 93: Procedure Disposition Section Contexts .................................................... 270
Table 94: Procedure Estimated Blood Loss Section Contexts .................................... 270
Table 95: Procedure Findings Section Contexts ........................................................ 271
Table 96: Procedure Implants Section Contexts ....................................................... 272
Table 97: Procedure Indications Section Contexts .................................................... 273

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Table 98: Procedure Specimens Taken Section Contexts .......................................... 274
Table 99: Procedures Section Contexts .................................................................... 275
Table 100: Reason for Referral Section Contexts ...................................................... 278
Table 101: Reason for Visit Section Contexts ........................................................... 279
Table 102: Results Section Contexts ........................................................................ 280
Table 103: Review of Systems Section Contexts ....................................................... 282
Table 104: Social History Section Contexts .............................................................. 283
Table 105: Subjective Section Contexts ................................................................... 285
Table 106: Surgical Drains Section Contexts ........................................................... 286
Table 107: Vital Signs Section Contexts ................................................................... 287
Table 108: Admission Medication Contexts .............................................................. 289
Table 109: Admission Medication Constraints Overview ........................................... 290
Table 110: Advance Directive Observation Contexts ................................................. 291
Table 111: Advance Directive Observation Constraints Overview .............................. 292
Table 112: Advance Directive Type Code Value Set .................................................. 295
Table 113: Age Observation Contexts ...................................................................... 296
Table 114: Age Observation Constraints Overview ................................................... 297
Table 115: AgePQ_UCUM Value Set ......................................................................... 298
Table 116: Allergy - Intolerance Observation Contexts ............................................. 298
Table 117: Allergy - Intolerance Observation Constraints Overview .......................... 299
Table 118: Allergy/Adverse Event Type Value Set .................................................... 303
Table 119: Medication Brand Name Value Set (excerpt) ............................................ 303
Table 120: Medication Clinical Drug Value Set (excerpt) ........................................... 304
Table 121: Medication Drug Class Value Set (excerpt) .............................................. 304
Table 122: Ingredient Name Value Set (excerpt) ....................................................... 305
Table 123: Allergy Problem Act Contexts .................................................................. 306
Table 124: Allergy Problem Act Constraints Overview ............................................... 307
Table 125: ProblemAct statusCode Value Set ........................................................... 308
Table 126: Allergy Status Observation Contexts ....................................................... 309
Table 127: Allergy Status Observation Constraints Overview .................................... 309
Table 128: HITSP Problem Status Value Set ............................................................ 310
Table 129: Assessment Scale Observation Contexts ................................................. 310
Table 130: Assessment Scale Observation Constraints Overview .............................. 311
Table 131: Assessment Scale Supporting Observation Contexts ............................... 314
Table 132: Assessment Scale Supporting Observation Constraints Overview ............ 314
Table 133: Authorization Activity Contexts .............................................................. 315

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Table 134: Authorization Activity Constraints Overview ........................................... 316
Table 135: Boundary Observation Contexts ............................................................. 317
Table 136: Boundary Observation Constraints Overview .......................................... 317
Table 137: Caregiver Characteristics Contexts ......................................................... 318
Table 138: Caregiver Characteristics Constraints Overview ...................................... 319
Table 139: Code Observations Contexts ................................................................... 321
Table 140: Code Observations Constraints Overview ................................................ 322
Table 141: Cognitive Status Problem Observation Contexts ...................................... 323
Table 142: Cognitive Status Problem Observation Constraints Overview ................... 324
Table 143: Problem type value set ........................................................................... 326
Table 144: Problem Value Set (excerpt) .................................................................... 326
Table 145: Cognitive Status Result Observation Contexts......................................... 328
Table 146: Cognitive Status Result Observation Constraints Overview ...................... 328
Table 147: Cognitive Status Result Organizer Contexts ............................................ 331
Table 148: Cognitive Status Result Organizer Constraints Overview ......................... 332
Table 149: Comment Activity Contexts .................................................................... 333
Table 150: Comment Activity Constraints Overview ................................................. 334
Table 151: Coverage Activity Contexts ..................................................................... 336
Table 152: Coverage Activity Constraints Overview .................................................. 336
Table 153: Deceased Observation Contexts .............................................................. 337
Table 154: Deceased Observation Constraints Overview ........................................... 338
Table 155: Discharge Medication Contexts ............................................................... 339
Table 156: Discharge Medication Constraints Overview............................................ 340
Table 157: Drug Vehicle Contexts ............................................................................ 341
Table 158: Drug Vehicle Constraints Overview ......................................................... 342
Table 159: Encounter Activities Contexts ................................................................. 343
Table 160: Encounter Activities Constraints Overview .............................................. 343
Table 161: Encounter Type Value Set ...................................................................... 345
Table 162: Encounter Diagnosis Contexts................................................................ 346
Table 163: Encounter Diagnosis Constraints Overview............................................. 347
Table 164: Estimated Date of Delivery Contexts ....................................................... 348
Table 165: Estimated Date of Delivery Constraints Overview .................................... 348
Table 166: Family History Death Observation Contexts ............................................ 349
Table 167: Family History Death Observation Constraints Overview ......................... 350
Table 168: Family History Observation Contexts ...................................................... 351
Table 169: Family History Observation Constraints Overview ................................... 351

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Table 170: Family History Organizer Contexts ......................................................... 356
Table 171: Family History Organizer Constraints Overview ...................................... 356
Table 172: Family History Related Subject Value Set (excerpt) ................................. 359
Table 173: Functional Status Problem Observation Contexts ................................... 360
Table 174: Functional Status Problem Observation Constraints Overview ................ 360
Table 175: Functional Status Result Observation Contexts ...................................... 363
Table 176: Functional Status Result Observation Constraints Overview ................... 364
Table 177: Functional Status Result Organizer Contexts .......................................... 366
Table 178: Functional Status Result Organizer Constraints Overview ....................... 367
Table 179: Health Status Observation Contexts ....................................................... 368
Table 180: Health Status Observation Constraints Overview .................................... 368
Table 181: HealthStatus Value Set .......................................................................... 369
Table 182: Highest Pressure Ulcer Stage Contexts ................................................... 371
Table 183: Highest Pressure Ulcer Stage Constraints Overview ................................ 371
Table 184: Hospital Admission Diagnosis Contexts .................................................. 372
Table 185: Hospital Admission Diagnosis Constraints Overview ............................... 372
Table 186: Hospital Discharge Diagnosis Contexts ................................................... 373
Table 187: Hospital Discharge Diagnosis Constraints Overview ................................ 374
Table 188: Immunization Activity Contexts .............................................................. 375
Table 189: Immunization Activity Constraints Overview ........................................... 376
Table 190: Immunization Medication Information Contexts ...................................... 381
Table 191: Immunization Medication Information Constraints Overview ................... 382
Table 192: Vaccine Administered (Hepatitis B) Value Set (excerpt) ............................ 383
Table 193: Immunization Refusal Reason Contexts .................................................. 384
Table 194: Immunization Refusal Reason Constraints Overview ............................... 384
Table 195: No Immunization Reason Value Set ........................................................ 385
Table 196: Indication Contexts ................................................................................ 386
Table 197: Indication Constraints Overview ............................................................. 386
Table 198: Instructions Contexts ............................................................................. 388
Table 199: Instructions Constraints Overview .......................................................... 388
Table 200: Patient Education Value Set ................................................................... 389
Table 201: Medication Activity Contexts .................................................................. 390
Table 202: Medication Activity Constraints Overview ............................................... 390
Table 203: MoodCodeEvnInt Value Set .................................................................... 395
Table 204: Medication Route FDA Value Set (excerpt) .............................................. 396
Table 205: Body Site Value Set (excerpt) .................................................................. 396

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Table 206: Medication Product Form Value Set (excerpt) .......................................... 397
Table 207: Unit of Measure Value Set (excerpt) ........................................................ 397
Table 208: Medication Dispense Contexts ................................................................ 399
Table 209: Medication Dispense Constraints Overview ............................................. 400
Table 210: Medication Fill Status Value Set ............................................................. 401
Table 211: Medication Information Contexts ............................................................ 402
Table 212: Medication Information Constraints Overview ......................................... 403
Table 213: Medication Supply Order Contexts ......................................................... 404
Table 214: Medication Supply Order Constraints Overview ...................................... 405
Table 215: Non-Medicinal Supply Activity Contexts .................................................. 408
Table 216: Non-Medicinal Supply Activity Constraints Overview ............................... 409
Table 217: Number of Pressure Ulcers Observation Contexts ................................... 410
Table 218: Number of Pressure Ulcers Observation Constraints Overview................. 410
Table 219: Plan of Care Activity Act Contexts ........................................................... 412
Table 220: Plan of Care Activity Act Constraints Overview ........................................ 412
Table 221: Plan of Care moodCode (Act/Encounter/Procedure) ................................ 413
Table 222: Plan of Care Activity Encounter Contexts ................................................ 413
Table 223: Plan of Care Activity Encounter Constraints Overview ............................. 414
Table 224: Plan of Care Activity Observation Contexts ............................................. 414
Table 225: Plan of Care Activity Observation Constraints Overview .......................... 415
Table 226: Plan of Care moodCode (Observation) Value Set ...................................... 415
Table 227: Plan of Care Activity Procedure Contexts ................................................ 416
Table 228: Plan of Care Activity Procedure Constraints Overview ............................. 416
Table 229: Plan of Care Activity Substance Administration Contexts ........................ 417
Table 230: Plan of Care Activity Substance Administration Constraints Overview ..... 417
Table 231: Plan of Care moodCode (SubstanceAdministration/Supply) Value Set ..... 418
Table 232: Plan of Care Activity Supply Contexts ..................................................... 418
Table 233: Plan of Care Activity Supply Constraints Overview .................................. 419
Table 234: Policy Activity Contexts .......................................................................... 419
Table 235: Policy Activity Constraints Overview ....................................................... 420
Table 236: Health Insurance Type Value Set (excerpt) .............................................. 426
Table 237: Coverage Type Value Set ........................................................................ 427
Table 238: Financially Responsible Party Value Set (excerpt) .................................... 427
Table 239: Postprocedure Diagnosis Contexts .......................................................... 430
Table 240: Postprocedure Diagnosis Constraints Overview ....................................... 430
Table 241: Precondition for Substance Administration Contexts ............................... 431

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Table 242: Precondition for Substance Administration Constraints Overview ............ 431
Table 243: Pregnancy Observation Contexts ............................................................ 432
Table 244: Pregnancy Observation Constraints Overview ......................................... 432
Table 245: Preoperative Diagnosis Contexts ............................................................. 434
Table 246: Preoperative Diagnosis Constraints Overview .......................................... 435
Table 247: Pressure Ulcer Observation Contexts ...................................................... 436
Table 248: Pressure Ulcer Observation Constraints Overview ................................... 436
Table 249 Pressure Ulcer Stage Value Set ................................................................ 440
Table 250: Pressure Point Value Set ........................................................................ 441
Table 251: Target Site Qualifiers Value Set .............................................................. 442
Table 252: Problem Concern Act (Condition) Contexts .............................................. 444
Table 253: Problem Concern Act (Condition) Constraints Overview ........................... 444
Table 254: Problem Observation Contexts ............................................................... 446
Table 255: Problem Observation Constraints Overview............................................. 446
Table 256: Problem Status Contexts ........................................................................ 451
Table 257: Problem Status Constraints Overview ..................................................... 451
Table 258: Procedure Activity Act Contexts .............................................................. 452
Table 259: Procedure Activity Act Constraints Overview ........................................... 454
Table 260: Procedure Act Status Code Value Set ...................................................... 458
Table 261: Act Priority Value Set ............................................................................. 458
Table 262: Procedure Activity Observation Contexts ................................................ 460
Table 263: Procedure Activity Observation Constraints Overview.............................. 460
Table 264: Procedure Activity Procedure Contexts.................................................... 466
Table 265: Procedure Activity Procedure Constraints Overview ................................. 466
Table 266: Procedure Context Contexts ................................................................... 472
Table 267: Procedure Context Constraints Overview ................................................ 472
Table 268: Product Instance Contexts ..................................................................... 473
Table 269: Product Instance Constraints Overview .................................................. 474
Table 270: Purpose of Reference Observation Contexts ............................................ 475
Table 271: Purpose of Reference Observation Constraints Overview ......................... 475
Table 272: DICOM Purpose of Reference Value Set .................................................. 476
Table 273: Quantity Measurement Observation Contexts ......................................... 476
Table 274: Quantity Measurement Observation Constraints Overview ...................... 477
Table 275: DIR Quantity Measurement Type Value Set ............................................ 478
Table 276: DICOM Quantity Measurement Type Value Set ....................................... 479
Table 277: Reaction Observation Contexts ............................................................... 480

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Table 278: Reaction Observation Constraints Overview ............................................ 480
Table 279: Referenced Frames Observation Constraints Overview ............................ 483
Table 280: Result Observation Contexts .................................................................. 484
Table 281: Result Observation Constraints Overview ............................................... 485
Table 282: Result Status Value Set .......................................................................... 487
Table 283: Result Organizer Contexts ...................................................................... 488
Table 284: Result Organizer Constraints Overview ................................................... 489
Table 285: Series Act Contexts ................................................................................ 490
Table 286: Series Act Constraints Overview ............................................................. 491
Table 287: Service Delivery Location Contexts ......................................................... 493
Table 288: Service Delivery Location Constraints Overview ...................................... 493
Table 289: HealthcareServiceLocation Value Set (excerpt) ........................................ 494
Table 290: Severity Observation Contexts ................................................................ 495
Table 291: Severity Observation Constraints Overview ............................................. 495
Table 292: Problem Severity Value Set ..................................................................... 496
Table 293: Smoking Status Observation Contexts .................................................... 497
Table 294: Smoking Status Observation Constraints Overview ................................. 498
Table 295: Smoking Status Value Set ...................................................................... 499
Table 296: Social History Observation Contexts ....................................................... 500
Table 297: Social History Observation Constraints Overview .................................... 500
Table 298: Social History Type Set Definition Value Set ........................................... 501
Table 299: SOP Instance Observation Contexts ........................................................ 502
Table 300: SOP Instance Observation Constraints Overview ..................................... 502
Table 301: Study Act Contexts ................................................................................ 505
Table 302: Study Act Constraints Overview ............................................................. 506
Table 303: Text Observation Contexts...................................................................... 507
Table 304: Text Observation Constraints Overview................................................... 508
Table 305: Tobacco Use Observation Contexts ......................................................... 510
Table 306: Tobacco Use Constraints Overview ......................................................... 511
Table 307: Tobacco Use Value Set ........................................................................... 512
Table 308: Vital Sign Observation Contexts ............................................................. 512
Table 309: Vital Sign Observation Constraints Overview .......................................... 513
Table 310: Vital Sign Result Type Value Set ............................................................. 514
Table 311: Vital Signs Organizer Contexts ............................................................... 515
Table 312: Vital Signs Organizer Constraints Overview ............................................ 516
Table 313: Templates Added and Updated in May 2012 Ballot ................................. 522

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Table 314: H&P Cardinality Updates ....................................................................... 523
Table 315: Consultation Note Cardinality Updates ................................................... 523
Table 316: Discharge Summary Cardinality Updates ............................................... 524
Table 317: Surgical Operative Codes Mapping to Generic Procedure Codes............... 524
Table 318: Consolidated Conformance Verb Matrix .................................................. 525
Table 319: Section Template Change Tracking ......................................................... 527
Table 320: Entry Change Tracking Table ................................................................. 535
Table 321: Result Section Changes .......................................................................... 539
Table 322: Problems Section Changes ..................................................................... 540
Table 323: Vital Signs Section Changes ................................................................... 543
Table 324: Procedures Section Changes .................................................................. 545
Table 325: Medications Section Changes ................................................................. 548
Table 326: Template Ids Alphabetically by Template Type ........................................ 557
Table 327: Code Systems in This Guide ................................................................... 563
Table 328: Value Sets in This Guide ........................................................................ 565
Table 329: Single-Value Bindings in This Guide....................................................... 568
Table 330: Comparison of XDS-SD and Clinical Document Header .......................... 571

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2

INTRODUCTION

2.1

Audience
The audiences for this implementation guide are the architects and developers of
healthcare information technology (HIT) systems in the US Realm that exchange
patient clinical data. This includes those exchanges that comply to the Health
Information Technology for Economic and Clinical Health (HITECH) provisions of
the American Recovery And Reinvestment Act of 2009, the Final Rules for Stage
1 Meaningful Use, and the 45 CFR Part 170 – Health Information Technology:
Initial Set of Standards, Implementation Specifications, and Certification Criteria
for Electronic Health Record Technology; Final Rule.1
Business analysts and policy managers can also benefit from a basic
understanding of the use of Clinical Document Architecture (CDA) templates
across multiple implementation use cases.

2.2

Purpose
This guide contains a library of CDA templates, incorporating and harmonizing
previous efforts from Health Level Seven (HL7), Integrating the Healthcare
Enterprise (IHE), and Health Information Technology Standards Panel (HITSP). It
represents harmonization of the HL7 Health Story guides, HITSP C32, related
components of IHE Patient Care Coordination (IHE PCC), and Continuity of Care
(CCD), and it includes all required CDA templates in Final Rules for Stage 1
Meaningful Use and 45 CFR Part 170 – Health Information Technology: Initial
Set of Standards, Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology; Final Rule.
This guide is a single source for implementing the following CDA documents (see
the References section for complete source listings):
Continuity of Care Document (CCD) (Release 1.1)
Consultation Notes (Release 1.1)
Discharge Summary (Release 1.1)
Imaging Integration, and DICOM Diagnostic Imaging Reports (DIR) (US
Realm - Release 1)
History and Physical (H&P) (Release 1.1)
Operative Note (Release 1.1)
Progress Note (Release 1.1)
Procedure Note (US Realm – Release 1)
Unstructured Documents (Release 1.1)

Many aspects of this guide were designed to meet the anticipated clinical document exchange
requirements of Stage 2 Meaningful Use. At the time of this publication, Stage 2 Meaningful Use
has not been published.
1

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The release 1.1 documents supersede existing release 1 publications. Procedure
Note and DIR are designated as release 1 because this guide is the first US
Realm release of these standards. The existing, separate Procedure Note and DIR
universal-realm guides are still valid for outside the US.

2.3

Scope
This document is scoped by the content of the eight Health Story Guides, CCD,
and additional constraints from IHE and HITSP. New conformance rules were
not introduced unless an ambiguity or conflict existed among the standards.
All CDA templates required for Final Rules for Stage 1 Meaningful Use2 are
included in this guide. All CDA templates required for Health Story compliance
to the section level are included, as well, of course, as the Health Story reuse of
Stage 1 Meaningful Use templates.
This guide fully specifies a compliant CDA R2 document for each document
type.
Additional optional CDA elements, not included here, can be included and the
result will be compliant with the documents in this standard.

2.4

Approach
In the development of this specification, the Consolidation Project team reviewed
the eight existing HL7 Health Story guides, CCD, and the additional constraints
from IHE, HITSP and Stage 1 Meaningful Use.
The Consolidation Project team members completed the analysis by creating a
fully compliant CCD document, then layering in the additional HITSP, IHE and
Stage 1 Meaningful Use constraints. When a new constraint introduced an
issue, conflict or ambiguity, the item was flagged for review with the full
consolidation team. The full analysis covered the CDA Header, section-level and
entry-level requirements sufficient for Stage 1 Meaningful Use. The Project also
reviewed document and section-level requirements for the full set of document
types.
All major template changes are summarized in the Change Appendix
All involved in the Consolidation Project recognize the critical need for an
intrinsic tie between the human-readable conformance requirements, the
computable expression of those requirements, the production of validation test
suites and application interfaces to facilitate adoption. To that end, the analysis
performed by the volunteers and staff of the Consolidation Project was the
prelude to data entry into a set of model-based tools.
Conformance requirements and value set tables published here are output from
the Template Database (Tdb), an open-source application first developed for the
Centers for Disease Control and Prevention and in active use by the National

http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf
Many aspects of this guide were designed to meet the anticipated clinical document exchange
requirements of Stage 2 Meaningful Use, which had not been released when this guide was
published
2

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Healthcare Safety Network3. The Tdb is the source for generation of platformindependent validation rules as Schematron 4 (compiled XPath). The Tdb is
available as the Trifolia Workbench (Consolidation Project Edition) on the HL7
website5.
The consolidation of templates developed across these organizations and their
publication in catalog form driven from model-based tools is a strong step
toward satisfying the full range of requirements for clinical information use and
reuse through templated CDA.

2.5

Organization of This Guide
This guide includes a set of CDA Templates and prescribes their use for a set of
specific document types. The main chapters are:
Chapter 2. General Header Template. This chapter defines a template for the
header constraints that apply across all of the consolidated document types.
Chapter 3. Document-Level Templates. This chapter defines each of the nine
document types. It defines header constraints specific to each and the sectionlevel templates (required and optional) for each.
Chapter 4. Section-Level Templates. This chapter defines the section templates
referenced within the document types described here. Sections are atomic units,
and can be reused by future specifications.
Chapter 5. Entry-Level Templates. This chapter defines entry-level templates,
called clinical statements. Machine processable data are sent in the entry
templates. The entry templates are referenced by one or more section templates.
Entry-level templates are always contained in section-level templates, and
section-level templates are always contained in a document.
Appendices. The Appendices include non-normative content to support
implementers. It includes a Change Appendix summary of previous and updated
templates.

2.6

Use of Templates
Template identifiers (templateId) are assigned at the document, section, and
entry level. When valued in an instance, the template identifier signals the
imposition of a set of template-defined constraints. The value of this attribute
(e.g. @root="2.16.840.1.113883.10.20.22.4.8") provides a unique identifier
for the template in question.
If a template is a specialization of another template, its first constraint indicates
the more general template. The general template is not always required. In all
cases where a more specific template conforms to a more general template,

http://www.lantanagroup.com/resources/tools/
http://www.schematron.com/
5 http://www.lantanagroup.com/newsroom/press-releases/trifolia-workbench/
You must be logged in as a member of HL7.org to access this resource:
http://www.hl7.org/login/singlesignon.cfm?next=/documentcenter/private/standards/cda/Trifo
lia_HL7_Consolidation_20110712-dist.zip
3
4

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asserting the more specific template also implies conformance to the more
general template.

2.6.1 Originator Responsibilities: General Case
An originator can apply a templateId if there is a desire to assert conformance
with a particular template.
In the most general forms of CDA exchange, an originator need not apply a
templateId for every template that an object in an instance document conforms
to. The implementation guide (IG) shall assert whenever templateIds are
required for conformance.

2.6.2 Recipient Responsibilities: General Case
A recipient may reject an instance that does not contain a particular
templateId (e.g., a recipient looking to receive only Procedure Note documents
can reject an instance without the appropriate templateId).
A recipient may process objects in an instance document that do not contain a
templateId (e.g., a recipient can process entries that contain Observation acts
within a Problems section, even if the entries do not have templateIds).

2.7

Levels of Constraint
The CDA standard describes conformance requirements in terms of three
general levels corresponding to three different, incremental types of conformance
statements:
Level 1 requirements impose constraints upon the CDA Header. The body
of a Level 1 document may be XML or an alternate allowed format. If
XML, it must be CDA-conformant markup.
Level 2 requirements specify constraints at the section level of a CDA
XML document: most critically, the section code and the cardinality of
the sections themselves, whether optional or required.
Level 3 requirements specify constraints at the entry level within a
section. A specification is considered “Level 3” if it requires any entrylevel templates.
Note that these levels are rough indications of what a recipient can expect in
terms of machine-processable coding and content reuse. They do not reflect the
level or type of clinical content, and many additional levels of reusability could
be defined.
In this consolidated guide, Unstructured Documents, by definition, are Level 1.
Stage 1 Meaningful Use of CCD requires certain entries and is therefore a Level
3 requirement. The balance of the document types can be implemented at any
level.
In all cases, required clinical content must be present. For example, a CDA
Procedure Note carrying the templateId that asserts conformance with Level 1
may use a PDF (portable document format) or HTML (hypertext markup

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language) format for the body of the document that contains the required
clinical content. Conformance, in this case, to the clinical content requirements
could not be validated without human review.
The section libraries for each document type list the required and optional
sections.

2.8

Conformance Conventions Used in This Guide

2.8.1 Templates and Conformance Statements
Conformance statements within this implementation guide are presented as
constraints from a Template Database (Tdb). An algorithm converts constraints
recorded in a Templates Database to a printable presentation. Each constraint is
uniquely identified by an identifier at or near the end of the constraint (e.g.,
CONF:7345). These identifiers are persistent but not sequential.
Bracketed information following each template title indicates the template type
(section, observation, act, procedure, etc.), the templateId, and whether the
template is open or closed.
Each section and entry template in the guide includes a context table. The "Used
By" column indicates which documents or sections use this template, and the
"Contains Entries" column indicates any entries that the template uses. Each
entry template also includes a constraint overview table to summarize the
constraints following the table.
The following figure shows a typical template explanation presented in this
guide. The next sections describe specific aspects of conformance statements—
open vs. closed statements, conformance verbs, cardinality, vocabulary
conformance, containment relationships, and null flavors.

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Figure 1: Constraints format example

Severity Observation
[observation: templateId 2.16.840.1.113883.10.20.22.4.8(open)]
Table xxx: Severity Observation Contexts
Used By:

Contains Entries:

Reaction Observation
Allergy - Intolerance Observation

This clinical statement represents the severity of the reaction to an agent. A
person may manifest many symptoms …
Table yyy: Severity Observation Contexts
Name

XPath

Green
Severity
Observation

observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.8']

severity
Coded

Verb

Data
Type

CONF#

Fixed Value

@classCode

1..1

SHALL

7345

2.16.840.1.113883.5.6
(HL7ActClass) = OBS

@moodCode

1..1

SHALL

7346

2.16.840.1.113883.5.1001
(ActMood) = EVN

templateId

1..1

SHALL

1..1

SHALL

code

1..1

SHALL

text

0..1

SHOULD

reference
/@value

0..1

SHOULD

statusCode

1..1

SHALL

CS

7352

2.16.840.1.113883.5.14 (ActStatus)
= completed

value

1..1

SHALL

CD

7356

2.16.840.1.113883.3.88.12.3221.6.8
(Problem Severity)

0..*

SHOULD

CE

9117

0..1

SHOULD

CE

9118

@root

severity
FreeText

Card.

interpretation
Code
code

SET

7347
10525

2.16.840.1.113883.10.20.22.4.8

CE

7349

2.16.840.1.113883.5.4 (ActCode) =
SEV

ED

7350
7351

2.16.840.1.113883.1.11.78
(Observation Interpretation (HL7))

1. SHALL contain exactly one [1..1] @classCode="OBS" Observation
(CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7345).
2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem:
ActMood 2.16.840.1.113883.5.1001) (CONF:7346).
3. SHALL contain exactly one [1..1] templateId (CONF:7347) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.4.8" (CONF:10525).
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4. SHALL contain exactly one [1..1] code with @xsi:type="CE"="SEV" Severity
Observation (CodeSystem: ActCode 2.16.840.1.113883.5.4)
(CONF:7349).
5. SHOULD contain zero or one [0..1] text (CONF:7350).
a. The text, if present, SHOULD contain zero or one [0..1]
reference/@value (CONF:7351).
i.

This reference/@value SHALL begin with a '#' and SHALL point
to its corresponding narrative (using the approach defined in
CDA Release 2, section 4.3.5.1) (CONF:7378).

6. SHALL contain exactly one [1..1] statusCode="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:7352).
7. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code
SHALL be selected from ValueSet Problem Severity
2.16.840.1.113883.3.88.12.3221.6.8 DYNAMIC (CONF:7356).
8. SHOULD contain zero or more [0..*] interpretationCode (CONF:9117).
a. The interpretationCode, if present, SHOULD contain zero or one [0..1]
code with @xsi:type="CE", where the @code SHOULD be selected from
ValueSet Observation Interpretation (HL7)
2.16.840.1.113883.1.11.78 DYNAMIC (CONF:9118).

2.8.2 Open and Closed Templates
In open templates, all of the features of the CDA R2 base specification are
allowed except as constrained by the templates. By contrast, a closed template
specifies everything that is allowed and nothing further may be included.
Estimated Date of Delivery (templateId 2.16.840.1.113883.10.20.15.3.1) is
an example of a closed template in this guide.
Open templates allow HL7 implementers to develop additional structured
content not constrained within this guide. HL7 encourages implementers to
bring their use cases forward as candidate requirements to be formalized in a
subsequent version of the standard to maximize the use of shared semantics.

2.8.3 Conformance Verbs (Keywords)
The keywords SHALL, SHOULD, MAY, NEED NOT, SHOULD NOT, and SHALL NOT in this
document are to be interpreted as described in the HL7 Version 3 Publishing
Facilitator's Guide (http://www.hl7.org/v3ballot/html/help/pfg/pfg.htm):
SHALL:

an absolute requirement

SHALL NOT:

an absolute prohibition against inclusion

SHOULD/SHOULD NOT:

best practice or recommendation. There may be
valid reasons to ignore an item, but the full implications must be
understood and carefully weighed before choosing a different course

MAY/NEED NOT:

truly optional; can be included or omitted as the author
decides with no implications

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The keyword "SHALL" allows the use of nullFlavor unless the requirement is on
an attribute or the use of nullFlavor is explicitly precluded.
The Consolidated Conformance Verb Matrix table represents a matrix of the
conformance verbs used across the standards reviewed for the consolidation
guide.
The subject of a conformance verb (keyword) in a top-level constraint is the
template itself; for example, the subject of CONF:5249 is the ClinicalDocument
element. In nested constraints, the subject is the element in the containing
constraint. Top-level constraints are those that begin with a number and are not
indented.

2.8.4 Cardinality
The cardinality indicator (0..1, 1..1, 1..*, etc.) specifies the allowable occurrences
within a document instance. The cardinality indicators are interpreted with the
following format “m…n” where m represents the least and n the most:
0..1 zero or one
1..1 exactly one
1..* at least one
0..* zero or more
1..n at least one and not more than n
When a constraint has subordinate clauses, the scope of the cardinality of the
parent constraint must be clear. In the next figure, the constraint says exactly
one participant is to be present. The subordinate constraint specifies some
additional characteristics of that participant.
Figure 2: Constraints format – only one allowed
1. SHALL contain exactly one [1..1] participant (CONF:2777).
a. This participant SHALL contain exactly one [1..1] @typeCode="LOC"
(CodeSystem: 2.16.840.1.113883.5.90 HL7ParticipationType)
(CONF:2230).

In the next figure, the constraint says only one participant “like this” is to be
present. Other participant elements are not precluded by this constraint.
Figure 3: Constraints format – only one like this allowed
1. SHALL contain exactly one [1..1] participant (CONF:2777) such that it
a. SHALL contain exactly one [1..1] @typeCode="LOC" (CodeSystem:
2.16.840.1.113883.5.90 HL7ParticipationType) (CONF:2230).

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2.8.5 Optional and Required with Cardinality
The terms optional and required describe the lower bound of cardinality as
follows:
Optional means that the number of allowable occurrences of an element may be
0; the cardinality will be expressed as [0..1] or [0..*] or similar. In these
cases, the element may not be present in the instance.
Required means that the number of allowable occurrences of an element must
be at least 1; the cardinality will be expressed as [m..n] where m >=1 and n
>=1 for example [1..1] or [1..*].. In these cases, the element must be
present in the instance. If an element is required, but is not known (and would
otherwise be omitted if it were optional), it must be represented by a nullFlavor.

2.8.6 Vocabulary Conformance
The templates in this document use terms from several code systems. These
vocabularies are defined in various supporting specifications and may be
maintained by other bodies, as is the case for the LOINC® and SNOMED CT®
vocabularies.
Note that value-set identifiers (e.g., ValueSet 2.16.840.1.113883.1.11.78
Observation Interpretation (HL7) DYNAMIC) do not appear in CDA
submissions; they tie the conformance requirements of an implementation guide
to the appropriate code system for validation.
Value-set bindings adhere to HL7 Vocabulary Working Group best practices,
and include both a conformance verb (SHALL, SHOULD, MAY, etc.) and an
indication of DYNAMIC vs. STATIC binding. Value-set constraints can be STATIC,
meaning that they are bound to a specified version of a value set, or DYNAMIC,
meaning that they are bound to the most current version of the value set. A
simplified constraint, used when the binding is to a single code, includes the
meaning of the code, as follows.
Figure 4: Binding to a single code

contain exactly one [1..1] code (CONF:15407).
a. This code SHALL contain exactly one [1..1] @code="11450-4" Problem

... SHALL

List

(CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15408) .

The notation conveys the actual code (11450-4), the code’s displayName
(Problem List), the OID of the codeSystem from which the code is drawn
(2.16.840.1.113883.6.1), and the codeSystemName (LOINC).
HL7 Data Types Release 1 requires the codeSystem attribute unless the
underlying data type is “Coded Simple” or “CS”, in which case it is prohibited.
The displayName and the codeSystemName are optional, but recommended, in
all cases.

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The above example would be properly expressed as follows.
Figure 5: XML expression of a single-code binding




A full discussion of the representation of vocabulary is outside the scope of this
document; for more information, see the HL7 V3 Normative Edition 2010 6
sections on Abstract Data Types and XML Data Types R1.
There is a discrepancy in the implementation of translation code versus the
original code between HL7 Data Types R1 and the convention agreed upon for
this specification. The R1 data type requires the original code in the root. This
implementation guide specifies the standard code in the root, whether it is
original or a translation. This discrepancy is resolved in HL7 Data Types R2.
Figure 6: Translation code example




2.8.7 Containment Relationships
Containment constraints between a section and its entry are indirect in this
guide, meaning that where a section asserts containment of an entry, that entry
can either be a direct child or a further descendent of that section.
For example, in the following constraint:
1. SHALL contain at least one [1..*] entry (CONF:8647) such that it
a. SHALL contain exactly one [1..1] Advance Directive Observation
(templateId:2.16.840.1.113883.10.20.22.4.48) (CONF:8801).
the Advance Directive Observation can be a direct child of the section (i.e.,
section/entry/AdvanceDirectiveObservation) or a further descendent of
that section (i.e., section/entry/…/AdvanceDirectiveObservation). Either of
these are conformant.

HL7 Version 3 Interoperability Standards, Normative Edition 2010.
http://www.hl7.org/memonly/downloads/v3edition.cfm - V32010
6

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All other containment relationships are direct, for example:
1. SHALL contain exactly one [1..1]
templateId/@root="2.16.840.1.113883.10.20.22.2.21" (CONF:7928).
The templateId must be a direct child of the section (i.e., section/templateId).

2.8.8 Null Flavor
Information technology solutions store and manage data, but sometimes data
are not available: an item may be unknown, not relevant, or not computable or
measureable. In HL7, a flavor of null, or nullFlavor, describes the reason for
missing data.
For example, if a patient arrives at an Emergency Department unconscious and
with no identification, we would use a null flavor to represent the lack of
information. The patient’s birth date would be represented with a null flavor of
“NAV”, which is the code for “temporarily unavailable”. When the patient regains
consciousness or a relative arrives, we expect to know the patient’s birth date.
Figure 7: nullFlavor example




Use null flavors for unknown, required, or optional attributes:
NI

No information. This is the most general and default null flavor.

NA

Not applicable. Known to have no proper value (e.g., last
menstrual period for a male).

UNK

Unknown. A proper value is applicable, but is not known.

ASKU

Asked, but not known. Information was sought, but not found
(e.g., the patient was asked but did not know).

NAV

Temporarily unavailable. The information is not available, but
is expected to be available later.

NASK

Not asked. The patient was not asked.

MSK

There is information on this item available but it has not been
provided by the sender due to security, privacy, or other
reasons. There may be an alternate mechanism for gaining
access to this information.

This above list contains those null flavors that are commonly used in clinical
documents. For the full list and descriptions, see the nullFlavor vocabulary
domain in the CDA normative edition7.
Any SHALL conformance statement may use nullFlavor, unless the attribute is
required or the nullFlavor is explicitly disallowed. SHOULD and MAY
conformance statement may also use nullFlavor.

HL7 Clinical Document Architecture (CDA Release 2)
http://www.hl7.org/implement/standards/cda.cfm
7

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Figure 8: Attribute required

contain exactly one [1..1] code (CONF:15407).
a. This code SHALL contain exactly one [1..1] @code="11450-4" Problem

1. SHALL

List

(CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15408) .

or
2. SHALL contain exactly one [1..1] effectiveTime/@value (CONF:5256).

Figure 9: Allowed nullFlavors when element is required (with xml examples)
1. SHALL contain at least one [1..*] id
2. SHALL contain exactly one [1..1] code
3. SHALL contain exactly one [1..1] effectiveTime




New Grading system




Spiculated mass grade 5




Figure 10: nullFlavor explicitly disallowed
1. SHALL contain exactly one [1..1] effectiveTime (CONF:5256).
a. SHALL NOT contain [0..0] nullFlavor (CONF:52580).

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2.8.9 Unknown Information
If a sender wants to state that a piece of information is unknown, the following
principles apply:
1. If the sender doesn’t know an attribute of an act, that attribute can be
null.
Figure 11: Unknown medication example

patient was given a medication but I do not know what it
was











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2. If the sender doesn’t know if an act occurred, the nullFlavor is on the
act (detail could include specific allergy, drug, etc.).
Figure 12: Unknown medication use of anticoagulant drug example


I do not know whether or not patient received an anticoagulant
drug










3. If the sender wants to state ‘no known’, a negationInd can be used on
the corresponding act (substanceAdministration, Procedure, etc.)
Figure 13: No known medications example


No known medications










Previously CCD, IHE, and HITSP recommended using specific codes to assert no
known content, for example 160244002 No known allergies or 160245001 No
current problems or disability. Specific codes are still allowed; however,
use of these codes is not recommended.

2.8.10 Data Types
All data types used in a CDA document are described in the CDA R2 normative
edition8. All attributes of a data type are allowed unless explicitly prohibited by
this specification.

HL7 Clinical Document Architecture (CDA Release 2).
http://www.hl7.org/implement/standards/cda.cfm
8

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2.9

XML Conventions Used in This Guide

2.9.1 XPath Notation
Instead of the traditional dotted notation used by HL7 to represent Reference
Information Model (RIM) classes, this document uses XML Path Language
(XPath) notation9 in conformance statements and elsewhere to identify the
Extended Markup Language (XML) elements and attributes within the CDA
document instance to which various constraints are applied. The implicit
context of these expressions is the root of the document. This notation provides
a mechanism that will be familiar to developers for identifying parts of an XML
document.
XPath statements appear in this document in a monospace font.
XPath syntax selects nodes from an XML document using a path containing the
context of the node(s). The path is constructed from node names and attribute
names (prefixed by a ‘@’) and catenated with a ‘/’ symbol.
Figure 14: XML document example


...

...



In the above example, the code attribute of the code could be selected with the
XPath expression in the next figure.
Figure 15: XPath expression example
author/assignedAuthor/code/@code

2.9.2 XML Examples and Sample Documents
Extended Mark-up Language (XML) examples appear in figures in this document
in this monospace font. Portions of the XML content may be omitted from the
content for brevity, marked by an ellipsis (...) as shown in the example below.
Figure 16: ClinicalDocument example

...


Within the narrative, XML element (code, assignedAuthor, etc.) and attribute
(SNOMED CT, 17561000, etc.) names also appear in this monospace font.

9

http://www.w3.org/TR/xpath/

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This publication package includes complete sample documents as listed in the
Content of the Package table below. These documents conform to the Level 1,
Level 2, and Level 3 constraints of this guide (see the Levels of Constraint
section).

2.10 UML Diagrams
Some sections may include a Unified Modeling Language (UML) class diagram to
provide further clarification. For example, a class diagram might describe the
generalization-specialization hierarchy of Act classes (see the Results section
UML Diagram figure.) The UML diagrams were output from the Model-Driven
Health Tools (MDHT) developed under the auspices of the Veterans
Administration and IBM with assistance from the ONC Standards &
Interoperability Framework10.

2.11 Content of the Package
The following files comprise the package:
Table 1: Content of the Package

10

Filename

Description

Standards
Applicability

CDAR2_IG_IHE_CONSOL_R1_U1_2012MAY

Implementation Guide

Normative

Consults.sample.xml

Consultation Note

Informative

DIR.sample.xml

Diagnostic Imaging Report

Informative

CCD.sample.xml

Continuity of Care
Document/C32

Informative

DS.sample.xml

Discharge Summary Report

Informative

HandP.sample.xml

History and Physical Report

Informative

OpNote.sample.xml

Operative Note

Informative

Procedure_Note.sample.xml

Procedure Note

Informative

Progress_Note.sample.xml

Progress Note

Informative

UD.sample.xml

Unstructured Document

Informative

cda.xsl

CDA stylesheet

Informative

Discharge_Summary_cda.xsl

Adds discharge disposition
to cda.xsl header

Informative

Consolidated CCD template hierarchy

Hierarchy of CCD sections
and entries

Informative

CDA_Schema_Files (folder)

Updated schema to validate
extensions to CDA R2
introduced in this guide

Informative

http://www.openhealthtools.org/charter/Charter-ModelingToolsForHealthcare.pdf

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3

GENERAL HEADER TEMPLATE
This template describes constraints that apply to the header for all documents
within the scope of this implementation guide. Header constraints specific to
each document type are described in the appropriate document-specific section
below.

3.1

Document Type Codes
CDA R2 states that LOINC is the preferred vocabulary for document type codes,
which specify the type of document being exchanged (e.g., History and Physical).
Each document type in this guide recommends a single preferred
clinicalDocument/code, with further specification provided by author or
performer, setting, or specialty.

3.2

US Realm Header
[ClinicalDocument: templateId
2.16.840.1.113883.10.20.22.1.1(open)]
1. SHALL contain exactly one [1..1] realmCode="US" (CONF:16791).
2. SHALL contain exactly one [1..1] typeId (CONF:5361).
a. This typeId SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.1.3" (CONF:5250).
b. This typeId SHALL contain exactly one [1..1]
@extension="POCD_HD000040" (CONF:5251).
3. SHALL contain exactly one [1..1] templateId (CONF:5252) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.1" (CONF:10036).
4. SHALL contain exactly one [1..1] id (CONF:5363).
a. This id SHALL be a globally unique identifier for the document
(CONF:9991).
5. SHALL contain exactly one [1..1] code (CONF:5253).
a. This code SHALL specify the particular kind of document (e.g. History
and Physical, Discharge Summary, Progress Note) (CONF:9992).
6. SHALL contain exactly one [1..1] title (CONF:5254).
a. Can either be a locally defined name or the display name
corresponding to clinicalDocument/code (CONF:5255).
7. SHALL contain exactly one [1..1] effectiveTime (CONF:5256).
a. The content SHALL be a conformant US Realm Date and Time
(DTM.US.FIELDED) (2.16.840.1.113883.10.20.22.5.4) (CONF:16865).
8. SHALL contain exactly one [1..1] confidentialityCode, which SHOULD be
selected from ValueSet HL7 BasicConfidentialityKind
2.16.840.1.113883.1.11.16926 STATIC 2010-04-21 (CONF:5259).

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9. SHALL contain exactly one [1..1] languageCode, which SHALL be selected from
ValueSet Language 2.16.840.1.113883.1.11.11526 DYNAMIC
(CONF:5372).
10. MAY contain zero or one [0..1] setId (CONF:5261).
a. If setId is present versionNumber SHALL be present (CONF:6380). 11
11. MAY contain zero or one [0..1] versionNumber (CONF:5264).
a. If versionNumber is present setId SHALL be present (CONF:6387). 12
Table 2: Basic Confidentiality Kind Value Set
Value Set: HL7 BasicConfidentialityKind 2.16.840.1.113883.1.11.16926 STATIC 2010-04-21
Code System(s): Confidentiality Code 2.16.840.1.113883.5.25
Code

Code System

Print Name

N

Confidentiality Code

Normal

R

Confidentiality Code

Restricted

V

Confidentiality Code

Very Restricted

Table 3: Language Value Set (excerpt)
Value Set: Language 2.16.840.1.113883.1.11.11526 DYNAMIC
Code System(s): Internet Society Language 2.16.840.1.113883.1.11.11526
Description:

A value set of codes defined by Internet RFC 4646 (replacing RFC 3066).
Please see ISO 639 language code set maintained by Library of Congress for
enumeration of language codes
http://www.ietf.org/rfc/rfc4646.txt

Code

Code System

Print Name

en

Internet Society Language

english

fr

Internet Society Language

french

ar

Internet Society Language

arabic

en-US

Internet Society Language

English, US

es-US

Internet Society Language

Spanish, US

…

From CDA Normative Web edition: 4.2.1.7 ClinicalDocument.setId - Represents an identifier
that is common across all document revisions and “Document Identification, Revisions, and
Addenda” under 4.2.3.1 ParentDocument
12 From CDA Normative Web edition: 4.2.1.8 ClinicalDocument.versionNumber An integer value
used to version successive replacement documents
11

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Figure 17: US Realm header example








Good Health History & Physical






Figure 18: effectiveTime with time zone example




3.2.1 RecordTarget
The recordTarget records the patient whose health information is described by
the clinical document; each recordTarget must contain at least one
patientRole element.
12. SHALL contain at least one [1..*] recordTarget (CONF:5266).
a. Such recordTargets SHALL contain exactly one [1..1] patientRole
(CONF:5267).
i.

This patientRole SHALL contain at least one [1..*] id
(CONF:5268).

ii. This patientRole SHALL contain at least one [1..*] addr
(CONF:5271).
1. The content of addr SHALL be a conformant US Realm
Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2) (CONF:10412).

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iii. This patientRole SHALL contain at least one [1..*] telecom
(CONF:5280).
1. Such telecoms SHOULD contain exactly one [1..1] @use,
which SHALL be selected from ValueSet Telecom Use
(US Realm Header)
2.16.840.1.113883.11.20.9.20 DYNAMIC
(CONF:5375).

3.2.1.1 Patient
iv. This patientRole SHALL contain exactly one [1..1] patient
(CONF:5283).
1. This patient SHALL contain exactly one [1..1] name
(CONF:5284).
a. The content of name SHALL be a conformant US
Realm Patient Name (PTN.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.1)
(CONF:10411).
2. This patient SHALL contain exactly one [1..1]
administrativeGenderCode, which SHALL be selected
from ValueSet Administrative Gender (HL7 V3)
2.16.840.1.113883.1.11.1 DYNAMIC (CONF:6394).
3. This patient SHALL contain exactly one [1..1]
birthTime (CONF:5298).
a. SHALL be precise to year (CONF:5299).
b. SHOULD be precise to day (CONF:5300).
4. This patient SHOULD contain zero or one [0..1]
maritalStatusCode, which SHALL be selected from
ValueSet HL7 MaritalStatus
2.16.840.1.113883.1.11.12212 DYNAMIC
(CONF:5303).
5. This patient MAY contain zero or one [0..1]
religiousAffiliationCode, which SHALL be selected
from ValueSet HL7 Religious Affiliation
2.16.840.1.113883.1.11.19185 DYNAMIC
(CONF:5317).
6. This patient MAY contain zero or one [0..1] raceCode,
which SHALL be selected from ValueSet Race
2.16.840.1.113883.1.11.14914 DYNAMIC
(CONF:5322).
7. This patient MAY contain zero or more [0..*]
sdwg:raceCode, where the @code SHALL be selected
from ValueSet Race 2.16.840.1.113883.1.11.14914
DYNAMIC (CONF:7263).
8. This patient MAY contain zero or one [0..1]
ethnicGroupCode, which SHALL be selected from
ValueSet Ethnicity Value

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2.16.840.1.114222.4.11.837 DYNAMIC
(CONF:5323).

3.2.1.2 Guardian
9. This patient MAY contain zero or more [0..*] guardian
(CONF:5325).
a. The guardian, if present, SHOULD contain zero
or one [0..1] code, which SHALL be selected
from ValueSet Personal Relationship Role
Type 2.16.840.1.113883.1.11.19563
DYNAMIC (CONF:5326).
b. The guardian, if present, SHOULD contain zero
or more [0..*] addr (CONF:5359).
i.

The content of addr SHALL be a
conformant US Realm Address
(AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2)
(CONF:10413).

c. The guardian, if present, MAY contain zero or
more [0..*] telecom (CONF:5382).
i.

The telecom, if present, SHOULD contain
exactly one [1..1] @use, which SHALL be
selected from ValueSet Telecom Use
(US Realm Header)
2.16.840.1.113883.11.20.9.20
DYNAMIC (CONF:7993).

d. The guardian, if present, SHALL contain exactly
one [1..1] guardianPerson (CONF:5385).
i.

This guardianPerson SHALL contain at
least one [1..*] name (CONF:5386).

1.

The content of name SHALL be a
conformant US Realm Person Name
(PN.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.1.1)
(CONF:10414).

3.2.1.3 Birthplace
10. This patient MAY contain zero or one [0..1] birthplace
(CONF:5395).
a. The birthplace, if present, SHALL contain
exactly one [1..1] place (CONF:5396).
i.

This place SHALL contain exactly one
[1..1] addr (CONF:5397).

1.

This addr SHOULD contain zero or
one [0..1] country, where the @code
SHALL be selected from ValueSet

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CountryValueSet
2.16.840.1.113883.3.88.12.80.63
DYNAMIC (CONF:5404).
2.

This addr MAY contain zero or
one [0..1] postalCode, where the @code
SHALL be selected from ValueSet
PostalCodeValueSet
2.16.840.1.113883.3.88.12.80.2
DYNAMIC (CONF:5403).

3.

If country is US, this addr SHALL
contain exactly one [1..1] state, which
SHALL be selected from ValueSet
2.16.840.1.113883.3.88.12.80.1
StateValueSet DYNAMIC (CONF:5402).

3.2.1.4 LanguageCommunication
11. This patient SHOULD contain zero or more [0..*]
languageCommunication (CONF:5406).
a. The languageCommunication, if present, SHALL
contain exactly one [1..1] languageCode, which
SHALL be selected from ValueSet Language
2.16.840.1.113883.1.11.11526 DYNAMIC
(CONF:5407).
b. The languageCommunication, if present, MAY
contain zero or one [0..1] modeCode, which
SHALL be selected from ValueSet HL7
LanguageAbilityMode
2.16.840.1.113883.1.11.12249 DYNAMIC
(CONF:5409).
c. The languageCommunication, if present,
SHOULD contain zero or one [0..1]
proficiencyLevelCode, which SHALL be
selected from ValueSet
LanguageAbilityProficiency
2.16.840.1.113883.1.11.12199 DYNAMIC
(CONF:9965).
d. The languageCommunication, if present, MAY
contain zero or one [0..1] preferenceInd
(CONF:5414).

3.2.1.5 ProviderOrganization
v. This patientRole MAY contain zero or one [0..1]
providerOrganization (CONF:5416).
1. The providerOrganization, if present, SHALL contain at
least one [1..*] id (CONF:5417).

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a. Such ids SHOULD contain zero or one [0..1]
@root="2.16.840.1.113883.4.6" National
Provider Identifier (CONF:16820).
2. The providerOrganization, if present, SHALL contain at
least one [1..*] name (CONF:5419).
3. The providerOrganization, if present, SHALL contain at
least one [1..*] telecom (CONF:5420).
a. Such telecoms SHOULD contain exactly one
[1..1] @use, which SHALL be selected from
ValueSet Telecom Use (US Realm Header)
2.16.840.1.113883.11.20.9.20 DYNAMIC
(CONF:7994).
4. The providerOrganization, if present, SHALL contain at
least one [1..*] addr (CONF:5422).
a. The content of addr SHALL be a conformant US
Realm Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2)
(CONF:10415).

3.2.1.6 RecordTarget Value Sets
Table 4: Telecom Use (US Realm Header) Value Set
Value Set: Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMIC
Code System(s): AddressUse 2.16.840.1.113883.5.1119
Code

Code System

Print Name

HP

AddressUse

primary home

WP

AddressUse

work place

MC

AddressUse

mobile contact

HV

AddressUse

vacation home

Table 5: Administrative Gender (HL7) Value Set
Value Set: Administrative Gender (HL7 V3) 2.16.840.1.113883.1.11.1 DYNAMIC
Code System(s): AdministrativeGender 2.16.840.1.113883.5.1
Code

Code System

Print Name

F

AdministrativeGender

Female

M

AdministrativeGender

Male

UN

AdministrativeGender

Undifferentiated

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Table 6: Marital Status Value Set
Value Set: HL7 Marital Status 2.16.840.1.113883.1.11.12212 DYNAMIC
Code System(s): MaritalStatus 2.16.840.1.113883.5.2
Code

Code System

Print Name

A

MaritalStatus

Annulled

D

MaritalStatus

Divorced

I

MaritalStatus

Interlocutory

L

MaritalStatus

Legally Separated

M

MaritalStatus

Married

P

MaritalStatus

Polygamous

S

MaritalStatus

Never Married

T

MaritalStatus

Domestic partner

W

MaritalStatus

Widowed

Table 7: Religious Affiliation Value Set (excerpt)
Value Set: HL7 Religious Affiliation 2.16.840.1.113883.1.11.19185 DYNAMIC
Code System(s): ReligiousAffiliation 2.16.840.1.113883.5.1076
Description:

A value set of codes that reflect spiritual faith affiliation
http://www.hl7.org/memonly/downloads/v3edition.cfm#V32008

Code

Code System

Print Name

1026

ReligiousAffiliation

Judaism

1020

ReligiousAffiliation

Hinduism

1041

ReligiousAffiliation

Roman Catholic Church

…

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Table 8: Race Value Set (excerpt)
Value Set: Race 2.16.840.1.113883.1.11.14914 DYNAMIC
Code System(s): Race and Ethnicity - CDC 2.16.840.1.113883.6.238
Description:

A Value Set of codes for Classifying data based upon race.
Race is always reported at the discretion of the person for whom this attribute
is reported, and reporting must be completed according to Federal guidelines
for race reporting. Any code descending from the Race concept (1000-9) in
that terminology may be used in the exchange
http://phinvads.cdc.gov/vads/ViewCodeSystemConcept.action?oid=2.16.840.
1.113883.6.238&code=1000-9

Code

Code System

Print Name

1002-5

Race and Ethnicity- CDC

American Indian or Alaska Native

2028-9

Race and Ethnicity- CDC

Asian

2054-5

Race and Ethnicity- CDC

Black or African American

2076-8

Race and Ethnicity- CDC

Native Hawaiian or Other Pacific
Islander

2106-3

Race and Ethnicity- CDC

White

...

Table 9: Ethnicity Value Set
Value Set: Ethnicity Value Set 2.16.840.1.114222.4.11.837 DYNAMIC
Code System(s): Race and Ethnicity - CDC 2.16.840.1.113883.6.238
Code

Code System

Print Name

2135-2

Race and Ethnicity Code Sets

Hispanic or Latino

2186-5

Race and Ethnicity Code Sets

Not Hispanic or Latino

Table 10: Personal Relationship Role Type Value Set (excerpt)
Value Set: Personal Relationship Role Type 2.16.840.1.113883.1.11.19563 DYNAMIC
Code System(s): RoleCode 2.16.840.1.113883.5.111
Description:

A Personal Relationship records the role of a person in relation to another
person. This value set is to be used when recording the relationships between
different people who are not necessarily related by family ties, but also
includes family relationships.
http://www.hl7.org/memonly/downloads/v3edition.cfm#V32008

Code

Code System

Print Name

HUSB

RoleCode

husband

WIFE

RoleCode

wife

FRND

RoleCode

friend

SISINLAW

RoleCode

sister-in-law

…

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Table 11: State Value Set (excerpt)
Value Set: StateValueSet 2.16.840.1.113883.3.88.12.80.1 DYNAMIC
Code System(s): FIPS 5-2 (State) 2.16.840.1.113883.6.92
Description:

Codes for the Identification of the States, the District of Columbia and the
Outlying Areas of the United States, and Associated Areas Publication # 5-2,
May, 1987
http://www.itl.nist.gov/fipspubs/fip5-2.htm

Code

Code System

Print Name

AL

FIPS 5-2 (State Alpha Codes)

Alabama

AK

FIPS 5-2 (State Alpha Codes)

Alaska

AZ

FIPS 5-2 (State Alpha Codes)

Arizona

AR

FIPS 5-2 (State Alpha Codes)

Arkansas

…

Table 12: Postal Code Value Set (excerpt)
Value Set: PostalCodeValueSet 2.16.840.1.113883.3.88.12.80.2 DYNAMIC
Code System(s): US Postal Codes 2.16.840.1.113883.6.231
Description:

A value set of codes postal (ZIP) Code of an address in the United States.
http://zip4.usps.com/zip4/welcome.jsp

Code

Code System

Print Name

19009

US Postal Codes

Bryn Athyn, PA

92869-1736

US Postal Codes

Orange, CA

32830-8413

US Postal Codes

Lake Buena Vista, FL

…

Table 13: Country Value Set (excerpt)
Value Set: CountryValueSet 2.16.840.1.113883.3.88.12.80.63 DYNAMIC
Code System(s): ISO 3166-1 Country Codes: 1.0.3166.1
Description:

A value set of codes for the representation of names of countries, territories
and areas of geographical interest.
Note: This table provides the ISO 3166-1 code elements available in the alpha2 code of ISO's country code standard
http://www.iso.org/iso/country_codes/iso_3166_code_lists.htm

Code

Code System

Print Name

AW

ISO 3166-1 Country Codes

Aruba

IL

ISO 3166-1 Country Codes

Israel

KZ

ISO 3166-1 Country Codes

Kazakhstan

US

ISO 3166-1 Country Codes

United States

…

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Table 14: Language Ability Value Set
Value Set: HL7 LanguageAbilityMode 2.16.840.1.113883.1.11.12249 DYNAMIC
Code System(s): LanguageAbilityMode 2.16.840.1.113883.5.60
Description:

A value representing the method of expression of the language.

Code

Code System

Print Name

ESGN

LanguageAbilityMode

Expressed signed

ESP

LanguageAbilityMode

Expressed spoken

EWR

LanguageAbilityMode

Expressed written

RSGN

LanguageAbilityMode

Received signed

RSP

LanguageAbilityMode

Received spoken

RWR

LanguageAbilityMode

Received written

Table 15: Language Ability Proficiency Value Set
Value Set: LanguageAbilityProficiency 2.16.840.1.113883.1.11.12199 DYNAMIC
Code System(s): LanguageAbilityProficiency 2.16.840.1.113883.5.61
Description:

A value representing the level of proficiency in a language.

Code

Code System

Print Name

E

LanguageAbilityProficiency

Excellent

F

LanguageAbilityProficiency

Fair

G

LanguageAbilityProficiency

Good

P

LanguageAbilityProficiency

Poor

3.2.1.7 RecordTarget Example
Figure 19: recordTarget example











Mr.
Adam
Frankie

Everyman










17 Daws Rd.
Blue Bell
MA
02368
US




Ralph
Relative






MA
02368
US




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Good Health Clinic


21 North Ave
Burlington
MA
02368
US





3.2.2 Author
The author element represents the creator of the clinical document. The author
may be a device, or a person.
13. SHALL contain at least one [1..*] author (CONF:5444).
a. Such authors SHALL contain exactly one [1..1] time (CONF:5445).
i.

The content SHALL be a conformant US Realm Date and Time
(DTM.US.FIELDED) (2.16.840.1.113883.10.20.22.5.4)
(CONF:16866).

b. Such authors SHALL contain exactly one [1..1] assignedAuthor
(CONF:5448).
i.

This assignedAuthor SHALL contain exactly one [1..1] id
(CONF:5449) such that it
1. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.4.6" National Provider
Identifier (CONF:16786).

ii. This assignedAuthor SHOULD contain zero or one [0..1] code
(CONF:16787).
1. The code, if present, SHOULD contain exactly one [1..1]
@code, which SHOULD be selected from ValueSet
Healthcare Provider Taxonomy (NUCC - HIPAA)
2.16.840.1.114222.4.11.1066 DYNAMIC
(CONF:16788).
iii. This assignedAuthor SHALL contain at least one [1..*] addr
(CONF:5452).

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1. The content SHALL be a conformant US Realm Address
(AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2)
(CONF:16871).
iv. This assignedAuthor SHALL contain at least one [1..*] telecom
(CONF:5428).
1. Such telecoms SHOULD contain exactly one [1..1] @use,
which SHALL be selected from ValueSet Telecom Use
(US Realm Header)
2.16.840.1.113883.11.20.9.20 DYNAMIC
(CONF:7995).
v. This assignedAuthor SHOULD contain zero or one [0..1]
assignedPerson (CONF:5430).
1. The assignedPerson, if present, SHALL contain at least
one [1..*] name (CONF:16789).
a. The content SHALL be a conformant US Realm
Person Name (PN.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.1.1)
(CONF:16872).
vi. This assignedAuthor SHOULD contain zero or one [0..1]
assignedAuthoringDevice (CONF:16783).
1. The assignedAuthoringDevice, if present, SHALL
contain exactly one [1..1] manufacturerModelName
(CONF:16784).
2. The assignedAuthoringDevice, if present, SHALL
contain exactly one [1..1] softwareName
(CONF:16785).
vii. There SHALL be exactly one assignedAuthor/assignedPerson or
exactly one assignedAuthor/assignedAuthoringDevice
(CONF:16790).

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Figure 20: Person author example



Figure 21: Device author example



3.2.3 DataEnterer
The dataEnterer element represents the person who transferred the content,
written or dictated by someone else, into the clinical document. The guiding rule
of thumb is that an author provides the content found within the header or
body of the document, subject to their own interpretation, and the dataEnterer
adds that information to the electronic system. In other words, a dataEnterer

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transfers information from one source to another (e.g., transcription from paper
form to electronic system).
14. MAY contain zero or one [0..1] dataEnterer (CONF:5441).
a. The dataEnterer, if present, SHALL contain exactly one [1..1]
assignedEntity (CONF:5442).
i.

This assignedEntity SHALL contain at least one [1..*] id
(CONF:5443).
1. Such ids SHOULD contain zero or one [0..1]
@root="2.16.840.1.113883.4.6" National Provider
Identifier (CONF:16821).

ii. This assignedEntity SHALL contain at least one [1..*] addr
(CONF:5460).
1. The content of addr SHALL be a conformant US Realm
Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2) (CONF:10417).
iii. This assignedEntity SHALL contain at least one [1..*] telecom
(CONF:5466).
1. Such telecoms SHOULD contain exactly one [1..1] @use,
which SHALL be selected from ValueSet Telecom Use
(US Realm Header)
2.16.840.1.113883.11.20.9.20 DYNAMIC
(CONF:7996).
iv. This assignedEntity SHALL contain exactly one [1..1]
assignedPerson (CONF:5469).
1. This assignedPerson SHALL contain at least one [1..*]
name (CONF:5470).
a. The content of name SHALL be a conformant US
Realm Person Name (PN.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.1.1)
(CONF:10418).
v. This assignedEntity MAY contain zero or one [0..1] code which
SHOULD be selected from coding system NUCC Health Care
Provider Taxonomy 2.16.840.1.113883.6.101 (CONF:9944).

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Figure 22: dataEnterer example




21 North Ave.
Burlington
MA
02368
US




Henry
Seven





3.2.4 Informant
The informant element describes the source of the information in a medical
document.
Assigned health care providers may be a source of information when a document
is created. (e.g., a nurse's aide who provides information about a recent
significant health care event that occurred within an acute care facility.) In these
cases, the assignedEntity element is used.
When the informant is a personal relation, that informant is represented in the
relatedEntity element. The code element of the relatedEntity describes the
relationship between the informant and the patient. The relationship between
the informant and the patient needs to be described to help the receiver of
the clinical document understand the information in the document.
15. MAY contain zero or more [0..*] informant (CONF:8001).
a. SHALL contain exactly one [1..1] assignedEntity OR exactly one [1..1]
relatedEntity (CONF:8002).
i.

SHOULD

contain at least one [1..*] addr (CONF:8220).

1. The content of addr SHALL be a conformant US Realm
Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2) (CONF:10419).
ii. SHALL contain exactly one [1..1] assignedPerson OR exactly
one [1..1] relatedPerson (CONF:8221).
1. SHALL contain at least one [1..*] name (CONF:8222).
a. The content of name SHALL be a conformant US
Realm Person Name (PN.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.1.1)
(CONF:10420).
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iii. Ii. This assignedEntity MAY contain zero or one [0..1] code
which SHOULD be selected from coding system NUCC Health
Care Provider Taxonomy 2.16.840.1.113883.6.101
(CONF:9947).
iv. SHOULD contain zero or more [0..*] id (CONF:9945).
1. If assignedEntity/id is a provider then this id, SHOULD
include zero or one [0..1] id where id/@root
="2.16.840.1.113883.4.6" National Provider Identifier
(CONF:9946).
Figure 23: Informant with assignedEntity example




21 North Ave.
Burlington
MA
02368
US




Henry
Seven





3.2.5 Custodian
The custodian element represents the organization that is in charge of
maintaining the document. The custodian is the steward that is entrusted with
the care of the document. Every CDA document has exactly one custodian. The
custodian participation satisfies the CDA definition of Stewardship. Because
CDA is an exchange standard and may not represent the original form of the
authenticated document (e.g., CDA could include scanned copy of original), the
custodian represents the steward of the original source document. The
custodian may be the document originator, a health information exchange, or
other responsible party.
16. SHALL contain exactly one [1..1] custodian (CONF:5519).
a. This custodian SHALL contain exactly one [1..1] assignedCustodian
(CONF:5520).
i.

This assignedCustodian SHALL contain exactly one [1..1]
representedCustodianOrganization (CONF:5521).
1. This representedCustodianOrganization SHALL contain
at least one [1..*] id (CONF:5522).

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a. Such ids SHOULD contain zero or one [0..1]
@root="2.16.840.1.113883.4.6" National
Provider Identifier (CONF:16822).
2. This representedCustodianOrganization SHALL contain
exactly one [1..1] name (CONF:5524).
3. This representedCustodianOrganization SHALL contain
exactly one [1..1] telecom (CONF:5525).
a. This telecom SHOULD contain exactly one [1..1]
@use, which SHALL be selected from ValueSet
Telecom Use (US Realm Header)
2.16.840.1.113883.11.20.9.20 DYNAMIC
(CONF:7998).
4. This representedCustodianOrganization SHALL contain
at least one [1..*] addr (CONF:5559).
a. The content of addr SHALL be a conformant US
Realm Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2)
(CONF:10421).
Figure 24: Custodian example




Good Health Clinic


17 Daws Rd.
Blue Bell
MA
02368
US





3.2.6 InformationRecipient
The informationRecipient element records the intended recipient of the
information at the time the document is created. For example, in cases where
the intended recipient of the document is the patient's health chart, set the
receivedOrganization to be the scoping organization for that chart.
17. MAY contain zero or more [0..*] informationRecipient (CONF:5565).
a. The informationRecipient, if present, SHALL contain exactly one [1..1]
intendedRecipient (CONF:5566).
i.

This intendedRecipient MAY contain zero or one [0..1]
informationRecipient (CONF:5567).

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1. The informationRecipient, if present, SHALL contain at
least one [1..*] name (CONF:5568).
a. The content of name SHALL be a conformant US
Realm Person Name (PN.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.1.1)
(CONF:10427).
ii. This intendedRecipient MAY contain zero or one [0..1]
receivedOrganization (CONF:5577).
1. The receivedOrganization, if present, SHALL contain
exactly one [1..1] name (CONF:5578).
Figure 25: informationRecipient example




Henry
Seven



Good Health Clinic




3.2.7 LegalAuthenticator
The legalAuthenticator identifies the single person legally responsible for the
document and must be present if the document has been legally authenticated.
(Note that per the following section, there may also be one or more document
authenticators.)
Based on local practice, clinical documents may be released before legal
authentication. This implies that a clinical document that does not contain this
element has not been legally authenticated.
The act of legal authentication requires a certain privilege be granted to the legal
authenticator depending upon local policy. All clinical documents have the
potential for legal authentication, given the appropriate credentials.
Local policies MAY choose to delegate the function of legal authentication to a
device or system that generates the clinical document. In these cases, the legal
authenticator is a person accepting responsibility for the document, not the
generating device or system.
Note that the legal authenticator, if present, must be a person.
18. SHOULD contain zero or one [0..1] legalAuthenticator (CONF:5579).
a. The legalAuthenticator, if present, SHALL contain exactly one [1..1]
time (CONF:5580).

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i.

The content SHALL be a conformant US Realm Date and Time
(DTM.US.FIELDED) (2.16.840.1.113883.10.20.22.5.4)
(CONF:16873).

b. The legalAuthenticator, if present, SHALL contain exactly one [1..1]
signatureCode (CONF:5583).
i.

This signatureCode SHALL contain exactly one [1..1]
@code="S" (CodeSystem: Participationsignature
2.16.840.1.113883.5.89) (CONF:5584).

c. The legalAuthenticator, if present, SHALL contain exactly one [1..1]
assignedEntity (CONF:5585).
i.

This assignedEntity SHALL contain at least one [1..*] id
(CONF:5586).
1. Such ids MAY contain zero or one [0..1]
@root="2.16.840.1.113883.4.6" National Provider
Identifier (CONF:16823).

ii.

This assignedEntity MAY contain zero or one [0..1] code,
which SHOULD be selected from ValueSet Healthcare
Provider Taxonomy (NUCC - HIPAA)
2.16.840.1.114222.4.11.1066 (CONF:17000).

iii. This assignedEntity SHALL contain at least one [1..*] addr
(CONF:5589).
1. The content of addr SHALL be a conformant US Realm
Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2) (CONF:10429).
iv. This assignedEntity SHALL contain at least one [1..*] telecom
(CONF:5595).
1. Such telecoms SHOULD contain exactly one [1..1] @use,
which SHALL be selected from ValueSet Telecom Use
(US Realm Header)
2.16.840.1.113883.11.20.9.20 DYNAMIC
(CONF:7999).
v. This assignedEntity SHALL contain exactly one [1..1]
assignedPerson (CONF:5597).
1. This assignedPerson SHALL contain at least one [1..*]
name (CONF:5598).
a. The content of name SHALL be a conformant US
Realm Person Name (PN.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.1.1)
(CONF:10430).

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Figure 26: legalAuthenticator example



3.2.8 Authenticator
The authenticator identifies a participant or participants who attested to the
accuracy of the information in the document.
19. MAY contain zero or more [0..*] authenticator (CONF:5607).
a. The authenticator, if present, SHALL contain exactly one [1..1] time
(CONF:5608).
i.

The content SHALL be a conformant US Realm Date and Time
(DTM.US.FIELDED) (2.16.840.1.113883.10.20.22.5.4)
(CONF:16874).

b. The authenticator, if present, SHALL contain exactly one [1..1]
signatureCode (CONF:5610).
i.

This signatureCode SHALL contain exactly one [1..1]
@code="S" (CodeSystem: Participationsignature
2.16.840.1.113883.5.89) (CONF:5611).

c. The authenticator, if present, SHALL contain exactly one [1..1]
assignedEntity (CONF:5612).
i.

This assignedEntity SHALL contain at least one [1..*] id
(CONF:5613).
1. Such ids SHOULD contain zero or one [0..1]
@root="2.16.840.1.113883.4.6" National Provider
Identifier (CONF:16824).

ii. This assignedEntity MAY contain zero or one [0..1] code
(CONF:16825).
1. The code, if present, MAY contain zero or one [0..1]
@code, which SHOULD be selected from ValueSet
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Healthcare Provider Taxonomy (NUCC - HIPAA)
2.16.840.1.114222.4.11.1066 (CONF:16826).
iii. This assignedEntity SHALL contain at least one [1..*] addr
(CONF:5616).
1. The content of addr SHALL be a conformant US Realm
Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2) (CONF:10425).
iv. This assignedEntity SHALL contain at least one [1..*] telecom
(CONF:5622).
1. Such telecoms SHOULD contain exactly one [1..1] @use,
which SHALL be selected from ValueSet Telecom Use
(US Realm Header)
2.16.840.1.113883.11.20.9.20 DYNAMIC
(CONF:8000).
v. This assignedEntity SHALL contain exactly one [1..1]
assignedPerson (CONF:5624).
1. This assignedPerson SHALL contain at least one [1..*]
name (CONF:5625).
a. The content of name SHALL be a conformant US
Realm Person Name (PN.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.1.1)
(CONF:10424).
Figure 27: Authenticator example



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3.2.9 Participant (Support)
The participant element identifies other supporting participants, including
parents, relatives, caregivers, insurance policyholders, guarantors, and other
participants related in some way to the patient.
A supporting person or organization is an individual or an organization with a
relationship to the patient. A supporting person who is playing multiple roles
would be recorded in multiple participants (e.g., emergency contact and next-ofkin)
20. MAY contain zero or more [0..*] participant (CONF:10003).
a. The participant, if present, MAY contain zero or one [0..1] time
(CONF:10004).
b. Such participants, if present, SHALL have an associatedPerson or
scopingOrganization element under participant/associatedEntity
(CONF:10006).
c. Unless otherwise specified by the document specific header
constraints, when participant/@typeCode is IND,
associatedEntity/@classCode SHALL be selected from ValueSet
2.16.840.1.113883.11.20.9.33 INDRoleclassCodes STATIC 2011-09-30
(CONF:10007).
Table 16: IND Role classCode Value Set
Value Set: INDRoleclassCodes 2.16.840.1.113883.11.20.9.33 STATIC 2011-09-30
Code System(s):
Code

RoleClass 2.16.840.1.113883.5.110
Code System

Print Name

PRS

RoleClass

personal relationship

NOK

RoleClass

next of kin

CAREGIVER

RoleClass

caregiver

AGNT

RoleClass

agent

GUAR

RoleClass

guarantor

ECON

RoleClass

emergency contact

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Figure 28: Participant example for a supporting person





17 Daws Rd.
Blue Bell
MA
02368
US




Mrs.
Martha
Mum





3.2.10 InFulfillmentOf
The inFulfillmentOf element represents orders that are fulfilled by this
document.
21. MAY contain zero or more [0..*] inFulfillmentOf (CONF:9952).
a. The inFulfillmentOf, if present, SHALL contain exactly one [1..1] order
(CONF:9953).
i.

This order SHALL contain at least one [1..*] id (CONF:9954).

3.2.11 DocumentationOf/serviceEvent
A serviceEvent represents the main act, such as a colonoscopy or a cardiac
stress study, being documented. In a continuity of care document, CCD, the
serviceEvent is a provision of healthcare over a period of time. In a provision of
healthcare serviceEvent, the care providers, PCP or other longitudinal
providers, are recorded within the serviceEvent. If the document is about a
single encounter, the providers associated can be recorded in the
componentOf/encompassingEncounter.
22. MAY contain zero or more [0..*] documentationOf (CONF:14835).
a. The documentationOf, if present, SHALL contain exactly one [1..1]
serviceEvent (CONF:14836).
i.

This serviceEvent SHALL contain exactly one [1..1]
effectiveTime (CONF:14837).

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1. This effectiveTime SHALL contain exactly one [1..1] low
(CONF:14838).
ii. This serviceEvent SHOULD contain zero or more [0..*]
performer (CONF:14839).
1. The performer, if present, SHALL contain exactly one
[1..1] @typeCode="PRF" Participation physical
performer (CodeSystem: HL7ParticipationType
2.16.840.1.113883.5.90) (CONF:14840).
a. The performer participant represents clinicians
who actually and principally carry out the
serviceEvent. In a transfer of care this
represents the healthcare providers involved in
the current or pertinent historical care of the
patient. Preferably, the patient’s key healthcare
care team members would be listed,
particularly their primary physician and any
active consulting physicians, therapists, and
counselors (CONF:16753).
2. The performer, if present, MAY contain zero or one
[0..1] functionCode (CONF:16818).
a. The functionCode, if present, SHOULD contain
zero or one [0..1] @codeSystem, which SHOULD
be selected from CodeSystem
participationFunction
(2.16.840.1.113883.5.88) (CONF:16819).
3. The performer, if present, SHALL contain exactly one
[1..1] assignedEntity (CONF:14841).
a. This assignedEntity SHALL contain at least one
[1..*] id (CONF:14846).
i.

Such ids SHOULD contain zero or one
[0..1]
@root="2.16.840.1.113883.4.6"
National Provider Identifier
(CONF:14847).

b. This assignedEntity SHOULD contain zero or one
[0..1] code (CONF:14842).
i.

The code, if present, SHALL contain
exactly one [1..1] @code, which SHOULD
be selected from CodeSystem
NUCCProviderTaxonomy
(2.16.840.1.113883.6.101)
(CONF:14843).

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Figure 29: DocumentationOf example
















Matthew
Care
MD







3.2.12 Authorization/consent
The header can record information about the patient’s consent.
The type of consent (e.g., a consent to perform the related serviceEvent) is
conveyed in consent/code. Consents in the header have been finalized
(consent/statusCode must equal Completed) and should be on file. This
specification does not address how Privacy Consent’ is represented, but does not
preclude the inclusion of ‘Privacy Consent’.
23. MAY contain zero or more [0..*] authorization (CONF:16792) such that it
a. SHALL contain exactly one [1..1] consent (CONF:16793).
i.

This consent MAY contain zero or more [0..*] id (CONF:16794).

ii. This consent MAY contain zero or one [0..1] code
(CONF:16795).
1. The type of consent (e.g., a consent to perform the
related serviceEvent) is conveyed in consent/code
(CONF:16796).

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iii. This consent SHALL contain exactly one [1..1] statusCode
(CONF:16797).
1. This statusCode SHALL contain exactly one [1..1]
@code="completed" Completed (CodeSystem:
HL7ActClass 2.16.840.1.113883.5.6)
(CONF:16798).
Figure 30: Procedure note consent example








3.2.13 ComponentOf
The componentOf element contains the encompassing encounter for this
document. The encompassing encounter represents the setting of the clinical
encounter during which the document act(s) or ServiceEvent occurred.
In order to represent providers associated with a specific encounter, they are
recorded within the encompassingEncounter as participants.
In a CCD the encompassingEncounter may be used when documenting a
specific encounter and its participants. All relevant encounters in a CCD may be
listed in the encounters section.
24. MAY contain zero or one [0..1] componentOf (CONF:9955).
a. The componentOf, if present, SHALL contain exactly one [1..1]
encompassingEncounter (CONF:9956).
i.

This encompassingEncounter SHALL contain at least one [1..*]
id (CONF:9959).

ii. This encompassingEncounter SHALL contain exactly one [1..1]
effectiveTime (CONF:9958).

3.3 US Realm Address (AD.US.FIELDED)
[addr: 2.16.840.1.113883.10.20.22.5.2(open)]
Reusable "address" template, designed for use in US Realm CDA Header.
1. SHOULD contain exactly one [1..1] @use, which SHALL be selected from
ValueSet PostalAddressUse 2.16.840.1.113883.1.11.10637 STATIC
2005-05-01 (CONF:7290).
2. SHOULD contain zero or one [0..1] country, where the @code SHALL be
selected from ValueSet CountryValueSet
2.16.840.1.113883.3.88.12.80.63 DYNAMIC (CONF:7295).

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3. SHOULD contain zero or one [0..1] state (ValueSet: StateValueSet
2.16.840.1.113883.3.88.12.80.1 DYNAMIC) (CONF:7293).
a. State is required if the country is US. If country is not specified, its
assumed to be US. If country is something other than US, the state
MAY be present but MAY be bound to different vocabularies
(CONF:10024).
4. SHALL contain exactly one [1..1] city (CONF:7292).
5. SHOULD contain zero or one [0..1] postalCode (ValueSet:
PostalCodeValueSet 2.16.840.1.113883.3.88.12.80.2 DYNAMIC)
(CONF:7294).
a. PostalCode is required if the country is US. If country is not specified,
its assumed to be US. If country is something other than US, the
postalCode MAY be present but MAY be bound to different
vocabularies (CONF:10025).
6. SHALL contain at least one and not more than 4 streetAddressLine
(CONF:7291).
7. SHALL NOT have mixed content except for white space 13 (CONF:7296).
Table 17: PostalAddressUse Value Set
Value Set: PostalAddressUse 2.16.840.1.113883.1.11.10637 STATIC 2005-05-01
Code System(s):
Code

3.4

AddressUse 2.16.840.1.113883.5.1119
Code System

Print Name

BAD

AddressUse

bad address

DIR

AddressUse

direct

H

AddressUse

home address

HP

AddressUse

primary home

HV

AddressUse

vacation home

PHYS

AddressUse

physical visit address

PST

AddressUse

postal address

PUB

AddressUse

public

TMP

AddressUse

temporary

WP

AddressUse

work place

US Realm Date and Time (DT.US.FIELDED)
[effectiveTime: 2.16.840.1.113883.10.20.22.5.3(open)]
The US Realm Clinical Document Date and Time datatype flavor records date
and time information. If no time zone offset is provided, you can make no
assumption about time, unless you have made a local exchange agreement.
This data type uses the same rules as US Realm Date and Time
(DTM.US.FIELDED), but is used with the effectiveTime element.

For information on mixed content see Extensible Markup Language (XML)
(http://www.w3.org/TR/2008/REC-xml-20081126/#sec-mixed-content).
13

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1. SHALL be precise to the day (CONF:10078).
2. SHOULD be precise to the minute (CONF:10079).
3. MAY be precise to the second (CONF:10080).
4. If more precise than day, SHOULD include time-zone offset (CONF:10081).

3.5

US Realm Date and Time (DTM.US.FIELDED)
[time: 2.16.840.1.113883.10.20.22.5.4(open)]
The US Realm Clinical Document Date and Time datatype flavor records date
and time information. If no time zone offset is provided, you can make no
assumption about time, unless you have made a local exchange agreement.
This data type uses the same rules as US Realm Date and Time
(DT.US.FIELDED), but is used with the time element.
1. SHALL be precise to the day (CONF:10127).
2. SHOULD be precise to the minute (CONF:10128).
3. MAY be precise to the second (CONF:10129).
4. If more precise than day, SHOULD include time-zone offset (CONF:10130).

3.6 US Realm Patient Name (PTN.US.FIELDED)
[PN: templateId 2.16.840.1.113883.10.20.22.5.1 (open)]
The US Realm Patient Name datatype flavor is a set of reusable constraints that
can be used for the patient or any other person. It requires a first (given) and
last (family) name. If a patient or person has only one name part (e.g., patient
with first name only) place the name part in the field required by the
organization. Use the appropriate nullFlavor, "Not Applicable" (NA), in the
other field.
For information on mixed content see the Extensible Markup Language
reference (http://www.w3c.org/TR/2008/REC-xml-20081126/).
1. MAY contain zero or one [0..1] @use, which SHALL be selected from ValueSet
EntityNameUse 2.16.840.1.113883.1.11.15913 STATIC 2005-05-01
(CONF:7154).
2. SHALL contain exactly one [1..1] family (CONF:7159).
a. This family MAY contain zero or one [0..1] @qualifier, which SHALL
be selected from ValueSet EntityPersonNamePartQualifier
2.16.840.1.113883.11.20.9.26 STATIC 2011-09-30 (CONF:7160).
3. SHALL contain at least one [1..*] given (CONF:7157).
a. Such givens MAY contain zero or one [0..1] @qualifier, which SHALL
be selected from ValueSet EntityPersonNamePartQualifier
2.16.840.1.113883.11.20.9.26 STATIC 2011-09-30 (CONF:7158).
b. The second occurrence of given (given[2]) if provided, SHALL include
middle name or middle initial (CONF:7163).
4. MAY contain zero or more [0..*] prefix (CONF:7155).
a. The prefix, if present, MAY contain zero or one [0..1] @qualifier,
which SHALL be selected from ValueSet
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EntityPersonNamePartQualifier
2.16.840.1.113883.11.20.9.26 STATIC 2011-09-30 (CONF:7156).
5. MAY contain zero or one [0..1] suffix (CONF:7161).
a. The suffix, if present, MAY contain zero or one [0..1] @qualifier,
which SHALL be selected from ValueSet
EntityPersonNamePartQualifier
2.16.840.1.113883.11.20.9.26 STATIC 2011-09-30 (CONF:7162).
6. SHALL NOT have mixed content except for white space (CONF:7278).
Table 18: EntityNameUse Value Set
Value Set: EntityNameUse 2.16.840.1.113883.1.11.15913 STATIC 2005-05-01
Code System(s):

EntityNameUse 2.16.840.1.113883.5.45

Code

Code System

Print Name

A

EntityNameUse

Artist/Stage

ABC

EntityNameUse

Alphabetic

ASGN

EntityNameUse

Assigned

C

EntityNameUse

License

I

EntityNameUse

Indigenous/Tribal

IDE

EntityNameUse

Ideographic

L

EntityNameUse

Legal

P

EntityNameUse

Pseudonym

PHON

EntityNameUse

Phonetic

R

EntityNameUse

Religious

SNDX

EntityNameUse

Soundex

SRCH

EntityNameUse

Search

SYL

EntityNameUse

Syllabic

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Table 19: EntityPersonNamePartQualifier Value Set
Value Set: EntityPersonNamePartQualifier 2.16.840.1.113883.11.20.9.26 STATIC
2011-09-30
Code System(s):
Code

3.7

EntityNamePartQualifier 2.16.840.1.113883.5.43
Code System

Print Name

AC

EntityNamePartQualifier

academic

AD

EntityNamePartQualifier

adopted

BR

EntityNamePartQualifier

birth

CL

EntityNamePartQualifier

callme

IN

EntityNamePartQualifier

initial

NB

EntityNamePartQualifier

nobility

PR

EntityNamePartQualifier

professional

SP

EntityNamePartQualifier

spouse

TITLE

EntityNamePartQualifier

title

VV

EntityNamePartQualifier

voorvoegsel

US Realm Person Name (PN.US.FIELDED)
[name: 2.16.840.1.113883.10.20.22.5.1.1(open)]
The US Realm Clinical Document Person Name datatype flavor is a set of
reusable constraints that can be used for Persons.
1. SHALL contain exactly one [1..1] name (CONF:9368).
a. The content of name SHALL be either a conformant Patient Name
(PTN.US.FIELDED), or a string (CONF:9371).
b. The string SHALL NOT contain name parts (CONF:9372).

3.8

Rendering Header Information for Human Presentation
Metadata carried in the header may already be available for rendering from
electronic medical records (EMRs) or other sources external to the document;
therefore, there is no strict requirement to render directly from the document.
An example of this would be a doctor using an EMR that already contains the
patient’s name, date of birth, current address, and phone number. When a CDA
document is rendered within that EMR, those pieces of information may not
need to be displayed since they are already known and displayed within the
EMR’s user interface.
Good practice would recommend that the following be present whenever the
document is viewed:
Document title and document dates
Service and encounter types, and date ranges as appropriate
Names of all persons along with their roles, participations, participation
date ranges, identifiers, address, and telecommunications information

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Names of selected organizations along with their roles, participations,
participation date ranges, identifiers, address, and telecommunications
information
Date of birth for recordTarget(s)
In Operative and Procedure Notes, the following information is typically
displayed in the electronic health record (EHR) and/or rendered directly in the
document:
The performers of the surgery or procedure, including any assistants
The surgery or procedure performed (serviceEvent)
The date of the surgery or procedure

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4

DOCUMENT-LEVEL TEMPLATES
Document-level templates describe the purpose and rules for constructing a
conforming CDA document. Document templates include constraints on the
CDA header and refer to section-level templates. The Document Types and
Required/Optional Sections table lists the sections used by each document type.
Each document-level template contains the following information:
Scope and intended use of the document type
Description and explanatory narrative.
Template metadata (e.g., templateId, etc.)
Header constraints: this includes a reference to the US Realm Clinical
Document Header template and additional constraints specific to each
document type
Required and optional section-level templates

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Table 20: Document Types and Required/Optional Sections with Structured Body
Required Sections

Optional Sections

CCD (Summarization of Episode
Note)
34133-9 (required)14
2.16.840.1.113883.10.20.22.1.2

Allergies
Medications
Problem List
Procedures15 (List of Surgeries)
(History of Procedures)
Results

Advance Directives
Encounters
Family History
Functional Status
Immunizations
Medical Equipment
Payers
Plan of Care
Social History
Vital Signs

Consultation Note
11488-4
2.16.840.1.113883.10.20.22.1.4

Assessment and
Plan/Assessment/Plan of
Care*

Allergies

Document Type
Preferred LOINC
templateId

Chief Complaint **

History of Present Illness

Chief Complaint and Reason
for Visit **

Physical Exam

Family History

Reason for Referral/Reason for
Visit16 **

General Status
History of Past Illness (Past
Medical History)
Immunizations
Medications
Problem List
Procedures (List of Surgeries)
(History of Procedures)
Results
Review of Systems
Social History
Vital Signs

14
15
16

CCD is the only document with a fixed clinicalDocument/code
Required only for inpatient settings
Either Reason for Referral or Reason for Visit must be present.

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Document Type

Required Sections

Optional Sections

DICOM Object Catalog

Addendum

Findings (Radiology Study
Observation)

Clinical Presentation

Preferred LOINC
templateId
Diagnostic Imaging Report
18748-4
2.16.840.1.113883.10.20.22.1.5

Complications
Conclusions
Current Imaging Procedure
Descriptions
Document Summary
Key Images
Medical (General) History
Prior Imaging Procedure
Descriptions
Radiology - Impression
Radiology Comparison Study Observation
Radiology Reason For Study
Radiology Study Recommendation
Requested Imaging Studies
Information

Discharge Summary (Discharge
Summarization Note)
18842-5
2.16.840.1.113883.10.20.22.1.8

Allergies

Chief Complaint **

Hospital Course
Hospital Discharge Diagnosis

Chief Complaint and Reason
for Visit **

Hospital Discharge Medications

Discharge Diet

Plan of Care

Family History
Functional Status
History of Past Illness (Past
Medical History)
History of Present Illness
Hospital Admissions Diagnosis
Hospital Consultations
Hospital Discharge
Instructions
Hospital Discharge Physical
Hospital Discharge Studies
Summary
Immunizations
Problem List
Procedures (List of Surgeries)
(History of Procedures)
Reason for Visit **
Review of Systems
Social History
Vital Signs

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Document Type

Required Sections

Optional Sections

Allergies

History of Present Illness

Assessment and
Plan/Assessment/Plan of
Care*

Immunizations

Chief Complaint **

Procedures (List of Surgeries)
(History of Procedures)

Preferred LOINC
templateId
History & Physical Note
34117-2
2.16.840.1.113883.10.20.22.1.3

Chief Complaint and Reason
for Visit **

Instructions
Problem List

Family History
General Status
History of Past Illness (Past
Medical History)
Medications
Physical Exam
Reason for Visit **
Results
Review of Systems
Social History
Vital Signs
Operative Note (Surgical
Operation Note)
11504-8
2.16.840.1.113883.10.20.22.1.7

Anesthesia
Complications
Postoperative Diagnosis
Preoperative Diagnosis
Procedure Estimated Blood
Loss
Procedure Findings
Procedure Specimens Taken
Procedure Description

Procedure Implants
Operative Note Fluids
Operative Note Surgical
Procedure
Plan of Care
Planned Procedure
Procedure Disposition
Procedure Indications
Surgical Drains

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Required Sections

Optional Sections

Procedure Note
28570-0
2.16.840.1.113883.10.20.22.1.6

Assessment and
Plan/Assessment/Plan of
Care*
Complications
Postprocedure Diagnosis
Procedure Description
Procedure Indications

Allergies
Anesthesia
Chief Complaint **
Chief Complaint and Reason
for Visit **
Family History
History of Past Illness
History of Present Illness
Medical (General) History
Medications
Medications Administered
Physical Exam
Planned Procedure
Procedure Disposition
Procedure Estimated Blood
Loss
Procedure Findings
Procedure Implants
Procedure Specimens Taken
Procedures (List of Surgeries)
(History of Procedures)
Reason for Visit **
Review of Systems
Social History

Progress Note (Subsequent
Evaluation Note)
11506-3
2.16.840.1.113883.10.20.22.1.9

Assessment and
Plan/Assessment/Plan of
Care*

Allergies
Chief Complaint
Instructions
Interventions
Medications
Objective
Physical Exam
Problem List
Results
Review of Systems
Subjective
Vital Signs

Unstructured Document
Non-preferred
2.16.840.1.113883.10.20.21.1.1
0

N/A

N/A

Document Type
Preferred LOINC
templateId

* Wherever referenced, intent is that either “Assessment and Plan” is present or both
“Assessment” and “Plan of Care”. Only these combinations should be used.
** Wherever referenced, intent is that either Chief Complaint/Reason for Visit Section is
present or Chief Complaint Section and/or Reason for Visit unique Sections should be
present.

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4.1

Continuity of Care Document (CCD)/HITSP C32
[ClinicalDocument: templateId 2.16.840.1.113883.10.20.22.1.2(open)]
This section—Continuity of Care Document (CCD) Release 1.1—describes CDA
constraints in accordance with Stage 1 Meaningful Use. The CCD requirements
in this guide supersede CCD Release 1; in the near future, this guide could
supersede HITSP C3217.
The CCD is a core data set of the most relevant administrative, demographic,
and clinical information facts about a patient's healthcare, covering one or more
healthcare encounters. It provides a means for one healthcare practitioner,
system, or setting to aggregate all of the pertinent data about a patient and
forward it to another practitioner, system, or setting to support the continuity of
care. The primary use case for the CCD is to provide a snapshot in time
containing the pertinent clinical, demographic, and administrative data for a
specific patient18. More specific use cases, such as a Discharge Summary or
Progress Note, are available as alternative documents in this guide.

4.1.1 Header Constraints Specific to CCD
The Continuity of Care Document must conform to the US Realm Header. The
following sections include additional header constraints for conformant CCD.
1. SHALL contain exactly one [1..1] templateId (CONF:9441) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.1" (CONF:10037).

4.1.1.1 ClinicalDocument/templateId
Conformant documents must carry the document-level templateId asserting
conformance with specific constraints of CCD as well as the templateId for the
US Realm Clinical Document Header template.
2. SHALL contain exactly one [1..1] templateId (CONF:8450) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.2" (CONF:10038).
Figure 31: CCD ClinicalDocument/templateId example





HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) Component;
(HITSP/C32); Versions 2.1, 2.2, 2.3, 2.5; December 13, 2007 - July 8, 2009
18 CCD was initially scoped to reflect the ASTM E2369-05 Standard Specification for Continuity of
Care Record (CCR). The requirements specified here, comply with Stage 1 Meaningful Use.
17

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4.1.1.2 ClinicalDocument/code
In accordance with the CDA specification, the ClinicalDocument/code element
must be present and specifies the type of the clinical document. CCD requires
the document type code 34133-9 "Summarization of Episode Note".
3. SHALL contain exactly one [1..1] code (CONF:17180).
a. This code SHALL contain exactly one [1..1] @code="34133-9"
Summarization of Episode Note (CodeSystem: LOINC
2.16.840.1.113883.6.1) (CONF:17181).
Figure 32: CCD code example


4.1.1.3 DocumentationOf/serviceEvent
The main activity being described by a CCD is the provision of healthcare over a
period of time. This is shown by setting the value of
ClinicalDocument/documentationOf/serviceEvent/@classCode to “PCPR”
(care provision) and indicating the duration over which care was provided in
ClinicalDocument/documentationOf/serviceEvent/effectiveTime.
Additional data from outside this duration may also be included if it is relevant
to care provided during that time range (e.g., reviewed during the stated time
range).
NOTE: Implementations originating a CCD should take care to discover what the
episode of care being summarized is. For example, when a patient fills out a
form providing relevant health history, the episode of care being documented
might be from birth to the present.
4. SHALL contain exactly one [1..1] documentationOf (CONF:8452).
a. This documentationOf SHALL contain exactly one [1..1] serviceEvent
(CONF:8480).
i. This serviceEvent SHALL contain exactly one [1..1]
@classCode="PCPR" Care Provision (CodeSystem:
HL7ActClass 2.16.840.1.113883.5.6) (CONF:8453).
ii. This serviceEvent SHALL contain exactly one [1..1]
effectiveTime (CONF:8481).
1. This effectiveTime SHALL contain exactly one [1..1] low
(CONF:8454).
2. This effectiveTime SHALL contain exactly one [1..1]
high (CONF:8455).
iii. This serviceEvent SHOULD contain zero or more [0..*]
performer (CONF:8482).
1. serviceEvent/performer represents the healthcare
providers involved in the current or pertinent historical
care of the patient. Preferably, the patient’s key
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healthcare providers would be listed, particularly their
primary physician and any active consulting
physicians, therapists, and counselors (CONF:10026).
2. Such performers SHALL contain exactly one [1..1]
@typeCode="PRF" Participation physical performer
(CodeSystem: HL7ParticipationType
2.16.840.1.113883.5.90) (CONF:8458).
3. Such performers MAY contain zero or more [0..1]
assignedEntity (CONF:8459).
a. This assignedEntity SHALL contain at least one
[1..*] id (CONF:8460).
i.

include zero or one [0..1] id
where id/@root
="2.16.840.1.113883.4.6" National
Provider Identifier (CONF:10027).
SHOULD

b. This assignedEntity MAY contain zero or one
[0..1] code (CONF:8461).
i. The code MAY be the NUCC Health Care
Provider Taxonomy (CodeSystem:
2.16.840.1.113883.6.101). (See
http://www.nucc.org) (CONF:8462).

4.1.1.4 Author
5. CCD SHALL contain at least one [1..*] author (CONF:9442)
a. SHALL contain exactly one [1..1] assignedAuthor (CONF:9443)
i.

contain exactly one [1..1] assignedPerson or exactly one
[1..1] representedOrganization. (CONF:8456).
SHALL

ii. If assignedAuthor has an associated representedOrganization
with no assignedPerson or assignedAuthoringDevice, then the
value for
"ClinicalDocument/author/assignedAuthor/id/@NullFlavor"
SHALL be "NA" "Not applicable" 2.16.840.1.113883.5.1008
NullFlavor STATIC. (CONF:8457).

4.1.2 CCD Body Constraints
The Continuity of Care Document supports both narrative sections and sections
requiring coded clinical statements. The required and optional sections are listed
in the Document Types and Required/Optional Sections table. The table below
the constraints shows all templates including entries within each section.
1. The component/structuredBody SHALL conform to the section constraints
below (CONF:9536).
a. SHALL contain exactly one [1..1] Allergies Section(entries
required) (templateId:2.16.840.1.113883.10.20.22.2.6.1)
(CONF:9445).

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b. SHALL contain exactly one [1..1] Medications Section (entries
required) (templateId:2.16.840.1.113883.10.20.22.2.1.1)
(CONF:9447).
c. SHALL contain exactly one [1..1] Problem Section (entries
required) (templateId:2.16.840.1.113883.10.20.22.2.5.1)
(CONF:9449).
d. SHOULD contain exactly one [1..1] Procedures Section (entries
required) (templateId:2.16.840.1.113883.10.20.22.2.7.1)
(CONF:9451).
e. SHALL contain exactly one [1..1] Results Section (entries
required) (templateId:2.16.840.1.113883.10.20.22.2.3.1)
(CONF:9453).
f.

contain zero or one [0..1] Advance Directives Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.21) (CONF:9455).
MAY

g. MAY contain zero or one [0..1] Encounters Section (entries
optional) (templateId:2.16.840.1.113883.10.20.22.2.22)
(CONF:9457).
h. MAY contain zero or one [0..1] Family History Section
(templateId:2.16.840.1.113883.10.20.22.2.15) (CONF:9459).
i.

MAY

contain zero or one [0..1] Functional Status Section
(templateId:2.16.840.1.113883.10.20.22.2.14) (CONF:9461).

j.

MAY

contain zero or one [0..1] Immunizations Section (entries
optional) (templateId:2.16.840.1.113883.10.20.22.2.2)
(CONF:9463).

k. MAY contain zero or one [0..1] Medical Equipment Section
(templateId:2.16.840.1.113883.10.20.22.2.23) (CONF:9466).
l.

contain zero or one [0..1] Payers Section
(templateId:2.16.840.1.113883.10.20.22.2.18) (CONF:9468).
MAY

m. MAY contain zero or one [0..1] Plan of Care Section
(templateId:2.16.840.1.113883.10.20.22.2.10) (CONF:9470).
n. MAY contain zero or one [0..1] Social History Section
(templateId:2.16.840.1.113883.10.20.22.2.17) (CONF:9472).
o. MAY contain zero or one [0..1] Vital Signs Section (entries
optional) (templateId:2.16.840.1.113883.10.20.22.2.4)
(CONF:9474).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
Page 87
July 2012
© 2012 Health Level Seven, Inc. All rights reserved.

The following table shows relationships among the templates in the body of a
CCD.
Table 21: Template Containment for a CCD
Template Title

Template
Type

templateId

Continuity of Care Document (CCD)

document

2.16.840.1.113883.10.20.22.1.2

section

2.16.840.1.113883.10.20.22.2.21

entry

2.16.840.1.113883.10.20.22.4.48

section

2.16.840.1.113883.10.20.22.2.6.1

entry

2.16.840.1.113883.10.20.22.4.30

entry

2.16.840.1.113883.10.20.22.4.7

Allergy Status Observation

entry

2.16.840.1.113883.10.20.22.4.28

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Advance Directives Section (entries
optional)
Advance Directive Observation
Allergies Section (entries required)
Allergy Problem Act
Allergy Observation

Page 88
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

Template Title

Template
Type

templateId

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.22

entry

2.16.840.1.113883.10.20.22.4.49

entry

2.16.840.1.113883.10.20.22.4.80

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

Medication Dispense

Severity Observation
Severity Observation
Encounters Section (entries optional)
Encounter Activities
Encounter Diagnosis
Problem Observation

entry

2.16.840.1.113883.10.20.22.4.6

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

section

2.16.840.1.113883.10.20.22.2.15

entry

2.16.840.1.113883.10.20.22.4.45

entry

2.16.840.1.113883.10.20.22.4.46

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Family History Death Observation

entry

2.16.840.1.113883.10.20.22.4.47

Family History Section
Family History Organizer
Family History Observation

Functional Status Section

section

2.16.840.1.113883.10.20.22.2.14

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

Cognitive Status Problem Observation

entry

2.16.840.1.113883.10.20.22.4.73

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
Page 89
July 2012
© 2012 Health Level Seven, Inc. All rights reserved.

Template Title

Template
Type

templateId

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

entry

2.16.840.1.113883.10.20.22.4.74

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

entry

2.16.840.1.113883.10.20.22.4.75

entry

2.16.840.1.113883.10.20.22.4.74

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

entry

2.16.840.1.113883.10.20.22.4.68

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

entry

2.16.840.1.113883.10.20.22.4.67

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

entry

2.16.840.1.113883.10.20.22.4.66

entry

2.16.840.1.113883.10.20.22.4.67

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

section

2.16.840.1.113883.10.20.22.2.2

entry

2.16.840.1.113883.10.20.22.4.52

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Immunization Refusal Reason

entry

2.16.840.1.113883.10.20.22.4.53

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Non-Medicinal Supply Activity
Product Instance
Cognitive Status Result Observation

Product Instance
Cognitive Status Result Organizer
Cognitive Status Result Observation

Product Instance
Functional Status Problem Observation

Product Instance
Functional Status Result Observation

Product Instance
Functional Status Result Organizer
Functional Status Result Observation

Product Instance
Non-Medicinal Supply Activity
Product Instance
Immunizations Section (entries optional)
Immunization Activity

Page 90
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

Template Title

Template
Type

templateId

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Medication Supply Order

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
Page 91
July 2012
© 2012 Health Level Seven, Inc. All rights reserved.

Template Title

Template
Type

templateId

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.23

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

section

2.16.840.1.113883.10.20.22.2.1.1

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Severity Observation
Medical Equipment Section
Non-Medicinal Supply Activity
Product Instance
Medications Section (entries required)
Medication Activity

Page 92
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

Template Title

Template
Type

templateId

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.18

Coverage Activity

entry

2.16.840.1.113883.10.20.22.4.60

Policy Activity

entry

2.16.840.1.113883.10.20.22.4.61

section

2.16.840.1.113883.10.20.22.2.10

Plan of Care Activity Act

entry

2.16.840.1.113883.10.20.22.4.39

Plan of Care Activity Encounter

entry

2.16.840.1.113883.10.20.22.4.40

Plan of Care Activity Observation

entry

2.16.840.1.113883.10.20.22.4.44

Plan of Care Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.41

Plan of Care Activity Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.42

Plan of Care Activity Supply

entry

2.16.840.1.113883.10.20.22.4.43

section

2.16.840.1.113883.10.20.22.2.5.1

entry

2.16.840.1.113883.10.20.22.4.3

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

section

2.16.840.1.113883.10.20.22.2.7.1

entry

2.16.840.1.113883.10.20.22.4.12

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Procedure Activity Procedure

Severity Observation
Payers Section

Plan of Care Section

Problem Section (entries required)
Problem Concern Act (Condition)
Problem Observation

Procedures Section (entries required)
Procedure Activity Act

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
Page 93
July 2012
© 2012 Health Level Seven, Inc. All rights reserved.

Template Title

Template
Type

templateId

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.32

Procedure Activity Procedure

Severity Observation
Service Delivery Location
Procedure Activity Observation

entry

2.16.840.1.113883.10.20.22.4.13

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

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Template Title

Template
Type

templateId

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

Procedure Activity Procedure

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.8

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

section

2.16.840.1.113883.10.20.22.2.3.1

entry

2.16.840.1.113883.10.20.22.4.1

Severity Observation

Results Section (entries required)
Result Organizer

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Template Title

Template
Type

templateId

entry

2.16.840.1.113883.10.20.22.4.2

section

2.16.840.1.113883.10.20.22.2.17

entry

2.16.840.1.113883.10.20.15.3.8

Estimated Date of Delivery

entry

2.16.840.1.113883.10.20.15.3.1

Smoking Status Observation

entry

2.16.840.1.113883.10.22.4.78

Social History Observation

entry

2.16.840.1.113883.10.20.22.4.38

section

2.16.840.1.113883.10.20.22.2.4

entry

2.16.840.1.113883.10.20.22.4.26

entry

2.16.840.1.113883.10.20.22.4.27

Result Observation
Social History Section
Pregnancy Observation

Vital Signs Section (entries optional)
Vital Signs Organizer
Vital Sign Observation

4.2

Consultation Note
[ClinicalDocument: templateId 2.16.840.1.113883.10.20.22.1.4(open)]
For the purpose of this Implementation Guide, a consultation visit is defined by
the evaluation and management guidelines for a consultation established by the
Centers for Medicare and Medicaid Services (CMS). According to those
guidelines, a Consultation Note must be generated as a result of a physician or
nonphysician practitioner's (NPP) request for an opinion or advice from another
physician or NPP. Consultations must involve face-to-face time with the patient
or fall under guidelines for telemedicine visits.
A Consultation Note must be provided to the referring physician or NPP and
must include the reason for the referral, history of present illness, physical
examination, and decision-making component (Assessment and Plan).
An NPP is defined as any licensed medical professional as recognized by the
state in which the professional practices, including, but not limited to, physician
assistants, nurse practitioners, clinical nurse specialists, social workers,
registered dietitians, physical therapists, and speech therapists.
Reports on visits requested by a patient, family member, or other third party are
not covered by this specification. Second opinions, sometimes called
"confirmatory consultations," also are not covered here. Any question on use of
the Consultation Note defined here should be resolved by reference to CMS or
American Medical Association (AMA) guidelines.

4.2.1 Consultation Note Header Constraints
The Consultation Note must conform to the US Realm Clinical Document
Header. The following sections include additional header constraints for
conformant Consultation Notes.
1. SHALL contain exactly one [1..1] templateId (CONF:9477) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.1" (CONF:10039)

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4.2.1.1 ClinicalDocument/templateId
Conformant documents must carry the document-level templateId asserting
conformance with specific constraints of a Consultation Note as well as the
templateId for the US Realm Clinical Document Header template.
2. SHALL contain exactly one [1..1] templateId (CONF:8375) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.4" (CONF:10040).
Figure 33: Consultation note ClinicalDocument/templateId example




4.2.1.2 ClinicalDocument/code
The Consultation Note limits document type codes to those codes listed in the
Consultation Note LOINC Document Codes table (invalid codes are listed in a
separate table). Implementation may use translation elements to specify a local
code that is equivalent to a document type (see the Consultation Note
translation of local code figure).
The Consultation Note recommends use of a single document type code, 114884 "Consultation Note", with further specification provided by author or
performer, setting, or specialty. The specialized codes in the Consultation Note
LOINC Document Codes table are pre-coordinated with the practice setting or
the training or professional level of the author. Use of these codes is not
recommended, as this duplicates information that may be present in the header.
When pre-coordinated codes are used, any coded values describing the author
or performer of the service act or the practice setting must be consistent with
the LOINC document type. For example, a Cardiology Consultation Note would
not be authored by an Obstetrician.
3. SHALL contain exactly one [1..1] code (CONF:17176).
a. This code SHALL contain exactly one [1..1] @code, which SHALL be
selected from ValueSet ConsultDocumentType
2.16.840.1.113883.11.20.9.31 DYNAMIC (CONF:17177).

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Table 22: Consultation Note LOINC Document Codes
Value Set: ConsultDocumentType 2.16.840.1.113883.11.20.9.31 DYNAMIC
Code System: LOINC 2.16.840.1.113883.6.1
LOINC Code

Type of Service
(“Component”)

Setting
(“System”)

Specialty/ Training/
Professional Level
(“Method”)

Root Level Document Type Code
11488-4

Consultation Note

{Provider}

Specialized by Setting
34100-8

Consultation Note

Critical care unit

{Provider}

34104-0

Consultation Note

Hospital

{Provider}

51845-6

Consultation Note

Outpatient

{Provider}

51853-0

Consultation Note

Inpatient

{Provider}

51846-4

Consultation Note

Emergency
Dept.

{Provider}

Specialized by Setting and Specialty
34101-6

Consultation Note

Outpatient

General medicine

34749-2

Consultation Note

Outpatient

Anesthesia

34102-4

Consultation Note

Hospital

Psychiatry

Specialized by Specialty19

19

34099-2

Consultation Note

Cardiology

34756-7

Consultation Note

Dentistry

34758-3

Consultation Note

Dermatology

34760-9

Consultation Note

Diabetology

34879-7

Consultation Note

Endocrinology

34761-7

Consultation Note

Gastroenterology

34764-1

Consultation Note

General medicine

34771-6

Consultation Note

General surgery

34776-5

Consultation Note

Gerontology

34777-3

Consultation Note

Gynecology

34779-9

Consultation Note

Hematology+Oncology

34781-5

Consultation Note

Infectious disease

34783-1

Consultation Note

Kinesiotherapy

34785-6

Consultation Note

Mental health

34795-5

Consultation Note

Nephrology

34797-1

Consultation Note

Neurology

34798-9

Consultation Note

Neurosurgery

34800-3

Consultation Note

Nutrition+Dietetics

34803-7

Consultation Note

Occupational health

34855-7

Consultation Note

Occupational therapy

34805-2

Consultation Note

Oncology

Use of these codes is not recommended, as it duplicates information that may be present in the header

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Value Set: ConsultDocumentType 2.16.840.1.113883.11.20.9.31 DYNAMIC
Code System: LOINC 2.16.840.1.113883.6.1
LOINC Code

Type of Service
(“Component”)

Setting
(“System”)

Specialty/ Training/
Professional Level
(“Method”)

34807-8

Consultation Note

Ophthalmology

34810-2

Consultation Note

Optometry

34812-8

Consultation Note

Oromaxillofacial surgery

34814-4

Consultation Note

Orthopedics

34816-9

Consultation Note

Otorhinolaryngology

34820-1

Consultation Note

Pharmacy

34822-7

Consultation Note

Physical medicine and
rehabilitation

34824-3

Consultation Note

Physical therapy

34826-8

Consultation Note

Plastic surgery

34828-4

Consultation Note

Podiatry

34788-0

Consultation Note

Psychiatry

34791-4

Consultation Note

Psychology

34103-2

Consultation Note

Pulmonary

34831-8

Consultation Note

Radiation oncology

34833-4

Consultation Note

Recreational therapy

34835-9

Consultation Note

Rehabilitation

34837-5

Consultation Note

Respiratory therapy

34839-1

Consultation Note

Rheumatology

34841-7

Consultation Note

Social work

34845-8

Consultation Note

Speech
therapy+Audiology

34847-4

Consultation Note

Surgery

34849-0

Consultation Note

Thoracic surgery

34851-6

Consultation Note

Urology

34853-2

Consultation Note

Vascular surgery

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Table 23: Invalid Codes for Consultation Note20
LOINC Code

Type of Service
(“Component”)

Setting
(“System”)

Specialty/ Training/
Professional Level
(“Method”)

18841-7

Hospital consultations

8647-0

Hospital consultations

33720-4

Blood bank consult

24611-6

Confirmatory consultation
note

47040-1

Confirmatory consultation
note

47041-9

Confirmatory consultation
note

28569-2

Subsequent evaluation note

Consulting physician

18763-3

Initial evaluation note

Consulting physician

(scale = nom)
Outpatient

{Provider}
{Provider}

Inpatient

{Provider}

Figure 34: Consultation note ClinicalDocument/code example


Figure 35: Consultation note translation of local code example




20

The Invalid Codes for Consultation Note are from the original Consultation Note DSTU.

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Figure 36: Consultation note uncoordinated document type codes example

...

Good Health Cardiology Consultation Note
...



...

...


...


...







4.2.1.3 InFulfillmentOf
The inFulfillmentOf element describes the prior orders that are fulfilled (in
whole or part) by the service events described in the Consultation Note. For
example, the prior order might be for the consultation being reported in the
Note.
4. SHALL contain at least one [1..*] inFulfillmentOf (CONF:8382).
a. This inFulfillmentOf SHOULD contain exactly one
[1..1] order (CONF:8385).
i.

This order SHALL contain at least one [1..*] id (CONF:9102).

Figure 37: Consultation note inFulfillmentOf example






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4.2.1.4 ComponentOf
A Consultation Note is always associated with an encounter; the componentOf
element must be present and the encounter must be identified.
CDA R2 requires encompasingEncounter and the id element of the
encompassingEncounter is required to be present and represents the identifier
for the encounter.
The encounterParticipant elements may be present. If present, they represent
only those participants in the encounter, not necessarily the entire episode of
care (see related information under Participant above).
The responsibleParty element may be present. If present, it represents only
the party responsible for the encounter, not necessarily the entire episode of
care.
5. SHALL contain exactly one [1..1] componentOf (CONF:8386).
a. This componentOf SHALL contain exactly one [1..1]
encompassingEncounter (CONF:8387).
i.

This encompassingEncounter SHALL contain exactly one [1..1]
id (CONF:8388).

ii. This encompassingEncounter SHALL contain exactly one [1..1]
effectiveTime (CONF:8389).
1. This effectiveTime SHALL contain exactly one [1..1] US
Realm Date and Time (DT.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.3)
(CONF:10132).
iii. This encompassingEncounter MAY contain zero or one [0..1]
responsibleParty (CONF:8391).
1. The responsibleParty element records only the party
responsible for the encounter, not necessarily the
entire episode of care. (CONF:8393).
2. The responsibleParty element, if present, SHALL
contain an assignedEntity element which SHALL
contain an assignedPerson element, a
representedOrganization element, or both.
(CONF:8394).
iv. This encompassingEncounter MAY contain zero or more [0..*]
encounterParticipant (CONF:8392).
1. The encounterParticipant element, if present, records
only participants in the encounter, not necessarily in
the entire episode of care. (CONF:8395).
2. An encounterParticipant element, if present, SHALL
contain an assignedEntity element which SHALL
contain an assignedPerson element, a
representedOrganization element, or both.
(CONF:8396).

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Figure 38: Consultation note componentOf example





...



4.2.2 Consultation Note Body Constraints
The Consultation Note supports both narrative sections and sections requiring
coded clinical statements. The required and optional sections are listed in the
Document Types and Required/Optional Sections table. The table below the
constraints shows all templates including entries within each section.
1. SHALL contain exactly one [1..1] component (CONF:8397).
a. A Consultation Note can have either a structuredBody or a
nonXMLBody. (CONF:8398).
i.

A Consultation Note can conform to CDA Level 1
(nonXMLBody), CDA Level 2 (structuredBody with sections
that contain a narrative block), or CDA Level 3
(structuredBody containing sections that contain a narrative
block and coded entries). In this template (templateId
2.16.840.1.113883.10.20.22.1.4), coded entries are optional.
(CONF:8399).

b. If structuredBody, the component/structuredBody SHALL conform to
the section constraints below. (CONF:9503).
i.

include an Assessment and Plan Section, or an
Assessment Section and a Plan Section. (CONF:9501).
SHALL

ii. SHALL NOT include an Assessment/Plan Section when an
Assessment Section and a Plan of Care Section are present.
(CONF:10028)
iii. MAY contain zero or one [0..1] Assessment Section
(templateId:2.16.840.1.113883.10.20.22.2.8)
(CONF:9487).
iv. MAY contain zero or one [0..1] Plan of Care Section
(templateId:2.16.840.1.113883.10.20.22.2.10)
(CONF:9489).
v. MAY contain zero or one [0..1] Assessment and Plan
Section (templateId:2.16.840.1.113883.10.20.22.2.9)
(CONF:9491).

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vi. SHALL contain exactly one [1..1] History of Present
Illness Section (templateId:
1.3.6.1.4.1.19376.1.5.3.1.3.4) (CONF:9493).
vii. SHOULD contain exactly one [1..1] Physical Exam Section
(templateId:2.16.840.1.113883.10.20.2.10)
(CONF:9495).
viii. SHALL include a Reason for Referral or Reason for Visit section
(CONF:9504).
ix. MAY contain zero or one [0..1] Reason for Referral
Section (templateId:1.3.6.1.4.1.19376.1.5.3.1.3.1)
(CONF:9498).
x. MAY contain zero or one [0..1] Reason for Visit Section
(templateId:2.16.840.1.113883.10.20.22.2.12)
(CONF:9500).
xi. MAY contain zero or one [0..1] Allergies Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.6)
(CONF:9507).
xii. SHALL NOT include a combined Chief Complaint and Reason
for Visit Section with either a Chief Complaint Section or a
Reason for Visit Section. (CONF:10029).
xiii. MAY contain zero or one [0..1] Chief Complaint Section
(templateId:1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1)
(CONF:9509).
xiv. MAY contain zero or one [0..1] Chief Complaint and Reason
for Visit Section
(templateId:2.16.840.1.113883.10.20.22.2.13)
(CONF:9511).
xv. MAY contain zero or one [0..1] Family History Section
(templateId:2.16.840.1.113883.10.20.22.2.15)
(CONF:9513).
xvi. MAY contain zero or one [0..1] General Status Section
(templateId:2.16.840.1.113883.10.20.2.5)
(CONF:9515).
xvii. MAY contain zero or one [0..1] History of Past Illness
Section
(templateId:2.16.840.1.113883.10.20.22.2.20)
(CONF:9517).
xviii. MAY contain zero or one [0..1] Immunizations Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.2)
(CONF:9519).
xix. MAY contain zero or one [0..1] Medications Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.1)
(CONF:9521).

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xx. MAY contain zero or one [0..1] Problem Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.5)
(CONF:9523).
xxi. MAY contain zero or one [0..1] Procedures Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.7)
(CONF:9525).
xxii. MAY contain zero or one [0..1] Results Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.3)
(CONF:9527).
xxiii. MAY contain zero or one [0..1] Review of Systems
Section (templateId:1.3.6.1.4.1.19376.1.5.3.1.3.18)
(CONF:9529).
xxiv. MAY contain zero or one [0..1] Social History Section
(templateId:2.16.840.1.113883.10.20.22.2.17)
(CONF:9531).
xxv. MAY contain zero or one [0..1] Vital Signs Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.4)
(CONF:9533).
The following table shows relationships among the templates in the body of a
Consultation Note.
Table 24: Template Containment for a Consultation Note
Template Title

Template
Type

templateId

Consultation Note

document

2.16.840.1.113883.10.20.22.1.4

section

2.16.840.1.113883.10.20.22.2.6

entry

2.16.840.1.113883.10.20.22.4.30

entry

2.16.840.1.113883.10.20.22.4.7

Allergy Status Observation

entry

2.16.840.1.113883.10.20.22.4.28

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

entry

2.16.840.1.113883.10.20.22.4.54

Allergies Section (entries optional)
Allergy Problem Act
Allergy - Intolerance Observation

Immunization Medication
Information

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Type

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Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.9

entry

2.16.840.1.113883.10.20.22.4.39

section

2.16.840.1.113883.10.20.22.2.8

Severity Observation
Severity Observation
Assessment and Plan Section
Plan of Care Activity Act
Assessment Section

Page 106
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July 2012

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Chief Complaint and Reason for Visit
Section

section

2.16.840.1.113883.10.20.22.2.13

Chief Complaint Section

section

1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1

Family History Section

section

2.16.840.1.113883.10.20.22.2.15

entry

2.16.840.1.113883.10.20.22.4.45

entry

2.16.840.1.113883.10.20.22.4.46

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Family History Death Observation

entry

2.16.840.1.113883.10.20.22.4.47

General Status Section

section

2.16.840.1.113883.10.20.2.5

History of Past Illness Section

section

2.16.840.1.113883.10.20.22.2.20

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

History of Present Illness Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.4

Immunizations Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.2

entry

2.16.840.1.113883.10.20.22.4.52

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Immunization Refusal Reason

entry

2.16.840.1.113883.10.20.22.4.53

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

Family History Organizer
Family History Observation

Problem Observation

Immunization Activity

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Medication Supply Order

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Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

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Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.1

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Severity Observation
Medications Section (entries optional)
Medication Activity

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.8

Physical Exam Section

Severity Observation

section

2.16.840.1.113883.10.20.2.10

Plan of Care Section

section

2.16.840.1.113883.10.20.22.2.10

Plan of Care Activity Act

entry

2.16.840.1.113883.10.20.22.4.39

Plan of Care Activity Encounter

entry

2.16.840.1.113883.10.20.22.4.40

Plan of Care Activity Observation

entry

2.16.840.1.113883.10.20.22.4.44

Plan of Care Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.41

Plan of Care Activity Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.42

Plan of Care Activity Supply

entry

2.16.840.1.113883.10.20.22.4.43

section

2.16.840.1.113883.10.20.22.2.5

Problem Section (entries optional)

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
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entry

2.16.840.1.113883.10.20.22.4.3

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

section

2.16.840.1.113883.10.20.22.2.7

entry

2.16.840.1.113883.10.20.22.4.12

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

Problem Concern Act (Condition)
Problem Observation

Procedures Section (entries optional)
Procedure Activity Act

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.13

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Procedure Activity Procedure

Severity Observation
Service Delivery Location
Procedure Activity Observation

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2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Medication Activity

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.8

Service Delivery Location

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.32

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

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Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.8

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Reason for Referral Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.1

Reason for Visit Section

section

2.16.840.1.113883.10.20.22.2.12

Results Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.3

entry

2.16.840.1.113883.10.20.22.4.1

Severity Observation

Result Organizer

entry

2.16.840.1.113883.10.20.22.4.2

Review of Systems Section

Result Observation

section

1.3.6.1.4.1.19376.1.5.3.1.3.18

Social History Section

section

2.16.840.1.113883.10.20.22.2.17

entry

2.16.840.1.113883.10.20.15.3.8

Estimated Date of Delivery

entry

2.16.840.1.113883.10.20.15.3.1

Smoking Status Observation

entry

2.16.840.1.113883.10.22.4.78

Social History Observation

entry

2.16.840.1.113883.10.20.22.4.38

section

2.16.840.1.113883.10.20.22.2.4

entry

2.16.840.1.113883.10.20.22.4.26

entry

2.16.840.1.113883.10.20.22.4.27

Pregnancy Observation

Vital Signs Section (entries optional)
Vital Signs Organizer
Vital Sign Observation

4.3

Diagnostic Imaging Report
[ClinicalDocument: templateId 2.16.840.1.113883.10.20.22.1.5(open)]
A Diagnostic Imaging Report (DIR) is a document that contains a consulting
specialist’s interpretation of image data. It conveys the interpretation to the
referring (ordering) physician and becomes part of the patient’s medical record.
It is for use in Radiology, Endoscopy, Cardiology, and other imaging specialties.

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4.3.1 DIR Header Constraints
The DIR must conform to the US Realm Clinical Document Header. The
following sections include additional header constraints for conformant DIR
Notes.
1. SHALL contain exactly one [1..1] templateId (CONF:9405) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.1" (CONF:10041).

4.3.1.1 ClinicalDocument/templateId
Conformant documents must carry the document-level templateId asserting
conformance with specific constraints of a DIR as well as the templateId for the
U.S. Realm CDA Header Constraints template.
2. SHALL contain exactly one [1..1] templateId (CONF:8404) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.5" (CONF:10042).
Figure 39: DIR ClinicalDocument/templateId example





4.3.1.2 ClinicalDocument/id
3. The ClinicalDocument/id/@root attribute SHALL be a syntactically correct
OID, and SHALL NOT be a UUID. (CONF:8405).
a. OIDs SHALL be represented in dotted decimal notation, where each
decimal number is either 0 or starts with a nonzero digit. More
formally, an OID SHALL be in the form ([0-2])(.([1-9][0-9]*|0))+
(CONF:8406).
b. OIDs SHALL be no more than 64 characters in length. (CONF:8407).

4.3.1.3 ClinicalDocument/code
Given that DIR documents may be transformed from established collections of
imaging reports already stored with their own type codes, there is no static set of
Document Type codes. The set of LOINC codes listed in the DIR LOINC
Document Type Codes table may be extended by additions to LOINC and
supplemented by local codes as translations.
The DIR document recommends use of a single document type code, 18748-4
"Diagnostic Imaging Report", with further specification provided by author
or performer, setting, or specialty. Some of these codes in the DIR LOINC
Document Type Codes table are pre-coordinated with either the imaging
modality, body part examined, or specific imaging method such as the view. Use

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of these codes is not recommended, as this duplicates information potentially
present with the header. When pre-coordinated codes are used, any coded
values describing the author or performer of the service act or the practice
setting must be consistent with the LOINC document type. This table is drawn
from LOINC Version 2.36, June 30, 2011, and consists of codes whose scale is
DOC and that refer to reports for diagnostic imaging procedures.
4. SHALL contain exactly one [1..1] code (CONF:14833).
a. This code SHOULD contain zero or one [0..1] @code, which SHOULD be
selected from ValueSet DIRDocumentTypeCode
2.16.840.1.113883.11.20.9.32 DYNAMIC (CONF:14834).
Table 25: DIR LOINC Document Type Codes
Value Set: DIRDocumentTypeCodes 2.16.840.1.113883.11.20.9.32 DYNAMIC
Code System: LOINC 2.16.840.1.113883.6.1
LOINC
Code

DIR
‘Modality’

Common
DIR
Display
Name

Type of
Service
‘Component’

Setting
‘System’

Specialty/
Training/
Professional Level
‘Method_Type’

Diagnositic
Imaging
Report

Study Report

Diagnostic Imaging

Preferred Code
18748-4

Any

Additional Codes
18747-6

Computed
Tomography

CT Report

Study

CT

18755-9

Magnetic
Resonance
Imaging

MRI Report

Study report

MRI

18760-9

Ultrasound

Ultrasound
Report

Study

US

18757-5

Nuclear
Medicine

Nuclear
Medicine
Report

Study report

RadNuc

18758-3

Positron
Emission
Tomography

PET Scan
Report

Study

Pet scan

18745-0

Cardiac
Radiography
/Fluoroscopy

Cardiac
Catheteriza
tion Report

Study report

Heart

Cardiac
catheterization

11522-0

Cardiac
Ultrasound

Echocardio
graphy
Report

Study report

Heart

Cardiac echo

18746-8

Colonoscopy

Colonoscopy
Report

Study report

Lower GI
tract

Colonoscopy

18751-8

Endoscopy

Endoscopy
Report

Study report

Upper GI
tract

Endoscopy

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Value Set: DIRDocumentTypeCodes 2.16.840.1.113883.11.20.9.32 DYNAMIC
Code System: LOINC 2.16.840.1.113883.6.1
LOINC
Code

DIR
‘Modality’

Common
DIR
Display
Name

Type of
Service
‘Component’

Setting
‘System’

Specialty/
Training/
Professional Level
‘Method_Type’

11525-3

Ultrasound

Obstetrical
Ultrasound
Report

Study report

Pelvis+Fe
tus

OB US

Figure 40: DIR ClinicalDocument/code example


Figure 41: DIR use of the translation element to include local codes for document
type







Amanda
Assigned
MD





4.3.1.6 InFulfillmentOf
An inFulfillmentOf element represents the Placer Order that is either a group
of orders (modeled as PlacerGroup in the Placer Order RMIM of the Orders &
Observations domain) or a single order item (modeled as ObservationRequest
in the same RMIM). This optionality reflects two major approaches to the
grouping of procedures as implemented in the installed base of imaging
information systems. These approaches differ in their handling of grouped
procedures and how they are mapped to identifiers in the Digital Imaging and
Communications in Medicine (DICOM) image and structured reporting data.
The example of a CT examination covering chest, abdomen, and pelvis will be
used in the discussion below.
In the IHE Scheduled Workflow model, the Chest CT, Abdomen CT, and Pelvis
CT each represent a Requested Procedure, and all three procedures are grouped
under a single Filler Order. The Filler Order number maps directly to the
DICOM Accession Number in the DICOM imaging and report data.
A widely deployed alternative approach maps the requested procedure identifiers
directly to the DICOM Accession Number. The Requested Procedure ID in such
implementations may or may not be different from the Accession Number, but is
of little identifying importance because there is only one Requested Procedure
per Accession Number. There is no identifier that formally connects the
requested procedures ordered in this group.

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In both cases, inFulfillmentOf/order/id is mapped to the DICOM Accession
Number in the imaging data.
Figure 43: DIR inFulfillmentOf example







4.3.1.7 DocumentationOf
Each documentationOf/serviceEvent indicates an imaging procedure that the
provider describes and interprets in the content of the DIR. The main activity
being described by this document is the interpretation of the imaging procedure.
This is shown by setting the value of the @classCode attribute of the
serviceEvent element to ACT, and indicating the duration over which care was
provided in the effectiveTime element. Within each documentationOf
element, there is one serviceEvent element. This event is the unit imaging
procedure corresponding to a billable item. The type of imaging procedure may
be further described in the serviceEvent/code element. This guide makes no
specific recommendations about the vocabulary to use for describing this event.
Figure 44: DIR procedure context (CDA Header) illustration (non-normative)

ClinicalDocument
classCode*: <= DOCCLIN
moodCode*: <= EVN
id*: II [1..1]
code*: CE CWE [1..1] <= DocumentType
title*: ST [1..1]
effectiveTime*: TS [1..1]
confidentialityCode*: CE CWE [1..1] <=
x_BasicConfidentialityKind
languageCode: CS CNE [0..1] <= HumanLanguage
setId: II [0..1]
versionNumber: INT [0..1]
copyTime: TS [0..1] (Deprecated)

0..* serviceEvent

documentationOf
typeCode*: <= DOC

ServiceEvent
classCode*: <= ACT
moodCode*: <= EVN
id: SET [0..*]
code: CE CWE [0..1]
effectiveTime: IVL [0..1]

performer
typeCode*: <= x_ServiceEventPerformer
functionCode: CE CWE [0..1] <= ParticipationFunction
time: IVL [0..1]

0..* assignedEntity

0..1 representedOrganization
AssignedEntity
0..1 assignedPerson

In IHE Scheduled Workflow environments, one serviceEvent/id element
contains the DICOM Study Instance UID from the Modality Worklist, and the
second serviceEvent/id element contains the DICOM Requested Procedure ID
from the Modality Worklist. These two ids are in a single serviceEvent.
The effectiveTime for the serviceEvent covers the duration of the imaging
procedure being reported. This event should have one or more performers, which
may participate at the same or different periods of time.
Service events map to DICOM Requested Procedures. That is,
documentationOf/serviceEvent/id is the ID of the Requested Procedure.
8. SHALL contain exactly one [1..1] documentationOf (CONF:8416) such that it
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a. SHALL contain exactly one [1..1] serviceEvent (CONF:8431).
i.

This serviceEvent SHALL contain exactly one [1..1]
@classCode="ACT" (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6) (CONF:8430).

ii. This serviceEvent SHOULD contain zero or more [0..*] id
(CONF:8418).
iii. This serviceEvent SHALL contain exactly one [1..1] code
(CONF:8419).
1. The value of serviceEvent/code SHALL NOT conflict with
the ClininicalDocument/code. When transforming
from DICOM SR documents that do not contain a
procedure code, an appropriate nullFlavor SHALL be
used on serviceEvent/code. (CONF:8420).
iv. This serviceEvent SHOULD contain zero or more [0..*]
Physician Reading Study Performer
(templateId:2.16.840.1.113883.10.20.6.2.1)
(CONF:8422).
Figure 45: DIR documentationOf example

















Christine
Cure
MD







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4.3.1.8 RelatedDocument
A DIR may have three types of parent document:
A superseded version that the present document wholly replaces
(typeCode = RPLC). DIRs may go through stages of revision prior to
being legally authenticated. Such early stages may be drafts from
transcription, those created by residents, or other preliminary versions.
Policies not covered by this specification may govern requirements for
retention of such earlier versions. Except for forensic purposes, the
latest version in a chain of revisions represents the complete and
current report.
An original version that the present document appends (typeCode =
APND). When a DIR is legally authenticated, it can be amended by a
separate addendum document that references the original.
A source document from which the present document is transformed
(typeCode = XFRM). A DIR may be created by transformation from a
DICOM Structured Report (SR) document or from another DIR. An
example of the latter case is the creation of a derived document for
inclusion of imaging results in a clinical document.

9. MAY contain zero or one [0..1] relatedDocument (CONF:8432) such that it
a. When a Diagnostic Imaging Report has been transformed from a
DICOM SR document, relatedDocument/@typeCode SHALL be XFRM,
and relatedDocument/parentDocument/id SHALL contain the SOP
Instance UID of the original DICOM SR document. (CONF:8433).
10. The relatedDocument/id/@root attribute SHALL be a syntactically correct
OID, and SHALL NOT be a UUID. (CONF:10030).
a. OIDs SHALL be represented in dotted decimal notation, where each
decimal number is either 0 or starts with a nonzero digit. More
formally, an OID SHALL be in the form ([0-2])(.([1-9][0-9]*|0))+
(CONF:10031).
b. OIDs SHALL be no more than 64 characters in length. (CONF:10032).
Figure 46: DIR relatedDocument example








4.3.1.9 ComponentOf
The id element of the encompassingEncounter represents the identifier for the
encounter. When the diagnostic imaging procedure is performed in the context

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of a hospital stay or an outpatient visit for which there is an Encounter Number,
that number should be present as the ID of the encompassingEncounter.
The effectiveTime represents the time interval or point in time in which the
encounter took place. The encompassing encounter might be that of the hospital
or office visit in which the diagnostic imaging procedure was performed. If the
effective time is unknown, a nullFlavor attribute can be used.
11. MAY contain zero or one [0..1] componentOf (CONF:8434).
a. This componentOf, if present, SHALL contain exactly one [1..1]
encompassingEncounter (CONF:8449).
i.

This encompassingEncounter SHALL contain at least one [1..*]
id (CONF:8435).
1. In the case of transformed DICOM SR documents, an
appropriate null flavor MAY be used if the id is
unavailable. (CONF:8436).

ii. This encompassingEncounter SHALL contain exactly one [1..1]
effectiveTime (CONF:8437).
1. This effectiveTime SHALL contain exactly one [1..1] US
Realm Date and Time (DT.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.3) (CONF:10133).
iii. This encompassingEncounter MAY contain zero or more [0..1]
responsibleParty (CONF:8438).
1. This responsibleParty, if present, SHALL contain exactly
one [1..1] assignedEntity (CONF:9407).
a. SHOULD contain zero or one [0..1]
assignedPerson OR contain zero or one [0..1]
representedOrganization (CONF:8439).
iv. This encompassingEncounter SHOULD contain zero or one
[0..1] Physician of Record Participant
(templateId:2.16.840.1.113883.10.20.6.2.2)
(CONF:8448).

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Figure 47: DIR componentOf example













Dr.
Fay 
Family







4.3.1.10 Physician Reading Study Performer
[performer: templateId 2.16.840.1.113883.10.20.6.2.1(open)]
This participant is the Physician Reading Study Performer defined in
documentationOf/serviceEvent and is usually different from the attending
physician. The reading physician interprets the images and evidence of the
study (DICOM Definition)
1. SHALL contain exactly one [1..1] @typeCode="PRF" Performer (CodeSystem:
HL7ActClass 2.16.840.1.113883.5.6) (CONF:8424).
2. SHALL contain exactly one [1..1]
templateId/@root="2.16.840.1.113883.10.20.6.2.1" (CONF:8423).
3. MAY contain zero or one [0..1] time (CONF:8425).
a. This time SHALL contain exactly one [1..1] US Realm Date and Time
(DTM.US.FIELDED) (2.16.840.1.113883.10.20.22.5.4)
(CONF:10134).
4. SHALL contain exactly one [1..1] assignedEntity (CONF:8426).
a. This assignedEntity SHALL contain at least one [1..*] id
(CONF:10033).
i.

The id SHOULD include zero or one [0..1] id where id/@root
="2.16.840.1.113883.4.6" National Provider Identifier
(CONF:10034).

b. This assignedEntity SHALL contain exactly one [1..1] code
(CONF:8427).

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i.

contain a valid DICOM personal identification code
sequence (@codeSystem is 1.2.840.10008.2.16.4) or an
appropriate national health care provider coding system (e.g.,
NUCC in the U.S., where @codeSystem is
2.16.840.1.113883.6.101). (CONF:8428).
SHALL

c. Every assignedEntity element SHALL have at least one assignedPerson
or representedOrganization. (CONF:8429).
Figure 48: Physician reading study performer example









Christine
Cure
MD





4.3.1.11 Physician of Record Participant
[encounterParticipant: templateId
2.16.840.1.113883.10.20.6.2.2(open)]
This encounterParticipant is the attending physician and is usually different
from the Physician Reading Study Performer defined in
documentationOf/serviceEvent.
1. SHALL contain exactly one [1..1] @typeCode="ATND" Attender (CodeSystem:
HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8881).
2. SHALL contain exactly one [1..1]
templateId/@root="2.16.840.1.113883.10.20.6.2.2" (CONF:8440).
3. SHALL contain exactly one [1..1] assignedEntity (CONF:8886).
a. This assignedEntity SHALL contain at least one [1..*] id (CONF:8887).
i.

The id SHOULD include zero or one [0..1] id where id/@root
="2.16.840.1.113883.4.6" National Provider Identifier
(CONF:10035).

b. This assignedEntity SHALL contain exactly one [1..1] code
(CONF:8888).

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i.

contain a valid DICOM Organizational Role from
DICOM CID 745221 (Value Set
1.2.840.10008.6.1.516)(@codeSystem is
1.2.840.10008.2.16.4) or an appropriate national health
care provider coding system (e.g., NUCC in the U.S., where
@codeSystem is 2.16.840.1.113883.6.101) (CONF:8889).
SHALL

c. This assignedEntity SHOULD contain zero or one [0..1] name
(CONF:8890).
Figure 49: Physician of record participant example









Dr.
Fay
Family





DICOM Part 16 (NEMA PS3.16), page 631 in the 2011 edition. See
ftp://medical.nema.org/medical/dicom/2011/11_16pu.pdf
21

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4.3.2 DIR Body Constraints
The DIR supports both narrative sections and sections requiring coded clinical
statements. The required and optional sections are listed in the Document Types
and Required/Optional Sections table.
The following table shows relationships among the constrained templates in the
body of a DIR report.
Table 26: Template Containment for Constrained DIR Sections
Template Title

Template
Type

templateId

Diagnostic Imaging Report

document

2.16.840.1.113883.10.20.22.1.5

Fetus Subject Context

section

2.16.840.1.113883.10.20.6.2.3

Findings Section (DIR)

section

2.16.840.1.113883.10.20.6.1.2

Observer Context

section

2.16.840.1.113883.10.20.6.2.4

Physician of Record Participant

unspecified

2.16.840.1.113883.10.20.6.2.2

Physician Reading Study Performer

unspecified

2.16.840.1.113883.10.20.6.2.1

Procedure Context

entry

2.16.840.1.113883.10.20.6.2.5

DICOM Object Catalog Section - DCM
121181

section

2.16.840.1.113883.10.20.6.1.1

entry

2.16.840.1.113883.10.20.6.2.6

entry

2.16.840.1.113883.10.20.22.4.63

entry

2.16.840.1.113883.10.20.6.2.8

Purpose of Reference Observation

entry

2.16.840.1.113883.10.20.6.2.9

Referenced Frames Observation

entry

2.16.840.1.113883.10.20.6.2.10

entry

2.16.840.1.113883.10.20.6.2.11

Study Act
Series Act
SOP Instance Observation

Boundary Observation

4.3.2.1 DIR Section Constraints
The Section Type codes used by DIR are described below in the DIR Section Type
Codes table. All section codes shown in this table describe narrative document
sections22. The column headings of this table are:

22

DCM Code:

The code of the section in DICOM (Context
Group CID 7001)

DCM Code Meaning:

The display name of the section in DICOM
(Context Group CID 7001)

LOINC Code:

The code of the section in LOINC

LOINC Component Name:

The display name of the section in LOINC

SCALE_TYP = 'NAR' in the LOINC tables.

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Use:

The use column indicates that a section in
a Diagnostic Imaging Report is:
R – required
C – conditionally required
O – optional
Table 27: DIR Section Type Codes

DICOM Code

DICOM Code Meaning

LOINC Code

LOINC Code Meaning

Use

121181

DICOM Object Catalog

N/A

N/A

C

121060

History

11329-0

HISTORY GENERAL

O

121062

Request

55115-0

REQUESTED IMAGING
STUDIES INFORMATION

O

121064

Current Procedure
Descriptions

55111-9

CURRENT IMAGING
PROCEDURE DESCRIPTIONS

O

121066

Prior Procedure
Descriptions

55114-3

PRIOR IMAGING PROCEDURE
DESCRIPTIONS

O

121068

Previous Findings

18834-2

RADIOLOGY COMPARISON
STUDY - OBSERVATION

O

121070

Findings (DIR)

18782-3

RADIOLOGY STUDY
OBSERVATION

R

121072

Impressions

19005-8

RADIOLOGY - IMPRESSION

O

121074

Recommendations

18783-1

RADIOLOGY STUDY RECOMMENDATION

O

121076

Conclusions

55110-1

CONCLUSIONS

O

121078

Addendum

55107-7

ADDENDUM

O

121109

Indications for
Procedure

18785-6

RADIOLOGY REASON FOR
STUDY

O

121110

Patient Presentation

55108-5

CLINICAL PRESENTATION

O

121113

Complications

55109-3

COMPLICATIONS

O

121111

Summary

55112-7

DOCUMENT SUMMARY

O

121180

Key Images

55113-5

KEY IMAGES

O

For Level 2 conformance, all section elements that are present in the Body of
the document must have a code and some nonblank text or one or more
subsections, even if the purpose of the text is only to indicate that information is
unknown.
There is no equivalent to section/title in DICOM SR, so for a CDA to SR
transformation, the section/code will be transferred and the title element
will be dropped.
1. SHALL contain exactly one [1..1] component (CONF:14907).
a. A Diagnostic Imaging Report can have either a structuredBody or a
nonXMLBody (CONF:14908).
i.

A Diagnostic Imaging Report can conform to CDA Level 1
(nonXMLBody), CDA Level 2 (structuredBody with sections
that contain a narrative block), or CDA Level 3

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(structuredBody containing sections that contain a narrative
block and coded entries). In this template (templateId
2.16.840.1.113883.10.20.22.1.5), coded entries are optional
(CONF:14909).
b. If structuredBody, the component/structuredBody SHALL conform to
the section constraints below (CONF:14910).
i.

The DICOM Object Catalog section (templateId
2.16.840.1.113883.10.20.6.1.1), if present, SHALL be the first
section in the document Body (CONF:9408).

ii. SHALL contain exactly one [1..1] Findings Section (DIR)
(templateId:2.16.840.1.113883.10.20.6.1.2)
(CONF:9484).
iii. SHOULD contain zero or one [0..1] DICOM Object Catalog
Section - DCM 121181
(templateId:2.16.840.1.113883.10.20.6.1.1)
(CONF:15141).
iv. With the exception of the DICOM Object Catalog (templateId
2.16.840.1.113883.10.20.6.1.1), all sections within the
Diagnostic Imaging Report content SHOULD contain a title
element (CONF:9409).
v. The section/code SHOULD be selected from LOINC or DICOM
for sections not listed in the DIR Section Type Codes table
(CONF:9410).
1. Descriptions for sections is under development in
DICOM in cooperation with the RSNA reporting
initiative (CONF:9423).
vi. All sections defined in the DIR Section Type Codes table SHALL
be top-level sections (CONF:9411).
vii. A section element SHALL have a code element, which SHALL
contain a LOINC code or DCM code for sections that have no
LOINC equivalent. This only applies to sections described in
the DIR Section Type Codes table (CONF:9412).
viii. Apart from the DICOM Object Catalog (templateId
2.16.840.1.113883.10.20.6.1.1), all other instances of section
SHALL contain at least one text element or one or more
component elements (CONF:9413).
ix. All text or component elements SHALL contain content. text
elements SHALL contain PCDATA or child elements, and
component elements SHALL contain child elements
(CONF:9414).
x. The text elements (and their children) MAY contain Web Access
to DICOM Persistent Object (WADO) references to DICOM
objects by including a linkHtml element where @href is a valid
WADO URL and the text content of linkHtml is the visible text
of the hyperlink (CONF:9415).

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xi. If clinical statements are present, the section/text SHALL
represent faithfully all such statements and MAY contain
additional text (CONF:9416).
xii. MAY contain zero or more [0..*] Procedure Context
(templateId:2.16.840.1.113883.10.20.6.2.5)
(CONF:9417).
1. If the service context of a section is different from the
value specified in documentationOf/serviceEvent, then
the section SHALL contain one or more entries
containing Procedure Context (templateId
2.16.840.1.113883.10.20.6.2.5), which will reset the
context for any clinical statements nested within those
elements (CONF:9418).
xiii. MAY contain zero or more [0..*] Fetus Subject Context
(templateId:2.16.840.1.113883.10.20.6.2.3)
(CONF:9419).
1. If the subject of a section is a fetus, the section SHALL
contain a subject element containing a Fetus Subject
Context (templateId 2.16.840.1.113883.10.20.6.2.3)
(CONF:9420).
xiv. MAY contain zero or more [0..*] Observer Context
(templateId:2.16.840.1.113883.10.20.6.2.4)
(CONF:9421).
1. : If the author of a section is different from the
author(s) listed in the Header, an author element
SHALL be present containing Observer Context
(templateId 2.16.840.1.113883.10.20.6.2.4)
(CONF:9422).
Figure 50: WADO reference using linkHtml example

...

Source of Measurement
Chest
_PA

...


4.3.2.2 Fetus Subject Context
[relatedSubject: templateId 2.16.840.1.113883.10.20.6.2.3(open)]
For reports on mothers and their fetus(es), information on a mother is mapped
to recordTarget, PatientRole, and Patient. Information on the fetus is mapped to
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subject, relatedSubject, and SubjectPerson at the CDA section level. Both
context information on the mother and fetus must be included in the document
if observations on fetus(es) are contained in the document.
1. SHALL contain exactly one [1..1] templateId (CONF:9189) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.6.2.3" (CONF:10535).
2. SHALL contain exactly one [1..1] code="121026" (CodeSystem: DCM
1.2.840.10008.2.16.4) (CONF:9190).
3. SHALL contain exactly one [1..1] subject (CONF:9191).
4. SHALL contain exactly one [1..1] name (CONF:9192).
a. The name element is used to store the DICOM fetus ID, typically a
pseudonym such as fetus_1 (CONF:9193).
Figure 51: Fetus subject context example




fetus_1



4.3.2.3 Observer Context
[assignedAuthor: templateId 2.16.840.1.113883.10.20.6.2.4(open)]
The Observer Context is used to override the author specified in the CDA
Header. It is valid as a direct child element of a section.
1. SHALL contain exactly one [1..1] templateId (CONF:9194) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.6.2.4" (CONF:10536).
2. SHALL contain exactly one [1..1] assignedAuthor (CONF:9195).
3. SHALL contain at least one [1..*] id (CONF:9196).
a. The id element contains the author's id or the DICOM device observer
UID (CONF:9197).
4. Either assignedPerson or assignedAuthoringDevice SHALL be present
(CONF:9198).

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Figure 52: Observer context example





Richard
Blitz
MD




4.3.2.4 DIR Clinical Statements
A Diagnostic Imaging Report may contain CDA entries that represent, in coded
form findings, image references, annotation, and numeric measurements based
on DICOM Basic Diagnostic Imaging Report (Template 2000) and Transcribed
Diagnostic Imaging Report (Template 2005). Most of the constraints for this
document have been inherited from the DICOM PS 3.20 “Transformation of
DICOM to and from HL7 Standards”.
This document type and the companion DICOM PS 3.20 “Transformation of
DICOM to and from HL7 Standards” guide further constrain the transformation
because image Spatial Coordinates region of interest (SCOORD) for linear, area,
and volume measurements are not encoded in the CDA document. If it is
desired to show images with such graphical annotations, the annotations should
be encoded in DICOM Softcopy Presentation State objects that reference the
image. Report applications that display referenced images and annotation
should retrieve a rendered image using a WADO reference, including the image
and Presentation State, or other DICOM retrieval and rendering methods. This
approach avoids the risks of errors in registering a region of interest annotation
with DICOM images.
DICOM Template 2000 defines imaging report documents that are comprised of
a number of optional sections, including those defined above in DIR Section
Type Codes Each section contains:
Text Observations (Text Elements in DICOM SR), optionally inferred from
Quantity Measurement Observation or Image references
Code Observations (Code Elements in DICOM SR), optionally inferred
from Quantity Measurement Observation or Image references
Quantity Measurement Observation (Numeric Elements in DICOM SR)
with a coded measurement type, optionally inferred from an image
reference
Service Object Pair (SOP) Instance Observations containing image
references
The number or order of the observations and image references in the above
bullet points are not constrained in a section.
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4.4 Discharge Summary
[ClinicalDocument: templateId 2.16.840.1.113883.10.20.22.1.8(open)]
The Discharge Summary is a document that is a synopsis of a patient's
admission to a hospital; it provides pertinent information for the continuation of
care following discharge. The Joint Commission requires the following
information to be included in the Discharge Summary23:
The reason for hospitalization
The procedures performed
The care, treatment, and services provided
The patient’s condition and disposition at discharge
Information provided to the patient and family
Provisions for follow-up care

4.4.1 Discharge Summary Header Constraints
The Discharge Summary must conform to the US Realm Clinical Document
Header. The following sections include additional header constraints for
conformant Discharge Summaries.
1. SHALL contain exactly one [1..1] templateId (CONF:9479) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.1" (CONF:10043).

4.4.1.1 ClinicalDocument/templateId
Conformant documents must carry the document-level templateId asserting
conformance with specific constraints of a Discharge Summary as well as the
templateId for the US Realm Clinical Document Header template.
2. SHALL contain exactly one [1..1] templateId (CONF:8463) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.8" (CONF:10044).
Figure 53: Discharge summary ClinicalDocument/templateId example





Joint Commission Requirements for Discharge Summary (JCAHO IM.6.10 EP7). See
http://www.jointcommission.org/NR/rdonlyres/C9298DD0-6726-4105-A007FE2C65F77075/0/CMS_New_Revised_HAP_FINAL_withScoring.pdf..
23

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4.4.1.2 ClinicalDocument/code
The Discharge Summary LOINC Document Codes table shows the LOINC codes
suitable for Discharge Summary, as of publication of this implementation guide.
This is a dynamic value set meaning that these codes may be added to or
deprecated by LOINC.
The Discharge Summary recommends use of a single document type code,
18842-5 "Discharge Summarization Note", with further specification
provided by author or performer, setting, or specialty. Some of the LOINC codes
listed here pre-coordinate the practice setting or the training or professional
level of the author. Use of these codes is not recommended, as this duplicates
information that may be present in the header. If used, the pre-coordinated
codes must be consistent with the LOINC document type code.
3. SHALL contain exactly one [1..1] code (CONF:17178).
a. This code SHALL contain exactly one [1..1] @code, which SHALL be
selected from ValueSet DischargeSummaryDocumentTypeCode
2.16.840.1.113883.11.20.4.1 DYNAMIC (CONF:17179).
Table 28: Discharge summary LOINC Document Codes
Value Set: DischargeSummaryDocumentTypeCode 2.16.840.1.113883.11.20.4.1 DYNAMIC
Code System: LOINC 2.16.840.1.113883.6.1
LOINC Code

Type of Service
‘Component’

Setting
‘System’

Specialty/Training/Professional
Level ‘Method_Type’

Discharge summarization
note

{Setting}

{Provider}

Preferred Code
18842-5

Additional Codes
11490-0

Discharge summarization
note

{Setting}

Physician

28655-9

Discharge summarization
note

{Setting}

Attending physician

29761-4

Discharge summarization
note

{Setting}

Dentistry

34745-0

Discharge summarization
note

{Setting}

Nursing

34105-7

Discharge summarization
note

Hospital

{Provider}

34106-5

Discharge summarization
note

Hospital

Physician

Figure 54: Discharge summary ClinicalDocument/code example


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4.4.1.3 Participant
The participant element in the Discharge Summary header follows the General
Header Constraints for participants. Discharge Summary does not specify any
use for functionCode for participants. Local policies will determine how this
element should be used in implementations.

4.4.1.4 ComponentOf
The Discharge Summary is always associated with a Hospital Admission using
the encompassingEncounter element in the header.
The dischargeDispositionCode records the disposition of the patient at time
of discharge. Access to the National Uniform Billing Committee (NUBC) code
system requires a membership. The following conformance statement aligns with
HITSP C80 requirements.
The responsibleParty element represents only the party responsible for the
encounter, not necessarily the entire episode of care.
The encounterParticipant elements represent only those participants in the
encounter, not necessarily the entire episode of care.
The admission date is recorded in the
componnentOf/encompassingEncounter/
effectiveTime/low.
4. SHALL contain exactly one [1..1] componentOf (CONF:8471).
a. This componentOf SHALL contain exactly one [1..1]
encompassingEncounter (CONF:8472).
i.

This encompassingEncounter SHALL contain exactly one [1..1]
effectiveTime/low (CONF:8473).

ii. This encompassingEncounter SHALL contain exactly one [1..1]
effectiveTime/high (CONF:8475).
iii. The dischargeDispositionCode SHALL be present where the
value of code SHOULD be selected from ValueSet NUBC UB-04
FL17-Patient Status 2.16.840.1.113883.3.88.12.80.33
DYNAMIC (http://www.nubc.org) (CONF:8476).
1. The dischargeDispositionCode, @displayName, or
NUBC UB-04 Print Name, SHALL be displayed when the
document is rendered. (CONF:8477).
iv. The responsibleParty element MAY be present. If present, the
responsibleParty/assignedEntity element SHALL have at least
one assignedPerson or representedOrganization element
present. (CONF:8479).
v. The encounterParticipant elements MAY be present. If present,
the encounterParticipant/assignedEntity element SHALL have
at least one assignedPerson or representedOrganization
element present. (CONF:8478).

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Table 29: HL7 Discharge Disposition Codes
Code System: HL7 Discharge Disposition 2.16.840.1.113883.12.112
Code

Print Name

01

Discharged to home or self care (routine discharge)

02

Discharged/transferred to another short-term general hospital for inpatient
care

03

Discharged/transferred to skilled nursing facility (SNF)

04

Discharged/transferred to an intermediate-care facility (ICF)

05

Discharged/transferred to another type of institution for inpatient care or
referred for outpatient services to another institution

06

Discharged/transferred to home under care of organized home health service
organization

07

Left against medical advice or discontinued care

08

Discharged/transferred to home under care of Home IV provider

09

Admitted as an inpatient to this hospital

10 …19

Discharge to be defined at state level, if necessary

20

Expired (i.e., dead)

21 ... 29

Expired to be defined at state level, if necessary

30

Still patient or expected to return for outpatient services (i.e., still a patient)

31 … 39

Still patient to be defined at state level, if necessary (i.e., still a patient)

40

Expired (i.e., died) at home

41

Expired (i.e., died) in a medical facility; e.g., hospital, SNF, ICF, or freestanding hospice

42

Expired (i.e., died) - place unknown

Figure 55: Discharge summary componentOf example











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4.4.2 Discharge Summary Body Constraints
The Discharge Summary supports both narrative sections and sections requiring
code clinical statements. The required and optional sections are listed in the
Document Types and Required/Optional Sections table. The table below the
constraints shows all templates including entries within each section.
1. SHALL contain exactly one [1..1] component (CONF:9539).
a. A Discharge Summary can have either a structuredBody or a
nonXMLBody. (CONF:9537).
i.

A Discharge Summary can conform to CDA Level 1
(nonXMLBody), CDA Level 2 (structuredBody with sections
that contain a narrative block), or CDA Level 3
(structuredBody containing sections that contain a narrative
block and coded entries). In this template (templateId
2.16.840.1.113883.10.20.22.1.8), coded entries are optional.
(CONF:9538).

b. If structuredBody, the component/structuredBody SHALL conform to
the section constraints below. (CONF:9540).
i.

contain exactly one [1..1] Allergies Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.6)
(CONF:9542).
SHALL

ii. SHALL contain exactly one [1..1] Hospital Course Section
(templateId:1.3.6.1.4.1.19376.1.5.3.1.3.5)
(CONF:9544).
iii. SHALL contain exactly one [1..1] Hospital Discharge
Diagnosis Section
(templateId:2.16.840.1.113883.10.20.22.2.24)
(CONF:9546).
iv. SHALL contain exactly one [1..1] Hospital Discharge
Medications Section (entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.11)
(CONF:9548).
v. SHALL contain exactly one [1..1] Plan of Care Section
(templateId:2.16.840.1.113883.10.20.22.2.10)
(CONF:9550).
vi. SHALL NOT include a Chief Complaint and Reason for Visit
Section with either a Chief Complaint Section or a Reason for
Visit Section. (CONF:10055)
vii. MAY contain zero or one [0..1] Chief Complaint Section
(templateId:1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1)
(CONF:9554).
viii. MAY contain zero or one [0..1] Chief Complaint and Reason
for Visit Section
(templateId:2.16.840.1.113883.10.20.22.2.13)
(CONF:9556).

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ix. MAY contain zero or one [0..1] Discharge Diet Section
(templateId:1.3.6.1.4.1.19376.1.5.3.1.3.33)
(CONF:9558).
x. MAY contain zero or one [0..1] Family History Section
(templateId:2.16.840.1.113883.10.20.22.2.15)
(CONF:9560).
xi. MAY contain zero or one [0..1] Functional Status Section
(templateId:2.16.840.1.113883.10.20.22.2.14)
(CONF:9562).
xii. MAY contain zero or one [0..1] History of Past Illness
Section
(templateId:2.16.840.1.113883.10.20.22.2.20)
(CONF:9564).
xiii. MAY contain zero or one [0..1] History of Present Illness
Section (templateId: 1.3.6.1.4.1.19376.1.5.3.1.3.4)
(CONF:9566).
xiv. MAY contain zero or one [0..1] Hospital Admission
Diagnosis Section
(templateId:2.16.840.1.113883.10.20.22.2.43)
(CONF:9928).
xv. MAY contain zero or one [0..1] Hospital Admission
Medications Section (entries optional)
(2.16.840.1.113883.10.20.22.2.44) (CONF:10111).
xvi. MAY contain zero or one [0..1] Hospital Consultations
Section
(templateId:2.16.840.1.113883.10.20.22.2.42)
(CONF:9924).
xvii. MAY contain zero or one [0..1] Hospital Discharge
Instructions Section
(templateId:2.16.840.1.113883.10.20.22.2.41)
(CONF:9926).
xviii. MAY contain zero or one [0..1] Hospital Discharge
Physical Section
(templateId:1.3.6.1.4.1.19376.1.5.3.1.3.26)
(CONF:9568).
xix. MAY contain zero or one [0..1] Hospital Discharge Studies
Summary Section
(templateId:2.16.840.1.113883.10.20.22.2.16)
(CONF:9570).
xx. MAY contain zero or one [0..1] Immunizations Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.2)
(CONF:9572).
xxi. MAY contain zero or one [0..1] Problem Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.5)
(CONF:9574).

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xxii. MAY contain zero or one [0..1] Procedures Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.7)
(CONF:9576).
xxiii. MAY contain zero or one [0..1] Reason for Visit Section
(templateId:2.16.840.1.113883.10.20.22.2.12)
(CONF:9578).
xxiv. MAY contain zero or one [0..1] Review of Systems
Section (templateId:1.3.6.1.4.1.19376.1.5.3.1.3.18)
(CONF:9580).
xxv. MAY contain zero or one [0..1] Social History Section
(templateId:2.16.840.1.113883.10.20.22.2.17)
(CONF:9582).
xxvi. MAY contain zero or one [0..1] Vital Signs Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.4)
(CONF:9584).

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The following table shows relationships among the templates in the body of a
Discharge Summary.
Table 30: Template Containment for a Discharge Summary
Template Title
Discharge Summary

Template
Type

templateId

document

2.16.840.1.113883.10.20.22.1.8

section

2.16.840.1.113883.10.20.22.2.6

entry

2.16.840.1.113883.10.20.22.4.30

entry

2.16.840.1.113883.10.20.22.4.7

Allergy Status Observation

entry

2.16.840.1.113883.10.20.22.4.28

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

entry

2.16.840.1.113883.10.20.22.4.54

Allergies Section (entries optional)
Allergy Problem Act
Allergy - Intolerance Observation

Immunization Medication
Information

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Template Title

Template
Type

templateId

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.8

Chief Complaint and Reason for Visit
Section

section

2.16.840.1.113883.10.20.22.2.13

Chief Complaint Section

section

1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1

Discharge Diet Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.33

Family History Section

section

2.16.840.1.113883.10.20.22.2.15

entry

2.16.840.1.113883.10.20.22.4.45

entry

2.16.840.1.113883.10.20.22.4.46

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Family History Death Observation

entry

2.16.840.1.113883.10.20.22.4.47

Severity Observation
Severity Observation

Family History Organizer
Family History Observation

Functional Status Section

section

2.16.840.1.113883.10.20.22.2.14

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

Cognitive Status Problem Observation

entry

2.16.840.1.113883.10.20.22.4.73

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

Product Instance
Cognitive Status Result Observation

entry

2.16.840.1.113883.10.20.22.4.74

Assessment Scale Observation

entry

2.16.840.1.113883.10.20.22.4.69

Caregiver Characteristics

entry

2.16.840.1.113883.10.20.22.4.72

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

entry

2.16.840.1.113883.10.20.22.4.37

entry

2.16.840.1.113883.10.20.22.4.75

Product Instance
Cognitive Status Result Organizer

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Template Title
Cognitive Status Result Observation

Template
Type

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Assessment Scale Observation

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Caregiver Characteristics

entry

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Non-Medicinal Supply Activity

entry

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Product Instance

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Functional Status Problem
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Assessment Scale Observation

entry

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Caregiver Characteristics

entry

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entry

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Caregiver Characteristics

entry

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Non-Medicinal Supply Activity

entry

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entry

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entry

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entry

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Caregiver Characteristics

entry

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Non-Medicinal Supply Activity

entry

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entry

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entry

2.16.840.1.113883.10.20.22.4.50

entry

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section

2.16.840.1.113883.10.20.22.2.20

entry

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Age Observation

entry

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Health Status Observation

entry

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Product Instance
Functional Status Result Observation

Product Instance
Functional Status Result Organizer
Functional Status Result
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Product Instance
Non-Medicinal Supply Activity
Product Instance
History of Past Illness Section
Problem Observation

entry

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History of Present Illness Section

section

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Hospital Admission Diagnosis Section

section

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entry

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entry

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Health Status Observation

entry

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Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

section

2.16.840.1.113883.10.20.22.2.44

entry

2.16.840.1.113883.10.20.22.4.36

Hospital Admission Diagnosis
Problem Observation

Hospital Admission Medications Section
(entries optional)
Admission Medication

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Template Title
Medication Activity

Template
Type

templateId

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

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Service Delivery Location

entry

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Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.8

Hospital Consultations Section

Severity Observation

section

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Hospital Course Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.5

Hospital Discharge Diagnosis Section

section

2.16.840.1.113883.10.20.22.2.24

entry

2.16.840.1.113883.10.20.22.4.33

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

Hospital Discharge Diagnosis
Problem Observation

entry

2.16.840.1.113883.10.20.22.4.6

Hospital Discharge Instructions Section

section

2.16.840.1.113883.10.20.22.2.41

Hospital Discharge Medications Section
(entries optional)

section

2.16.840.1.113883.10.20.22.2.11

Discharge Medication

entry

2.16.840.1.113883.10.20.22.4.35

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

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July 2012

Template Title

Template
Type

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Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

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Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

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Indication

entry

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Instructions

entry

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Product Instance

entry

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Service Delivery Location

entry

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entry

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Hospital Discharge Physical Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.26

Hospital Discharge Studies Summary
Section

section

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Immunizations Section (entries
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section

2.16.840.1.113883.10.20.22.2.2

entry

2.16.840.1.113883.10.20.22.4.52

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Immunization Medication
Information

entry

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Immunization Refusal Reason

entry

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Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

entry

2.16.840.1.113883.10.20.22.4.54

Procedure Activity Procedure

Severity Observation

Immunization Activity

Immunization Medication
Information

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Template
Type

templateId

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

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Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
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entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

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Medication Supply Order

entry

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Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

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Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

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Type

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Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Product Instance

entry

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Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.10

Plan of Care Activity Act

entry

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Plan of Care Activity Encounter

entry

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Plan of Care Activity Observation

entry

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Plan of Care Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.41

Plan of Care Activity Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.42

Plan of Care Activity Supply

entry

2.16.840.1.113883.10.20.22.4.43

section

2.16.840.1.113883.10.20.22.2.5

entry

2.16.840.1.113883.10.20.22.4.3

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

section

2.16.840.1.113883.10.20.22.2.7

entry

2.16.840.1.113883.10.20.22.4.12

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

entry

2.16.840.1.113883.10.20.22.4.24

Severity Observation
Plan of Care Section

Problem Section (entries optional)
Problem Concern Act (Condition)
Problem Observation

Procedures Section (entries optional)
Procedure Activity Act

Drug Vehicle

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Template
Type

templateId

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.32

Procedure Activity Procedure

Severity Observation
Service Delivery Location
Procedure Activity Observation

entry

2.16.840.1.113883.10.20.22.4.13

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

entry

2.16.840.1.113883.10.20.22.4.54

Immunization Medication
Information

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Type

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Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

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Product Instance

entry

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Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

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Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

Procedure Activity Procedure

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance

entry

2.16.840.1.113883.10.20.22.4.25

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Template Title

Template
Type

templateId

Administration
Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.8

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Reason for Visit Section

section

2.16.840.1.113883.10.20.22.2.12

Review of Systems Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.18

Social History Section

section

2.16.840.1.113883.10.20.22.2.17

entry

2.16.840.1.113883.10.20.15.3.8

Estimated Date of Delivery

entry

2.16.840.1.113883.10.20.15.3.1

Smoking Status Observation

entry

2.16.840.1.113883.10.22.4.78

Social History Observation

entry

2.16.840.1.113883.10.20.22.4.38

section

2.16.840.1.113883.10.20.22.2.4

entry

2.16.840.1.113883.10.20.22.4.26

entry

2.16.840.1.113883.10.20.22.4.27

Severity Observation

Pregnancy Observation

Vital Signs Section (entries optional)
Vital Signs Organizer
Vital Sign Observation

4.5 History and Physical (H&P) Note
[ClinicalDocument: templateId 2.16.840.1.113883.10.20.22.1.3(open)]
A History and Physical (H&P) Note is a medical report that documents the
current and past conditions of the patient. It contains essential information that
helps determine an individual's health status.
The first portion of the report is a current collection of organized information
unique to an individual, typically supplied by the patient or their caregiver,
about the current medical problem or the reason for the patient encounter. This
information is followed by a description of any past or ongoing medical issues,
including current medications and allergies. Information is also obtained about
the patient's lifestyle, habits, and diseases among family members.
The next portion of the report contains information obtained by physically
examining the patient and gathering diagnostic information in the form of
laboratory tests, imaging, or other diagnostic procedures.
The report ends with the clinician's assessment of the patient's situation and the
intended plan to address those issues.
A History and Physical Examination is required upon hospital admission as well
as before operative procedures. An initial evaluation in an ambulatory setting is
often documented in the form of an H&P Note.

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4.5.1 H&P Note Header Constraints
The H&P Note must conform to the US Realm Clinical Document Header. The
following sections include additional header constraints for conformant H&P
Notes.
1. SHALL contain exactly one [1..1] templateId(CONF:9968) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.1" (CONF:10045).

4.5.1.1 ClinicalDocument/templateId
Conformant documents must carry the document-level templateId asserting
conformance with specific constraints of a H&P Note as well as the templateId
for the US Realm Clinical Document Header template.
1. SHALL contain exactly one [1..1] templateId (CONF:8283) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.3" History and Physical
Note (CONF:10046).
Figure 56: H&P ClinicalDocument/templateId example





4.5.1.2 ClinicalDocument/code
At publication time for this guide, H&P Note limits the
ClinicalDocument/code to those codes shown in the H&P LOINC Document
Type Codes table. Valid codes are those whose scale is DOC and whose type of
service is some variation of History and Physical.
The H&P Note recommends use of a single document type code, 34117-2
"History & Physical", with further specification provided by author or
performer, setting, or specialty. Some codes in the H&P LOINC Document Type
Codes table are pre-coordinated with the practice setting or the training or
professional level of the author. Use of these codes is not recommended, as this
duplicates information potentially present with the header. When precoordinated codes are used, any coded values describing the author or
performer of the service act or the practice setting must be consistent with the
LOINC document type.
2. SHALL contain exactly one [1..1] code (CONF:17185).
a. This code SHALL contain exactly one [1..1] @code, which SHALL be
selected from ValueSet HPDocumentType
2.16.840.1.113883.1.11.20.22 DYNAMIC (CONF:17186).

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Table 31: H&P LOINC Document Type Codes
Value Set: HPDocumentType 2.16.840.1.113883.1.11.20.22 DYNAMIC
Code System: LOINC 2.16.840.1.113883.6.1
LOINC Code

Type of Service
‘Component’

Setting
‘System’

Specialty/Training/
Professional Level
‘Method_Type’

Preferred Code
34117-2

History & Physical

Additional Codes
11492-6

History & Physical

Hospital

28626-0

History & Physical

Physician

34774-0

History & Physical

General surgery

34115-6

History & Physical

Hospital

Medical Student

34116-4

History & Physical

Nursing home

Physician

34095-0

Comprehensive History &
Physical

34096-8

Comprehensive History &
Physical

51849-8

Admission History & Physical

47039-3

Admission History & Physical

34763-3

Admission History & Physical

34094-3

Admission History & Physical

34138-8

Targeted History & Physical

Nursing home

Inpatient
General medicine
Hospital

Cardiology

Figure 57: H&P ClinicalDocument/code example


Figure 58: H&P use of translation to include local equivalents for document type




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4.5.1.3 Participant
The participant element in the H&P header follows the General Header
Constraints for participants. H&P Note does not specify any use for
functionCode for participants. Local policies will determine how this element
should be used in implementations.

4.5.1.4 InFulfillmentOf
inFulfillmentOf elements describe the prior orders that are fulfilled (in whole
or part) by the service events described in this document. For example, the prior
order might be a referral and the H&P Note may be in partial fulfillment of that
referral.
2. MAY contain zero or more [0..*] inFulfillmentOf (CONF:8336).
a. An inFulfillmentOf element records the prior orders that are fulfilled
(in whole or part) by the service events described in this document.
For example, the prior order might be a referral and this H&P Note
may be in partial fulfillment of that referral. (CONF:8337).

4.5.1.5 ComponentOf
The H&P Note is always associated with an encounter.
The effectiveTime represents the time interval or point in time in which the
encounter took place.
The encounterParticipant elements represent only those participants in the
encounter, not necessarily the entire episode of care.
The responsibleParty element represents only the party responsible for the
encounter, not necessarily the entire episode of care.
3. SHALL contain exactly one [1..1] componentOf (CONF:8338).
a. This componentOf SHALL contain exactly one [1..1]
encompassingEncounter (CONF:8339).
i. This encompassingEncounter SHALL contain exactly one [1..1]
id (CONF:8340).
ii. This encompassingEncounter SHALL contain exactly one [1..1]
effectiveTime (CONF:8341).
1. This effectiveTime SHALL contain exactly one [1..1] US
Realm Date and Time (DT.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.3) (CONF:10135).
iii. This encompassingEncounter MAY contain zero or one [0..1]
location (CONF:8344).
iv. This encompassingEncounter MAY contain zero or one [0..1]
responsibleParty (CONF:8345).
1. The responsibleParty element records only the party
responsible for the encounter, not necessarily the
entire episode of care. (CONF:8347).
2. The responsibleParty element, if present, SHALL
contain an assignedEntity element, which SHALL
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contain an assignedPerson element, a
representedOrganization element, or both.
(CONF:8348).
v. This encompassingEncounter MAY contain zero or more [0..*]
encounterParticipant (CONF:8342).
1. The encounterParticipant element, if present, records
only participants in the encounter, not necessarily in
the entire episode of care. (CONF:8346).
2. An encounterParticipant element, if present, SHALL
contain an assignedEntity element, which SHALL
contain an assignedPerson element, a
representedOrganization element, or both.
(CONF:8343).
Figure 59: H&P componentOf example











4.5.2 H&P Note Body Constraints
The H&P Note supports both narrative sections and sections requiring code
clinical statements. The required and optional sections are listed in the
Document Types and Required/Optional Sections table. The table below the
constraints shows all templates including entries within each section.
1. SHALL contain exactly one [1..1] component (CONF:8349).
a. A History and Physical document can have either a structuredBody
or a nonXMLBody. (CONF:8350).
i.

A History and Physical document can conform to CDA Level 1
(nonXMLBody), CDA Level 2 (structuredBody with sections
that contain a narrative block), or CDA Level 3
(structuredBody containing sections that contain a narrative
block and coded entries). In this template (templateId
2.16.840.1.113883.10.20.22.1.3), coded entries are optional.
(CONF:8352).

b. If structuredBody, the component/structuredBody SHALL conform to
the section constraints below (CONF:9597).
i.

This section SHALL contain exactly one [1..1] Allergies
Section (entries optional)

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(templateId:2.16.840.1.113883.10.20.22.2.6)
(CONF:9602).
ii. SHALL include an Assessment and Plan Section, or an
Assessment Section and a Plan Section. (CONF:9986).
iii. SHALL NOT include an Assessment/Plan Section when an
Assessment Section and a Plan of Care Section are present.
(CONF:10056)
iv. MAY contain zero or one [0..1] Assessment Section
(templateId:2.16.840.1.113883.10.20.22.2.8)
(CONF:9605).
v. MAY contain zero or one [0..1] Plan of Care Section
(templateId:2.16.840.1.113883.10.20.22.2.10)
(CONF:9607).
vi. MAY contain zero or one [0..1] Assessment and Plan
Section (templateId:2.16.840.1.113883.10.20.22.2.9)
(CONF:9987).
vii. SHALL include a Chief Complaint and Reason for Visit Section,
Chief Complaint Section, or a Reason for Visit Section.
(CONF:9642).
viii. SHALL NOT include a Chief Complaint and Reason for Visit
Section with either a Chief Complaint Section or a Reason for
Visit Section. (CONF:10057)
ix. MAY contain zero or one [0..1] Chief Complaint Section
(templateId:1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1)
(CONF:9611).
x. MAY contain zero or one [0..1] Chief Complaint and Reason
for Visit Section
(templateId:2.16.840.1.113883.10.20.22.2.13)
(CONF:9613).
xi. SHALL contain exactly one [1..1] Family History Section
(templateId:2.16.840.1.113883.10.20.22.2.15)
(CONF:9615).
xii. SHALL contain exactly one [1..1] General Status Section
(templateId:2.16.840.1.113883.10.20.2.5)
(CONF:9617).
xiii. SHALL contain exactly one [1..1] History of Past Illness
Section
(templateId:2.16.840.1.113883.10.20.22.2.20)
(CONF:9619).
xiv. SHALL contain exactly one [1..1] Medications Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.1)
(CONF:9623).
xv. SHALL contain exactly one [1..1] Physical Exam Section
(templateId:2.16.840.1.113883.10.20.2.10)
(CONF:9625).

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xvi. SHALL contain exactly one [1..1] Reason for Visit Section
(templateId:2.16.840.1.113883.10.20.22.2.12)
(CONF:9627).
xvii. SHALL contain exactly one [1..1] Results Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.3)
(CONF:9629).
xviii. SHALL contain exactly one [1..1] Review of Systems
Section (templateId:1.3.6.1.4.1.19376.1.5.3.1.3.18)
(CONF:9631).
xix. SHALL contain exactly one [1..1] Social History Section
(templateId:2.16.840.1.113883.10.20.22.2.17)
(CONF:9633).
xx. SHALL contain exactly one [1..1] Vital Signs Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.4)
(CONF:9635).
xxi. SHOULD contain exactly one [1..1] History of Present
Illness Section (templateId:
1.3.6.1.4.1.19376.1.5.3.1.3.4) (CONF:9621).
xxii. MAY contain zero or one [0..1] Immunizations Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.2)
(CONF:9637).
xxiii. MAY contain zero or one [0..1] Instructions Section
(templateId:2.16.840.1.113883.10.20.22.2.45)
(CONF:16807).
xxiv. MAY contain zero or one [0..1] Problem Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.5)
(CONF:9639).
xxv. MAY contain zero or one [0..1] Procedures Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.7)
(CONF:9641).
The following table shows relationships among the templates in the body of an
H&P Note.
Table 32: Template Containment for an H&P Note
Template Title

Template
Type

templateId

History and Physical

document

2.16.840.1.113883.10.20.22.1.3

section

2.16.840.1.113883.10.20.22.2.6

entry

2.16.840.1.113883.10.20.22.4.30

entry

2.16.840.1.113883.10.20.22.4.7

entry

2.16.840.1.113883.10.20.22.4.28

Allergies Section (entries optional)
Allergy Problem Act
Allergy - Intolerance Observation
Allergy Status Observation

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Template Title

Template
Type

templateId

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

entry

2.16.840.1.113883.10.20.22.4.54

Immunization Medication

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Template Title

Template
Type

templateId

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.9

Information

Severity Observation
Severity Observation
Assessment and Plan Section

entry

2.16.840.1.113883.10.20.22.4.39

Assessment Section

Plan of Care Activity Act

section

2.16.840.1.113883.10.20.22.2.8

Chief Complaint and Reason for Visit
Section

section

2.16.840.1.113883.10.20.22.2.13

Chief Complaint Section

section

1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1

Family History Section

section

2.16.840.1.113883.10.20.22.2.15

entry

2.16.840.1.113883.10.20.22.4.45

Family History Organizer
Family History Observation

entry

2.16.840.1.113883.10.20.22.4.46

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Family History Death Observation

entry

2.16.840.1.113883.10.20.22.4.47

General Status Section

section

2.16.840.1.113883.10.20.2.5

History of Past Illness Section

section

2.16.840.1.113883.10.20.22.2.20

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

Problem Observation

entry

2.16.840.1.113883.10.20.22.4.6

History of Present Illness Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.4

Immunizations Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.2

entry

2.16.840.1.113883.10.20.22.4.52

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Immunization Refusal Reason

entry

2.16.840.1.113883.10.20.22.4.53

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Immunization Activity

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Template Title

Template
Type

templateId

entry

2.16.840.1.113883.10.20.22.4.23

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

Medication Information
Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

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Template Title

Template
Type

templateId

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.1

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

Severity Observation
Medications Section (entries optional)
Medication Activity

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

Severity Observation

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Template Title

Template
Type

templateId

Physical Exam Section

section

2.16.840.1.113883.10.20.2.10

Plan of Care Section

section

2.16.840.1.113883.10.20.22.2.10

Plan of Care Activity Act

entry

2.16.840.1.113883.10.20.22.4.39

Plan of Care Activity Encounter

entry

2.16.840.1.113883.10.20.22.4.40

Plan of Care Activity Observation

entry

2.16.840.1.113883.10.20.22.4.44

Plan of Care Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.41

Plan of Care Activity Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.42

Plan of Care Activity Supply

entry

2.16.840.1.113883.10.20.22.4.43

section

2.16.840.1.113883.10.20.22.2.5

entry

2.16.840.1.113883.10.20.22.4.3

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

section

2.16.840.1.113883.10.20.22.2.7

entry

2.16.840.1.113883.10.20.22.4.12

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Problem Section (entries optional)
Problem Concern Act (Condition)
Problem Observation

Procedures Section (entries optional)
Procedure Activity Act

Procedure Activity Procedure

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Template Title

Template
Type

templateId

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.13

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

Severity Observation
Service Delivery Location
Procedure Activity Observation

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Severity Observation

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Template Title

Template
Type

templateId

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.8

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.32

Reason for Visit Section

section

2.16.840.1.113883.10.20.22.2.12

Results Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.3

entry

2.16.840.1.113883.10.20.22.4.1

entry

2.16.840.1.113883.10.20.22.4.2

Review of Systems Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.18

Social History Section

section

2.16.840.1.113883.10.20.22.2.17

entry

2.16.840.1.113883.10.20.15.3.8

Result Organizer
Result Observation

Pregnancy Observation
Estimated Date of Delivery

entry

2.16.840.1.113883.10.20.15.3.1

Smoking Status Observation

entry

2.16.840.1.113883.10.22.4.78

Social History Observation

entry

2.16.840.1.113883.10.20.22.4.38

section

2.16.840.1.113883.10.20.22.2.4

entry

2.16.840.1.113883.10.20.22.4.26

entry

2.16.840.1.113883.10.20.22.4.27

Vital Signs Section (entries optional)
Vital Signs Organizer
Vital Sign Observation

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4.6 Operative Note
[ClinicalDocument: templateId 2.16.840.1.113883.10.20.22.1.7(open)]
The Operative Note is a frequently used type of procedure note with specific
requirements set forth by regulatory agencies.
The Operative Note is created immediately following a surgical procedure and
records the pre- and post-surgical diagnosis, pertinent events of the procedure,
as well as the condition of the patient following the procedure. The report should
be sufficiently detailed to support the diagnoses, justify the treatment, document
the course of the procedure, and provide continuity of care.24

4.6.1 Operative Note Header Constraints
The Operative Note must conform to the US Realm Clinical Document Header.
The following sections include additional header constraints for conformant
Operative Notes.
1. SHALL contain exactly one [1..1] templateId (CONF:9914) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.1" (CONF:10047).

4.6.1.1 ClinicalDocument/templateId
Conformant documents must carry the document-level templateId asserting
conformance with specific constraints of an Operative Note as well as the
templateId for the US Realm Clinical Document Header template.
The following asserts conformance to an Operative Note.
2. SHALL contain exactly one [1..1] templateId (CONF:8483) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.7" (CONF:10048).
Figure 60: Operative note ClinicalDocument/templateId example





4.6.1.2 ClinicalDocument/code
The Surgical Operation Note LOINC Document Codes table shows the LOINC
codes suitable for Discharge Summary, as of publication of this implementation
guide. This is a dynamic value set meaning that these codes may be added to or
deprecated by LOINC.
24

http://www.jointcommission.org/mobile/standards_information/jcfaqdetails.aspx?Stan
dardsFAQId=215&StandardsFAQChapterId=13
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The Operative Note recommends use of a single document type code, 11504-8
"Surgical Operation Note", with further specification provided by author or
performer, setting, or specialty. Some of the LOINC codes in the Surgical
Operation Note LOINC Document Codes table are pre-coordinated with the
practice setting or the training or professional level of the author. Use of precoordinated codes is not recommended because of potential conflict with other
information in the header. When these codes are used, any coded values
describing the author or performer of the service act or the practice setting must
be consistent with the LOINC document type.
3. SHALL contain exactly one [1..1] code (CONF:17187).
a. This code SHALL contain exactly one [1..1] @code, which SHALL be
selected from ValueSet SurgicalOperationNoteDocumentTypeCode
2.16.840.1.113883.11.20.1.1 DYNAMIC (CONF:17188).
Table 33: Surgical Operation Note LOINC Document Codes
Value Set: SurgicalOperationNoteDocumentTypeCode 2.16.840.1.113883.11.20.1.1
DYNAMIC
Code System: LOINC 2.16.840.1.113883.6.1
LOINC
Code

Type of Service
‘Component’

Setting
‘System’

Specialty/Training/Professional
Level ‘Method_Type’

{Setting}

{Provider}

Preferred Code
11504-8

Surgical operation
note

Additional Codes
34137-0

Surgical operation
note

Outpatient

{Provider}

28583-3

Surgical operation
note

{Setting}

Dentistry

28624-5

Surgical operation
note

{Setting}

Podiatry

28573-4

Surgical operation
note

{Setting}

Physician

34877-1

Surgical operation
note

{Setting}

Urology

34874-8

Surgical operation
note

{Setting}

Surgery

34870-6

Surgical operation
note

{Setting}

Plastic surgery

34868-0

Surgical operation
note

{Setting}

Orthopedics

34818-5

Surgical operation
note

{Setting}

Otorhinolaryngology

The following code should not be used; it is a duplicate
34871-4

Surgical operation
note

{Setting}

Podiatry

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Figure 61: Operative note ClinicalDocument/code example


4.6.1.3 DocumentationOf
A serviceEvent represents the main act, such as a colonoscopy or an
appendectomy, being documented. A serviceEvent can further specialize the
act inherent in the ClinicalDocument/code, such as where the
ClinicalDocument/code is simply "Surgical Operation Note" and the procedure
is "Appendectomy." serviceEvent is required in the Operative Note and it must
be equivalent to or further specialize the value inherent in the
ClinicalDocument/code; it shall not conflict with the value inherent in the
ClinicalDocument/code, as such a conflict would create ambiguity.
serviceEvent/effectiveTime can be used to indicate the time the actual
event (as opposed to the encounter surrounding the event) took place.
If the date and the duration of the procedure is known,
serviceEvent/effectiveTime/low is used with a width element that
describes the duration; no high element is used. However, if only the date is
known, the date is placed in both the low and high elements.
4. SHALL contain at least one [1..*] documentationOf (CONF:8486).
a. Such documentationOf SHALL contain exactly one [1..1]
serviceEvent (CONF:8493).
i. The value of Clinical Document
/documentationOf/serviceEvent/code SHALL be from ICD9
CM Procedures (CodeSystem 2.16.840.1.113883.6.104), CPT4 (CodeSystem 2.16.840.1.113883.6.12), or values
descending from 71388002 (Procedure) from the SNOMED
CT (CodeSystem 2.16.840.1.113883.6.96) ValueSet
Procedure 2.16.840.1.113883.3.88.12.80.28 DYNAMIC.
(CONF:8487).
ii. This serviceEvent SHALL contain exactly one [1..1]
effectiveTime (CONF:8494).
1. This effectiveTime SHALL contain exactly one [1..1] US
Realm Date and Time (DT.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.3)
(CONF:10136).
2. The serviceEvent/effectiveTime SHALL be present with
effectiveTime/low (CONF:8488).
3. If a width is not present, the
serviceEvent/effectiveTime SHALL include
effectiveTime/high. (CONF:10058)
4. When only the date and the length of the procedure
are known a width element SHALL be present and the

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serviceEvent/effectiveTime/high SHALL not be
present. (CONF:10060).
The performer represents clinicians who actually and principally carry out the
serviceEvent. Typically, these are clinicians who have surgical privileges in
their institutions such as Surgeons, Obstetrician/Gynecologists, and Family
Practice Physicians. The performer may also be Nonphysician Providers (NPP)
who have surgical privileges. There may be more than one primary performer in
the case of complicated surgeries. There are occasionally co-surgeons. Usually
they will be billing separately and will each dictate their own notes. An example
may be spinal surgery , where a general surgeon and an orthopedic surgeon
both are present and billing off the same Current Procedural Terminology (CPT)
codes. Typically two Operative Notes are generated; however, each will list the
other as a co-surgeon.
iii. This serviceEvent SHALL contain exactly one [1..1] performer
(CONF:8489) such that it
1. SHALL contain exactly one [1..1] @typeCode="PPRF"
Primary performer (CodeSystem:
HL7ParticipationType 2.16.840.1.113883.5.90)
(CONF:8495).
2. SHALL contain exactly one [1..1] assignedEntity
(CONF:10917).
a. This assignedEntity SHALL contain exactly one
[1..1] code with @xsi:type="CE" (CONF:8490).
i.

This code SHOULD contain exactly one
[1..1] @code, which SHOULD be selected
from ValueSet Provider Type
2.16.840.1.113883.3.88.12.3221.4
DYNAMIC (CONF:8491).

b. Any assistants SHALL be identified and SHALL be identified as
secondary performers (SPRF). (CONF:8512).

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Table 34: Provider Type Value Set (excerpt)
Value Set: Provider Type 2.16.840.1.113883.3.88.12.3221.4 DYNAMIC
Code System(s):

NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101

Description:

The Provider type vocabulary classifies providers according to the type of
license or accreditation they hold or the service they provide.

http://www.nucc.org/index.php?option=com_content&task=view
&id=14&Itemid=40
Code

Code System

Print Name

207L00000X

NUCC Health Care Provider
Taxonomy

Anesthesiology

207X00000X

NUCC Health Care Provider
Taxonomy

Orthopedic Surgery

207VG0400X

NUCC Health Care Provider
Taxonomy

Gynecology

…
Table 35: Procedure Codes from SNOMED CT
Value Set: Procedure 2.16.840.1.113883.3.88.12.80.28 DYNAMIC
Code System(s):

SNOMED CT 2.16.840.1.113883.6.96

Description:

SNOMED CT Procedure codes. Any code descending from 71388002
(Procedure) inclusive.
https://uts.nlm.nih.gov/snomedctBrowser.html (requires sign-up)

Code

Code System

Print Name

408816000

SNOMED CT

Artificial rupture of membranes

20050329

SNOMED CT

Laparoscopic Appendectomy

62013009

SNOMED CT

Ambulating patient

…

Figure 62: Operative note serviceEvent example






...


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July 2012

Figure 63: Operative note performer example





1013 Healthcare Drive
Ann Arbor
MI
99999
US




Dr.
Carl
Cutter





4.6.2 Operative Note Body Constraints
The Operative Note supports both narrative sections and sections requiring code
clinical statements. The required and optional sections are listed in the
Document Types and Required/Optional Sections table. The table below the
constraints shows all templates including entries within each section.
1. SHALL contain exactly one [1..1] component (CONF:9585).
a. An Operative Note can have either a structuredBody or a
nonXMLBody (CONF:9586).
i.

An Operative Note can conform to CDA Level 1 (nonXMLBody),
CDA Level 2 (structuredBody with sections that contain a
narrative block), or CDA Level 3 (structuredBody containing
sections that contain a narrative block and coded entries). In
this template (templateId 2.16.840.1.113883.10.20.22.1.7),
coded entries are optional. (CONF:9587).

b. If structuredBody, the component/structuredBody SHALL conform to
the section constraints below (CONF:9596).
i.

contain exactly one [1..1] Anesthesia Section
(2.16.840.1.113883.10.20.22.2.25) (CONF:9883).
SHALL

ii. SHALL contain exactly one [1..1] Complications Section
(2.16.840.1.113883.10.20.22.2.37) (CONF:9885).
iii. SHALL contain exactly one [1..1] Postoperative Diagnosis
Section (2.16.840.1.113883.10.20.22.2.35)
(CONF:9913).

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iv. SHALL contain exactly one [1..1] Preoperative Diagnosis
Section (2.16.840.1.113883.10.20.22.2.34)
(CONF:9888).
v. SHALL contain exactly one [1..1] Procedure Estimated
Blood Loss Section
(2.16.840.1.113883.10.20.18.2.9) (CONF:9890).
vi. SHALL contain exactly one [1..1] Procedure Findings
Section (2.16.840.1.113883.10.20.22.2.28)
(CONF:9892).
vii. SHALL contain exactly one [1..1] Procedure Specimens
Taken Section (2.16.840.1.113883.10.20.22.2.31)
(CONF:9894).
viii. SHALL contain exactly one [1..1] Procedure Description
Section (2.16.840.1.113883.10.20.22.2.27)
(CONF:9896).
ix. MAY contain zero or one [0..1] Procedure Implants Section
(2.16.840.1.113883.10.20.22.2.40) (CONF:9898).
x. MAY contain zero or one [0..1] Operative Note Fluids
Section (2.16.840.1.113883.10.20.7.12) (CONF:9900).
xi. MAY contain zero or one [0..1] Operative Note Surgical
Procedure Section (2.16.840.1.113883.10.20.7.14)
(CONF:9902).
xii. MAY contain zero or one [0..1] Plan of Care Section
(2.16.840.1.113883.10.20.22.2.10) (CONF:9904).
xiii. MAY contain zero or one [0..1] Planned Procedure Section
(2.16.840.1.113883.10.20.22.2.30) (CONF:9906).
xiv. MAY contain zero or one [0..1] Procedure Disposition
Section (2.16.840.1.113883.10.20.18.2.12)
(CONF:9908).
xv. MAY contain zero or one [0..1] Procedure Indications
Section (2.16.840.1.113883.10.20.22.2.29)
(CONF:9910).
xvi. MAY contain zero or one [0..1] Surgical Drains Section
(2.16.840.1.113883.10.20.7.13) (CONF:9912).

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The following table shows relationships among the templates in the body of an
Operative Note.
Table 36: Template Containment for an Operative Note
Template Title

Template
Type

templateId

Operative Note

document

2.16.840.1.113883.10.20.22.1.7

section

2.16.840.1.113883.10.20.22.2.25

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Anesthesia Section
Medication Activity

Procedure Activity Procedure

Severity Observation
Procedure Activity Procedure

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Template Title

Template
Type

templateId

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.8

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

section

2.16.840.1.113883.10.20.22.2.37

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

Operative Note Fluids Section

section

2.16.840.1.113883.10.20.7.12

Operative Note Surgical Procedure Section

section

2.16.840.1.113883.10.20.7.14

Plan of Care Section

Severity Observation

Complications Section
Problem Observation

section

2.16.840.1.113883.10.20.22.2.10

Plan of Care Activity Act

entry

2.16.840.1.113883.10.20.22.4.39

Plan of Care Activity Encounter

entry

2.16.840.1.113883.10.20.22.4.40

Plan of Care Activity Observation

entry

2.16.840.1.113883.10.20.22.4.44

Plan of Care Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.41

Plan of Care Activity Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.42

Plan of Care Activity Supply

entry

2.16.840.1.113883.10.20.22.4.43

section

2.16.840.1.113883.10.20.22.2.30

entry

2.16.840.1.113883.10.20.22.4.41

Postoperative Diagnosis Section

section

2.16.840.1.113883.10.20.22.2.35

Preoperative Diagnosis Section

section

2.16.840.1.113883.10.20.22.2.34

Preoperative Diagnosis

entry

2.16.840.1.113883.10.20.22.4.65

Problem Observation

entry

2.16.840.1.113883.10.20.22.4.4

Planned Procedure Section
Plan of Care Activity Procedure

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Template Title

Template
Type

templateId

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

Procedure Description Section

section

2.16.840.1.113883.10.20.22.2.27

Procedure Disposition Section

section

2.16.840.1.113883.10.20.18.2.12

Procedure Estimated Blood Loss Section

section

2.16.840.1.113883.10.20.18.2.9

Procedure Findings Section

section

2.16.840.1.113883.10.20.22.2.28

Problem Observation

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

Procedure Implants Section

section

2.16.840.1.113883.10.20.22.2.40

Procedure Indications Section

section

2.16.840.1.113883.10.20.22.2.29

entry

2.16.840.1.113883.10.20.22.4.19

Procedure Specimens Taken Section

section

2.16.840.1.113883.10.20.22.2.31

Surgical Drains Section

section

2.16.840.1.113883.10.20.7.13

Indication

4.7 Procedure Note
[ClinicalDocument: templateId 2.16.840.1.113883.10.20.22.1.6(open)]
Procedure Note is a broad term that encompasses many specific types of nonoperative procedures including interventional cardiology, interventional
radiology, gastrointestinal endoscopy, osteopathic manipulation, and many
other specialty fields. Procedure Notes are documents that are differentiated
from Operative Notes in that the procedures documented do not involve incision
or excision as the primary act.
The Procedure Note is created immediately following a non-operative procedure
and records the indications for the procedure and, when applicable, postprocedure diagnosis, pertinent events of the procedure, and the patient’s
tolerance of the procedure. The document should be sufficiently detailed to
justify the procedure, describe the course of the procedure, and provide
continuity of care.

4.7.1 Procedure Note Header Constraints
The Procedure Note must conform to the US Realm Clinical Document Header.
The following sections include additional header constraints for conformant
Procedure Notes
1. SHALL contain exactly one [1..1] templateId/ (CONF:9969) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.1" (CONF:10049).

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4.7.1.1 ClinicalDocument/templateId
Conformant documents must carry the document-level templateId asserting
conformance with specific constraints of a Procedure Note as well as the
templateId for the US Realm Clinical Document Header template.
2. SHALL contain exactly one [1..1] templateId (CONF:8496) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.6" (CONF:10050).
Figure 64: Procedure note ClinicalDocument/templateId category I example





4.7.1.2 ClinicalDocument/code
The Procedure Note limits document type codes to those codes listed in the
LOINC Codes for Procedure Note Documents. The tables lists all codes having
the scale DOC (document) and a ‘component’ referring to a non-operative
procedure, whether or not the text string "Procedure" is present.
The Procedure Note recommends use of a single document type code, 28570-0
"Procedure Note", with further specification provided by author or performer,
setting, or specialty. Some of the LOINC codes in the LOINC Codes for Procedure
Note Documents table are pre-coordinated with the practice setting or the
training or professional level of the author. Use of pre-coordinated codes is not
recommended because of potential conflict with other information in the header.
When these codes are used, any coded values describing the author or
performer of the service act or the practice setting must be consistent with the
LOINC document type.
3. SHALL contain exactly one [1..1] code (CONF:17182).
a. This code SHALL contain exactly one [1..1] @code, which SHALL be
selected from ValueSet ProcedureNoteDocumentTypeCodes
2.16.840.1.113883.11.20.6.1 DYNAMIC (CONF:17183).

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Table 37: Procedure Note LOINC Document Type Codes
Value Set: ProcedureNoteDocumentTypeCodes 2.16.840.1.113883.11.20.6.1 DYNAMIC
Code System: LOINC 2.16.840.1.113883.6.1
LOINC
Code

Type of Service
‘Component’

Setting
‘System’

Specialty/Training/Professional Level
‘Method_Type’

{Setting}

{Provider}

Preferred Code
28570-0

Procedure note

Additional Codes
11505-5

Procedure note

{Setting}

Physician

18744-3

Study report

Respiratory
system

Bronchoscopy

18745-0

Study report

Heart

Cardiac catheterization

18746-8

Study report

Lower GI
tract

Colonoscopy

18751-8

Study report

Upper GI
tract

Endoscopy

18753-4

Study report

Lower GI
tract

Flexible sigmoidoscopy

18836-7

Procedure

Cardiac
stress study

*

28577-5

Procedure note

{Setting}

Dentistry

28625-2

Procedure note

{Setting}

Podiatry

29757-2

Study report

Cvx/Vag

Colposcopy

33721-2

Bone marrow biopsy
report

Bone mar

34121-4

Interventional
procedure note

{Setting}

34896-1

Interventional
procedure note

{Setting}

Cardiology

34899-5

Interventional
procedure note

{Setting}

Gastroenterology

47048-4

Diagnostic
interventional study
report

{Setting}

Interventional radiology

48807-2

Bone marrow
aspiration report

Bone mar

Figure 65: Procedure note ClinicalDocument/code example


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4.7.1.3 ComponentOf
4. SHOULD contain zero or one [0..1] componentOf/encompassingEncounter
(CONF:8499).
a. This componentOf/encompassingEncounter SHALL contain exactly
one [1..1] code (CONF:8501).
b. This componentOf/encompassingEncounter SHALL contain at least
one [1..*] location/healthCareFacility/id (CONF:8500).
c. This componentOf/encompassingEncounter MAY contain zero or one
[0..1] encounterParticipant (CONF:8502) such that it
i. SHALL contain exactly one [1..1] @typeCode="REF" Referrer
(CodeSystem: HL7ParticipationType
2.16.840.1.113883.5.90) (CONF:8503).

4.7.1.4 Generic Participant: Primary Care Provider
The participant element in the Procedure Note header follows the General
Header Constraints for participants. The Participant Scenarios table shows a
number of scenarios and the values for various participants.
5. MAY contain zero or more [0..*] participant (CONF:8504) such that it
a. SHALL contain exactly one [1..1] @typeCode="IND" Individual
(CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90)
(CONF:8505).
b. SHALL contain exactly one [1..1] functionCode="PCP" Primary Care
Physician (CodeSystem: participationFunction
2.16.840.1.113883.5.88) (CONF:8506).
c. SHALL contain exactly one [1..1]
associatedEntity/@classCode="PROV" Provider (CodeSystem:
HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8507).
i. This associatedEntity/@classCode SHALL contain exactly one
[1..1] associatedPerson (CONF:8508).

4.7.1.5 Participant Scenarios
Table 38: Participant Scenario
Scenario

Author

Custodian

Data
Enterer

Encompassing
Encounter/
Encounter
Participant

Legal
Authenticator

Participant

Service
Event/
Performer

Colonoscopy Participant Scenario: A surgeon refers a patient to an endoscopist. A colonoscopy is
performed at an outpatient surgery center. The endoscopist inputs information into an EHR. The
outpatient surgery center EHR generates a Procedure Note to send to the Hospital EHR.
Endoscopic
CDA
Procedure
Note

Endoscopist

Outpatient
surgery
center

None

Surgeon
[REF
(referrer)]

Endoscopist

None

Endoscopis
t

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Scenario

Author

Custodian

Data
Enterer

Encompassing
Encounter/
Encounter
Participant

Legal
Authenticator

Participant

Service
Event/
Performer

Office Removal of Wart Participation Scenario: A wart is removed during an office visit. The PCP
dictates the procedure into the local transcription system. The transcription system generates a CDA
Procedure Note to the EHR.
CDA
Procedure
Note

PCP

PCP
office

Transcriptionist

None

PCP

None

PCP

Dental Procedure Participation Scenario: Dentist extracts a tooth after the patient has a cleaning by
the hygenist. He enters the information into his Dental EHR.
Procedure
input to
EHR

Dentist

Dentist
office

Varies

None

Dentist

None

Dentist
Hygenist

Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure (Interventional Radiology)
Participant Scenario: At a university hospital, a TIPS procedure is performed by the interventional
radiology fellow, with the help of an interventional radiology nurse, under the supervision of an
attending interventional radiologist. The radiology technician enters the data into the EMR. The patient
was referred to the university hospital by his oncologist. The patient is insured by Cigna.
Procedure
Note is
input in
EHR

Interventional
radiology
fellow

Good
Health
Hospita
l

Interventional
radiology
technician

REF
(referrer)
Oncologist

Attending
interventional
radiologist

Cigna

Interventional
radiology
fellow
Nurse
Attending
interventional
radiologist

Lumbar Puncture (spinal tap) Procedure Participant Scenario: At a university hospital, a lumbar
puncture is performed by a medical student, with the help of an intern, under the supervisory authority
of an attending neurologist. The student performs the procedure and dictates the note. The note is
signed by the intern and attending. The patient has a family doctor that is not participating in the
procedure, did not refer the patient, and does not have privileges at the providing organization but is
recorded in the note.
Procedure
Note is
dictated
by the
medical
student

Medical
student

Good
Health
Hospita
l

Transcriptionist

None

Neurology
attending
(Intern is
authenticator)

Family
doctor

Medical
student
Intern

4.7.1.6 ServiceEvent
A serviceEvent is required in the Procedure Note to represent the main act,
such as a colonoscopy or a cardiac stress study, being documented. It must be
equivalent to or further specialize the value inherent in the
ClinicalDocument/@code (such as where the ClinicalDocument/@code is
simply "Procedure Note" and the procedure is "colonoscopy"), and it shall not

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conflict with the value inherent in the ClinicalDocument/@code, as such a
conflict would create ambiguity. A serviceEvent/effectiveTime element
indicates the time the actual event (as opposed to the encounter surrounding
the event) took place.
serviceEvent/effectiveTime may be represented two different ways in the
Procedure Note. For accuracy to the second, the best method is
effectiveTime/low together with effectiveTime/high. If a more general
time, such as minutes or hours, is acceptable OR if the duration is unknown, an
effectiveTime/low with a width element may be used. If the duration is
unknown, the appropriate HL7 null value such as "NI" or "NA" must be used for
the width element.
6. SHALL contain at least one [1..*] documentationOf (CONF:8510).
a. Such documentationOf SHALL contain exactly one [1..1]
serviceEvent (CONF:10061).
i.

The value of Clinical Document
/documentationOf/serviceEvent/code SHALL be from ICD9 CM
Procedures (codeSystem 2.16.840.1.113883.6.104), CPT-4
(codeSystem 2.16.840.1.113883.6.12), or values descending
from 71388002 (Procedure) from the SNOMED CT
(codeSystem 2.16.840.1.113883.6.96) ValueSet Procedure
2.16.840.1.113883.3.88.12.80.28 DYNAMIC. (CONF:8511).

ii. This serviceEvent SHALL contain exactly one [1..1]
effectiveTime (CONF:10062).
1. This effectiveTime SHALL contain exactly one [1..1] US
Realm Date and Time (DT.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.3) (CONF:10063)
2. The serviceEvent/effectiveTime SHALL be present with
effectiveTime/low (CONF:8513).
3. If a width is not present, the
serviceEvent/effectiveTime SHALL include
effectiveTime/high. (CONF:8514)
4. When only the date and the length of the procedure
are known a width element SHALL be present and the
serviceEvent/effectiveTime/high SHALL not be present.
(CONF:8515).
The performer participant represents clinicians who actually and principally
carry out the serviceEvent. Typically, these are clinicians who have the
appropriate privileges in their institutions such as gastroenterologists,
interventional radiologists, and family practice physicians. Performers may also
be non-physician providers (NPPs) who have other significant roles in the
procedure such as a radiology technician, dental assistant, or nurse.
iii. SHALL contain exactly one [1..1] performer (CONF:8520) such
that it
1. SHALL contain exactly one [1..1] @typeCode="PPRF"
Primary Performer (CodeSystem:
HL7ParticipationType 2.16.840.1.113883.5.90)
(CONF:8521).
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2. SHALL contain exactly one [1..1] assignedEntity
(CONF:14911).
a. This assignedEntity SHOULD contain zero or one
[0..1] code (CONF:14912).
i.

The code, if present, SHOULD contain
zero or one [0..1] @code, which SHALL be
selected from ValueSet Healthcare
Provider Taxonomy (NUCC - HIPAA)
2.16.840.1.114222.4.11.1066
DYNAMIC (CONF:14913).

iv. Any assistants SHALL be identified and SHALL be identified as
secondary performers (SPRF). (CONF:8524).
Table 39: Healthcare Provider Taxonomy Value Set
Value Set: Healthcare Provider Taxonomy (NUCC - HIPAA) 2.16.840.1.114222.4.11.1066
DYNAMIC
Code System(s):
Code

NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101
Code System

Print Name

122300000X

NUCC Health Care Provider Taxonomy

Dentist

124Q00000X

NUCC Health Care Provider Taxonomy

Dental Hygienist

126800000X

NUCC Health Care Provider Taxonomy

Dental Assistant/Tech

133V00000X

NUCC Health Care Provider Taxonomy

Dietitian, Registered

146L00000X

NUCC Health Care Provider Taxonomy

EMT/Paramedic

163W00000X

NUCC Health Care Provider Taxonomy

Registered Nurse

163WI0500X

NUCC Health Care Provider Taxonomy

IVT Team Staff

163WI0600X

NUCC Health Care Provider Taxonomy

Infection Control Professional

163WX0106X

NUCC Health Care Provider Taxonomy

Occupational Health
Professional

164W00000X

NUCC Health Care Provider Taxonomy

Licensed Practical Nurse

167G00000X

NUCC Health Care Provider Taxonomy

Psychiatric Technician

183500000X

NUCC Health Care Provider Taxonomy

Pharmacist

207PE0004X

NUCC Health Care Provider Taxonomy

Other First Responder

227800000X

NUCC Health Care Provider Taxonomy

Respiratory Therapist/Tech

227900000X

NUCC Health Care Provider Taxonomy

Other Student

246QM0706X

NUCC Health Care Provider Taxonomy

Medical Technologist

246RP1900X

NUCC Health Care Provider Taxonomy

Phlebotomist/IV Team

247100000X

NUCC Health Care Provider Taxonomy

Radiologic Technologist

261QD0000X

NUCC Health Care Provider Taxonomy

Other Dental Worker

261QP2000X

NUCC Health Care Provider Taxonomy

Physical Therapist

261QR1100X

NUCC Health Care Provider Taxonomy

Researcher

332B00000X

NUCC Health Care Provider Taxonomy

Central Supply

363A00000X

NUCC Health Care Provider Taxonomy

Physician Assistant

363L00000X

NUCC Health Care Provider Taxonomy

Nurse Practitioner

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
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July 2012
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Value Set: Healthcare Provider Taxonomy (NUCC - HIPAA) 2.16.840.1.114222.4.11.1066
DYNAMIC
Code System(s):
Code

NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101
Code System

Print Name

364SC1501X

NUCC Health Care Provider Taxonomy

Public Health Worker

367500000X

NUCC Health Care Provider Taxonomy

Nurse Anesthetist

367A00000X

NUCC Health Care Provider Taxonomy

Nurse Midwife

3747A0650X

NUCC Health Care Provider Taxonomy

Attendant/orderly

376K00000X

NUCC Health Care Provider Taxonomy

Nursing Assistant

Figure 66: Procedure note serviceEvent example






...


Figure 67: Procedure note serviceEvent example with null value in width element






...


Page 176
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© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

Figure 68: Procedure note performer example





1001 Hospital Lane
Ann Arbor
MI
99999
US




Dr.
Tony
Tum




4.7.2 Procedure Note Body Constraints
The Procedure Note supports both narrative sections and sections requiring code
clinical statements. The required and optional sections are listed in the
Document Types and Required/Optional Sections table. The table below the
constraints shows all templates including entries within each section.
1. SHALL contain exactly one [1..1] component (CONF:9588).
a. A Procedure Note can have either a structuredBody or a
nonXMLBody (CONF:9589).
i.

A Procedure Note can conform to CDA Level 1 (nonXMLBody),
CDA Level 2 (structuredBody with sections that contain a
narrative block), or CDA Level 3 (structuredBody containing
sections that contain a narrative block and coded entries). In
this template (templateId 2.16.840.1.113883.10.20.22.1.6),
coded entries are optional. (CONF:9590).

b. If structuredBody, the component/structuredBody SHALL conform to
the section constraints below (CONF:9595).
i.

Each section SHALL have a title and the title SHALL NOT
be empty (CONF:9937).

ii. SHALL include an Assessment and Plan Section, or an
Assessment Section and a Plan Section. (CONF:9643).
iii. SHALL NOT include an Assessment/Plan Section when an
Assessment Section and a Plan of Care Section are present.
(CONF:10064)

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July 2012
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iv. MAY contain zero or one [0..1] Assessment Section
(templateId:2.16.840.1.113883.10.20.22.2.8)
(CONF:9645).
v. MAY contain zero or one [0..1] Plan of Care Section
(templateId:2.16.840.1.113883.10.20.22.2.10)
(CONF:9647).
vi. MAY contain zero or one [0..1] Assessment and Plan
Section (templateId:2.16.840.1.113883.10.20.22.2.9)
(CONF:9649).
vii. SHALL contain exactly one [1..1] Complications Section
(templateId:2.16.840.1.113883.10.20.22.2.37)
(CONF:9802).
viii. SHALL contain exactly one [1..1] Postprocedure Diagnosis
Section
(templateId:2.16.840.1.113883.10.20.22.2.36)
(CONF:9850).
ix. SHALL contain exactly one [1..1] Procedure Description
Section
(templateId:2.16.840.1.113883.10.20.22.2.27)
(CONF:9805).
x. SHALL contain exactly one [1..1] Procedure Indications
Section
(templateId:2.16.840.1.113883.10.20.22.2.29)
(CONF:9807).
xi. MAY contain zero or one [0..1] Allergies Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.6)
(CONF:9809).
xii. MAY contain zero or one [0..1] Anesthesia Section
(templateId:2.16.840.1.113883.10.20.22.2.25)
(CONF:9811).
xiii. SHALL NOT include a Chief Complaint and Reason for Visit
Section with either a Chief Complaint Section or a Reason for
Visit Section. (CONF:10065)
xiv. MAY contain zero or one [0..1] Chief Complaint Section
(templateId:1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1)
(CONF:9813).
xv. MAY contain zero or one [0..1] Chief Complaint and Reason
for Visit Section
(templateId:2.16.840.1.113883.10.20.22.2.13)
(CONF:9815).
xvi. MAY contain zero or one [0..1] Family History Section
(templateId:2.16.840.1.113883.10.20.22.2.15)
(CONF:9817).
xvii. MAY contain zero or one [0..1] History of Past Illness
Section

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© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

(templateId:2.16.840.1.113883.10.20.22.2.20)
(CONF:9819).
xviii. MAY contain zero or one [0..1] History of Present
Illness Section (templateId:
1.3.6.1.4.1.19376.1.5.3.1.3.4) (CONF:9821).
xix. MAY contain zero or one [0..1] Medical (General) History
Section
(templateId:2.16.840.1.113883.10.20.22.2.39)
(CONF:9823).
xx. MAY contain zero or one [0..1] Medications Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.1)
(CONF:9825).
xxi. MAY contain zero or one [0..1] Medications Administered
Section
(templateId:2.16.840.1.113883.10.20.22.2.38)
(CONF:9827).
xxii. MAY contain zero or one [0..1] Physical Exam Section
(templateId:2.16.840.1.113883.10.20.2.10)
(CONF:9829).
xxiii. MAY contain zero or one [0..1] Planned Procedure
Section
(templateId:2.16.840.1.113883.10.20.22.2.30)
(CONF:9831).
xxiv. MAY contain zero or one [0..1] Procedure Disposition
Section
(templateId:2.16.840.1.113883.10.20.18.2.12)
(CONF:9833).
xxv. MAY contain zero or one [0..1] Procedure Estimated Blood
Loss Section
(templateId:2.16.840.1.113883.10.20.18.2.9)
(CONF:9835).
xxvi. MAY contain zero or one [0..1] Procedure Findings
Section
(templateId:2.16.840.1.113883.10.20.22.2.28)
(CONF:9837).
xxvii. MAY contain zero or one [0..1] Procedure Implants
Section
(templateId:2.16.840.1.113883.10.20.22.2.40)
(CONF:9839).
xxviii. MAY contain zero or one [0..1] Procedure Specimens
Taken Section
(templateId:2.16.840.1.113883.10.20.22.2.31)
(CONF:9841).
xxix. MAY contain zero or one [0..1] Procedures Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.7)
(CONF:9843).
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
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July 2012
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xxx. MAY contain zero or one [0..1] Reason for Visit Section
(templateId:2.16.840.1.113883.10.20.22.2.12)
(CONF:9845).
xxxi. MAY contain zero or one [0..1] Review of Systems
Section (templateId:1.3.6.1.4.1.19376.1.5.3.1.3.18)
(CONF:9847).
xxxii. MAY contain zero or one [0..1] Social History Section
(templateId:2.16.840.1.113883.10.20.22.2.17)
(CONF:9849).
The following table shows relationships among the templates in the body of a
Procedure Note.
Table 40: Template Containment for a Procedure Note
Template Title

Template
Type

templateId

Procedure Note

document

2.16.840.1.113883.10.20.22.1.6

section

2.16.840.1.113883.10.20.22.2.6

entry

2.16.840.1.113883.10.20.22.4.30

Allergies Section (entries optional)
Allergy Problem Act
Allergy - Intolerance Observation

entry

2.16.840.1.113883.10.20.22.4.7

Allergy Status Observation

entry

2.16.840.1.113883.10.20.22.4.28

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

entry

2.16.840.1.113883.10.20.22.4.19

Indication

Page 180
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July 2012

Template Title

Template
Type

templateId

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.25

Severity Observation
Severity Observation
Anesthesia Section
Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

entry

2.16.840.1.113883.10.20.22.4.54

Immunization Medication Information

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
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Template Title

Template
Type

templateId

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

Procedure Activity Procedure

Severity Observation
Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.8

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

section

2.16.840.1.113883.10.20.22.2.9

entry

2.16.840.1.113883.10.20.22.4.39

section

2.16.840.1.113883.10.20.22.2.8

Severity Observation

Assessment and Plan Section
Plan of Care Activity Act
Assessment Section

Page 182
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July 2012

Template Title

Template
Type

templateId

Chief Complaint and Reason for Visit
Section

section

2.16.840.1.113883.10.20.22.2.13

Chief Complaint Section

section

1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1

Complications Section

section

2.16.840.1.113883.10.20.22.2.37

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

section

2.16.840.1.113883.10.20.22.2.15

entry

2.16.840.1.113883.10.20.22.4.45

entry

2.16.840.1.113883.10.20.22.4.46

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Family History Death Observation

entry

2.16.840.1.113883.10.20.22.4.47

section

2.16.840.1.113883.10.20.22.2.20

Problem Observation

Family History Section
Family History Organizer
Family History Observation

History of Past Illness Section
Problem Observation

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

History of Present Illness Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.4

Medical (General) History Section

section

2.16.840.1.113883.10.20.22.2.39

Medications Administered Section

section

2.16.840.1.113883.10.20.22.2.38

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
Page 183
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Template Title

Template
Type

templateId

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.1

Procedure Activity Procedure

Severity Observation
Medications Section (entries optional)
Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

Physical Exam Section

section

2.16.840.1.113883.10.20.2.10

Plan of Care Section

section

2.16.840.1.113883.10.20.22.2.10

Plan of Care Activity Act

entry

2.16.840.1.113883.10.20.22.4.39

Plan of Care Activity Encounter

entry

2.16.840.1.113883.10.20.22.4.40

Plan of Care Activity Observation

entry

2.16.840.1.113883.10.20.22.4.44

Plan of Care Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.41

Plan of Care Activity Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.42

Procedure Activity Procedure

Severity Observation

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July 2012

Template Title

Template
Type

templateId

entry

2.16.840.1.113883.10.20.22.4.43

section

2.16.840.1.113883.10.20.22.2.30

entry

2.16.840.1.113883.10.20.22.4.41

section

2.16.840.1.113883.10.20.22.2.36

Postprocedure Diagnosis

entry

2.16.840.1.113883.10.20.22.4.51

Problem Observation

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

Procedure Description Section

section

2.16.840.1.113883.10.20.22.2.27

Procedure Disposition Section

section

2.16.840.1.113883.10.20.18.2.12

Procedure Estimated Blood Loss Section

section

2.16.840.1.113883.10.20.18.2.9

Procedure Findings Section

section

2.16.840.1.113883.10.20.22.2.28

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

Procedure Implants Section

section

2.16.840.1.113883.10.20.22.2.40

Procedure Indications Section

section

2.16.840.1.113883.10.20.22.2.29

entry

2.16.840.1.113883.10.20.22.4.19

Procedure Specimens Taken Section

section

2.16.840.1.113883.10.20.22.2.31

Procedures Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.7

entry

2.16.840.1.113883.10.20.22.4.12

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

entry

2.16.840.1.113883.10.20.22.4.54

Plan of Care Activity Supply
Planned Procedure Section
Plan of Care Activity Procedure
Postprocedure Diagnosis Section

Problem Observation

Indication

Procedure Activity Act

Immunization Medication Information

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
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Template Title

Template
Type

templateId

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.13

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

Procedure Activity Procedure

Severity Observation
Service Delivery Location
Procedure Activity Observation

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Procedure Activity Procedure

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July 2012

Template Title

Template
Type

templateId

entry

2.16.840.1.113883.10.20.22.4.8

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.8

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

Reason for Visit Section

section

2.16.840.1.113883.10.20.22.2.12

Review of Systems Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.18

Social History Section

section

2.16.840.1.113883.10.20.22.2.17

entry

2.16.840.1.113883.10.20.15.3.8

Estimated Date of Delivery

entry

2.16.840.1.113883.10.20.15.3.1

Smoking Status Observation

entry

2.16.840.1.113883.10.22.4.78

Social History Observation

entry

2.16.840.1.113883.10.20.22.4.38

Severity Observation

Severity Observation

Pregnancy Observation

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
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4.8 Progress Note
[ClinicalDocument: templateId 2.16.840.1.113883.10.20.22.1.9(open)]
A Progress Note documents a patient’s clinical status during a hospitalization or
outpatient visit; thus, it is associated with an encounter.
Taber’s25 medical dictionary defines a Progress Note as “An ongoing record of a
patient's illness and treatment. Physicians, nurses, consultants, and therapists
record their notes concerning the progress or lack of progress made by the
patient between the time of the previous note and the most recent note.”
Mosby’s26 medical dictionary defines a Progress Note as “Notes made by a nurse,
physician, social worker, physical therapist, and other health care professionals
that describe the patient's condition and the treatment given or planned.”
A Progress Note is not a re-evaluation note. A Progress Note is not intended to be
a Progress Report for Medicare. Medicare B Section 1833(e) defines the
requirements of a Medicare Progress Report.

4.8.1 Progress Note Header Constraints
The Progress Note must conform to the US Realm Clinical Document Header.
The following sections include additional header constraints for conformant
Progress Notes.
1. SHALL contain exactly one [1..1] templateId/ (CONF:9483) such that it
a. SHALL contain exactly one [1..1]
templateId/@root="2.16.840.1.113883.10.20.22.1.1"
(CONF:10051).

4.8.1.1 ClinicalDocument/templateId
Conformant documents must carry the document-level templateId asserting
conformance with specific constraints of a Progress Note as well as the
templateId for the US Realm Clinical Document Header template.
The following asserts conformance to a Progress Note.
2. SHALL contain exactly one [1..1] templateId (CONF:7588) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.9" (CONF:10052).
Figure 69: Progress note ClinicalDocument/templateId example





Taber's Cyclopedic Medical Dictionary, 21st Edition, F.A. Davis Company.
http://www.tabers.com
26 Mosby's Medical Dictionary, 8th edition. © 2009, Elsevier.
25

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July 2012

4.8.1.2 ClinicalDocument/code
The Progress Note limits document type codes to those codes listed in the
Progress Note LOINC Document Codes, as of publication of this implementation
guide. This is a dynamic value set meaning that these codes may be added to or
deprecated by LOINC. The table lists all codes that have the scale DOC
(document) and a ‘component’ referring to “subsequent evaluation notes”.
The Progress Note recommends use of a single document type code, 11506-3
"Subsequent evaluation note", with further specification provided by author
or performer, setting, or specialty. Some of the LOINC codes in the Progress Note
LOINC Document Codes table are pre-coordinated with the practice setting or
the training or professional level of the author. Use of pre-coordinated codes is
not recommended because of potential conflict with other information in the
header. When these pre-coordinated codes are used, any coded values
describing the author or performer of the service act or the practice setting must
be consistent with the LOINC document type. Note: The LOINC display name
"Subsequent evaluation note" is equivalent to Progress Note.
3. SHALL contain exactly one [1..1] code (CONF:17189).
a. This code SHALL contain exactly one [1..1] @code, which SHALL be
selected from ValueSet ProgressNoteDocumentTypeCode
2.16.840.1.113883.11.20.8.1 DYNAMIC (CONF:17190).

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Table 41: Progress Note LOINC Document Codes
Value Set: ProgressNoteDocumentTypeCode 2.16.840.1.113883.11.20.8.1 DYNAMIC
Code System: LOINC 2.16.840.1.113883.6.1
LOINC
Code

Type of Service
‘Component’

Setting ‘System’

Specialty/Training/
Professional Level
‘Method_Type’

{Setting}

{Provider}

Preferred Code
11506-3

Subsequent evaluation note

Additional Codes
18733-6

Subsequent evaluation note

{Setting}

Attending physician

18762-5

Subsequent evaluation note

{Setting}

Chiropractor

28569-2

Subsequent evaluation note

{Setting}

Consulting physician

28617-9

Subsequent evaluation note

{Setting}

Dentistry

34900-1

Subsequent evaluation note

{Setting}

General medicine

34904-3

Subsequent evaluation note

{Setting}

Mental health

18764-1

Subsequent evaluation note

{Setting}

Nurse practitioner

28623-7

Subsequent evaluation note

{Setting}

Nursing

11507-1

Subsequent evaluation note

{Setting}

Occupational therapy

11508-9

Subsequent evaluation note

{Setting}

Physical therapy

11509-7

Subsequent evaluation note

{Setting}

Podiatry

28627-8

Subsequent evaluation note

{Setting}

Psychiatry

11510-5

Subsequent evaluation note

{Setting}

Psychology

28656-7

Subsequent evaluation note

{Setting}

Social service

11512-1

Subsequent evaluation note

{Setting}

Speech therapy

34126-3

Subsequent evaluation note

Critical care unit

{Provider}

15507-7

Subsequent evaluation note

Emergency …

{Provider}

34129-7

Subsequent evaluation note

Home health

{Provider}

34125-5

Subsequent evaluation note

Home health care

Case manager

34130-5

Subsequent evaluation note

Hospital

{Provider}

34131-3

Subsequent evaluation note

Outpatient

{Provider}

34124-8

Subsequent evaluation note

Outpatient

Cardiology

34127-1

Subsequent evaluation note

Outpatient

Dental hygienist

34128-9

Subsequent evaluation note

Outpatient

Dentistry

34901-9

Subsequent evaluation note

Outpatient

General medicine

34132-1

Subsequent evaluation note

Outpatient

Pharmacy

Figure 70: Progress note ClinicalDocument/code example

Progress Note

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July 2012

4.8.1.3 DocumentationOf
A documentationOf can contain a serviceEvent to further specialize the act
inherent in the ClinicalDocument/code.
In a Progress Note, a serviceEvent can represent the event of writing the
Progress Note. The serviceEvent/effectiveTime is the time period the note
documents.
4. SHOULD contain zero or one [0..1] documentationOf (CONF:7603).
a. SHALL contain exactly one [1..1] serviceEvent/@classCode="PCPR"
(CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7604).
i.

contain exactly one [1..1] templateId (CONF:9480)
such that it
SHALL

1. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.21.3.1"
(CONF:10068).
ii. SHOULD contain exactly one [1..1] effectiveTime
(CONF:9481).
1. The serviceEvent/effectiveTime SHALL contain exactly
one [1..1] US Realm Date and Time
(DT.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.3) (CONF:10137)
2. The serviceEvent/effectiveTime element SHOULD be
present with effectiveTime/low element (CONF:9482).
3. If a width element is not present, the serviceEvent
SHALL include effectiveTime/high (CONF:10066).
Figure 71: Progress note serviceEvent example







...



4.8.1.4 ComponentOf
The Progress Note is always associated with an encounter by the
componentOf/encompassingEncounter element in the header.
The effectiveTime element for an encompassingEncounter represents the
time or time interval in which the encounter took place. A single encounter may
contain multiple Progress Notes; hence the effectiveTime elements for a
Progress Note (recorded in serviceEvent) and for an encounter (recorded in
encompassingEncounter) represent different time intervals.

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All visits take place at a specific location. When available, the location ID is
included in the encompassingEncounter/location/healthCareFacility/id
element.
5. SHALL contain exactly one [1..1] componentOf (CONF:7595).
a. This componentOf SHALL contain exactly one [1..1]
encompassingEncounter (CONF:7596).
i. This encompassingEncounter SHALL contain at least [1..*] id
(CONF:7597).
ii. This encompassingEncounter SHALL contain exactly one [1..1]
effectiveTime (CONF:7598).
1. This effectiveTime SHALL contain exactly one [1..1] US
Realm Date and Time (DT.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.3)
(CONF:10138).
2. This effectiveTime SHALL contain exactly one [1..1] low
(CONF:7599).
iii. This encompassingEncounter SHALL contain exactly one [1..1]
location/healthCareFacility/id (CONF:7611).
Figure 72: Progress note componentOf example















4.8.2 Progress Note Body Constraints
The Progress Note supports both narrative sections and sections requiring code
clinical statements. The sections are listed in the table below and in the
Document Types and Required/Optional Sections table. The table below the
constraints shows all templates including entries within each section.
1. SHALL contain exactly one [1..1] component (CONF:9591).
a. A Progress Note can have either a structuredBody or a nonXMLBody
(CONF:9592).
i.

A Progress Note can conform to CDA Level 1 (nonXMLBody),
CDA Level 2 (structuredBody with sections that contain a
narrative block), or CDA Level 3 (structuredBody containing

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July 2012

sections that contain a narrative block and coded entries). In
this template (templateId 2.16.840.1.113883.10.20.22.1.9),
coded entries are optional (CONF:9593).
b. If structuredBody, the component/structuredBody SHALL conform to
the section constraints below (CONF:9594).
i.

include an Assessment and Plan Section, or an
Assessment Section and a Plan Section. (CONF:8704).
SHALL

ii. SHALL NOT include an Assessment/Plan Section when an
Assessment Section and a Plan of Care Section are present.
(CONF:10069)
iii. MAY contain zero or one [0..1] Assessment Section
(templateId:2.16.840.1.113883.10.20.22.2.8)
(CONF:8776).
iv. MAY contain zero or one [0..1] Plan of Care Section
(templateId:2.16.840.1.113883.10.20.22.2.10)
(CONF:8775).
contain zero or one [0..1] Assessment and Plan
Section (templateId:2.16.840.1.113883.10.20.22.2.9)
(CONF:8774).
MAY

v. MAY contain zero or one [0..1] Allergies Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.6)
(CONF:8773).
vi. MAY contain zero or one [0..1] Chief Complaint Section
(templateId:1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1)
(CONF:8772).
vii. MAY contain zero or one [0..1] Instructions Section
(templateId:2.16.840.1.113883.10.20.22.2.45)
(CONF:16806).
viii. MAY contain zero or one [0..1] Interventions Section
(templateId:2.16.840.1.113883.10.20.21.2.3)
(CONF:8778).
ix. MAY contain zero or one [0..1] Medications Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.1)
(CONF:8771).
x. MAY contain zero or one [0..1] Objective Section
(templateId:2.16.840.1.113883.10.20.21.2.1)
(CONF:8770).
xi. MAY contain zero or one [0..1] Physical Exam Section
(templateId:2.16.840.1.113883.10.20.2.10)
(CONF:8780).
xii. MAY contain zero or one [0..1] Problem Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.5)
(CONF:8786).

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xiii. MAY contain zero or one [0..1] Results Section (entries
optional)
(templateId:2.16.840.1.113883.10.20.22.2.3)
(CONF:8782).
xiv. MAY contain zero or one [0..1] Review of Systems Section
(templateId:1.3.6.1.4.1.19376.1.5.3.1.3.18)
(CONF:8788).
xv. MAY contain zero or one [0..1] Subjective Section
(templateId:2.16.840.1.113883.10.20.21.2.2)
(CONF:8790).
xvi. MAY contain zero or one [0..1] Vital Signs Section
(entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.4)
(CONF:8784).
The following table shows relationships among the templates in the body of a
Progress Note.
Table 42: Template Containment for a Progress Note
Template Title

Template
Type

templateId

Progress Note

document

2.16.840.1.113883.10.20.22.1.9

section

2.16.840.1.113883.10.20.22.2.6

entry

2.16.840.1.113883.10.20.22.4.30

entry

2.16.840.1.113883.10.20.22.4.7

Allergy Status Observation

entry

2.16.840.1.113883.10.20.22.4.28

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Allergies Section (entries optional)
Allergy Problem Act
Allergy - Intolerance Observation

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Template Title

Template
Type

templateId

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Activity

entry

2.16.840.1.113883.10.20.22.4.16

Drug Vehicle

entry

2.16.840.1.113883.10.20.22.4.24

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

entry

2.16.840.1.113883.10.20.22.4.8

section

2.16.840.1.113883.10.20.22.2.9

entry

2.16.840.1.113883.10.20.22.4.39

Assessment Section

section

2.16.840.1.113883.10.20.22.2.8

Chief Complaint Section

section

1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1

Instructions Section

section

2.16.840.1.113883.10.20.21.2.45

entry

2.16.840.1.113883.10.20.22.4.20

Interventions Section

section

2.16.840.1.113883.10.20.21.2.3

Medications Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.1

entry

2.16.840.1.113883.10.20.22.4.16

entry

2.16.840.1.113883.10.20.22.4.24

Severity Observation
Severity Observation
Assessment and Plan Section
Plan of Care Activity Act

Instructions

Medication Activity
Drug Vehicle

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Template Title

Template
Type

templateId

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication
Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Medication Supply Order

entry

2.16.840.1.113883.10.20.22.4.17

Immunization Medication Information

entry

2.16.840.1.113883.10.20.22.4.54

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Information

entry

2.16.840.1.113883.10.20.22.4.23

Precondition for Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

entry

2.16.840.1.113883.10.20.22.4.14

Indication

entry

2.16.840.1.113883.10.20.22.4.19

Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

entry

2.16.840.1.113883.10.20.22.4.8

Objective Section

section

2.16.840.1.113883.10.20.21.2.1

Physical Exam Section

section

2.16.840.1.113883.10.20.2.10

Plan of Care Section

section

2.16.840.1.113883.10.20.22.2.10

Plan of Care Activity Act

entry

2.16.840.1.113883.10.20.22.4.39

Plan of Care Activity Encounter

entry

2.16.840.1.113883.10.20.22.4.40

Plan of Care Activity Observation

entry

2.16.840.1.113883.10.20.22.4.44

Plan of Care Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.41

Plan of Care Activity Substance
Administration

entry

2.16.840.1.113883.10.20.22.4.42

Plan of Care Activity Supply

entry

2.16.840.1.113883.10.20.22.4.43

section

2.16.840.1.113883.10.20.22.2.5

entry

2.16.840.1.113883.10.20.22.4.3

Procedure Activity Procedure

Severity Observation

Problem Section (entries optional)
Problem Concern Act (Condition)
Problem Observation

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

2.16.840.1.113883.10.20.22.4.31

Health Status Observation

entry

2.16.840.1.113883.10.20.22.4.5

Problem Status

entry

2.16.840.1.113883.10.20.22.4.6

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Template Title

Template
Type

templateId

section

2.16.840.1.113883.10.20.22.2.3

entry

2.16.840.1.113883.10.20.22.4.1

entry

2.16.840.1.113883.10.20.22.4.2

Review of Systems Section

section

1.3.6.1.4.1.19376.1.5.3.1.3.18

Subjective Section

section

2.16.840.1.113883.10.20.21.2.2

Vital Signs Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.4

entry

2.16.840.1.113883.10.20.22.4.26

entry

2.16.840.1.113883.10.20.22.4.27

Results Section (entries optional)
Result Organizer
Result Observation

Vital Signs Organizer
Vital Sign Observation

4.9

Unstructured Document
[ClinicalDocument: templateId 2.16.840.1.113883.10.20.21.1.10(open)]
An unstructured document is a document which is used when the patient
record is captured in an unstructured format that is encapsulated within an
image file or as unstructured text in an electronic file such as a word processing
or Portable Document Format (PDF) document.
There is a need to raise the level of interoperability for these documents to
provide full access to the longitudinal patient record across a continuum of care.
Until this gap is addressed, image and multi-media files will continue to be a
portion of the patient record that remains difficult to access and share with all
participants in a patient’s care. The Unstructured Document type addresses this
gap by providing consistent guidance on the use of CDA for such documents.
An Unstructured Document (UD) document type can (1) include unstructured
content, such as a graphic, directly in a text element with a mediaType
attribute, or (2) reference a single document file, such as a word-processing
document, using a text/reference element.
For guidance on how to handle multiple files, on the selection of media types for
this IG, and on the identification of external files, see the subsections which
follow the constraints below.
IHE’s XDS-SD (Cross-Transaction Specifications and Content Specifications,
Scanned Documents Module) profile addresses a similar, more restricted use
case, specifically for scanned documents or documents electronically created
from existing text sources, and limits content to PDF-A or text. This
Unstructured Documents implementation guide is applicable not only for
scanned documents in non-PDF formats, but also for clinical documents
produced through word processing applications, etc.
For conformance with both specifications, please review the appendix on XDSSD and US Realm Clinical Document Header Comparison and ensure that your

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documents at a minimum conform to all the SHALL constraints from either
specification27.

4.9.1 Unstructured Document Header Constraints
An Unstructured Document must conform to the US Realm Clinical Document
Header. The following sections include additional header constraints for
conformant Unstructured Documents.
1. SHALL contain exactly one [1..1] templateId (CONF:9970) such that it
a. SHALL contain exactly one [1..1]
templateId/@root="2.16.840.1.113883.10.20.22.1.1"
(CONF:10053).

4.9.1.1 ClinicalDocument/templateId
Conformant Unstructured Documents must carry the document-level
templateId asserting conformance with this guide.
2. SHALL contain exactly one [1..1] templateId (CONF:7710) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.1.10" (CONF:10054).

4.9.1.2 RecordTarget
The recordTarget element records the patient or patients whose health
information is recorded in the Unstructured Documents instance. The following
constraint is an addition to those in the US Realm Clinical Document Header.
3. SHALL contain exactly one [1..1] recordTarget/patientRole/id
(CONF:7643).

4.9.1.3 Author
The author represents the person who created the original document.
If the referenced document is a scan, the person who did the scan must be
recorded in dataEnterer.
The following constraints are in addition to those in the US Realm Clinical
Document Header.
4. SHALL contain exactly one [1..1] author/assignedAuthor (CONF:7640).
a. This author/assignedAuthor SHALL contain exactly one [1..1] addr
(CONF:7641).
b. This author/assignedAuthor SHALL contain exactly one [1..1] telecom
(CONF:7642).

Note that the Consolidation Project is providing a number of change requests to IHE. One of
those recommendations should be the elimination of these discrepancies so that the IHE profile is
a proper subset of this guide.
27

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4.9.1.4 Custodian
The following constraints are in addition to those in the US Ream Header.
5. SHALL contain exactly one [1..1]
custodian/assignedCustodian/representedCustodianOrganization
(CONF:7645).
a. This
custodian/assignedCustodian/representedCustodianOrganization
SHALL contain exactly one [1..1] id (CONF:7648).
b. This
custodian/assignedCustodian/representedCustodianOrganization
SHALL contain exactly one [1..1] name (CONF:7649).
c. This
custodian/assignedCustodian/representedCustodianOrganization
SHALL contain exactly one [1..1] telecom (CONF:7650).
d. This
custodian/assignedCustodian/representedCustodianOrganization
SHALL contain exactly one [1..1] addr (CONF:7651).

4.9.2 Unstructured Document Body Constraints
An Unstructured Document must include a nonXMLBody component with a
single text element. The text element can reference an external file using a
reference element, or include unstructured content directly with a mediaType
attribute.
The nonXMLBody/text element also has a "compression" attribute that can be
used to indicate that the unstructured content was compressed before being
Base64Encoded. At a minimum, a compression value of "DF" for the deflate
compression algorithm (RFC 1951 [http://www.ietf.org/rfc/rfc1951.txt]) must
be supported although it is not required that content be compressed.
6. SHALL contain exactly one [1..1] component/nonXMLBody (CONF:7620).
a. This component/nonXMLBody SHALL contain exactly one [1..1] text
(CONF:7622).
i. The text element SHALL either contain a reference element
with a value attribute, or have a representation attribute
with the value of B64, a mediaType attribute, and contain
the media content. (CONF:7623).
1. The value of @mediaType, if present, SHALL be drawn
from the value set 2.16.840.1.113883.11.20.7.1
SupportedFileFormats STATIC 20100512.
(CONF:7624).

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Table 43: Supported File Formats Value Set (Unstructured Documents)
Value Set: SupportedFileFormats 2.16.840.1.113883.11.20.7.1 STATIC 20100512
Word Processing/Narrative Formats

Code

MSWord

application/msword*

PDF

application/pdf

Plain Text

text/plain

RTF Text

text/rtf

HTML

text/html

Graphic Formats

Code

GIF Image

image/gif

TIF Image

image/tiff

JPEG Image

image/jpeg

PNG Image

image/png

* The developers explicitly excluded newer versions of MSWord because they are wellformed, structured XML documents, which are not appropriate in an Unstructured
Document. MSWord versions after 2007 have media type:
application/vnd.openxmlformats-officedocument.wordprocessingml.document.
Figure 73: nonXMLBody example with embedded content


e1xydGY...



Figure 74: nonXMLBody example with referenced content








Figure 75: nonXMLBody example with compressed content


dhUhkasd437hbjfQS7…



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4.9.2.1 Multiple Files and File Packaging
If multiple files, such as several scanned files, constitute a single document,
options include: use a CDA document type that has a structuredBody, use a
multi-page/graphic file type such as PDF, or stitch the separate images into a
single image.
For guidance on how to package a CDA Unstructured Document together with
an unstructured document it references, see the MIME Multipart/Related
Messages appendix.

4.9.2.2 Media Types Supported
The Unstructured Document model does not support all possible file formats
and it excludes structured formats such as generic XML. The media types
supported are commonly used within a healthcare setting as part of the patient
record.
The CDA Data Types specification 28 provides an extensible value set of MIME
(Multipurpose Internet Mail Extensions) media types that are supported by base
CDA. Exclusions from and extensions to that list are discussed below.
Media type exclusions. This guide restricts usage of media types listed in the
CDA Data Types specification. In the absence of a use case for a video format as
part of the patient record, video formats are not included. However, an
unstructured document can link to a video or other file format; for example, a
Microsoft Word file can contain a link to a video.
Media type extensions. Although the CDA Data Types specification indicates
that ‘application/msword’ should not be used, that format is very common in
use cases that apply to Unstructured Documents, and this guide allows it. The
usage applies only to documents in binary format; it is not appropriate for rich
text format (RTF) which has a separate MIME type, or the .docx format, which is
not currently recommended for use in an Unstructured Document.
Local policy. Some content formats—in particular, tagged-image file format
(TIFF)—entail further complexity. While this guide allows TIFF because it is in
common use, its variants introduce profound interoperability issues: local
implementations would establish policy to ensure appropriate interoperability.
Microsoft Word binary formats entail similar issues.

4.9.2.3 Identification of Referenced Files
The example code in this section and in the sample file use simple filenames
with relative paths because they are easy to read as examples. However, simple
filenames and relative paths can cause problems when files are moved among
systems.
The hazard to be avoided can be illustrated as follows: Suppose an
Unstructured Document that references a file "ekg.pdf" is transmitted to a
receiver who places that Unstructured Document in a directory that already
contains an Unstructured Document for another patient, which also references
28

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a file "ekg.pdf". Now the patient header information for the transmitted
document is associated with the ekg.pdf of the previously-existing document.
Thus, the use of relative paths and simple filenames can pose a danger to
patient safety.
The alternative of providing an absolute URL (Uniform Resource Locator) will
fail if the URL is inaccessible; even within a single organization, machine
identifiers may be mapped differently at different locations.
Therefore this guide, while it cannot specify business practices, recommends
the use of unique names for referenced files.
One approach to generating a unique name is to construct it from the globallyunique document id (root and extension) concatenated to a locally unique
reference for the external file. The following figure illustrates this technique
used with a CDA document that has an id root 2.16.840.1.113883.19 and
extension 999021.
Figure 76: Unique file reference example


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5

SECTION-LEVEL TEMPLATES
This section contains the section-level templates referenced by one or more of
the document types of this consolidated guide. These templates describe the
purpose of each section and the section-level constraints.
Section-level templates are always included in a document.
Each section-level template contains the following:
Template metadata (e.g., templateId, etc.)
Description and explanatory narrative
LOINC section code
Section title
Requirements for a text element
Entry-level template names and Ids for referenced templates (required
and optional)
Narrative Text
The text element within the section stores the narrative to be rendered, as
described in the CDA R2 specification 29, and is referred to as the CDA narrative
block.
The content model of the CDA narrative block schema is hand crafted to meet
requirements of human readability and rendering. The schema is registered as a
MIME type (text/x-hl7-text+xml), which is the fixed media type for the text
element.
As noted in the CDA R2 specification, the document originator is responsible for
ensuring that the narrative block contains the complete, human readable,
attested content of the section. Structured entries support computer processing
and computation and are not a replacement for the attestable, human-readable
content of the CDA narrative block. The special case of structured entries with
an entry relationship of "DRIV" (is derived from) indicates to the receiving
application that the source of the narrative block is the structured entries, and
that the contents of the two are clinically equivalent.
As for all CDA documents—even when a report consisting entirely of structured
entries is transformed into CDA—the encoding application must ensure that the
authenticated content (narrative plus multimedia) is a faithful and complete
rendering of the clinical content of the structured source data. As a general
guideline, a generated narrative block should include the same human readable
content that would be available to users viewing that content in the originating
system. Although content formatting in the narrative block need not be identical
to that in the originating system, the narrative block should use elements from
the CDA narrative block schema to provide sufficient formatting to support

29

HL7 Clinical Document Architecture, Release 2.0.

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human readability when rendered according to the rules defined in Section
Narrative Block (§ 4.3.5 ) of the CDA R2 specification.
By definition, a receiving application cannot assume that all clinical content in a
section (i.e., in the narrative block and multimedia) is contained in the
structured entries unless the entries in the section have an entry relationship of
"DRIV".
Additional specification information for the CDA narrative block can be found in
the CDA R2 specification in sections 1.2.1, 1.2.3, 1.3, 1.3.1, 1.3.2, 4.3.4.2, and
6.
Required and Optional Sections
The table on Sections and Required/Optional Document Types summarizes the
use and reuse of section-level templates across the document types. Note that
the constraints for the entry templates themselves are contained in the entrylevel templates section of this guide. The templates required for the Final Rules
on Stage 1 Meaningful Use are noted by an “R” in the last column of the table.

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

O

–

–

–

–

–

–

–

*

–

–

O

–

–

–

–

–

*

2.16.840.1.113883.10.20.22.2.6.1
2.16.840.1.113883.10.20.22.2.6

R

O

–

R

R

–

O

O

*

59774-0

(no coded entries required)
2.16.840.1.113883.10.20.22.2.25

–

–

–

–

–

R

O

–

*

Assessment
**

51848-0

(no coded entries required)
2.16.840.1.113883.10.20.22.2.8

–

R

–

–

R

–

R

–

*

Assessment
and Plan**

51847-2

(no coded entries required)
2.16.840.1.113883.10.20.22.2.9

–

R

–

–

R

–

R

R

*

Chief
Complaint***

10154-3

1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1

–

O

–

O

R

–

O

O

Chief
Complaint
and Reason
for Visit***

46239-0

(no coded entries required)
2.16.840.1.113883.10.20.22.2.13

–

R

–

O

R

–

O

–

Section
Name

LOINC

Advance
Directives

42348-3

Addendum

55107-7

Allergies

48765-2

Anesthesia

templateId
Coded Entries Required
Coded Entries Optional
(no coded entries required)
2.16.840.1.113883.10.20.22.2.21

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© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

*

Stage 1 Meaningful Use

CCD

Table 44: Sections and Required/Optional Document Types with Structured Body

R

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

–

O

–

–

–

–

–

*

–

–

O

–

–

R

R

–

*

55110-1

–

–

O

–

–

–

–

–

*

Current
Imaging
Procedure
Descriptions

55111-9

–

–

O

–

–

–

–

–

*

DICOM
Object
Catalog

121181
(DCM)

2.16.840.1.113883.10.20.6.1.1

–

–

R

–

–

–

–

–

–

Discharge
Diet

42344-2

(no coded entries required)
1.3.6.1.4.1.19376.1.5.3.1.3.33

–

–

–

O

–

–

–

–

*

Document
Summary

55112-7

–

–

O

–

–

–

–

–

*

Encounters

46240-8

(no coded entries required)
2.16.840.1.113883.10.20.22.2.22

O

–

–

–

–

–

–

–

*

Family
History

10157-6

—
2.16.840.1.113883.10.20.22.2.15

O

O

–

O

R

–

O

–

*

Findings
(Radiology
Study Observation)

18782-3

(no coded entries required)
2.16.840.1.113883.10.20.6.1.2

–

–

R

–

–

–

–

–

*

Functional
Status

47420-5

(no coded entries required)
2.16.840.1.113883.10.20.22.2.14

O

–

–

O

–

–

–

–

*

General
Status

10210-3

(no coded entries required)
2.16.840.1.113883.10.20.2.5

–

O

–

–

R

–

–

–

History of
Past Illness
(Past Medical
History)

11348-0

(no coded entries required)
2.16.840.1.113883.10.20.22.2.20

–

O

–

O

O

–

O

–

*

History of
Present
Illness

10164-2

(no coded entries required)
1.3.6.1.4.1.19376.1.5.3.1.3.4

–

R

–

O

O

–

O

–

*

LOINC

Clinical
Presentation

55108-5

Complications

55109-3

Conclusions

templateId
Coded Entries Required
Coded Entries Optional

(no coded entries required)
2.16.840.1.113883.10.20.22.2.37

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
Page 205
July 2012
© 2012 Health Level Seven, Inc. All rights reserved.

Stage 1 Meaningful Use

CCD
–

Section
Name

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

46241-6

(no coded entries required)
2.16.840.1.113883.10.20.22.2.43

–

–

–

O

–

–

–

–

–

Hospital
Consultation

18841-7

(no coded entries required)
2.16.840.1.113883.10.20.22.2.42

–

–

–

O

–

–

–

–

–

Hospital
Course

8648-8

(no coded entries required)
1.3.6.1.4.1.19376.1.5.3.1.3.5

–

–

–

R

–

–

–

–

*

Hospital
Discharge
Diagnosis

11535-2

(no coded entries required)
2.16.840.1.113883.10.20.22.2.24

–

–

–

R

–

–

–

–

*

Hospital
Discharge
Instructions

8653-8

(no coded entries required)
2.16.840.1.113883.10.20.22.2.41

–

–

–

O

–

–

–

–

–

Hospital
Discharge
Medications

10183-2

2.16.840.1.113883.10.20.22.2.11.1
2.16.840.1.113883.10.20.22.2.11

–

–

–

R

–

–

–

–

*

Hospital
Discharge
Physical

10184-0

(no coded entries required)
1.3.6.1.4.1.19376.1.5.3.1.3.26

–

–

–

O

–

–

–

–

*

Hospital
Discharge
Studies
Summary

11493-4

(no coded entries required)
2.16.840.1.113883.10.20.22.2.16

–

–

–

O

–

–

–

–

*

Immunizations

11369-6

2.16.840.1.113883.10.20.22.2.2.1
2.16.840.1.113883.10.20.22.2.2

O

O

–

O

O

–

–

–

*

Instructions

69730-0

(no coded entries required)
2.16.840.1.113883.10.20.22.2.45

–

–

–

–

O

–

–

O

*

Interventions

62387-6

(no coded entries required)
2.16.840.1.113883.10.20.21.2.3

–

–

–

–

–

–

–

O

*

Key Images

55113-5

–

–

O

–

–

–

–

–

*

Medical
Equipment

46264-8

(no coded entries required)
2.16.840.1.113883.10.20.22.2.23

O

–

–

–

–

–

–

–

*

Medical
(General)
History

11329-0

2.16.840.1.113883.10.20.22.2.39

–

–

O

–

–

–

O

–

*

LOINC

templateId
Coded Entries Required
Coded Entries Optional

Page 206
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

Stage 1 Meaningful Use

CCD

Hospital
Admission
Diagnosis

Section
Name

CCD

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

Stage 1 Meaningful Use

Medications

10160-0

2.16.840.1.113883.10.20.22.2.1.1
2.16.840.1.113883.10.20.22.2.1

R

O

–

–

R

–

O

O

*

R

Medications
Administered

29549-3

(no coded entries required)
2.16.840.1.113883.10.20.22.2.38

–

–

–

–

–

–

O

–

*

Objective

61149-1

(no coded entries required)
2.16.840.1.113883.10.20.21.2.1

–

–

–

–

–

–

–

O

*

Operative
Note Fluids

10216-0

(no coded entries required)
2.16.840.1.113883.10.20.7.12

–

–

–

–

–

O

–

–

*

Operative
Note Surgical
Procedure

10223-6

(no coded entries required)
2.16.840.1.113883.10.20.7.14

–

–

–

–

–

O

–

–

*

Payers

48768-6

(no coded entries required)
2.16.840.1.113883.10.20.22.2.18

O

–

–

–

–

–

–

–

*

Physical
Exam

29545-1

(no coded entries required)
2.16.840.1.113883.10.20.2.10

–

R

–

–

R

–

O

O

*

Plan of
Care**

18776-5

(no coded entries required)
2.16.840.1.113883.10.20.22.2.10

O

R

–

R

R

O

R

–

*

Planned
Procedure

59772-4

(no coded entries required)
2.16.840.1.113883.10.20.22.2.30

–

–

–

–

–

O

O

–

*

Postoperative
Diagnosis

10218-6

(no coded entries required)
2.16.840.1.113883.10.20.22.2.35

–

–

–

–

–

R

–

–

*

Postprocedure
Diagnosis

59769-0

(no coded entries required)
2.16.840.1.113883.10.20.22.2.36

–

–

–

–

–

–

R

–

*

Preoperative
Diagnosis

10219-4

(no coded entries required)
2.16.840.1.113883.10.20.22.2.34

–

–

–

–

–

R

–

–

*

Prior Imaging
Procedure
Descriptions

55114-3

(no coded entries required)

–

–

O

–

–

–

–

–

*

Problem

11450-4

2.16.840.1.113883.10.20.22.2.5.1
2.16.840.1.113883.10.20.22.2.5

R

O

–

O

O

–

–

O

*

Procedure
Description

29554-3

(no coded entries required)
2.16.840.1.113883.10.20.22.2.27

–

–

–

–

–

R

R

–

*

Procedure
Disposition

59775-7

(no coded entries required)
2.16.840.1.113883.10.20.18.2.12

–

–

–

–

–

O

R

–

*

Section
Name

LOINC

templateId
Coded Entries Required
Coded Entries Optional

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
Page 207
July 2012
© 2012 Health Level Seven, Inc. All rights reserved.

R

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

59770-8

(no coded entries required)
2.16.840.1.113883.10.20.18.2.9

–

–

–

–

–

R

O

–

*

Procedure
Findings

59776-5

(no coded entries required)
2.16.840.1.113883.10.20.22.2.28

–

–

–

–

–

R

O

–

*

Procedure
Implants

59771-6

(no coded entries required)
2.16.840.1.113883.10.20.22.2.40

–

–

–

–

–

–

O

Procedure
Indications

59768-2

(no coded entries required)
2.16.840.1.113883.10.20.22.2.29

–

–

–

–

–

O

R

–

*

Procedure
Specimens
Taken

59773-2

(no coded entries required)
2.16.840.1.113883.10.20.22.2.31

–

–

–

–

–

R

O

–

*

Procedures
List of
Surgeries
(History of
Procedures)

47519-4

2.16.840.1.113883.10.20.22.2.7.1
2.16.840.1.113883.10.20.22.2.7

O

O

–

O

O

–

O

–

*

Radiology
Comparison
Study –
Observation

18834-2

–

–

O

–

–

–

–

–

*

Radiology –
Impression

19005-8

–

–

O

–

–

–

–

–

*

Radiology
Study –
Recommenda
tions

18783-1

–

–

O

–

–

–

–

–

*

Radiology
Reason for
Study

18785-6

–

–

O

–

–

–

–

–

*

Reason for
Referral****

42349-1

(no coded entries required)
1.3.6.1.4.1.19376.1.5.3.1.3.1

–

R

–

–

–

–

–

–

*

Reason for
Visit***

29299-5

2.16.840.1.113883.10.20.22.2.12

–

R

–

O

R

–

O

–

–

Requested
Imaging
Studies
Information

55115-0

–

–

O

–

–

–

–

–

*

30

LOINC

templateId
Coded Entries Required
Coded Entries Optional

Stage 1 Meaningful Use

CCD

Procedure
Estimated
Blood Loss

Section
Name

*

R
30

Required only for inpatient settings

Page 208
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© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

Section
Name

LOINC

CCD

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

Stage 1 Meaningful Use

Results

30954-2

2.16.840.1.113883.10.20.22.2.3.1
2.16.840.1.113883.10.20.22.2.3

R

O

–

–

R

–

–

O

*

R

Review of
Systems

10187-3

(no coded entries required)
1.3.6.1.4.1.19376.1.5.3.1.3.18

–

O

–

O

R

–

O

O

*

Social
History

29762-2

(no coded entries required)
2.16.840.1.113883.10.20.22.2.17

O

O

–

O

R

–

O

–

*

Subjective

61150-9

(no coded entries required)
2.16.840.1.113883.10.20.21.2.2

–

–

–

–

–

–

–

O

*

Surgical
Drains

11537-8

(no coded entries required)
2.16.840.1.113883.10.20.7.13

–

–

–

–

–

O

–

–

*

Vital Signs

8716-3

2.16.840.1.113883.10.20.22.2.4.1
2.16.840.1.113883.10.20.22.2.4

O

O

–

O

R

–

–

O

*

templateId
Coded Entries Required
Coded Entries Optional

– not required or optional; these sections can be included if appropriate for the
document type
* content could be present and is unstructured
** wherever referenced, intent is that either “Assessment and Plan” is present or both
“Assessment” and “Plan of Care”. Only these combinations should be used
*** wherever referenced, intent is that either “Chief Complaint/Reason for Visit” is
present or “Chief Complaint”, and/or “Reason for Visit”. Only these combinations
should be used
****in Consultation Note, either “Reason for Referral”, “Reason for Visit”, or “Chief
Complaint/Reason for Visit” must be present

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1
Page 209
July 2012
© 2012 Health Level Seven, Inc. All rights reserved.

5.1

Advance Directives Section 42348-3
Table 45: Advance Directives Section Contexts
Used By:

Contains Entries:

Coded entries optional:
Continuity of Care Document (CCD) (optional)

Advance Directive Observation

Coded entries required:
---

Figure 77: Advance directives section UML diagram

This section contains data defining the patient’s advance directives and any
reference to supporting documentation. The most recent and up-to-date
directives are required, if known, and should be listed in as much detail as
possible. This section contains data such as the existence of living wills,
healthcare proxies, and CPR and resuscitation status. If referenced documents
are available, they can be included in the CCD exchange package.
NOTE: The descriptions in this section differentiate between “advance directives”
and “advance directive documents”. The former are the directions whereas the
latter are legal documents containing those directions. Thus, an advance
directive might be “no cardiopulmonary resuscitation”, and this directive might
be stated in a legal advance directive document.
Advance Directives Section with Coded Entries Optional
[section: templateId 2.16.840.1.113883.10.20.22.2.21(open)]
The following constraints apply to an Advance Directive section in which entries
are not required.
1. SHALL contain exactly one [1..1] templateId (CONF:7928) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.2.21" (CONF:10376).
2. SHALL contain exactly one [1..1] code (CONF:15340).
a. This code SHALL contain exactly one [1..1] @code="42348-3" Advance
Directives (CodeSystem: LOINC 2.16.840.1.113883.6.1)
(CONF:15342).
3. SHALL contain exactly one [1..1] title (CONF:7930).
4. SHALL contain exactly one [1..1] text (CONF:7931).
5. MAY contain zero or more [0..*] entry (CONF:7957) such that it
a. SHALL contain exactly one [1..1] Advance Directive Observation
(2.16.840.1.113883.10.20.22.4.48) (CONF:8800).
Page 210
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© 2012 Health Level Seven, Inc. All rights reserved.
July 2012

Advance Directives Section with Coded Entries Required
[section: templateId 2.16.840.1.113883.10.20.22.2.21.1(open)]
The following constraints apply to an Advance Directive section in which entries
are required.
1. Conforms to Advance Directives Section (entries optional)
template (2.16.840.1.113883.10.20.22.2.21).
2. SHALL contain exactly one [1..1] templateId (CONF:8643) such that it
a. SHALL contain exactly one [1..1]
@root="2.16.840.1.113883.10.20.22.2.21.1" (CONF:10377).
3. SHALL contain exactly one [1..1] code (CONF:15343).
a. This code SHALL contain exactly one [1..1] @code="42348-3" Advance
Directives (CodeSystem: LOINC 2.16.840.1.113883.6.1)
(CONF:15344).
4. SHALL contain exactly one [1..1] title (CONF:8645).
5. SHALL contain exactly one [1..1] text (CONF:8646).
6. SHALL contain at least one [1..*] entry (CONF:8647) such that it
a. SHALL contain exactly one [1..1] Advance Directive Observation
(2.16.840.1.113883.10.20.22.4.48) (CONF:8801).
Figure 78: Advance directives section example
Advance Directives ... ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 211 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.2 Allergies Section 48765-2 Table 46: Allergies Section Contexts Used By: Contains Entries: Coded entries optional: Progress Note (optional) Consultation Note (optional) Discharge Summary (required) History and Physical (required) Procedure Note (optional) Allergy Problem Act Coded entries required: Continuity of Care Document (CCD) (required) Figure 79: Allergies section UML diagram This section lists and describes any medication allergies, adverse reactions, idiosyncratic reactions, anaphylaxis/anaphylactoid reactions to food items, and metabolic variations or adverse reactions/allergies to other substances (such as latex, iodine, tape adhesives) used to assure the safety of health care delivery. At a minimum, it should list currently active and any relevant historical allergies and adverse reactions. Allergies Section with Coded Entries Optional [section: templateId 2.16.840.1.113883.10.20.22.2.6(open)] The following constraints apply to an Allergies section in which entries are not required. 1. SHALL contain exactly one [1..1] templateId (CONF:7800) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.6" (CONF:10378). 2. SHALL contain exactly one [1..1] code (CONF:15345). Page 212 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. This code SHALL contain exactly one [1..1] @code="48765-2" Allergies, adverse reactions, alerts (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15346). 3. SHALL contain exactly one [1..1] title (CONF:7802). 4. SHALL contain exactly one [1..1] text (CONF:7803). 5. SHOULD contain zero or more [0..*] entry (CONF:7804) such that it a. SHALL contain exactly one [1..1] Allergy Problem Act (2.16.840.1.113883.10.20.22.4.30) (CONF:7805) Allergies Section with Coded Entries Required [section: templateId 2.16.840.1.113883.10.20.22.2.6.1(open)] The following constraints apply to an Allergies section in which entries are required. 1. Conforms to Allergies Section (entries optional) template (2.16.840.1.113883.10.20.22.2.6). 2. SHALL contain exactly one [1..1] templateId (CONF:7527) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.6.1" (CONF:10379). 3. SHALL contain exactly one [1..1] code (CONF:15349). a. This code SHALL contain exactly one [1..1] @code="48765-2" Allergies, adverse reactions, alerts (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15350). 4. SHALL contain exactly one [1..1] title (CONF:7534). 5. SHALL contain exactly one [1..1] text (CONF:7530). 6. SHALL contain at least one [1..*] entry (CONF:7531) such that it a. SHALL contain exactly one [1..1] Allergy Problem Act (2.16.840.1.113883.10.20.22.4.30) (CONF:7532). Figure 80: Allergies section example
Allergies ... ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 213 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.3 Anesthesia Section 59774-0 [section: templateId 2.16.840.1.113883.10.20.22.2.25(open)] Table 47: Anesthesia Section Contexts Used By: Contains Entries: Procedure Note (optional) Operative Note (required) Medication Activity Procedure Activity Procedure The Anesthesia section briefly records the type of anesthesia (e.g., general or local) and may state the actual agent used. This may or may not be a subsection of the Procedure Description section. The full details of anesthesia are usually found in a separate Anesthesia Note. 1. SHALL contain exactly one [1..1] templateId (CONF:8066) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.25" (CONF:10380). 2. SHALL contain exactly one [1..1] code (CONF:15351). a. This code SHALL contain exactly one [1..1] @code="59774-0" Anesthesia (CONF:15352). 3. SHALL contain exactly one [1..1] title (CONF:8068). 4. SHALL contain exactly one [1..1] text (CONF:8069). 5. MAY contain zero or more [0..*] entry (CONF:8092) such that it a. SHALL contain exactly one [1..1] Procedure Activity Procedure (2.16.840.1.113883.10.20.22.4.14) (CONF:8093). 6. MAY contain zero or more [0..*] entry (CONF:8094) such that it a. SHALL contain exactly one [1..1] Medication Activity (2.16.840.1.113883.10.20.22.4.16) (CONF:8095). Page 214 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 81: Anesthesia section example
Procedure Anesthesia Conscious sedation with propofol 200 mg IV ... ...
5.4 Assessment and Plan Section 51847-2 [section: templateId 2.16.840.1.113883.10.20.22.2.9(open)] Table 48: Assessment and Plan Section Contexts Used By: Contains Entries: Progress Note (optional) Consultation Note (optional) Procedure Note (optional) History and Physical (optional) Plan of Care Activity Act The Assessment and Plan sections may be combined or separated to meet local policy requirements. The Assessment and Plan section represents both the clinician’s conclusions and working assumptions that will guide treatment of the patient (see Assessment Section above) and pending orders, interventions, encounters, services, and procedures for the patient (see Plan of Care Section below). 1. SHALL contain exactly one [1..1] templateId (CONF:7705) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.9" (CONF:10381). 2. SHALL contain exactly one [1..1] code (CONF:15353). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 215 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. This code SHALL contain exactly one [1..1] @code="51847-2" Assessment and Plan (CONF:15354). 3. SHALL contain exactly one [1..1] text (CONF:7707). 4. MAY contain zero or more [0..*] entry (CONF:7708) such that it a. SHALL contain exactly one [1..1] Plan of Care Activity Act (2.16.840.1.113883.10.20.22.4.39) (CONF:8798). Figure 82: Assessment and plan section example
ASSESSMENT AND PLAN ... ...
5.5 Assessment Section 51848-0 [section: templateId 2.16.840.1.113883.10.20.22.2.8(open)] Table 49: Assessment Section Contexts Used By: Contains Entries: Progress Note (optional) Consultation Note (optional) History and Physical (optional) Procedure Note (optional) The Assessment section (also referred to as “impression” or “diagnoses” outside of the context of CDA) represents the clinician's conclusions and working assumptions that will guide treatment of the patient. The assessment may be a list of specific disease entities or a narrative block. 1. SHALL contain exactly one [1..1] templateId (CONF:7711) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.8" (CONF:10382). 2. SHALL contain exactly one [1..1] code (CONF:14757). a. This code SHALL contain exactly one [1..1] @code="51848-0" Assessments (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:14758). Page 216 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 3. SHALL contain exactly one [1..1] title (CONF:16774). 4. SHALL contain exactly one [1..1] text (CONF:7713). Figure 83: Assessment section example
ASSESSMENTS ...
5.6 Chief Complaint and Reason for Visit Section 46239-0 [section: templateId 2.16.840.1.113883.10.20.22.2.13(open)] Table 50: Chief Complaint and Reason for Visit Section Contexts Used By: Contains Entries: Consultation Note (optional) Discharge Summary (optional) History and Physical (optional) Procedure Note (optional) This section records the patient's chief complaint (the patient’s own description) and/or the reason for the patient's visit (the provider’s description of the reason for visit). Local policy determines whether the information is divided into two sections or recorded in one section serving both purposes. 1. SHALL contain exactly one [1..1] templateId (CONF:7840) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.13" (CONF:10383). 2. SHALL contain exactly one [1..1] code (CONF:15449). a. This code SHALL contain exactly one [1..1] @code="46239-0" Chief Complaint and Reason for Visit (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15450). 3. SHALL contain exactly one [1..1] title (CONF:7842). 4. SHALL contain exactly one [1..1] text (CONF:7843). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 217 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 84: Chief complaint and reason for visit section example
CHIEF COMPLAINT Back Pain
5.7 Chief Complaint Section 10154-3 [section: templateId 1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1(open)] Table 51: Chief Complaint Section Contexts Used By: Contains Entries: Progress Note (optional) Consultation Note (optional) Discharge Summary (optional) History and Physical (optional) Procedure Note (optional) This section records the patient's chief complaint (the patient’s own description). 1. SHALL contain exactly one [1..1] templateId (CONF:7832) such that it a. SHALL contain exactly one [1..1] @root="1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1" (CONF:10453). 2. SHALL contain exactly one [1..1] code (CONF:15451). a. This code SHALL contain exactly one [1..1] @code="10154-3" Chief Complaint (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15452). 3. SHALL contain exactly one [1..1] title (CONF:7834). 4. SHALL contain exactly one [1..1] text (CONF:7835). Figure 85: Chief complaint section example
CHIEF COMPLAINT Back Pain
Page 218 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.8 Complications Section 55109-3 [section: templateId 2.16.840.1.113883.10.20.22.2.37(open)] Table 52: Complications Section Contexts Used By: Contains Entries: Procedure Note (required) Operative Note (required) Problem Observation The Complications section records problems that occurred during the procedure or other activity. The complications may have been known risks or unanticipated problems. 1. SHALL contain exactly one [1..1] templateId (CONF:8174) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.37" (CONF:10384). 2. SHALL contain exactly one [1..1] code (CONF:15453). a. This code SHALL contain exactly one [1..1] @code="55109-3" Complications (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15454). 3. SHALL contain exactly one [1..1] title (CONF:8176). 4. SHALL contain exactly one [1..1] text (CONF:8177). 5. There SHALL be a statement providing details of the complication(s) or it SHALL explicitly state there were no complications. (CONF:8797). 6. MAY contain zero or more [0..*] entry (CONF:8795) such that it a. SHALL contain exactly one [1..1] Problem Observation (2.16.840.1.113883.10.20.22.4.4) (CONF:8796). Figure 86: Complications section example
Complications Asthmatic symptoms while under general anesthesia. ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 219 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.9 DICOM Object Catalog Section - DCM 121181 [section: templateId 2.16.840.1.113883.10.20.6.1.1(open)] Table 53: DICOM Object Catalog Section - DCM 121181 Contexts Used By: Contains Entries: Diagnostic Imaging Report Study Act DICOM Object Catalog lists all referenced objects and their parent Series and Studies, plus other DICOM attributes required for retrieving the objects. DICOM Object Catalog sections are not intended for viewing and contain empty section text. 9. SHALL contain exactly one [1..1] templateId (CONF:8525) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.1.1" (CONF:10454). 10. A DICOM Object Catalog SHALL be present if the document contains references to DICOM Images. If present, it SHALL be the first section in the document (CONF:8527). 11. SHALL contain exactly one [1..1] code (CONF:15456). a. This code SHALL contain exactly one [1..1] @code="121181" Dicom Object Catalog (CodeSystem: DCM 1.2.840.10008.2.16.4) (CONF:15457). 12. SHALL contain at least one [1..*] entry (CONF:8530). a. Such entries SHALL contain exactly one [1..1] Study Act (templateId:2.16.840.1.113883.10.20.6.2.6) (CONF:15458). Page 220 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 87: DICOM object catalog section example
... ... ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 221 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.10 Discharge Diet Section 42344-2 [section: templateId 1.3.6.1.4.1.19376.1.5.3.1.3.33(open)] Table 54: Discharge Diet Section Contexts Used By: Contains Entries: Discharge Summary (optional) This section records a narrative description of the expectations for diet and nutrition, including nutrition prescription, proposals, goals, and order requests for monitoring, tracking, or improving the nutritional status of the patient, used in a discharge from a facility such as an emergency department, hospital, or nursing home. 1. SHALL contain exactly one [1..1] templateId (CONF:7975) such that it a. SHALL contain exactly one [1..1] @root="1.3.6.1.4.1.19376.1.5.3.1.3.33" (CONF:10455). 2. SHALL contain exactly one [1..1] code (CONF:15459). a. This code SHALL contain exactly one [1..1] @code="42344-2" Discharge Diet (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15460). 3. SHALL contain exactly one [1..1] title (CONF:7977). 4. SHALL contain exactly one [1..1] text (CONF:7978). Figure 88: Discharge diet section example
Discharge Diet Low-fat, low-salt, cardiac diet
5.11 Encounters Section 46240-8 Table 55: Encounters Section Contexts Used By: Contains Entries: Coded entries optional: Continuity of Care Document (CCD) (optional) Encounter Activities Coded entries required: --- Page 222 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 89: Encounters section UML diagram This section lists and describes any healthcare encounters pertinent to the patient’s current health status or historical health history. An Encounter is an interaction, regardless of the setting, between a patient and a practitioner who is vested with primary responsibility for diagnosing, evaluating, or treating the patient’s condition. It may include visits, appointments, as well as non-face-toface interactions. It is also a contact between a patient and a practitioner who has primary responsibility for assessing and treating the patient at a given contact, exercising independent judgment. This section may contain all encounters for the time period being summarized, but should include notable encounters. Encounters Section with Coded Entries Optional [section: templateId 2.16.840.1.113883.10.20.22.2.22(open)] The following constraints apply to an Encounters section in which entries are not required. 1. SHALL contain exactly one [1..1] templateId (CONF:7940) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.22" (CONF:10386). 2. SHALL contain exactly one [1..1] code (CONF:15461). a. This code SHALL contain exactly one [1..1] @code="46240-8" Encounters (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15462). 3. SHALL contain exactly one [1..1] title (CONF:7942). 4. SHALL contain exactly one [1..1] text (CONF:7943). 5. SHOULD contain zero or more [0..*] entry (CONF:7951) such that it a. SHALL contain exactly one [1..1] Encounter Activities (2.16.840.1.113883.10.20.22.4.49) (CONF:8802). Encounters Section with Coded Entries Required [section: templateId 2.16.840.1.113883.10.20.22.2.22.1(open)] The following constraints apply to an Encounters section in which entries are required. 1. Conforms to Encounters Section (entries optional) template (2.16.840.1.113883.10.20.22.2.22). 2. SHALL contain exactly one [1..1] templateId (CONF:8705) such that it HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 223 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.22.1" (CONF:10387). 3. SHALL contain exactly one [1..1] code (CONF:15466). a. This code SHALL contain exactly one [1..1] @code="46240-8" Encounters (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15467). 4. SHALL contain exactly one [1..1] title (CONF:8707). 5. SHALL contain exactly one [1..1] text (CONF:8708). 6. SHALL contain at least one [1..*] entry (CONF:8709) such that it a. SHALL contain exactly one [1..1] Encounter Activities (2.16.840.1.113883.10.20.22.4.49) (CONF:8803). Figure 90: Encounters section example
Encounters ... ...
5.12 Family History Section 10157-6 [section: templateId 2.16.840.1.113883.10.20.22.2.15(open)] Table 56: Family History Section Contexts Used By: Contains Entries: Consultation Note (optional) Discharge Summary (optional) History and Physical (required) Procedure Note (optional) Continuity of Care Document (CCD) (optional) Family History Organizer Page 224 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 91: Family history section UML diagram This section contains data defining the patient’s genetic relatives in terms of possible or relevant health risk factors that have a potential impact on the patient’s healthcare risk profile. 1. SHALL contain exactly one [1..1] templateId (CONF:7932) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.15" (CONF:10388). 2. SHALL contain exactly one [1..1] code (CONF:15469). a. This code SHALL contain exactly one [1..1] @code="10157-6" Family History (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15470). 3. SHALL contain exactly one [1..1] title (CONF:7934). 4. SHALL contain exactly one [1..1] text (CONF:7935). 5. MAY contain zero or more [0..*] entry (CONF:7955) such that it a. SHALL contain exactly one [1..1] Family History Organizer (2.16.840.1.113883.10.20.22.4.45) (CONF:8799). Figure 92: Family history section example
Family history ... ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 225 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.13 Findings Section (DIR) 18782-3 [section: templateId 2.16.840.1.113883.10.20.6.1.2(open)] Table 57: Findings Section Contexts Used By: Contains Entries: Diagnostic Imaging Report (required) The Findings section contains the main narrative body of the report. While not an absolute requirement for transformed DICOM SR reports, it is suggested that Diagnostic Imaging Reports authored in CDA follow Term Info guidelines 31 for the codes in the various observations and procedures recorded in this section. 1. SHALL contain exactly one [1..1] templateId (CONF:8531) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.1.2" (CONF:10456). 2. This section SHOULD contain only the direct observations in the report, with topics such as Reason for Study, History, and Impression placed in separate sections. However, in cases where the source of report content provides a single block of text not separated into these sections, that text SHALL be placed in the Findings section. (CONF:8532). Figure 93: Findings section example
Findings Finding The cardiomediastinum is Diameter 45mm ... ...
31 . http://www.hl7.org/special/committees/terminfo/index.cfm Page 226 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.14 Functional Status Section 47420-5 [section: templateId 2.16.840.1.113883.10.20.22.2.14(open)] Table 58: Functional Status Section Contexts Used By: Contains Entries: Discharge Summary (optional) Continuity of Care Document (CCD) (optional) Assessment Scale Observation Caregiver Characteristics Cognitive Status Problem Observation Cognitive Status Result Observation Cognitive Status Result Organizer Functional Status Problem Observation Functional Status Result Observation Functional Status Result Organizer Non-Medicinal Supply Activity Highest Pressure Ulcer Stage Number of Pressure Ulcers Observation Pressure Ulcer Observation Figure 94: Functional status section UML diagram *The Large UML Diagrams appendix provides a larger version of this diagram The Functional Status section describes the patient’s physical state, status of functioning, and environmental status at the time the document was created. A patient’s physical state may include information regarding the patient’s physical findings as they relate to problems, including but not limited to: Pressure Ulcers Amputations Heart murmur Ostomies A patient’s functional status may include information regarding the patient relative to their general functional and cognitive ability, including: Ambulatory ability Mental status or competency Activities of Daily Living (ADLs), including bathing, dressing, feeding, grooming Home or living situation having an effect on the health status of the patient Ability to care for self HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 227 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Social activity, including issues with social cognition, participation with friends and acquaintances other than family members Occupation activity, including activities partly or directly related to working, housework or volunteering, family and home responsibilities or activities related to home and family Communication ability, including issues with speech, writing or cognition required for communication Perception, including sight, hearing, taste, skin sensation, kinesthetic sense, proprioception, or balance A patient’s environmental status may include information regarding the patient’s current exposures from their daily environment, including but not limited to: Airborne hazards such as second-hand smoke, volatile organic compounds, dust, or other allergens Radiation Safety hazards in home, such as throw rugs, poor lighting, lack of railings/grab bars, etc. Safety hazards at work, such as communicable diseases, excessive heat, excessive noise, etc. The patient's functional status may be expressed as a problem or as a result observation. A functional or cognitive status problem observation describes a patient’s problem, symptoms or condition. A functional or cognitive status result observation may include observations resulting from an assessment scale, evaluation or question and answer assessment. Any deviation from normal function displayed by the patient and recorded in the record should be included. Of particular interest are those limitations that would interfere with self-care or the medical therapeutic process in any way. In addition, a note of normal function, an improvement, or a change in functioning status may be included. Table 59: Functional and Cognitive Status Problem Observation Examples Problem Observation Problem/Condition/Symptom Functional Status Cognitive Status Dysphagia Dementia Orthopnea Chronic confusion Shortness of Breath Depressed mood Page 228 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 60: Functional and Cognitive Status Result Observation Examples Result Observation Functional Status Cognitive Status Frequency Observation Incontinency Frequency Behavior Frequency Assessment Scale or Evaluation Result Pain Scale Brief Interview for Mental Status Eating Independent Partial/Moderate Assistance Substantial Assistance Dependent Disorganized thinking Behavior not present Behavior continuously present Behavior present, fluctuates Assessment Question/Answer 1. SHALL contain exactly one [1..1] templateId (CONF:7920) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.14" (CONF:10389). 2. SHALL contain exactly one [1..1] code (CONF:14578). a. This code SHALL contain exactly one [1..1] @code="47420-5" Functional Status (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:14579). 3. SHALL contain exactly one [1..1] title (CONF:7922). 4. SHALL contain exactly one [1..1] text (CONF:7923). 5. MAY contain zero or more [0..*] entry (CONF:14414) such that it a. SHALL contain exactly one [1..1] Functional Status Result Organizer (templateId:2.16.840.1.113883.10.20.22.4.66) (CONF:14415). 6. MAY contain zero or more [0..*] entry (CONF:14416) such that it a. SHALL contain exactly one [1..1] Cognitive Status Result Organizer (templateId:2.16.840.1.113883.10.20.22.4.75) (CONF:14417). 7. MAY contain zero or more [0..*] entry (CONF:14418) such that it a. SHALL contain exactly one [1..1] Functional Status Result Observation (templateId:2.16.840.1.113883.10.20.22.4.67) (CONF:14419). 8. MAY contain zero or more [0..*] entry (CONF:14420) such that it a. SHALL contain exactly one [1..1] Cognitive Status Result Observation (templateId:2.16.840.1.113883.10.20.22.4.74) (CONF:14421). 9. MAY contain zero or more [0..*] entry (CONF:14422) such that it a. SHALL contain exactly one [1..1] Functional Status Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.68) (CONF:14423). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 229 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 10. MAY contain zero or more [0..*] entry (CONF:14424) such that it a. SHALL contain exactly one [1..1] Cognitive Status Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.73) (CONF:14425). 11. MAY contain zero or more [0..*] entry (CONF:14426) such that it a. SHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:14427). 12. MAY contain zero or more [0..*] entry (CONF:14580) such that it a. SHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14581). 13. MAY contain zero or more [0..*] entry (CONF:14582) such that it a. SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14583). 14. MAY contain zero or more [0..*] entry (CONF:16777) such that it a. SHALL contain exactly one [1..1] Pressure Ulcer Observation (templateId:2.16.840.1.113883.10.20.22.4.70) (CONF:16778). 15. MAY contain zero or more [0..*] entry (CONF:16779) such that it a. SHALL contain exactly one [1..1] Number of Pressure Ulcers Observation (templateId:2.16.840.1.113883.10.20.22.4.76) (CONF:16780). 16. MAY contain zero or more [0..*] entry (CONF:16781) such that it a. SHALL contain exactly one [1..1] Highest Pressure Ulcer Stage (templateId:2.16.840.1.113883.10.20.22.4.77) (CONF:16782). Figure 95: Functional status section example
Functional Status Page 230 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012
Functional and Cognitive Assessment March 23 to March 25, 2012 Condition Status
Dependence on cane 1998 Active
Memory impairment 1999 Active
... ... ... ... ... ... ... ... ... ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 231 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.15 General Status Section 10210-3 [section: templateId 2.16.840.1.113883.10.20.2.5(open)] Table 61: General Status Section Contexts Used By: Contains Entries: Consultation Note (optional) History and Physical (required) The General Status section describes general observations and readily observable attributes of the patient, including affect and demeanor, apparent age compared to actual age, gender, ethnicity, nutritional status based on appearance, body build and habitus (e.g., muscular, cachectic, obese), developmental or other deformities, gait and mobility, personal hygiene, evidence of distress, and voice quality and speech. 1. SHALL contain exactly one [1..1] templateId (CONF:7985) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.2.5" (CONF:10457). 2. SHALL contain exactly one [1..1] code (CONF:15472). a. This code SHALL contain exactly one [1..1] @code="10210-3" General Status (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15473). 3. SHALL contain exactly one [1..1] title (CONF:7987). 4. SHALL contain exactly one [1..1] text (CONF:7988). Figure 96: General status section example
GENERAL STATUS Alert and in good spirits, no acute distress.
Page 232 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.16 History of Past Illness Section 11348-0 [section: templateId 2.16.840.1.113883.10.20.22.2.20(open)] Table 62: History of Past Illness Section Contexts Used By: Contains Entries: Consultation Note (optional) Discharge Summary (optional) History and Physical (required) Procedure Note (optional) Problem Observation This section describes the history related to the patient’s past complaints, problems, or diagnoses. It records these details up until, and possibly pertinent to, the patient’s current complaint or reason for seeking medical care. 1. SHALL contain exactly one [1..1] templateId (CONF:7828) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.20" (CONF:10390). 2. SHALL contain exactly one [1..1] code (CONF:15474). a. This code SHALL contain exactly one [1..1] @code="11348-0" History of Past Illness (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15475). 3. SHALL contain exactly one [1..1] title (CONF:7830). 4. SHALL contain exactly one [1..1] text (CONF:7831). 5. MAY contain zero or more [0..*] entry (CONF:8791) such that it a. SHALL contain exactly one [1..1] Problem Observation (2.16.840.1.113883.10.20.22.4.4) (CONF:8792). Figure 97: History of past illness section example
PAST MEDICAL HISTORY Patient has had ..... ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 233 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.17 History of Present Illness Section 10164-2 [section: templateId 1.3.6.1.4.1.19376.1.5.3.1.3.4(open)] Table 63: History of Present Illness Section Contexts Used By: Contains Entries: Consultation Note (required) Discharge Summary (optional) History and Physical (optional) Procedure Note (optional) The History of Present Illness section describes the history related to the reason for the encounter. It contains the historical details leading up to and pertaining to the patient’s current complaint or reason for seeking medical care. 1. SHALL contain exactly one [1..1] templateId (CONF:7848) such that it a. SHALL contain exactly one [1..1] @root=" 1.3.6.1.4.1.19376.1.5.3.1.3.4" (CONF:10458). 2. SHALL contain exactly one [1..1] code (CONF:15477). a. This code SHALL contain exactly one [1..1] @code="10164-2" History of Present Illness (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15478). 3. SHALL contain exactly one [1..1] title (CONF:7850). 4. SHALL contain exactly one [1..1] text (CONF:7851). Figure 98: History of present illness section example
HISTORY OF PRESENT ILLNESS This patient was only recently discharged for a recurrent GI bleed as described below. He presented to the ER today c/o a dark stool yesterday but a normal brown stool today. On exam he was hypotensive in the 80?s resolved after .... .... .... Lab at discharge: Glucose 112, BUN 16, creatinine 1.1, electrolytes normal. H. pylori antibody pending. Admission hematocrit 16%, discharge hematocrit 29%. WBC 7300, platelet count 256,000. Urinalysis normal. Urine culture: No growth. INR 1.1, PTT 40. He was transfused with 6 units of packed red blood cells with .... .... .... GI evaluation 12 September: Colonoscopy showed single red clot in .... .... ....
Page 234 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.18 Hospital Admission Diagnosis Section 46241-6 [section: templateId 2.16.840.1.113883.10.20.22.2.43(open)] Table 64: Hospital Admission Diagnosis Section Contexts Used By: Contains Entries: Discharge Summary (optional) Hospital Admission Diagnosis The Hospital Admitting Diagnosis section contains a narrative description of the primary reason for admission to a hospital facility. The section includes an optional entry to record patient conditions. 1. SHALL contain exactly one [1..1] templateId (CONF:9930) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.43" (CONF:10391). 2. SHALL contain exactly one [1..1] code (CONF:15479). a. This code SHALL contain exactly one [1..1] @code="46241-6" Hospital Admission Diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15480). 3. SHALL contain exactly one [1..1] title (CONF:9932). 4. SHALL contain exactly one [1..1] text (CONF:9933). 5. SHOULD contain zero or one [0..1] entry (CONF:9934). a. SHALL contain exactly one [1..1] Hospital Admission Diagnosis (2.16.840.1.113883.10.20.22.4.34) (CONF:9935). Figure 99: Hospital admission diagnosis section example
HOSPITAL ADMISSION DIAGNOSIS Appendicitis ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 235 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.19 Hospital Admission Medications Section 42346-7 (entries optional) [section: templateId 2.16.840.1.113883.10.20.22.2.44 (open)] Table 65: Hospital Admission Medications Section Contexts Used By: Contains Entries: Discharge Summary (optional) Admission Medication The Hospital Admission Medications section defines the relevant medications administered prior to admission to the facility. The currently active medications must be listed. 1. SHALL contain exactly one [1..1] templateId (CONF:10098) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.44" (CONF:10392). 2. SHALL contain exactly one [1..1] code (CONF:15482). a. This code SHALL contain exactly one [1..1] @code="42346-7" Medications on Admission (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15483). 3. SHALL contain exactly one [1..1] title (CONF:10100). 4. SHALL contain exactly one [1..1] text (CONF:10101). 5. SHOULD contain zero or more [0..*] entry (CONF:10102) such that it a. SHALL contain exactly one [1..1] Admission Medication (2.16.840.1.113883.10.20.22.4.36) (CONF:10110). Figure 100: Hospital admission medications section example
Hospital Admission Medications ... ... ...
Page 236 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.20 Hospital Consultations Section 18841-7 [section: templateId 2.16.840.1.113883.10.20.22.2.42(open)] Table 66: Hospital Consultations Section Contexts Used By: Contains Entries: Discharge Summary (optional) The Hospital Consultations section records consultations that occurred during the admission. 1. SHALL contain exactly one [1..1] templateId (CONF:9915) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.42" (CONF:10393). 2. SHALL contain exactly one [1..1] code (CONF:15485). a. This code SHALL contain exactly one [1..1] @code="18841-7" Hospital Consultations Section (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15486). 3. SHALL contain exactly one [1..1] title (CONF:9917). 4. SHALL contain exactly one [1..1] text (CONF:9918). Figure 101: Hospital consultations section example
HOSPITAL CONSULTATIONS Gastroenterology Cardiology Dietitian
5.21 Hospital Course Section 8648-8 [section: templateId 1.3.6.1.4.1.19376.1.5.3.1.3.5(open)] Table 67: Hospital Course Section Contexts Used By: Contains Entries: Discharge Summary (required) The Hospital Course section describes the sequence of events from admission to discharge in a hospital facility. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 237 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 1. SHALL contain exactly one [1..1] templateId (CONF:7852) such that it a. SHALL contain exactly one [1..1] @root="1.3.6.1.4.1.19376.1.5.3.1.3.5" (CONF:10459) 2. SHALL contain exactly one [1..1] code (CONF:15487). a. This code SHALL contain exactly one [1..1] @code="8648-8" Hospital Course (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15488). 3. SHALL contain exactly one [1..1] title (CONF:7854) 4. SHALL contain exactly one [1..1] text (CONF:7855) Figure 102: Hospital course section example
Hospital Course The patient was admitted and started on Lovenox and nitroglycerin paste. The patient had ...
5.22 Hospital Discharge Diagnosis Section 11535-2 [section: templateId 2.16.840.1.113883.10.20.22.2.24(open)] Table 68: Hospital Discharge Diagnosis Section Contexts Used By: Contains Entries: Discharge Summary (required) Hospital Discharge Diagnosis The Hospital Discharge Diagnosis section describes the relevant problems or diagnoses at the time of discharge that occurred during the hospitalization or that need to be followed after hospitalization. This section includes an optional entry to record patient conditions. 1. SHALL contain exactly one [1..1] templateId (CONF:7979) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.24" (CONF:10394). 2. SHALL contain exactly one [1..1] code (CONF:15355). a. This code SHALL contain exactly one [1..1] @code="11535-2" Hospital Discharge Diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15356). 3. SHALL contain exactly one [1..1] title (CONF:7981). 4. SHALL contain exactly one [1..1] text (CONF:7982). 5. SHOULD contain zero or one [0..1] entry (CONF:7983). Page 238 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. This entry, if present, SHALL contain exactly one [1..1] Hospital Discharge Diagnosis (templateId:2.16.840.1.113883.10.20.22.4.33) (CONF:7984). Figure 103: Hospital discharge diagnosis section example
Hospital Discharge Diagnosis Diverticula of intestine ...
5.23 Hospital Discharge Instructions Section 8653-8 [section: templateId 2.16.840.1.113883.10.20.22.2.41(open)] Table 69: Hospital Discharge Instructions Section Contexts Used By: Contains Entries: Discharge Summary (optional) The Hospital Discharge Instructions section records instructions at discharge. 1. SHALL contain exactly one [1..1] templateId (CONF:9919) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.41" (CONF:10395). 2. SHALL contain exactly one [1..1] code (CONF:15357). a. This code SHALL contain exactly one [1..1] @code="8653-8" Hospital Discharge Instructions (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15358). 3. SHALL contain exactly one [1..1] title (CONF:9921). 4. SHALL contain exactly one [1..1] text (CONF:9922). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 239 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 104: Hospital discharge instructions section example
HOSPITAL DISCHARGE INSTRUCTIONS Take all of your prescription medication as directed. Make an appointment with your doctor to be seen two weeks from the date of your procedure. You may feel slightly bloated after the procedure because of air that was introduced during the examination. Call your physician if you notice:
Bleeding or black stools.
Abdominal pain.
Fever or chills.
Nausea or vomiting.
Any unusual pain or problem.
Pain or redness at the site where the intravenous needle was placed.
Do not drink alcohol for 24 hours. Alcohol amplifies the effect of the sedatives given. Do not drive or operate machinery for 24 hours.
5.24 Hospital Discharge Medications Section 10183-2 Table 70: Hospital Discharge Medications Section Contexts Used By: Contains Entries: Coded entries optional: Discharge Summary (required) Discharge Medication Coded entries required: --- The Hospital Discharge Medications section defines the medications that the patient is intended to take (or stop) after discharge. The currently active medications must be listed. The section may also include a patient’s prescription history and indicate the source of the medication list, for example, from a pharmacy system versus from the patient. Page 240 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Hospital Discharge Medications Section with Coded Entries Optional [section: templateId 2.16.840.1.113883.10.20.22.2.11(open)] The following constraints apply to a Hospital Discharge Medications section in which entries are not required. 1. SHALL contain exactly one [1..1] templateId (CONF:7816) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.11" (CONF:10396). 2. SHALL contain exactly one [1..1] code (CONF:15359). a. This code SHALL contain exactly one [1..1] @code="10183-2" Hospital Discharge Medications (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15360). 3. SHALL contain exactly one [1..1] title (CONF:7818). 4. SHALL contain exactly one [1..1] text (CONF:7819). 5. SHOULD contain zero or more [0..*] entry (CONF:7820) such that it a. SHALL contain exactly one [1..1] Discharge Medication (2.16.840.1.113883.10.20.22.4.35) (CONF:7883). Hospital Discharge Medications Section with Coded Entries Required [section: templateId 2.16.840.1.113883.10.20.22.2.11.1(open)] The following constraints apply to a Hospital Discharge Medications section in which entries are required. 1. Conforms to Hospital Discharge Medications Section (entries optional) template (2.16.840.1.113883.10.20.22.2.11). 2. SHALL contain exactly one [1..1] templateId (CONF:7822) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.11.1" (CONF:10397). 3. SHALL contain exactly one [1..1] code (CONF:15361). a. This code SHALL contain exactly one [1..1] @code="10183-2" Hospital Discharge Medications (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15362). 4. SHALL contain exactly one [1..1] title (CONF:7824). 5. SHALL contain exactly one [1..1] text (CONF:7825). 6. SHALL contain at least one [1..*] entry (CONF:7826) such that it a. SHALL contain exactly one [1..1] Discharge Medication (2.16.840.1.113883.10.20.22.4.35) (CONF:7827). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 241 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 105: Hospital discharge medications section example
Hospital Discharge Medications ... ... ...
5.25 Hospital Discharge Physical Section 10184-0 [section: templateId 1.3.6.1.4.1.19376.1.5.3.1.3.26(open)] Table 71: Hospital Discharge Physical Section Contexts Used By: Contains Entries: Discharge Summary (optional) The Hospital Discharge Physical section records a narrative description of the patient’s physical findings. 1. SHALL contain exactly one [1..1] templateId (CONF:7971) such that it a. SHALL contain exactly one [1..1] @root="1.3.6.1.4.1.19376.1.5.3.1.3.26" (CONF:10460) 2. SHALL contain exactly one [1..1] code (CONF:15363). a. This code SHALL contain exactly one [1..1] @code="10184-0" Hospital Discharge Physical (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15364). 3. SHALL contain exactly one [1..1] title (CONF:7973). 4. SHALL contain exactly one [1..1] text (CONF:7974). Page 242 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 106: Hospital discharge physical section example
Hospital Discharge Physical GENERAL: Well-developed, slightly obese man.
NECK: Supple, with no jugular venous distension.
HEART: Intermittent tachycardia without murmurs or gallops.
PULMONARY: Decreased breath sounds, but no clear-cut rales or wheezes.
EXTREMITIES: Free of edema.
5.26 Hospital Discharge Studies Summary Section 11493-4 [section: templateId 2.16.840.1.113883.10.20.22.2.16(open)] Table 72: Hospital Discharge Studies Summary Section Contexts Used By: Contains Entries: Discharge Summary (optional) This section records the results of observations generated by laboratories, imaging procedures, and other procedures. The scope includes hematology, chemistry, serology, virology, toxicology, microbiology, plain x-ray, ultrasound, CT, MRI, angiography, echocardiography, nuclear medicine, pathology, and procedure observations. This section often includes notable results such as abnormal values or relevant trends, and could record all results for the period of time being documented. Laboratory results are typically generated by laboratories providing analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology, microbiology, and/or virology. These observations are based on analysis of specimens obtained from the patient and submitted to the laboratory. Imaging results are typically generated by a clinician reviewing the output of an imaging procedure, such as where a cardiologist reports the left ventricular ejection fraction based on the review of an echocardiogram. Procedure results are typically generated by a clinician wanting to provide more granular information about component observations made during the performance of a procedure, such as when a gastroenterologist reports the size of a polyp observed during a colonoscopy. Note that there are discrepancies between CCD and the lab domain model, such as the effectiveTime in specimen collection. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 243 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 1. SHALL contain exactly one [1..1] templateId (CONF:7910) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.16" (CONF:10398). 2. SHALL contain exactly one [1..1] code (CONF:15365). a. This code SHALL contain exactly one [1..1] @code="11493-4" Hospital Discharge Studies Summary (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15366). 3. SHALL contain exactly one [1..1] title (CONF:7912). 4. SHALL contain exactly one [1..1] text (CONF:7913). Figure 107: Hospital discharge studies summary section example
Hospital Discharge Studies Summary ...
5.27 Immunizations Section 11369-6 Table 73: Immunizations Section Contexts Used By: Contains Entries: Coded entries optional: Consultation Note (optional) Discharge Summary (optional) Continuity of Care Document (CCD) (optional) History and Physical (optional) Immunization Activity Coded entries required: --- Figure 108: Immunization section* UML diagram *The Large UML Diagrams appendix provides a larger version of this diagram The Immunizations section defines a patient's current immunization status and pertinent immunization history. The primary use case for the Immunization Page 244 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 section is to enable communication of a patient's immunization status. The section should include current immunization status, and may contain the entire immunization history that is relevant to the period of time being summarized. Immunizations Section with Coded Entries Optional [section: templateId 2.16.840.1.113883.10.20.22.2.2(open)] The following constraints apply to an Immunization section in which entries are not required. 1. SHALL contain exactly one [1..1] templateId (CONF:7965) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.2" (CONF:10399). 2. SHALL contain exactly one [1..1] code (CONF:15367). a. This code SHALL contain exactly one [1..1] @code="11369-6" Immunizations (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15368). 3. SHALL contain exactly one [1..1] title (CONF:7967). 4. SHALL contain exactly one [1..1] text (CONF:7968). 5. SHOULD contain zero or more [0..*] entry (CONF:7969) such that it a. SHALL contain exactly one [1..1] Immunization Activity (2.16.840.1.113883.10.20.22.4.52) (CONF:7970). Immunizations Section with Coded Entries Required [section: templateId 2.16.840.1.113883.10.20.22.2.2.1(open)] The following constraints apply to an Immunization section in which entries are required. 1. Conforms to Immunizations Section (entries optional) template (2.16.840.1.113883.10.20.22.2.2) 2. SHALL contain exactly one [1..1] templateId (CONF:9015) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.2.1" (CONF:10400) 3. SHALL contain exactly one [1..1] code (CONF:15369). a. This code SHALL contain exactly one [1..1] @code="11369-6" Immunizations (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15370). 4. SHALL contain exactly one [1..1] title (CONF:9017) 5. SHALL contain exactly one [1..1] text (CONF:9018) 6. SHALL contain at least one [1..*] entry (CONF:9019) such that it a. SHALL contain exactly one [1..1] Immunization Activity (2.16.840.1.113883.10.20.22.4.52) (CONF:9020) HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 245 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 109: Immunization section example
Immunizations
Vaccine Date Status
Influenza virus vaccine, IM Nov 1999 Completed
Influenza virus vaccine, IM Dec 1998 Completed
Pneumococcal polysaccharide vaccine, IM Dec 1998 Completed
Tetanus and diphtheria toxoids, IM 1997 Refused
Page 246 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 ... ...
5.28 Instructions Section 69730-0 [section: templateId 2.16.840.1.113883.10.20.22.2.45 (open)] Table 74: Interventions Section Contexts Used By: Contains Entries: History and Physical (optional) Progress Note (optional) Instructions The Instructions section records instructions given to a patient. List patient decision aids here. 1. SHALL contain exactly one [1..1] templateId (CONF:10112) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.45" (CONF:10402). 2. SHALL contain exactly one [1..1] code (CONF:15375). a. This code SHALL contain exactly one [1..1] @code="69730-0" Instructions (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15376). 3. SHALL contain exactly one [1..1] title (CONF:10114). 4. SHALL contain exactly one [1..1] text (CONF:10115). 5. SHOULD contain zero or more [0..*] entry (CONF:10116). a. SHALL contain exactly one [1..1] Instructions (2.16.840.1.113883.10.20.22.4.20) (CONF:10117). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 247 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 110: Instructions section example
INSTRUCTIONS Patient may have low grade fever, mild joint pain and injection area tenderness ...
5.29 Interventions Section 62387-6 [section: templateId 2.16.840.1.113883.10.20.21.2.3(open)] Table 75: Interventions Section Contexts Used By: Contains Entries: Progress Note (optional) The Interventions section contains information about the specific interventions provided during the healthcare visit. Depending on the type of intervention(s) provided (procedural, education, application of assistive equipment, etc.), the details will vary but may include specification of frequency, intensity, and duration. 1. SHALL contain exactly one [1..1] templateId (CONF:8680) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.21.2.3" (CONF:10461). 2. SHALL contain exactly one [1..1] code (CONF:15377). a. This code SHALL contain exactly one [1..1] @code="62387-6" Interventions Provided (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15378). 3. SHALL contain exactly one [1..1] title (CONF:8682). 4. SHALL contain exactly one [1..1] text (CONF:8683). Page 248 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 111: Interventions section example
INTERVENTIONS PROVIDED Therapeutic exercise intervention: knee extension, 3 sets, 10 repetitions, 10-lb weight. Therapeutic exercise intervention: arm curl, 3 sets, 10 repetitions, 15-lb weight
5.30 Medical Equipment Section 46264-8 [section: templateId 2.16.840.1.113883.10.20.22.2.23(open)] Table 76: Medical Equipment Section Contexts Used By: Contains Entries: Continuity of Care Document (CCD) (optional) Non-Medicinal Supply Activity Figure 112: Medical equipment section UML diagram The Medical Equipment section defines a patient’s implanted and external medical devices and equipment that their health status depends on, as well as any pertinent equipment or device history. This section is also used to itemize any pertinent current or historical durable medical equipment (DME) used to help maintain the patient’s health status. All pertinent equipment relevant to the diagnosis, care, and treatment of a patient should be included. 1. SHALL contain exactly one [1..1] templateId (CONF:7944) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.23" (CONF:10404). 2. SHALL contain exactly one [1..1] code (CONF:15381). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 249 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. This code SHALL contain exactly one [1..1] @code="46264-8" Medical Equipment (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15382). 3. SHALL contain exactly one [1..1] title (CONF:7946). 4. SHALL contain exactly one [1..1] text (CONF:7947). 5. SHOULD contain zero or more [0..*] entry (CONF:7948) such that it a. SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (2.16.840.1.113883.10.20.22.4.50) (CONF:8755). Figure 113: Medical equipment section example
Medical Equipment ... ...
5.31 Medical (General) History Section 11329-0 [section: templateId 2.16.840.1.113883.10.20.22.2.39(open)] Table 77: Medical (General) History Section Contexts Used By: Contains Entries: Procedure Note (optional) The Medical History section describes all aspects of the medical history of the patient even if not pertinent to the current procedure, and may include chief complaint, past medical history, social history, family history, surgical or procedure history, medication history, and other history information. The history may be limited to information pertinent to the current procedure or may be more comprehensive. The history may be reported as a collection of random clinical statements or it may be reported categorically. Categorical report formats may be divided into multiple subsections including Past Medical History, Social History. 1. SHALL contain exactly one [1..1] templateId (CONF:8160) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.39" (CONF:10403). Page 250 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 2. SHALL contain exactly one [1..1] code (CONF:15379). a. This code SHALL contain exactly one [1..1] @code="11329-0" Medical (General) History (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15380). 3. SHALL contain exactly one [1..1] title (CONF:8162). 4. SHALL contain exactly one [1..1] text (CONF:8163). Figure 114: Medical (general) history section example
MEDICAL (GENERAL) HISTORY Patient has had recent issue with acne that does not seem to be related to any particular cause. Previous concerns of oral cancer was actually irritated gums as a result of mild food allergy. Patient had recent weight gain due to sedentary lifestyle and new job.
5.32 Medications Administered Section 29549-3 [section: templateId 2.16.840.1.113883.10.20.22.2.38(open)] Table 78: Medications Administered Section Contexts Used By: Contains Entries: Procedure Note (optional) Medication Activity The Medications Administered section defines medications and fluids administered during the procedure, encounter, or other activity excluding anesthetic medications. This guide recommends anesthesia medications be documented as described in the section on Anesthesia. 1. SHALL contain exactly one [1..1] templateId (CONF:8152) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.38" (CONF:10405). 2. SHALL contain exactly one [1..1] code (CONF:15383). a. This code SHALL contain exactly one [1..1] @code="29549-3" Medications Administered (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15384). 3. SHALL contain exactly one [1..1] title (CONF:8154). 4. SHALL contain exactly one [1..1] text (CONF:8155). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 251 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5. MAY contain zero or more [0..*] entry (CONF:8156). a. SHALL contain exactly one [1..1] Medication Activity (2.16.840.1.113883.10.20.22.4.16) (CONF:8157). Figure 115: Medications administered section example
Medications Administered Secretin 100 IU administered IV ...
5.33 Medications Section 10160-0 Table 79: Medications Section Contexts Used By: Contains Entries: Coded entries optional: Medication Activity Progress Note (optional) Consultation Note (optional) History and Physical (required) Procedure Note (optional) Coded entries required: Continuity of Care Document (CCD) (required) Figure 116: Medications section UML diagram *The Large UML Diagrams appendix provides a larger version of this diagram The Medications section defines a patient's current medications and pertinent medication history. At a minimum, the currently active medications are to be listed, with an entire medication history as an option. The section may also include a patient's prescription and dispense history. Page 252 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 This section requires that there be either an entry indicating the subject is not known to be on any medications, or that there be entries summarizing the subject's medications. Medications Section With Coded Entries Optional [section: templateId 2.16.840.1.113883.10.20.22.2.1(open)] The following constraints apply to a Medications section in which entries are not required. 1. SHALL contain exactly one [1..1] templateId (CONF:7791) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.1" (CONF:10432). 2. SHALL contain exactly one [1..1] @code="10160-0" History of medication use (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:7792). 3. SHALL contain exactly one [1..1] title="Medications" (CONF:7793). 4. SHALL contain exactly one [1..1] text (CONF:7794). 5. SHOULD contain zero or more [0..*] entry (CONF:7795) such that it a. SHALL contain exactly one [1..1] Medication Activity (2.16.840.1.113883.10.20.22.4.16) (CONF:7796). b. If medication use is unknown, the appropriate nullFlavor MAY be present (see unknown information in Section 1) (CONF:10076). Medications Section With Coded Entries Required [section: templateId 2.16.840.1.113883.10.20.22.2.1.1(open)] The following constraints apply to a Medications section in which entries are required. 1. Conforms to Medications Section (entries optional) template (2.16.840.1.113883.10.20.22.2.1). 2. SHALL contain exactly one [1..1] templateId (CONF:7568) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.1.1" (CONF:10433). 3. SHALL contain exactly one [1..1] @code="10160-0" History of medication use (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:7569). 4. SHALL contain exactly one [1..1] title="Medications" (CONF:7570). 5. SHALL contain exactly one [1..1] text (CONF:7571). 6. SHALL contain at least one [1..*] entry (CONF:7572) such that it a. SHALL contain exactly one [1..1] Medication Activity (2.16.840.1.113883.10.20.22.4.16) (CONF:7573). b. If medication use is unknown, the appropriate nullFlavor MAY be present (see unknown information in Section 1) (CONF:10077). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 253 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 117: Medications section entries example
MEDICATIONS ... ...
5.34 Objective Section 61149-1 [section: templateId 2.16.840.1.113883.10.20.21.2.1(open)] Table 80: Objective Section Contexts Used By: Contains Entries: Progress Note (optional) The Objective section contains data about the patient gathered through tests, measures, or observations that produce a quantified or categorized result. It includes important and relevant positive and negative test results, physical findings, review of systems, and other measurements and observations. 1. SHALL contain exactly one [1..1] templateId (CONF:7869) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.21.2.1" (CONF:10462). 2. SHALL contain exactly one [1..1] code (CONF:15389). a. This code SHALL contain exactly one [1..1] @code="61149-1" Objective (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15390). 3. SHALL contain exactly one [1..1] title (CONF:7871). 4. SHALL contain exactly one [1..1] text (CONF:7872). Page 254 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 118: Objective section example
OBJECTIVE DATA Chest: clear to ausc. No rales, normal breath sounds Heart: RR, PMI in normal location and no heave or evidence of cardiomegaly,normal heart sounds, no murm or gallop
5.35 Operative Note Fluid Section 10216-0 [section: templateId 2.16.840.1.113883.10.20.7.12(open)] Table 81: Operative Note Fluids Section Contexts Used By: Contains Entries: Operative Note (optional) The Operative Note Fluids section may be used to record fluids administered during the surgical procedure. 1. SHALL contain exactly one [1..1] templateId (CONF:8030) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.7.12" (CONF:10463). 2. SHALL contain exactly one [1..1] code (CONF:15391). a. This code SHALL contain exactly one [1..1] @code="10216-0" Operative Note Fluids (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15392). 3. SHALL contain exactly one [1..1] title (CONF:8032). 4. SHALL contain exactly one [1..1] text (CONF:8033). 5. If the Operative Note Fluids section is present, there SHALL be a statement providing details of the fluids administered or SHALL explicitly state there were no fluids administered (CONF:8052). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 255 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 119: Operative Note fluid section example
Operative Note Fluids 250 ML Ringers Lactate
5.36 Operative Note Surgical Procedure Section 10223-6 [section: templateId 2.16.840.1.113883.10.20.7.14(open)] Table 82: Operative Note Surgical Procedure Section Contexts Used By: Contains Entries: Operative Note (optional) The Operative Note Surgical Procedure section can be used to restate the procedures performed if appropriate for an enterprise workflow. The procedure(s) performed associated with the Operative Note are formally modeled in the header using serviceEvent. 1. SHALL contain exactly one [1..1] templateId (CONF:8034) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.7.14" (CONF:10464). 2. SHALL contain exactly one [1..1] code (CONF:15393). a. This code SHALL contain exactly one [1..1] @code="10223-6" Operative Note Surgical Procedure (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15394). 3. SHALL contain exactly one [1..1] title (CONF:8036). 4. SHALL contain exactly one [1..1] text (CONF:8037). 5. If the surgical procedure section is present there SHALL be text indicating the procedure performed (CONF:8054). Figure 120: Operative Note surgical procedure section example
Surgical Procedure Laparoscopic Appendectomy
Page 256 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.37 Payers Section 48768-6 [section: templateId 2.16.840.1.113883.10.20.22.2.18(open)] Table 83: Payers Section Contexts Used By: Contains Entries: Continuity of Care Document (CCD) (optional) Coverage Activity Figure 121: Payers section UML diagram The Payers section contains data on the patient’s payers, whether a ‘third party’ insurance, self-pay, other payer or guarantor, or some combination of payers, and is used to define which entity is the responsible fiduciary for the financial aspects of a patient’s care. Each unique instance of a payer and all the pertinent data needed to contact, bill to, and collect from that payer should be included. Authorization information that can be used to define pertinent referral, authorization tracking number, procedure, therapy, intervention, device, or similar authorizations for the patient or provider, or both should be included. At a minimum, the patient’s pertinent current payment sources should be listed. The sources of payment are represented as a Coverage Activity, which identifies all of the insurance policies or government or other programs that cover some or all of the patient's healthcare expenses. The policies or programs are sequenced by preference. The Coverage Activity has a sequence number that represents the preference order. Each policy or program identifies the covered party with respect to the payer, so that the identifiers can be recorded. 1. SHALL contain exactly one [1..1] templateId (CONF:7924) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.18" (CONF:10434). 2. SHALL contain exactly one [1..1] code (CONF:15395). a. This code SHALL contain exactly one [1..1] @code="48768-6" Payers (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15396). 3. SHALL contain exactly one [1..1] title (CONF:7926). 4. SHALL contain exactly one [1..1] text (CONF:7927). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 257 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5. SHOULD contain zero or more [0..*] entry (CONF:7959) such that it a. SHALL contain exactly one [1..1] Coverage Activity (2.16.840.1.113883.10.20.22.4.60) (CONF:8905). Figure 122: Payers section example
Insurance Providers
Payer name Policy type / Coverage type Policy ID Covered party ID Policy Holder
Good Health Insurance Extended healthcare / Family Contract Number 1138345 Patient's Mother
...
Page 258 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.38 Physical Exam Section 29545-1 [section: templateId 2.16.840.1.113883.10.20.2.10 (open)] Table 84: Physical Exam Section Contexts Used By: Contains Entries: Progress Note (optional) Consultation Note (optional) History and Physical (required) Procedure Note (optional) Highest Pressure Ulcer Stage Number of Pressure Ulcers Observation Pressure Ulcer Observation The Physical Exam section includes direct observations made by the clinician. The examination may include the use of simple instruments and may also describe simple maneuvers performed directly on the patient’s body. This section includes only observations made by the examining clinician using inspection, palpation, auscultation, and percussion; it does not include laboratory or imaging findings. The exam may be limited to pertinent body systems based on the patient’s chief complaint or it may include a comprehensive examination. The examination may be reported as a collection of random clinical statements or it may be reported categorically. The Physical Exam section may contain multiple nested subsections: Vital Signs, General Status, and those listed in the Additional Physical Examination Subsections appendix. 1. SHALL contain exactly one [1..1] templateId (CONF:7806) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.2.10" (CONF:10465). 2. SHALL contain exactly one [1..1] code (CONF:15397). a. This code SHALL contain exactly one [1..1] @code="29545-1" Physical Findings (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15398). 3. SHALL contain exactly one [1..1] title (CONF:7808). 4. SHALL contain exactly one [1..1] text (CONF:7809). 5. MAY contain zero or more [0..*] entry (CONF:17094) such that it a. SHALL contain exactly one [1..1] Pressure Ulcer Observation (templateId:2.16.840.1.113883.10.20.22.4.70) (CONF:17095). 6. MAY contain zero or more [0..*] entry (CONF:17096) such that it a. SHALL contain exactly one [1..1] Number of Pressure Ulcers Observation (templateId:2.16.840.1.113883.10.20.22.4.76) (CONF:17097). 7. MAY contain zero or more [0..*] entry (CONF:17098) such that it a. SHALL contain exactly one [1..1] Highest Pressure Ulcer Stage (templateId:2.16.840.1.113883.10.20.22.4.77) (CONF:17099). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 259 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 123: Physical exam section example
PHYSICAL EXAMINATION All normal to examination.
5.39 Plan of Care Section 18776-5 [section: templateId 2.16.840.1.113883.10.20.22.2.10(open)] Table 85: Plan of Care Section Contexts Used By: Contains Entries: Progress Note (optional) Consultation Note (optional) Discharge Summary (required) History and Physical (optional) Procedure Note (optional) Operative Note (optional) Continuity of Care Document (CCD) (optional) Instructions Plan of Care Plan of Care Plan of Care Plan of Care Plan of Care Plan of Care Activity Activity Activity Activity Activity Activity Act Encounter Observation Procedure Substance Administration Supply Figure 124: Plan of care section UML diagram *The Large UML Diagrams appendix provides a larger version of this diagram The Plan of Care section contains data that defines pending orders, interventions, encounters, services, and procedures for the patient. It is limited to prospective, unfulfilled, or incomplete orders and requests only, which are indicated by the @moodCode of the entries within this section. All active, incomplete, or pending orders, appointments, referrals, procedures, services, or any other pending event of clinical significance to the current care of the patient should be listed unless constrained due to privacy issues. The plan may also contain information about ongoing care of the patient and information regarding goals and clinical reminders. Clinical reminders are placed here to provide prompts for disease prevention and management, patient safety, and health-care quality improvements, including widely accepted performance measures. The plan may also indicate that patient education will be provided. 1. SHALL contain exactly one [1..1] templateId (CONF:7723) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.10" (CONF:10435). Page 260 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 2. SHALL contain exactly one [1..1] code (CONF:14749). a. This code SHALL contain exactly one [1..1] @code="18776-5" Plan of Care (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:14750). 3. SHALL contain exactly one [1..1] title (CONF:16986). 4. SHALL contain exactly one [1..1] text (CONF:7725). 5. MAY contain zero or more [0..*] entry (CONF:7726) such that it a. SHALL contain exactly one [1..1] Plan of Care Activity Act (2.16.840.1.113883.10.20.22.4.39) (CONF:8804). 6. MAY contain zero or more [0..*] entry (CONF:8805) such that it a. SHALL contain exactly one [1..1] Plan of Care Activity Encounter (2.16.840.1.113883.10.20.22.4.40) (CONF:8806). 7. MAY contain zero or more [0..*] entry (CONF:8807) such that it a. SHALL contain exactly one [1..1] Plan of Care Activity Observation (2.16.840.1.113883.10.20.22.4.44) (CONF:8808). 8. MAY contain zero or more [0..*] entry (CONF:8809) such that it a. SHALL contain exactly one [1..1] Plan of Care Activity Procedure (2.16.840.1.113883.10.20.22.4.41) (CONF:8810). 9. MAY contain zero or more [0..*] entry (CONF:8811) such that it a. SHALL contain exactly one [1..1] Plan of Care Activity Substance Administration (2.16.840.1.113883.10.20.22.4.42) (CONF:8812). 10. MAY contain zero or more [0..*] entry (CONF:8813) such that it a. SHALL contain exactly one [1..1] Plan of Care Activity Supply (templateId:2.16.840.1.113883.10.20.22.4.43) (CONF:14756). 11. MAY contain zero or more [0..*] entry (CONF:14695) such that it a. SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:16751). Figure 125: Plan of care section example
Plan of Care ... ... ... ... ...
5.40 Planned Procedure Section 59772-4 [section: templateId 2.16.840.1.113883.10.20.22.2.30(open)] Table 86: Planned Procedure Section Contexts Used By: Contains Entries: Procedure Note (optional) Operative Note (optional) Plan of Care Activity Procedure The Planned Procedure section records the procedure(s) that a clinician thought would need to be done based on the preoperative assessment. It may be important to record the procedure(s) that were originally planned for, consented to, and perhaps pre-approved by the payor, particularly if different from the actual procedure(s) and procedure details, to provide evidence to various Page 262 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 stakeholders that the providers are aware of the discrepancy and the justification can be found in the procedure details. 1. SHALL contain exactly one [1..1] templateId (CONF:8082) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.30" (CONF:10436). 2. SHALL contain exactly one [1..1] code (CONF:15399). a. This code SHALL contain exactly one [1..1] @code="59772-4" Planned Procedure (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15400). 3. SHALL contain exactly one [1..1] title (CONF:8084). 4. SHALL contain exactly one [1..1] text (CONF:8085). 5. MAY contain zero or more [0..*] entry (CONF:8744) such that it a. SHALL contain exactly one [1..1] Plan of Care Activity Procedure (2.16.840.1.113883.10.20.22.4.41) (CONF:8766). Figure 126: Planned procedure section example
Planned Procedure ... ...
5.41 Postoperative Diagnosis Section 10218-6 [section: templateId 2.16.840.1.113883.10.20.22.2.35(open)] Table 87: Postoperative Diagnosis Section Contexts Used By: Contains Entries: Operative Note (required) The Postoperative Diagnosis section records the diagnosis or diagnoses discovered or confirmed during the surgery. Often it is the same as the preoperative diagnosis. 1. SHALL contain exactly one [1..1] templateId (CONF:8101) such that it HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 263 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.35" (CONF:10437). 2. SHALL contain exactly one [1..1] code (CONF:15401). a. This code SHALL contain exactly one [1..1] @code="10218-6" Postoperative Diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15402). 3. SHALL contain exactly one [1..1] title (CONF:8103). 4. SHALL contain exactly one [1..1] text (CONF:8104). Figure 127: Postoperative diagnosis section example
Postoperative Diagnosis Appendicitis with periappendiceal abscess
5.42 Postprocedure Diagnosis Section 59769-0 [section: templateId 2.16.840.1.113883.10.20.22.2.36(open)] Table 88: Postprocedure Diagnosis Section Contexts Used By: Contains Entries: Procedure Note (required) Postprocedure Diagnosis The Postprocedure Diagnosis section records the diagnosis or diagnoses discovered or confirmed during the procedure. Often it is the same as the preprocedure diagnosis or indication. 1. SHALL contain exactly one [1..1] templateId (CONF:8167) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.36" (CONF:10438). 2. SHALL contain exactly one [1..1] code (CONF:15403). a. This code SHALL contain exactly one [1..1] @code="59769-0" Postprocedure Diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15404). 3. SHALL contain exactly one [1..1] title (CONF:8170). 4. SHALL contain exactly one [1..1] text (CONF:8171). 5. SHOULD contain zero or one [0..1] entry (CONF:8762) such that it a. SHALL contain exactly one [1..1] Postprocedure Diagnosis (2.16.840.1.113883.10.20.22.4.51) (CONF:8764). Page 264 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 128: Postprocedure diagnosis section example
Postprocedure Diagnosis ... ...
5.43 Preoperative Diagnosis Section 10219-4 [section: templateId 2.16.840.1.113883.10.20.22.2.34(open)] Table 89: Preoperative Diagnosis Section Contexts Used By: Contains Entries: Operative Note (required) Preoperative Diagnosis The Preoperative Diagnosis section records the surgical diagnosis or diagnoses assigned to the patient before the surgical procedure and is the reason for the surgery. The preoperative diagnosis is, in the opinion of the surgeon, the diagnosis that will be confirmed during surgery. 1. SHALL contain exactly one [1..1] templateId (CONF:8097) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.34" (CONF:10439). 2. SHALL contain exactly one [1..1] code (CONF:15405). a. This code SHALL contain exactly one [1..1] @code="10219-4" Preoperative Diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15406). 3. SHALL contain exactly one [1..1] title (CONF:8099). 4. SHALL contain exactly one [1..1] text (CONF:8100). 5. SHOULD contain zero or one [0..1] entry (CONF:10096) such that it a. SHALL contain exactly one [1..1] Preoperative Diagnosis (2.16.840.1.113883.10.20.22.4.65) (CONF:10097). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 265 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 129: Preoperative diagnosis section example
Preoperative Diagnosis Appendicitis ...
5.44 Problem Section 11450-4 Table 90: Problem Section Contexts Used By: Contains Entries: Entries optional: Progress Note (optional) Consultation Note (optional) Discharge Summary (optional) History and Physical (optional) Problem Concern Act (Condition) Entries required: Continuity of Care Document (CCD) (required) Figure 130: Problem section UML diagram Page 266 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 This section lists and describes all relevant clinical problems at the time the document is generated. At a minimum, all pertinent current and historical problems should be listed. Problem Section with Coded Entries Optional [section: templateId 2.16.840.1.113883.10.20.22.2.5(open)] The following constraints apply to a Problem section in which entries are not required. 1. SHALL contain exactly one [1..1] templateId (CONF:7877) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.5" (CONF:10440). 2. SHALL contain exactly one [1..1] code (CONF:15407). a. This code SHALL contain exactly one [1..1] @code="11450-4" Problem List (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15408). 3. SHALL contain exactly one [1..1] title (CONF:7879). 4. SHALL contain exactly one [1..1] text (CONF:7880). 5. SHOULD contain zero or more [0..*] entry (CONF:7881). a. SHALL contain exactly one [1..1] Problem Concern Act (Condition) (2.16.840.1.113883.10.20.22.4.3) (CONF:7882). Problem Section with Coded Entries Required [section: templateId 2.16.840.1.113883.10.20.22.2.5.1(open)] The following constraints apply to a Problem section in which entries are required. 1. Conforms to Problem Section (entries optional) template (2.16.840.1.113883.10.20.22.2.5). 2. SHALL contain exactly one [1..1] templateId (CONF:9179) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.5.1" (CONF:10441). 3. SHALL contain exactly one [1..1] code (CONF:15409). a. This code SHALL contain exactly one [1..1] @code="11450-4" Problem List (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15410). 4. SHALL contain exactly one [1..1] title (CONF:9181). 5. SHALL contain exactly one [1..1] text (CONF:9182). 6. SHALL contain at least one [1..*] entry (CONF:9183). a. SHALL contain exactly one [1..1] Problem Concern Act (Condition) (2.16.840.1.113883.10.20.22.4.3) (CONF:9184). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 267 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 131: Problem section example
PROBLEMS Pneumonia: Resolved in March 1998 ... ...
Figure 132: Pressure ulcer on a problem list example
Problems 2 Stage 3 Pressure Ulcers ...
Page 268 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.45 Procedure Description Section 29554-3 [section: templateId 2.16.840.1.113883.10.20.22.2.27(open)] Table 91: Procedure Description Section Contexts Used By: Contains Entries: Procedure Note (required) Operative Note (required) The Procedure Description section records the particulars of the procedure and may include procedure site preparation, surgical site preparation, pertinent details related to sedation/anesthesia, pertinent details related to measurements and markings, procedure times, medications administered, estimated blood loss, specimens removed, implants, instrumentation, sponge counts, tissue manipulation, wound closure, sutures used, vital signs and other monitoring data. Local practice often identifies the level and type of detail required based on the procedure or specialty. 1. SHALL contain exactly one [1..1] templateId (CONF:8062) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.27" (CONF:10442). 2. SHALL contain exactly one [1..1] code (CONF:15411). a. This code SHALL contain exactly one [1..1] @code="29554-3" Procedure Description (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15412). 3. SHALL contain exactly one [1..1] title (CONF:8064). 4. SHALL contain exactly one [1..1] text (CONF:8065). Figure 133: Procedure description section example
Procedure Description The patient was taken to the endoscopy suite where ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 269 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.46 Procedure Disposition Section 59775-7 [section: templateId 2.16.840.1.113883.10.20.18.2.12(open)] Table 92: Procedure Disposition Section Contexts Used By: Contains Entries: Procedure Note (optional) Operative Note (optional) The Procedure Disposition section records the status and condition of the patient at the completion of the procedure or surgery. It often also states where the patent was transferred to for the next level of care. 1. SHALL contain exactly one [1..1] templateId (CONF:8070) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.18.2.12" (CONF:10466). 2. SHALL contain exactly one [1..1] code (CONF:15413). a. This code SHALL contain exactly one [1..1] @code="59775-7" Procedure Disposition (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15414). 3. SHALL contain exactly one [1..1] title (CONF:8072). 4. SHALL contain exactly one [1..1] text (CONF:8073). Figure 134: Procedure disposition section example
PROCEDURE DISPOSITION The patient was taken to the Endoscopy Recovery Unit in stable condition.
5.47 Procedure Estimated Blood Loss Section 59770-8 [section: templateId 2.16.840.1.113883.10.20.18.2.9(open)] Table 93: Procedure Estimated Blood Loss Section Contexts Used By: Contains Entries: Procedure Note (optional) Operative Note (required) The Estimated Blood Loss section may be a subsection of another section such as the Procedure Description section. The Estimated Blood Loss section records the approximate amount of blood that the patient lost during the procedure or Page 270 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 surgery. It may be an accurate quantitative amount, e.g., 250 milliliters, or it may be descriptive, e.g., “minimal” or “none”. 1. SHALL contain exactly one [1..1] templateId (CONF:8074) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.18.2.9" (CONF:10467). 2. SHALL contain exactly one [1..1] code (CONF:15415). a. This code SHALL contain exactly one [1..1] @code="59770-8" Procedure Estimated Blood Loss (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15416). 3. SHALL contain exactly one [1..1] title (CONF:8076). 4. SHALL contain exactly one [1..1] text (CONF:8077). 5. The Estimated Blood Loss section SHALL include a statement providing an estimate of the amount of blood lost during the procedure, even if the estimate is text, such as "minimal" or "none" (CONF:8741). Figure 135: Procedure estimated blood loss section example
Procedure Estimated Blood Loss Minimal
5.48 Procedure Findings Section 59776-5 [section: templateId 2.16.840.1.113883.10.20.22.2.28(open)] Table 94: Procedure Findings Section Contexts Used By: Contains Entries: Procedure Note (optional) Operative Note (required) Problem Observation The Procedure Findings section records clinically significant observations confirmed or discovered during the procedure or surgery. 1. SHALL contain exactly one [1..1] templateId (CONF:8078) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.28" (CONF:10443). 2. SHALL contain exactly one [1..1] code (CONF:15417). a. This code SHALL contain exactly one [1..1] @code="59776-5" Procedure Findings (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15418). 3. SHALL contain exactly one [1..1] title (CONF:8080). 4. SHALL contain exactly one [1..1] text (CONF:8081). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 271 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5. MAY contain zero or more [0..*] entry (CONF:8090) such that it a. SHALL contain exactly one [1..1] Problem Observation (2.16.840.1.113883.10.20.22.4.4) (CONF:8091). Figure 136: Procedure findings section example
Procedure Findings A 6 mm sessile polyp was found in the ascending colon and removed by snare, no cautery. Bleeding was controlled. Moderate diverticulosis and hemorrhoids were incidentally noted. ...
5.49 Procedure Implants Section 59771-6 [section: templateId 2.16.840.1.113883.10.20.22.2.40(open)] Table 95: Procedure Implants Section Contexts Used By: Contains Entries: Procedure Note (optional) Operative Note (optional) The Procedure Implants section records any materials placed during the procedure including stents, tubes, and drains. 1. SHALL contain exactly one [1..1] templateId (CONF:8178) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.40" (CONF:10444). 2. SHALL contain exactly one [1..1] code (CONF:15373). a. This code SHALL contain exactly one [1..1] @code="59771-6" Procedure Implants (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15374). 3. SHALL contain exactly one [1..1] title (CONF:8180). 4. SHALL contain exactly one [1..1] text (CONF:8181). 5. The Implants section SHALL include a statement providing details of the implants placed, or assert no implants were placed (CONF:8769). Page 272 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 137: Procedure implants section example
Procedure Implants No implants were placed.
5.50 Procedure Indications Section 59768-2 [section: templateId 2.16.840.1.113883.10.20.22.2.29(open)] Table 96: Procedure Indications Section Contexts Used By: Contains Entries: Procedure Note (required) Operative Note (optional) Indication The Procedure Indications section records details about the reason for the procedure or surgery. This section may include the pre-procedure diagnosis or diagnoses as well as one or more symptoms that contribute to the reason the procedure is being performed. 1. SHALL contain exactly one [1..1] templateId (CONF:8058) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.29" (CONF:10445). 2. SHALL contain exactly one [1..1] code (CONF:15419). a. This code SHALL contain exactly one [1..1] @code="59768-2" Procedure Indications (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15420). 3. SHALL contain exactly one [1..1] title (CONF:8060). 4. SHALL contain exactly one [1..1] text (CONF:8061). 5. MAY contain zero or more [0..*] entry (CONF:8743) such that it a. SHALL contain exactly one [1..1] Indication (2.16.840.1.113883.10.20.22.4.19) (CONF:8765). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 273 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 138: Procedure indications section example
Procedure Indications The procedure is performed for screening in a low risk individual. ...
5.51 Procedure Specimens Taken Section 59773-2 [section: templateId 2.16.840.1.113883.10.20.22.2.31(open)] Table 97: Procedure Specimens Taken Section Contexts Used By: Contains Entries: Procedure Note (optional) Operative Note (required) The Procedure Specimens Taken section records the tissues, objects, or samples taken from the patient during the procedure including biopsies, aspiration fluid, or other samples sent for pathological analysis. The narrative may include a description of the specimens. 1. SHALL contain exactly one [1..1] templateId (CONF:8086) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.31" (CONF:10446). 2. SHALL contain exactly one [1..1] code (CONF:15421). a. This code SHALL contain exactly one [1..1] @code="59773-2" Procedure Specimens Taken (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15422). 3. SHALL contain exactly one [1..1] title (CONF:8088). 4. SHALL contain exactly one [1..1] text (CONF:8089). 5. 5. The Procedure Specimens Taken section SHALL list all specimens removed or SHALL explicitly state that no specimens were taken (CONF:8742). Page 274 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 139: Procedure specimens taken section example
Procedure Specimens Taken Ascending colon polyp
5.52 Procedures Section 47519-4 Table 98: Procedures Section Contexts Used By: Contains Entries: Entries optional: Consultation Note (optional) Discharge Summary (optional) Procedure Note (optional) History and Physical (optional) Procedure Activity Act Procedure Activity Observation Procedure Activity Procedure Entries required: Continuity of Care Document (CCD) (optional) Figure 140: Procedures section UML diagram This section defines all interventional, surgical, diagnostic, or therapeutic procedures or treatments pertinent to the patient historically at the time the document is generated. The section is intended to include notable procedures, but can contain all procedures for the period of time being summarized. The common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore this section contains procedure templates represented with three RIM classes: Act. Observation, and Procedure. Procedure act is for procedures the alter that physical condition of a patient (Splenectomy). Observation act is for procedures that result in new information about a patient but do not cause physical alteration (EEG). Act is for all other types of procedures (dressing change). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 275 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. The length of an encounter is documented in the documentationOf/encompassingEncounter/effectiveTime and length of service in documentationOf/ServiceEvent/effectiveTime. Procedures Section with Coded Entries Optional [section: templateId 2.16.840.1.113883.10.20.22.2.7(open)] The following constraints apply to a Procedures section in which entries are not required. 1. SHALL contain exactly one [1..1] templateId (CONF:6270) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.7" (CONF:6271). 2. SHALL contain exactly one [1..1] code (CONF:15423). a. This code SHALL contain exactly one [1..1] @code="47519-4" History of Procedures (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15424). 3. SHALL contain exactly one [1..1] title (CONF:17184). 4. SHALL contain exactly one [1..1] text (CONF:6273). 5. MAY contain zero or more [0..*] entry (CONF:6274) such that it a. SHALL contain exactly one [1..1] Procedure Activity Procedure (templateId:2.16.840.1.113883.10.20.22.4.14) (CONF:15509). 6. MAY contain zero or one [0..1] entry (CONF:6278) such that it a. SHALL contain exactly one [1..1] Procedure Activity Observation (templateId:2.16.840.1.113883.10.20.22.4.13) (CONF:15510). 7. MAY contain zero or one [0..1] entry (CONF:8533) such that it a. SHALL contain exactly one [1..1] Procedure Activity Act (templateId:2.16.840.1.113883.10.20.22.4.12) (CONF:15511). Procedures Section with Coded Entries Required [section: templateId 2.16.840.1.113883.10.20.22.2.7.1(open)] The following constraints apply to a Procedures section in which entries are required. 1. Conforms to Procedures Section (entries optional) template (2.16.840.1.113883.10.20.22.2.7) 2. SHALL contain exactly one [1..1] templateId (CONF:7891) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.7.1" (CONF:10447). 3. SHALL contain exactly one [1..1] code (CONF:15425). a. This code SHALL contain exactly one [1..1] @code="47519-4" History of Procedures (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15426). 4. SHALL contain exactly one [1..1] title (CONF:7893). 5. SHALL contain exactly one [1..1] text (CONF:7894). 6. MAY contain zero or more [0..*] entry (CONF:7895) such that it a. SHALL contain exactly one [1..1] Procedure Activity Procedure (2.16.840.1.113883.10.20.22.4.14) (CONF:7896). Page 276 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 7. MAY contain zero or more [0..*] entry (CONF:8017) such that it a. SHALL contain exactly one [1..1] Procedure Activity Observation (2.16.840.1.113883.10.20.22.4.13) (CONF:8018). 8. MAY contain zero or more [0..*] entry (CONF:8019) such that it a. SHALL contain exactly one [1..1] Procedure Activity Act (2.16.840.1.113883.10.20.22.4.12) (CONF:8020). 9. There SHALL be at least one procedure, observation or act entry conformant to Procedure Activity Procedure template, Procedure Activity Observation template or Procedure Activity Act template in the Procedure Section (CONF:8021). Figure 141: Procedures section example
Procedures ... ... ... ...
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 277 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.53 Reason for Referral Section 42349-1 [section: templateId 1.3.6.1.4.1.19376.1.5.3.1.3.1(open)] Table 99: Reason for Referral Section Contexts Used By: Contains Entries: Consultation Note (optional) A Reason for Referral section records the reason the patient is being referred for a consultation by a provider. An optional Chief Complaint section may capture the patient’s description of the reason for the consultation. 1. SHALL contain exactly one [1..1] templateId (CONF:7844) such that it a. SHALL contain exactly one [1..1] @root="1.3.6.1.4.1.19376.1.5.3.1.3.1" (CONF:10468). 2. SHALL contain exactly one [1..1] code (CONF:15427). a. This code SHALL contain exactly one [1..1] @code="42349-1" Reason for Referral (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15428). 3. SHALL contain exactly one [1..1] title (CONF:7846). 4. SHALL contain exactly one [1..1] text (CONF:7847). Figure 142: Reason for referral section example
REASON FOR REFERRAL Lumbar spinal stenosis with radiculopathy.
Page 278 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.54 Reason for Visit Section 29299-5 [section: templateId 2.16.840.1.113883.10.20.22.2.12(open)] Table 100: Reason for Visit Section Contexts Used By: Contains Entries: Consultation Note (optional) Discharge Summary (optional) History and Physical (required) Procedure Note (optional) This section records the patient’s reason for the patient's visit (as documented by the provider). Local policy determines whether Reason for Visit and Chief Complaint are in separate or combined sections. 1. SHALL contain exactly one [1..1] templateId (CONF:7836) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.12" (CONF:10448). 2. SHALL contain exactly one [1..1] code (CONF:15429). a. This code SHALL contain exactly one [1..1] @code="29299-5" Reason for Visit (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15430). 3. SHALL contain exactly one [1..1] title (CONF:7838). 4. SHALL contain exactly one [1..1] text (CONF:7839). Figure 143: Reason for visit section example
REASON FOR VISIT Dark stools.
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 279 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.55 Results Section 30954-2 Table 101: Results Section Contexts Used by: Contains entries: Coded entries optional: History and Physical (required) Consultation Note (optional) Progress Note (optional) Results Organizer Coded entries required: CCD (required) Figure 144: Results section UML diagram The Results section contains the results of observations generated by laboratories, imaging procedures, and other procedures. The scope includes observations such as hematology, chemistry, serology, virology, toxicology, microbiology, plain x-ray, ultrasound, CT, MRI, angiography, echocardiography, nuclear medicine, pathology, and procedure observations. The section often includes notable results such as abnormal values or relevant trends, and could contain all results for the period of time being documented. Laboratory results are typically generated by laboratories providing analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology, microbiology, and/or virology. These observations are based on analysis of specimens obtained from the patient and submitted to the laboratory. Imaging results are typically generated by a clinician reviewing the output of an imaging procedure, such as where a cardiologist reports the left ventricular ejection fraction based on the review of a cardiac echocardiogram. Procedure results are typically generated by a clinician to provide more granular information about component observations made during a procedure, such as where a gastroenterologist reports the size of a polyp observed during a colonoscopy. Page 280 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Results Section with Coded Entries Optional [section: templateId 2.16.840.1.113883.10.20.22.2.3(open)] The following constraints apply to a Results section in which entries are not required. 1. SHALL contain exactly one [1..1] templateId (CONF:7116) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.3" (CONF:9136). 2. SHALL contain exactly one [1..1] code (CONF:15431). a. This code SHALL contain exactly one [1..1] @code="30954-2" Relevant diagnostic tests and/or laboratory data (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15432). 3. SHALL contain exactly one [1..1] title (CONF:8891). 4. SHALL contain exactly one [1..1] text (CONF:7118). 5. SHOULD contain zero or more [0..*] entry (CONF:7119) such that it a. SHALL contain exactly one [1..1] Result Organizer (2.16.840.1.113883.10.20.22.4.1) (CONF:7120). Results Section with Coded Entries Required [section: templateId 2.16.840.1.113883.10.20.22.2.3.1(open)] The following constraints apply to a Results section in which entries are required. 1. Conforms to Results Section (entries optional) template (2.16.840.1.113883.10.20.22.2.3) 2. SHALL contain exactly one [1..1] templateId (CONF:7108) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.3.1" (CONF:9137). 3. SHALL contain exactly one [1..1] code (CONF:15433). a. This code SHALL contain exactly one [1..1] @code="30954-2" Relevant diagnostic tests and/or laboratory data (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15434). 4. SHALL contain exactly one [1..1] title (CONF:8892). 5. SHALL contain exactly one [1..1] text (CONF:7111). 6. SHALL contain at least one [1..*] entry (CONF:7112) such that it a. SHALL contain exactly one [1..1] Result Organizer (2.16.840.1.113883.10.20.22.4.1) (CONF:7113). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 281 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 145: Results section example
codeSystemName="LOINC" displayName="RESULTS" /> Results ... ...
5.56 Review of Systems Section 10187-3 [section: templateId 1.3.6.1.4.1.19376.1.5.3.1.3.18(open)] Table 102: Review of Systems Section Contexts Used By: Contains Entries: Progress Note (optional) Consultation Note (optional) Discharge Summary (optional) History and Physical (required) Procedure Note (optional) The Review of Systems section contains a relevant collection of symptoms and functions systematically gathered by a clinician. It includes symptoms the patient is currently experiencing, some of which were not elicited during the history of present illness, as well as a potentially large number of pertinent negatives, for example, symptoms that the patient denied experiencing. 1. SHALL contain exactly one [1..1] templateId (CONF:7812) such that it a. SHALL contain exactly one [1..1] @root="1.3.6.1.4.1.19376.1.5.3.1.3.18" (CONF:10469). 2. SHALL contain exactly one [1..1] code (CONF:15435). a. This code SHALL contain exactly one [1..1] @code="10187-3" Review of Systems (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15436). 3. SHALL contain exactly one [1..1] title (CONF:7814). 4. SHALL contain exactly one [1..1] text (CONF:7815). Page 282 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 146: Review of systems section example
REVIEW OF SYSTEMS Patient denies recent history of fever or malaise. Positive For weakness and shortness of breath. One episode of melena. No recent headaches. Positive for osteoarthritis in hips, knees and hands.
5.57 Social History Section 29762-2 [section: templateId 2.16.840.1.113883.10.20.22.2.17(open)] Table 103: Social History Section Contexts Used By: Contains Entries: Consultation Note (optional) Discharge Summary (optional) History and Physical (required) Procedure Note (optional) Continuity of Care Document (CCD) (optional) Pregnancy Observation Smoking Status Observation Social History Observation Tobacco Use Figure 147: Social history section UML diagram This section contains data defining the patient’s occupational, personal (e.g. lifestyle), social, and environmental history and health risk factors, as well as administrative data such as marital status, race, ethnicity and religious affiliation. Social history can have significant influence on a patient’s physical, psychological and emotional health and wellbeing so should be considered in the development of a complete record. 1. SHALL contain exactly one [1..1] templateId (CONF:7936) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.17" (CONF:10449). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 283 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 2. SHALL contain exactly one [1..1] code (CONF:14819). a. This code SHALL contain exactly one [1..1] @code="29762-2" Social History (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:14820). 3. SHALL contain exactly one [1..1] title (CONF:7938). 4. SHALL contain exactly one [1..1] text (CONF:7939). 5. MAY contain zero or more [0..*] entry (CONF:7953) such that it a. SHALL contain at least one [1..*] Social History Observation (2.16.840.1.113883.10.20.22.4.38) (CONF:7954). 6. MAY contain zero or more [0..*] entry (CONF:9132) such that it a. SHALL contain exactly one [1..1] Pregnancy Observation (2.16.840.1.113883.10.20.15.3.8) (CONF:9133). 7. SHOULD contain zero or more [0..*] entry (CONF:14823) such that it a. SHALL contain exactly one [1..1] Smoking Status Observation (templateId:2.16.840.1.113883.10.22.4.78) (CONF:14824). 8. MAY contain zero or more [0..*] entry (CONF:16816) such that it a. SHALL contain exactly one [1..1] Tobacco Use (templateId:2.16.840.1.113883.10.20.22.4.85) (CONF:16817). Figure 148: Social history section example
Social History ... ... ...
Page 284 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.58 Subjective Section 61150-9 [section: templateId 2.16.840.1.113883.10.20.21.2.2(open)] Table 104: Subjective Section Contexts Used By: Contains Entries: Progress Note (optional) The Subjective section describes in a narrative format the patient’s current condition and/or interval changes as reported by the patient or by the patient’s guardian or another informant. 1. SHALL contain exactly one [1..1] templateId (CONF:7873) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.21.2.2" (CONF:10470). 2. SHALL contain exactly one [1..1] code (CONF:15437). a. This code SHALL contain exactly one [1..1] @code="61150-9" Subjective (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15438). 3. SHALL contain exactly one [1..1] title (CONF:7875). 4. SHALL contain exactly one [1..1] text (CONF:7876). Figure 149: Subjective section example
SUBJECTIVE DATA I have used the peripheral nerve stimulator in my back for five days. While using it I found that I was able to do physical activity without pain. However, afterwards for one day, I would feel pain but then it would go away. I also noticed that I didn’t have to take the Vicodin as much. I took 2 less Vicodin per day and 2 less tramadol everyday. I have not lain in my bed in a year and a half. I sleep in a recliner.
HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 285 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5.59 Surgical Drains Section 11537-8 [section: templateId 2.16.840.1.113883.10.20.7.13(open)] Table 105: Surgical Drains Section Contexts Used By: Contains Entries: Operative Note (optional) The Surgical Drains section may be used to record drains placed during the surgical procedure. Optionally, surgical drain placement may be represented with a text element in the Procedure Description Section. 1. SHALL contain exactly one [1..1] templateId (CONF:8038) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.7.13" (CONF:10473). 2. SHALL contain exactly one [1..1] code (CONF:15441). a. This code SHALL contain exactly one [1..1] @code="11537-8" Surgical Drains (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15442). 3. SHALL contain exactly one [1..1] title (CONF:8040). 4. SHALL contain exactly one [1..1] text (CONF:8041). 5. If the Surgical Drains section is present, there SHALL be a statement providing details of the drains placed or SHALL explicitly state there were no drains placed (CONF:8056). Figure 150: Surgical drains section example
Surgical Drains Penrose drain placed
Page 286 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 5.60 Vital Signs Section 8716-3 Table 106: Vital Signs Section Contexts Used By: Contains Entries: Entries optional: Progress Note (optional) Consultation Note (optional) Discharge Summary (optional) History and Physical (required) Continuity of Care Document (CCD) (optional) Vital Signs Organizer Entries required: --- Figure 151: Vital signs section UML diagram The Vital Signs section contains relevant vital signs for the context and use case of the document type, such as blood pressure, heart rate, respiratory rate, height, weight, body mass index, head circumference, and pulse oximetry. The section should include notable vital signs such as the most recent, maximum and/or minimum, baseline, or relevant trends. Vital signs are represented in the same way as other results, but are aggregated into their own section to follow clinical conventions. Vital Signs Section with Coded Entries Optional [section: templateId 2.16.840.1.113883.10.20.22.2.4(open)] The following constraints apply to a Vital Signs section in which entries are not required. 1. SHALL contain exactly one [1..1] templateId (CONF:7268) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.4" (CONF:10451). 2. SHALL contain exactly one [1..1] code (CONF:15242). a. This code SHALL contain exactly one [1..1] @code="8716-3" Vital Signs (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15243). 3. SHALL contain exactly one [1..1] title (CONF:9966). 4. SHALL contain exactly one [1..1] text (CONF:7270). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 287 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 5. SHOULD contain zero or more [0..*] entry (CONF:7271) such that it a. SHALL contain exactly one [1..1] Vital Signs Organizer (2.16.840.1.113883.10.20.22.4.26) (CONF:7272). Vital Signs Section with Coded Entries Required [section: templateId 2.16.840.1.113883.10.20.22.2.4.1(open)] The following constraints apply to a Vital Signs section in which entries are required. 1. Conforms to Vital Signs Section (entries optional) template (2.16.840.1.113883.10.20.22.2.4) 2. SHALL contain exactly one [1..1] templateId (CONF:7273) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.4.1" (CONF:10452). 3. SHALL contain exactly one [1..1] code (CONF:15962). a. This code SHALL contain exactly one [1..1] @code="8716-3" Vital Signs (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15963). 4. SHALL contain exactly one [1..1] title (CONF:9967). 5. SHALL contain exactly one [1..1] text (CONF:7275). 6. SHALL contain at least one [1..*] entry (CONF:7276) such that it a. SHALL contain exactly one [1..1] Vital Signs Organizer (2.16.840.1.113883.10.20.22.4.26) (CONF:7277). Figure 152: Vital signs section example
Vital Signs ... ...
Page 288 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6 ENTRY-LEVEL TEMPLATES This part of the guide describes the clinical statement entry templates used within the sections of the consolidated documents. Entry templates contain constraints that are required for conformance. Note that the clinical statement templates are presented in alphabetical order; templates are not grouped by possible containing templates. Entry-level templates are always allowed in sections. Each entry-level template description contains the following information: Key template metadata (e.g., templateId, etc.) Description and explanatory narrative. Required CDA acts, participants and vocabularies. Optional CDA acts, participants and vocabularies. Several entry-level templates require an effectiveTime: The effectiveTime of an observation is the time interval over which the observation is known to be true. The low and high values should be as precise as possible, but no more precise than known. While CDA has multiple mechanisms to record this time interval (e.g., by low and high values, low and width, high and width, or center point and width), we constrain most to use only the low/high form. The low value is the earliest point for which the condition is known to have existed. The high value, when present, indicates the time at which the observation was no longer known to be true. The full description of effectiveTime and time intervals is contained in the CDA R2 normative edition 32. Entry-level templates may also describe an id element, which is an identifier for that entry. This id may be referenced within the document, or by the system receiving the document. The id assigned must be globally unique. 6.1 Admission Medication [act: templateId 2.16.840.1.113883.10.20.22.4.36 (open)] Table 107: Admission Medication Contexts Used By: Contains Entries: Hospital Admission Medications Section (entries optional) (optional) Medication Activity The Admission Medications entry codes medications that the patient took prior to admission. HL7 Clinical Document Architecture (CDA Release 2). http://www.hl7.org/implement/standards/cda.cfm 32 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 289 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 108: Admission Medication Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.36'] @classCode 1..1 SHALL 7698 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 7699 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 16758 1..1 SHALL 16759 1..1 SHALL 15518 0..1 MAY 15519 1..* SHALL 7701 1..1 SHALL 7702 1..1 SHALL 15520 @root code @code entryRelationship @typeCode 2.16.840.1.113883.10.20.2 2.4.36 2.16.840.1.113883.6.1 (LOINC) = 42346-7 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ substanceAdministration 1. SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7698). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7699). 3. SHALL contain exactly one [1..1] templateId (CONF:16758) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.36" (CONF:16759). 4. SHALL contain exactly one [1..1] code (CONF:15518). a. This code MAY contain zero or one [0..1] @code="42346-7" Medications on Admission (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:15519). 5. SHALL contain at least one [1..*] entryRelationship (CONF:7701) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7702). b. SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15520). Page 290 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 153: Admission medication entry example ... 6.2 Advance Directive Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.48(open)] Table 109: Advance Directive Observation Contexts Used By: Contains Entries: Advance Directives Section (entries optional) Advance Directives Section (entries required) Advance Directives Observatations assert findings (e.g., “resuscitation status is Full Code”) rather than orders, and should not be considered legal documents. A legal document can be referenced using the reference/externalReference construct. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 291 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 110: Advance Directive Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.48'] @classCode 1..1 SHALL 8648 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 8649 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL id 1..* SHALL II 8654 code 1..1 SHALL CD 8651 2.16.840.1.113883.1.11.20. 2 (AdvanceDirectiveTypeCode) statusCode 1..1 SHALL CS 8652 2.16.840.1.113883.5.14 (ActStatus) = completed effectiveTime 1..1 SHALL TS or IVL 8656 low 1..1 SHALL TS 8657 high 1..1 SHALL TS 8659 1..* SHOULD 8662 @typeCode 1..1 SHALL 8663 templateId 1..1 SHALL 1..1 SHALL 0..1 SHOULD participant Role 1..1 SHALL 8825 participant 1..1 SHOULD 8667 @typeCode 1..1 SHALL 8668 participant Role 1..1 SHALL 8669 1..1 SHALL 8670 addr 0..1 SHOULD SET 8671 telecom 0..1 SHOULD SET 8672 1..1 SHALL 1..1 SHALL @root Advance Directive Type effective Date participant @root time custodian of the Document SET 8655 10485 SET 2.16.840.1.113883.5.90 (HL7ParticipationType) = VRF 8664 10486 IVL 2.16.840.1.113883.10.20.2 2.4.48 2.16.840.1.113883.10.20.1. 58 8665 @classCode 2.16.840.1.113883.5.90 (HL7ParticipationType) = CST 2.16.840.1.113883.5.110 (RoleClass) = AGNT 8824 playingEntity name PN 8673 Page 292 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb 1..* SHOULD 8692 1..1 SHALL 8694 external Document 1..1 SHALL 8693 id 1..* SHALL II 8695 text 0..1 MAY ED 8696 0..1 MAY 8703 0..1 MAY 8697 reference @typeCode Data Type CONF# Fixed Value 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR @mediaType reference 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8648). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:8649). 3. SHALL contain exactly one [1..1] templateId (CONF:8655) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.48" (CONF:10485). 4. SHALL contain at least one [1..*] id (CONF:8654). 5. SHALL contain exactly one [1..1] code, where the @code SHOULD be selected from ValueSet AdvanceDirectiveTypeCode 2.16.840.1.113883.1.11.20.2 STATIC 2006-10-17 (CONF:8651). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:8652). 7. SHALL contain exactly one [1..1] effectiveTime (CONF:8656). a. This effectiveTime SHALL contain exactly one [1..1] low (CONF:8657). i. If the starting time is unknown, the element SHALL have the nullFlavor attribute set to UNK (CONF:8658). b. This effectiveTime SHALL contain exactly one [1..1] high (CONF:8659). i. If the ending time is unknown, the element SHALL have the nullFlavor attribute set to UNK (CONF:8660). ii. If the Advance Directive does not have a specified ending time, the element SHALL have the nullFlavor attribute set to NA (CONF:8661). 8. SHOULD contain at least one [1..*] participant (CONF:8662) such that it a. SHALL contain exactly one [1..1] @typeCode="VRF" Verifier (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8663). b. SHALL contain exactly one [1..1] templateId (CONF:8664) such that it i. contain exactly one [1..1] @root="2.16.840.1.113883.10.20.1.58" (CONF:10486). SHALL HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 293 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. c. SHOULD contain zero or one [0..1] time (CONF:8665). i. The data type of Observation/participant/time in a verification SHALL be TS (time stamp) (CONF:8666). d. SHALL contain exactly one [1..1] participantRole (CONF:8825). 9. SHOULD contain exactly one [1..1] participant (CONF:8667) such that it a. SHALL contain exactly one [1..1] @typeCode="CST" Custodian (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8668). b. SHALL contain exactly one [1..1] participantRole (CONF:8669). i. This participantRole SHALL contain exactly one [1..1] @classCode="AGNT" Agent (CodeSystem: RoleClass 2.16.840.1.113883.5.110) (CONF:8670). ii. This participantRole SHOULD contain zero or one [0..1] addr (CONF:8671). iii. This participantRole SHOULD contain zero or one [0..1] telecom (CONF:8672). iv. This participantRole SHALL contain exactly one [1..1] playingEntity (CONF:8824). 1. This playingEntity SHALL contain exactly one [1..1] name (CONF:8673). a. The name of the agent who can provide a copy of the Advance Directive SHALL be recorded in the element inside the element (CONF:8674). 10. SHOULD contain at least one [1..*] reference (CONF:8692) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:8694). b. SHALL contain exactly one [1..1] externalDocument (CONF:8693). i. This externalDocument SHALL contain at least one [1..*] id (CONF:8695). ii. This externalDocument MAY contain zero or one [0..1] text (CONF:8696). 1. The text, if present, MAY contain zero or one [0..1] @mediaType (CONF:8703). 2. The text, if present, MAY contain zero or one [0..1] reference (CONF:8697). a. The URL of a referenced advance directive document MAY be present, and SHALL be represented in Observation/reference/ExternalDocument/text /reference (CONF:8698). b. If a URL is referenced, then it SHOULD have a corresponding linkHTML element in narrative block (CONF:8699). Page 294 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 111: Advance Directive Type Code Value Set Value Set: AdvanceDirectiveTypeCode 2.16.840.1.113883.1.11.20.2 STATIC 2006-10-17 Code System(s): Code SNOMED CT 2.16.840.1.113883.6.96 Code System Print Name 52765003 SNOMED CT Intubation 61420007 SNOMED CT Tube Feedings 71388002 SNOMED CT Other Directive 78823007 SNOMED CT Life Support 89666000 SNOMED CT CPR 225204009 SNOMED CT IV Fluid and Support 281789004 SNOMED CT Antibiotics 304251008 SNOMED CT Resuscitation Figure 154: Advance directive observation example HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 295 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 21 North Ave. Burlington MA 02368 US Dr. Dolin Robert 6.3 Age Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.31(open)] Table 112: Age Observation Contexts Used By: Contains Entries: Family History Observation Problem Observation This Age Observation represents the subject's age at onset of an event or observation. The age of a relative in a Family History Observation at the time of that observation could also be inferred by comparing RelatedSubject/subject/birthTime with Observation/effectiveTime. However, a common scenario is that a patient will know the age of a relative when the relative had a certain condition or when the relative died, but will not know the actual year (e.g., "grandpa died of a heart attack at the age of 50"). Often times, neither precise dates nor ages are known (e.g. "cousin died of congenital heart disease as an infant"). Page 296 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 113: Age Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.31'] @classCode 1..1 SHALL 7613 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 7614 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10487 1..1 SHALL 7615 1..1 SHALL 16776 1..1 SHALL 15965 1..1 SHALL 15966 1..1 SHALL 1..1 SHALL @root code @code statusCode @code value @unit SET PQ 7899 2.16.840.1.113883.10.20.22.4.31 2.16.840.1.113883.6.96 (SNOMEDCT) = 445518008 2.16.840.1.113883.5.14 (ActStatus) = completed 7617 7618 2.16.840.1.113883.11.20.9.21 (AgePQ_UCUM) = 1 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7613). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7614). 3. SHALL contain exactly one [1..1] templateId (CONF:7899) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.31" (CONF:10487). 4. SHALL contain exactly one [1..1] code (CONF:7615). a. This code SHALL contain exactly one [1..1] @code="445518008" Age At Onset (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:16776). 5. SHALL contain exactly one [1..1] statusCode (CONF:15965). a. This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:15966). 6. SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:7617). a. This value SHALL contain exactly one [1..1] @unit="1", which SHALL be selected from ValueSet AgePQ_UCUM 2.16.840.1.113883.11.20.9.21 DYNAMIC (CONF:7618). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 297 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 114: AgePQ_UCUM Value Set Value Set: AgePQ_UCUM 2.16.840.1.113883.11.20.9.21 DYNAMIC Code System(s): Unified Code for Units of Measure (UCUM) 2.16.840.1.113883.6.8 Description: A valueSet of UCUM codes for representing age value units Code Code System Print Name min UCUM Minute h UCUM Hour d UCUM Day wk UCUM Week mo UCUM Month a UCUM Year Figure 155: Age observation example 6.4 Allergy - Intolerance Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.7(open)] Table 115: Allergy - Intolerance Observation Contexts Used By: Contains Entries: Allergy Problem Act (required) Allergy Status Observation Reaction Observation Severity Observation This clinical statement represents that an allergy or adverse reaction exists or does not exist. The agent that is the cause of the allergy or adverse reaction is represented as a manufactured material participant playing entity in the allergy - intolerance observation. While the agent is often implicit in the alert observation (e.g. "allergy to penicillin"), it should also be asserted explicitly as an entity. The manufactured material participant is used to represent natural and non-natural occurring substances. NOTE: The agent responsible for an allergy or adverse reaction is not always a manufactured material (for example, food allergies), nor is it necessarily Page 298 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 consumed. The following constraints reflect limitations in the base CDA R2 specification, and should be used to represent any type of responsible agent. Table 116: Allergy - Intolerance Observation Constraints Overview Name XPath Card. Allergy – Intolerance Observation observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.7'] product Fixed Value SHALL 7379 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 7380 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10488 id 1..* SHALL 7382 code 1..1 SHALL 15947 1..1 SHALL 15948 2.16.840.1.113883.5.4 (ActCode) = ASSERTION statusCode 1..1 SHALL 7386 2.16.840.1.113883.5.14 (ActStatus) = completed effectiveTime 1..1 SHALL TS or IVL 7387 value 1..1 SHALL CD 7390 @code 1..1 SHALL 9139 originalText 0..1 SHOULD 7422 reference 0..1 MAY 15949 @value 0..1 SHOULD 15950 0..1 SHOULD 7402 1..1 SHALL 7403 1..1 SHALL 7404 participant @typeCode productDet ail CONF# 1..1 @code adverseEve nt Type Data Type @classCode @root adverseEve nt Date Verb SET 7381 2.16.840.1.113883.10.20.22.4. 7 2.16.840.1.113883.3.88.12.32 21.6.2 (Allergy/Adverse Event Type) 2.16.840.1.113883.5.90 (HL7ParticipationType) = CSM participantRole HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 299 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name XPath @classCode Card. Verb 1..1 Data Type CONF# Fixed Value SHALL 7405 2.16.840.1.113883.5.110 (RoleClass) = MANU 1..1 SHALL 7406 1..1 SHALL 7407 1..1 SHALL 7419 0..1 SHOULD 7424 0..1 SHOULD 7425 0..1 SHOULD 15952 0..* MAY 0..1 MAY 7440 1..1 SHALL 7906 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1..1 SHALL 7446 true 1..1 SHALL 15954 0..* SHOULD 7447 1..1 SHALL 7907 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = MFST 1..1 SHALL 7449 true 1..1 SHALL 15955 0..1 SHOULD 9961 1..1 SHALL 9962 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1..1 SHALL 9964 true 1..1 SHALL 15956 playingEntity @classCode product Coded productFree Text code 2.16.840.1.113883.5.41 (EntityClass) = MMAT originalText reference @value translation entryRelations hip @typeCode SET

7431 @inversionInd observation reaction entryRelations hip @typeCode @inversionInd observation severity entryRelations hip @typeCode @inversionInd observation 1. Conforms to Substance or Device Allergy - Intolerance Observation template (2.16.840.1.113883.10.20.24.3.90). 2. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7379). Page 300 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 3. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7380). 4. SHALL contain exactly one [1..1] templateId (CONF:7381) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.7" (CONF:10488). 5. SHALL contain at least one [1..*] id (CONF:7382). 6. SHALL contain exactly one [1..1] code (CONF:15947). a. This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:15948). 7. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:7386). 8. SHALL contain exactly one [1..1] effectiveTime (CONF:7387). a. If it is unknown when the allergy began, this effectiveTime SHALL contain low/@nullFLavor="UNK" (CONF:9103). b. If the allergy is no longer a concern, this effectiveTime MAY contain zero or one [0..1] high (CONF:10082). 9. SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:7390). a. This value SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Allergy/Adverse Event Type 2.16.840.1.113883.3.88.12.3221.6.2 DYNAMIC (CONF:9139). b. This value SHOULD contain zero or one [0..1] originalText (CONF:7422). i. The originalText, if present, MAY contain zero or one [0..1] reference (CONF:15949). 1. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15950). a. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15951). 10. SHOULD contain zero or one [0..1] participant (CONF:7402) such that it a. SHALL contain exactly one [1..1] @typeCode="CSM" Consumable (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:7403). b. SHALL contain exactly one [1..1] participantRole (CONF:7404). i. This participantRole SHALL contain exactly one [1..1] @classCode="MANU" Manufactured Product (CodeSystem: RoleClass 2.16.840.1.113883.5.110 STATIC) (CONF:7405). ii. This participantRole SHALL contain exactly one [1..1] playingEntity (CONF:7406). 1. This playingEntity SHALL contain exactly one [1..1] @classCode="MMAT" Manufactured Material (CodeSystem: EntityClass 2.16.840.1.113883.5.41 STATIC) (CONF:7407). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 301 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 2. This playingEntity SHALL contain exactly one [1..1] code (CONF:7419). a. This code SHOULD contain zero or one [0..1] originalText (CONF:7424). i. The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:7425). 1. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15952). 1. This reference/@value begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15953). SHALL b. This code MAY contain zero or more [0..*] translation (CONF:7431). c. In an allergy to a specific medication the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.16 Medication Brand Name DYNAMIC or the ValueSet 2.16.840.1.113883.3.88.12.80.17 Medication Clinical Drug DYNAMIC (CONF:7421). d. In an allergy to a class of medications the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.18 Medication Drug Class DYNAMIC (CONF:10083). e. In an allergy to a food or other substance the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.20 Ingredient Name DYNAMIC (CONF:10084). 11. MAY contain zero or one [0..1] entryRelationship (CONF:7440) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7906). b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7446). c. SHALL contain exactly one [1..1] Allergy Status Observation (templateId:2.16.840.1.113883.10.20.22.4.28) (CONF:15954). 12. SHOULD contain zero or more [0..*] entryRelationship (CONF:7447) such that it a. SHALL contain exactly one [1..1] @typeCode="MFST" Is Manifestation of (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7907). b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7449). Page 302 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 c. SHALL contain exactly one [1..1] Reaction Observation (templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:15955). 13. SHOULD contain zero or one [0..1] entryRelationship (CONF:9961) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9962). b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:9964). c. SHALL contain exactly one [1..1] Severity Observation (templateId:2.16.840.1.113883.10.20.22.4.8) (CONF:15956). Table 117: Allergy/Adverse Event Type Value Set Value Set: Allergy/Adverse Event Type 2.16.840.1.113883.3.88.12.3221.6.2 DYNAMIC Code System(s): SNOMED CT 2.16.840.1.113883.6.96 Description: This describes the type of product and intolerance suffered by the patient http://phinvads.cdc.gov/vads/ViewValueSet.action?id=7AFDBFB5-A277DE11-9B52-0015173D1785 Code Code System Print Name 420134006 SNOMED CT Propensity to adverse reactions (disorder) SNOMED CT Propensity to adverse reactions to substance (disorder) 419511003 SNOMED CT Propensity to adverse reactions to drug (disorder) 418471000 SNOMED CT Propensity to adverse reactions to food (disorder) 419199007 SNOMED CT Allergy to substance (disorder) 416098002 SNOMED CT Drug allergy (disorder) 414285001 SNOMED CT Food allergy (disorder) 59037007 SNOMED CT Drug intolerance (disorder) 235719002 SNOMED CT Food intolerance (disorder) 418038007 Table 118: Medication Brand Name Value Set (excerpt) Value Set: Medication Brand Name 2.16.840.1.113883.3.88.12.80.16 DYNAMIC Code System(s): RxNorm 2.16.840.1.113883.6.88 Description: Brand names http://phinvads.cdc.gov/vads/ViewValueSet.action?id=229BEF3E-971CDF11-B334-0015173D1785 Code Code System Print Name 205734 RxNorm Amoxicillin 25 MG/ML Oral Suspension [Amoxil] 856537 RxNorm 24 HR Propranolol Hydrochloride 60 MG Extended Release Capsule [Inderal] 104700 RxNorm Diazepam 5 MG Oral Tablet [Valium] … HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 303 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 119: Medication Clinical Drug Value Set (excerpt) Value Set: Medication Clinical Drug 2.16.840.1.113883.3.88.12.80.17 DYNAMIC Code System(s): RxNorm 2.16.840.1.113883.6.88 Description: Clinical drug names http://phinvads.cdc.gov/vads/ViewValueSet.action?id=239BEF3E-971CDF11-B334-0015173D1785 Code Code System Print Name 313850 RxNorm Amoxicillin 40 MG/ML Oral Suspension 856448 RxNorm Propranolol Hydrochloride 10 MG Oral Tablet 197589 RxNorm Diazepam 10 MG Oral Tablet … Table 120: Medication Drug Class Value Set (excerpt) Value Set: Medication Drug Class 2.16.840.1.113883.3.88.12.80.18 DYNAMIC Code System(s): NDF-RT 2.16.840.1.113883.3.26.1.5 Description: This identifies the pharmacological drug class, such as Cephalosporins. Shall contain a value descending from the NDF-RT concept types of “Mechanism of Action - N0000000223”, “Physiologic Effect N0000009802” or “Chemical Structure - N0000000002”`. NUI will be used as the concept code. http://phinvads.cdc.gov/vads/ViewValueSet.action?id=77FDBFB5-A277DE11-9B52-0015173D1785 Code Code System Print Name N0000011161 NDF-RT Cephalosporins N0000005909 NDF-RT 2-Propanol N0000006629 NDF-RT Filgrastim … Page 304 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 121: Ingredient Name Value Set (excerpt) Value Set: Ingredient Name 2.16.840.1.113883.3.88.12.80.20 DYNAMIC Code System(s): Unique Ingredient Identifier (UNII) 2.16.840.1.113883.4.9 Description: Unique ingredient identifiers (UNIIs) for substances in drugs, biologics, foods, and devices. http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabe ling/ucm162523.htm Code Code System Print Name OLT4M28U3Z UNII ((3-TRIFLUOROMETHYL)PHENYL)METHYLPHOSPHONIC ACID L0VRY82PKO UNII CYCLOHEXENE, 4-[(1Z)-1,5-DIMETHYL-1,4HEXADIEN-1-YL]-1-METHYL- 62H4W26906 UNII BISNAFIDE QE1QX6B99R UNII PEANUT … Figure 156: Allergy - intolerance observation example HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 305 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Penicillin 6.5 Allergy Problem Act [act: templateId 2.16.840.1.113883.10.20.22.4.30(open)] Table 122: Allergy Problem Act Contexts Used By: Contains Entries: Allergies Section (entries required) Allergies Section (entries optional) Allergy - Intolerance Observation This clinical statement act represents a concern relating to a patient's allergies or adverse events. A concern is a term used when referring to patient's problems that are related to one another. Observations of problems or other clinical statements captured at a point in time are wrapped in a Allergy Problem Act, or "Concern" act, which represents the ongoing process tracked over time. This outer Allergy Problem Act (representing the "Concern") can contain nested problem observations or other nested clinical statements relevant to the allergy concern. Page 306 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 123: Allergy Problem Act Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.30'] @classCode 1..1 SHALL 7469 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 7470 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL id 1..* SHALL II 7472 code 1..1 SHALL CD 7477 2.16.840.1.113883.6.1 (LOINC) = 487652 statusCode 1..1 SHALL CS 7485 2.16.840.1.113883.11.20.9.19 (ProblemAct statusCode) effectiveTime 1..1 SHALL TS or IVL 7498 1..* SHALL 7509 1..1 SHALL 7915 @root Entry Relationship @typeCode SET 7471 10489 2.16.840.1.113883.10.20.22.4.30 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1. SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7469). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7470). 3. SHALL contain exactly one [1..1] templateId (CONF:7471) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.30" (CONF:10489). 4. SHALL contain at least one [1..*] id (CONF:7472). 5. SHALL contain exactly one [1..1] code="48765-2" Allergies, adverse reactions, alerts (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:7477). 6. SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet ProblemAct statusCode 2.16.840.1.113883.11.20.9.19 STATIC 2011-09-09 (CONF:7485). 7. SHALL contain exactly one [1..1] effectiveTime (CONF:7498). a. If statusCode="active" Active, then effectiveTime SHALL contain [1..1] low (CONF:7504). b. If statusCode="completed" Completed, then effectiveTime SHALL contain [1..1] high (CONF:10085). 8. SHALL contain at least one [1..*] entryRelationship (CONF:7509) such that it HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 307 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7915). b. SHALL contain exactly one [1..1] Allergy - Intolerance Observation (templateId:2.16.840.1.113883.10.20.22.4.7) (CONF:14925). Table 124: ProblemAct statusCode Value Set Value Set: ProblemAct statusCode 2.16.840.1.113883.11.20.9.19 STATIC 2011-09-09 Code System(s): ActStatus 2.16.840.1.113883.5.14 Description: This value set indicates the status of the problem concern act Code Code System Print Name active ActStatus active suspended ActStatus suspended aborted ActStatus aborted completed ActStatus completed Figure 157: Allergy problem act example ... Page 308 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.6 Allergy Status Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.28(open)] Table 125: Allergy Status Observation Contexts Used By: Contains Entries: Allergy - Intolerance Observation This template represents the status of the allergy indicating whether it is active, no longer active, or is an historic allergy. There can be only one allergy status observation per alert observation. Table 126: Allergy Status Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.28'] @classCode 1..1 SHALL 7318 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 7319 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10490 2.16.840.1.113883.10.20.22.4.28 code 1..1 SHALL 7320 2.16.840.1.113883.6.1 (LOINC) = 33999-4 statusCode 1..1 SHALL 7321 2.16.840.1.113883.5.14 (ActStatus) = completed value 1..1 SHALL 7322 2.16.840.1.113883.3.88.12.80.68 (HITSPProblemStatus) @root SET CE 7317 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7318). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7319). 3. SHALL contain exactly one [1..1] templateId (CONF:7317) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.28" (CONF:10490). 4. SHALL contain exactly one [1..1] code="33999-4" Status (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:7320). 5. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:7321). 6. SHALL contain exactly one [1..1] value with @xsi:type="CE", where the @code SHALL be selected from ValueSet HITSPProblemStatus 2.16.840.1.113883.3.88.12.80.68 DYNAMIC (CONF:7322). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 309 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 127: HITSP Problem Status Value Set Value Set: HITSPProblemStatus 2.16.840.1.113883.3.88.12.80.68 DYNAMIC Code System: SNOMED CT 2.16.840.1.113883.6.96 Code Code System Display Name 55561003 SNOMED CT Active 73425007 SNOMED CT Inactive* 413322009 SNOMED CT Resolved** * An inactive problems refers to one that is quiescent, and may appear again in future. ** A resolved problem refers to one that used to affect a patient, but does not any more. Figure 158: Allergy status observation example 6.7 Assessment Scale Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.69 (open)] Table 128: Assessment Scale Observation Contexts Used By: Contains Entries: Functional Status Problem Observation (optional) Functional Status Result Observation (optional) Cognitive Status Problem Observation (optional) Cognitive Status Result Observation (optional) Functional Status Section (optional) Assessment Scale Supporting Observation An assessment scale is a collection of observations that together yield a summary evaluation of a particular condition. Examples include the Braden Scale (assesses pressure ulcer risk), APACHE Score (estimates mortality in critically ill patients), Mini-Mental Status Exam (assesses cognitive function), APGAR Score (assesses the health of a newborn), and Glasgow Coma Scale (assesses coma and impaired consciousness.) Page 310 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 129: Assessment Scale Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.69'] @classCode 1..1 SHALL 14434 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 14435 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 14436 1..1 SHALL 14437 id 1..* SHALL 14438 code 1..1 SHALL 14439 derivationExpr 0..1 MAY 14637 statusCode 1..1 SHALL 14444 effectiveTime 1..1 SHALL 14445 value 1..1 SHALL 14450 interpretationCode 0..* MAY 14459 0..* MAY 14888 author 0..* MAY 14460 entryRelationship 0..* SHOULD 14451 @typeCode 1..1 SHALL 16741 observation 1..1 SHALL 16742 referenceRange 0..* MAY 16799 1..1 SHALL 16800 0..1 SHOULD 16801 reference 0..1 SHOULD 16802 @value 0..1 MAY 16803 @root translation 2.16.840.1.113883.10.20.22.4.69 2.16.840.1.113883.5.14 (ActStatus) = completed COMP observationRange text 1. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14434). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14435). 3. SHALL contain exactly one [1..1] templateId (CONF:14436) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.69" (CONF:14437). 4. SHALL contain at least one [1..*] id (CONF:14438). 5. SHALL contain exactly one [1..1] code (CONF:14439). a. SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) identifying the assessment scale (CONF:14440). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 311 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Such derivation expression can contain a text calculation of how the components total up to the summed score 6. MAY contain zero or one [0..1] derivationExpr (CONF:14637). 7. SHALL contain exactly one [1..1] statusCode="completed" (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:14444). Represents clinically effective time of the measurement, which may be when the measurement was performed (e.g., a BP measurement), or may be when sample was taken (and measured some time afterwards) 8. SHALL contain exactly one [1..1] effectiveTime (CONF:14445). 9. SHALL contain exactly one [1..1] value (CONF:14450). 10. MAY contain zero or more [0..*] interpretationCode (CONF:14459). a. The interpretationCode, if present, MAY contain zero or more [0..*] translation (CONF:14888). 11. MAY contain zero or more [0..*] author (CONF:14460). 12. SHOULD contain zero or more [0..*] entryRelationship (CONF:14451) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" has component (CONF:16741). b. SHALL contain exactly one [1..1] Assessment Scale Supporting Observation (templateId:2.16.840.1.113883.10.20.22.4.86) (CONF:16742). The referenceRange/observationRange/text, if present, MAY contain a description of the scale (e.g. for a Pain Scale 1 to 10: 1 to 3 = little pain, 4 to 7= moderate pain, 8 to 10 = severe pain) 13. MAY contain zero or more [0..*] referenceRange (CONF:16799). a. The referenceRange, if present, SHALL contain exactly one [1..1] observationRange (CONF:16800). i. This observationRange SHOULD contain zero or one [0..1] text (CONF:16801). 1. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:16802). a. The reference, if present, MAY contain zero or one [0..1] @value (CONF:16803). i. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:16804). Page 312 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 159: Assessment scale observation example

... Text description of the calculation HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 313 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. ... 6.8 Assessment Scale Supporting Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.86 (open)] Table 130: Assessment Scale Supporting Observation Contexts Used By: Contains Entries: Assessment Scale Observation (required) An Assessment Scale Supporting observation represents the components of a scale used in an Assessment Scale Observation. The individual parts that make up the component may be a group of cognitive or functional status observations. Table 131: Assessment Scale Supporting Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.86'] @classCode 1..1 SHALL 16715 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 16716 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 16723 id 1..* SHALL 16724 code 1..1 SHALL @root @code SET CE 16722 2.16.840.1.113883.10.20.22.4.86 16717 1..1 SHALL 16738 statusCode 1..1 SHALL 16720 value 1..* SHALL 16754 2.16.840.1.113883.5.14 (ActStatus) = completed 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:16715). Page 314 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:16716). 3. SHALL contain exactly one [1..1] templateId (CONF:16722) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.86" (CONF:16723). 4. SHALL contain at least one [1..*] id (CONF:16724). 5. SHALL contain exactly one [1..1] code with @xsi:type="CE" (CONF:16717). a. This code SHALL contain exactly one [1..1] @code (CONF:16738). i. Such that observation/code SHALL be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) and represents components of the scale (CONF:14458) (CONF:16739). 6. SHALL contain exactly one [1..1] statusCode="completed" (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:16720). 7. SHALL contain at least one [1..*] value (CONF:16754). a. If xsi:type="CD" , MAY have a translation code to further specify the source if the instrument has an applicable code system and valueSet for the integer (CONF:14639) (CONF:16755). Figure 160: Assessment scale supporting observation example 6.9 Authorization Activity [act: templateId 2.16.840.1.113883.10.20.1.19(open)] Table 132: Authorization Activity Contexts Used By: Contains Entries: Policy Activity (optional) An Authorization Activity represents authorizations or pre-authorizations currently active for the patient for the particular payer. Authorizations are represented using an act subordinate to the policy or program that provided it. The authorization refers to the policy or program. Authorized treatments can be grouped into an organizer class, where common properties, such as the reason for the authorization, can be expressed. Subordinate acts represent what was authorized. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 315 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 133: Authorization Activity Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.1.19'] @classCode 1..1 SHALL 8944 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 8945 2.16.840.1.113883.5.6 (HL7ActClass) = EVN templateId 1..1 SHALL 1..1 SHALL 1..1 SHALL 1..* SHALL 8948 1..1 SHALL 8949 @root id entry Relationship @typeCode SET 8946 10529 II 2.16.840.1.113883.10.20.1.19 8947 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1. SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8944). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8945). 3. SHALL contain exactly one [1..1] templateId (CONF:8946) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.1.19" (CONF:10529). 4. SHALL contain exactly one [1..1] id (CONF:8947). 5. SHALL contain at least one [1..*] entryRelationship (CONF:8948) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:8949). b. The target of an authorization activity with act/entryRelationship/@typeCode="SUBJ" SHALL be a clinical statement with moodCode="PRMS" Promise (CONF:8951). c. The target of an authorization activity MAY contain one or more performer, to indicate the providers that have been authorized to provide treatment (CONF:8952). Page 316 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 161: Authorization activity example 6.10 Boundary Observation [observation: templateId 2.16.840.1.113883.10.20.6.2.11(open)] Table 134: Boundary Observation Contexts Used By: Contains Entries: Referenced Frames Observation A Boundary Observation contains a list of integer values for the referenced frames of a DICOM multiframe image SOP instance. It identifies the frame numbers within the referenced SOP instance to which the reference applies. The CDA Boundary Observation numbers frames using the same convention as DICOM, with the first frame in the referenced object being Frame 1. A Boundary Observation must be used if a referenced DICOM SOP instance is a multiframe image and the reference does not apply to all frames. Table 135: Boundary Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.6.2.11'] @classCode 1..1 SHALL 9282 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 9283 2.16.840.1.113883.5.6 (HL7ActClass) = EVN code 1..1 SHALL 9284 1.2.840.10008.2.16.4 (DCM) = 113036 value 1..* SHALL CD 9285 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9282). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9283). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 317 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 3. SHALL contain exactly one [1..1] code="113036" Frames for Display (CodeSystem: DCM 1.2.840.10008.2.16.4) (CONF:9284). Each number represents a frame for display. 4. SHALL contain at least one [1..*] value with @xsi:type="INT" (CONF:9285). Figure 162: Boundary observation example 6.11 Caregiver Characteristics [observation: templateId 2.16.840.1.113883.10.20.22.4.72 (open)] Table 136: Caregiver Characteristics Contexts Used By: Contains Entries: Functional Status Result Observation (optional) Cognitive Status Result Observation (optional) Functional Status Problem Observation (optional) Cognitive Status Problem Observation (required) Functional Status Section (optional) This clinical statement represents a caregiver’s willingness to provide care and the abilities of that caregiver to provide assistance to a patient in relation to a specific need. Page 318 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 137: Caregiver Characteristics Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.72'] @classCode 1..1 SHALL 14219 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 14220 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 14221 1..1 SHALL 14222 id 1..* SHALL 14223 code 1..1 SHALL 14230 statusCode 1..1 SHALL 14233 value 1..1 SHALL 14599 participant 0..* SHALL 14227 0..1 MAY 14830 low 1..1 SHALL 14831 high 0..1 MAY 14832 1..1 SHALL 14228 1..1 SHALL 14229 @root time 2.16.840.1.113883.10.20.22.4.72 2.16.840.1.113883.5.14 (ActStatus) = Completed participantRole @classCode IND 1. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14219). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14220). 3. SHALL contain exactly one [1..1] templateId (CONF:14221) such that it a. This templateId SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.72" (CONF:14222). 4. SHALL contain at least one [1..*] id (CONF:14223). 5. SHALL contain exactly one [1..1] code (CONF:14230). 6. SHALL contain exactly one [1..1] statusCode="Completed" (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:14233). 7. SHALL contain exactly one [1..1] value (CONF:14599). a. Where the @code SHALL be selected from LOINC (codeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96 (CONF:14600). 8. SHALL contain at least one [1..*] participant (CONF:14227). a. Such participants MAY contain zero or one [0..1] time (CONF:14830). i. The time, if present, SHALL contain exactly one [1..1] low (CONF:14831). ii. The time, if present, MAY contain zero or one [0..1] high (CONF:14832). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 319 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. b. Such participants SHALL contain exactly one [1..1] participantRole (CONF:14228). i. This participantRole SHALL contain exactly one [1..1] @classCode="IND" (CONF:14229). Figure 163: Caregiver characteristics example with assertion
... ... ...
Figure 164: Caregiver characteristics example without assertion Page 320 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.12 Code Observations [observation: templateId 2.16.840.1.113883.10.20.6.2.13(open)] Table 138: Code Observations Contexts Used By: Contains Entries: Quantity Measurement Observation SOP Instance Observation DICOM Template 2000 specifies that Imaging Report Elements of Value Type Code are contained in sections. The Imaging Report Elements are inferred from Basic Diagnostic Imaging Report Observations that consist of image references and measurements (linear, area, volume, and numeric). Coded DICOM Imaging Report Elements in this context are mapped to CDA-coded observations that are section components and are related to the SOP Instance Observations (templateId 2.16.840.1.113883.10.20.6.2.8) or Quantity Measurement Observations (templateId 2.16.840.1.113883.10.20.6.2.14) by the SPRT (Support) act relationship. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 321 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 139: Code Observations Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.6.2.13'] @classCode 1..1 SHALL 9304 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 9305 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 15523 1..1 SHALL 15524 code 1..1 SHALL CD 9307 effectiveTime 0..1 SHOULD TS or IVL 9309 value 1..1 SHALL 9308 entryRelationship 0..* MAY 9311 1..1 SHALL 9312 0..* MAY 9314 1..1 SHALL 9315 @root @typeCode entryRelationship @typeCode 2.16.840.1.113883.10.20.6.2.13 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SPRT 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SPRT 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9304). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9305). 3. SHALL contain exactly one [1..1] templateId (CONF:15523). a. This templateId SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.2.13" (CONF:15524). 4. SHALL contain exactly one [1..1] code with @xsi:type="CE" (CONF:9307). 5. SHOULD contain zero or one [0..1] effectiveTime (CONF:9309). 6. SHALL contain exactly one [1..1] value (CONF:9308). 7. Code Observations SHALL be rendered into section/text in separate paragraphs (CONF:9310). 8. MAY contain zero or more [0..*] entryRelationship (CONF:9311) such that it a. SHALL contain exactly one [1..1] @typeCode="SPRT" Has Support (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:9312). b. SHALL contain exactly one [1..1] SOP Instance Observation (2.16.840.1.113883.10.20.6.2.8) (CONF:9313). 9. MAY contain zero or more [0..*] entryRelationship (CONF:9314) such that it a. SHALL contain exactly one [1..1] @typeCode="SPRT" Has Support (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:9315). Page 322 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 b. SHALL contain exactly one [1..1] Quantity Measurement Observation (2.16.840.1.113883.10.20.6.2.14) (CONF:9316). Figure 165: Code observation example 6.13 Cognitive Status Problem Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.73 (open)] Table 140: Cognitive Status Problem Observation Contexts Used By: Contains Entries: Functional Status Section (optional) Assessment Scale Observation Caregiver Characteristics Non-Medicinal Supply Activity A cognitive status problem observation is a clinical statement that describes a patient's cognitive condition, findings, or symptoms. Examples of cognitive problem observations are inability to recall, amnesia, dementia, and aggressive behavior. A cognitive problem observation is a finding or medical condition. This is different from a cognitive result observation, which is a response to a question that provides insight into the patient's cognitive status, judgement, comprehension ability, or response speed. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 323 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 141: Cognitive Status Problem Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.73'] @classCode 1..1 SHALL 14319 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @mood Code 1..1 SHALL 14320 2.16.840.1.113883.5.1001 (ActMood) = EVN @negation Ind 0..1 MAY 14344 templateId 1..1 SHALL 14346 1..1 SHALL 14347 id 1..1 SHALL 14321 code 1..1 SHALL 14804 0..1 SHOULD 14805 0..1 SHOULD 14341 reference/ @value 0..1 SHOULD 14342 statusCode 1..1 SHALL 14323 effective Time 0..1 SHOULD TS or IVL 14324 value 1..1 SHALL CD 14349 Method Code 0..* MAY 14693 entry Relationship 0..* MAY 14331 1..1 SHALL 14588 supply 1..1 SHALL 14351 entry Relationship 0..* SHALL 14335 1..1 SHALL 14589 1..1 SHALL 14352 0..* SHALL 14467 1..1 SHALL 14590 1..1 SHALL 14468 @root @code text @typeCode @typeCode 2.16.840.1.113883.10.20.22.4.73 2.16.840.1.113883.6.96 (SNOMEDCT) = 373930000 2.16.840.1.113883.5.14 (ActStatus) = completed 2.16.840.1.113883.3.88.12.3221.7. 4 (Problem) 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR observation entry Relationship @typeCode 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP observation Page 324 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 1. Conforms to Problem Observation template (2.16.840.1.113883.10.20.22.4.4). 2. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14319). 3. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14320). Use negationInd="true" to indicate that the problem was not observed. 4. MAY contain zero or one [0..1] @negationInd (CONF:14344). 5. SHALL contain exactly one [1..1] templateId (CONF:14346) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.73" (CONF:14347). 6. SHALL contain exactly one [1..1] id (CONF:14321). 7. SHALL contain exactly one [1..1] code (CONF:14804). a. This code SHOULD contain zero or one [0..1] @code="373930000" Cognitive function finding (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:14805). 8. SHOULD contain zero or one [0..1] text (CONF:14341). a. The text, if present, SHOULD contain zero or one [0..1] reference/@value (CONF:14342). i. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:14343). 9. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:14323). 10. SHOULD contain zero or one [0..1] effectiveTime (CONF:14324). a. The onset date SHALL be recorded in the low element of the effectiveTime element when known (CONF:14325). b. The resolution date SHALL be recorded in the high element of the effectiveTime element when known (CONF:14326). c. If the problem is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'. Therefore, the existence of a high element within a problem does indicate that the problem has been resolved (CONF:14327). 11. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Problem 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:14349). 12. MAY contain zero or more [0..*] methodCode (CONF:14693). 13. MAY contain zero or more [0..*] entryRelationship (CONF:14331) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14588). b. SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14351). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 325 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 14. SHALL contain zero or more [0..*] entryRelationship (CONF:14335) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14589). b. SHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:14352). 15. SHALL contain zero or more [0..*] entryRelationship (CONF:14467) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14590). b. SHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14468). Table 142: Problem type value set Value Set: Problem Type 2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 Code System(s): Description: SNOMED CT 2.16.840.1.113883.6.96 This value set indicates the level of medical judgment used to determine the existence of a problem. Code Code System Print Name 404684003 SNOMED CT Finding 409586006 SNOMED CT Complaint 282291009 SNOMED CT Diagnosis 64572001 SNOMED CT Condition 248536006 SNOMED CT Finding of functional performance and activity 418799008 SNOMED CT Symptom 55607006 SNOMED CT Problem 373930000 SNOMED CT Cognitive function finding Table 143: Problem Value Set (excerpt) Value Set: Problem 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC Code System(s): SNOMED CT 2.16.840.1.113883.6.96 Description: Problems and diagnoses. Limited to terms descending from the Clinical Findings (404684003) or Situation with Explicit Context (243796009) hierarchies. http://phinvads.cdc.gov/vads/ViewValueSet.action?id=70FDBFB 5-A277-DE11-9B52-0015173D1785 Code Code System Print Name 46635009 SNOMED CT Diabetes mellitus type 1 234422006 SNOMED CT Acute porphyria 31712002 SNOMED CT Primary biliary cirrhosis 302002000 SNOMED CT Difficulty moving Page 326 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Value Set: Problem 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC Code System(s): SNOMED CT 2.16.840.1.113883.6.96 Description: Problems and diagnoses. Limited to terms descending from the Clinical Findings (404684003) or Situation with Explicit Context (243796009) hierarchies. http://phinvads.cdc.gov/vads/ViewValueSet.action?id=70FDBFB 5-A277-DE11-9B52-0015173D1785 Code Code System Print Name 15188001 SNOMED CT Hearing loss 48167000 SNOMED CT Amnesia … Figure 166:Cognitive status problem observation example ... ... ... HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 327 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.14 Cognitive Status Result Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.74 (open)] Table 144: Cognitive Status Result Observation Contexts Used By: Contains Entries: Cognitive Status Result Organizer (required) Functional Status Section (optional) Assessment Scale Observation Caregiver Characteristics Non-Medicinal Supply Activity This clinical statement contains details of an evaluation or assessment of a patient’s cognitive status. The evaluation may include assessment of a patient's mood, memory, and ability to make decisions. The statement, if present, will include supporting caregivers, non-medical devices, and the time period for which the evaluation and assessment were performed. This is different from a cognitive status problem observation, which is a clinical statement that describes a patient's cognitive condition, findings, or symptoms. Examples of cognitive problem observations are inability to recall, amnesia, dementia, and aggressive behavior. Table 145: Cognitive Status Result Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.74'] @classCode 1..1 SHALL 14249 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 14250 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 14256 id 1..* SHALL 14257 code 1..1 SHALL 14591 0..1 SHOULD 14592 0..1 SHOULD 14258 reference/ @value 0..1 SHOULD 14259 statusCode 1..1 SHALL 14254 effectiveTime 1..1 SHALL value 1..1 SHALL @root @code text SET TS or IVL 14255 2.16.840.1.113883.10.20.22.4.74 2.16.840.1.113883.6.96 (SNOMED-CT) = 373930000 2.16.840.1.113883.5.14 (ActStatus) = completed 14261 14263 Page 328 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb interpretationCode 0..* SHOULD methodCode 0..1 MAY SET 14265 targetSiteCode 0..1 MAY SET 14270 author 0..1 MAY 14266 entryRelationship 0..* MAY 14272 @typeCode 1..1 SHALL 14593 supply 1..1 SHALL 14273 0..* MAY 14276 @typeCode 1..1 SHALL 14594 observation 1..1 SHALL 14277 0..* MAY 14469 @typeCode 1..1 SHALL 14595 observation 1..1 SHALL 14470 referenceRange 0..* SHOULD 14267 1..1 SHALL 14268 0..0 SHALL NOT 14269 entryRelationship entryRelationship Data Type CONF# Fixed Value 14264 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP observationRange code 1. Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2). 2. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14249). 3. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14250). 4. SHALL contain exactly one [1..1] templateId (CONF:14255) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.74" (CONF:14256). 5. SHALL contain at least one [1..*] id (CONF:14257). 6. SHALL contain exactly one [1..1] code (CONF:14591). a. This code SHOULD contain zero or one [0..1] @code="373930000" Cognitive function finding (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:14592). 7. SHOULD contain zero or one [0..1] text (CONF:14258). a. The text, if present, SHOULD contain zero or one [0..1] reference/@value (CONF:14259). i. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:14260). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 329 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 8. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:14254). Represents clinically effective time of the measurement, which may be the time the measurement was performed (e.g., a BP measurement), or may be the time the sample was taken (and measured some time afterwards). 9. SHALL contain exactly one [1..1] effectiveTime (CONF:14261). 10. SHALL contain exactly one [1..1] value (CONF:14263). a. If xsi:type=“CD”, SHOULD contain a code from SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) (CONF:14271). 11. SHOULD contain zero or more [0..*] interpretationCode (CONF:14264). 12. MAY contain zero or one [0..1] methodCode (CONF:14265). 13. MAY contain zero or one [0..1] targetSiteCode (CONF:14270). 14. MAY contain zero or one [0..1] author (CONF:14266). 15. MAY contain zero or more [0..*] entryRelationship (CONF:14272) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14593). b. SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14273). 16. MAY contain zero or more [0..*] entryRelationship (CONF:14276) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14594). b. SHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:14277). 17. MAY contain zero or more [0..*] entryRelationship (CONF:14469) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14595). b. SHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14470). 18. SHOULD contain zero or more [0..*] referenceRange (CONF:14267). a. The referenceRange, if present, SHALL contain exactly one [1..1] observationRange (CONF:14268). i. This observationRange SHALL NOT contain [0..0] code (CONF:14269). Page 330 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 167: Cognitive status result observation example ... ... 6.15 Cognitive Status Result Organizer [organizer: templateId 2.16.840.1.113883.10.20.22.4.75 (open)] Table 146: Cognitive Status Result Organizer Contexts Used By: Contains Entries: Functional Status Section (optional) Cognitive Status Result Observation This clinical statement identifies a set of cognitive status result observations. It contains information applicable to all of the contained cognitive status result observations. A result organizer may be used to group questions in a Patient Health Questionaire (PHQ). An appropriate nullFlavor can be used when the organizer/code or organizer/id is unknown. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 331 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 147: Cognitive Status Result Organizer Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value organizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.75'] @classCode 1..1 SHALL 14369 2.16.840.1.113883.5.6 (HL7ActClass) = CLUSTER @moodCode 1..1 SHALL 14371 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 14376 id 1..* SHALL 14377 code 1..1 SHALL 14378 0..1 SHOULD 14697 statusCode 1..1 SHALL 14372 component 1..* SHALL 14373 1..1 SHALL 14381 @root @code SET 14375 2.16.840.1.113883.10.20.22.4.75 2.16.840.1.113883.5.14 (ActStatus) = completed observation 1. Conforms to Result Organizer template (2.16.840.1.113883.10.20.22.4.1). 2. SHALL contain exactly one [1..1] @classCode, which SHALL be selected from CodeSystem HL7ActClass (2.16.840.1.113883.5.6)="CLUSTER" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14369). 3. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14371). 4. SHALL contain exactly one [1..1] templateId (CONF:14375) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.75" (CONF:14376). 5. SHALL contain at least one [1..*] id (CONF:14377). 6. SHALL contain exactly one [1..1] code (CONF:14378). a. This code SHOULD contain zero or one [0..1] @code (CONF:14697). i. Should be selected from ICF (codeSystem 2.16.840.1.113883.6.254) or SNOMED CT (codeSystem 2.16.840.1.113883.6.96) (CONF:14698). 7. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:14372). 8. SHALL contain at least one [1..*] component (CONF:14373) such that it a. SHALL contain exactly one [1..1] Cognitive Status Result Observation (templateId:2.16.840.1.113883.10.20.22.4.74) (CONF:14381). Page 332 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 168 Cognitive status result organizer example ... ... 6.16 Comment Activity [act: templateId 2.16.840.1.113883.10.20.22.4.64(open)] Table 148: Comment Activity Contexts Used By: Contains Entries: Any document Comments are free text data that cannot otherwise be recorded using data elements already defined by this specification. They are not to be used to record information that can be recorded elsewhere. For example, a free text description of the severity of an allergic reaction would not be recorded in a comment. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 333 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 149: Comment Activity Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.64'] @classCode 1..1 SHALL 9425 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 9426 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL code 1..1 SHALL text 1..1 SHALL 1..1 SHALL 9431 9433 @root SET 9427 10491 2.16.840.1.113883.10.20.22.4 .64 CD 9428 2.16.840.1.113883.6.1 (LOINC) = 48767-8 ED 9430 free Text Comment reference/@value author author 0..1 MAY time 1..1 SHALL assignedAuthor 1..1 SHALL id 1..1 SHALL II 9436 addr 1..1 SHALL SET 9437 IVL 9434 9435 1. Data elements defined elsewhere in the specification SHALL NOT be recorded using the Comment Activity (CONF:9429). 2. SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9425). 3. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9426). 4. SHALL contain exactly one [1..1] templateId (CONF:9427) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.64" (CONF:10491). 5. SHALL contain exactly one [1..1] code="48767-8" Annotation Comment (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:9428). a. This text SHALL contain exactly one [1..1] reference (CONF:15967). i. This reference SHALL contain exactly one [1..1] @value (CONF:15968). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15969). 6. MAY contain zero or one [0..1] author (CONF:9433). a. The author, if present, SHALL contain exactly one [1..1] time (CONF:9434). Page 334 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 b. The author, if present, SHALL contain exactly one [1..1] assignedAuthor (CONF:9435). i. This assignedAuthor SHALL contain exactly one [1..1] id (CONF:9436). ii. This assignedAuthor SHALL contain exactly one [1..1] addr (CONF:9437). 1. The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10480). iii. SHALL include assignedPerson/name or representedOrganization/name (CONF:9438). iv. An assignedPerson/name SHALL be a conformant US Realm Person Name (PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:9439). Figure 169: Comment act example The patient stated that he was looking forward to an upcoming vacation to New York with his family. He was concerned that he may not have enough medication for the trip. An additional prescription was provided to cover that period of time. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 335 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.17 Coverage Activity [act: templateId 2.16.840.1.113883.10.20.22.4.60 (open)] Table 150: Coverage Activity Contexts Used By: Contains Entries: Payers Section (optional) Policy Activity A Coverage Activity groups the policy and authorization acts within a Payers Section to order the payment sources. A Coverage Activity contains one or more policy activities, each of which contains zero or more authorization activities. The Coverage Activity id is the Id from the patient's insurance card. The sequenceNumber/@value shows the policy order of preference. Table 151: Coverage Activity Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.60'] @classCode 1..1 SHALL 8872 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 8873 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10492 id 1..* SHALL 8874 code 1..1 SHALL statusCode 1..1 entryRelationship @root SET CE 8897 2.16.840.1.113883.10.20.22.4.60 8876 2.16.840.1.113883.6.1 (LOINC) = 48768-6 SHALL 8875 2.16.840.1.113883.5.14 (ActStatus) = completed 1..* SHALL 8878 @typeCode 1..1 SHALL 8879 act 1..1 SHALL 15528 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 1. SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8872). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:8873). 3. SHALL contain exactly one [1..1] templateId (CONF:8897) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.60" (CONF:10492). 4. SHALL contain at least one [1..*] id (CONF:8874). 5. SHALL contain exactly one [1..1] code="48768-6" Payment Sources with @xsi:type="CE" (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:8876). Page 336 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:8875). 7. SHALL contain at least one [1..*] entryRelationship (CONF:8878) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:8879). b. SHALL contain exactly one [1..1] Policy Activity (templateId:2.16.840.1.113883.10.20.22.4.61) (CONF:15528). Figure 170: Coverage activity example ... 6.18 Deceased Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.79 (open)] Table 152: Deceased Observation Contexts Used By: Contains Entries: Problem Observation This clinical statement represents the observation that a patient has expired. It also represents the cause of death, indicated by an entryRelationship type of “CAUS”. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 337 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 153: Deceased Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.79'] @classCode 1..1 SHALL 14851 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 14852 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 14871 1..1 SHALL 14872 id 1..* SHALL 14873 code 1..1 SHALL 14853 2.16.840.1.113883.5.4 (ActCode) = ASSERTION statusCode 1..1 SHALL 14854 2.16.840.1.113883.5.14 (ActStatus) = completed effectiveTime 1..1 SHALL 14855 low 1..1 SHALL 14874 value 1..1 SHALL 1..1 SHALL 15142 0..1 SHOULD 14868 @typeCode 1..1 SHALL 14875 observation 1..1 SHALL 14870 @root @code entryRelationship CD 2.16.840.1.113883.10.20.22.4 .79 14857 2.16.840.1.113883.6.96 (SNOMED-CT) = 419099009 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = CAUS 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14851). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14852). 3. SHALL contain exactly one [1..1] templateId (CONF:14871) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.79" (CONF:14872). 4. SHALL contain at least one [1..*] id (CONF:14873). 5. SHALL contain exactly one [1..1] code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:14853). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:14854). 7. SHALL contain exactly one [1..1] effectiveTime (CONF:14855). a. This effectiveTime SHALL contain exactly one [1..1] low (CONF:14874). 8. SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:14857). a. This value SHALL contain exactly one [1..1] @code="419099009" Dead (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:15142). Page 338 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 9. SHOULD contain zero or one [0..1] entryRelationship (CONF:14868) such that it a. SHALL contain exactly one [1..1] @typeCode="CAUS" Is etiology for (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14875). b. SHALL contain exactly one [1..1] Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:14870). Figure 171: Deceased observation example 6.19 Discharge Medication [act: templateId 2.16.840.1.113883.10.20.22.4.35(open)] Table 154: Discharge Medication Contexts Used By: Contains Entries: Hospital Discharge Medications Section (entries required) Hospital Discharge Medications Section (entries optional) Medication Activity The Discharge Medications entry codes medications that the patient is intended to take (or stop) after discharge. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 339 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 155: Discharge Medication Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.35'] @classCode 1..1 SHALL 7689 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 7690 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 16760 1..1 SHALL 16761 2.16.840.1.113883.10.20.22.4.35 code 1..1 SHALL 7691 2.16.840.1.113883.6.1 (LOINC) = 10183-2 entryRelationship 1..1 SHALL 7692 1..1 SHALL 7693 1..1 SHALL 15525 @root @typeCode CD 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ substanceAdministration 1. SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7689). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7690). 3. SHALL contain exactly one [1..1] templateId (CONF:16760) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.35" (CONF:16761). 4. SHALL contain exactly one [1..1] code="10183-2" Discharge medication (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:7691). 5. SHALL contain at least one [1..*] entryRelationship (CONF:7692) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7693). b. SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15525). Page 340 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 172: Discharge medication entry example ... 6.20 Drug Vehicle [participantRole: templateId 2.16.840.1.113883.10.20.22.4.24(open)] Table 156: Drug Vehicle Contexts Used By: Contains Entries: Medication Activity Immunization Activity This template represents the vehicle (e.g., saline, dextrose) for administering a medication. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 341 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 157: Drug Vehicle Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value participantRole[templateId/@root = '2.16.840.1.113883.10.20.22.4.24'] @classCode 1..1 SHALL templateId 1..1 SHALL @root 7490 SET 2.16.840.1.113883.5.110 (RoleClass) = MANU 7495 1..1 SHALL 10493 2.16.840.1.113883.10.20.22.4.24 code 1..1 SHALL 7491 2.16.840.1.113883.6.96 (SNOMED-CT) = 412307009 playingEntity 1..1 SHALL 7492 code 1..1 SHALL 7493 name 0..1 MAY 7494 1. SHALL contain exactly one [1..1] @classCode="MANU" (CodeSystem: RoleClass 2.16.840.1.113883.5.110) (CONF:7490). 2. SHALL contain exactly one [1..1] templateId (CONF:7495) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.24" (CONF:10493). 3. SHALL contain exactly one [1..1] code="412307009" Drug Vehicle (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:7491). 4. SHALL contain exactly one [1..1] playingEntity (CONF:7492). This playingEntity/code is used to supply a coded term for the drug vehicle. a. This playingEntity SHALL contain exactly one [1..1] code (CONF:7493). b. This playingEntity MAY contain zero or one [0..1] name (CONF:7494). i. This playingEntity/name MAY be used for the vehicle name in text, such as Normal Saline (CONF:10087). Figure 173: Drug vehicle entry example Normal Saline Page 342 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.21 Encounter Activities [encounter: templateId 2.16.840.1.113883.10.20.22.4.49(open)] Table 158: Encounter Activities Contexts Used By: Contains Entries: Encounters Section (entries optional) (optional) Encounters Section (entries required) (required) Encounter Diagnosis Indication Service Delivery Location This clinical statement describes the interactions between the patient and clinicians. Interactions include in-person encounters, telephone conversations, and email exchanges. Table 159: Encounter Activities Constraints Overview Name XPath Card. Verb Data Type CONF # Fixed Value Green Encounter Activities encounter[templateId/@root = '2.16.840.1.113883.10.20.22.4.49'] @classCode 1..1 SHALL 8710 2.16.840.1.113883.5.6 (HL7ActClass) = ENC @moodCode 1..1 SHALL 8711 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL encounter ID id 1..* SHALL 8713 encounter Type code 0..1 SHOULD 8714 originalText 0..1 SHOULD 8719 reference 0..1 SHOULD 15970 @value 0..1 SHOULD 15971 0..1 SHOULD 8720 effectiveTime 1..1 SHALL performer 0..* MAY 8725 1..1 SHALL 8726 code 0..1 MAY 8727 participant 0..* MAY 8738 1..1 SHALL 8740 encounter FreeText Type encounter DateTime encounter Provider facility Location reference/@value assignedEntity @typeCode SET< II> TS or IVL< TS> 8712 2.16.840.1.113883.3.88.1 2.80.32 (EncounterTypeCode) 8715 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 343 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name XPath Card. Verb Data Type CONF # Fixed Value = LOC reasonFor Visit participantRole 1..1 SHALL 14903 entryRelationship 0..* MAY 8722 @typeCode 1..1 SHALL 8723 observation 1..1 SHALL 14899 0..* MAY 15492 1..1 SHALL 15973 entryRelationship act 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON 1. SHALL contain exactly one [1..1] @classCode="ENC" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8710). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:8711). 3. SHALL contain exactly one [1..1] templateId (CONF:8712) such that it 4. SHALL contain at least one [1..*] id (CONF:8713). 5. SHOULD contain zero or one [0..1] code, which SHOULD be selected from ValueSet EncounterTypeCode 2.16.840.1.113883.3.88.12.80.32 DYNAMIC (CONF:8714). a. The code, if present, SHOULD contain zero or one [0..1] originalText (CONF:8719). i. The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:15970). 1. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15971). a. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15972). ii. The originalText, if present, SHOULD contain zero or one [0..1] reference/@value (CONF:8720). 6. SHALL contain exactly one [1..1] effectiveTime (CONF:8715). 7. MAY contain zero or more [0..*] performer (CONF:8725). a. The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8726). i. This assignedEntity MAY contain zero or one [0..1] code (CONF:8727). 8. MAY contain zero or more [0..*] participant (CONF:8738) such that it a. SHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8740). Page 344 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 b. SHALL contain exactly one [1..1] Service Delivery Location (templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:14903). 9. MAY contain zero or more [0..*] entryRelationship (CONF:8722) such that it a. SHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:8723). b. SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:14899). 10. MAY contain zero or more [0..*] entryRelationship (CONF:15492) such that it a. SHALL contain exactly one [1..1] Encounter Diagnosis (templateId:2.16.840.1.113883.10.20.22.4.80 ) (CONF:15973). 11. MAY contain zero or one [0..1] sdtc:dischargeDispositionCode, which SHALL be selected from ValueSet 2.16.840.1.113883.3.88.12.80.33 NUBC UB-04 FL17-Patient Status DYNAMIC or, if access to NUBC is unavailable, from CodeSystem 2.16.840.1.113883.12.112 HL7 Discharge Disposition. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the dischargeDispositionCode element (CONF:9929). Table 160: Encounter Type Value Set Value Set: EncounterTypeCode 2.16.840.1.113883.3.88.12.80.32 DYNAMIC Code System: CPT-4 2.16.840.1.113883.6.12 This value set includes only the codes of the Current Procedure and Terminology designated for Evaluation and Management (99200 – 99607) (subscription to AMA Required http://www.amacodingonline.com/) Code Code System Print Name 99201 CPT-4 Office or other outpatient visit (problem focused) 99202 CPT-4 Office or other outpatient visit (expanded problem (expanded) 99203 CPT-4 Office or other outpatient visit (detailed) 99204 CPT-4 Office or other outpatient visit (comprehensive, (comprehensive moderate) 99205 CPT-4 Office or other outpatient visit (comprehensive, comprehensive-high) … CPT-4 … HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 345 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 174: Encounter activities example Checkup Examination ... ... 6.22 Encounter Diagnosis [act: templateId 2.16.840.1.113883.10.20.22.4.80 (open)] Table 161: Encounter Diagnosis Contexts Used By: Contains Entries: Encounter Activities (optional) Problem Observation Page 346 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 This template wraps relevant problems or diagnoses at the close of a visit or that need to be followed after the visit. If the encounter is associated with a Hospital Discharge, the Hospital Discharge Diagnosis must be used. This entry requires at least one Problem Observation entry. Table 162: Encounter Diagnosis Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.80 '] @classCode 1..1 SHALL 14889 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 14890 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 14895 1..1 SHALL 14896 @root code 1..1 SHALL @code 1..1 SHALL CE 14897 entry Relationship 1..* SHALL 14892 1..1 SHALL 14893 1..1 SHALL 14898 2.16.840.1.113883.10.20.22.4.80 14891 @typeCode 2.16.840.1.113883.6.1 (LOINC) = 29308-4 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ observation 1. SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14889). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14890). 3. SHALL contain exactly one [1..1] templateId (CONF:14895) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.80" (CONF:14896). 4. SHALL contain exactly one [1..1] code with @xsi:type="CE" (CONF:14891). a. This code SHALL contain exactly one [1..1] @code="29308-4" Diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:14897). 5. SHALL contain at least one [1..*] entryRelationship (CONF:14892) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14893). b. SHALL contain exactly one [1..1] Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:14898). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 347 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 175: Encounter diagnosis act example ... 6.23 Estimated Date of Delivery [observation: templateId 2.16.840.1.113883.10.20.15.3.1(closed)] Table 163: Estimated Date of Delivery Contexts Used By: Contains Entries: Pregnancy Observation This clinical statement represents the anticipated date when a woman will give birth. Table 164: Estimated Date of Delivery Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.15.3.1'] @classCode 1..1 SHALL 444 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 445 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 16762 1..1 SHALL 16763 2.16.840.1.113883.10.20.15.3.1 code 1..1 SHALL 446 2.16.840.1.113883.6.1 (LOINC) = 11778-8 statusCode 1..1 SHALL 448 2.16.840.1.113883.5.14 (ActStatus) = completed value 1..1 SHALL @root CE TS 450 Page 348 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:444). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:445). 3. SHALL contain exactly one [1..1] templateId (CONF:16762) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.15.3.1" (CONF:16763). 4. SHALL contain exactly one [1..1] code="11778-8" Estimated date of delivery (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:446). 5. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:448). 6. SHALL contain exactly one [1..1] value with @xsi:type="TS" (CONF:450). Figure 176: Estimated date of delivery example 20110919 6.24 Family History Death Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.47(open)] Table 165: Family History Death Observation Contexts Used By: Contains Entries: Family History Observation This clinical statement records whether the family member is deceased. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 349 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 166: Family History Death Observation Constraints Overview Name XPath Card . Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.47'] @classCode 1..1 SHALL 8621 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 8622 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10495 2.16.840.1.113883.10.20.22.4.4 7 code 1..1 SHALL 16889 2.16.840.1.113883.5.4 (ActCode) = ASSERTION statusCode 1..1 SHALL 8625 2.16.840.1.113883.5.14 (ActStatus) = completed value 1..1 SHALL 8626 2.16.840.1.113883.6.96 (SNOMED-CT) = 419099009 @root SET CD 8623 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8621). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:8622). 3. SHALL contain exactly one [1..1] templateId (CONF:8623) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.47" (CONF:10495). 4. SHALL contain exactly one [1..1] code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:16889). 5. SHALL contain exactly one [1..1] statusCode="completed" (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:8625). 6. SHALL contain exactly one [1..1] value="419099009" Dead with @xsi:type="CD" (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:8626). Figure 177: Family history death observation example Page 350 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.25 Family History Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.46(open)] Table 167: Family History Observation Contexts Used By: Contains Entries: Family History Organizer (optional) Age Observation Family History Death Observation Family History Observations related to a particular family member are contained within a Family History Organizer. The effectiveTime in the Family History Observation is the biologically or clinically relevant time of the observation. The biologically or clinically relevant time is the time at which the observation holds (is effective) for the family member (the subject of the observation). Table 168: Family History Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value Green Family History Observation observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.46'] @classCode 1..1 SHALL 8586 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 8587 2.16.840.1.113883.5.100 1 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10496 id 1..* SHALL 8592 code 1..1 SHALL 8589 2.16.840.1.113883.3.88.1 2.3221.7.2 (Problem Type) statusCode 1..1 SHALL 8590 2.16.840.1.113883.5.14 (ActStatus) = completed effectiveTime 0..1 SHOULD TS or IVL< TS> 8593 value 1..1 SHALL CD 8591 entryRelationship 0..1 MAY 8675 @typeCode 1..1 SHALL 8676 2.16.840.1.113883.5.90 (HL7ParticipationType) = SUBJ @inversionInd 1..1 SHALL 8677 true observation 1..1 SHALL 15526 @root SET< II> 8599 2.16.840.1.113883.10.20. 22.4.46 2.16.840.1.113883.3.88.1 2.3221.7.4 (Problem) HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 351 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name XPath Card. Verb 0..1 MAY 8678 @typeCode 1..1 SHALL 8679 observation 1..1 SHALL 15527 entryRelationship Data Type CONF# Fixed Value 2.16.840.1.113883.5.90 (HL7ParticipationType) = CAUS 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8586). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:8587). 3. SHALL contain exactly one [1..1] templateId (CONF:8599) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.46" (CONF:10496). 4. SHALL contain at least one [1..*] id (CONF:8592). 5. SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type 2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 (CONF:8589). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:8590). 7. SHOULD contain zero or one [0..1] effectiveTime (CONF:8593). 8. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet Problem 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:8591). 9. MAY contain zero or one [0..1] entryRelationship (CONF:8675) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Subject (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8676). b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:8677). c. SHALL contain exactly one [1..1] Age Observation (templateId:2.16.840.1.113883.10.20.22.4.31) (CONF:15526). 10. MAY contain zero or one [0..1] entryRelationship (CONF:8678) such that it a. SHALL contain exactly one [1..1] @typeCode="CAUS" Causal or Contributory (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8679). b. SHALL contain exactly one [1..1] Family History Death Observation (templateId:2.16.840.1.113883.10.20.22.4.47) (CONF:15527). Page 352 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 178: Family history observation scenario SCENARIO A patient's father was diagnosed with diabetes at the age of 40. He died of Myocardial Infarction at the age of 57. If the patient's father was born in 1910, the family history organizer for the father would contain the following items: The Date of Birth RelatedSubject/subject/birthTime => 1910 The Date of Death RelatedSubject/subject/sdtc:deceasedInd => true RelatedSubject/subject/sdtc:deceasedTime => 1967 The Diabetes Diagnosis component/observation/effectiveTime => 1950 component/observation/value => contains the code and displayName for diabetes component/observation/entryRelationship/observation/value/@value => 40 with the unit set to "a" to indicate years The Myocardial Infarction Diagnosis and Cause of Death component/observation/effectiveTime => 1967 component/observation/value => contains the code and displayName for MI component/observation/entryRelationship/observation/value/@value => 57 with the unit set to "a" to indicate years component/observation/entryRelationship/@typeCode => "CAUS". This second entryRelationship shows that the MI was the cause of death. The next example uses the above scenario . HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 353 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 179: Family history observation example
FAMILY HISTORY Father (deceased)
Diagnosis Age At Onset
Myocardial Infarction (cause of death) 57
Diabetes 40
Page 354 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 ******** Family history death observation template ******** -- > HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 355 July 2012 © 2012 Health Level Seven, Inc. All rights reserved.
6.26 Family History Organizer [organizer: templateId 2.16.840.1.113883.10.20.22.4.45(open)] Table 169: Family History Organizer Contexts Used By: Contains Entries: Family History Section Family History Observation The Family History Organizer associates a set of observations with a family member. For example, the Family History Organizer can group a set of observations about the patient’s father. Table 170: Family History Organizer Constraints Overview Name XPath Green Family History Organizer organizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.45'] Verb Data Type CONF# Fixed Value @classCode 1..1 SHALL 8600 2.16.840.1.113883.5.6 (HL7ActClass) = CLUSTER @moodCode 1..1 SHALL 8601 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10497 2.16.840.1.113883.10.20.2 2.4.45 statusCode 1..1 SHALL 8602 2.16.840.1.113883.5.14 (ActStatus) = completed subject 1..1 SHALL 8609 @root familyMember Demographics Card. SET< II> 8604 Page 356 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb Data Type CONF# 1..1 SHALL 15244 @classCode 1..1 SHALL 15245 code 1..1 SHALL 15246 @code 0..1 SHALL 15247 subject 0..1 SHOULD 15248 1..1 SHALL 15974 @code 1..1 SHALL 15975 birthTime 0..1 SHOULD 15976 1..1 SHALL 8610 Fixed Value relatedSubject 2.16.840.1.113883.5.41 (EntityClass) = PRS 2.16.840.1.113883.1.11.19 579 (FamilyHistoryRelatedSubje ctCode) administrative GenderCode relatedSubject /@classCode familyMember Relationship ToPatient code 1..1 SHALL familyMember Person Information subject 0..1 SHOULD 1..1 SHALL CE 8614 0..1 SHOULD TS 8615 1..* SHALL 8607 1..1 SHOULD 16888 familyMember Administrative Gender familyMember DateOfBirth familyMember MedicalHistory CE component observation 2.16.840.1.113883.5.41 (EntityClass) = PRS 8611 8613 administrative GenderCode birthTime 2.16.840.1.113883.1.11.1 (Administrative Gender (HL7 V3)) 2.16.840.1.113883.1.11.1 (Administrative Gender (HL7 V3)) 1. SHALL contain exactly one [1..1] @classCode="CLUSTER" Cluster (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8600). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:8601). 3. SHALL contain exactly one [1..1] templateId (CONF:8604) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.45" (CONF:10497). 4. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:8602). 5. SHALL contain exactly one [1..1] subject (CONF:8609). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 357 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. This subject SHALL contain exactly one [1..1] relatedSubject (CONF:15244). i. This relatedSubject SHALL contain exactly one [1..1] @classCode="PRS" Person (CodeSystem: EntityClass 2.16.840.1.113883.5.41) (CONF:15245). ii. This relatedSubject SHALL contain exactly one [1..1] code (CONF:15246). 1. This code SHALL contain zero or one [0..1] @code, which SHOULD be selected from ValueSet FamilyHistoryRelatedSubjectCode 2.16.840.1.113883.1.11.19579 DYNAMIC (CONF:15247). iii. This relatedSubject SHOULD contain zero or one [0..1] subject (CONF:15248). 1. The subject, if present, SHALL contain exactly one [1..1] administrativeGenderCode (CONF:15974). a. This administrativeGenderCode SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Administrative Gender (HL7 V3) 2.16.840.1.113883.1.11.1 (CONF:15975). 2. The subject, if present, SHOULD contain zero or one [0..1] birthTime (CONF:15976). 3. The subject SHOULD contain zero or more [0..*] sdtc:id. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the id element (CONF:15249). 4. The subject MAY contain zero or one sdtc:deceasedInd. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the deceasedInd element (CONF:15981). 5. The subject MAY contain zero or one sdtc:deceasedTime. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the deceasedTime element (CONF:15982). 6. The age of a relative at the time of a family history observation SHOULD be inferred by comparing RelatedSubject/subject/birthTime with Observation/effectiveTime (CONF:15983). 6. SHALL contain at least one [1..*] component (CONF:8607). a. Such components SHALL contain exactly one [1..1] Family History Observation (templateId:2.16.840.1.113883.10.20.22.4.46) (CONF:16888). Page 358 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 171: Family History Related Subject Value Set (excerpt) Value Set: FamilyHistoryRelatedSubjectCode 2.16.840.1.113883.1.11.19579 DYNAMIC Code System: RoleCode 2.16.840.1.113883.5.111 (any subtype of RoleCode: FAMMEMB) See HL7 Vocabulary Domains included in the CDA R2 Normative Web Edition http://www.hl7.org/documentcenter/private/standards/cda/r2/cda_r2_normativewebeditio n2010.zip Code Code System Print Name CHILD RoleCode Child CHLDADOPT RoleCode Adopted Child DAUADOPT RoleCode Adopted Daughter SONADOPT RoleCode Adopted Son CHLDINLAW RoleCode Child in-law … Figure 180: Family history organizer example ... HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 359 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.27 Functional Status Problem Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.68 (open)] Table 172: Functional Status Problem Observation Contexts Used By: Contains Entries: Functional Status Section (optional) Assessment Scale Observation Caregiver Characteristics Non-Medicinal Supply Activity A functional status problem observation is a clinical statement that represents a patient’s functional perfomance and ability. Table 173: Functional Status Problem Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.68'] @classCode 1..1 SHALL 14282 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 14283 2.16.840.1.113883.5.1001 (ActMood) = EVN @negationInd 0..1 MAY 14307 templateId 1..1 SHALL 14312 1..1 SHALL 14313 id @root 1..* SHALL 14284 code 1..1 SHALL 14314 0..1 SHOULD 14315 0..1 SHOULD 14304 reference 1..1 SHOULD 15552 @value @code text 0..1 SHOULD 15553 statusCode 1..1 SHALL 14286 effectiveTime 0..1 SHOULD TS or IVL 14287 value 1..1 SHALL CD 14291 0..1 MAY 14292 methodCode 0..1 MAY 14316 entryRelationship 0..* MAY 14294 @nullFlavor 2.16.840.1.113883.10.20.22.4.68 2.16.840.1.113883.6.96 (SNOMED-CT) = 248536006 2.16.840.1.113883.5.14 (ActStatus) = completed 2.16.840.1.113883.3.88.12.3221.7 .4 (Problem) Page 360 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb @typeCode 1..1 supply CONF# Fixed Value SHALL 14584 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 1..1 SHALL 14317 0..* MAY 14298 @typeCode 1..1 SHALL 14586 observation 1..1 SHALL 14318 0..* MAY 14463 @typeCode 1..1 SHALL 14587 observation 1..1 SHALL 14464 entryRelationship entryRelationship Data Type 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 1. Conforms to Problem Observation template (2.16.840.1.113883.10.20.22.4.4). 2. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14282). 3. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14283). Use negationInd="true" to indicate that the problem was not observed. 4. MAY contain zero or one [0..1] @negationInd (CONF:14307). 5. SHALL contain exactly one [1..1] templateId (CONF:14312) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.68" (CONF:14313). 6. SHALL contain at least one [1..*] id (CONF:14284). 7. SHALL contain exactly one [1..1] code (CONF:14314). a. This code SHOULD contain zero or one [0..1] @code="248536006" finding of functional performance and activity (CodeSystem: SNOMEDCT 2.16.840.1.113883.6.96) (CONF:14315). 8. SHOULD contain zero or one [0..1] text (CONF:14304). a. The text, if present, SHOULD contain exactly one [1..1] reference (CONF:15552). i. This reference SHOULD contain zero or one [0..1] @value (CONF:15553). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15554). 9. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:14286). 10. SHOULD contain zero or one [0..1] effectiveTime (CONF:14287). a. The onset date SHALL be recorded in the low element of the effectiveTime element when known (CONF:14288). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 361 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. b. The resolution date SHALL be recorded in the high element of the effectiveTime element when known (CONF:14289). c. If the problem is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'. Therefore, the existence of an high element within a problem does indicate that the problem has been resolved (CONF:14290). 11. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Problem 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:14291). a. This value MAY contain zero or one [0..1] @nullFlavor (CONF:14292). i. If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and the other code SHOULD be placed in the translation element (CONF:14293). 12. MAY contain zero or one [0..1] methodCode (CONF:14316). 13. MAY contain zero or more [0..*] entryRelationship (CONF:14294) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14584). b. SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14317). 14. MAY contain zero or more [0..*] entryRelationship (CONF:14298) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14586). b. SHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:14318). 15. MAY contain zero or more [0..*] entryRelationship (CONF:14463) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14587). b. SHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14464). Page 362 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 181: Functional status problem observation example ... ... ... 6.28 Functional Status Result Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.67 (open)] Table 174: Functional Status Result Observation Contexts Used By: Contains Entries: Functional Status Result Organizer (required) Functional Status Section (optional) Assessment Scale Observation Caregiver Characteristics Non-Medicinal Supply Activity This clinical statement represents details of an evaluation or assessment of a patient's functional status. The evaluation may include assessment of a patient's language, vision, hearing, activities of daily living, behavior, general function, mobility, and self-care status. The statement, if present, will include supporting caregivers, non-medical devices, and the time period for which the evaluation and assessment were performed. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 363 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 175: Functional Status Result Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.67'] @classCode 1..1 SHALL 13905 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 13906 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 13889 1..1 SHALL 13890 id 1..* SHALL code 1..1 SHALL text 0..1 SHOULD 13926 reference 0..1 SHOULD 13927 statusCode 1..1 SHALL 13929 effectiveTime 1..1 SHALL 13930 value 1..1 SHALL 13932 interpretationCode 0..* SHOULD 13933 methodCode 0..1 MAY 13934 targetSiteCode 0..1 MAY 13935 author 0..1 MAY 13936 entryRelationship 0..1 MAY 13892 @typeCode 1..1 SHALL 14596 supply 1..1 SHALL 14218 @root entryRelationship 13907 CE 13908 0..1 MAY 13895 @typeCode 1..1 SHALL 14597 observation 1..1 SHALL 13897 0..1 MAY 14465 @typeCode 1..1 SHALL 14598 observation 1..1 SHALL 14466 referenceRange 0..* SHOULD 13937 1..1 SHALL 13938 entryRelationship observationRange 2.16.840.1.113883.10.20.22. 4.67 2.16.840.1.113883.6.1 (LOINC) Completed REFR REFR COMP 1. Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2). 2. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:13905). 3. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:13906). 4. SHALL contain exactly one [1..1] templateId (CONF:13889) such that it Page 364 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.67" (CONF:13890). 5. SHALL contain at least one [1..*] id (CONF:13907). 6. SHALL contain exactly one [1..1] code with @xsi:type="CE", where the @code SHOULD be selected from CodeSystem LOINC (2.16.840.1.113883.6.1) (CONF:13908). 7. SHOULD contain zero or one [0..1] text (CONF:13926). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:13927). i. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:13928). 8. SHALL contain exactly one [1..1] statusCode="Completed" (CONF:13929). Represents clinically effective time of the measurement, which may be when the measurement was performed (e.g., a BP measurement), or may be when sample was taken (and measured some time afterwards) 9. SHALL contain exactly one [1..1] effectiveTime (CONF:13930). 10. SHALL contain exactly one [1..1] value (CONF:13932). a. If xsi:type=“CD”, SHOULD contain a code from SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) (CONF:14234). 11. SHOULD contain zero or more [0..*] interpretationCode (CONF:13933). 12. MAY contain zero or one [0..1] methodCode (CONF:13934). 13. MAY contain zero or one [0..1] targetSiteCode (CONF:13935). 14. MAY contain zero or one [0..1] author (CONF:13936). 15. MAY contain zero or one [0..1] entryRelationship (CONF:13892) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" refers to (CONF:14596). b. SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14218). 16. MAY contain zero or one [0..1] entryRelationship (CONF:13895) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" refers to (CONF:14597). b. SHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:13897). 17. MAY contain zero or one [0..1] entryRelationship (CONF:14465) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" has component (CONF:14598). b. SHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14466). 18. SHOULD contain zero or more [0..*] referenceRange (CONF:13937). a. The referenceRange, if present, SHALL contain exactly one [1..1] observationRange (CONF:13938). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 365 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. i. This observationRange SHALL NOT contain [0..0] code (CONF:13939). Figure 182: Functional status result observation example ... ... 6.29 Functional Status Result Organizer [organizer: templateId 2.16.840.1.113883.10.20.22.4.66 (open)] Table 176: Functional Status Result Organizer Contexts Used By: Contains Entries: Functional Status Section (optional) Functional Status Result Observation This clinical statement identifies a set of functional status result observations. It contains information applicable to all of the contained functional status result observations. A functional status organizer may group self-care observations related to a patient's ability to feed, bathe, and dress. An appropriate nullFlavor can be used when the organizer/code or organizer/id is unknown. Page 366 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 177: Functional Status Result Organizer Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value organizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.66'] @classCode 1..1 SHALL 14355 2.16.840.1.113883.5.6 (HL7ActClass) = CLUSTER 1..1 SHALL 14357 2.16.840.1.113883.5.1001 (ActMood) = EVN 1..1 SHALL 1..1 SHALL 14362 id 1..* SHALL 14363 code 1..1 SHALL 14364 0..1 SHOULD 14747 statusCode 1..1 SHALL 14358 component 1..* SHALL 14359 1..1 SHALL 14368 @mood Code templateId @root @code SET 14361 2.16.840.1.113883.10.20.22.4.66 2.16.840.1.113883.5.14 (ActStatus) = completed observation 1. Conforms to Result Organizer template (2.16.840.1.113883.10.20.22.4.1). 2. SHALL contain exactly one [1..1] @classCode, which SHALL be selected from CodeSystem HL7ActClass (2.16.840.1.113883.5.6)="CLUSTER" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14355). 3. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14357). 4. SHALL contain exactly one [1..1] templateId (CONF:14361) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.66" (CONF:14362). 5. SHALL contain at least one [1..*] id (CONF:14363). 6. SHALL contain exactly one [1..1] code (CONF:14364). a. This code SHOULD contain zero or one [0..1] @code (CONF:14747). i. be selected from ICF (codeSystem 2.16.840.1.113883.6.254) or SNOMED CT (codeSystem 2.16.840.1.113883.6.96) (CONF:14748). SHOULD 7. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:14358). 8. SHALL contain at least one [1..*] component (CONF:14359) such that it a. SHALL contain exactly one [1..1] Functional Status Result Observation (templateId:2.16.840.1.113883.10.20.22.4.67) (CONF:14368). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 367 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 183: Functional status result organizer example ... ... 6.30 Health Status Observation [Observation: templateId 2.16.840.1.113883.10.20.22.4.5(open)] Table 178: Health Status Observation Contexts Used By: Contains Entries: Problem Observation The Health Status Observation records information about the current health status of the patient. Table 179: Health Status Observation Constraints Overview Page 368 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.5'] @classCode 1..1 SHALL 9057 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 9072 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 16756 1..1 SHALL 16757 2.16.840.1.113883.10.20.22.4.5 code 1..1 SHALL 9073 2.16.840.1.113883.6.1 (LOINC) = 11323-3 text 0..1 SHOULD 9270 reference 0..1 SHOULD 15529 @value 0..1 SHOULD 15530 statusCode 1..1 SHALL 9074 2.16.840.1.113883.5.14 (ActStatus) = completed value 1..1 SHALL 9075 2.16.840.1.113883.1.11.20.12 (HealthStatus) @root CE CD 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9057). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9072). 3. SHALL contain exactly one [1..1] templateId (CONF:16756) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.5" (CONF:16757). 4. SHALL contain exactly one [1..1] code="11323-3" Health status with @xsi:type="CE" (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:9073). 5. SHOULD contain zero or one [0..1] text (CONF:9270). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15529). i. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15530). 1. SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15531). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:9074). 7. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet HealthStatus 2.16.840.1.113883.1.11.20.12 DYNAMIC (CONF:9075). Table 180: HealthStatus Value Set HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 369 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Value Set: HealthStatus 2.16.840.1.113883.1.11.20.12 DYNAMIC Code System(s): Description: Code SNOMED CT 2.16.840.1.113883.6.96 Represents the general health status of the patient. Code System Print Name 81323004 SNOMED CT Alive and well 313386006 SNOMED CT In remission 162467007 SNOMED CT Symptom free 161901003 SNOMED CT Chronically ill 271593001 SNOMED CT Severely ill 21134002 SNOMED CT Disabled 161045001 SNOMED CT Severely disabled Figure 184: Health status observation example Page 370 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.31 Highest Pressure Ulcer Stage [observation: templateId 2.16.840.1.113883.10.20.22.4.77 (open)] Table 181: Highest Pressure Ulcer Stage Contexts Used By: Contains Entries: Functional Status Section (optional) Physical Exam Section (optional) This observation contains a description of the wound tissue of the most severe or highest staged pressure ulcer observed on a patient. Table 182: Highest Pressure Ulcer Stage Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.77'] @classCode 1..1 SHALL 14726 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 14727 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 14728 1..1 SHALL 14729 id 1..* SHALL 14730 code 1..1 SHALL 14731 1..1 SHALL 14732 1..1 SHALL 14733 @root @code value 2.16.840.1.113883.10.20.22.4.77 2.16.840.1.113883.6.96 (SNOMED-CT) = 420905001 1. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14726). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14727). 3. SHALL contain exactly one [1..1] templateId (CONF:14728) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.77" (CONF:14729). 4. SHALL contain at least one [1..*] id (CONF:14730). 5. SHALL contain exactly one [1..1] code (CONF:14731). a. This code SHALL contain exactly one [1..1] @code="420905001" Highest Pressure Ulcer Stage (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:14732). 6. SHALL contain exactly one [1..1] value (CONF:14733). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 371 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.32 Hospital Admission Diagnosis [act: templateId 2.16.840.1.113883.10.20.22.4.34(open) Table 183: Hospital Admission Diagnosis Contexts Used By: Contains Entries: Hospital Admission Diagnosis Section Problem Observation The Hospital Admission Diagnosis entry describes the relevant problems or diagnoses at the time of admission. Table 184: Hospital Admission Diagnosis Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.34'] @classCode 1..1 SHALL 7671 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 7672 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 16747 1..1 SHALL 16748 2.16.840.1.113883.10.20.22.4.34 code 1..1 SHALL 7673 2.16.840.1.113883.6.1 (LOINC) = 46241-6 entryRelationship 1..* SHALL 7674 @typeCode 1..1 SHALL 7675 observation 1..1 SHALL 15535 @root CE 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1. SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7671). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7672). 3. SHALL contain exactly one [1..1] templateId (CONF:16747) such that it Page 372 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.34" (CONF:16748). 4. SHALL contain exactly one [1..1] code="46241-6" Admission diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:7673). 5. SHALL contain at least one [1..*] entryRelationship (CONF:7674) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7675). b. SHALL contain exactly one [1..1] Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:15535). Figure 185: Hospital admission diagnosis example ... 6.33 Hospital Discharge Diagnosis [act: templateId 2.16.840.1.113883.10.20.22.4.33(open) Table 185: Hospital Discharge Diagnosis Contexts Used By: Contains Entries: Hospital Discharge Diagnosis Section Problem Observation The Hospital Discharge Diagnosis act wraps relevant problems or diagnoses at the time of discharge that occurred during the hospitalization or that need to be followed after hospitalization. This entry requires at least one Problem Observation entry. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 373 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 186: Hospital Discharge Diagnosis Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.33'] @classCode 1..1 SHALL 7663 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 7664 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 16764 1..1 SHALL 16765 2.16.840.1.113883.10.20.22.4.33 code 1..1 SHALL 7665 2.16.840.1.113883.6.1 (LOINC) = 11535-2 entryRelationship 1..* SHALL 7666 @typeCode 1..1 SHALL 7667 observation 1..1 SHALL 15536 @root CE 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1. SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7663). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7664). 3. SHALL contain exactly one [1..1] templateId (CONF:16764) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.33" (CONF:16765). 4. SHALL contain exactly one [1..1] code="11535-2" Hospital discharge diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:7665). 5. SHALL contain at least one [1..*] entryRelationship (CONF:7666) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7667). b. SHALL contain exactly one [1..1] Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:15536). Page 374 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 186: Hospital discharge diagnosis act example ... 6.34 Immunization Activity [substanceAdministration: templateId 2.16.840.1.113883.10.20.22.4.52 (open)] Table 187: Immunization Activity Contexts Used By: Contains Entries: Immunizations Section (entries optional) (optional) Immunizations Section (entries required) (required) Drug Vehicle Immunization Medication Information Immunization Refusal Reason Indication Instructions Medication Dispense Medication Supply Order Precondition for Substance Administration Reaction Observation An Immunization Activity describes immunization substance administrations that have actually occurred or are intended to occur. Immunization Activities in "INT" mood are reflections of immunizations a clinician intends a patient to receive. Immunization Activities in "EVN" mood reflect immunizations actually received. An Immunization Activity is very similar to a Medication Activity with some key differentiators. The drug code system is constrained to CVX codes. Administration timing is less complex. Patient refusal reasons should be captured. All vaccines administered should be fully documented in the patient's HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 375 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. permanent medical record. Healthcare providers who administer vaccines covered by the National Childhood Vaccine Injury Act are required to ensure that the permanent medical record of the recipient indicates: 1) 2) 3) 4) Date of administration Vaccine manufacturer Vaccine lot number Name and title of the person who administered the vaccine and the address of the clinic or facility where the permanent record will reside 5) Vaccine information statement (VIS) a. date printed on the VIS b. date VIS given to patient or parent/guardian. This information should be included in an Immunization Activity when available. 33 Table 188: Immunization Activity Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value Green Immunization Activity substanceAdministration[templateId/@root = '2.16.840.1.113883.10.20.22.4.52'] @classCode 1..1 SHALL 8826 2.16.840.1.113883.5.6 (HL7ActClass) = SBADM @moodCode 1..1 SHALL 8827 2.16.840.1.113883.11.20.9. 18 (MoodCodeEvnInt) @negationInd 1..1 SHALL templateId 1..1 SHALL 1..1 SHALL 10498 id 1..* SHALL 8829 code 0..1 MAY text 0..1 SHOULD 8831 reference 0..1 SHOULD 15543 @value 0..1 SHOULD 15544 statusCode 1..1 SHALL 8833 administered Date effectiveTime 1..1 SHALL TS or IVL< TS> 8834 medication SeriesNumber repeatNumber 0..1 MAY IVL 8838 routeCode 0..1 MAY approachSiteCode 0..1 MAY refusal @root 33 8985 SET< II> CE SET< 8828 2.16.840.1.113883.10.20.2 2.4.52 8830 8839 2.16.840.1.113883.3.88.12. 3221.8.7 (Medication Route FDA Value Set) 8840 2.16.840.1.113883.3.88.12. 3221.8.9 (Body Site Value Vaccine Administration Guidelines. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/D/vacc_admin. pdf Page 376 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb Data Type CONF# CD> doseQuantity SHOULD 0..1 SHOULD 8842 2.16.840.1.113883.1.11.12 839 (UCUM Units of Measure (case sensitive)) = 1 0..1 MAY 8846 2.16.840.1.113883.3.88.12. 3221.8.11 (Medication Product Form) 1..1 SHALL 8847 1..1 SHALL 15546 performer 0..1 SHOULD 8849 participant 0..* MAY 8850 @typeCode 1..1 SHALL 8851 participantRole 1..1 SHALL 15547 entryRelationship 0..* MAY 8853 @typeCode 1..1 SHALL 8854 observation 1..1 SHALL 15537 0..1 MAY 8856 @typeCode 1..1 SHALL 8857 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ @inversionInd 1..1 SHALL 8858 true act 1..1 SHALL 15538 0..1 MAY 8860 @typeCode 1..1 SHALL 8861 supply 1..1 SHALL 15539 0..1 MAY 8863 @typeCode 1..1 SHALL 8864 supply 1..1 SHALL 15540 0..1 MAY 8866 1..1 SHALL 8867 administrationUni tCode medication Information Set) 0..1 @unit consumable IVL< PQ> Fixed Value 8841 manufacturedPro duct performer entryRelationship entryRelationship entryRelationship reaction entryRelationship @typeCode 2.16.840.1.113883.5.90 (HL7ParticipationType) = CSM 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = CAUS HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 377 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name XPath Card. Verb 1..1 SHALL 15541 0..1 MAY 8988 @typeCode 1..1 SHALL 8989 observation 1..1 SHALL 15542 precondition 0..* MAY 8869 @typeCode 1..1 SHALL 8870 criterion 1..1 SHALL 15548 observation refusal Reason entryRelationship Data Type CONF# Fixed Value 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = PRCN 1. SHALL contain exactly one [1..1] @classCode="SBADM" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8826). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC (CONF:8827). Use negationInd="true" to indicate that the immunization was not given. 3. SHALL contain exactly one [1..1] @negationInd (CONF:8985). 4. SHALL contain exactly one [1..1] templateId (CONF:8828) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.52" (CONF:10498). 5. SHALL contain at least one [1..*] id (CONF:8829). 6. MAY contain zero or one [0..1] code with @xsi:type="CE" (CONF:8830). 7. SHOULD contain zero or one [0..1] text (CONF:8831). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15543). i. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15544). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1 (CONF:15545). 8. SHALL contain exactly one [1..1] statusCode (CONF:8833). 9. SHALL contain exactly one [1..1] effectiveTime (CONF:8834). In "INT" (intent) mood, the repeatNumber defines the number of allowed administrations. For example, a repeatNumber of "3" means that the substance can be administered up to 3 times. In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a repeatNumber of "3" in a dispense act means that the current dispensation is the 3rd. A repeatNumber of "3" in a substance administration event means that the current administration is the 3rd in a series. Page 378 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 10. MAY contain zero or one [0..1] repeatNumber (CONF:8838). 11. MAY contain zero or one [0..1] routeCode, which SHALL be selected from ValueSet Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC (CONF:8839). 12. MAY contain zero or one [0..1] approachSiteCode, where the @code SHALL be selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:8840). 13. SHOULD contain zero or one [0..1] doseQuantity (CONF:8841). a. The doseQuantity, if present, SHOULD contain zero or one [0..1] @unit="1", which SHALL be selected from ValueSet UCUM Units of Measure (case sensitive) 2.16.840.1.113883.1.11.12839 DYNAMIC (CONF:8842). 14. MAY contain zero or one [0..1] administrationUnitCode, which SHALL be selected from ValueSet Medication Product Form 2.16.840.1.113883.3.88.12.3221.8.11 DYNAMIC (CONF:8846). 15. SHALL contain exactly one [1..1] consumable (CONF:8847). a. This consumable SHALL contain exactly one [1..1] Immunization Medication Information (templateId:2.16.840.1.113883.10.20.22.4.54) (CONF:15546). 16. SHOULD contain zero or one [0..1] performer (CONF:8849). 17. MAY contain zero or more [0..*] participant (CONF:8850). a. The participant, if present, SHALL contain exactly one [1..1] @typeCode="CSM" (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:8851). b. The participant, if present, SHALL contain exactly one [1..1] Drug Vehicle (templateId:2.16.840.1.113883.10.20.22.4.24) (CONF:15547). 18. MAY contain zero or more [0..*] entryRelationship (CONF:8853) such that it a. SHALL contain exactly one [1..1] @typeCode="RSON" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8854). b. SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15537). 19. MAY contain zero or one [0..1] entryRelationship (CONF:8856) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8857). b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:8858). c. SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15538). 20. MAY contain zero or one [0..1] entryRelationship (CONF:8860) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8861). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 379 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. b. SHALL contain exactly one [1..1] Medication Supply Order (templateId:2.16.840.1.113883.10.20.22.4.17) (CONF:15539). 21. MAY contain zero or one [0..1] entryRelationship (CONF:8863) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8864). b. SHALL contain exactly one [1..1] Medication Dispense (templateId:2.16.840.1.113883.10.20.22.4.18) (CONF:15540). 22. MAY contain zero or one [0..1] entryRelationship (CONF:8866) such that it a. SHALL contain exactly one [1..1] @typeCode="CAUS" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8867). b. SHALL contain exactly one [1..1] Reaction Observation (templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:15541). 23. MAY contain zero or one [0..1] entryRelationship (CONF:8988) such that it a. SHALL contain exactly one [1..1] @typeCode="RSON" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8989). b. SHALL contain exactly one [1..1] Immunization Refusal Reason (templateId:2.16.840.1.113883.10.20.22.4.53) (CONF:15542). 24. MAY contain zero or more [0..*] precondition (CONF:8869) such that it a. SHALL contain exactly one [1..1] @typeCode="PRCN" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8870). b. SHALL contain exactly one [1..1] Precondition for Substance Administration (templateId:2.16.840.1.113883.10.20.22.4.25) (CONF:15548). Page 380 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 187: Immunization activity example ... ... ... 6.35 Immunization Medication Information [manufacturedProduct: templateId 2.16.840.1.113883.10.20.22.4.54(open)] Table 189: Immunization Medication Information Contexts Used By: Contains Entries: Immunization Activity Medication Dispense Medication Supply Order HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 381 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. The Immunization Medication Information represents product information about the immunization substance. The vaccine manufacturer and vaccine lot number are typically recorded in the medical record and should be included if known. 34 Table 190: Immunization Medication Information Constraints Overview Name XPath Card. Green Immunization Medication Information manufacturedProduct[templateId/@root = '2.16.840.1.113883.10.20.22.4.54'] SHALL templateId 1..1 SHALL 1..1 SHALL 10499 0..* MAY 9005 1..1 SHALL 9006 1..1 SHALL 9007 originalText 0..1 SHOULD 9008 reference 0..1 SHOULD 15555 @value 0..1 SHOULD 15556 translation 0..* MAY lotNumberText 0..1 SHOULD 9014 0..1 SHOULD 9012 manufactured Material lotNumber drug Manufacturer CONF# 1..1 id freeText ProductName Data Type @classCode @root codedProduct Name Verb code manufacturer Organization 9002 SET< II> SET< PQR > Fixed Value 2.16.840.1.113883.5.11 0 (RoleClass) = MANU 9004 2.16.840.1.113883.10.2 0.22.4.54 2.16.840.1.113883.3.88 .12.80.22 (Vaccine Administered Value Set) 9011 1. SHALL contain exactly one [1..1] @classCode="MANU" (CodeSystem: RoleClass 2.16.840.1.113883.5.110 STATIC) (CONF:9002). 2. SHALL contain exactly one [1..1] templateId (CONF:9004) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.54" (CONF:10499). 3. MAY contain zero or more [0..*] id (CONF:9005). 4. SHALL contain exactly one [1..1] manufacturedMaterial (CONF:9006). a. This manufacturedMaterial SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Vaccine Administered 34 Vaccine Administration Guidelines. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/D/vacc_admin. pdf Page 382 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Value Set 2.16.840.1.113883.3.88.12.80.22 DYNAMIC (CONF:9007). i. This code SHOULD contain zero or one [0..1] originalText (CONF:9008). 1. The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:15555). a. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15556). i. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15557). Translations can be used to represent generic product name, packaged product code, etc. ii. This code MAY contain zero or more [0..*] translation (CONF:9011). b. This manufacturedMaterial SHOULD contain zero or one [0..1] lotNumberText (CONF:9014). 5. SHOULD contain zero or one [0..1] manufacturerOrganization (CONF:9012). Table 191: Vaccine Administered (Hepatitis B) Value Set (excerpt) Value Set: Vaccine Administered Value Set 2.16.840.1. 113883.3.88.12.80.22 DYNAMIC Code System(s): Vaccines administered (CVX) 2.16.840.1.113883.12.292 http://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.113883.12.292 Code Code System Print Name 82 CVX adenovirus vaccine, NOS 54 CVX adenovirus vaccine, type 4, live, oral 55 CVX adenovirus vaccine, type 7, live, oral 24 CVX anthrax vaccine … HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 383 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 188: Immunization medication information example Tetanus and diphtheria toxoids - preservative free 6.36 Immunization Refusal Reason [observation: templateId 2.16.840.1.113883.10.20.22.4.53(open)] Table 192: Immunization Refusal Reason Contexts Used By: Contains Entries: Immunization Activity The Immunization Refusal Reason Observation documents the rationale for the patient declining an immunization. Table 193: Immunization Refusal Reason Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.53'] @classCode 1..1 SHALL 8991 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 8992 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL id 1..* SHALL II 8994 code 1..1 SHALL CD 8995 2.16.840.1.113883.1.11.19717 (No Immunization Reason Value Set) statusCode 1..1 SHALL CS 8996 2.16.840.1.113883.5.14 (ActStatus) = completed @root SET 8993 10500 2.16.840.1.113883.10.20.22.4.53 Page 384 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8991). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:8992). 3. SHALL contain exactly one [1..1] templateId (CONF:8993) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.53" (CONF:10500). 4. SHALL contain at least one [1..*] id (CONF:8994). 5. SHALL contain exactly one [1..1] code, where the @code SHALL be selected from ValueSet No Immunization Reason Value Set 2.16.840.1.113883.1.11.19717 DYNAMIC (CONF:8995). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:8996). Table 194: No Immunization Reason Value Set Value Set: No Immunization Reason Value Set 2.16.840.1.113883.1.11.19717 DYNAMIC Code System(s): ActReason 2.16.840.1.113883.5.8 Code Code System Print Name IMMUNE ActReason Immunity MEDPREC ActReason Medical precaution OSTOCK ActReason Out of stock PATOBJ ActReason Patient objection PHILISOP ActReason Philosophical objection RELIG ActReason Religious objection VACEFF ActReason Vaccine efficacy concerns VACSAF ActReason Vaccine safety concerns Figure 189: Immunization refusal reason HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 385 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.37 Indication [observation: templateId 2.16.840.1.113883.10.20.22.4.19 (open)] Table 195: Indication Contexts Used By: Contains Entries: Encounter Activities (optional) Procedure Indications Section (optional) Immunization Activity (optional) Procedure Activity Act (optional) Procedure Activity Observation (optional) Procedure Activity Procedure (optional) Medication Activity (optional) The Indication Observation documents the rationale for an activity. It can do this with the id element to reference a problem recorded elsewhere in the document or with a code and value to record the problem type and problem within the Indication. For example, the indication for a prescription of a painkiller might be a headache that is documented in the Problems Section. Table 196: Indication Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.19'] @classCode 1..1 SHALL 7480 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 7481 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL @root SET 7482 1..1 SHALL 10502 id 1..1 SHALL 7483 2.16.840.1.113883.10.20.22.4.19 code 1..1 SHALL 16886 2.16.840.1.113883.3.88.12.3221.7.2 (Problem Type) statusCode 1..1 SHALL 7487 2.16.840.1.113883.5.14 (ActStatus) = completed effectiveTime 0..1 SHOULD TS or IVL 7488 value 0..1 SHOULD CD 7489 0..1 MAY 15990 0..1 SHOULD 15985 @nullFlavor @code 2.16.840.1.113883.3.88.12.3221.7.4 (Problem) 1. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7480). Page 386 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7481). 3. SHALL contain exactly one [1..1] templateId (CONF:7482) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.19" (CONF:10502). 4. SHALL contain exactly one [1..1] id (CONF:7483). a. Set the observation/id equal to an ID on the problem list to signify that problem as an indication (CONF:16885). 5. SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type 2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 (CONF:16886). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:7487). 7. SHOULD contain zero or one [0..1] effectiveTime (CONF:7488). 8. SHOULD contain zero or one [0..1] value with @xsi:type="CD" (CONF:7489). a. The value, if present, MAY contain zero or one [0..1] @nullFlavor (CONF:15990). i. If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and the other code SHOULD be placed in the translation element (CONF:15991). b. The value, if present, SHOULD contain zero or one [0..1] @code (ValueSet: Problem 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC) (CONF:15985). Figure 190: Indication entry example HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 387 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.38 Instructions [act: templateId 2.16.840.1.113883.10.20.22.4.20(open)] Table 197: Instructions Contexts Used By: Contains Entries: Medication Supply Order Medication Activity Procedure Activity Procedure Procedure Activity Observation Procedure Activity Act Immunization Activity Instructions Section Plan of Care Section The Instructions template can be used in several ways, such as to record patient instructions within a Medication Activity or to record fill instructions within a supply order. The act/code defines the type of instruction. Though not defined in this template, a Vaccine Information Statement (VIS) document could be referenced through act/reference/externalDocument, and patient awareness of the instructions can be represented with the generic participant and the participant/awarenessCode. Table 198: Instructions Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.20'] @classCode 1..1 SHALL 7391 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 7392 2.16.840.1.113883.5.1001 (ActMood) = INT templateId 1..1 SHALL 1..1 SHALL code 1..1 SHALL text 0..1 SHOULD 7395 reference 1..1 SHOULD 15577 @value 1..1 SHOULD 15578 1..1 SHALL 7396 @root statusCode SET CE 7393 10503 2.16.840.1.113883.10.20.22.4.20 7394 2.16.840.1.113883.11.20.9.34 (Patient Education) 2.16.840.1.113883.5.14 (ActStatus) = completed 1. SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7391). 2. SHALL contain exactly one [1..1] @moodCode="INT" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7392). 3. SHALL contain exactly one [1..1] templateId (CONF:7393) such that it Page 388 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.20" (CONF:10503). 4. SHALL contain exactly one [1..1] code with @xsi:type="CE", where the @code SHOULD be selected from ValueSet Patient Education 2.16.840.1.113883.11.20.9.34 DYNAMIC (CONF:7394). 5. SHOULD contain zero or one [0..1] text (CONF:7395). a. The text, if present, SHOULD contain exactly one [1..1] reference (CONF:15577). i. This reference SHOULD contain exactly one [1..1] @value (CONF:15578). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15579). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:7396). Figure 191: Instructions entry example Patient may have low grade fever, mild joint pain and injection area tenderness . Table 199: Patient Education Value Set Value Set: Patient Education 2.16.840.1.113883.11.20.9.34 DYNAMIC Code System(s): SNOMED CT 2.16.840.1.113883.6.96 Description: Limited to terms descending from the Education (409073007) hierarchy. Code system browser: https://uts.nlm.nih.gov/snomedctBrowser.html Code Code System Print Name 311401005 SNOMED CT Patient Education 171044003 SNOMED CT Immunization Education 243072006 SNOMED CT Cancer Education … HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 389 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.39 Medication Activity [substanceAdministration: templateId 2.16.840.1.113883.10.20.22.4.16(open)] Table 200: Medication Activity Contexts Used By: Contains Entries: Reaction Observation Medications Section (entries required) Discharge Medication Admission Medication Medications Section (entries optional) Procedure Activity Procedure Anesthesia Section Medications Administered Section Procedure Activity Observation Procedure Activity Act Drug Vehicle Indication Instructions Medication Dispense Medication Information Medication Supply Order Precondition for Substance Administration Reaction Observation A medication activity describes substance administrations that have actually occurred (e.g. pills ingested or injections given) or are intended to occur (e.g. "take 2 tablets twice a day for the next 10 days"). Medication activities in "INT" mood are reflections of what a clinician intends a patient to be taking. Medication activities in "EVN" mood reflect actual use. Medication timing is complex. This template requires that there be a substanceAdministration/effectiveTime valued with a time interval, representing the start and stop dates. Additional effectiveTime elements are optional, and can be used to represent frequency and other aspects of more detailed dosing regimens. Table 201: Medication Activity Constraints Overview Name XPath Card. Verb Data Type CONF # Fixed Value Green Medication Activity substanceAdministration[templateId/@root = '2.16.840.1.113883.10.20.22.4.16'] @classCode 1..1 SHALL 7496 2.16.840.1.113883.5.6 (HL7ActClass) = SBADM @moodCode 1..1 SHALL 7497 2.16.840.1.113883.11.20. 9.18 (MoodCodeEvnInt) templateId 1..1 SHALL 1..1 SHALL 10504 id 1..* SHALL 7500 delivery Method code 0..1 MAY 7506 freeTextSig text 0..1 SHOULD 7501 @root SET< II> 7499 2.16.840.1.113883.10.20. 22.4.16 Page 390 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb Data Type CONF # reference 0..1 SHOULD 15977 @value 0..1 SHOULD 15978 statusCode 1..1 SHALL 7507 effectiveTime 1..1 SHALL TS or IVL< TS> 7508 indicate Medication Started low 1..1 SHALL TS 7511 indicate Medication Stopped high 1..1 SHALL TS 7512 effectiveTime 0..1 SHOULD TS or IVL< TS> 7513 administrationTiming @operator 1..1 SHALL repeatNumber 0..1 MAY route routeCode 0..1 MAY site approachSiteCode 0..1 MAY dose doseQuantity 0..1 SHOULD 0..1 SHOULD 0..1 MAY 1..1 SHALL maxDoseQuantity 0..1 MAY administrationUni tCode 0..1 MAY 7519 1..1 SHALL 7520 1..1 SHALL 16085 0..1 MAY 7522 @unit rateQuantity @unit dose Restriction product Form medication Information consumable 9106 IVL Fixed Value A 7555 7514 2.16.840.1.113883.3.88.1 2.3221.8.7 (Medication Route FDA Value Set) SET< CD> 7515 2.16.840.1.113883.3.88.1 2.3221.8.9 (Body Site Value Set) IVL< PQ> 7516 7526 IVL< PQ> 7517 7525 RTO< PQ, PQ> 2.16.840.1.113883.1.11.1 2839 (UCUM Units of Measure (case sensitive)) = 1 2.16.840.1.113883.1.11.1 2839 (UCUM Units of Measure (case sensitive)) = 1 7518 2.16.840.1.113883.3.88.1 2.3221.8.11 (Medication Product Form) manufacturedPro duct performer HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 391 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name XPath vehicle Verb 0..* MAY 7523 @typeCode 1..1 SHALL 7524 participantRole 1..1 SHALL 16086 entryRelationship participant indication patient Instructions order Information fulfillment Instructions reaction Card. Data Type CONF # Fixed Value 2.16.840.1.113883.5.90 (HL7ParticipationType) = CSM 0..* MAY 7536 @typeCode 1..1 SHALL 7537 observation 1..1 SHALL 16087 0..1 MAY 7539 @typeCode 1..1 SHALL 7540 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ @inversionInd 1..1 SHALL 7542 true act 1..1 SHALL 16088 0..1 MAY 7543 @typeCode 1..1 SHALL 7547 supply 1..1 SHALL 16089 0..* MAY 7549 @typeCode 1..1 SHALL 7553 supply 1..1 SHALL 16090 0..1 MAY 7552 @typeCode 1..1 SHALL 7544 observation 1..1 SHALL 16091 precondition 0..* MAY 7546 @typeCode 1..1 SHALL 7550 criterion 1..1 SHALL 16092 entryRelationship entryRelationship entryRelationship entryRelationship 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = CAUS 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = PRCN 1. SHALL contain exactly one [1..1] @classCode="SBADM" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7496). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 201104-03 (CONF:7497). Page 392 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 3. SHALL contain exactly one [1..1] templateId (CONF:7499) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.16" (CONF:10504). 4. SHALL contain at least one [1..*] id (CONF:7500). 5. MAY contain zero or one [0..1] code (CONF:7506). 6. SHOULD contain zero or one [0..1] text (CONF:7501). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15977). i. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15978). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15979). 7. SHALL contain exactly one [1..1] statusCode (CONF:7507). 8. SHALL contain exactly one [1..1] effectiveTime (CONF:7508) such that it a. SHALL contain exactly one [1..1] low (CONF:7511). b. SHALL contain exactly one [1..1] high (CONF:7512). 9. SHOULD contain zero or one [0..1] effectiveTime (CONF:7513) such that it a. SHALL contain exactly one [1..1] @operator="A" (CONF:9106). b. SHALL contain exactly one [1..1] @xsi:type=”PIVL_TS” or “EIVL_TS” (CONF:9105). 10. MAY contain zero or one [0..1] repeatNumber (CONF:7555). a. In "INT" (intent) mood, the repeatNumber defines the number of allowed administrations. For example, a repeatNumber of "3" means that the substance can be administered up to 3 times. In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a repeatNumber of "3" in a substance administration event means that the current administration is the 3rd in a series (CONF:16877). 11. MAY contain zero or one [0..1] routeCode, which SHALL be selected from ValueSet Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC (CONF:7514). 12. MAY contain zero or one [0..1] approachSiteCode, where the @code SHALL be selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:7515). 13. SHOULD contain zero or one [0..1] doseQuantity (CONF:7516). a. The doseQuantity, if present, SHOULD contain zero or one [0..1] @unit="1", which SHALL be selected from ValueSet UCUM Units of Measure (case sensitive) 2.16.840.1.113883.1.11.12839 DYNAMIC (CONF:7526). b. Pre-coordinated consumable: If the consumable code is a precoordinated unit dose (e.g. "metoprolol 25mg tablet") then doseQuantity is a unitless number that indicates the number of products given per administration (e.g. "2", meaning 2 x "metoprolol 25mg tablet") (CONF:16878). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 393 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. c. Not pre-coordinated consumable: If the consumable code is not precoordinated (e.g. is simply "metoprolol"), then doseQuantity must represent a physical quantity with @unit, e.g. "25" and "mg", specifying the amount of product given per administration (CONF:16879). 14. MAY contain zero or one [0..1] rateQuantity (CONF:7517). a. The rateQuantity, if present, SHALL contain exactly one [1..1] @unit="1", which SHALL be selected from ValueSet UCUM Units of Measure (case sensitive) 2.16.840.1.113883.1.11.12839 DYNAMIC (CONF:7525). 15. MAY contain zero or one [0..1] maxDoseQuantity (CONF:7518). 16. MAY contain zero or one [0..1] administrationUnitCode, which SHALL be selected from ValueSet Medication Product Form 2.16.840.1.113883.3.88.12.3221.8.11 DYNAMIC (CONF:7519). 17. SHALL contain exactly one [1..1] consumable (CONF:7520). a. This consumable SHALL contain exactly one [1..1] Medication Information (templateId:2.16.840.1.113883.10.20.22.4.23) (CONF:16085). 18. MAY contain zero or one [0..1] performer (CONF:7522). 19. MAY contain zero or more [0..*] participant (CONF:7523) such that it a. SHALL contain exactly one [1..1] @typeCode="CSM" (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:7524). b. SHALL contain exactly one [1..1] Drug Vehicle (templateId:2.16.840.1.113883.10.20.22.4.24) (CONF:16086). 20. MAY contain zero or more [0..*] entryRelationship (CONF:7536) such that it a. SHALL contain exactly one [1..1] @typeCode="RSON" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7537). b. SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:16087). 21. MAY contain zero or one [0..1] entryRelationship (CONF:7539) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7540). b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7542). c. SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:16088). 22. MAY contain zero or one [0..1] entryRelationship (CONF:7543) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7547). b. SHALL contain exactly one [1..1] Medication Supply Order (templateId:2.16.840.1.113883.10.20.22.4.17) (CONF:16089). Page 394 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 23. MAY contain zero or more [0..*] entryRelationship (CONF:7549) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7553). b. SHALL contain exactly one [1..1] Medication Dispense (templateId:2.16.840.1.113883.10.20.22.4.18) (CONF:16090). 24. MAY contain zero or one [0..1] entryRelationship (CONF:7552) such that it a. SHALL contain exactly one [1..1] @typeCode="CAUS" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7544). b. SHALL contain exactly one [1..1] Reaction Observation (templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:16091). 25. MAY contain zero or more [0..*] precondition (CONF:7546) such that it a. SHALL contain exactly one [1..1] @typeCode="PRCN" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7550). b. SHALL contain exactly one [1..1] Precondition for Substance Administration (templateId:2.16.840.1.113883.10.20.22.4.25) (CONF:16092). 26. Medication Activity SHOULD include doseQuantity OR rateQuantity (CONF:7529). Table 202: MoodCodeEvnInt Value Set Value Set: MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 Code System(s): ActMood 2.16.840.1.113883.5.1001 Description: Subset of HL7 ActMood codes, constrained to represent event (EVN) and intent (INT) moods Code Code System Print Name EVN ActMood Event INT ActMood Intent HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 395 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 203: Medication Route FDA Value Set (excerpt) Value Set: Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC Code System(s): National Cancer Institute (NCI) Thesaurus 2.16.840.1.113883.3.26.1.1 Description: This indicates the method for the medication received by the individual (e.g., by mouth, intravenously, topically, etc.). NCI concept code for route of administration: C38114 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling /ucm162034.htm Code Code System Print Name C38229 INTRACAUDAL C38276 NCI Thesaurus NCI Thesaurus C38288 NCI Thesaurus ORAL C38295 NCI Thesaurus RECTAL INTRAVENOUS … Table 204: Body Site Value Set (excerpt) Value Set: Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC Code System(s): SNOMED CT 2.16.840.1.113883.6.96 Description: Contains values descending from the SNOMED CT® Anatomical Structure (91723000) hierarchy or Acquired body structure (body structure) (280115004) or Anatomical site notations for tumor staging (body structure) (258331007) or Body structure, altered from its original anatomical structure (morphologic abnormality) (118956008) or Physical anatomical entity (body structure) (91722005) This indicates the anatomical site. http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html Code Code System Print Name 361316009 SNOMED CT entire embryonic artery 38033009 SNOMED CT amputation stump 9550003 SNOMED CT bronchogenic cyst 302509004 SNOMED CT heart … Page 396 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 205: Medication Product Form Value Set (excerpt) Value Set: Medication Product Form 2.16.840.1.113883.3.88.12.3221.8.11 DYNAMIC Code System(s): National Cancer Institute (NCI) Thesaurus 2.16.840.1.113883.3.26.1.1 Description: This is the physical form of the product as presented to the individual. For example: tablet, capsule, liquid or ointment. http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling /ucm162038.htm Code Code System Print Name C42887 NCI Thesaurus AEROSOL C42909 NCI Thesaurus GRANULE, EFFERVESCENT C42998 NCI Thesaurus TABLET … Table 206: Unit of Measure Value Set (excerpt) Value Set: UCUM Units of Measure (case sensitive) 2.16.840.1.113883.1.11.12839 DYNAMIC Code System(s): Unified Code for Units of Measure (UCUM) 2.16.840.1.113883.6.8 Description: UCUM codes include all units of measures being contemporarily used in international science, engineering, and business. The purpose is to facilitate unambiguous electronic communication of quantities together with their units. The focus is on electronic communication, as opposed to communication between humans. http://www.regenstrief.org/medinformatics/ucum Code Code System Print Name mmol/kg UCUM MilliMolesPerKiloGram fL UCUM FemtoLiter ug/mL UCUM MicroGramsPerMilliLiter … Figure 192: Medication activity example HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 397 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. ... ... ... ... ... ... Page 398 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 ... ... 6.40 Medication Dispense [supply: templateId 2.16.840.1.113883.10.20.22.4.18(open)] Table 207: Medication Dispense Contexts Used By: Contains Entries: Medication Activity Immunization Activity Immunization Medication Information Medication Information Medication Supply Order This template records the act of supplying medications (i.e., dispensing). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 399 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 208: Medication Dispense Constraints Overview Name XPath Card. Verb Data Type CONF # Green Medication Dispense supply[templateId/@root = '2.16.840.1.113883.10.20.22.4.18'] Fixed Value @classCode 1..1 SHALL 7451 2.16.840.1.113883.5.6 (HL7ActClass) = SPLY @moodCode 1..1 SHALL 7452 2.16.840.1.113883.5.100 1 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10505 id 1..* SHALL 7454 statusCode 1..1 SHALL 7455 dispense Date effectiveTime 0..1 SHOULD TS or IVL 7456 fillNumber repeatNumber 0..1 SHOULD IVL 7457 quantity Dispensed quantity 0..1 SHOULD 7458 product 0..1 MAY 7459 1..1 SHALL 15607 0..1 MAY 9331 1..1 SHALL 15608 0..1 MAY 7461 1..1 SHALL 7467 0..1 SHOULD 0..1 MAY 7473 @typeCode 1..1 SHALL 7474 supply 1..1 SHALL 15606 @root prescriptio nNumber manufactured Product product manufactured Product performer provider assignedEntity addr order Information entryRelationship SET SET 7453 2.16.840.1.113883.10.20 .22.4.18 2.16.840.1.113883.3.88. 12.80.64 (Medication Fill Status) 7468 2.16.840.1.113883.5.100 2 (HL7ActRelationshipType) = REFR 1. SHALL contain exactly one [1..1] @classCode="SPLY" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7451). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7452). 3. SHALL contain exactly one [1..1] templateId (CONF:7453) such that it Page 400 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.18" (CONF:10505). 4. SHALL contain at least one [1..*] id (CONF:7454). 5. SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet Medication Fill Status 2.16.840.1.113883.3.88.12.80.64 DYNAMIC (CONF:7455). 6. SHOULD contain zero or one [0..1] effectiveTime (CONF:7456). 7. SHOULD contain zero or one [0..1] repeatNumber (CONF:7457). a. In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a repeatNumber of "3" in a dispense act means that the current dispensation is the 3rd (CONF:16876). 8. SHOULD contain zero or one [0..1] quantity (CONF:7458). 9. MAY contain zero or one [0..1] product (CONF:7459) such that it a. SHALL contain exactly one [1..1] Medication Information (templateId:2.16.840.1.113883.10.20.22.4.23) (CONF:15607). 10. MAY contain zero or one [0..1] product (CONF:9331) such that it a. SHALL contain exactly one [1..1] Immunization Medication Information (templateId:2.16.840.1.113883.10.20.22.4.54) (CONF:15608). 11. MAY contain zero or one [0..1] performer (CONF:7461). a. The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:7467). i. This assignedEntity SHOULD contain zero or one [0..1] addr (CONF:7468). 1. The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10565). 12. MAY contain zero or one [0..1] entryRelationship (CONF:7473) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7474). b. SHALL contain exactly one [1..1] Medication Supply Order (templateId:2.16.840.1.113883.10.20.22.4.17) (CONF:15606). 13. A supply act SHALL contain one product/Medication Information or one product/Immunization Medication Information template (CONF:9333). Table 209: Medication Fill Status Value Set Value Set: Medication Fill Status 2.16.840.1.113883.3.88.12.80.64 DYNAMIC Code System: ActStatus 2.16.840.1.113883.5.14 Code Code System Print Name aborted ActStatus Aborted completed ActStatus Completed HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 401 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 193: Medication dispense example 6.41 Medication Information [manufacturedProduct: templateId 2.16.840.1.113883.10.20.22.4.23(open)] Table 210: Medication Information Contexts Used By: Contains Entries: Medication Supply Order Medication Dispense Medication Activity The medication can be recorded as a precoordinated product strength, product form, or product concentration (e.g., "metoprolol 25mg tablet", "amoxicillin 400mg/5mL suspension"); or not pre-coordinated (e.g., "metoprolol product"). Page 402 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 211: Medication Information Constraints Overview Name XPath Card. Green Medication Information manufacturedProduct[templateId/@root = '2.16.840.1.113883.10.20.22.4.23'] SHALL templateId 1..1 SHALL 1..1 SHALL 10506 0..* MAY 7410 1..1 SHALL 7411 1..1 SHALL 7412 originalText 0..1 SHOULD 7413 reference 0..1 SHOULD 15986 @value 0..1 SHOULD 15987 translation 0..* MAY Manufacturer Organization 0..1 MAY manufactured Material codedBrand Name drug Manufacturer CONF # 1..1 id freeText ProductName Data Type @classCode @root codedProduct Name Verb code 7408 SET< II> SET< PQR> Fixed Value 2.16.840.1.113883.5.110 (RoleClass) = MANU 7409 2.16.840.1.113883.10.20.2 2.4.23 2.16.840.1.113883.3.88.12. 80.17 (Medication Clinical Drug) 7414 7416 1. SHALL contain exactly one [1..1] @classCode="MANU" (CodeSystem: RoleClass 2.16.840.1.113883.5.110) (CONF:7408). 2. SHALL contain exactly one [1..1] templateId (CONF:7409) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.23" (CONF:10506). 3. MAY contain zero or more [0..*] id (CONF:7410). 4. SHALL contain exactly one [1..1] manufacturedMaterial (CONF:7411). a. This manufacturedMaterial SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Medication Clinical Drug 2.16.840.1.113883.3.88.12.80.17 DYNAMIC (CONF:7412). i. This code SHOULD contain zero or one [0..1] originalText (CONF:7413). 1. The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:15986). a. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15987). i. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 403 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. approach defined in CDA Release 2, section 4.3.5.1) (CONF:15988). ii. This code MAY contain zero or more [0..*] translation (CONF:7414). 1. Translations can be used to represent generic product name, packaged product code, etc (CONF:16875). 5. MAY contain zero or one [0..1] manufacturerOrganization (CONF:7416). Figure 194: Medication information example ... ... ... 6.43 Medication Use – None Known (deprecated) [observation: templateId 2.16.840.1.113883.10.20.22.4.29(open)] The recommended approach to stating no known medications is to use the appropriate nullFlavor instead of this template. See "Unknown Information" in Section 1. This template indicates that the subject is not known to be on any medications. 1. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7557). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7558). 3. SHALL contain exactly one [1..1] templateId (CONF:7559) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.29" (CONF:10508). 4. SHALL contain at least one [1..*] id (CONF:7560). 5. SHALL contain exactly one [1..1] code="ASSERTION" (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:7561). 6. MAY contain zero or one [0..1] text (CONF:7565). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 407 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15580). i. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15581). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15582). 7. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:7562). 8. SHOULD contain zero or one [0..1] effectiveTime (CONF:7563). 9. SHALL contain exactly one [1..1] value with @xsi:type="ANY"="182904002" Drug treatment unknown (CodeSystem: SNOMEDCT 2.16.840.1.113883.6.96) (CONF:7564). Figure 196: Medication use – none known example 6.44 Non-Medicinal Supply Activity [supply: templateId 2.16.840.1.113883.10.20.22.4.50(open)] Table 214: Non-Medicinal Supply Activity Contexts Used By: Contains Entries: Medical Equipment Section Functional Status Result Observation (optional) Cognitive Status Problem Observation Cognitive Status Result Observation Functional Status Problem Observation Functional Status Result Observation Product Instance This template records non-medicinal supplies provided, such as medical equipment. Page 408 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 215: Non-Medicinal Supply Activity Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value supply[templateId/@root = '2.16.840.1.113883.10.20.22.4.50'] @classCode 1..1 SHALL 8745 2.16.840.1.113883.5.6 (HL7ActClass) = SPLY @moodCode 1..1 SHALL 8746 2.16.840.1.113883.11.20.9.18 (MoodCodeEvnInt) templateId 1..1 SHALL 1..1 SHALL 10509 id 1..* SHALL 8748 statusCode 1..1 SHALL 8749 effectiveTime 0..1 SHOULD quantity 0..1 SHOULD 8751 participant 0..1 MAY 8752 @typeCode 1..1 SHALL 8754 participantRole 1..1 SHALL 15900 @root SET< II> IVL_T S 8747 2.16.840.1.113883.10.20.22.4.50 15498 2.16.840.1.113883.5.90 (HL7ParticipationType) = PRD 1. SHALL contain exactly one [1..1] @classCode="SPLY" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8745). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 201104-03 (CONF:8746). 3. SHALL contain exactly one [1..1] templateId (CONF:8747) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.50" (CONF:10509). 4. SHALL contain at least one [1..*] id (CONF:8748). 5. SHALL contain exactly one [1..1] statusCode (CONF:8749). 6. SHOULD contain zero or one [0..1] effectiveTime (CONF:15498). a. The effectiveTime, if present, SHOULD contain zero or one [0..1] high (CONF:16867). 7. SHOULD contain zero or one [0..1] quantity (CONF:8751). 8. MAY contain zero or one [0..1] participant (CONF:8752) such that it a. SHALL contain exactly one [1..1] @typeCode="PRD" Product (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8754). b. SHALL contain exactly one [1..1] Product Instance (templateId:2.16.840.1.113883.10.20.22.4.37) (CONF:15900). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 409 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 197: Non-medicinal supply activity example
... 6.45 Number of Pressure Ulcers Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.76 (open)] Table 216: Number of Pressure Ulcers Observation Contexts Used By: Contains Entries: Functional Status Section (optional) This clinical statement enumerates the number of pressure ulcers observed in a particular stage. Table 217: Number of Pressure Ulcers Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.76'] @classCode 1..1 SHALL 14705 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 14706 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 14707 1..1 SHALL 14708 id 1..* SHALL 14709 code 1..1 SHALL 14767 1..1 SHALL 14768 2264892003 statusCode 1..1 SHALL 14714 2.16.840.1.113883.5.14 (ActStatus) = completed effectiveTime 1..1 SHALL 14715 value 1..1 SHALL @root @code INT 2.16.840.1.113883.10.20.22.4.76 14771 Page 410 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb 0..1 MAY 14717 1..1 SHALL 14718 @typeCode 1..1 SHALL 14719 observation 1..1 SHALL 14720 1..1 SHALL 14721 2.16.840.1.113883.5.6 (HL7ActClass) = OBS 1..1 SHALL 14722 2.16.840.1.113883.5.1001 (ActMood) = EVN 1..1 SHALL 14725 2.16.840.1.113883.11.20.9.35 (Pressure Ulcer Stage) author entry Relationship Data Type CONF# @classCode @moodCode value CD Fixed Value 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14705). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14706). 3. SHALL contain exactly one [1..1] templateId (CONF:14707) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.76" (CONF:14708). 4. SHALL contain at least one [1..*] id (CONF:14709). 5. SHALL contain exactly one [1..1] code (CONF:14767). a. This code SHALL contain exactly one [1..1] @code="2264892003" number of pressure ulcers (CONF:14768). 6. SHALL contain exactly one [1..1] statusCode="completed" (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:14714). 7. SHALL contain exactly one [1..1] effectiveTime (CONF:14715). 8. SHALL contain exactly one [1..1] value with @xsi:type="INT" (CONF:14771). 9. MAY contain zero or one [0..1] author (CONF:14717). 10. SHALL contain exactly one [1..1] entryRelationship (CONF:14718). a. This entryRelationship SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14719). b. This entryRelationship SHALL contain exactly one [1..1] observation (CONF:14720). i. This observation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14721). ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14722). iii. This observation SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 411 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. ValueSet Pressure Ulcer Stage 2.16.840.1.113883.11.20.9.35 (CONF:14725). Figure 198: Number of pressure ulcers example 6.46 Plan of Care Activity Act [act: templateId 2.16.840.1.113883.10.20.22.4.39(open)] Table 218: Plan of Care Activity Act Contexts Used By: Contains Entries: Assessment and Plan Section Plan of Care Section This is the generic template for the Plan of Care Activity. Table 219: Plan of Care Activity Act Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.39'] @classCode 1..1 SHALL 8538 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 8539 2.16.840.1.113883.11.20.9.23 (Plan of Care moodCode (Act/Encounter/Procedure)) templateId 1..1 SHALL 1..1 SHALL 1..* SHALL @root id SET 8544 10510 II 2.16.840.1.113883.10.20.22.4.39 8546 Page 412 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 1. SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8538). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30 (CONF:8539). 3. SHALL contain exactly one [1..1] templateId (CONF:8544) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.39" (CONF:10510). 4. SHALL contain at least one [1..*] id (CONF:8546). Table 220: Plan of Care moodCode (Act/Encounter/Procedure) Value Set: Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30 Code System(s): HL7 ActMood 2.16.840.1.113883.5.1001 Code Code System Print Name INT HL7 ActMood Intent ARQ HL7 ActMood Appointment Request PRMS HL7 ActMood Promise PRP HL7 ActMood Proposal RQO HL7 ActMood Request Figure 199: Plan of care activity act example
6.47 Plan of Care Activity Encounter [encounter: templateId 2.16.840.1.113883.10.20.22.4.40(open)] Table 221: Plan of Care Activity Encounter Contexts Used By: Contains Entries: Plan of Care Section This is the template for the Plan of Care Activity Encounter. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 413 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 222: Plan of Care Activity Encounter Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value encounter[templateId/@root = '2.16.840.1.113883.10.20.22.4.40'] @classCode 1..1 SHALL 8564 2.16.840.1.113883.5.6 (HL7ActClass) = ENC @moodCode 1..1 SHALL 8565 2.16.840.1.113883.11.20.9.23 (Plan of Care moodCode (Act/Encounter/Procedure)) templateId 1..1 SHALL 1..1 SHALL 1..* SHALL @root id SET 8566 10511 II 2.16.840.1.113883.10.20.22.4.40 8567 1. SHALL contain exactly one [1..1] @classCode="ENC" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8564). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30 (CONF:8565). 3. SHALL contain exactly one [1..1] templateId (CONF:8566) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.40" (CONF:10511). 4. SHALL contain at least one [1..*] id (CONF:8567). Figure 200: Plan of care activity encounter example 6.48 Plan of Care Activity Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.44(open)] Table 223: Plan of Care Activity Observation Contexts Used By: Contains Entries: Plan of Care Section This is the template for the Plan of Care Activity Observation. Page 414 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 224: Plan of Care Activity Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.44'] @classCode 1..1 SHALL 8581 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 8582 2.16.840.1.113883.11.20.9.25 (Plan of Care moodCode (Observation)) templateId 1..1 SHALL 1..1 SHALL 1..* SHALL @root id SET 8583 10512 II 2.16.840.1.113883.10.20.22.4.44 8584 1. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8581). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Observation) 2.16.840.1.113883.11.20.9.25 STATIC 2011-09-30 (CONF:8582). 3. SHALL contain exactly one [1..1] templateId (CONF:8583) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.44" (CONF:10512). 4. SHALL contain at least one [1..*] id (CONF:8584). Table 225: Plan of Care moodCode (Observation) Value Set Value Set: Plan of Care moodCode (Observation) 2.16.840.1.113883.11.20.9.25 STATIC 201109-30 Code System(s): HL7 ActMood 2.16.840.1.113883.5.1001 Code Code System Print Name INT ActMood Intent GOL ActMood Goal PRMS ActMood Promise PRP ActMood Proposal RQO ActMood Request HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 415 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 201: Plan of care activity observation example
6.49 Plan of Care Activity Procedure [procedure: templateId 2.16.840.1.113883.10.20.22.4.41(open)] Table 226: Plan of Care Activity Procedure Contexts Used By: Contains Entries: Planned Procedure Section Plan of Care Section This is the template for the Plan of Care Activity Procedure. Table 227: Plan of Care Activity Procedure Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value procedure[templateId/@root = '2.16.840.1.113883.10.20.22.4.41'] @classCode 1..1 SHALL 8568 2.16.840.1.113883.5.6 (HL7ActClass) = PROC @moodCode 1..1 SHALL 8569 2.16.840.1.113883.11.20.9.23 (Plan of Care moodCode (Act/Encounter/Procedure)) templateId 1..1 SHALL 1..1 SHALL 1..* SHALL @root id SET 8570 10513 II 2.16.840.1.113883.10.20.22.4.41 8571 1. SHALL contain exactly one [1..1] @classCode="PROC" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8568). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30 (CONF:8569). 3. SHALL contain exactly one [1..1] templateId (CONF:8570) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.41" (CONF:10513). 4. SHALL contain at least one [1..*] id (CONF:8571). Page 416 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 202: Plan of care activity procedure example
6.50 Plan of Care Activity Substance Administration [substanceAdministration: templateId 2.16.840.1.113883.10.20.22.4.42(open)] Table 228: Plan of Care Activity Substance Administration Contexts Used By: Contains Entries: Plan of Care Section This is the template for the Plan of Care Activity Substance Administration Table 229: Plan of Care Activity Substance Administration Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value substanceAdministration[templateId/@root = '2.16.840.1.113883.10.20.22.4.42'] @classCode 1..1 SHALL 8572 2.16.840.1.113883.5.6 (HL7ActClass) = SBADM @moodCode 1..1 SHALL 8573 2.16.840.1.113883.11.20.9.24 (Plan of Care moodCode (SubstanceAdministration/Supply)) templateId 1..1 SHALL 1..1 SHALL 1..* SHALL @root id SET 8574 10514 II 2.16.840.1.113883.10.20.22.4.42 8575 1. SHALL contain exactly one [1..1] @classCode="SBADM" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8572). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (SubstanceAdministration/Supply) 2.16.840.1.113883.11.20.9.24 STATIC 2011-09-30 (CONF:8573). 3. SHALL contain exactly one [1..1] templateId (CONF:8574) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.42" (CONF:10514). 4. SHALL contain at least one [1..*] id (CONF:8575). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 417 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 230: Plan of Care moodCode (SubstanceAdministration/Supply) Value Set Value Set: Plan of Care moodCode (SubstanceAdministration/Supply) 2.16.840.1.113883.11.20.9.24 STATIC 2011-09-30 Code System(s): HL7 ActMood 2.16.840.1.113883.5.1001 Code Code System Print Name INT ActMood Intent PRMS ActMood Promise PRP ActMood Proposal RQO ActMood Request Figure 203: Plan of care activity substance administration example 6.51 Plan of Care Activity Supply [supply: templateId 2.16.840.1.113883.10.20.22.4.43(open)] Table 231: Plan of Care Activity Supply Contexts Used By: Contains Entries: Plan of Care Section This is the template for the Plan of Care Activity Supply. Page 418 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 232: Plan of Care Activity Supply Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value supply[templateId/@root = '2.16.840.1.113883.10.20.22.4.43'] @classCode 1..1 SHALL 8577 2.16.840.1.113883.5.6 (HL7ActClass) = SPLY @moodCode 1..1 SHALL 8578 2.16.840.1.113883.11.20.9.24 (Plan of Care moodCode (SubstanceAdministration/Supply)) templateId 1..1 SHALL 1..1 SHALL 1..* SHALL @root id SET 8579 10515 II 2.16.840.1.113883.10.20.22.4.43 8580 1. SHALL contain exactly one [1..1] @classCode="SPLY" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8577). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (SubstanceAdministration/Supply) 2.16.840.1.113883.11.20.9.24 STATIC 2011-09-30 (CONF:8578). 3. SHALL contain exactly one [1..1] templateId (CONF:8579) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.43" (CONF:10515). 4. SHALL contain at least one [1..*] id (CONF:8580). Figure 204: Plan of care activity supply example 6.52 Policy Activity [act: templateId 2.16.840.1.113883.10.20.22.4.61 (closed)] Table 233: Policy Activity Contexts Used By: Contains Entries: Coverage Activity (required) A policy activity represents the policy or program providing the coverage. The person for whom payment is being provided (i.e., the patient) is the covered party. The subscriber of the policy or program is represented as a participant that is the holder the coverage. The payer is represented as the performer of the policy activity. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 419 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 234: Policy Activity Constraints Overview Name XPath Card. Green Policy Activity act[templateId/@root = '2.16.840.1.113883.10.20.22.4.61'] health InsuranceType Data Type CONF# Fixed Value @classCode 1..1 SHALL 8898 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 8899 2.16.840.1.113883.5.1 001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10516 id 1..* SHALL 8901 code 0..1 SHOULD @code 0..1 SHOULD 15993 2.16.840.1.113883.3.8 8.12.3221.5.2 (Health Insurance Type Value Set) code 0..1 SHOULD 8904 2.16.840.1.113883.3.8 8.12.3221.5.2 (Health Insurance Type Value Set) statusCode 1..1 SHALL 8902 2.16.840.1.113883.5.1 4 (ActStatus) = completed performer 1..1 SHALL 8906 @typeCode 1..1 SHALL 8907 templateId 1..1 SHALL 16808 1..1 SHALL 16809 1..1 SHALL 8908 id 1..* SHALL 8909 code 0..1 SHOULD 8914 0..1 SHALL 15992 0..1 MAY @root resultId Verb @root payer SET< II> CE 8900 2.16.840.1.113883.10. 20.22.4.61 8903 2.16.840.1.113883.5.9 0 (HL7ParticipationType) = PRF 2.16.840.1.113883.10. 20.22.4.87 assignedEntity healthPlan Insurance Information SourceId @code healthPlan Insurance Information SourceAddress addr SET< AD> 2.16.840.1.113883.1.1 1.10416 (HL7FinanciallyRespo nsiblePartyType) 8910 Page 420 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name healthPlan Insurance Information SourcePhone EmailURL XPath telecom Card. Verb Data Type CONF# 0..1 MAY SET< TEL> 8911 0..1 SHOULD 0..1 SHOULD 0..1 SHOULD 8961 1..1 SHALL 16810 1..1 SHALL 16811 0..1 SHOULD 1..1 SHALL 8962 1..1 SHALL 8968 1..1 SHALL 16096 Fixed Value 8912 representedOr ganization healthPlan Insurance Information SourceName guarantorInfor mation name performer templateId @root effectiveDateOf Financial Responsibility time PN IVL< TS> 8913 2.16.840.1.113883.5.9 0 (HL7ParticipationType) = PRF 2.16.840.1.113883.10. 20.22.4.88 8963 assignedEntity code @code financial Responsibility PartyAddress addr 0..1 SHOULD SET< AD> 8964 financial Responsibility PartyPhone EmailURL telecom 0..1 SHOULD SET< TEL> 8965 participant 1..1 SHALL 8916 @typeCode 1..1 SHALL 8917 templateId 1..1 SHALL 16812 1..1 SHALL 16814 0..1 SHOULD IVL< TS> 8918 low 0..1 SHOULD TS 8919 high 0..1 SHOULD TS 8920 1..1 SHALL member Information @root healthPlan CoverageDates time patient 2.16.840.1.113883.5.1 11 (RoleCode) = GUAR 2.16.840.1.113883.5.9 0 (HL7ParticipationType) = COV 2.16.840.1.113883.10. 20.22.4.89 8921 participantRole HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 421 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name XPath memberId patient RelationshipTo Subscriber patientAddress Card. Verb id 1..* SHALL 8922 code 1..1 SHALL 8923 @code 0..1 SHOULD 16078 2.16.840.1.113883.1.1 1.18877 (Coverage Role Type Value Set) code 1..1 SHALL CE 8924 2.16.840.1.113883.1.1 1.18877 (Coverage Role Type Value Set) 0..1 SHOULD SET< AD> 8956 0..1 SHOULD 8932 name 1..1 SHALL 8930 participant 0..1 SHOULD 8934 @typeCode 1..1 SHALL 8935 templateId 1..1 SHALL 16813 1..1 SHALL 16815 0..1 MAY 1..1 SHALL 8936 8937 addr Data Type CONF# Fixed Value playingEntity patientName @root time subscriber Information IVL< TS> 2.16.840.1.113883.10. 20.22.4.90 8938 participantRole subscriberId id 1..* SHALL subscriber Address addr 0..1 SHOULD 1..* SHALL 8939 1..1 SHALL 8940 healthPlan 2.16.840.1.113883.5.9 0 (HL7ParticipationType) = HLD entryRelations hip @typeCode SET< AD> 8925 2.16.840.1.113883.5.1 002 (HL7ActRelationshipTy pe) = REFR 1. SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8898). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:8899). 3. SHALL contain exactly one [1..1] templateId (CONF:8900) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.61" (CONF:10516). This id is a unique identifier for the policy or program providing the coverage 4. SHALL contain at least one [1..*] id (CONF:8901). 5. SHOULD contain zero or one [0..1] code with @xsi:type="CE" (CONF:8903). Page 422 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. The code, if present, SHOULD contain zero or one [0..1] @code (ValueSet: Health Insurance Type Value Set 2.16.840.1.113883.3.88.12.3221.5.2 DYNAMIC) (CONF:15993). b. The code, if present, SHOULD contain zero or one [0..1] code, which SHOULD be selected from ValueSet Health Insurance Type Value Set 2.16.840.1.113883.3.88.12.3221.5.2 DYNAMIC (CONF:8904). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:8902). This performer represents the Payer. 7. SHALL contain exactly one [1..1] performer (CONF:8906) such that it a. SHALL contain exactly one [1..1] @typeCode="PRF" Performer (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8907). b. SHALL contain exactly one [1..1] templateId (CONF:16808) such that it i. contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.87" Payer Performer (CONF:16809). SHALL c. SHALL contain exactly one [1..1] assignedEntity (CONF:8908). i. This assignedEntity SHALL contain at least one [1..*] id (CONF:8909). ii. This assignedEntity SHOULD contain zero or one [0..1] code (CONF:8914). 1. The code, if present, SHALL contain zero or one [0..1] @code (ValueSet: HL7FinanciallyResponsiblePartyType 2.16.840.1.113883.1.11.10416 DYNAMIC) (CONF:15992). iii. This assignedEntity MAY contain zero or one [0..1] addr (CONF:8910). 1. The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10481). iv. This assignedEntity MAY contain zero or one [0..1] telecom (CONF:8911). v. This assignedEntity SHOULD contain zero or one [0..1] representedOrganization (CONF:8912). 1. The representedOrganization, if present, SHOULD contain zero or one [0..1] name (CONF:8913). This performer represents the Guarantor. 8. SHOULD contain zero or one [0..1] performer="PRF" Performer (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8961) such that it a. SHALL contain exactly one [1..1] templateId (CONF:16810) such that it HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 423 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. i. contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.88" Guarantor Performer (CONF:16811). SHALL b. SHOULD contain zero or one [0..1] time (CONF:8963). c. SHALL contain exactly one [1..1] assignedEntity (CONF:8962). i. This assignedEntity SHALL contain exactly one [1..1] code (CONF:8968). 1. This code SHALL contain exactly one [1..1] @code="GUAR" Guarantor (CodeSystem: RoleCode 2.16.840.1.113883.5.111) (CONF:16096). ii. This assignedEntity SHOULD contain zero or one [0..1] addr (CONF:8964). 1. The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10482). iii. This assignedEntity SHOULD contain zero or one [0..1] telecom (CONF:8965). iv. SHOULD include assignedEntity/assignedPerson/name AND/OR assignedEntity/representedOrganization/name (CONF:8967). 9. SHALL contain exactly one [1..1] participant (CONF:8916) such that it a. SHALL contain exactly one [1..1] @typeCode="COV" Coverage target (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8917). b. SHALL contain exactly one [1..1] templateId (CONF:16812) such that it i. contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.89" Covered Party Participant (CONF:16814). SHALL c. SHOULD contain zero or one [0..1] time (CONF:8918). i. The time, if present, SHOULD contain zero or one [0..1] low (CONF:8919). ii. The time, if present, SHOULD contain zero or one [0..1] high (CONF:8920). d. SHALL contain exactly one [1..1] participantRole (CONF:8921). i. This participantRole SHALL contain at least one [1..*] id (CONF:8922). 1. This id is a unique identifier for the covered party member. Implementers SHOULD use the same GUID for each instance of a member identifier from the same health plan (CONF:8984). ii. This participantRole SHALL contain exactly one [1..1] code (CONF:8923). 1. This code SHOULD contain zero or one [0..1] @code (ValueSet: Coverage Role Type Value Set Page 424 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 2.16.840.1.113883.1.11.18877 DYNAMIC) (CONF:16078). 2. This code SHALL contain exactly one [1..1] code with @xsi:type="CE", where the @code SHOULD be selected from ValueSet Coverage Role Type Value Set 2.16.840.1.113883.1.11.18877 DYNAMIC (CONF:8924). iii. This participantRole SHOULD contain zero or one [0..1] addr (CONF:8956). 1. The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10484). iv. This participantRole SHOULD contain zero or one [0..1] playingEntity (CONF:8932). 1. The playingEntity, if present, SHALL contain exactly one [1..1] name (CONF:8930). a. If the member name as recorded by the health plan differs from the patient name as recorded in the registration/medication summary (e.g., due to marriage or for other reasons), then the member name SHALL be recorded in the name element (CONF:8931). 2. If the member date of birth as recorded by the health plan differs from the patient date of birth as recorded in the registration/medication summary, then the member date of birth SHALL be recorded in sdwg:birthTime. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the birthTime element (CONF:8933). When the Subscriber is the patient, the participant element describing the subscriber SHALL NOT be present. This information will be recorded instead in the data elements used to record member information. 10. SHOULD contain zero or one [0..1] participant (CONF:8934) such that it a. SHALL contain exactly one [1..1] @typeCode="HLD" Holder (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8935). b. SHALL contain exactly one [1..1] templateId (CONF:16813) such that it i. contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.90" Policy Holder Participant (CONF:16815). SHALL c. MAY contain zero or one [0..1] time (CONF:8938). d. SHALL contain exactly one [1..1] participantRole (CONF:8936). i. This participantRole SHALL contain at least one [1..*] id (CONF:8937). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 425 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 1. This id is a unique identifier for the subscriber of the coverage (CONF:10120). ii. This participantRole SHOULD contain zero or one [0..1] addr (CONF:8925). 1. The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10483). 11. SHALL contain at least one [1..*] entryRelationship (CONF:8939) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:8940). b. The target of a policy activity with act/entryRelationship/@typeCode="REFR" SHALL be an authorization activity (templateId 2.16.840.1.113883.10.20.1.19) OR an act, with act[@classCode="ACT"] and act[@moodCode="DEF"], representing a description of the coverage plan (CONF:8942). c. A description of the coverage plan SHALL contain one or more act/id, to represent the plan identifier, and an act/text with the name of the plan (CONF:8943). Table 235: Health Insurance Type Value Set (excerpt) Value Set: Health Insurance Type Value Set 2.16.840.1.113883.3.88.12.3221.5.2 DYNAMIC Code System(s): Code ASC X12 2.16.840.1.113883.6.255.1336 The full value set is available in HITSP C80 (see HITSP.org). Code System Print Name 12 ASC X12 Medicare Secondary Working Aged Beneficiary or Spouse with Employer Group Health Plan 13 ASC X12 Medicare Secondary End-Stage Renal Disease Beneficiary in the 12 month coordination period with an employer’s group health plan 14 ASC X12 Medicare Secondary, No-fault Insurance including Auto is Primary … Page 426 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 236: Coverage Type Value Set Value Set: Coverage Role Type Value Set 2.16.840.1.113883.1.11.18877 DYNAMIC Code System(s): Code RoleCode 2.16.840.1.113883.5.111 Code System Print Name FAMDEP RoleCode Family dependent FSTUD RoleCode Full-time student HANDIC RoleCode Handicapped dependent INJ RoleCode Injured plaintiff PSTUD RoleCode Part-time student SELF RoleCode Self SPON RoleCode Sponsored dependent STUD RoleCode Student Table 237: Financially Responsible Party Value Set (excerpt) Value Set: FinanciallyResponsiblePartyType 2.16.840.1.113883.1.11.10416 DYNAMIC Code System(s): Code RoleCode 2.16.840.1.113883.5.110 http://www.hl7.org/memonly/downloads/v3edition.cfm#V32008 Code System Print Name EMP RoleCode employee GUAR RoleCode guarantor INVSBJ RoleCode Investigation Subject COVPTY RoleCode Covered party … Figure 205: Policy activity example HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 427 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 17 Daws Rd. Blue Bell MA 02368 US Mr. Frank A. Everyman 17 Daws Rd. Blue Bell MA 02368 US ... ... HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 429 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.53 Postprocedure Diagnosis [act: templateId 2.16.840.1.113883.10.20.22.4.51 (open)] Table 238: Postprocedure Diagnosis Contexts Used By: Contains Entries: Postprocedure Diagnosis Section (optional) Problem Observation The Postprocedure Diagnosis entry encodes the diagnosis or diagnoses discovered or confirmed during the procedure. Often it is the same as the preprocedure diagnosis or indication. Table 239: Postprocedure Diagnosis Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.51'] @classCode 1..1 SHALL 8756 ACT @moodCode 1..1 SHALL 8757 EVN templateId 1..1 SHALL 16766 1..1 SHALL 16767 2.16.840.1.113883.10.20.22.4.51 code 1..1 SHALL 8758 2.16.840.1.113883.6.1 (LOINC) = 59769-0 entryRelationship 1..* SHALL 8759 @typeCode 1..1 SHALL 8760 observation 1..1 SHALL 15583 @root CE 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1. SHALL contain exactly one [1..1] @classCode="ACT" (CONF:8756). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:8757). 3. SHALL contain exactly one [1..1] templateId (CONF:16766) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.51" (CONF:16767). 4. SHALL contain exactly one [1..1] code="59769-0" Postprocedure Diagnosis with @xsi:type="CE" (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:8758). 5. SHALL contain at least one [1..*] entryRelationship (CONF:8759). a. Such entryRelationships SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:8760). b. Such entryRelationships SHALL contain exactly one [1..1] Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:15583). Page 430 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 206: Postprocedure diagnosis example ... 6.54 Precondition for Substance Administration [precondition: templateId 2.16.840.1.113883.10.20.22.4.25(open)] Table 240: Precondition for Substance Administration Contexts Used By: Contains Entries: Medication Activity Immunization Activity A criterion for administration can be used to record that the medication is to be administered only when the associated criteria are met. Table 241: Precondition for Substance Administration Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value criterion[templateId/@root = '2.16.840.1.113883.10.20.22.4.25'] templateId 1..1 SHALL 1..1 SHALL 10517 code 0..1 SHOULD 16854 text 0..1 MAY 7373 value 0..1 SHOULD @root SET CD 7372 2.16.840.1.113883.10.20.22.4.25 7369 1. SHALL contain exactly one [1..1] templateId (CONF:7372) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.25" (CONF:10517). 2. SHOULD contain zero or one [0..1] code (CONF:16854). 3. MAY contain zero or one [0..1] text (CONF:7373). 4. SHOULD contain zero or one [0..1] value with @xsi:type="CD" (CONF:7369). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 431 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 207: Precondition for substance administration example ... 6.55 Pregnancy Observation [observation: templateId 2.16.840.1.113883.10.20.15.3.8 (open)] Table 242: Pregnancy Observation Contexts Used By: Contains Entries: Social History Section (optional) Estimated Date of Delivery This clinical statement represents current and/or prior pregnancy dates enabling investigators to determine if the subject of the case report was pregnant during the course of a condition. Table 243: Pregnancy Observation Constraints Overview Name XPath Card. Verb Data Type CONF # Fixed Value Green Pregnancy Observation observation[templateId/@root = '2.16.840.1.113883.10.20.15.3.8'] @classCode 1..1 SHALL 451 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 452 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 16768 1..1 SHALL 16868 2.16.840.1.113883.10.20.15.3. 8 code 1..1 SHALL 454 2.16.840.1.113883.5.4 (ActCode) = ASSERTION statusCode 1..1 SHALL 455 2.16.840.1.113883.5.14 (ActStatus) = completed effectiveTime 0..1 SHOULD @root CE TS or IVL< TS> 2018 Page 432 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name pregnancy XPath Card. Verb Data Type CONF # Fixed Value value 1..1 SHALL CD 457 2.16.840.1.113883.6.96 (SNOMED-CT) = 77386006 entryRelationship 0..1 MAY 458 @typeCode 1..1 SHALL 459 observation 1..1 SHALL 15584 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:451). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:452). 3. SHALL contain exactly one [1..1] templateId (CONF:16768) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.15.3.8" (CONF:16868). 4. SHALL contain exactly one [1..1] code="ASSERTION" Assertion with @xsi:type="CE" (CodeSystem: ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:454). 5. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:455). 6. SHOULD contain zero or one [0..1] effectiveTime (CONF:2018). 7. SHALL contain exactly one [1..1] value="77386006" Pregnant with @xsi:type="CD" (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:457). 8. MAY contain zero or one [0..1] entryRelationship (CONF:458) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:459). b. SHALL contain exactly one [1..1] Estimated Date of Delivery (templateId:2.16.840.1.113883.10.20.15.3.1) (CONF:15584). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 433 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 208: Pregnancy observation example ... 6.56 Preoperative Diagnosis [act: templateId 2.16.840.1.113883.10.20.22.4.65 (open)] Table 244: Preoperative Diagnosis Contexts Used By: Contains Entries: Preoperative Diagnosis Section (optional) Problem Observation The Preoperative Diagnosis entry encodes the surgical diagnosis or diagnoses assigned to the patient before the surgical procedure and is the reason for the surgery. The preoperative diagnosis is, in the opinion of the surgeon, the diagnosis that will be confirmed during surgery. Page 434 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 245: Preoperative Diagnosis Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.65'] @classCode 1..1 SHALL 10090 ACT @moodCode 1..1 SHALL 10091 EVN templateId 1..1 SHALL 16770 1..1 SHALL 16771 2.16.840.1.113883.10.20.22.4.65 code 1..1 SHALL 10092 2.16.840.1.113883.6.1 (LOINC) = 10219-4 entryRelationship 1..* SHALL 10093 @typeCode 1..1 SHALL 10094 observation 1..1 SHALL 15605 @root CE 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1. SHALL contain exactly one [1..1] @classCode="ACT" (CONF:10090). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CONF:10091). 3. SHALL contain exactly one [1..1] templateId (CONF:16770) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.65" (CONF:16771). 4. SHALL contain exactly one [1..1] code="10219-4" Preoperative Diagnosis with @xsi:type="CE" (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:10092). 5. SHALL contain at least one [1..*] entryRelationship (CONF:10093). a. Such entryRelationships SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:10094). b. Such entryRelationships SHALL contain exactly one [1..1] Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:15605). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 435 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 209: Preoperative diagnosis example ... 6.57 Pressure Ulcer Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.70 (open)] Table 246: Pressure Ulcer Observation Contexts Used By: Contains Entries: Functional Status Section (optional) The pressure ulcer observation contains details about the pressure ulcer such as the stage of the ulcer, location, and dimensions. If the pressure ulcer is a diagnosis, you may find this on the problem list. An example of how this would appear is in the Problem Section. Table 247: Pressure Ulcer Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.70'] @classCode 1..1 SHALL 14383 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 14384 2.16.840.1.113883.5.1001 (ActMood) = EVN @negationInd 0..1 MAY 14385 templateId 1..1 SHALL 14387 1..1 SHALL 14388 id 1..* SHALL 14389 code 1..1 SHALL 14759 1..1 SHOULD 14760 0..1 SHOULD 14391 0..1 SHOULD 14392 @root @code text reference 2.16.840.1.113883.10.20.22.4.70 2.16.840.1.113883.5.4 (ActCode) = ASSERTION Page 436 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb 1..1 SHALL 15585 statusCode 1..1 SHALL 14394 effectiveTime 1..1 SHALL 14395 value 1..1 SHALL @nullFlavor 0..1 MAY 14397 targetSiteCode 1..* SHOULD 14797 @code 1..1 SHALL 14798 qualifier 1..1 MAY 14799 name 1..1 SHALL 14800 1..1 MAY 14801 1..1 SHALL 14802 @code 1..1 SHOULD 14803 entry Relationship 0..1 SHOULD 14410 @typeCode 1..1 SHALL 14411 observation 1..1 SHALL 14619 1..1 SHALL 14685 2.16.840.1.113883.5.6 (HL7ActClass) = OBS 1..1 SHALL 14686 2.16.840.1.113883.5.1001 (ActMood) = EVN 1..1 SHALL 14620 1..1 SHALL 14621 1..1 SHALL 0..1 SHOULD 14601 @typeCode 1..1 SHALL 14602 observation 1..1 SHALL 14623 1..1 SHALL 14687 2.16.840.1.113883.5.6 (HL7ActClass) = OBS 1..1 SHALL 14688 2.16.840.1.113883.5.1001 (ActMood) = EVN 1..1 SHALL 14624 1..1 SHALL 14625 1..1 SHALL 0..1 SHOULD @value @code value Data Type CD CONF# 14396 @classCode @moodCode code @code value entry Relationship PQ @moodCode @code value entry Relationship PQ 2.16.840.1.113883.5.14 (ActStatus) = completed 2.16.840.1.113883.11.20.9.35 (Pressure Ulcer Stage) 2.16.840.1.113883.11.20.9.36 (Pressure Point ) 2.16.840.1.113883.6.96 (SNOMEDCT) = 272741003 2.16.840.1.113883.11.20.9.37 (TargetSite Qualifiers ) 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 2.16.840.1.113883.6.96 (SNOMEDCT) = 401238003 14622 @classCode code Fixed Value COMP 2.16.840.1.113883.6.96 (SNOMEDCT) = 401239006 14626 14605 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 437 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name XPath Card. Verb @typeCode 1..1 observation Data Type CONF# Fixed Value SHALL 14606 COMP 1..1 SHALL 14627 1..1 SHALL 14689 2.16.840.1.113883.5.6 (HL7ActClass) = OBS 1..1 SHALL 14690 2.16.840.1.113883.5.1001 (ActMood) = EVN 1..1 SHALL 14628 1..1 SHALL 14629 1..1 SHALL @classCode @moodCode code @code value PQ 2.16.840.1.113883.6.96 (SNOMEDCT) = 425094009 14630 1. SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14383). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14384). 3. MAY contain zero or one [0..1] @negationInd (CONF:14385). a. NegationInd="true" SHALL be used to represent that the problem was not observed (CONF:14386). 4. SHALL contain exactly one [1..1] templateId (CONF:14387) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.70" (CONF:14388). 5. SHALL contain at least one [1..*] id (CONF:14389). 6. SHALL contain exactly one [1..1] code (CONF:14759). a. This code SHOULD contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:14760). 7. SHOULD contain zero or one [0..1] text (CONF:14391). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:14392). i. The reference, if present, SHALL contain exactly one [1..1] @value (CONF:15585). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15586). 8. SHALL contain exactly one [1..1] statusCode="completed" (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:14394). 9. SHALL contain exactly one [1..1] effectiveTime (CONF:14395). 10. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Pressure Ulcer Stage 2.16.840.1.113883.11.20.9.35 (CONF:14396). a. This value MAY contain zero or one [0..1] @nullFlavor (CONF:14397). Page 438 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 i. If the stage unknown or the SNOMED code is unknown, @nullFlavor SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and the other code SHOULD be placed in the translation element (CONF:14398). 11. SHOULD contain at least one [1..*] targetSiteCode (CONF:14797). a. Such targetSiteCodes SHALL contain exactly one [1..1] @code, which SHOULD be selected from ValueSet Pressure Point 2.16.840.1.113883.11.20.9.36 (CONF:14798). b. Such targetSiteCodes MAY contain exactly one [1..1] qualifier (CONF:14799). i. This qualifier SHALL contain exactly one [1..1] name (CONF:14800). 1. This name MAY contain exactly one [1..1] @code="272741003" laterality (CodeSystem: SNOMEDCT 2.16.840.1.113883.6.96) (CONF:14801). ii. This qualifier SHALL contain exactly one [1..1] value (CONF:14802). 1. This value SHOULD contain exactly one [1..1] @code, which SHOULD be selected from ValueSet TargetSite Qualifiers 2.16.840.1.113883.11.20.9.37 (CONF:14803). 12. SHOULD contain zero or one [0..1] entryRelationship (CONF:14410) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:14411). b. SHALL contain exactly one [1..1] observation (CONF:14619). i. This observation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14685). ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14686). iii. This observation SHALL contain exactly one [1..1] code (CONF:14620). 1. This code SHALL contain exactly one [1..1] @code="401238003" Length of Wound (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:14621). iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:14622). 13. SHOULD contain zero or one [0..1] entryRelationship (CONF:14601) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" (CONF:14602). b. SHALL contain exactly one [1..1] observation (CONF:14623). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 439 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. i. This observation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14687). ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14688). iii. This observation SHALL contain exactly one [1..1] code (CONF:14624). 1. This code SHALL contain exactly one [1..1] @code="401239006" Width of Wound (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:14625). iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:14626). 14. SHOULD contain zero or one [0..1] entryRelationship (CONF:14605) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" (CONF:14606). b. SHALL contain exactly one [1..1] observation (CONF:14627). i. This observation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14689). ii. This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14690). iii. This observation SHALL contain exactly one [1..1] code (CONF:14628). 1. This code SHALL contain exactly one [1..1] @code="425094009" Depth of Wound (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:14629). iv. This observation SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:14630). Table 248 Pressure Ulcer Stage Value Set Value Set: Pressure Ulcer Stage 2.16.840.1.113883.11.20.9.35 DYNAMIC Code System: SNOMED CT 2.16.840.1.113883.6.96 Descriptions: This value set enumerates the type of a pressure ulcer. Code Code System Print Name 421076008 SNOMED CT Pressure Ulcer Stage 1 420324007 SNOMED CT Pressure Ulcer Stage 2 421927004 SNOMED CT Pressure Ulcer Stage 3 420597008 SNOMED CT Pressure Ulcer Stage 4 421594008 SNOMED CT Nonstageable pressure ulcer Page 440 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 The Pressure Point Value Set contains a list of body structures from the Pressure Ulcer Prevention Domain Analysis Model (DAM), Informative Ballot published May 2011 35by HL7 combined with a list of structures suggested in the DAM currently available on HL7. 36 HL7 is consulting with the National Skin Assessment team to reconcile the DAM. The vocabulary is in review by the International Health Terminology Standards Development Organisation (IHTSDO) Nursing Sig for international standardization. Table 249: Pressure Point Value Set Value Set: Pressure Point 2.16.840.1.113883.11.20.9.36 DYNAMIC Code System: SNOMED CT 2.16.840.1.113883.6.96 Description: This value set represents points on the body that are susceptible to pressure ulcer development Code (CID) Code System Print Name 79951008 SNOMED CT skin of occipital region (body structure) 23747009 SNOMED CT skin structure of chin (body structure) 76552005 SNOMED CT skin structure of shoulder (body structure) 45980000 SNOMED CT skin structure of scapular region of back (body structure) 74757004 SNOMED CT skin structure of elbow (body structure) 51027004 SNOMED CT skin structure of sacral region (body structure) 304037003 SNOMED CT thoracic region back structure (body structure) 286591006 SNOMED CT skin of lumbar region (body structure) 49812005 SNOMED CT skin structure of hip (body structure) 29850006 SNOMED CT iliac crest structure (body structure)* 22180002 SNOMED CT skin structure of buttock (body structure) 63464009 SNOMED CT skin structure of knee (body structure) 84607009 SNOMED CT skin structure of heel (body structure) 67269001 SNOMED CT skin structure of ankle (body structure) 50938007 SNOMED CT skin structure of sacrococcygeal region (body structure) 181512003 SNOMED CT skin of dorsal region (body structure) 1902009 SNOMED CT skin structure of ear (body structure) 36141000 SNOMED CT skin structure of cheek (body structure) 113179006 SNOMED CT skin structure of nose (body structure) 6141000 SNOMED CT skin structure of cheek (body structure) 113179006 SNOMED CT skin structure of nose (body structure) 1797002 SNOMED CT structure of anterior naris (body structure) … *mapped to parent and not to “posterior” iliac crest structure 35 http://wiki.hl7.org/images/b/be/PressureUlcerPreventionDomainAnalysisModel_May2011.pdf Accessed May 2, 2012 36 Domain Analysis Model, HL7 http://pressureulcerpreventionmodel.com/DAM20110325/ Accessed May 2, 2012. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 441 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 250: Target Site Qualifiers Value Set Value Set: TargetSite Qualifiers 2.16.840.1.113883.11.20.9.37 DYNAMIC Code System: SNOMED CT 2.16.840.1.113883.6.96 Code Code System Print Name 255549009 SNOMED CT anterior 7771000 SNOMED CT left 255561001 SNOMED CT medial 255551008 SNOMED CT posterior 24028007 SNOMED CT right Page 442 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 210: Pressure ulcer observation example HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 443 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.58 Problem Concern Act (Condition) [act: templateId 2.16.840.1.113883.10.20.22.4.3(open)] Table 251: Problem Concern Act (Condition) Contexts Used By: Contains Entries: Problem Section (entries optional) Problem Section (entries required) Problem Observation Observations of problems or other clinical statements captured at a point in time are wrapped in a "Concern" act, which represents the ongoing process tracked over time. This allows for binding related observations of problems. For example, the observation of "Acute MI" in 2004 can be related to the observation of "History of MI" in 2006 because they are the same concern. The conformance statements in this section define an outer "problem act" (representing the "Concern") that can contain a nested "problem observation" or other nested clinical statements. Table 252: Problem Concern Act (Condition) Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.3'] @classCode 1..1 SHALL 9024 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 9025 2.16.840.1.113883.5.1001 (ActMood) = EVN id 1..* SHALL II 9026 code 1..1 SHALL CD 9027 1..1 SHALL statusCode 1..1 SHALL effectiveTime 1..1 low high @code 9440 2.16.840.1.113883.5.6 (HL7ActClass) = CONC CS 9029 2.16.840.1.113883.11.20.9.19 (ProblemAct statusCode) SHALL TS or IVL 9030 1..1 SHALL TS 9032 0..1 SHOULD TS 9033 1..* SHALL 9034 @typeCode 1..1 SHALL 9035 observation 1..1 SHALL 15980 entryRelationship 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1. SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9024). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9025). Page 444 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 3. SHALL contain exactly one [1..1] templateId (CONF:16772) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.3" (CONF:16773). 4. SHALL contain at least one [1..*] id (CONF:9026). 5. SHALL contain exactly one [1..1] code (CONF:9027). a. This code SHALL contain exactly one [1..1] @code="CONC" Concern (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9440). 6. SHALL contain exactly one [1..1] statusCode, where the @code SHALL be selected from ValueSet ProblemAct statusCode 2.16.840.1.113883.11.20.9.19 STATIC 2011-09-09 (CONF:9029). The effectiveTime element records the starting and ending times during which the concern was active on the Problem List. 7. SHALL contain exactly one [1..1] effectiveTime (CONF:9030). a. This effectiveTime SHALL contain exactly one [1..1] low (CONF:9032). b. This effectiveTime SHOULD contain zero or one [0..1] high (CONF:9033). 8. SHALL contain at least one [1..*] entryRelationship (CONF:9034) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:9035). b. SHALL contain exactly one [1..1] Problem Observation (2.16.840.1.113883.10.20.22.4.4) (CONF:15980). Figure 211: Problem concern act (condition) example ... HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 445 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.59 Problem Observation [Observation: templateId 2.16.840.1.113883.10.20.22.4.4(open)] Table 253: Problem Observation Contexts Used By: Contains Entries: Hospital Discharge Diagnosis Hospital Admission Diagnosis Procedure Findings Section Postprocedure Diagnosis History of Past Illness Section Complications Section Problem Concern Act (Condition) Functional Status Section Preoperative Diagnosis Age Observation Health Status Observation Problem Status A problem is a clinical statement that a clinician has noted. In health care it is a condition that requires monitoring or diagnostic, therapeutic, or educational action. It also refers to any unmet or partially met basic human need. A Problem Observation is required to be wrapped in an act wrapper in locations such as the Problem Section, Allergies Section, and Hospital Discharge Diagnosis Section, where the type of problem needs to be identified or the condition tracked. A Problem Observation can be a valid "standalone" template instance in cases where a simple problem observation is to be sent. The negationInd attribute, if true, specifies that the problem indicated was observed to not have occurred (which is subtly but importantly different from having not been observed). NegationInd='true' is an acceptable way to make a clinical assertion that something did not occur, for example, "no diabetes". Table 254: Problem Observation Constraints Overview Name XPath Green Problem Observation observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.4'] Verb Data Type CONF# Fixed Value @classCode 1..1 SHALL 9041 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 9042 2.16.840.1.113883.5.1001 (ActMood) = EVN @negationInd 0..1 MAY 10139 templateId 1..1 SHALL 14926 1..1 SHALL 14927 id 1..* SHALL 9043 code 1..1 SHALL 9045 @root problem Card. 2.16.840.1.113883.10.20. 22.4.4 2.16.840.1.113883.3.88.1 Page 446 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb Data Type CONF# Type 2.3221.7.2 (Problem Type) problem Name text problem Date problem Code 0..1 SHOULD 9185 reference 0..1 SHOULD 15587 @value 1..1 SHALL 15588 statusCode 1..1 SHALL 9049 effectiveTime 0..1 SHOULD low 1..1 SHALL 15603 high 0..1 SHOULD 15604 1..1 SHALL @nullFlavor 0..1 MAY 10141 translation 0..* MAY 16749 0..1 MAY 16750 0..1 MAY 9059 @typeCode 1..1 SHALL 9060 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ @inversionInd 1..1 SHALL 9069 true observation 1..1 SHALL 15590 0..1 MAY 9063 @typeCode 1..1 SHALL 9068 observation 1..1 SHALL 15591 0..1 MAY 9067 @typeCode 1..1 SHALL 9064 observation 1..1 SHALL 15592 value @code ageAtOnset problem Status Fixed Value entryRelationship entryRelationship entryRelationship TS or IVL CD 2.16.840.1.113883.5.14 (ActStatus) = completed 9050 9058 2.16.840.1.113883.3.88.1 2.3221.7.4 (Problem) 2.16.840.1.113883.6.3 (ICD10) 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9041). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:9042). 3. MAY contain zero or one [0..1] @negationInd (CONF:10139). a. Use negationInd="true" to indicate that the problem was not observed (CONF:16880). 4. SHALL contain exactly one [1..1] templateId (CONF:14926) such that it HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 447 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.4" (CONF:14927). 5. SHALL contain at least one [1..*] id (CONF:9043). 6. SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type 2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 (CONF:9045). 7. SHOULD contain zero or one [0..1] text (CONF:9185). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15587). i. The reference, if present, SHALL contain exactly one [1..1] @value (CONF:15588). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15589). 8. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:9049). 9. SHOULD contain zero or one [0..1] effectiveTime (CONF:9050). a. The effectiveTime, if present, SHALL contain exactly one [1..1] low (CONF:15603). i. This field represents the onset date (CONF:16882). b. The effectiveTime, if present, SHOULD contain zero or one [0..1] high (CONF:15604). i. This field represents the resolution date (CONF:16883). c. If the problem is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'. Therefore, the existence of an high element within a problem does indicate that the problem has been resolved (CONF:16881). 10. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Problem 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:9058). a. This value MAY contain zero or one [0..1] @nullFlavor (CONF:10141). i. If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and the other code SHOULD be placed in the translation element (CONF:10142). b. This value MAY contain zero or more [0..*] translation (CONF:16749). i. The translation, if present, MAY contain zero or one [0..1] @code (CodeSystem: ICD10 2.16.840.1.113883.6.3) (CONF:16750). 11. MAY contain zero or one [0..1] entryRelationship (CONF:9059) such that it Page 448 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9060). b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:9069). c. SHALL contain exactly one [1..1] Age Observation (templateId:2.16.840.1.113883.10.20.22.4.31) (CONF:15590). 12. MAY contain zero or one [0..1] entryRelationship (CONF:9063) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9068). b. SHALL contain exactly one [1..1] Problem Status (templateId:2.16.840.1.113883.10.20.22.4.6) (CONF:15591). 13. MAY contain zero or one [0..1] entryRelationship (CONF:9067) such that it a. SHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9064). b. SHALL contain exactly one [1..1] Health Status Observation (templateId:2.16.840.1.113883.10.20.22.4.5) (CONF:15592). Figure 212: Problem observation example ... ... HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 449 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. ... Figure 213: Problem observation with specific problem not observed No known problems Figure 214: Problem observation for no known problems Figure 215: NullFlavor example Page 450 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.60 Problem Status [observation: templateId 2.16.840.1.113883.10.20.22.4.6(open)] Table 255: Problem Status Contexts Used By: Contains Entries: Problem Observation The Problem Status records whether the indicated problem is active, inactive, or resolved. Table 256: Problem Status Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.6'] @classCode 1..1 SHALL 7357 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 7358 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL code 1..1 SHALL text 0..1 SHOULD 7362 reference 0..1 SHOULD 15593 @value 1..1 SHALL 15594 statusCode 1..1 SHALL 7364 2.16.840.1.113883.5.14 (ActStatus) = completed value 1..1 SHALL 7365 2.16.840.1.113883.3.88.12.80.68 (HITSPProblemStatus) @root SET CE CD 7359 10518 2.16.840.1.113883.10.20.22.4.6 7361 2.16.840.1.113883.6.1 (LOINC) = 33999-4 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7357). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7358). 3. SHALL contain exactly one [1..1] templateId (CONF:7359) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.6" (CONF:10518). 4. SHALL contain exactly one [1..1] code="33999-4" Status with @xsi:type="CE" (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:7361). 5. SHOULD contain zero or one [0..1] text (CONF:7362). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15593). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 451 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. i. The reference, if present, SHALL contain exactly one [1..1] @value (CONF:15594). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15595). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:7364). 7. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet HITSPProblemStatus 2.16.840.1.113883.3.88.12.80.68 DYNAMIC (CONF:7365). Figure 216: Problem status example 6.61 Procedure Activity Act [act: templateId 2.16.840.1.113883.10.20.22.4.12(open)] Table 257: Procedure Activity Act Contexts Used By: Contains Entries: Procedures Section (entries required) Procedures Section (entries optional) Indication Instructions Medication Activity Service Delivery Location The common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore procedure templates can be represented with various RIM classes: act (e.g., dressing change), observation (e.g., EEG), procedure (e.g. splenectomy). This clinical statement represents any procedure that cannot be classified as an observation or a procedure according to the HL7 RIM. Examples of these Page 452 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 procedures are a dressing change, teaching or feeding a patient or providing comfort measures. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 453 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 258: Procedure Activity Act Constraints Overview Name XPath Card. Verb Data Type CONF# Green Procedure Activity Act act[templateId/@root = '2.16.840.1.113883.10.20.22.4.12'] @classCode 1..1 SHALL 8289 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 8290 2.16.840.1.113883.11.20. 9.18 (MoodCodeEvnInt) templateId 1..1 SHALL 1..1 SHALL 10519 8292 @root SET 8291 procedure Id id 1..* SHALL procedure Type code 1..1 SHALL originalText 0..1 SHOULD 8295 reference 0..1 MAY 15596 @value procedure FreeText Type procedure DateTime procedure Performer Fixed Value CE 8293 0..1 MAY 15597 statusCode 1..1 SHALL 8298 effectiveTime 0..1 SHOULD priorityCode 0..1 MAY 8300 performer 0..* SHOULD 8301 1..1 SHALL 8302 id 1..* SHALL addr 1..1 SHALL SET 8304 telecom 1..1 SHALL SET 8305 represented Organization 0..1 SHOULD 8306 id 0..* SHOULD 8307 name 0..* MAY PN 8308 telecom 1..1 SHALL SET 8310 addr 1..1 SHALL SET 8309 0..* MAY assignedEntity participant TS or IVL 2.16.840.1.113883.10.20. 22.4.12 2.16.840.1.113883.11.20. 9.22 (ProcedureAct statusCode) 8299 2.16.840.1.113883.1.11.1 6866 (ActPriority) 8303 8311 Page 454 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath CONF# Fixed Value SHALL 8312 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = LOC 1..1 SHALL 15599 0..* MAY 8314 @typeCode 1..1 SHALL 8315 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP @inversionInd 1..1 SHALL 8316 true encounter 1..1 SHALL 8317 @classCode 1..1 SHALL 8318 2.16.840.1.113883.5.6 (HL7ActClass) = ENC @moodCode 1..1 SHALL 8319 2.16.840.1.113883.5.1001 (ActMood) = EVN id 1..1 SHALL 8320 entry Relationship 0..1 MAY 8322 @typeCode 1..1 SHALL 8323 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ @inversionInd 1..1 SHALL 8324 true act 1..1 SHALL 15600 0..* MAY 8326 @typeCode 1..1 SHALL 8327 observation 1..1 SHALL 15601 0..1 MAY 8329 1..1 SHALL 8330 1..1 SHALL 15602 @typeCode Card. Verb 1..1 Data Type participantRole entry Relationship entry Relationship entry Relationship @typeCode substance Administration 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 1. SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8289). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 201104-03 (CONF:8290). 3. SHALL contain exactly one [1..1] templateId (CONF:8291) such that it HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 455 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.12" (CONF:10519). 4. SHALL contain at least one [1..*] id (CONF:8292). 5. SHALL contain exactly one [1..1] code with @xsi:type="CE" (CONF:8293). a. This code SHOULD contain zero or one [0..1] originalText (CONF:8295). i. The originalText, if present, MAY contain zero or one [0..1] reference (CONF:15596). 1. The reference, if present, MAY contain zero or one [0..1] @value (CONF:15597). a. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15598). b. This code in a procedure activity observation SHOULD be selected from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) (CONF:8294). 6. SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC (CONF:8298). 7. SHOULD contain zero or one [0..1] effectiveTime (CONF:8299). 8. MAY contain zero or one [0..1] priorityCode, which SHALL be selected from ValueSet ActPriority 2.16.840.1.113883.1.11.16866 DYNAMIC (CONF:8300). 9. SHOULD contain zero or more [0..*] performer (CONF:8301). a. The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8302). i. This assignedEntity SHALL contain at least one [1..*] id (CONF:8303). ii. This assignedEntity SHALL contain exactly one [1..1] addr (CONF:8304). iii. This assignedEntity SHALL contain exactly one [1..1] telecom (CONF:8305). iv. This assignedEntity SHOULD contain zero or one [0..1] representedOrganization (CONF:8306). 1. The representedOrganization, if present, SHOULD contain zero or more [0..*] id (CONF:8307). 2. The representedOrganization, if present, MAY contain zero or more [0..*] name (CONF:8308). 3. The representedOrganization, if present, SHALL contain exactly one [1..1] telecom (CONF:8310). 4. The representedOrganization, if present, SHALL contain exactly one [1..1] addr (CONF:8309). 10. MAY contain zero or more [0..*] participant (CONF:8311). Page 456 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. The participant, if present, SHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8312). b. The participant, if present, SHALL contain exactly one [1..1] Service Delivery Location (templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:15599). 11. MAY contain zero or more [0..*] entryRelationship (CONF:8314). a. The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8315). b. The entryRelationship, if present, SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8316). c. The entryRelationship, if present, SHALL contain exactly one [1..1] encounter (CONF:8317). i. This encounter SHALL contain exactly one [1..1] @classCode="ENC" Encounter (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8318). ii. This encounter SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8319). iii. This encounter SHALL contain exactly one [1..1] id (CONF:8320). 1. Set the encounter ID to the ID of an encounter in another section to signify they are the same encounter (CONF:16849). 12. MAY contain zero or one [0..1] entryRelationship (CONF:8322). a. The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8323). b. The entryRelationship, if present, SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8324). c. The entryRelationship, if present, SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15600). 13. MAY contain zero or more [0..*] entryRelationship (CONF:8326). a. The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8327). b. The entryRelationship, if present, SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15601). 14. MAY contain zero or one [0..1] entryRelationship (CONF:8329). a. The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 457 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8330). b. The entryRelationship, if present, SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15602). Table 259: Procedure Act Status Code Value Set Value Set: ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC Code System(s): ActStatus 2.16.840.1.113883.5.14 Description: A ValueSet of HL7 actStatus codes for use with a procedure activity Code Code System Print Name completed ActStatus Completed active ActStatus Active aborted ActStatus Aborted cancelled ActStatus Cancelled Table 260: Act Priority Value Set Value Set: ActPriority 2.16.840.1.113883.1.11.16866 DYNAMIC Code System(s): Description: ActPriority 2.16.840.1.113883.5.7 A code or set of codes (e.g., for routine, emergency,) specifying the urgency under which the Act happened, can happen, is happening, is intended to happen, or is requested/demanded to happen. Code Code System Print Name A ActPriority ASAP CR ActPriority Callback results CS ActPriority Callback for scheduling CSP ActPriority Callback placer for scheduling CSR ActPriority Contact recipient for scheduling EL ActPriority Elective EM ActPriority Emergency P ActPriority Preoperative PRN ActPriority As needed R ActPriority Routine RR ActPriority Rush reporting S ActPriority Stat T ActPriority Timing critical UD ActPriority Use as directed UR ActPriority Urgent Page 458 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 217: Procedure activity act example 17 Daws Rd. Blue Bell MA 02368 US Good Health Clinic ... ... HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 459 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.62 Procedure Activity Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.13(open)] Table 261: Procedure Activity Observation Contexts Used By: Contains Entries: Procedures Section (entries optional) Procedures Section (entries required) Indication Instructions Medication Activity Service Delivery Location The common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore procedure templates can be represented with various RIM classes: act (e.g., dressing change), observation (e.g., EEG), procedure (e.g. splenectomy). This clinical statement represents procedures that result in new information about the patient that cannot be classified as a procedure according to the HL7 RIM. Examples of these procedures are diagnostic imaging procedures, EEGs and EKGs. Table 262: Procedure Activity Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Green Procedure Activity Observation observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.13'] @classCode 1..1 SHALL 8282 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 8237 2.16.840.1.113883.11.20.9. 18 (MoodCodeEvnInt) templateId 1..1 SHALL 1..1 SHALL 10520 8239 @root SET 8238 procedureId id 1..* SHALL procedure Type code 1..1 SHALL originalText 0..1 SHOULD 8242 reference 0..1 SHOULD 15901 @value 0..1 SHOULD 15902 statusCode 1..1 SHALL 8245 effectiveTime 0..1 SHOULD procedure FreeText Type procedure Fixed Value CE TS or IVL priorityCode 0..1 MAY 8247 value 1..1 SHALL 16846 methodCode 0..1 MAY SET< CE> 8248 targetSiteCode 0..* SHOULD SET< CD> 8250 @code 1..1 SHALL 16071 performer 0..* SHOULD 8251 1..1 SHALL 8252 id 1..* SHALL 8253 addr 1..1 SHALL SET 8254 telecom 1..1 SHALL SET 8255 0..1 SHOULD 8256 id 0..* SHOULD 8257 name 0..* MAY PN 8258 telecom 1..1 SHALL SET 8260 addr 1..1 SHALL SET 8259 0..* MAY 8261 1..1 SHALL 8262 1..1 SHALL 15904 0..* MAY 8264 1..1 SHALL 8265 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 1..1 SHALL 8266 true 1..1 SHALL 8267 @classCode 1..1 SHALL 8268 2.16.840.1.113883.5.6 (HL7ActClass) = ENC @moodCode 1..1 SHALL 8269 2.16.840.1.113883.5.1001 (ActMood) = EVN 2.16.840.1.113883.3.88.12. 3221.8.9 (Body Site Value Set) assignedEntity representedOrg anization participant @typeCode 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = LOC participantRole entryRelations hip @typeCode @inversionInd encounter HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 461 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name XPath Card. Verb 1..1 SHALL 8270 0..1 MAY 8272 1..1 SHALL 8273 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 1..1 SHALL 8274 true 1..1 SHALL 15905 0..* MAY 8276 @typeCode 1..1 SHALL 8277 observation 1..1 SHALL 15906 0..1 MAY 8279 1..1 SHALL 8280 1..1 SHALL 15907 id entryRelations hip @typeCode Data Type CONF# Fixed Value @inversionInd act entryRelations hip entryRelations hip @typeCode 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP substanceAdmi nistration 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8282). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 201104-03 (CONF:8237). 3. SHALL contain exactly one [1..1] templateId (CONF:8238) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.13" (CONF:10520). 4. SHALL contain at least one [1..*] id (CONF:8239). 5. SHALL contain exactly one [1..1] code with @xsi:type="CE" (CONF:8240). a. This code SHOULD contain zero or one [0..1] originalText (CONF:8242). i. The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:15901). 1. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15902). a. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15903). Page 462 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 b. This code in a procedure activity SHOULD be selected from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (CodeSystem: 2.16.840.1.113883.6.12), ICD9 Procedures (CodeSystem: 2.16.840.1.113883.6.4) (CONF:8241). 6. SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC (CONF:8245). 7. SHOULD contain zero or one [0..1] effectiveTime (CONF:8246). 8. MAY contain zero or one [0..1] priorityCode, which SHALL be selected from ValueSet ActPriority 2.16.840.1.113883.1.11.16866 DYNAMIC (CONF:8247). 9. SHALL contain exactly one [1..1] value (CONF:16846). 10. MAY contain zero or one [0..1] methodCode (CONF:8248). a. MethodCode SHALL NOT conflict with the method inherent in Observation / code (CONF:8249). 11. SHOULD contain zero or more [0..*] targetSiteCode (CONF:8250). a. The targetSiteCode, if present, SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:16071). 12. SHOULD contain zero or more [0..*] performer (CONF:8251). a. The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8252). i. This assignedEntity SHALL contain at least one [1..*] id (CONF:8253). ii. This assignedEntity SHALL contain exactly one [1..1] addr (CONF:8254). iii. This assignedEntity SHALL contain exactly one [1..1] telecom (CONF:8255). iv. This assignedEntity SHOULD contain zero or one [0..1] representedOrganization (CONF:8256). 1. The representedOrganization, if present, SHOULD contain zero or more [0..*] id (CONF:8257). 2. The representedOrganization, if present, MAY contain zero or more [0..*] name (CONF:8258). 3. The representedOrganization, if present, SHALL contain exactly one [1..1] telecom (CONF:8260). 4. The representedOrganization, if present, SHALL contain exactly one [1..1] addr (CONF:8259). 13. MAY contain zero or more [0..*] participant (CONF:8261). a. The participant, if present, SHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8262). b. The participant, if present, SHALL contain exactly one [1..1] Service Delivery Location (templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:15904). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 463 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 14. MAY contain zero or more [0..*] entryRelationship (CONF:8264). a. The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="COMP" Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8265). b. The entryRelationship, if present, SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8266). c. The entryRelationship, if present, SHALL contain exactly one [1..1] encounter (CONF:8267). i. This encounter SHALL contain exactly one [1..1] @classCode="ENC" Encounter (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8268). ii. This encounter SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8269). iii. This encounter SHALL contain exactly one [1..1] id (CONF:8270). 1. Set encounter/id to the id of an encounter in another section to signify they are the same encounter (CONF:16847). 15. MAY contain zero or one [0..1] entryRelationship (CONF:8272) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8273). b. SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8274). c. SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15905). 16. MAY contain zero or more [0..*] entryRelationship (CONF:8276) such that it a. SHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8277). b. SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15906). 17. MAY contain zero or one [0..1] entryRelationship (CONF:8279) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8280). b. SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15907). Page 464 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 218: Procedure activity observation example 17 Daws Rd. Blue Bell MA 02368 US Good Health Clinic ... HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 465 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.63 Procedure Activity Procedure [procedure: templateId 2.16.840.1.113883.10.20.22.4.14(open)] Table 263: Procedure Activity Procedure Contexts Used By: Contains Entries: Procedures Section (entries optional) Reaction Observation Procedures Section (entries required) Anesthesia Section Indication Instructions Medication Activity Product Instance Service Delivery Location The common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore procedure templates can be represented with various RIM classes: act (e.g., dressing change), observation (e.g., EEG), procedure (e.g. splenectomy). This clinical statement represents procedures whose immediate and primary outcome (post-condition) is the alteration of the physical condition of the patient. Examples of these procedures are an appendectomy, hip replacement and a creation of a gastrostomy. Table 264: Procedure Activity Procedure Constraints Overview Name XPath Card. Verb Data Type CONF # Green Procedure Activity Procedure procedure[templateId/@root = '2.16.840.1.113883.10.20.22.4.14'] @classCode 1..1 SHALL 7652 2.16.840.1.113883.5.6 (HL7ActClass) = PROC @moodCode 1..1 SHALL 7653 2.16.840.1.113883.11.20. 9.18 (MoodCodeEvnInt) templateId 1..1 SHALL 1..1 SHALL 10521 7655 @root SET< II> 7654 procedure Id id 1..* SHALL procedure Type code 1..1 SHALL originalText 0..1 SHOULD 7658 reference 0..1 SHOULD 15908 @value 0..1 SHOULD 15909 0..1 SHOULD 7659 1..1 SHALL 7661 procedure FreeText Type Fixed Value CE 2.16.840.1.113883.10.20. 22.4.14 7656 reference/@value statusCode 2.16.840.1.113883.11.20. Page 466 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb Data Type CONF # Fixed Value 9.22 (ProcedureAct statusCode) procedure DateTime bodySite effectiveTime 0..1 SHOULD priorityCode 0..1 MAY methodCode 0..1 MAY targetSiteCode 0..* SHOULD 7683 @code 1..1 SHALL 16082 specimen 0..* MAY 7697 1..1 SHALL 7704 0..* SHOULD 7716 0..* SHOULD 7718 1..1 SHALL 7720 id 1..* SHALL addr 1..1 SHALL SET< AD> 7731 telecom 1..1 SHALL SET< TEL> 7732 represented Organization 0..1 SHOULD 7733 id 0..* SHOULD 7734 name 0..* MAY PN 7735 telecom 1..1 SHALL SET< TEL> 7737 addr 1..1 SHALL SET< AD> 7736 0..* MAY 7751 @typeCode 1..1 SHALL 7752 participantRole 1..1 SHALL 15911 0..* MAY 7765 @typeCode 1..1 SHALL 7766 participantRole 1..1 SHALL 15912 entryRelationship 0..* MAY 7768 1..1 SHALL 7769 specimenRole id performer procedure Provider assignedEntity participant participant @typeCode TS or IVL< TS> 7662 7668 SET< CE> 2.16.840.1.113883.1.11.1 6866 (ActPriority) 7670 2.16.840.1.113883.3.88.1 2.3221.8.9 (Body Site Value Set) 7722 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = DEV 2.16.840.1.113883.5.90 (HL7ParticipationType) = LOC 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 467 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name XPath Card. Verb Data Type CONF # Fixed Value = COMP @inversionInd 1..1 SHALL 8009 encounter 1..1 SHALL 7770 @classCode 1..1 SHALL 7771 2.16.840.1.113883.5.6 (HL7ActClass) = ENC @moodCode 1..1 SHALL 7772 2.16.840.1.113883.5.1001 (ActMood) = EVN id 1..1 SHALL 7773 0..1 MAY 7775 @typeCode 1..1 SHALL 7776 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ @inversionInd 1..1 SHALL 7777 true act 1..1 SHALL 15913 0..* MAY 7779 @typeCode 1..1 SHALL 7780 observation 1..1 SHALL 15914 0..1 MAY 7886 1..1 SHALL 7887 1..1 SHALL 15915 entryRelationship entryRelationship entryRelationship @typeCode substance Administration true 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 1. SHALL contain exactly one [1..1] @classCode="PROC" Procedure (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7652). 2. SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 201104-03 (CONF:7653). 3. SHALL contain exactly one [1..1] templateId (CONF:7654) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.14" (CONF:10521). 4. SHALL contain at least one [1..*] id (CONF:7655). 5. SHALL contain exactly one [1..1] code with @xsi:type="CE" (CONF:7656). a. This code SHOULD contain zero or one [0..1] originalText (CONF:7658). i. The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:15908). 1. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15909). a. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative Page 468 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15910). ii. The originalText, if present, SHOULD contain zero or one [0..1] reference/@value (CONF:7659). b. This code in a procedure activity SHOULD be selected from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (CodeSystem: 2.16.840.1.113883.6.12), ICD9 Procedures (CodeSystem: 2.16.840.1.113883.6.104), ICD10 Procedure Coding System (CodeSystem: 2.16.840.1.113883.6.4) (CONF:7657). 6. SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC (CONF:7661). 7. SHOULD contain zero or one [0..1] effectiveTime (CONF:7662). 8. MAY contain zero or one [0..1] priorityCode, which SHALL be selected from ValueSet ActPriority 2.16.840.1.113883.1.11.16866 DYNAMIC (CONF:7668). 9. MAY contain zero or one [0..1] methodCode (CONF:7670). a. MethodCode SHALL NOT conflict with the method inherent in Procedure / code (CONF:7890). 10. SHOULD contain zero or more [0..*] targetSiteCode (CONF:7683). a. The targetSiteCode, if present, SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:16082). 11. MAY contain zero or more [0..*] specimen (CONF:7697). a. The specimen, if present, SHALL contain exactly one [1..1] specimenRole (CONF:7704). i. This specimenRole SHOULD contain zero or more [0..*] id (CONF:7716). 1. If you want to indicate that the Procedure and the Results are referring to the same specimen, the Procedure/specimen/specimenRole/id SHOULD be set to equal an Organizer/specimen/ specimenRole/id (CONF:7717). b. This specimen is for representing specimens obtained from a procedure (CONF:16842). 12. SHOULD contain zero or more [0..*] performer (CONF:7718) such that it a. SHALL contain exactly one [1..1] assignedEntity (CONF:7720). i. This assignedEntity SHALL contain at least one [1..*] id (CONF:7722). ii. This assignedEntity SHALL contain exactly one [1..1] addr (CONF:7731). iii. This assignedEntity SHALL contain exactly one [1..1] telecom (CONF:7732). iv. This assignedEntity SHOULD contain zero or one [0..1] representedOrganization (CONF:7733). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 469 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 1. The representedOrganization, if present, SHOULD contain zero or more [0..*] id (CONF:7734). 2. The representedOrganization, if present, MAY contain zero or more [0..*] name (CONF:7735). 3. The representedOrganization, if present, SHALL contain exactly one [1..1] telecom (CONF:7737). 4. The representedOrganization, if present, SHALL contain exactly one [1..1] addr (CONF:7736). 13. MAY contain zero or more [0..*] participant (CONF:7751) such that it a. SHALL contain exactly one [1..1] @typeCode="DEV" Device (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7752). b. SHALL contain exactly one [1..1] Product Instance (templateId:2.16.840.1.113883.10.20.22.4.37) (CONF:15911). 14. MAY contain zero or more [0..*] participant (CONF:7765) such that it a. SHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:7766). b. SHALL contain exactly one [1..1] Service Delivery Location (templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:15912). 15. MAY contain zero or more [0..*] entryRelationship (CONF:7768) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7769). b. SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8009). c. SHALL contain exactly one [1..1] encounter (CONF:7770). i. This encounter SHALL contain exactly one [1..1] @classCode="ENC" Encounter (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7771). ii. This encounter SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7772). iii. This encounter SHALL contain exactly one [1..1] id (CONF:7773). 1. Set the encounter ID to the ID of an encounter in another section to signify they are the same encounter (CONF:16843). 16. MAY contain zero or one [0..1] entryRelationship (CONF:7775) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7776). b. SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:7777). Page 470 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 c. SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15913). 17. MAY contain zero or more [0..*] entryRelationship (CONF:7779) such that it a. SHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7780). b. SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15914). 18. MAY contain zero or one [0..1] entryRelationship (CONF:7886) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7887). b. SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15915). Figure 219: Procedure activity procedure example Bronchoalveolar HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 471 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. ... ... 6.64 Procedure Context [act: templateId 2.16.840.1.113883.10.20.6.2.5(open)] Table 265: Procedure Context Contexts Used By: Contains Entries: Diagnostic Imaging Report (optional) The ServiceEvent Procedure Context of the document header may be overridden in the CDA structured body if there is a need to refer to multiple imaging procedures or acts. The selection of the Procedure or Act entry from the clinical statement choice box depends on the nature of the imaging service that has been performed. The Procedure entry shall be used for image-guided interventions and minimal invasive imaging services, whereas the Act entry shall be used for diagnostic imaging services. Table 266: Procedure Context Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.6.2.5'] templateId 1..1 SHALL 1..1 SHALL code 1..1 SHALL CD 9201 effectiveTime 0..1 SHOULD TS 9203 1..1 SHALL @root @value SET 9200 10530 2.16.840.1.113883.10.20.6.2.5 17173 1. Procedure Context SHALL be represented with the procedure or act elements depending on the nature of the procedure (CONF:9199). 2. SHALL contain exactly one [1..1] templateId (CONF:9200) such that it Page 472 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.2.5" (CONF:10530). 3. SHALL contain exactly one [1..1] code (CONF:9201). 4. SHOULD contain zero or one [0..1] effectiveTime (CONF:9203). a. The effectiveTime, if present, SHALL contain exactly one [1..1] @value (CONF:17173). Figure 220: Procedure context template example 6.65 Product Instance [participantRole: templateId 2.16.840.1.113883.10.20.22.4.37(open)] Table 267: Product Instance Contexts Used By: Contains Entries: Procedure Activity Procedure Non-Medicinal Supply Activity This clinical statement represents a particular device that was placed in or used as part of a procedure or other act. This provides a record of the identifier and other details about the given product that was used. For example, it is important to have a record that indicates not just that a hip prostheses was placed in a patient but that it was a particular hip prostheses number with a unique identifier. The FDA Amendments Act specifies the creation of a Unique Device Identification (UDI) System that requires the label of devices to bear a unique identifier that will standardize device identification and identify the device through distribution and use. The UDI should be sent in the participantRole/id. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 473 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 268: Product Instance Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value participantRole[templateId/@root = '2.16.840.1.113883.10.20.22.4.37'] @classCode 1..1 SHALL templateId 1..1 SHALL 1..1 SHALL 1..* SHALL 1..1 SHALL 0..1 SHOULD scoping Entity 1..1 SHALL id 1..* SHALL @root id playing Device code 7900 SET 7901 10522 II 2.16.840.1.113883.5.110 (RoleClass) = MANU 2.16.840.1.113883.10.20.22.4.37 7902 7903 CE 7904 7905 II 7908 1. SHALL contain exactly one [1..1] @classCode="MANU" Manufactured Product (CodeSystem: RoleClass 2.16.840.1.113883.5.110) (CONF:7900). 2. SHALL contain exactly one [1..1] templateId (CONF:7901) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.37" (CONF:10522). 3. SHALL contain at least one [1..*] id (CONF:7902). 4. SHALL contain exactly one [1..1] playingDevice (CONF:7903). a. This playingDevice SHOULD contain zero or one [0..1] code (CONF:7904). 5. SHALL contain exactly one [1..1] scopingEntity (CONF:7905). a. This scopingEntity SHALL contain at least one [1..*] id (CONF:7908). Figure 221: Product instance example Page 474 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.66 Purpose of Reference Observation [observation: templateId 2.16.840.1.113883.10.20.6.2.9(open)] Table 269: Purpose of Reference Observation Contexts Used By: Contains Entries: SOP Instance Observation A Purpose of Reference Observation describes the purpose of the DICOM composite object reference. Appropriate codes, such as externally defined DICOM codes, may be used to specify the semantics of the purpose of reference. When this observation is absent, it implies that the reason for the reference is unknown. Table 270: Purpose of Reference Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.6.2.9'] @classCode 1..1 SHALL 9264 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 9265 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 1..1 SHALL 0..1 SHOULD 0..1 SHOULD @root code code value SET 9266 10531 CD CD 2.16.840.1.113883.10.20.6.2.9 9267 9268 2.16.840.1.113883.5.4 (ActCode) = ASSERTION 9273 2.16.840.1.113883.11.20.9.28 (DICOMPurposeOfReference) 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9264). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9265). 3. SHALL contain exactly one [1..1] templateId (CONF:9266) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.2.9" (CONF:10531). 4. SHALL contain exactly one [1..1] code (CONF:9267). a. This code SHOULD contain zero or one [0..1] code="ASSERTION" (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:9268). b. For backwards compatibility with the DICOM CMET, the code MAY be drawn from ValueSet 2.16.840.1.113883.11.20.9.28 DICOMPurposeOfReference DYNAMIC (CONF:9269). 5. SHOULD contain zero or one [0..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet DICOMPurposeOfReference 2.16.840.1.113883.11.20.9.28 DYNAMIC (CONF:9273). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 475 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. The value element is a SHOULD to allow backwards compatibility with the DICOM CMET. Note that the use of ASSERTION for the code differs from the DICOM CMET. This is intentional. The DICOM CMET was created before the Term Info guidelines describing the use of the assertion pattern were released. It was determined that this IG should follow the latest Term Info guidelines. Implementers using both this IG and the DICOM CMET will need to be aware of this difference and apply appropriate transformations (CONF:9274). Table 271: DICOM Purpose of Reference Value Set Value Set: DICOMPurposeOfReference 2.16.840.1.113883.11.20.9.28 DYNAMIC Code System(s): DCM 1.2.840.10008.2.16.4 Code Code System Print Name 121079 DCM Baseline 121080 DCM Best illustration of finding 121112 DCM Source of Measurement Figure 222: Purpose of reference example 6.67 Quantity Measurement Observation [observation: templateId 2.16.840.1.113883.10.20.6.2.14(open)] Table 272: Quantity Measurement Observation Contexts Used By: Contains Entries: Text Observation Code Observations SOP Instance Observation A Quantity Measurement Observation records quantity measurements based on image data such as linear, area, volume, and numeric measurements. The codes in DIRQuantityMeasurementTypeCodes (ValueSet: 2.16.840.1.113883.11.20.9.29) are from the qualifier hierarchy of SNOMED CT and are not valid for observation/code according to the Term Info guidelines. These codes can be used for backwards compatibility, but going forward, codes from the observable entity hierarchy will be requested and used. Page 476 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 273: Quantity Measurement Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.6.2.14'] @classCode 1..1 SHALL 9317 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 9318 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 1..1 SHALL code 0..1 SHOULD 9322 2.16.840.1.113883.11.20.9.29 (DIRQuantityMeasurementTypeCod es) code 0..1 SHOULD 9323 2.16.840.1.113883.11.20.9.30 (DICOMQuantityMeasurementType Codes) 1..1 SHALL 9324 @xsi:type 1..1 SHALL effectiveTime 0..1 SHOULD 0..* MAY 9327 1..1 SHALL 9328 @root code value entry Relationship @typeCode SET 9319 10532 CD 9320 9325 TS or IVL 2.16.840.1.113883.10.20.6.2.14 PQ 9326 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SPRT 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9317). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9318). 3. SHALL contain exactly one [1..1] templateId (CONF:9319) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.2.14" (CONF:10532). 4. SHALL contain exactly one [1..1] code (CONF:9320). a. This code SHOULD contain zero or one [0..1] code, which SHALL be selected from ValueSet DIRQuantityMeasurementTypeCodes 2.16.840.1.113883.11.20.9.29 DYNAMIC (CONF:9322). b. This code SHOULD contain zero or one [0..1] code, which SHALL be selected from ValueSet DICOMQuantityMeasurementTypeCodes 2.16.840.1.113883.11.20.9.30 DYNAMIC (CONF:9323). c. The value set of the observation/code includes numeric measurement types for linear dimensions, areas, volumes, and other numeric measurements. This value set is extensible and comprises the union of SNOMED codes for observable entities as reproduced in DIRQuantityMeasurementTypeCodes (ValueSet: 2.16.840.1.113883.11.20.9.29) and DICOM Codes in HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 477 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. DICOMQuantityMeasurementTypeCodes (ValueSet: 2.16.840.1.113883.11.20.9.30) (CONF:9330). 5. SHALL contain exactly one [1..1] value (CONF:9324). a. This value SHALL contain exactly one [1..1] @xsi:type, where the @code="PQ" (CONF:9325). 6. SHOULD contain zero or one [0..1] effectiveTime (CONF:9326). 7. MAY contain zero or more [0..*] entryRelationship (CONF:9327) such that it a. SHALL contain exactly one [1..1] @typeCode="SPRT" Has Support (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:9328). b. SHALL contain exactly one [1..1] SOP Instance Observation (2.16.840.1.113883.10.20.6.2.8) (CONF:9329). Table 274: DIR Quantity Measurement Type Value Set Value Set: DIRQuantityMeasurementTypeCodes 2.16.840.1.113883.11.20.9.29 DYNAMIC Code System(s): SNOMED CT 2.16.840.1.113883.6.96 Code Code System Print Name 439932008 SNOMED CT Length of structure 440357003 SNOMED CT Width of structure 439934009 SNOMED CT Depth of structure 439984002 SNOMED CT Diameter of structure 439933003 SNOMED CT Long axis length of structure 439428006 SNOMED CT Short axis length of structure 439982003 SNOMED CT Major axis length of structure 439983008 SNOMED CT Minor axis length of structure 440356007 SNOMED CT Perpendicular axis length of structure 439429003 SNOMED CT Radius of structure 440433004 SNOMED CT Perimeter of non-circular structure 439747008 SNOMED CT Circumference of circular structure 439748003 SNOMED CT Diameter of circular structure 439746004 SNOMED CT Area of structure 439985001 SNOMED CT Area of body region 439749006 SNOMED CT Volume of structure Page 478 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 275: DICOM Quantity Measurement Type Value Set Value Set: DICOMQuantityMeasurementTypeCodes 2.16.840.1.113883.11.20.9.30 DYNAMIC Code System(s): DCM 1.2.840.10008.2.16.4 Code Code System Print Name Measurement Type 121211 DCM Path length Linear 121206 DCM Distance Linear 121207 DCM Height Linear 121216 DCM Volume estimated from single 2D region Volume 121218 DCM Volume estimated from two non-coplanar 2D regions Volume 121217 DCM Volume estimated from three or more noncoplanar 2D regions Volume 121222 DCM Volume of sphere Volume 121221 DCM Volume of ellipsoid Volume 121220 DCM Volume of circumscribed sphere Volume 121219 DCM Volume of bounding three dimensional region Volume Figure 223: Quantity measurement observation example codeSystemVersion="1.5"/> HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 479 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.68 Reaction Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.9(open)] Table 276: Reaction Observation Contexts Used By: Contains Entries: Allergy - Intolerance Observation Medication Activity Immunization Activity Medication Activity Procedure Activity Procedure Severity Observation This clinical statement represents an undesired symptom, finding, etc., due to an administered or exposed substance. A reaction can be defined with respect to its severity, and can have been treated by one or more interventions. Table 277: Reaction Observation Constraints Overview Name XPath Green Reaction Observation observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.9'] reaction Coded Verb Data Type CONF # Fixed Value @classCode 1..1 SHALL 7325 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 7326 2.16.840.1.113883.5.10 01 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10523 id 1..1 SHALL 7329 code 1..1 SHALL 16851 text 0..1 SHOULD 7330 reference 0..1 SHOULD 15917 @value @root reaction FreeText Card. SET 7323 0..1 SHOULD 15918 statusCode 1..1 SHALL 7328 effectiveTime 0..1 SHOULD TS or IVL 7332 low 0..1 SHOULD TS 7333 high 2.16.840.1.113883.10.2 0.22.4.9 2.16.840.1.113883.5.14 (ActStatus) = completed 0..1 SHOULD TS 7334 value 1..1 SHALL CD 7335 entryRelationship 0..* MAY 7337 @typeCode 1..1 SHALL 7338 2.16.840.1.113883.5.10 02 (HL7ActRelationshipTyp e) = RSON @inversionInd 1..1 SHALL 7343 true 2.16.840.1.113883.3.88. 12.3221.7.4 (Problem) Page 480 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb 1..1 SHALL 15920 0..* MAY 7340 @typeCode 1..1 SHALL 7341 2.16.840.1.113883.5.10 02 (HL7ActRelationshipTyp e) = RSON @inversionInd 1..1 SHALL 7344 true 1..1 SHALL 15921 0..1 SHOULD 7580 @typeCode 1..1 SHALL 7581 2.16.840.1.113883.5.10 02 (HL7ActRelationshipTyp e) = SUBJ @inversionInd 1..1 SHALL 10375 true observation 1..1 SHALL 15922 procedure entryRelationship substance Administration severity entryRelationship Data Type CONF # Fixed Value 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7325). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7326). 3. SHALL contain exactly one [1..1] templateId (CONF:7323) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.9" (CONF:10523). 4. SHALL contain exactly one [1..1] id (CONF:7329). 5. SHALL contain exactly one [1..1] code (CONF:16851). a. The value set for this code element has not been specified. Implementers are allowed to use any code system, such as SNOMED CT, a locally determined code, or a nullFlavor (CONF:16852). 6. SHOULD contain zero or one [0..1] text (CONF:7330). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15917). i. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15918). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15919). 7. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:7328). 8. SHOULD contain zero or one [0..1] effectiveTime (CONF:7332). a. The effectiveTime, if present, SHOULD contain zero or one [0..1] low (CONF:7333). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 481 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. b. The effectiveTime, if present, SHOULD contain zero or one [0..1] high (CONF:7334). 9. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet Problem 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:7335). 10. MAY contain zero or more [0..*] entryRelationship (CONF:7337) such that it a. SHALL contain exactly one [1..1] @typeCode="RSON" Has reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7338). b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7343). c. SHALL contain exactly one [1..1] Procedure Activity Procedure (templateId:2.16.840.1.113883.10.20.22.4.14) (CONF:15920). i. This procedure activity is intended to contain information about procedures that were performed in response to an allergy reaction (CONF:16853). 11. MAY contain zero or more [0..*] entryRelationship (CONF:7340) such that it a. SHALL contain exactly one [1..1] @typeCode="RSON" Has reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7341). b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7344). c. SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15921). i. This medication activity is intended to contain information about medications that were administered in response to an allergy reaction (CONF:16840). 12. SHOULD contain zero or one [0..1] entryRelationship (CONF:7580) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:7581). b. SHALL contain exactly one [1..1] @inversionInd="true" TRUE (CONF:10375). c. SHALL contain exactly one [1..1] Severity Observation (templateId:2.16.840.1.113883.10.20.22.4.8) (CONF:15922). Page 482 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Figure 224: Reaction observation example 6.69 Referenced Frames Observation [observation: templateId 2.16.840.1.113883.10.20.6.2.10(open)] A Referenced Frames Observation is used if the referenced DICOM SOP instance is a multiframe image and the reference does not apply to all frames. The list of integer values for the referenced frames of a DICOM multiframe image SOP instance is contained in a Boundary Observation nested inside this class. Table 278: Referenced Frames Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.6.2.10'] @classCode 1..1 SHALL 9276 2.16.840.1.113883.5.6 (HL7ActClass) = ROIBND @moodCode 1..1 SHALL 9277 2.16.840.1.113883.5.1001 (ActMood) = EVN code 1..1 SHALL 9278 1.2.840.10008.2.16.4 (DCM) = 121190 entryRelationship 1..1 SHALL 9279 @typeCode 1..1 SHALL 9280 observation 1..1 SHALL 15923 CE 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 1. SHALL contain exactly one [1..1] @classCode="ROIBND" Bounded Region of Interest (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) (CONF:9276). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 ActMood) (CONF:9277). 3. SHALL contain exactly one [1..1] code="121190" Referenced Frames (CodeSystem: 1.2.840.10008.2.16.4 DCM) (CONF:9278). 4. SHALL contain exactly one [1..1] entryRelationship (CONF:9279). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 483 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. This entryRelationship SHALL contain exactly one [1..1] @typeCode="COMP" Component (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) (CONF:9280). b. This entryRelationship SHALL contain exactly one [1..1] Boundary Observation (templateId:2.16.840.1.113883.10.20.6.2.11) (CONF:9281). Figure 225: Referenced frames observation example 6.70 Result Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.2(open)] Table 279: Result Observation Contexts Used By: Contains Entries: Result Organizer Functional Status Section This clinical statement represents details of a lab, radiology, or other study performed on a patient. The result observation includes a statusCode to allow recording the status of an observation. If a Results Observation is not completed, the Result Organizer must include corresponding statusCode. “Pending” results (e.g., a test has been run but results have not been reported yet) should be represented as “active” ActStatus. Page 484 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 280: Result Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Green Result Observation observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.2'] @classCode 1..1 SHALL 7130 2.16.840.1.113883.5. 6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 7131 2.16.840.1.113883.5. 1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL @root SET< II> 7136 9138 resultID id 1..* SHALL resultType code 1..1 SHALL text 0..1 SHOULD 7138 reference 0..1 SHOULD 15924 @value 0..1 SHOULD 15925 1..1 SHALL 7134 1..1 SHALL 14849 resultStatus statusCode @code 1..1 SHALL resultValue value 1..1 SHALL 7143 resultInterp retation interpretationCode 0..* SHOULD 7147 methodCode 0..1 MAY SET< CE> 7148 targetSiteCode 0..1 MAY SET< CD> 7153 author 0..1 MAY 7149 referenceRange 0..* SHOULD 7150 1..1 SHALL 7151 0..0 SHALL NOT 7152 code TS or IVL< TS> 7133 effectiveTime observationRange 2.16.840.1.113883.1 0.20.22.4.2 7137 CE resultDate Time resultRefere nceRange Fixed Value 2.16.840.1.113883.1 1.20.9.39 (Result Status) 7140 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:7130). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7131). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 485 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 3. SHALL contain exactly one [1..1] templateId (CONF:7136) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.2" (CONF:9138). 4. SHALL contain at least one [1..*] id (CONF:7137). 5. SHALL contain exactly one [1..1] code with @xsi:type="CE" (CONF:7133). a. SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) (CONF:7166). b. Laboratory results SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or other constrained terminology named by the US Department of Health and Human Services Office of National Coordinator or other federal agency. Local and/or regional codes for laboratory results are allowed. The Local and/or regional codes SHOULD be sent in the translation element. See the Local code example figure (CONF:9109). 6. SHOULD contain zero or one [0..1] text (CONF:7138). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15924). i. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15925). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15926). 7. SHALL contain exactly one [1..1] statusCode (CONF:7134). a. This statusCode SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Result Status 2.16.840.1.113883.11.20.9.39 STATIC (CONF:14849). 8. SHALL contain exactly one [1..1] effectiveTime (CONF:7140). a. Represents clinically effective time of the measurement, which may be when the measurement was performed (e.g., a BP measurement), or may be when sample was taken (and measured some time afterwards) (CONF:16838). 9. SHALL contain exactly one [1..1] value (CONF:7143). 10. SHOULD contain zero or more [0..*] interpretationCode (CONF:7147). 11. MAY contain zero or one [0..1] methodCode (CONF:7148). 12. MAY contain zero or one [0..1] targetSiteCode (CONF:7153). 13. MAY contain zero or one [0..1] author (CONF:7149). 14. SHOULD contain zero or more [0..*] referenceRange (CONF:7150). a. The referenceRange, if present, SHALL contain exactly one [1..1] observationRange (CONF:7151). i. This observationRange SHALL NOT contain [0..0] code (CONF:7152). Page 486 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 281: Result Status Value Set Value Set: Result Status 2.16.840.1.113883.11.20.9.39 STATIC 2012-07-01 Code System(s): ActStatus 2.16.840.1.113883.5.14 Description: This value set indicates the status of the results observation or organizer Code Code System Print Name aborted ActStatus aborted active ActStatus active cancelled ActStatus cancelled completed ActStatus completed held ActStatus held suspended ActStatus suspended Figure 226: Result observation example M 13-18 g/dl; F 12-16 g/dl HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 487 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 227: No evaluation procedures (e.g., labs/x-rays) performed example No Evaluation Procedures Performed Figure 228: Local code example 6.71 Result Organizer [organizer: templateId 2.16.840.1.113883.10.20.22.4.1(open)] Table 282: Result Organizer Contexts Used By: Contains Entries: Results Section (entries required) Results Section (entries optional) Result Observation This clinical statement identifies set of result observations. It contains information applicable to all of the contained result observations. Result type codes categorize a result into one of several commonly accepted values (e.g., “Hematology”, “Chemistry”, “Nuclear Medicine”). These values are often implicit in the Organizer/code (e.g., an Organizer/code of “complete blood count” implies a ResultTypeCode of “Hematology”). This template requires Organizer/code to include a ResultTypeCode either directly or as a translation of a code from some other code system. An appropriate nullFlavor can be used when the organizer/code or organizer/id is unknown. If any Results Observation within the organizer has a statusCode of ‘active’, the Result Organizer must also have as statusCode of ‘active. Page 488 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 283: Result Organizer Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value organizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.1'] @classCode 1..1 SHALL 7121 2.16.840.1.113883.5.6 (HL7ActClass) @moodCode 1..1 SHALL 7122 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 9134 id 1..* SHALL 7127 code 1..1 SHALL statusCode 1..1 SHALL 7123 1..1 SHALL 14848 1..* SHALL 7124 1..1 SHALL 14850 @root @code component SET CE 7126 2.16.840.1.113883.10.20.22.4.1 7128 2.16.840.1.113883.11.20.9.39 (Result Status) observation 1. SHALL contain exactly one [1..1] @classCode (CONF:7121). a. SHOULD contain zero or one [0..1] @classCode="CLUSTER" Cluster (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) OR SHOULD contain zero or one [0..1] @classCode="BATTERY" Battery (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) (CONF:7165). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:7122). 3. SHALL contain exactly one [1..1] templateId (CONF:7126) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.1" (CONF:9134). 4. SHALL contain at least one [1..*] id (CONF:7127). 5. SHALL contain exactly one [1..1] code with @xsi:type="CE" (CONF:7128). a. SHOULD be selected from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT (codeSystem 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (codeSystem 2.16.840.1.113883.6.12) (CONF:7164). b. Laboratory results SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or other constrained terminology named by the US Department of Health and Human Services Office of National Coordinator or other federal agency. Local and/or regional codes for laboratory results SHOULD also be allowed (CONF:9108). 6. SHALL contain exactly one [1..1] statusCode (CONF:7123). a. This statusCode SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Result Status 2.16.840.1.113883.11.20.9.39 STATIC 2012-04-27 (CONF:14848). 7. SHALL contain at least one [1..*] component (CONF:7124) such that it HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 489 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. a. SHALL contain exactly one [1..1] Result Observation (templateId:2.16.840.1.113883.10.20.22.4.2) (CONF:14850). Figure 229: Result organizer example ... ... ... 6.72 Series Act [act: templateId 2.16.840.1.113883.10.20.22.4.63 (open)] Table 284: Series Act Contexts Used By: Contains Entries: Study Act (required) SOP Instance Observation A Series Act contains the DICOM series information for referenced DICOM composite objects. The series information defines the attributes that are used to group composite instances into distinct logical sets. Each series is associated with exactly one study. Series Act clinical statements are only instantiated in the DICOM Object Catalog section inside a Study Act, and thus do not require a separate templateId; in other sections, the SOP Instance Observation is included directly. Page 490 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 285: Series Act Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.63'] @classCode 1..1 SHALL 9222 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 9223 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 10918 1..1 SHALL 10919 1..* SHALL 9224 @root 1..1 SHALL 9225 @extension 0..0 SHALL NOT 9226 1..1 SHALL CE 9228 qualifier 1..1 SHALL SET 9229 name 1..1 SHALL PN 9230 value ANY 9231 @root id code 1..1 SHALL text 0..1 MAY effectiveTime 0..1 SHOULD entryRelationship 1..* SHALL 9237 @typeCode 1..1 SHALL 9238 observation 1..1 SHALL 15927 2.16.840.1.113883.10.20.22.4.63 1.2.840.10008.2.16.4 (DCM) = 113015 1.2.840.10008.2.16.4 (DCM) = 121139 9233 TS or IVL 9235 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 1. SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9222). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9223). 3. SHALL contain exactly one [1..1] templateId (CONF:10918) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.63" (CONF:10919). 4. SHALL contain at least one [1..*] id (CONF:9224). The @root contains the OID of the study instance UID since DICOM study ids consist only of an OID a. Such ids SHALL contain exactly one [1..1] @root (CONF:9225). b. Such ids SHALL NOT contain [0..0] @extension (CONF:9226). 5. SHALL contain exactly one [1..1] code="113015" with @xsi:type="CE" (CodeSystem: DCM 1.2.840.10008.2.16.4) (CONF:9228). a. This code SHALL contain exactly one [1..1] qualifier (CONF:9229). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 491 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. i. This qualifier SHALL contain exactly one [1..1] name="121139" Modality (CodeSystem: DCM 1.2.840.10008.2.16.4) (CONF:9230). The value element code contains a modality code and codeSystem is 1.2.840.10008.2.16.4 ii. This qualifier SHALL contain exactly one [1..1] value with @xsi:type="ANY" (CONF:9231). If present, the text element contains the description of the series 6. MAY contain zero or one [0..1] text (CONF:9233). If present, the effectiveTime contains the time the series was started 7. SHOULD contain zero or one [0..1] effectiveTime (CONF:9235). 8. SHALL contain at least one [1..*] entryRelationship (CONF:9237) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:9238). b. SHALL contain exactly one [1..1] SOP Instance Observation (templateId:2.16.840.1.113883.10.20.6.2.8) (CONF:15927). Figure 230: Series act example ... Page 492 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.73 Service Delivery Location [participantRole: templateId 2.16.840.1.113883.10.20.22.4.32(open)] Table 286: Service Delivery Location Contexts Used By: Contains Entries: Procedure Activity Procedure Procedure Activity Observation Procedure Activity Act Encounter Activities This clinical statement represents the location of a service event where an act, observation or procedure took place. Table 287: Service Delivery Location Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value participantRole[templateId/@root = '2.16.840.1.113883.10.20.22.4.32'] @classCode 1..1 SHALL templateId 1..1 SHALL 1..1 SHALL 10524 2.16.840.1.113883.10.20.22.4. 32 code 1..1 SHALL 16850 2.16.840.1.113883.1.11.20275 (HealthcareServiceLocation) addr 0..* SHOULD SET 7760 telecom 0..* SHOULD SET 7761 playingEntity 0..1 MAY 7762 @classCode 1..1 SHALL 7763 name 0..1 MAY 16037 @root 7758 SET 2.16.840.1.113883.5.111 (RoleCode) = SDLOC 7635 2.16.840.1.113883.5.41 (EntityClass) = PLC 1. SHALL contain exactly one [1..1] @classCode="SDLOC" (CodeSystem: RoleCode 2.16.840.1.113883.5.111 STATIC) (CONF:7758). 2. SHALL contain exactly one [1..1] templateId (CONF:7635) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.32" (CONF:10524). 3. SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet HealthcareServiceLocation 2.16.840.1.113883.1.11.20275 (CONF:16850). 4. SHOULD contain zero or more [0..*] addr (CONF:7760). 5. SHOULD contain zero or more [0..*] telecom (CONF:7761). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 493 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6. MAY contain zero or one [0..1] playingEntity (CONF:7762). a. The playingEntity, if present, SHALL contain exactly one [1..1] @classCode="PLC" (CodeSystem: EntityClass 2.16.840.1.113883.5.41 STATIC) (CONF:7763). b. The playingEntity, if present, MAY contain zero or one [0..1] name (CONF:16037). Table 288: HealthcareServiceLocation Value Set (excerpt) Value Set: HealthcareServiceLocation 2.16.840.1.113883.1.11.20275 DYNAMIC Code System(s): HealthcareServiceLocation 2.16.840.1.113883.6.259 Description: A comprehensive classification of locations and settings where healthcare services are provided. This value set is based on the National Healthcare Safety Network (NHSN) location code system that has been developed over a number of years through CDC's interaction with a variety of healthcare facilities and is intended to serve a variety of reporting needs where coding of healthcare service locations is required. Full value set may be found at: http://phinvads.cdc.gov/vads/SearchAllVocab_search.action?searchOption s.searchText=Healthcare+Service+Location+%28NHSN%29 Code Code System Print Name 1024-9 HealthcareServiceLocation Critical Care Unit 1117-1 HealthcareServiceLocation Family Medicine Clinic 1128-8 HealthcareServiceLocation Pediatric Clinic 1160-1 HealthcareServiceLocation Urgent Care Center … Figure 231: Service delivery location example 17 Daws Rd. Blue Bell MA 02368 US Good Health Clinic Page 494 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.74 Severity Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.8(open)] Table 289: Severity Observation Contexts Used By: Contains Entries: Reaction Observation Allergy - Intolerance Observation This clinical statement represents the gravity of the problem, such as allergy or reaction, in terms of its actual or potential impact on the patient. The Severity Observation can be associated with an Allergy Observation, Reaction Observation or both. When the Severity Observation is associated directly with an Allergy it characterizes the Allergy. When the Severity Observation is associated with a Reaction Observation it characterizes a Reaction. A person may manifest many symptoms in a reaction to a single substance, and each reaction to the substance can be represented. However, each reaction observation can have only one severity observation associated with it. For example, someone may have a rash reaction observation as well as an itching reaction observation, but each can have only one level of severity. Table 290: Severity Observation Constraints Overview Name XPath Green Severity Observation observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.8'] Verb Data Type CONF# Fixed Value @classCode 1..1 SHALL 7345 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 7346 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL code 1..1 SHALL text 0..1 SHOULD 7350 reference 0..1 SHOULD 15928 @value 0..1 SHOULD 15929 1..1 SHALL 7352 @root severityFree Text Card. statusCode SET< II> CE 7347 10525 2.16.840.1.113883.10.20.22. 4.8 7349 2.16.840.1.113883.5.4 (ActCode) = SEV 2.16.840.1.113883.5.14 (ActStatus) = completed HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 495 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Name severity Coded XPath value interpretation Code @code Card. Verb Data Type CONF# Fixed Value 1..1 SHALL CD 7356 2.16.840.1.113883.3.88.12.3 221.6.8 (Problem Severity) 0..* SHOULD 9117 0..1 SHOULD 16038 2.16.840.1.113883.1.11.78 (Observation Interpretation (HL7)) 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7345). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7346). 3. SHALL contain exactly one [1..1] templateId (CONF:7347) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.8" (CONF:10525). 4. SHALL contain exactly one [1..1] code="SEV" Severity Observation with @xsi:type="CE" (CodeSystem: ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:7349). 5. SHOULD contain zero or one [0..1] text (CONF:7350). a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15928). i. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15929). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15930). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:7352). 7. SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet Problem Severity 2.16.840.1.113883.3.88.12.3221.6.8 DYNAMIC (CONF:7356). 8. SHOULD contain zero or more [0..*] interpretationCode (CONF:9117). a. The interpretationCode, if present, SHOULD contain zero or one [0..1] @code, which SHOULD be selected from ValueSet Observation Interpretation (HL7) 2.16.840.1.113883.1.11.78 DYNAMIC (CONF:16038). Table 291: Problem Severity Value Set Page 496 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Value Set: Problem Severity 2.16.840.1.113883.3.88.12.3221.6.8 DYNAMIC Code System(s): SNOMED CT 2.16.840.1.113883.6.96 Description: This is a description of the level of the severity of the problem. Code Code System Print Name 255604002 SNOMED CT Mild (qualifier value) 371923003 SNOMED CT Mild to moderate (qualifier value) 6736007 SNOMED CT Moderate (severity modifier) (qualifier value) 371924009 SNOMED CT Moderate to severe (qualifier value) 24484000 SNOMED CT Severe (severity modifier) (qualifier value) 399166001 SNOMED CT Fatal (qualifier value) Figure 232: Severity observation example 6.75 Smoking Status Observation [observation: templateId 2.16.840.1.113883.10.22.4.78 (open)] Table 292: Smoking Status Observation Contexts Used By: Contains Entries: Social History Section (optional) This clinical statement represents a patient’s current smoking status. The vocabulary selected for this clinical statement is the best approximation of the statuses in Meaningful Use (MU) Stage 1. If the patient is a smoker (77176002), the effectiveTime/low element must be present. If the patient is an ex-smoker (8517006), both the effectiveTime/low and effectiveTime/high element must be present. The smoking status value set includes a special code to communicate if the smoking status is unknown which is different from how Consolidated CDA generally communicates unknown information. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 497 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 293: Smoking Status Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.22.4.78'] @classCode 1..1 SHALL 14806 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 14807 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 14815 1..1 SHALL 14816 2.16.840.1.113883.10.22.4.78 code 1..1 SHALL 14808 2.16.840.1.113883.5.4 (ActCode) = ASSERTION statusCode 1..1 SHALL 14809 2.16.840.1.113883.5.14 (ActStatus) = completed effectiveTime 1..1 SHALL low 1..1 SHALL value 1..1 SHALL 1..1 SHALL @root @code TS or IVL 14814 14818 CD 14810 14817 2.16.840.1.113883.10.22.4.78 (Smoking Status) 1. Conforms to Tobacco Use template (2.16.840.1.113883.10.20.22.4.85). 2. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:14806). 3. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:14807). 4. SHALL contain exactly one [1..1] templateId (CONF:14815) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.22.4.78" (CONF:14816). 5. SHALL contain exactly one [1..1] code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:14808). 6. SHALL contain exactly one [1..1] statusCode="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:14809). 7. SHALL contain exactly one [1..1] effectiveTime (CONF:14814). a. This effectiveTime SHALL contain exactly one [1..1] low (CONF:14818). 8. SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:14810). a. This value SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Smoking Status 2.16.840.1.113883.10.22.4.78 DYNAMIC (CONF:14817). Page 498 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Table 294: Smoking Status Value Set Value Set: Smoking Status 2.16.840.1.113883.11.20.9.38 STATIC 2012-07-01 Code System(s): SNOMED CT 2.16.840.1.113883.6.96 Description: This value set indicates the current smoking status of a patient Code Code System Print Name 449868002 SNOMED CT Current every day smoker 428041000124106 SNOMED CT Current some day smoker 8517006 SNOMED CT Former smoker 266919005 SNOMED CT Never smoker (Never Smoked) 77176002 SNOMED CT Smoker, current status unknown 266927001 SNOMED CT Unknown if ever smoked Figure 233: Smoking status observation example Figure 234: Unknown if ever smoked HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 499 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. 6.76 Social History Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.38(open)] Table 295: Social History Observation Contexts Used By: Contains Entries: Social History Section This Social History Observation defines the patient’s occupational, personal (e.g., lifestyle), social, and environmental history and health risk factors, as well as administrative data such as marital status, race, ethnicity, and religious affiliation. Table 296: Social History Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.38'] @classCode 1..1 SHALL 8548 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 8549 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL id 1..* SHALL II 8551 code 0..1 SHOULD CD 8558 code 0..1 SHOULD original Text 0..1 SHOULD reference /@value 0..1 SHOULD statusCode 1..1 SHALL CS 8553 value 0..1 SHOULD ANY 8559 @root social History Type social History FreeText social History Observed Value SET 8550 10526 8896 ED 2.16.840.1.113883.10.20.22. 4.38 2.16.840.1.113883.3.88.12.8 0.60 (Social History Type Set Definition) 8893 8894 2.16.840.1.113883.5.14 (ActStatus) = completed 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:8548). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:8549). 3. SHALL contain exactly one [1..1] templateId (CONF:8550) such that it Page 500 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.38" (CONF:10526). 4. SHALL contain at least one [1..*] id (CONF:8551). 5. SHOULD contain zero or one [0..1] code (CONF:8558). a. The code, if present, SHOULD contain zero or one [0..1] code, where the @code SHOULD be selected from ValueSet Social History Type Set Definition 2.16.840.1.113883.3.88.12.80.60 STATIC (2008-12-18 CONF:8896). b. The code, if present, SHOULD contain zero or one [0..1] originalText (CONF:8893). i. The originalText, if present, SHOULD contain zero or one [0..1] reference/@value (CONF:8894). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:8895). 6. SHALL contain exactly one [1..1] statusCode="completed" (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:8553). 7. SHOULD contain zero or one [0..1] value with @xsi:type="ANY" (CONF:8559). a. Observation/value can be any data type. Where Observation/value is a physical quantity, the unit of measure SHALL be expressed using a valid Unified Code for Units of Measure (UCUM) expression (CONF:8555). Table 297: Social History Type Set Definition Value Set Value Set: Social History Type Set Definition 2.16.840.1.113883.3.88.12.80.60 STATIC 2008-12-18 Code System(s): Code SNOMED CT 2.16.840.1.113883.6.96 Code System Print Name 229819007 SNOMED CT Tobacco use and exposure 256235009 SNOMED CT Exercise 160573003 SNOMED CT Alcohol intake 364393001 SNOMED CT Nutritional observable 364703007 SNOMED CT Employment detail 425400000 SNOMED CT Toxic exposure status 363908000 SNOMED CT Details of drug misuse behavior 228272008 SNOMED CT Health-related behavior 105421008 SNOMED CT Educational Achievement HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 501 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Figure 235: Social history observation template example None 6.77 SOP Instance Observation [observation: templateId 2.16.840.1.113883.10.20.6.2.8(open)] Table 298: SOP Instance Observation Contexts Used By: Contains Entries: Series Act Text Observation Code Observations Quantity Measurement Observation Purpose of Reference Observation Referenced Frames Observation SOP Instance Observation A SOP Instance Observation contains the DICOM Service Object Pair (SOP) Instance information for referenced DICOM composite objects. The SOP Instance act class is used to reference both image and non-image DICOM instances. The text attribute contains the DICOM WADO reference. Table 299: SOP Instance Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.6.2.8'] @classCode 1..1 SHALL 9240 2.16.840.1.113883.5.6 (HL7ActClass) = DGIMG @moodCode 1..1 SHALL 9241 2.16.840.1.113883.5.1001 (ActMood) = EVN id 1..* SHALL II 9242 code 1..1 SHALL CD 9244 text 0..1 SHOULD ED 9246 @mediaType 1..1 SHALL 9247 reference 1..1 SHALL 9248 application/dicom Page 502 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 Name XPath Card. Verb Data Type CONF# 0..1 SHOULD TS or IVL 9250 @value 1..1 SHALL low 0..0 SHALL NOT TS 9252 high 0..0 SHALL NOT TS 9253 0..* MAY 9254 1..1 SHALL 9255 0..* MAY 9257 @typeCode 1..1 SHALL 9258 observation 1..1 SHALL 15935 effectiveTime entryRelationship @typeCode entryRelationship entryRelationship Fixed Value 9251 0..* MAY 9260 @typeCode 1..1 SHALL 9261 observation 1..1 SHALL 15936 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 1. SHALL contain exactly one [1..1] @classCode="DGIMG" Diagnostic Image (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9240). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9241). 3. SHALL contain at least one [1..*] id (CONF:9242). a. The @root contains an OID representing the DICOM SOP Instance UID (CONF:9243). 4. SHALL contain exactly one [1..1] code (CONF:9244). a. SHALL contain codeSystem 1.2.840.10008.2.6.1 DCMUID and code is an OID for a valid SOP class name UID (CONF:9245). 5. SHOULD contain zero or one [0..1] text (CONF:9246). a. The text, if present, SHALL contain exactly one [1..1] @mediaType="application/dicom" (CONF:9247). b. The text, if present, SHALL contain exactly one [1..1] reference (CONF:9248). i. contain a @value that contains a WADO reference as a URI (CONF:9249). SHALL 6. SHOULD contain zero or one [0..1] effectiveTime (CONF:9250). a. The effectiveTime, if present, SHALL contain exactly one [1..1] @value (CONF:9251). b. The effectiveTime, if present, SHALL NOT contain [0..0] low (CONF:9252). HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 503 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. c. The effectiveTime, if present, SHALL NOT contain [0..0] high (CONF:9253). 7. MAY contain zero or more [0..*] entryRelationship (CONF:9254) such that it a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:9255). b. SHALL contain exactly one [1..1] SOP Instance Observation (2.16.840.1.113883.10.20.6.2.8) (CONF:9256). 8. MAY contain zero or more [0..*] entryRelationship (CONF:9257) such that it a. SHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:9258). b. SHALL contain exactly one [1..1] Purpose of Reference Observation (2.16.840.1.113883.10.20.6.2.9) (CONF:15935). 9. MAY contain zero or more [0..*] entryRelationship (CONF:9260) such that it a. This entryRelationship SHALL be present if the referenced DICOM object is a multiframe object and the reference does not apply to all frames (CONF:9263). b. SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:9261). c. SHALL contain exactly one [1..1] Referenced Frames Observation (2.16.840.1.113883.10.20.6.2.10) (CONF:15936). Figure 236: SOP instance observation example Page 504 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 6.78 Study Act [act: templateId 2.16.840.1.113883.10.20.6.2.6 (open)] Table 300: Study Act Contexts Used By: Contains Entries: DICOM Object Catalog Section - DCM 121181 (required) Series Act A Study Act contains the DICOM study information that defines the characteristics of a referenced medical study performed on a patient. A study is a collection of one or more series of medical images, presentation states, SR documents, overlays, and/or curves that are logically related for the purpose of diagnosing a patient. Each study is associated with exactly one patient. A study may include composite instances that are created by a single modality, multiple modalities, or by multiple devices of the same modality. The study information is modality-independent. Study Act clinical statements are only instantiated in the DICOM Object Catalog section; in other sections, the SOP Instance Observation is included directly. HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 505 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. Table 301: Study Act Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.6.2.6'] @classCode 1..1 SHALL 9207 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL 9208 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL 10533 1..* SHALL 9210 @root 1..1 SHALL 9213 @extension 0..0 SHALL NOT 9211 code 1..1 SHALL text 0..1 MAY 9215 reference 0..1 SHOULD 15995 @value 0..1 SHOULD 15996 effectiveTime 0..1 SHOULD entryRelationship 1..* SHALL 9219 @typeCode 1..1 SHALL 9220 act 1..1 SHALL 15937 @root id SET CE TS or IVL 9209 9214 2.16.840.1.113883.10.20.6.2.6 1.2.840.10008.2.16.4 (DCM) = 113014 9216 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP 1. SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:9207). 2. SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9208). 3. SHALL contain exactly one [1..1] templateId (CONF:9209) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.2.6" (CONF:10533). 4. SHALL contain at least one [1..*] id (CONF:9210). The @root contains the OID of the study instance UID since DICOM study ids consist only of an OID a. Such ids SHALL contain exactly one [1..1] @root (CONF:9213). b. Such ids SHALL NOT contain [0..0] @extension (CONF:9211). 5. SHALL contain exactly one [1..1] code="113014" with @xsi:type="CE" (CodeSystem: DCM 1.2.840.10008.2.16.4) (CONF:9214). If present, the text element contains the description of the study. 6. MAY contain zero or one [0..1] text (CONF:9215). Page 506 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 © 2012 Health Level Seven, Inc. All rights reserved. July 2012 a. The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15995). i. The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15996). 1. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15997). If present, the effectiveTime contains the time the study was started 7. SHOULD contain zero or one [0..1] effectiveTime (CONF:9216). 8. SHALL contain at least one [1..*] entryRelationship (CONF:9219) such that it a. SHALL contain exactly one [1..1] @typeCode="COMP" Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:9220). b. SHALL contain exactly one [1..1] Series Act (templateId:2.16.840.1.113883.10.20.22.4.63) (CONF:15937). Figure 237: Study act example ... 6.79 Text Observation [observation: templateId 2.16.840.1.113883.10.20.6.2.12 (open)] Table 302: Text Observation Contexts Used By: Contains Entries: Quantity Measurement Observation SOP Instance Observation DICOM Template 2000 specifies that Imaging Report Elements of Value Type Text are contained in sections. The Imaging Report Elements are inferred from Basic Diagnostic Imaging Report Observations that consist of image references and measurements (linear, area, volume, and numeric). Text DICOM Imaging Report Elements in this context are mapped to CDA text observations that are HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 507 July 2012 © 2012 Health Level Seven, Inc. All rights reserved. section components and are related to the SOP Instance Observations (templateId 2.16.840.1.113883.10.20.6.2.8) or Quantity Measurement Observations (templateId 2.16.840.1.113883.10.20.6.2.14) by the SPRT (Support) act relationship. A Text Observation is required if the findings in the section text are represented as inferred from SOP Instance Observations. Table 303: Text Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.6.2.12'] @classCode 1..1 SHALL 9288 2.16.840.1.113883.5.4 (ActCode) = OBS @moodCode 1..1 SHALL 9289 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL 1..1 SHALL code 1..1 SHALL text 0..1 MAY 9295 reference 0..1 SHOULD 15938 @value 0..1 SHOULD 15939 effectiveTime 0..1 SHOULD TS or IVL 9294 value 1..1 SHALL ED 9292 entryRelationship @root SET 9290 10534 CE 9291 0..* MAY 9298 @typeCode 1..1 SHALL 9299 observation 1..1 SHALL 15941 0..* MAY 9301 @typeCode 1..1 SHALL 9302 observation 1..1 SHALL 15942 entryRelationship 2.16.840.1.113883.10.20.6.2.12 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SPRT 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SPRT 1. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:9288). 2. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:9289). 3. SHALL contain exactly one [1..1] templateId (CONF:9290) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.2.12" (CONF:10534). 4. SHALL contain exactly one [1..1] code with @xsi:type="CE" (CONF:9291). 5. MAY contain zero or one [