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.

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.

Page 2 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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Following is a non-exhaustive list of third-party terminologies that may require a separate license:

Terminology

Owner/Contact

Current Procedures Terminology

(CPT) code set

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resources/solutions-managing-your-practice/coding-billing-

insurance/cpt/cpt-products-services/licensing.page?

SNOMED CT

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Organization (IHTSDO) http://www.ihtsdo.org/snomed-

ct/get-snomed-ct or info@ihtsdo.org

Logical Observation Identifiers

Names & Codes (LOINC)

Regenstrief Institute

International Classification of

Diseases (ICD) codes

World Health Organization (WHO)

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 3

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

Page 4 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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,

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 5

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 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

2 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

Page 6 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

3 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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 7

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

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

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

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

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

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

4 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

Page 8 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

5 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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 9

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

Page 10 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 11

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

6 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

Page 12 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

CD Examples .................................................................................................................. 578

APPENDIX L — LARGE UML DIAGRAMS ......................................................................... 580

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 13

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

Page 14 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 15

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

Page 16 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 17

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

Page 18 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 19

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

Page 20 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 21

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

Page 22 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 23

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

Page 24 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 25

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

Page 26 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 27

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

Page 28 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 29

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

Page 30 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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)

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 31

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

2 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

Page 32 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Healthcare Safety Network3. The Tdb is the source for generation of platform-

independent validation rules as Schematron4 (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 section-

level 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,

3 http://www.lantanagroup.com/resources/tools/

4 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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 33

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 entry-

level 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

Page 34 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 35

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

Card.

Verb

Data

Type

CONF#

Fixed Value

Green

Severity

Observation

observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.8']

@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

SET<II>

7347

@root

1..1

SHALL

10525

2.16.840.1.113883.10.20.22.4.8

code

1..1

SHALL

7349

2.16.840.1.113883.5.4 (ActCode) =

SEV

severity

FreeText

text

0..1

SHOULD

7350

reference

/@value

0..1

SHOULD

7351

statusCode

1..1

SHALL

7352

2.16.840.1.113883.5.14 (ActStatus)

= completed

severity

Coded

value

1..1

SHALL

7356

2.16.840.1.113883.3.88.12.3221.6.8

(Problem Severity)

interpretation

Code

0..*

SHOULD

9117

code

0..1

SHOULD

9118

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).

Page 36 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 37

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).

Page 38 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

... 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).

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 39

The above example would be properly expressed as follows.

Figure 5: XML expression of a single-code binding

<code code="11450-4" codeSystem="2.16.840.1.113883.6.1"

displayName="Problem List"

codeSystemName=”LOINC”/>

A full discussion of the representation of vocabulary is outside the scope of this

document; for more information, see the HL7 V3 Normative Edition 20106

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

<code code='206525008’

displayName='neonatal necrotizing enterocolitis'

codeSystem='2.16.840.1.113883.6.96'

codeSystemName='SNOMED CT'>

<translation code='NEC-1'

displayName='necrotizing enterocolitis'

codeSystem='2.16.840.1.113883.19'/>

</code>

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.

6 HL7 Version 3 Interoperability Standards, Normative Edition 2010.

http://www.hl7.org/memonly/downloads/v3edition.cfm - V32010

Page 40 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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.

7 HL7 Clinical Document Architecture (CDA Release 2)

http://www.hl7.org/implement/standards/cda.cfm

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 41

Figure 8: Attribute required

1. 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).

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

<entry>

<originalText>New Grading system</originalText>

</code>

<originalText>Spiculated mass grade 5</originalText>

</value>

</observation>

</entry>

Figure 10: nullFlavor explicitly disallowed

1. SHALL contain exactly one [1..1] effectiveTime (CONF:5256).

a. SHALL NOT contain [0..0] nullFlavor (CONF:52580).

Page 42 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<entry>

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

was</text>

</manufacturedLabeledDrug>

</manufacturedProduct>

</consumable>

</substanceAdministration>

</entry>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 43

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

<entry>

<substanceAdministration moodCode="EVN" classCode="SBADM"

nullFlavor="NI">

<text>I do not know whether or not patient received an anticoagulant

drug</text>

<code code="81839001" displayName="anticoagulant drug"

codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED CT"/>

</manufacturedLabeledDrug>

</manufacturedProduct>

</consumable>

</substanceAdministration>

</entry>

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

<entry>

<substanceAdministration moodCode="EVN" classCode="SBADM"

negationInd=”true”>

<text>No known medications</text>

<code code="410942007" displayName="drug or medication"

codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED CT"/>

</manufacturedLabeledDrug>

</manufacturedProduct>

</consumable>

</substanceAdministration>

</entry>

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.

8 HL7 Clinical Document Architecture (CDA Release 2).

http://www.hl7.org/implement/standards/cda.cfm

Page 44 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

...

<code codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'

code='17561000' displayName='Cardiologist' />

...

</assignedAuthor>

</author>

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

...

</ClinicalDocument>

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/

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 45

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

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

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

Page 46 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 47

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

Confidentiality Code

Normal

Confidentiality Code

Restricted

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

Internet Society Language

english

Internet Society Language

french

Internet Society Language

arabic

en-US

Internet Society Language

English, US

es-US

Internet Society Language

Spanish, US

…

11 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

Page 48 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 17: US Realm header example

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" code="34117-2"

displayName="History and Physical Note"/>

<title>Good Health History & Physical</title>

<languageCode code="en-US"

displayName="English, US"

codeSystem="2.16.840.1.113883.1.11.11526"

codeSystemName="Internet Society Language"/>

Figure 18: effectiveTime with time zone example

<!-- the syntax is "YYYYMMDDHHMMSS.UUUU[+|-ZZzz]" where digits can be

omitted

the right side to express less precision. -->

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 49

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

Page 50 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 51

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).

Page 52 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

AddressUse

primary home

AddressUse

work place

AddressUse

mobile contact

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

AdministrativeGender

Female

AdministrativeGender

Male

AdministrativeGender

Undifferentiated

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 53

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

MaritalStatus

Annulled

MaritalStatus

Divorced

MaritalStatus

Interlocutory

MaritalStatus

Legally Separated

MaritalStatus

Married

MaritalStatus

Polygamous

MaritalStatus

Never Married

MaritalStatus

Domestic partner

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

…

Page 54 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

…

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 55

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

FIPS 5-2 (State Alpha Codes)

Alabama

FIPS 5-2 (State Alpha Codes)

Alaska

FIPS 5-2 (State Alpha Codes)

Arizona

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 alpha-

2 code of ISO's country code standard

http://www.iso.org/iso/country_codes/iso_3166_code_lists.htm

Code

Code System

Print Name

ISO 3166-1 Country Codes

Aruba

ISO 3166-1 Country Codes

Israel

ISO 3166-1 Country Codes

Kazakhstan

ISO 3166-1 Country Codes

United States

…

Page 56 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

LanguageAbilityProficiency

Excellent

LanguageAbilityProficiency

Fair

LanguageAbilityProficiency

Good

LanguageAbilityProficiency

Poor

3.2.1.7 RecordTarget Example

Figure 19: recordTarget example

<!-- HP is "primary home" from codeSystem 2.16.840.1.113883.5.1119 --

<!-- US is "United States" from ISO 3166-1 Country Codes:

1.0.3166.1 -->

</addr>

<!-- HP is "primary home" from AddressUse 2.16.840.1.113883.5.1119 --

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 57

<given qualifier="CL">Frankie</given>

<!-- CL is "Call me" from EntityNamePartQualifier

2.16.840.1.113883.5.43 -->

<family>Everyman</family>

</name>

<administrativeGenderCode code="M"

codeSystem="2.16.840.1.113883.5.1" displayName="Male"/>

<maritalStatusCode code="M" displayName="Married"

codeSystem="2.16.840.1.113883.5.2"

codeSystemName="MaritalStatusCode"/>

<religiousAffiliationCode code="1013"

displayName="Christian (non-Catholic, non-specific)"

codeSystemName="Religious Affiliation "

codeSystem="2.16.840.1.113883.5.1076"/>

<raceCode code="2106-3" displayName="White"

codeSystem="2.16.840.1.113883.6.238"

codeSystemName="Race & Ethnicity - CDC"/>

<ethnicGroupCode code="2186-5"

displayName="Not Hispanic or Latino"

codeSystem="2.16.840.1.113883.6.238"

codeSystemName="Race & Ethnicity - CDC"/>

<code code="GRFTH" displayName="Grandfather"

codeSystem="2.16.840.1.113883.5.111"

codeSystemName="RoleCode"/>

</addr>

<name>

<given>Ralph</given>

<family>Relative</family>

</name>

</guardianPerson>

</guardian>

<place>

<addr>

</addr>

</place>

</birthplace>

Page 58 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

<modeCode code="RWR" displayName="Receive Written"

codeSystem="2.16.840.1.113883.5.60"

codeSystemName="LanguageAbilityMode"/>

</languageCommunication>

</patient>

<name>Good Health Clinic</name>

<addr>

<streetAddressLine>21 North Ave</streetAddressLine>

<city>Burlington</city>

</addr>

</providerOrganization>

</patientRole>

</recordTarget>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 59

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).

Page 60 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 20: Person author example

<addr>

<streetAddressLine>21 North Ave.</streetAddressLine>

<city>Burlington</city>

</addr>

<name>

<given>Henry</given>

<family>Seven</family>

</name>

</assignedPerson>

</assignedAuthor>

</author>

Figure 21: Device author example

<addr>

<streetAddressLine>21 North Ave.</streetAddressLine>

<city>Burlington</city>

</addr>

<manufacturerModelName>Good Health Medical

Device</manufacturerModelName >

<softwareName>Good Health Report Generator</softwareName >

</ assignedAuthoringDevice >

</assignedAuthor>

</author>

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 61

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).

Page 62 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 22: dataEnterer example

<addr>

<streetAddressLine>21 North Ave.</streetAddressLine>

<city>Burlington</city>

</addr>

<name>

<given>Henry</given>

<family>Seven</family>

</name>

</assignedPerson>

</assignedEntity>

</dataEnterer>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 63

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

<addr>

<streetAddressLine>21 North Ave.</streetAddressLine>

<city>Burlington</city>

</addr>

<name>

<given>Henry</given>

<family>Seven</family>

</name>

</assignedPerson>

</assignedEntity>

</informant>

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).

Page 64 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<name>Good Health Clinic</name>

</addr>

</representedCustodianOrganization>

</assignedCustodian>

</custodian>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 65

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

<name>

<given>Henry</given>

<family>Seven</family>

</name>

</informationRecipient>

<name>Good Health Clinic</name>

</receivedOrganization>

</intendedRecipient>

</informationRecipient>

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).

Page 66 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 67

Figure 26: legalAuthenticator example

<addr>

<streetAddressLine>21 North Ave.</streetAddressLine>

<city>Burlington</city>

</addr>

<name>

<given>Henry</given>

<family>Seven</family>

</name>

</assignedPerson>

</assignedEntity>

</legalAuthenticator>

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

Page 68 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<addr>

<streetAddressLine>21 North Ave.</streetAddressLine>

<city>Burlington</city>

</addr>

<name>

<given>Henry</given>

<family>Seven</family>

</name>

</assignedPerson>

</assignedEntity>

</authenticator>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 69

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-of-

kin)

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):

RoleClass 2.16.840.1.113883.5.110

Code

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

Page 70 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 28: Participant example for a supporting person

</time>

<addr>

</addr>

<name>

<given>Martha</given>

</name>

</associatedPerson>

</associatedEntity>

</participant>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 71

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).

Page 72 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 29: DocumentationOf example

<id extension="123453"

root="1.2.840.113619.2.62.994044785528.26"/>

<code code="93041"

displayName="Rhythm ECG, one to three leads; tracing

only without interpretation and report"

codeSystem="2.16.840.1.113883.6.12"

codeSystemName="CPT4"/>

<code code="208D00000X "

codeSystem="2.16.840.1.113883.6.101"

codeSystemName="NUCC"

displayName="General Practice"/>

<name>

<given>Matthew</given>

</name>

</assignedPerson>

</assignedEntity>

</performer>

</serviceEvent>

</documentationOf>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 73

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

<code codeSystem=" 2.16.840.1.113883.6.1" codeSystemName="LOINC"

code="64293-4" displayName="Procedure consent"/>

</consent>

</authorization>

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).

Page 74 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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 space13 (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):

AddressUse 2.16.840.1.113883.5.1119

Code

Code System

Print Name

BAD

AddressUse

bad address

DIR

AddressUse

direct

AddressUse

home address

AddressUse

primary home

AddressUse

vacation home

PHYS

AddressUse

physical visit address

PST

AddressUse

postal address

PUB

AddressUse

public

TMP

AddressUse

temporary

AddressUse

work place

3.4 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.

13 For information on mixed content see Extensible Markup Language (XML)

(http://www.w3.org/TR/2008/REC-xml-20081126/#sec-mixed-content).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 75

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

Page 76 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

EntityNameUse

Artist/Stage

ABC

EntityNameUse

Alphabetic

ASGN

EntityNameUse

Assigned

EntityNameUse

License

EntityNameUse

Indigenous/Tribal

IDE

EntityNameUse

Ideographic

EntityNameUse

Legal

EntityNameUse

Pseudonym

PHON

EntityNameUse

Phonetic

EntityNameUse

Religious

SNDX

EntityNameUse

Soundex

SRCH

EntityNameUse

SYL

EntityNameUse

Syllabic

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 77

Table 19: EntityPersonNamePartQualifier Value Set

Value Set: EntityPersonNamePartQualifier 2.16.840.1.113883.11.20.9.26 STATIC

2011-09-30

Code System(s):

EntityNamePartQualifier 2.16.840.1.113883.5.43

Code

Code System

Print Name

EntityNamePartQualifier

academic

EntityNamePartQualifier

adopted

EntityNamePartQualifier

birth

EntityNamePartQualifier

callme

EntityNamePartQualifier

initial

EntityNamePartQualifier

nobility

EntityNamePartQualifier

professional

EntityNamePartQualifier

spouse

TITLE

EntityNamePartQualifier

title

EntityNamePartQualifier

voorvoegsel

3.7 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

Page 78 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

 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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 79

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

Page 80 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Document Type

Preferred LOINC

templateId

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*

History of Present Illness

Physical Exam

Reason for Referral/Reason for

Visit16 **

Allergies

Chief Complaint **

Chief Complaint and Reason

for Visit **

Family History

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 CCD is the only document with a fixed clinicalDocument/code

15 Required only for inpatient settings

16 Either Reason for Referral or Reason for Visit must be present.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 81

Document Type

Preferred LOINC

templateId

Required Sections

Optional Sections

Diagnostic Imaging Report

18748-4

2.16.840.1.113883.10.20.22.1.5

DICOM Object Catalog

Findings (Radiology Study

Observation)

Addendum

Clinical Presentation

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

Hospital Course

Hospital Discharge Diagnosis

Hospital Discharge Medications

Plan of Care

Chief Complaint **

Chief Complaint and Reason

for Visit **

Discharge Diet

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

Page 82 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Document Type

Preferred LOINC

templateId

Required Sections

Optional Sections

History & Physical Note

34117-2

2.16.840.1.113883.10.20.22.1.3

Allergies

Assessment and

Plan/Assessment/Plan of

Care*

Chief Complaint **

Chief Complaint and Reason

for Visit **

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

History of Present Illness

Immunizations

Instructions

Problem List

Procedures (List of Surgeries)

(History of Procedures)

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 83

Document Type

Preferred LOINC

templateId

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

N/A

* 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.

Page 84 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<!-- indicates conformance with US Realm Clinical Document Header

template -->

17 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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 85

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

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" code="34133-9"

displayName="Summarization of Episode Note"/>

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

Page 86 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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. SHOULD include zero or one [0..1] id

where id/@root

="2.16.840.1.113883.4.6" National

Provider Identifier (CONF:10027).

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. SHALL contain exactly one [1..1] assignedPerson or exactly one

[1..1] representedOrganization. (CONF:8456).

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 87

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. MAY contain zero or one [0..1] Advance Directives Section

(entries optional)

(templateId:2.16.840.1.113883.10.20.22.2.21) (CONF:9455).

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. MAY contain zero or one [0..1] Payers Section

(templateId:2.16.840.1.113883.10.20.22.2.18) (CONF:9468).

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).

Page 88 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Advance Directives Section (entries

optional)

section

2.16.840.1.113883.10.20.22.2.21

Advance Directive Observation

entry

2.16.840.1.113883.10.20.22.4.48

Allergies Section (entries required)

section

2.16.840.1.113883.10.20.22.2.6.1

Allergy Problem Act

entry

2.16.840.1.113883.10.20.22.4.30

Allergy 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

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 89

Template Title

Template

Type

templateId

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Encounters Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.22

Encounter Activities

entry

2.16.840.1.113883.10.20.22.4.49

Encounter Diagnosis

entry

2.16.840.1.113883.10.20.22.4.80

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

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

Family History Section

section

2.16.840.1.113883.10.20.22.2.15

Family History Organizer

entry

2.16.840.1.113883.10.20.22.4.45

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

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

Page 90 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Template Title

Template

Type

templateId

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

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

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Cognitive Status Result Organizer

entry

2.16.840.1.113883.10.20.22.4.75

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

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Functional Status Problem Observation

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

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Functional Status Result Observation

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

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Functional Status Result Organizer

entry

2.16.840.1.113883.10.20.22.4.66

Functional Status Result Observation

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

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Immunizations Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.2

Immunization Activity

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 91

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 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

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

Page 92 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Medical Equipment Section

section

2.16.840.1.113883.10.20.22.2.23

Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Medications Section (entries required)

section

2.16.840.1.113883.10.20.22.2.1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 93

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

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Payers Section

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

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

Problem Section (entries required)

section

2.16.840.1.113883.10.20.22.2.5.1

Problem Concern Act (Condition)

entry

2.16.840.1.113883.10.20.22.4.3

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

Procedures Section (entries required)

section

2.16.840.1.113883.10.20.22.2.7.1

Procedure Activity Act

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

Page 94 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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

Severity Observation

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 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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 95

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

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

Severity Observation

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

Severity Observation

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

Results Section (entries required)

section

2.16.840.1.113883.10.20.22.2.3.1

Result Organizer

entry

2.16.840.1.113883.10.20.22.4.1

Page 96 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Template Title

Template

Type

templateId

Result Observation

entry

2.16.840.1.113883.10.20.22.4.2

Social History Section

section

2.16.840.1.113883.10.20.22.2.17

Pregnancy Observation

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

Vital Signs Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.4

Vital Signs Organizer

entry

2.16.840.1.113883.10.20.22.4.26

Vital Sign Observation

entry

2.16.840.1.113883.10.20.22.4.27

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)

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 97

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

<!-- indicates conformance with US Realm Clinical Document Header

template -->

<templateId

root=2.16.840.1.113883.10.20.22.1.4'/>

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, 11488-

4 "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).

Page 98 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 99

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

Page 100 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

(scale = nom)

33720-4

Blood bank consult

24611-6

Confirmatory consultation

note

Outpatient

{Provider}

47040-1

Confirmatory consultation

note

{Provider}

47041-9

Confirmatory consultation

note

Inpatient

{Provider}

28569-2

Subsequent evaluation note

Consulting physician

18763-3

Initial evaluation note

Consulting physician

Figure 34: Consultation note ClinicalDocument/code example

<code codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'

code='11488-4' displayName='CONSULTATION NOTE'/>

Figure 35: Consultation note translation of local code example

<code code='34761-7'

displayName='GASTROENTEROLOGY CONSULTATION NOTE'

codeSystem='2.16.840.1.113883.6.1'

codeSystemName='LOINC'>

<translation code='X-GICON'

displayName='GI CONSULTATION NOTE'

codeSystem='2.16.840.1.113883.19'/>

</code>

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 101

Figure 36: Consultation note uncoordinated document type codes example

...

<code codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'

code='11488-4' displayName='CONSULTATION NOTE'/>

<title>Good Health Cardiology Consultation Note</title>

...

<functionCode codeSystem='2.16.840.1.113883.5.88'

codeSystemName='ParticipationFunction'

code='ATTPHYS' />

...

<code codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED

CT'

code='17561000' displayName='Cardiologist' />

...

</assignedAuthor>

</author>

...

...

<code codeSystem='2.16.840.1.113883.5.111'

codeSystemName='RoleCode'

code='HOSP' />

</healthCareFacility>

</encompassingEncounter>

</componentOf>

</ClinicalDocument>

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

</order>

</inFulfillmentOf>

Page 102 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 103

Figure 38: Consultation note componentOf example

<code codeSystem='2.16.840.1.113883.6.12'

codeSystemName='CPT-4'

code='99213'

displayName='Evaluation and Management'/>

...

</encompassingEncounter>

</componentOf>

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. SHALL include an Assessment and Plan Section, or an

Assessment Section and a Plan Section. (CONF:9501).

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).

Page 104 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 105

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

Allergies Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.6

Allergy Problem Act

entry

2.16.840.1.113883.10.20.22.4.30

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

Page 106 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Assessment and Plan Section

section

2.16.840.1.113883.10.20.22.2.9

Plan of Care Activity Act

entry

2.16.840.1.113883.10.20.22.4.39

Assessment Section

section

2.16.840.1.113883.10.20.22.2.8

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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

Family History Organizer

entry

2.16.840.1.113883.10.20.22.4.45

Family History Observation

entry

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Age Observation

entry

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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

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

Immunizations Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.2

Immunization Activity

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

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Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

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Immunization Medication Information

entry

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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

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Medication Information

entry

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Medication Supply Order

entry

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Immunization Medication Information

entry

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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

Precondition for Substance

Administration

entry

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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

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Instructions

entry

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Medication Dispense

entry

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Immunization Medication

Information

entry

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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

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Medication Information

entry

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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

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

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Medication Activity

entry

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Drug Vehicle

entry

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Indication

entry

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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

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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

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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

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 109

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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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Medications Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.1

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

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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

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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

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

Severity Observation

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

Plan of Care Activity Supply

entry

2.16.840.1.113883.10.20.22.4.43

Problem Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.5

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Problem Concern Act (Condition)

entry

2.16.840.1.113883.10.20.22.4.3

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

Procedures Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.7

Procedure Activity Act

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

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

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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

Severity Observation

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 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

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Medication Activity

entry

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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

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

Severity Observation

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

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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

Severity Observation

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

Result Organizer

entry

2.16.840.1.113883.10.20.22.4.1

Result Observation

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

Pregnancy Observation

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

Vital Signs Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.4

Vital Signs Organizer

entry

2.16.840.1.113883.10.20.22.4.26

Vital Sign Observation

entry

2.16.840.1.113883.10.20.22.4.27

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 113

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

<!-- indicates conformance with US Realm Clinical Document Header

template -->

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

Page 114 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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’

Preferred Code

18748-4

Any

Diagnositic

Imaging

Report

Study Report

Diagnostic Imaging

Additional Codes

18747-6

Computed

Tomography

CT Report

Study

18755-9

Magnetic

Resonance

Imaging

MRI Report

Study report

MRI

18760-9

Ultrasound

Report

Study

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

/Fluoro-

scopy

Cardiac

Catheteriza

tion Report

Study report

Heart

Cardiac

catheterization

11522-0

Cardiac

Ultrasound

Echocardio

graphy

Report

Study report

Heart

Cardiac echo

18746-8

Colonoscopy

Colon-

oscopy

Report

Study report

Lower GI

tract

Colonoscopy

18751-8

Endoscopy

Report

Study report

Upper GI

tract

Endoscopy

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 115

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

<code code="18748-4"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Diagnostic Imaging Report"/>

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

type

<code code="18748-4"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Diagnostic Imaging Report”>

<translation code='XRPEDS'

displayName='Pediatric Radiography Report'

codeSystem='2.16.840.1.123456.78.9'/>

</code>

4.3.1.4 InformationRecipient

5. SHALL NOT contain [0..0] informant (CONF:8410).

6. MAY contain zero or more [0..*] informationRecipient (CONF:8411).

a. The physician requesting the imaging procedure

(ClincalDocument/participant[@typeCode=REF]/associatedEntity), if

present, SHOULD also be recorded as an informationRecipient, unless

in the local setting another physician (such as the attending

physician for an inpatient) is known to be the appropriate recipient of

the report. (CONF:8412).

b. When no referring physician is present, as in the case of self-referred

screening examinations allowed by law, the intendedRecipient MAY be

absent. The intendedRecipient MAY also be the health chart of the

patient, in which case the receivedOrganization SHALL be the scoping

organization of that chart. (CONF:8413).

4.3.1.5 Participant

7. MAY contain zero or one [0..1] participant (CONF:8414) such that it

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a. If participant is present, the assignedEntity/assignedPerson element

SHALL be present and SHALL represent the physician requesting the

imaging procedure (the referring physician AssociatedEntity that is

the target of ClincalDocument/participant@typeCode=REF).

(CONF:8415).

i. This SHALL contain exactly one [1..1] US Realm Person Name

(PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5)

(CONF:9406).

Figure 42: DIR participant example

<name>

<given>Amanda</given>

<family>Assigned</family>

</name>

</associatedPerson>

</associatedEntity>

</participant>

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 117

In both cases, inFulfillmentOf/order/id is mapped to the DICOM Accession

Number in the imaging data.

Figure 43: DIR inFulfillmentOf example

<order>

</order>

</inFulfillmentOf>

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)

0..* serviceEvent

typeCode*: <= DOC

documentationOf

ServiceEvent

classCode*: <= ACT

moodCode*: <= EVN

id: SET<II> [0..*]

code: CE CWE [0..1]

effectiveTime: IVL<TS> [0..1]

0..* assignedEntity

performer

typeCode*: <= x_ServiceEventPerformer

functionCode: CE CWE [0..1] <= ParticipationFunction

time: IVL<TS> [0..1]

0..1 assignedPerson

0..1 representedOrganization

AssignedEntity

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)

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

Page 118 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="71020"

displayName="Radiologic examination, chest, two views,

frontal and lateral

codeSystem="2.16.840.1.113883.6.12"

codeSystemName="CPT4"/>

<code code="2085R0202X" codeSystem="2.16.840.1.113883.6.101"

codeSystemName="NUCC"

displayName="Diagnostic Radiology"/>

<name>

<given>Christine</given>

</name>

</assignedPerson>

</assignedEntity>

</performer>

</serviceEvent>

</documentationOf>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 119

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

<id

root="1.2.840.113619.2.62.994044785528.20060823.200608232232322.9"/>

</parentDocument>

</relatedDocument>

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

Page 120 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 121

Figure 47: DIR componentOf example

<code code="208D00000X" codeSystem="2.16.840.1.113883.6.101"

codeSystemName="NUCC"

displayName="General Practice"/>

<name>

<family>Family</family>

</name>

</assignedPerson>

</assignedEntity>

</encounterParticipant>

</encompassingEncounter>

</componentOf>

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. SHALL 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).

c. Every assignedEntity element SHALL have at least one assignedPerson

or representedOrganization. (CONF:8429).

Figure 48: Physician reading study performer example

<code code="2085R0202X"

codeSystem="2.16.840.1.113883.6.101"

codeSystemName="NUCC"

displayName="Diagnostic Radiology"/>

<name>

<given>Christine</given>

</name>

</assignedPerson>

</assignedEntity>

</performer>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 123

i. SHALL 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).

c. This assignedEntity SHOULD contain zero or one [0..1] name

(CONF:8890).

Figure 49: Physician of record participant example

<code code="208D00000X"

codeSystem="2.16.840.1.113883.6.101"

codeSystemName="NUCC"

displayName="General Practice"/>

<name>

<family>Family</family>

</name>

</assignedPerson>

</assignedEntity>

</encounterParticipant>

21 DICOM Part 16 (NEMA PS3.16), page 631 in the 2011 edition. See

ftp://medical.nema.org/medical/dicom/2011/11_16pu.pdf

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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

Study Act

entry

2.16.840.1.113883.10.20.6.2.6

Series Act

entry

2.16.840.1.113883.10.20.22.4.63

SOP Instance Observation

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

Boundary Observation

entry

2.16.840.1.113883.10.20.6.2.11

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:

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

22 SCALE_TYP = 'NAR' in the LOINC tables.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 125

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

121060

History

11329-0

HISTORY GENERAL

121062

Request

55115-0

REQUESTED IMAGING

STUDIES INFORMATION

121064

Current Procedure

Descriptions

55111-9

CURRENT IMAGING

PROCEDURE DESCRIPTIONS

121066

Prior Procedure

Descriptions

55114-3

PRIOR IMAGING PROCEDURE

DESCRIPTIONS

121068

Previous Findings

18834-2

RADIOLOGY COMPARISON

STUDY - OBSERVATION

121070

Findings (DIR)

18782-3

RADIOLOGY STUDY

OBSERVATION

121072

Impressions

19005-8

RADIOLOGY - IMPRESSION

121074

Recommendations

18783-1

RADIOLOGY STUDY -

RECOMMENDATION

121076

Conclusions

55110-1

CONCLUSIONS

121078

Addendum

55107-7

ADDENDUM

121109

Indications for

Procedure

18785-6

RADIOLOGY REASON FOR

STUDY

121110

Patient Presentation

55108-5

CLINICAL PRESENTATION

121113

Complications

55109-3

COMPLICATIONS

121111

Summary

55112-7

DOCUMENT SUMMARY

121180

Key Images

55113-5

KEY IMAGES

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 127

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

<text>

...

<caption>Source of Measurement</caption>

<linkHtml

href="http://www.example.org/wado?requestType=WADO&studyUID=1.2.840.1

13619.2.62.994044785528.114289542805&seriesUID=1.2.840.113619.2.62.99

4044785528.20060823223142485051&objectUID=1.2.840.113619.2.62.9940447

85528.20060823.200608232232322.3&contentType=application/dicom">Chest

_PA</linkHtml>

</paragraph>

...

</text>

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

Page 128 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="121026"

codeSystem="1.2.840.10008.2.16.4"

displayName="Fetus"/>

<name>fetus_1</name>

</subject>

</relatedSubject>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 129

Figure 52: Observer context example

<name>

<given>Richard</given>

<family>Blitz</family>

</name>

</assignedPerson>

</assignedAuthor>

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.

Page 130 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<!—indicates conformance to Discharge Summary -->

23 Joint Commission Requirements for Discharge Summary (JCAHO IM.6.10 EP7). See

http://www.jointcommission.org/NR/rdonlyres/C9298DD0-6726-4105-A007-

FE2C65F77075/0/CMS_New_Revised_HAP_FINAL_withScoring.pdf..

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 131

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’

Preferred Code

18842-5

Discharge summarization

note

{Setting}

{Provider}

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

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" code="18842-5"

displayName="DISCHARGE SUMMARIZATION NOTE"/>

Page 132 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 133

Table 29: HL7 Discharge Disposition Codes

Code System: HL7 Discharge Disposition 2.16.840.1.113883.12.112

Code

Print Name

Discharged to home or self care (routine discharge)

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

care

Discharged/transferred to skilled nursing facility (SNF)

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

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

referred for outpatient services to another institution

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

organization

Left against medical advice or discontinued care

Discharged/transferred to home under care of Home IV provider

Admitted as an inpatient to this hospital

10 …19

Discharge to be defined at state level, if necessary

Expired (i.e., dead)

21 ... 29

Expired to be defined at state level, if necessary

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)

Expired (i.e., died) at home

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

standing hospice

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

Figure 55: Discharge summary componentOf example

</effectiveTime>

<dischargeDispositionCode code="01"

codeSystem="2.16.840.1.113883.12.112"

displayName="Routine Discharge"

codeSystemName="HL7 Discharge Disposition"/>

</encompassingEncounter>

</componentOf>

Page 134 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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. SHALL contain exactly one [1..1] Allergies Section

(entries optional)

(templateId:2.16.840.1.113883.10.20.22.2.6)

(CONF:9542).

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 135

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).

Page 136 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 137

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

Template

Type

templateId

Discharge Summary

document

2.16.840.1.113883.10.20.22.1.8

Allergies Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.6

Allergy Problem Act

entry

2.16.840.1.113883.10.20.22.4.30

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

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

Page 138 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Severity Observation

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

Family History Organizer

entry

2.16.840.1.113883.10.20.22.4.45

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

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

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

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

Product Instance

entry

2.16.840.1.113883.10.20.22.4.37

Cognitive Status Result Organizer

entry

2.16.840.1.113883.10.20.22.4.75

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Cognitive Status Result Observation

entry

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Assessment Scale Observation

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Caregiver Characteristics

entry

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Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

Product Instance

entry

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Functional Status Problem

Observation

entry

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Assessment Scale Observation

entry

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Caregiver Characteristics

entry

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Non-Medicinal Supply Activity

entry

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Product Instance

entry

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Functional Status Result Observation

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Assessment Scale Observation

entry

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Caregiver Characteristics

entry

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Non-Medicinal Supply Activity

entry

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Product Instance

entry

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Functional Status Result Organizer

entry

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Functional Status Result

Observation

entry

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Assessment Scale Observation

entry

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Caregiver Characteristics

entry

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Non-Medicinal Supply Activity

entry

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Product Instance

entry

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Non-Medicinal Supply Activity

entry

2.16.840.1.113883.10.20.22.4.50

Product Instance

entry

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History of Past Illness Section

section

2.16.840.1.113883.10.20.22.2.20

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

Hospital Admission Diagnosis Section

section

2.16.840.1.113883.10.20.22.2.43

Hospital Admission Diagnosis

entry

2.16.840.1.113883.10.20.22.4.34

Problem Observation

entry

2.16.840.1.113883.10.20.22.4.4

Age Observation

entry

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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

Hospital Admission Medications Section

(entries optional)

section

2.16.840.1.113883.10.20.22.2.44

Admission Medication

entry

2.16.840.1.113883.10.20.22.4.36

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Type

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Medication Activity

entry

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entry

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Indication

entry

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Instructions

entry

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Medication Dispense

entry

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Immunization Medication

Information

entry

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Medication Information

entry

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Medication Supply Order

entry

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Immunization Medication

Information

entry

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Instructions

entry

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Medication Information

entry

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Medication Information

entry

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Medication Supply Order

entry

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Immunization Medication

Information

entry

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Instructions

entry

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Medication Information

entry

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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

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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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Hospital Consultations Section

section

2.16.840.1.113883.10.20.22.2.42

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

Hospital Discharge Diagnosis

entry

2.16.840.1.113883.10.20.22.4.33

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

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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Type

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Drug Vehicle

entry

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Indication

entry

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Instructions

entry

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Medication Dispense

entry

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Immunization Medication

Information

entry

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Medication Information

entry

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Medication Supply Order

entry

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Immunization Medication

Information

entry

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Instructions

entry

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Medication Information

entry

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Medication Information

entry

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Medication Supply Order

entry

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Immunization Medication

Information

entry

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Instructions

entry

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Medication Information

entry

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Precondition for Substance

Administration

entry

2.16.840.1.113883.10.20.22.4.25

Reaction Observation

entry

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Procedure Activity Procedure

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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Severity Observation

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

2.16.840.1.113883.10.20.22.2.16

Immunizations Section (entries

optional)

section

2.16.840.1.113883.10.20.22.2.2

Immunization Activity

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

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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

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Type

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Medication Information

entry

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Medication Supply Order

entry

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Immunization Medication

Information

entry

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Instructions

entry

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Medication Information

entry

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Medication Supply Order

entry

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Immunization Medication

Information

entry

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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

Precondition for Substance

Administration

entry

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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

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Immunization Medication

Information

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

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Instructions

entry

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Medication Information

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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

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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Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

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Immunization Medication

Information

entry

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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

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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

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

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

Problem Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.5

Problem Concern Act (Condition)

entry

2.16.840.1.113883.10.20.22.4.3

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

Procedures Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.7

Procedure Activity Act

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

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Indication

entry

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Instructions

entry

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Medication Dispense

entry

2.16.840.1.113883.10.20.22.4.18

Immunization Medication

Information

entry

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Medication Information

entry

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Medication Supply Order

entry

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Immunization Medication

Information

entry

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Instructions

entry

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Medication Information

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Medication Information

entry

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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

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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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Severity Observation

entry

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Service Delivery Location

entry

2.16.840.1.113883.10.20.22.4.32

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

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Instructions

entry

2.16.840.1.113883.10.20.22.4.20

Medication Dispense

entry

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Immunization 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

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Medication Information

entry

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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

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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

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

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Severity Observation

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

entry

2.16.840.1.113883.10.20.22.4.25

Page 146 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Template Title

Template

Type

templateId

Administration

Reaction Observation

entry

2.16.840.1.113883.10.20.22.4.9

Severity Observation

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

Pregnancy Observation

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

Vital Signs Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.4

Vital Signs Organizer

entry

2.16.840.1.113883.10.20.22.4.26

Vital Sign Observation

entry

2.16.840.1.113883.10.20.22.4.27

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 147

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

<!-- indicates conformance with US Realm Clinical Document Header

template -->

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 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.

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).

Page 148 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Nursing home

51849-8

Admission History & Physical

47039-3

Admission History & Physical

Inpatient

34763-3

Admission History & Physical

General medicine

34094-3

Admission History & Physical

Hospital

Cardiology

34138-8

Targeted History & Physical

Figure 57: H&P ClinicalDocument/code example

<code codeSystem='2.16.840.1.113883.6.1'

codeSystemName='LOINC'

code='34117-2'

displayName='HISTORY and PHYSICAL'/>

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

<code code='34117-2'

displayName='HISTORY and PHYSICAL'

codeSystem='2.16.840.1.113883.6.1'

codeSystemName='LOINC'>

<translation code='X-GISOE'

displayName='GI HISTORY and PHYSICAL'

codeSystem='2.16.840.1.113883.19'/>

</code>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 149

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

Page 150 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code codeSystem='2.16.840.1.113883.6.12' codeSystemName='CPT-4'

code='99213' displayName='Evaluation and Management'/>

</effectiveTime>

</encompassingEncounter>

</componentOf>

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)

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 151

(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).

Page 152 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Allergies Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.6

Allergy Problem Act

entry

2.16.840.1.113883.10.20.22.4.30

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 153

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

Immunization Medication

entry

2.16.840.1.113883.10.20.22.4.54

Page 154 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Template Title

Template

Type

templateId

Information

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Assessment and Plan Section

section

2.16.840.1.113883.10.20.22.2.9

Plan of Care Activity Act

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 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

Family History Organizer

entry

2.16.840.1.113883.10.20.22.4.45

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

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

Immunizations Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.2

Immunization Activity

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 155

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

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

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

Page 156 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Medications Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.1

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

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 157

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

Problem Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.5

Problem Concern Act (Condition)

entry

2.16.840.1.113883.10.20.22.4.3

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

Procedures Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.7

Procedure Activity Act

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

Procedure Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.14

Page 158 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Severity Observation

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 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

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

Severity Observation

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 159

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

Severity Observation

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

Results Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.3

Result Organizer

entry

2.16.840.1.113883.10.20.22.4.1

Result Observation

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

Pregnancy Observation

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

Vital Signs Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.4

Vital Signs Organizer

entry

2.16.840.1.113883.10.20.22.4.26

Vital Sign Observation

entry

2.16.840.1.113883.10.20.22.4.27

Page 160 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<!-- indicates conformance with US Realm Clinical Document Header

template -->

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.

http://www.jointcommission.org/mobile/standards_information/jcfaqdetails.aspx?Stan

dardsFAQId=215&StandardsFAQChapterId=13

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 161

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 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: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’

Preferred Code

11504-8

Surgical operation

note

{Setting}

{Provider}

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

Page 162 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 61: Operative note ClinicalDocument/code example

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"code="11504-8"

displayName="SURGICAL OPERATION NOTE"/>

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), 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: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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 163

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).

Page 164 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="801460020"

codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED CT"

displayName="Laparoscopic Appendectomy"/>

</effectiveTime>

...

</serviceEvent>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 165

Figure 63: Operative note performer example

<code code="2086S0120X" codeSystem="2.16.840.1.113883.6.101"

codeSystemName="NUCC" displayName="Pediatric Surgeon"/>

<addr>

<streetAddressLine>1013 Healthcare Drive</streetAddressLine>

<city>Ann Arbor</city>

</addr>

<name>

<family>Cutter</family>

</name>

</assignedPerson>

</assignedEntity>

</performer>

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. SHALL contain exactly one [1..1] Anesthesia Section

(2.16.840.1.113883.10.20.22.2.25) (CONF:9883).

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).

Page 166 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 167

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

Anesthesia Section

section

2.16.840.1.113883.10.20.22.2.25

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

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

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

Page 168 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Severity Observation

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

Complications Section

section

2.16.840.1.113883.10.20.22.2.37

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

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

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

Planned Procedure Section

section

2.16.840.1.113883.10.20.22.2.30

Plan of Care Activity Procedure

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 169

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

Indication

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

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 non-

operative 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, post-

procedure 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).

Page 170 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<!-- indicates conformance with US Realm Clinical Document Header

template -->

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 171

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’

Preferred Code

28570-0

Procedure note

{Setting}

{Provider}

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

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

code="28570-0"

displayName="PROCEDURE NOTE"/>

Page 172 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Custo-

dian

Data

Enterer

Encom-

passing

Encounter/

Encounter

Participant

Legal

Authen-

ticator

Parti-

cipant

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.

Endo-

scopic

CDA

Procedure

Note

Endo-

scopist

Out-

patient

surgery

center

None

Surgeon

[REF

(referrer)]

Endo-

scopist

None

Endoscopis

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 173

Scenario

Author

Custo-

dian

Data

Enterer

Encom-

passing

Encounter/

Encounter

Participant

Legal

Authen-

ticator

Parti-

cipant

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

office

Transcrip-

tionist

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

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

Interven-

tional

radiology

fellow

Good

Health

Hospita

Interven-

tional

radiology

technician

REF

(referrer)

Oncologist

Attending

interven-

tional

radiolo-

gist

Cigna

Interven-

tional

radiology

fellow

Nurse

Attending

interven-

tional

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

Transcrip-

tionist

None

Neurology

attending

(Intern is

authen-

ticator)

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

Page 174 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 175

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):

NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101

Code

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

Page 176 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Value Set: Healthcare Provider Taxonomy (NUCC - HIPAA) 2.16.840.1.114222.4.11.1066

DYNAMIC

Code System(s):

NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101

Code

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

<code code="118155006" codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED CT"

displayName="Gastrointestinal tract endoscopy"/>

</effectiveTime>

...

</serviceEvent>

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

<code code="118155006" codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED CT"

displayName="Gastrointestinal tract endoscopy"/>

</effectiveTime>

...

</serviceEvent>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 177

Figure 68: Procedure note performer example

<code code="207RG0100X"

codeSystem="2.16.840.1.113883.6.96"

codeSystemName="NUCC"

displayName="Gastroenterologist" />

<addr>

<streetAddressLine>1001 Hospital Lane</streetAddressLine>

<city>Ann Arbor</city>

</addr>

<name>

</name>

</assignedEntity>

</performer>

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)

Page 178 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 179

(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).

Page 180 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Allergies Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.6

Allergy Problem Act

entry

2.16.840.1.113883.10.20.22.4.30

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

Indication

entry

2.16.840.1.113883.10.20.22.4.19

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 181

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Anesthesia Section

section

2.16.840.1.113883.10.20.22.2.25

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

Page 182 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

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

Severity Observation

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

Assessment and Plan Section

section

2.16.840.1.113883.10.20.22.2.9

Plan of Care Activity Act

entry

2.16.840.1.113883.10.20.22.4.39

Assessment Section

section

2.16.840.1.113883.10.20.22.2.8

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

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

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

Family History Section

section

2.16.840.1.113883.10.20.22.2.15

Family History Organizer

entry

2.16.840.1.113883.10.20.22.4.45

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

History of Past Illness Section

section

2.16.840.1.113883.10.20.22.2.20

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

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

Page 184 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Template Title

Template

Type

templateId

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Medications Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.1

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

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

Severity Observation

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 185

Template Title

Template

Type

templateId

Plan of Care Activity Supply

entry

2.16.840.1.113883.10.20.22.4.43

Planned Procedure Section

section

2.16.840.1.113883.10.20.22.2.30

Plan of Care Activity Procedure

entry

2.16.840.1.113883.10.20.22.4.41

Postprocedure Diagnosis Section

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

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

Indication

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

Procedure Activity Act

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

Page 186 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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

Severity Observation

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 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

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 187

Template Title

Template

Type

templateId

Severity Observation

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

Severity Observation

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

Pregnancy Observation

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

Page 188 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<!-- indicates conformance with US Realm Clinical Document Header

template -->

25 Taber's Cyclopedic Medical Dictionary, 21st Edition, F.A. Davis Company.

http://www.tabers.com

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 189

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).

Page 190 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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’

Preferred Code

11506-3

Subsequent evaluation note

{Setting}

{Provider}

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

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" code="11056-3"

displayName="Subsequent evaluation note"/>

<title>Progress Note</title>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 191

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

such that it

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

</effectiveTime>

...

</serviceEvent>

</documentationOf>

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.

Page 192 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

</effectiveTime>

</healthCareFacility>

</location>

</encompassingEncounter>

</componentOf>

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 193

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. SHALL include an Assessment and Plan Section, or an

Assessment Section and a Plan Section. (CONF:8704).

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).

MAY contain zero or one [0..1] Assessment and Plan

Section (templateId:2.16.840.1.113883.10.20.22.2.9)

(CONF:8774).

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).

Page 194 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

Allergies Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.6

Allergy Problem Act

entry

2.16.840.1.113883.10.20.22.4.30

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 195

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

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Severity Observation

entry

2.16.840.1.113883.10.20.22.4.8

Assessment and Plan Section

section

2.16.840.1.113883.10.20.22.2.9

Plan of Care Activity Act

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

Instructions

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

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

Page 196 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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

Severity Observation

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

Problem Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.5

Problem Concern Act (Condition)

entry

2.16.840.1.113883.10.20.22.4.3

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 197

Template Title

Template

Type

templateId

Results Section (entries optional)

section

2.16.840.1.113883.10.20.22.2.3

Result Organizer

entry

2.16.840.1.113883.10.20.22.4.1

Result Observation

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

Vital Signs Organizer

entry

2.16.840.1.113883.10.20.22.4.26

Vital Sign Observation

entry

2.16.840.1.113883.10.20.22.4.27

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 XDS-

SD and US Realm Clinical Document Header Comparison and ensure that your

Page 198 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

27 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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 199

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).

Page 200 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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 well-

formed, 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

<text mediaType="text/rtf" representation="B64">e1xydGY...</text>

</nonXMLBody>

</component>

Figure 74: nonXMLBody example with referenced content

<text>

</text>

</nonXMLBody>

</component>

Figure 75: nonXMLBody example with compressed content

<text mediaType="text/rtf" representation="B64"

compression="DF">dhUhkasd437hbjfQS7…</text>

</nonXMLBody>

</component>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 201

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 specification28 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 http://www.hl7.org/v3ballot/html/infrastructure/datatypes/datatypes.htm

Page 202 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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 globally-

unique 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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 203

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 specification29, 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.

http://www.hl7.org/v3ballot/html/infrastructure/cda/cda.htm

Page 204 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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 entry-

level 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.

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

Section

Name

LOINC

templateId

Coded Entries Required

Coded Entries Optional

CCD

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

Stage 1 Meaningful Use

Advance

Directives

42348-3

(no coded entries required)

2.16.840.1.113883.10.20.22.2.21

–

Addendum

55107-7

–

Allergies

48765-2

2.16.840.1.113883.10.20.22.2.6.1

2.16.840.1.113883.10.20.22.2.6

–

Anesthesia

59774-0

(no coded entries required)

2.16.840.1.113883.10.20.22.2.25

–

Assessment

51848-0

(no coded entries required)

2.16.840.1.113883.10.20.22.2.8

–

Assessment

and Plan**

51847-2

(no coded entries required)

2.16.840.1.113883.10.20.22.2.9

–

Chief

Complaint***

10154-3

1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1

–

Chief

Complaint

and Reason

for Visit***

46239-0

(no coded entries required)

2.16.840.1.113883.10.20.22.2.13

–

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 205

Section

Name

LOINC

templateId

Coded Entries Required

Coded Entries Optional

CCD

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

Stage 1 Meaningful Use

Clinical

Presentation

55108-5

–

Complica-

tions

55109-3

(no coded entries required)

2.16.840.1.113883.10.20.22.2.37

–

Conclusions

55110-1

–

Current

Imaging

Procedure

Descriptions

55111-9

–

DICOM

Object

Catalog

121181

(DCM)

2.16.840.1.113883.10.20.6.1.1

–

Discharge

Diet

42344-2

(no coded entries required)

1.3.6.1.4.1.19376.1.5.3.1.3.33

–

Document

Summary

55112-7

–

Encounters

46240-8

(no coded entries required)

2.16.840.1.113883.10.20.22.2.22

–

Family

History

10157-6

—

2.16.840.1.113883.10.20.22.2.15

–

Findings

(Radiology

Study -

Observation)

18782-3

(no coded entries required)

2.16.840.1.113883.10.20.6.1.2

–

Functional

Status

47420-5

(no coded entries required)

2.16.840.1.113883.10.20.22.2.14

–

General

Status

10210-3

(no coded entries required)

2.16.840.1.113883.10.20.2.5

–

History of

Past Illness

(Past Medical

History)

11348-0

(no coded entries required)

2.16.840.1.113883.10.20.22.2.20

–

History of

Present

Illness

10164-2

(no coded entries required)

1.3.6.1.4.1.19376.1.5.3.1.3.4

–

Page 206 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Section

Name

LOINC

templateId

Coded Entries Required

Coded Entries Optional

CCD

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

Stage 1 Meaningful Use

Hospital

Admission

Diagnosis

46241-6

(no coded entries required)

2.16.840.1.113883.10.20.22.2.43

–

Hospital

Consultation

18841-7

(no coded entries required)

2.16.840.1.113883.10.20.22.2.42

–

Hospital

Course

8648-8

(no coded entries required)

1.3.6.1.4.1.19376.1.5.3.1.3.5

–

Hospital

Discharge

Diagnosis

11535-2

(no coded entries required)

2.16.840.1.113883.10.20.22.2.24

–

Hospital

Discharge

Instructions

8653-8

(no coded entries required)

2.16.840.1.113883.10.20.22.2.41

–

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

–

Hospital

Discharge

Physical

10184-0

(no coded entries required)

1.3.6.1.4.1.19376.1.5.3.1.3.26

–

Hospital

Discharge

Studies

Summary

11493-4

(no coded entries required)

2.16.840.1.113883.10.20.22.2.16

–

Immuniza-

tions

11369-6

2.16.840.1.113883.10.20.22.2.2.1

2.16.840.1.113883.10.20.22.2.2

–

Instructions

69730-0

(no coded entries required)

2.16.840.1.113883.10.20.22.2.45

–

Interventions

62387-6

(no coded entries required)

2.16.840.1.113883.10.20.21.2.3

–

Key Images

55113-5

–

Medical

Equipment

46264-8

(no coded entries required)

2.16.840.1.113883.10.20.22.2.23

–

Medical

(General)

History

11329-0

2.16.840.1.113883.10.20.22.2.39

–

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 207

Section

Name

LOINC

templateId

Coded Entries Required

Coded Entries Optional

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

–

Medications

Administered

29549-3

(no coded entries required)

2.16.840.1.113883.10.20.22.2.38

–

Objective

61149-1

(no coded entries required)

2.16.840.1.113883.10.20.21.2.1

–

Operative

Note Fluids

10216-0

(no coded entries required)

2.16.840.1.113883.10.20.7.12

–

Operative

Note Surgical

Procedure

10223-6

(no coded entries required)

2.16.840.1.113883.10.20.7.14

–

Payers

48768-6

(no coded entries required)

2.16.840.1.113883.10.20.22.2.18

–

Physical

Exam

29545-1

(no coded entries required)

2.16.840.1.113883.10.20.2.10

–

Plan of

Care**

18776-5

(no coded entries required)

2.16.840.1.113883.10.20.22.2.10

–

Planned

Procedure

59772-4

(no coded entries required)

2.16.840.1.113883.10.20.22.2.30

–

Post-

operative

Diagnosis

10218-6

(no coded entries required)

2.16.840.1.113883.10.20.22.2.35

–

Post-

procedure

Diagnosis

59769-0

(no coded entries required)

2.16.840.1.113883.10.20.22.2.36

–

Preoperative

Diagnosis

10219-4

(no coded entries required)

2.16.840.1.113883.10.20.22.2.34

–

Prior Imaging

Procedure

Descriptions

55114-3

(no coded entries required)

–

Problem

11450-4

2.16.840.1.113883.10.20.22.2.5.1

2.16.840.1.113883.10.20.22.2.5

–

Procedure

Description

29554-3

(no coded entries required)

2.16.840.1.113883.10.20.22.2.27

–

Procedure

Disposition

59775-7

(no coded entries required)

2.16.840.1.113883.10.20.18.2.12

–

Page 208 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Section

Name

LOINC

templateId

Coded Entries Required

Coded Entries Optional

CCD

Consultation Note

Diagnostic Imaging Report

Discharge Summary

H&P Note

Operative Note

Procedure Note

Progress Note

Unstructured Document

Stage 1 Meaningful Use

Procedure

Estimated

Blood Loss

59770-8

(no coded entries required)

2.16.840.1.113883.10.20.18.2.9

–

Procedure

Findings

59776-5

(no coded entries required)

2.16.840.1.113883.10.20.22.2.28

–

Procedure

Implants

59771-6

(no coded entries required)

2.16.840.1.113883.10.20.22.2.40

–

Procedure

Indications

59768-2

(no coded entries required)

2.16.840.1.113883.10.20.22.2.29

–

Procedure

Specimens

Taken

59773-2

(no coded entries required)

2.16.840.1.113883.10.20.22.2.31

–

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

–

Radiology

Comparison

Study –

Observation

18834-2

–

Radiology –

Impression

19005-8

–

Radiology

Study –

Recommenda

tions

18783-1

–

Radiology

Reason for

Study

18785-6

–

Reason for

Referral****

42349-1

(no coded entries required)

1.3.6.1.4.1.19376.1.5.3.1.3.1

–

Reason for

Visit***

29299-5

2.16.840.1.113883.10.20.22.2.12

–

Requested

Imaging

Studies

Information

55115-0

–

30 Required only for inpatient settings

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 209

Section

Name

LOINC

templateId

Coded Entries Required

Coded Entries Optional

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

–

Review of

Systems

10187-3

(no coded entries required)

1.3.6.1.4.1.19376.1.5.3.1.3.18

–

Social

History

29762-2

(no coded entries required)

2.16.840.1.113883.10.20.22.2.17

–

Subjective

61150-9

(no coded entries required)

2.16.840.1.113883.10.20.21.2.2

–

Surgical

Drains

11537-8

(no coded entries required)

2.16.840.1.113883.10.20.7.13

–

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

–

– 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

Page 210 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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)

Coded entries required:

---

Advance Directive Observation

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 211

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

<title>Advance Directives</title>

<text>

...

</text>

<entry>

...

</observation>

</entry>

</section>

Page 212 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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)

Coded entries required:

Continuity of Care Document (CCD) (required)

Allergy Problem Act

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 213

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

<code code="48765-2"

displayName="Allergies, adverse reactions, alerts"

codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>

<title>Allergies</title>

<text>

...

</text>

...

</act>

</entry>

</section>

Page 214 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 215

Figure 81: Anesthesia section example

<code code="59774-0"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="PROCEDURE ANESTHESIA"/>

<title>Procedure Anesthesia</title>

<text> Conscious sedation with propofol 200 mg IV </text>

<entry>

...

</procedure>

</entry>

<entry>

...

</subtanceAdministration>

</entry>

</section>

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).

Page 216 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" code="51847-2"

displayName="ASSESSMENT AND PLAN"/>

<title>ASSESSMENT AND PLAN</title>

<text>

...

</text>

<entry>

...

</act>

</entry>

</section>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 217

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

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" code="51848-0"

displayName="ASSESSMENTS"/>

<title>ASSESSMENTS</title>

<text>

...

</text>

</section>

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).

Page 218 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 84: Chief complaint and reason for visit section example

<code code="46239-0"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="CHIEF COMPLAINT AND REASON FOR VISIT"/>

<title> CHIEF COMPLAINT</title>

</section>

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

<code code="10154-3"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="CHIEF COMPLAINT"/>

<title> CHIEF COMPLAINT</title>

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 219

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

<code code="55109-3" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Complications"/>

<title>Complications</title>

<text>Asthmatic symptoms while under general anesthesia.</text>

<entry>

...

</observation>

</entry>

</section>

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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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 221

Figure 87: DICOM object catalog section example

<code code="121181" codeSystem="1.2.840.10008.2.16.4"

codeSystemName="DCM" displayName="DICOM Object Catalog"/>

<entry>

<code code="113014" codeSystem="1.2.840.10008.2.16.4"

codeSystemName="DCM" displayName="Study"/>

<id

root="1.2.840.113619.2.62.994044785528.20060823223142485051"/>

<code code="113015" codeSystem="1.2.840.10008.2.16.4"

codeSystemName="DCM" displayName="Series">

...

</code>

...

</observation>

</entryRelationship>

...

</observation>

</entryRelationship>

</act>

</entryRelationship>

</act>

</entry>

</section>

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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

<code code="42344-2"

displayName="DISCHARGE DIET"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"/>

<title>Discharge Diet</title>

<text> Low-fat, low-salt, cardiac diet </text>

</section>

5.11 Encounters Section 46240-8

Table 55: Encounters Section Contexts

Used By:

Contains Entries:

Coded entries optional:

Continuity of Care Document (CCD) (optional)

Coded entries required:

---

Encounter Activities

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 223

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-to-

face 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

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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

<code code="46240-8" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="History of encounters"/>

<title>Encounters</title>

<text>

...

</text>

...

</encounter>

</entry>

</section>

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 225

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

<title>Family history</title>

<text>

...

</text>

...

</organizer>

</entry>

</section>

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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 guidelines31 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

<code code="121070"

codeSystem="1.2.840.10008.2.16.4"

codeSystemName="DCM"

displayName="Findings"/>

<title>Findings</title>

<text>

<caption>Finding</caption>

<content ID="Fndng2">The cardiomediastinum is . </content>

</paragraph>

<caption>Diameter</caption>

</paragraph>

...

</text>

<entry>

...

</entry>

</section>

31 http://www.hl7.org/special/committees/terminfo/index.cfm

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 227

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

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 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

Functional Status

Cognitive Status

Problem/Condition/Symptom

Dysphagia

Dementia

Orthopnea

Chronic confusion

Shortness of Breath

Depressed mood

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 229

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

Assessment

Question/Answer

Eating

Independent

Partial/Moderate

Assistance

Substantial Assistance

Dependent

Disorganized thinking

Behavior not present

Behavior continuously present

Behavior present, fluctuates

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).

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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

<title>Functional Status</title>

<text>

<thead>

<tr>

<th>Functional and Cognitive Assessment</th>

<th>March 23 to March 25, 2012</th>

<th>Condition Status</th>

</tr>

</thead>

<tbody>

<tr>

<td>Dependence on cane</td>

<td>Active</td>

</tr>

<tr>

<td>Memory impairment</td>

<td>Active</td>

</tr>

</tbody>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 231

</table>

</text>

...

</entry>

...

</entry>

...

</entry>

...

</entry>

...

</entry>

...

</entry>

...

</entry>

...

</entry>

...

</entry>

...

</section>

Page 232 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="10210-3"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="GENERAL STATUS" />

<title>GENERAL STATUS</title>

<text>

<paragraph>Alert and in good spirits, no acute distress.

</paragraph>

</text>

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 233

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

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" code="11348-0"

displayName="HISTORY OF PAST ILLNESS"/>

<title>PAST MEDICAL HISTORY</title>

<text>

<paragraph>Patient has had ..... </paragraph>

</text>

<entry>

...

</observation>

</entry>

</section>

Page 234 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"

code="10164-2"

displayName="HISTORY OF PRESENT ILLNESS"/>

<title>HISTORY OF PRESENT ILLNESS</title>

<text>

<paragraph>This patient was only recently discharged for a recurrent

GI bleed as described below.</paragraph>

<paragraph>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 .... .... .... </paragraph>

<paragraph>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.</paragraph>

<paragraph>He was transfused with 6 units of packed red blood cells

with .... .... ....</paragraph>

<paragraph>GI evaluation 12 September: Colonoscopy showed single red

clot in .... .... ....</paragraph>

</text>

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 235

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

<code code="46241-6" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Hospital Admission Diagnosis"/>

<title>HOSPITAL ADMISSION DIAGNOSIS</title>

<text>Appendicitis</text>

<entry>

<!—Hospital Admission Diagnosis template -->

...

</entry>

</section>

Page 236 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="42346-7"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="ADMISSION MEDICATIONS"/>

<title>Hospital Admission Medications</title>

<text>

...

</text>

...

</act>

</entry>

...

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 237

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

<code code="18841-7" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Hospital Consultations Section"/>

<title>HOSPITAL CONSULTATIONS</title>

<text>

<item>Gastroenterology</item>

<item>Cardiology</item>

<item>Dietitian</item>

</list>

</text>

</section>

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.

Page 238 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="8648-8"

displayName="HOSPITAL COURSE"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"/>

<title>Hospital Course</title>

<text> The patient was admitted and started on Lovenox and

nitroglycerin paste. The patient had ... </text>

</section>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 239

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

<code code="11535-2" displayName="Hospital Discharge Diagnosis"

codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>

<title>Hospital Discharge Diagnosis</title>

<text>Diverticula of intestine</text>

<entry>

<!—Hospital discharge Diagnosis act -->

...

</act>

</entry>

</section>

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).

Page 240 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 104: Hospital discharge instructions section example

<code code="8653-8" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="HOSPITAL DISCHARGE INSTRUCTIONS"/>

<title>HOSPITAL DISCHARGE INSTRUCTIONS</title>

<text>

<item>Take all of your prescription medication as directed.</item>

<item>Make an appointment with your doctor to be seen two weeks

from the

date of your procedure.</item>

<item>You may feel slightly bloated after the procedure because of

air

that was introduced during the examination.</item>

<item>Call your physician if you notice:<br/>

Bleeding or black stools.<br/>

Abdominal pain.<br/>

Fever or chills.<br/>

Nausea or vomiting.<br/>

Any unusual pain or problem.<br/>

Pain or redness at the site where the intravenous needle was

placed.<br/>

</item>

<item>Do not drink alcohol for 24 hours. Alcohol amplifies the

effect of

the sedatives given.</item>

<item>Do not drive or operate machinery for 24 hours.</item>

</list>

</text>

</section>

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)

Coded entries required:

---

Discharge Medication

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 241

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).

Page 242 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 105: Hospital discharge medications section example

<code code="10183-2"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName=" HOSPITAL DISCHARGE MEDICATIONS"/>

<title>Hospital Discharge Medications</title>

<text>

...

</text>

...

</act>

</entry>

...

</section>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 243

Figure 106: Hospital discharge physical section example

<code code="10184-0"

displayName="HOSPITAL DISCHARGE PHYSICAL"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"/>

<title>Hospital Discharge Physical</title>

<text>GENERAL: Well-developed, slightly obese man. <br/>

NECK: Supple, with no jugular venous distension. <br/>

HEART: Intermittent tachycardia without murmurs or

gallops.<br/>

PULMONARY: Decreased breath sounds, but no clear-cut rales

wheezes. <br/>

EXTREMITIES: Free of edema.</text>

</section>

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.

Page 244 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="11493-4"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="HOSPITAL DISCHARGE STUDIES SUMMARY"/>

<title>Hospital Discharge Studies Summary</title>

<text>

...

</text>

</section>

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)

Coded entries required:

---

Immunization Activity

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 245

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)

Page 246 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 109: Immunization section example

<code code="11369-6"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="History of immunizations"/>

<title>Immunizations</title>

<text>

<thead>

<tr>

<th>Vaccine</th>

<th>Status</th>

</tr>

</thead>

<tbody>

<tr>

<td>

<content ID="immun1"/>Influenza virus vaccine, IM</td>

<td>Completed</td>

</tr>

<tr>

<td>

<content ID="immun2"/>Influenza virus vaccine, IM</td>

<td>Completed</td>

</tr>

<tr>

<td>

Pneumococcal polysaccharide vaccine, IM</td>

<td>Completed</td>

</tr>

<tr>

<td>

<content ID="immun4"/>Tetanus and diphtheria toxoids, IM</td>

<td>Refused</td>

</tr>

</tbody>

</table>

</text>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 247

<substanceAdministration classCode="SBADM" moodCode="EVN"

negationInd="false">

...

</substanceAdministration>

</entry>

...

</section>

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).

Page 248 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 110: Instructions section example

<code code="69730-0" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="INSTRUCTIONS"/>

<title>INSTRUCTIONS</title>

<text>

Patient may have low grade fever, mild joint pain and injection area

tenderness

</text>

...

</supply>

</act>

</section>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 249

Figure 111: Interventions section example

<code code="62387-6" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="INTERVENTIONS PROVIDED"/>

<title>INTERVENTIONS PROVIDED</title>

<text>

<item>Therapeutic exercise intervention: knee

extension, 3 sets, 10 repetitions, 10-lb weight. </item>

<item>Therapeutic exercise intervention: arm curl, 3 sets, 10

repetitions, 15-lb weight </item>

</list>

</text>

</section>

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).

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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

<title>Medical Equipment</title>

<text>

...

</text>

...

</supply>

</entry>

</section>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 251

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

<code code="11329-0" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="MEDICAL (GENERAL) HISTORY"/>

<title>MEDICAL (GENERAL) HISTORY</title>

<text>

<item>Patient has had recent issue with acne that does not seem to

be related to any particular cause.</item>

<item>Previous concerns of oral cancer was actually irritated gums

as a result of mild food allergy.</item>

<item>Patient had recent weight gain due to sedentary lifestyle and

new job.</item>

</list>

</text>

</section>

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).

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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

<code code="29549-3"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="MEDICATIONS ADMINISTERED" />

<title>Medications Administered</title>

<text>Secretin 100 IU administered IV</text>

<entry>

...

</entry>

</section>

5.33 Medications Section 10160-0

Table 79: Medications Section Contexts

Used By:

Contains Entries:

Coded entries optional:

Progress Note (optional)

Consultation Note (optional)

History and Physical (required)

Procedure Note (optional)

Coded entries required:

Continuity of Care Document (CCD) (required)

Medication Activity

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 253

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).

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Figure 117: Medications section entries example

<code code="10160-0"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="HISTORY OF MEDICATION USE"/>

<title>MEDICATIONS</title>

<text>

...

</text>

...

</substanceAdministration>

</entry>

</section>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 255

Figure 118: Objective section example

<code code="61149-1 " codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="OBJECTIVE DATA "/>

<title>OBJECTIVE DATA</title>

<text>

<item>Chest: clear to ausc. No rales, normal breath sounds</item>

<item>Heart: RR, PMI in normal location and no heave or evidence

cardiomegaly,normal heart sounds, no murm or gallop</item>

</list>

</text>

</section>

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).

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Figure 119: Operative Note fluid section example

<code code="10216-0"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="SURGICAL OPERATION NOTE FLUIDS"/>

<title>Operative Note Fluids</title>

<text>250 ML Ringers Lactate</text>

</section>

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

<code code="10223-6"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="SURGICAL OPERATION NOTE SURGICAL PROCEDURE"/>

<title>Surgical Procedure</title>

<text>Laparoscopic Appendectomy</text>

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 257

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).

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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

<code code="48768-6" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="Payments"/>

<title>Insurance Providers</title>

<text>

<thead>

<tr>

<th>Payer name</th>

<th>Policy type / Coverage type</th>

<th>Policy ID</th>

<th>Covered party ID</th>

<th>Policy Holder</th>

</tr>

</thead>

<tbody>

<tr>

<td>Good Health Insurance</td>

<td>Extended healthcare / Family</td>

<td>Contract Number</td>

<td>Patient's Mother</td>

</tr>

</tbody>

</table>

</text>

...

</act>

</entry>

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 259

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).

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Figure 123: Physical exam section example

<code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"

code="29545-1" displayName="PHYSICAL FINDINGS"/>

<title>PHYSICAL EXAMINATION</title>

<text>

<paragraph>All normal to examination.</paragraph>

</text>

</section>

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 Activity Act

Plan of Care Activity Encounter

Plan of Care Activity Observation

Plan of Care Activity Procedure

Plan of Care Activity Substance Administration

Plan of Care Activity 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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 261

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

<code code="18776-5" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="Treatment plan"/>

<text>

...

</text>

<!-- **** Plan of Care Activity Observation template **** --

...

</observation>

</entry>

Page 262 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

<entry>

...

</act>

</entry>

<entry>

...

</encounter>

</entry>

<entry>

...

</procedure>

</entry>

<entry>

<!-- **** Plan of Care Activity Substance Administration **** --

...

</substanceAdministration>

</entry>

<entry>

...

</supply>

</entry>

</section>

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 263

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

<code code="59772-4" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="Planned Procedure"/>

<title>Planned Procedure</title>

<text>

...

</text>

<entry>

...

</procedure>

</entry>

</section>

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

Page 264 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="10218-6"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="POSTOPERATIVE DIAGNOSIS"/>

<title>Postoperative Diagnosis</title>

<text>Appendicitis with periappendiceal abscess</text>

</section>

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 pre-

procedure 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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 265

Figure 128: Postprocedure diagnosis section example

<code code="59769-0" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="POSTPROCEDURE DIAGNOSIS"/>

<title>Postprocedure Diagnosis</title>

<text>

...

</text>

<entry>

...

</act>

</entry>

</section>

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).

Page 266 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 129: Preoperative diagnosis section example

<code code="10219-4"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="SURGICAL OPERATION NOTE PREOPERATIVE DX"/>

<title>Preoperative Diagnosis</title>

<text>Appendicitis</text>

<entry>

...

</act>

</entry>

</section>

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)

Entries required:

Continuity of Care Document (CCD) (required)

Problem Concern Act (Condition)

Figure 130: Problem section UML diagram

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 267

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).

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Figure 131: Problem section example

<code code="11450-4" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="PROBLEM LIST"/>

<title>PROBLEMS</title>

<text>

<item>Pneumonia: Resolved in March 1998 </item>

</list>

</text>

...

</act>

</entry>

</section>

Figure 132: Pressure ulcer on a problem list example

<code code="11450-4" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="PROBLEM LIST"/>

<title>Problems</title>

<text>

<item>2 Stage 3 Pressure Ulcers</item>

</list>

</text>

<code code="CONC" displayName="Concern"

codeSystem="2.16.840.1.113883.5.6"

codeSystemName="HL7ActClass"/>

</effectiveTime>

</act>

</entry>

</section>

</component>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 269

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

<code code="29554-3"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="PROCEDURE DESCRIPTION" />

<title>Procedure Description</title>

<text>The patient was taken to the endoscopy suite where ...

</text>

</section>

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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

<code code="59775-7" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="PROCEDURE DISPOSITION"/>

<title>PROCEDURE DISPOSITION</title>

<text>The patient was taken to the Endoscopy Recovery Unit in stable

condition.</text>

</section>

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 271

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

<code code="59770-8" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="PROCEDURE ESTIMATED BLOOD

LOSS"/>

<title>Procedure Estimated Blood Loss</title>

<text>Minimal</text>

</section>

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).

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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

<code code="59776-5"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="PROCEDURE FINDINGS" />

<title>Procedure Findings</title>

<text>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.</text>

<entry>

...

</observation>

</entry>

</section>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 273

Figure 137: Procedure implants section example

<code code="59771-6" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="PROCEDURE IMPLANTS"/>

<title>Procedure Implants</title>

<text>No implants were placed.</text>

</section>

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).

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Figure 138: Procedure indications section example

<code code="59768-2" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="PROCEDURE INDICATIONS"/>

<title>Procedure Indications</title>

<text>The procedure is performed for screening in a low risk

individual.

</text>

<entry>

...

</observation>

</entry>

</section>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 275

Figure 139: Procedure specimens taken section example

<code code="59773-2"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="PROCEDURE SPECIMENS TAKEN"/>

<title>Procedure Specimens Taken</title>

<text>Ascending colon polyp</text>

</section>

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)

Entries required:

Continuity of Care Document (CCD) (optional)

Procedure Activity Act

Procedure Activity Observation

Procedure Activity Procedure

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).

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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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 277

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

<code code="47519-4"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="PROCEDURES" />

<title>Procedures</title>

<text>

...

</text>

...

</procedure>

</entry>

...

</observation>

</entry>

<entry>

...

</act>

</entry>

</section>

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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

<code codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" code="42349-1"

displayName="REASON FOR REFERRAL"/>

<title>REASON FOR REFERRAL</title>

<text>

<paragraph>Lumbar spinal stenosis with radiculopathy.</paragraph>

</text>

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 279

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

<code code="29299-5"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="REASON FOR VISIT"/>

<title>REASON FOR VISIT</title>

<text>

<paragraph>Dark stools.</paragraph>

</text>

</section>

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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)

Coded entries required:

CCD (required)

Results Organizer

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 281

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).

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Figure 145: Results section example

<code code="30954-2"

codeSystem="2.16.840.1.113883.6.1"/>

codeSystemName="LOINC"

displayName="RESULTS" />

<title>Results</title>

<text>

...

</text>

...

</organizer>

</entry>

</section>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 283

Figure 146: Review of systems section example

<code code="10187-3" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="REVIEW OF SYSTEMS"/>

<title>REVIEW OF SYSTEMS</title>

<text>

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.

</paragraph>

</text>

</section>

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).

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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

<code code="29762-2" codeSystem="2.16.840.1.113883.6.1"

displayName="Social History"/>

<title>Social History</title>

<text>

...

</text>

...

</observation>

</entry>

...

</observation>

</entry>

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 285

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

<code code="61150-9" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="SUBJECTIVE"/>

<title>SUBJECTIVE DATA</title>

<text>

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

a recliner.

</paragraph>

</text>

</section>

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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

<code code="11537-8"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="SURGICAL DRAINS"/>

<title>Surgical Drains</title>

<text>Penrose drain placed</text>

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 287

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)

Entries required:

---

Vital Signs Organizer

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).

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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

<code code="8716-3"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="VITAL SIGNS" />

<title>Vital Signs</title>

<text>

...

</text>

...

</organizer>

</entry>

</section>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 289

6 ENTRY- L EVEL 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 edition32.

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.

32 HL7 Clinical Document Architecture (CDA Release 2).

http://www.hl7.org/implement/standards/cda.cfm

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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

@root

1..1

SHALL

16759

2.16.840.1.113883.10.20.2

2.4.36

code

1..1

SHALL

15518

@code

0..1

MAY

15519

2.16.840.1.113883.6.1

(LOINC) = 42346-7

entryRelationship

1..*

SHALL

7701

@typeCode

1..1

SHALL

7702

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) =

SUBJ

substanceAdministration

1..1

SHALL

15520

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

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 291

Figure 153: Admission medication entry example

<entry>

<code code="42346-7"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Admission medication"/>

</effectiveTime>

...

</substanceAdministration>

</entryRelationship>

</act>

</entry>

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.

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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

SET<II>

8655

@root

1..1

SHALL

10485

2.16.840.1.113883.10.20.2

2.4.48

1..*

SHALL

8654

Advance

Directive

Type

code

1..1

SHALL

8651

2.16.840.1.113883.1.11.20.

(AdvanceDirectiveTypeCode)

statusCode

1..1

SHALL

8652

2.16.840.1.113883.5.14

(ActStatus) = completed

effective

Date

effectiveTime

1..1

SHALL

TS or

IVL<TS>

8656

low

1..1

SHALL

8657

high

1..1

SHALL

8659

participant

1..*

SHOULD

8662

@typeCode

1..1

SHALL

8663

2.16.840.1.113883.5.90

(HL7ParticipationType) =

VRF

templateId

1..1

SHALL

SET<II>

8664

@root

1..1

SHALL

10486

2.16.840.1.113883.10.20.1.

time

0..1

SHOULD

IVL<TS>

8665

participant

Role

1..1

SHALL

8825

custodian

of the

Document

participant

1..1

SHOULD

8667

@typeCode

1..1

SHALL

8668

2.16.840.1.113883.5.90

(HL7ParticipationType) =

CST

participant

Role

1..1

SHALL

8669

@classCode

1..1

SHALL

8670

2.16.840.1.113883.5.110

(RoleClass) = AGNT

addr

0..1

SHOULD

SET<AD>

8671

telecom

0..1

SHOULD

SET<TEL

8672

playingEntity

1..1

SHALL

8824

name

1..1

SHALL

8673

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 293

Name

XPath

Card.

Verb

Data

Type

CONF#

Fixed Value

reference

1..*

SHOULD

8692

@typeCode

1..1

SHALL

8694

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) =

REFR

external

Document

1..1

SHALL

8693

1..*

SHALL

8695

text

0..1

MAY

8696

@mediaType

0..1

MAY

8703

reference

0..1

MAY

8697

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 <low> 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 <high> element SHALL have

the nullFlavor attribute set to UNK (CONF:8660).

ii. If the Advance Directive does not have a specified ending time,

the <high> 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

i. SHALL contain exactly one [1..1]

@root="2.16.840.1.113883.10.20.1.58" (CONF:10486).

Page 294 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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 <name> element inside the <playingEntity>

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 295

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):

SNOMED CT 2.16.840.1.113883.6.96

Code

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

<code code="304251008"

codeSystem="2.16.840.1.113883.6.96"

displayName="Resuscitation"/>

</effectiveTime>

<value xsi:type="CD" code="304253006"

codeSystem="2.16.840.1.113883.6.96"

displayName="Do not resuscitate">

</originalText>

</value>

<name>

<family>Dolin</family>

<given>Robert</given>

</name>

</playingEntity>

</participantRole>

</participant>

Page 296 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

<addr>

<streetAddressLine>21 North Ave.</streetAddressLine>

<city>Burlington</city>

</addr>

<name>

<family>Dolin</family>

<given>Robert</given>

</name>

</playingEntity>

</participantRole>

</participant>

<reference

value="AdvanceDirective.b50b7910-7ffb-4f4c-bbe4-

177ed68cbbf3.pdf"/>

</text>

</externalDocument>

</reference>

</observation>

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").

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 297

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

SET<II>

7899

@root

1..1

SHALL

10487

2.16.840.1.113883.10.20.22.4.31

code

1..1

SHALL

7615

@code

1..1

SHALL

16776

2.16.840.1.113883.6.96 (SNOMED-

CT) = 445518008

statusCode

1..1

SHALL

15965

@code

1..1

SHALL

15966

2.16.840.1.113883.5.14 (ActStatus) =

completed

value

1..1

SHALL

7617

@unit

1..1

SHALL

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).

Page 298 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

UCUM

Hour

UCUM

Day

UCUM

Week

UCUM

Month

UCUM

Year

Figure 155: Age observation example

<code code="397659008"

codeSystem="2.16.840.1.113883.6.96"

displayName="Age"

codeSystemName="SNOMED CT"/>

</observation>

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 299

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.

Verb

Data

Type

CONF#

Fixed Value

Allergy –

Intolerance

Observation

observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.7']

@classCode

1..1

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

SET<I

7381

@root

1..1

SHALL

10488

2.16.840.1.113883.10.20.22.4.

1..*

SHALL

7382

code

1..1

SHALL

15947

@code

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

adverseEve

Date

effectiveTime

1..1

SHALL

TS or

IVL<T

7387

value

1..1

SHALL

7390

adverseEve

Type

@code

1..1

SHALL

9139

2.16.840.1.113883.3.88.12.32

21.6.2 (Allergy/Adverse Event

Type)

originalText

0..1

SHOULD

7422

reference

0..1

MAY

15949

@value

0..1

SHOULD

15950

product

participant

0..1

SHOULD

7402

@typeCode

1..1

SHALL

7403

2.16.840.1.113883.5.90

(HL7ParticipationType) = CSM

productDet

ail

participantRole

1..1

SHALL

7404

Page 300 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Name

XPath

Card.

Verb

Data

Type

CONF#

Fixed Value

@classCode

1..1

SHALL

7405

2.16.840.1.113883.5.110

(RoleClass) = MANU

playingEntity

1..1

SHALL

7406

@classCode

1..1

SHALL

7407

2.16.840.1.113883.5.41

(EntityClass) = MMAT

product

Coded

code

1..1

SHALL

7419

productFree

Text

originalText

0..1

SHOULD

7424

reference

0..1

SHOULD

7425

@value

0..1

SHOULD

15952

translation

0..*

MAY

SET<P

QR>

7431

entryRelations

hip

0..1

MAY

7440

@typeCode

1..1

SHALL

7906

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) =

SUBJ

@inversionInd

1..1

SHALL

7446

true

observation

1..1

SHALL

15954

reaction

entryRelations

hip

0..*

SHOULD

7447

@typeCode

1..1

SHALL

7907

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) =

MFST

@inversionInd

1..1

SHALL

7449

true

observation

1..1

SHALL

15955

severity

entryRelations

hip

0..1

SHOULD

9961

@typeCode

1..1

SHALL

9962

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) =

SUBJ

@inversionInd

1..1

SHALL

9964

true

observation

1..1

SHALL

15956

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 301

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).

Page 302 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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:15953).

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 303

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-A277-

DE11-9B52-0015173D1785

Code

Code System

Print Name

420134006

SNOMED CT

Propensity to adverse reactions (disorder)

418038007

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)

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-971C-

DF11-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]

…

Page 304 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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-971C-

DF11-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-A277-

DE11-9B52-0015173D1785

Code

Code System

Print Name

N0000011161

NDF-RT

Cephalosporins

N0000005909

NDF-RT

2-Propanol

N0000006629

NDF-RT

Filgrastim

…

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 305

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)METHYL-

PHOSPHONIC ACID

L0VRY82PKO

UNII

CYCLOHEXENE, 4-[(1Z)-1,5-DIMETHYL-1,4-

HEXADIEN-1-YL]-1-METHYL-

62H4W26906

UNII

BISNAFIDE

QE1QX6B99R

UNII

PEANUT

…

Figure 156: Allergy - intolerance observation example

</effectiveTime>

<value xsi:type="CD" code="282100009"

displayName="Adverse reaction to substance"

codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED CT">

</originalText>

</value>

Page 306 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

<code code="QE1QX6B99R" displayName="PEANUT"

codeSystem="2.16.840.1.113883.4.9" codeSystemName=" UNII">

</originalText>

</code>

<name>Penicillin</name>

</playingEntity>

</participantRole>

</participant>

</observation>

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 307

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

SET<II>

7471

@root

1..1

SHALL

10489

2.16.840.1.113883.10.20.22.4.30

1..*

SHALL

7472

code

1..1

SHALL

7477

2.16.840.1.113883.6.1 (LOINC) = 48765-

statusCode

1..1

SHALL

7485

2.16.840.1.113883.11.20.9.19

(ProblemAct statusCode)

effectiveTime

1..1

SHALL

TS or

IVL<TS>

7498

Entry

Relationship

1..*

SHALL

7509

@typeCode

1..1

SHALL

7915

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

Page 308 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="48765-2"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Allergies, adverse reactions, alerts"/>

</effectiveTime>

...

</observation>

</entryRelationship>

</act>

</entry>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 309

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

SET<II>

7317

@root

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)

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).

Page 310 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="33999-4"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Status"/>

<value xsi:type="CE" code="55561003"

codeSystem="2.16.840.1.113883.6.96"

displayName="Active"/>

</observation>

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.)

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 311

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

@root

1..1

SHALL

14437

2.16.840.1.113883.10.20.22.4.69

1..*

SHALL

14438

code

1..1

SHALL

14439

derivationExpr

0..1

MAY

14637

statusCode

1..1

SHALL

14444

2.16.840.1.113883.5.14

(ActStatus) = completed

effectiveTime

1..1

SHALL

14445

value

1..1

SHALL

14450

interpretationCode

0..*

MAY

14459

translation

0..*

MAY

14888

author

0..*

MAY

14460

entryRelationship

0..*

SHOULD

14451

@typeCode

1..1

SHALL

16741

COMP

observation

1..1

SHALL

16742

referenceRange

0..*

MAY

16799

observationRange

1..1

SHALL

16800

text

0..1

SHOULD

16801

reference

0..1

SHOULD

16802

@value

0..1

MAY

16803

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).

Page 312 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 313

Figure 159: Assessment scale observation example

...

<!—Assessment Scale Observation -->

<code code="248241002" displayName="Brief Interview for Mental

Status"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"/>

<derivationExpr>Text description of the

calculation</derivationExpr>

<code code="52731-7" displayName="Repetition of Three Words"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"/>

<value xsi:type="CD" code="LA6395-3" displayName="Three"

codeSystem="2.16.840.1.113883.6.1"/>

</observation

</entryRelationship>

<code code="52732-5"

displayName="Temporal orientation - current year"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"/>

<value xsi:type="CD" code="LA10966-2"

displayName="Missed by 2-5 years"

codeSystem="2.16.840.1.113883.6.1"/>

</observation>

</entryRelationship>

Page 314 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

<code code="248240001" displayName="motor response"

codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED"/>

</observation>

</entryRelationship>

</observation>

</entry>

...

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

SET<II>

16722

@root

1..1

SHALL

16723

2.16.840.1.113883.10.20.22.4.86

1..*

SHALL

16724

code

1..1

SHALL

16717

@code

1..1

SHALL

16738

statusCode

1..1

SHALL

16720

2.16.840.1.113883.5.14 (ActStatus) =

completed

value

1..*

SHALL

16754

1. SHALL contain exactly one [1..1] @classCode="OBS" Observation

(CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:16715).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 315

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

<code code="248240001" displayName="motor response"

codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED"/>

</observation>

</entryRelationship>

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.

Page 316 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

SET<II>

8946

@root

1..1

SHALL

10529

2.16.840.1.113883.10.20.1.19

1..1

SHALL

8947

entry

Relationship

1..*

SHALL

8948

@typeCode

1..1

SHALL

8949

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

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 317

Figure 161: Authorization activity example

<code code="73761001"

codeSystem="2.16.840.1.113883.6.96"

displayName="Colonoscopy"/>

</procedure>

</entryRelationship>

</act>

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

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).

Page 318 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

<code code="113036"

codeSystem="1.2.840.10008.2.16.4"

displayName="Frames for Display"/>

</observation>

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 319

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

@root

1..1

SHALL

14222

2.16.840.1.113883.10.20.22.4.72

1..*

SHALL

14223

code

1..1

SHALL

14230

statusCode

1..1

SHALL

14233

2.16.840.1.113883.5.14 (ActStatus) =

Completed

value

1..1

SHALL

14599

participant

0..*

SHALL

14227

time

0..1

MAY

14830

low

1..1

SHALL

14831

high

0..1

MAY

14832

participantRole

1..1

SHALL

14228

@classCode

1..1

SHALL

14229

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).

Page 320 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

...

...

<value xsi:type="CD" code="422615001"

codeSystem="2.16.840.1.113883.6.96"

displayName="caregiver difficulty providing physical

care"/>

<code code="MTH" codeSystem="2.16.840.1.113883.5.111"

displayName="Mother"/>

</participantRole>

</participant>

</observation>

</entryRelationship>

</observation>

</entry>

...

</section>

Figure 164: Caregiver characteristics example without assertion

<code code="404684003"

codeSystem="2.16.840.1.113883.6.96"

displayName="Finding of Functional Performance and activity"/>

</effectiveTime>

<value xsi:type="CD" code=" 424445006"

codeSystem="2.16.840.1.113883.6.96"

displayName="difficulty with dressing upper body"/>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 321

<code code=" 5267-7" codeSystem="2.16.840.1.113883.6.1"

displayName=" ADL or IADL assistance from any caregiver”

<value xsi:type="CD" code=" 422615001"

codeSystem="2.16.840.1.113883.6.96"

displayName="caregiver difficulty providing physical care"/>

<code code="MTH" codeSystem="2.16.840.1.113883.5.111"

displayName="Mother"/>

</participantRole>

</participant>

</observation>

</entryRelationship>

</observation>

</entryRelationship>

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.

Page 322 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

@root

1..1

SHALL

15524

2.16.840.1.113883.10.20.6.2.13

code

1..1

SHALL

9307

effectiveTime

0..1

SHOULD

TS or

IVL<TS>

9309

value

1..1

SHALL

9308

entryRelationship

0..*

MAY

9311

@typeCode

1..1

SHALL

9312

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = SPRT

entryRelationship

0..*

MAY

9314

@typeCode

1..1

SHALL

9315

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

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

a. SHALL contain exactly one [1..1] @typeCode="SPRT" Has Support

(CodeSystem: HL7ActRelationshipType

2.16.840.1.113883.5.1002) (CONF:9315).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 323

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

<code code="18782-3" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Study observation"/>

<value xsi:type="CD" code="309530007"

codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED CT"

displayName="Hilar mass"/>

<!-- entryRelationship elements referring to SOP Instance Observations

or Quantity Measurement Observations may appear here -->

</observation>

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.

Page 324 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

@root

1..1

SHALL

14347

2.16.840.1.113883.10.20.22.4.73

1..1

SHALL

14321

code

1..1

SHALL

14804

@code

0..1

SHOULD

14805

2.16.840.1.113883.6.96 (SNOMED-

CT) = 373930000

text

0..1

SHOULD

14341

reference/

@value

0..1

SHOULD

14342

statusCode

1..1

SHALL

14323

2.16.840.1.113883.5.14 (ActStatus)

= completed

effective

Time

0..1

SHOULD

TS or

IVL<TS>

14324

value

1..1

SHALL

14349

2.16.840.1.113883.3.88.12.3221.7.

4 (Problem)

Method

Code

0..*

MAY

14693

entry

Relationship

0..*

MAY

14331

@typeCode

1..1

SHALL

14588

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = REFR

supply

1..1

SHALL

14351

entry

Relationship

0..*

SHALL

14335

@typeCode

1..1

SHALL

14589

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = REFR

observation

1..1

SHALL

14352

entry

Relationship

0..*

SHALL

14467

@typeCode

1..1

SHALL

14590

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = COMP

observation

1..1

SHALL

14468

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 325

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

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).

Page 326 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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):

SNOMED CT 2.16.840.1.113883.6.96

Description:

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 327

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

<code code="373930000"

codeSystem="2.16.840.1.113883.6.96"

displayName="Cognitive Function Finding"/>

<text>

...

</text>

</effectiveTime>

<value xsi:type="CD" code=" 371632003"

codeSystem="2.16.840.1.113883.6.96" displayName=" Comatose"/>

<!—Caregiver Characteristics -->

...

</observation>

</entryRelationship>

<!—Assessment Scale Observation -->

...

</observation>

</entryRelationship>

</observation>

Page 328 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

SET<II>

14255

@root

1..1

SHALL

14256

2.16.840.1.113883.10.20.22.4.74

1..*

SHALL

14257

code

1..1

SHALL

14591

@code

0..1

SHOULD

14592

2.16.840.1.113883.6.96 (SNOMED-CT)

= 373930000

text

0..1

SHOULD

14258

reference/

@value

0..1

SHOULD

14259

statusCode

1..1

SHALL

14254

2.16.840.1.113883.5.14 (ActStatus) =

completed

effectiveTime

1..1

SHALL

TS or

IVL<TS>

14261

value

1..1

SHALL

14263

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 329

Name

XPath

Card.

Verb

Data

Type

CONF#

Fixed Value

interpretationCode

0..*

SHOULD

14264

methodCode

0..1

MAY

SET<CE>

14265

targetSiteCode

0..1

MAY

SET<CD>

14270

author

0..1

MAY

14266

entryRelationship

0..*

MAY

14272

@typeCode

1..1

SHALL

14593

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = REFR

supply

1..1

SHALL

14273

entryRelationship

0..*

MAY

14276

@typeCode

1..1

SHALL

14594

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = REFR

observation

1..1

SHALL

14277

entryRelationship

0..*

MAY

14469

@typeCode

1..1

SHALL

14595

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = COMP

observation

1..1

SHALL

14470

referenceRange

0..*

SHOULD

14267

observationRange

1..1

SHALL

14268

code

0..0

SHALL

NOT

14269

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).

Page 330 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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

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

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 331

Figure 167: Cognitive status result observation example

<!—Cognitive Status Result Oservation template -->

<code code="5249-2"

displayName="Observational Assessment of Cognitive Status

at 2D Assessment"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"/>

<code code="61372001" displayName="Aggressive behavior"

codeSystem="2.16.840.1.113883.5.83"

codeSystemName="SNOMED CT"/>

<!—- Assessment Scale Observation -->

...

</observation>

</entryRelationship>

<!—Caregiver Support and Ablility -->

...

</observation>

</entryRelationship>

</observation>

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.

Page 332 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

SET<II>

14375

@root

1..1

SHALL

14376

2.16.840.1.113883.10.20.22.4.75

1..*

SHALL

14377

code

1..1

SHALL

14378

@code

0..1

SHOULD

14697

statusCode

1..1

SHALL

14372

2.16.840.1.113883.5.14 (ActStatus) =

completed

component

1..*

SHALL

14373

observation

1..1

SHALL

14381

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 333

Figure 168 Cognitive status result organizer example

<code code="d3" displayName="Communication"

codeSystem="2.16.840.1.113883.6.254" codeSystemName="ICF"/>

<!-- Cognitive Status Result observation

(Understanding Verbal Content) -->

...

</observation>

</component>

...

</observation>

</component>

</organizer>

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.

Page 334 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

SET<II>

9427

@root

1..1

SHALL

10491

2.16.840.1.113883.10.20.22.4

.64

code

1..1

SHALL

9428

2.16.840.1.113883.6.1

(LOINC) = 48767-8

text

1..1

SHALL

9430

free

Text

Comment

reference/@value

1..1

SHALL

9431

author

0..1

MAY

9433

time

1..1

SHALL

IVL<TS>

9434

assignedAuthor

1..1

SHALL

9435

1..1

SHALL

9436

addr

1..1

SHALL

SET<AD>

9437

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 335

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

<code code="48767-8" displayName="comment"

codeSystemName="LOINC"

codeSystem="2.16.840.1.113883.6.1"/>

<text>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.

</text>

<addr>

<streetAddressLine>21 North Ave.</streetAddressLine>

<city>Burlington</city>

</addr>

<name>

<given>Henry</given>

<family>Seven</family>

</name>

</assignedPerson>

</assignedAuthor>

</author>

</act>

Page 336 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

SET<II>

8897

@root

1..1

SHALL

10492

2.16.840.1.113883.10.20.22.4.60

1..*

SHALL

8874

code

1..1

SHALL

8876

2.16.840.1.113883.6.1 (LOINC) =

48768-6

statusCode

1..1

SHALL

8875

2.16.840.1.113883.5.14 (ActStatus)

= completed

entryRelationship

1..*

SHALL

8878

@typeCode

1..1

SHALL

8879

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = COMP

act

1..1

SHALL

15528

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 337

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

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

<code code="48768-6" codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC" displayName="Payment sources"/>

...

</act>

</entryRelationship>

</act>

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”.

Page 338 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

@root

1..1

SHALL

14872

2.16.840.1.113883.10.20.22.4

.79

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

14857

@code

1..1

SHALL

15142

2.16.840.1.113883.6.96

(SNOMED-CT) = 419099009

entryRelationship

0..1

SHOULD

14868

@typeCode

1..1

SHALL

14875

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) =

CAUS

observation

1..1

SHALL

14870

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 339

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

</effectiveTime>

<value xsi:type="CD" code="419099009"

codeSystem="2.16.840.1.113883.6.96"

displayName="Dead"/>

</observation>

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.

Page 340 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

@root

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

@typeCode

1..1

SHALL

7693

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) =

SUBJ

substanceAdministration

1..1

SHALL

15525

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

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 341

Figure 172: Discharge medication entry example

<entry>

<code code="10183-2"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="Discharge medication"/>

</effectiveTime>

...

</substanceAdministration>

</entryRelationship>

</act>

</entry>

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.

Page 342 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

7490

2.16.840.1.113883.5.110 (RoleClass) =

MANU

templateId

1..1

SHALL

SET<II>

7495

@root

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

<code code="412307009"

codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED CT"

displayName="drug vehicle" />

<code code="125464" displayName="Normal Saline"

codeSystem="2.16.840.1.113883.6.88"

codeSystemName="RxNorm"/>

<name>Normal Saline</name>

</playingEntity>

</participantRole>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 343

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

SET<

II>

8712

encounter

1..*

SHALL

8713

encounter

Type

code

0..1

SHOULD

8714

2.16.840.1.113883.3.88.1

2.80.32

(EncounterTypeCode)

originalText

0..1

SHOULD

8719

reference

0..1

SHOULD

15970

@value

0..1

SHOULD

15971

encounter

FreeText

Type

reference/@value

0..1

SHOULD

8720

encounter

DateTime

effectiveTime

1..1

SHALL

TS or

IVL<

TS>

8715

performer

0..*

MAY

8725

encounter

Provider

assignedEntity

1..1

SHALL

8726

code

0..1

MAY

8727

facility

Location

participant

0..*

MAY

8738

@typeCode

1..1

SHALL

8740

2.16.840.1.113883.5.1002

(HL7ActRelationshipType)

Page 344 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Name

XPath

Card.

Verb

Data

Type

CONF

Fixed Value

= LOC

participantRole

1..1

SHALL

14903

reasonFor

Visit

entryRelationship

0..*

MAY

8722

@typeCode

1..1

SHALL

8723

2.16.840.1.113883.5.1002

(HL7ActRelationshipType)

= RSON

observation

1..1

SHALL

14899

entryRelationship

0..*

MAY

15492

act

1..1

SHALL

15973

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 345

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

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

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

…

Page 346 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 174: Encounter activities example

<code code="99241"

displayName="Office consultation - 15 minutes"

codeSystemName="CPT-4"

codeSystem="2.16.840.1.113883.6.12"

codeSystemVersion="4">

<originalText>Checkup Examination<reference

value="#Encounter1"/>

</originalText>

<translation code="AMB"

codeSystem="2.16.840.1.113883.5.4"

displayName="Ambulatory"

codeSystemName="HL7ActEncounterCode"/>

</code>

<code code="59058001"

codeSystem="2.16.840.1.113883.6.96"

codeSystemName="SNOMED CT"

displayName="General Physician"/>

</assignedEntity>

</performer>

...

</participantRole>

</participant>

...

</observation>

</entryRelationship>

</encounter>

</entry>

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 347

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

@root

1..1

SHALL

14896

2.16.840.1.113883.10.20.22.4.80

code

1..1

SHALL

14891

@code

1..1

SHALL

14897

2.16.840.1.113883.6.1 (LOINC) = 29308-4

entry

Relationship

1..*

SHALL

14892

@typeCode

1..1

SHALL

14893

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = SUBJ

observation

1..1

SHALL

14898

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).

Page 348 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 175: Encounter diagnosis act example

<!—Encounter diagnosis act -->

<code code="29038-4"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"

displayName="ENCOUNTER DIAGNOSIS"/>

</effectiveTime>

...

</observation>

</entryRelationship>

</act>

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

@root

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

450

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 349

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

<code code="11778-8" codeSystem="2.16.840.1.113883.6.1"

displayName="Estimated date of delivery"/>

</observation>

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.

Page 350 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

SET<I

8623

@root

1..1

SHALL

10495

2.16.840.1.113883.10.20.22.4.4

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

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

<value xsi:type="CD" code="419099009"

codeSystem="2.16.840.1.113883.6.96"

displayName="Dead"/>

</observation>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 351

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

SET<

II>

8599

@root

1..1

SHALL

10496

2.16.840.1.113883.10.20.

22.4.46

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

8591

2.16.840.1.113883.3.88.1

2.3221.7.4 (Problem)

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

Page 352 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Name

XPath

Card.

Verb

Data

Type

CONF#

Fixed Value

entryRelationship

0..1

MAY

8678

@typeCode

1..1

SHALL

8679

2.16.840.1.113883.5.90

(HL7ParticipationType) =

CAUS

observation

1..1

SHALL

15527

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 353

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 .

Page 354 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

Figure 179: Family history observation example

<title>FAMILY HISTORY</title>

<text>

<paragraph>Father (deceased)</paragraph>

<thead>

<tr>

<th>Diagnosis</th>

<th>Age At Onset</th>

</tr>

</thead>

<tbody>

<tr>

<td>Myocardial Infarction (cause of death)</td>

</tr>

<tr>

<td>Diabetes</td>

</tr>

</tbody>

</table>

</text>

<code code="FTH" displayName="Father"

codeSystemName="HL7 FamilyMember"

codeSystem="2.16.840.1.113883.5.111">

<translation code="9947008"

displayName="Biological father"

codeSystemName="SNOMED"

codeSystem="2.16.840.1.113883.6.96"/>

</code>

<administrativeGenderCode code="M"

codeSystem="2.16.840.1.113883.5.1"

displayName="Male"/>

<sdtc:deceasedInd value="true"/>

<sdtc:deceasedTime value="1967"/>

</subject>

</relatedSubject>

</subject>

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 355

<code code="55561003" displayName="Active"

codeSystemName="SNOMED CT"

codeSystem="2.16.840.1.113883.6.96"/>

<value xsi:type="CD" code="22298006"

codeSystem="2.16.840.1.113883.6.96"

displayName="Myocardial infarction"/>

<!-- ******** Family history death observation template ******** --

<code code="ASSERTION"

codeSystem="2.16.840.1.113883.5.4"/>

<value xsi:type="CD" code="419099009"

codeSystem="2.16.840.1.113883.6.96"

displayName="Dead"/>

</observation>

</entryRelationship>

<code code="397659008"

codeSystem="2.16.840.1.113883.6.96"

displayName="Age"/>

</observation>

</entryRelationship>

</observation>

</component>

<code code="7087005" displayName="Intermittent"

codeSystemName="SNOMED CT"

codeSystem="2.16.840.1.113883.6.96"/>

<value xsi:type="CD" code="46635009"

codeSystem="2.16.840.1.113883.6.96"

displayName="Diabetes mellitus type 1"/>

Page 356 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

<code code="397659008"

codeSystem="2.16.840.1.113883.6.96"

displayName="Age"/>

</observation>

</entryRelationship>

</observation>

</component>

</organizer>

</entry>

</section>

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

Card.

Verb

Data

Type

CONF#

Fixed Value

Green Family

History

Organizer

organizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.45']

@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

SET<

II>

8604

@root

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

familyMember

Demographics

subject

1..1

SHALL

8609

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 357

Name

XPath

Card.

Verb

Data

Type

CONF#

Fixed Value

relatedSubject

1..1

SHALL

15244

@classCode

1..1

SHALL

15245

2.16.840.1.113883.5.41

(EntityClass) = PRS

code

1..1

SHALL

15246

@code

0..1

SHALL

15247

2.16.840.1.113883.1.11.19

579

(FamilyHistoryRelatedSubje

ctCode)

subject

0..1

SHOULD

15248

administrative

GenderCode

1..1

SHALL

15974

@code

1..1

SHALL

15975

2.16.840.1.113883.1.11.1

(Administrative Gender

(HL7 V3))

birthTime

0..1

SHOULD

15976

relatedSubject

/@classCode

1..1

SHALL

8610

2.16.840.1.113883.5.41

(EntityClass) = PRS

familyMember

Relationship

ToPatient

code

1..1

SHALL

8611

familyMember

Person

Information

subject

0..1

SHOULD

8613

familyMember

Administrative

Gender

administrative

GenderCode

1..1

SHALL

8614

2.16.840.1.113883.1.11.1

(Administrative Gender

(HL7 V3))

familyMember

DateOfBirth

birthTime

0..1

SHOULD

8615

familyMember

MedicalHistory

component

1..*

SHALL

8607

observation

1..1

SHOULD

16888

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).

Page 358 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 359

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

<code code="FTH" displayName="Father"

codeSystemName="HL7RoleCode"

codeSystem="2.16.840.1.113883.5.111">

<translation code="9947008"

displayName="Biological father"

codeSystemName="SNOMED CT"

codeSystem="2.16.840.1.113883.6.96"/>

</code>

<administrativeGenderCode

code="M" codeSystem="2.16.840.1.113883.5.1"

codeSystemName="HL7AdministrativeGender"

displayName="Male"/>

</subject>

</relatedSubject>

</subject>

...

</observation>

</component>

</organizer>

</entry>

Page 360 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

@root

1..1

SHALL

14313

2.16.840.1.113883.10.20.22.4.68

1..*

SHALL

14284

code

1..1

SHALL

14314

@code

0..1

SHOULD

14315

2.16.840.1.113883.6.96

(SNOMED-CT) = 248536006

text

0..1

SHOULD

14304

reference

1..1

SHOULD

15552

@value

0..1

SHOULD

15553

statusCode

1..1

SHALL

14286

2.16.840.1.113883.5.14

(ActStatus) = completed

effectiveTime

0..1

SHOULD

TS or

IVL<T

14287

value

1..1

SHALL

14291

2.16.840.1.113883.3.88.12.3221.7

.4 (Problem)

@nullFlavor

0..1

MAY

14292

methodCode

0..1

MAY

14316

entryRelationship

0..*

MAY

14294

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 361

Name

XPath

Card.

Verb

Data

Type

CONF#

Fixed Value

@typeCode

1..1

SHALL

14584

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = REFR

supply

1..1

SHALL

14317

entryRelationship

0..*

MAY

14298

@typeCode

1..1

SHALL

14586

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = REFR

observation

1..1

SHALL

14318

entryRelationship

0..*

MAY

14463

@typeCode

1..1

SHALL

14587

2.16.840.1.113883.5.1002

(HL7ActRelationshipType) = COMP

observation

1..1

SHALL

14464

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: SNOMED-

CT 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).

Page 362 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

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

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

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).

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 363

Figure 181: Functional status problem observation example

<code code="404684003"

codeSystem="2.16.840.1.113883.6.96"

displayName="Finding of Functional Performance and activity"/>

<text>

...

</text>

</effectiveTime>

<value xsi:type="CD" code=" 162891007"

codeSystem="2.16.840.1.113883.6.96"

displayName="dyspnea"/>

<!—Caregiver Characteristics -->

...

</observation>

</entryRelationship>

<!— Assessment Scale Observation -->

...

</observation>

</entryRelationship>

</observation>

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.

Page 364 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

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

@root

1..1

SHALL

13890

2.16.840.1.113883.10.20.22.

4.67

1..*

SHALL

13907

code

1..1

SHALL

13908

2.16.840.1.113883.6.1

(LOINC)

text

0..1

SHOULD

13926

reference

0..1

SHOULD

13927

statusCode

1..1

SHALL

13929

Completed

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

REFR

supply

1..1

SHALL

14218

entryRelationship

0..1

MAY

13895

@typeCode

1..1

SHALL

14597

REFR

observation

1..1

SHALL

13897

entryRelationship

0..1

MAY

14465

@typeCode

1..1

SHALL

14598

COMP

observation

1..1

SHALL

14466

referenceRange

0..*

SHOULD

13937

observationRange

1..1

SHALL

13938

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

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 365

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

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

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

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).

Page 366 HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1

i. This observationRange SHALL NOT contain [0..0] code

(CONF:13939).

Figure 182: Functional status result observation example

<!—Cognitive Status Result Oservation template -->

<code code="54744-8"

displayName="Dressing upper body in last 7D(MDSv3)"

codeSystem="2.16.840.1.113883.6.1"

codeSystemName="LOINC"/>

<code code="371153006" displayName=" Independently able"

codeSystem="2.16.840.1.113883.5.83"

codeSystemName="SNOMED CT"/>

<!—- Assessment Scale Observation -->

...

</observation>

</entryRelationship>

<!—Caregiver Support and Ablility -->

...

</observation>

</entryRelationship>

</observation>

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.

HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1 Page 367

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

@mood

Code

1..1

SHALL

14357

2.16.840.1.113883.5.1001 (ActMood)

= EVN

templateId

1..1

SHALL

SET<II>

14361

@root

1..1

SHALL

14362

2.16.840.1.113883.10.20.22.4.66

1..*

SHALL

14363

code

1..1

SHALL

14364

@code

0..1

SHOULD

14747

statusCode

1..1

SHALL

14358

2.16.840.1.113883.5.14 (ActStatus) =

completed

component

1..*

SHALL

14359

observation

1..1

SHALL