ATION 2567 Pod 00

User Manual: 2567

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PRINCIPLES OF DOCUMENTATION - 2000

FOR THE STATEMENT OF DEFICIENCIES (HCFA-2567)

Table of Contents

Introduction ............................................................................. 2

Definitions .............................................................................. 3

The Legal Aspects of the Statement of Deficiencies ............................................. 5

The Principles of Documentation/Overview ................................................... 8

Principle # 1: Entity Compliance and Noncompliance ........................................ 10

Principle # 2: Using Plain Language. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Principle # 3: Composition of a Deficiency Citation ........................................ . . 12

! Regulatory Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

! Statement of Deficient Practice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . 14

! Extent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . .15

! Identifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . .. . . . . . . . . . . 18

! Sources of the Evidence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

! Outcomes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . 29

! Findings. . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

! Facts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

! Organization of the Findings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Principle # 4: Relevance of Onsite Correction of Findings. . . . . . . . . . . . . . . . . . . . . 36

Principle # 5: Interpretive Guidelines ...................................................... 40

Principle # 6: Citation of State or Local Code Violations ...................................... 42

Principle #7: Cross References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Principle #8: Condition of Participation (COP) Deficiencies. . . . . . . . . . . . . . . . . . . . .45

Appendix A: The HCFA-2567/HCFA-2567L

Appendix B: Checklist for Citations

Appendix C: Statement of Isolated Deficiencies

Principles of Documentation

INTRODUCTION

This manual provides guidance on how to structure a deficiency statement on the HCFA Form 2567 after all the

necessary information and evidence have been gathered. These guidelines include a general discussion of the legal

aspects of the Statements of Deficiencies and identify and explain the principles considered in the citation of

deficiencies to be documented on the HCFA-2567. The principles are generic and apply to the documentation

of survey results regardless of the particular program (Medicare, Medicaid or the Clinical Laboratory

Improvement Amendments) or the particular provider or supplier type.

This guide does not replace or supersede the law, regulations, or State Operations Manual (SOM). Rather, this

manual is intended to provide guidance for documenting citations. Therefore, this manual does not create

additional substantive or procedural requirements that must be present to sustain a valid citation.

The HCFA-2567 is the record of the survey where the survey team documents and justifies its determination of

compliance and informs the provider or supplier of its state of compliance with the requirements for participation

in the Federal programs. This information will serve as the basis for the facility to analyze its deficient practices

or system failures and to develop plans of correction. The HCFA-2567 may also document deficient practices

identified by means other than an on-site survey, e.g., a review of compliance with the requirements to transmit

comprehensive assessments to the State Agency.

Each principle is discussed in depth and includes an example of that principle. Each example is identified as being

effective and is included to illustrate a particular documentation principle and may not represent a complete

citation. In each case, there may be other language that may be as effective. The adequacy of any citation can

be evaluated only in the context of the particular type and source of evidence, the extent and consequence of

deficiency, and other relevant factors.

DEFINITIONS

Listed below are definitions that will be used throughout these materials.

COP: an abbreviation that commonly refers to a “condition of participation.” COP also is used throughout this

manual to refer to a “condition for coverage” relevant to suppliers. The Conditions of Participation are

requirements with which an entity must comply in order to participate in the programs.

Principles of Documentation

Deficiency Citation: an entry made on the HCFA-2567 that includes: 1) the alpha prefix and data tag number,

2) the Code of Federal Regulations (CFR), or Life Safety Code (LSC) reference, 3) the language from that

reference which pinpoints the aspect(s) of the requirement with which the entity failed to comply, 4) an explicit

statement that the requirement was “NOT MET” and 5) the evidence (the deficient entity practice statement and

relevant individual findings or facts) to support the decision of noncompliance (see Exhibit 0-1).

Deficient Practice: the action(s), error(s), or lack of action on the part of the entity relative to a requirement (and

to the extent possible, the resulting outcome). (“practice” and “entity practice” are used interchangeably

throughout this manual.)

Deficient Practice Statement: a statement at the beginning of the evidence that sets out why the entity was not

in compliance with a regulation.

Entity: a generic term used to describe providers and suppliers under the Social Security Act or laboratories that

participate in the CLIA program.

Evidence: an integral part of the citation that begins with a description of the deficient entity practice and identifies

the relevant individual findings and facts that substantiate the failure of the entity to comply with the regulation.

Extent of deficient practice: the prevalence or frequency of a deficient entity practice.

Finding: a generic term used to describe each discrete item of information observed or discovered during the

survey about practices of an entity relative to the specific requirement being cited as being not met.

Fact: an event known to have actually happened. A truth known by actual experience or observation.

HCFA-2567/HCFA-2567L Statement of Deficiencies and Plan of Correction: the official document on

which citations are recorded (see Appendix A).

Outcome: a result/consequence of entity practices (e.g., development of avoidable pressure sore/ulcer; reaction

due to receipt of blood of wrong blood type.).

Recipient: one who receives services (a patient, resident or a client) from an entity regardless of whether or not

that person is eligible for, or is receiving, Medicare or Medicaid.

Requirement: any structure, process or outcome that is required by the law, regulations, or the Life Safety Code

Principles of Documentation

(LSC).

S/S: In the LTC survey, symbol accompanied by a unique letter (A through L) that illustrates the effect of the

noncompliance on the nursing home resident (severity) and the number of residents actually or potentially affected

(scope) by the provider’s noncompliance. The symbol with the letter assigned to the noncompliance appears

under the tag number on the HCFA-2567L for nursing homes.( See Appendix P).

Universe: the total number of individuals, records, observations, objects, related to the entity practice or

recipients at risk as a result of a deficient practice. Used as the denominator when determining the extent of a

deficient practice.

Appendix P: Survey Protocol for Long Term Care

Appendix Q: Guidelines for Determining Immediate Jeopardy

Principles of Documentation

LEGAL ASPECTS OF THE STATEMENT OF DEFICIENCIES

The survey and certification of an entity that participates in Medicare, Medicaid or the Clinical Laboratory

Improvement Amendments (CLIA) of the Public Health Service Act, is a process that must adhere to legal

requirements. These programs are administered under extensive laws, regulations, operation manuals and other

guidelines. Surveys and the documentation from surveys become an important part of subsequent legal

proceedings arising out of the certification process.

This section is a brief overview of the legal aspects of surveying and the importance of surveyor documentation

to the decision making and appeals process. It is not intended to provide complete and detailed information on

the mechanics of the process. Please refer to the State Operations Manual (SOM) for more detailed information.

The survey process determines, and the documentation records, the compliance or noncompliance of providers,

suppliers, and CLIA laboratories. The surveyor provides the reasons justifying any resulting enforcement action

and the record on which to defend that action in the appeals process. Consistent and accurate documentation

is imperative in the entire certification process as it forms the basis for the record and the certification decision.

Moreover, the documentation may also be reviewed in any subsequent appeal, i.e., reconsideration, hearing

before an Administrative Law Judge (ALJ) of the Departmental Appeals Board (DAB), review by the Board’s

Appellate Division, and judicial review.

A certification of compliance or noncompliance with the applicable requirements by the State agency or the

Federal Government is an official finding and determines whether or not the provider or supplier may participate

in the Medicare or Medicaid program or whether a laboratory is issued a certificate to operate under CLIA. It

also determines whether any of these entities are subject to other sanctions. The decision-making process and

subsequent certifications are based on the documentation of the survey in the Statement of Deficiencies (HCFA

2567), as well as, other documentation such as surveyor worksheets or notes.

A prospective provider, supplier or clinical laboratory may request a reconsideration of a determination that it

does not qualify to participate in the Medicare/Medicaid program. A formal reconsideration is a thorough,

independent review of the prior decision and the entire body of evidence. If the reconsideration determination

upholds the initial decision, the entity may request an evidentiary hearing before an ALJ.

If an entity is determined to no longer meet the requirements and is subject to termination or alternate

remedies/sanctions, the actual or projected termination or remedy may be appealed through an evidentiary hearing

before an ALJ. If a laboratory’s certificate is subject to limitation, suspension, revocation, or is actually limited,

suspended, or revoked, the actual or projected limitation, suspension or revocation may be appealed through an

Principles of Documentation

evidentiary hearing before an ALJ. During a hearing, the government has the responsibility to show why a

provider or supplier should be terminated or be subject to alternate remedies, and/or a laboratory’s certificate

should be limited, suspended or revoked. The evidence must provide the underlying reason, basis or rationale

for the findings of noncompliance with the regulatory requirement(s).

Such a hearing is an adversarial proceeding. At the hearing, witnesses testify for both the entity and for HCFA,

and are subject to cross-examination. The primary evidence is the HCFA-2567, and any other documentation

used to make the determination of survey results (e.g., worksheets, narratives, etc.). The ALJ relies on the

testimony of witnesses and the documentation from the survey in making a decision. All documentation used at

the hearing becomes part of the public record. The ALJ issues a written decision as to whether or not the entity

should be found in compliance with the requirements of the program. The ALJ is usually not a health professional,

therefore, it is important that the surveyor present the findings in plain language. For this reason, the HCFA-2567

does not contain technical jargon or abbreviations that would not be readily understood by a lay person.

If either HCFA or the entity is dissatisfied with an ALJ decision or dismissal, it may file a request for review to

the DAB Appellate Division. The DAB considers the evidence introduced at the ALJ hearing to determine

whether the ALJ’s decision had a sound factual basis. An entity dissatisfied with the DAB decision has the right

to seek judicial review, HCFA does not. The survey documentation again becomes an important document of

the proceedings. The review by the Court is limited to the record of the proceedings before the ALJ and the

DAB’s Appellate Division.

Documentation on the HCFA-2567 remains the key element in the record to support a determination to certify

compliance or noncompliance with applicable requirements and, if necessary, to defend the determination before

the public, during the appeals process, or in court. The documentation of each and every survey should be

treated as if it will be subject to close scrutiny. The determination of compliance, as well as non-compliance must

be based on objective, factual observations and not vague conclusions. A judge will usually rely on surveyor

judgement if the documentation is thorough and comprehensive.

If, during the course of the survey, information/evidence involving recipient outcomes is discovered, surveyors

should make every effort to relate the deficiencies to the effect on the recipient and recipient’s care. Citations

must relate to the statutory or regulatory requirements.

In addition, a clear and comprehensive Statement of Deficiencies is necessary to provide the entity with the

information necessary to analyze its problems, define appropriate corrective action and come into compliance

with the requirements.

Principles of Documentation

OVERVIEW

Listed immediately below for easy reference are the principles considered in the development and completion

of the HCFA-2567. Following this listing, each principle is explained in detail in a separate section.

Principle #1: Entity Compliance and Noncompliance

When an entity complies with the requirements applicable to the survey conducted, the HCFA-2567 should

consist of an explicit statement that the entity is in compliance. If an entity does not comply with one or more

applicable requirements, the HCFA-2567 includes corresponding citations of noncompliance.

Principle #2: Using Plain Language

The deficiency citation is written clearly, objectively and in a manner that is easily understood. The deficiency

citation does not include consultation, advice, comments or direction aimed at the surveyed entity.

Principle #3: Components of a Deficiency Citation

A deficiency citation consists of (A) a regulatory reference, (B) a deficient practice statement and (C) relevant

findings.

A. Regulatory Reference:

A Regulatory Reference includes the following components:

1) a survey data tag number,

2) the CFR or LSC reference,

3) the language from that reference which specifies the aspect(s) of the requirement with which

the entity was noncompliant

4) an explicit statement that the requirement was “NOT MET”.

B. Deficient Practice Statement

The statement of deficient practice is one component of the evidence. It includes:

1) the specific action(s), error(s), or lack of action (deficient practice),

2) outcome(s) relative to the deficient practice, when possible

3) a description of the extent of the deficient practice or the number of deficient cases relative

to the total number of such cases,

4) the identifier of the individuals or situations referenced in the extent of the deficient practice,

and

5) the source(s) of the information through which the evidence was obtained.

Principles of Documentation

C. Relevant Facts and Findings

The facts and findings relevant to the deficient practice, answer the questions: who, what, where, when, and how.

They illustrate the entity’s noncompliance with the requirement or regulation.

Principle #4: Relevance of Onsite Correction of Findings

If, during the survey, the entity corrects the situation that resulted in the deficiency, a determination of “NOT

MET” must be documented on the HCFA-2567. The entity may indicate its correction in the right-hand column

of the HCFA-2567. If, during the survey, the entity initiates corrective actions that abate a finding of immediate

jeopardy, follow the guidance described in Appendix Q.

Principle #5: Interpretive Guidelines

The deficiency citation explains how the entity fails to comply with the regulatory requirements, not how it fails

to comply with the guidelines for the interpretation of those requirements.

Principle #6: Citation of State or Local Code Violations

The entity’s failure to comply with State or local laws or regulations is not documented in the HCFA-2567 except

when the Federal regulation requires compliance with State or local laws. When the authority having jurisdiction

for that State or local law has made a decision of noncompliance and has effectuated an adverse action which

has been sustained through the hearing process (such as removal of the license to operate), the HCFA-2567

should note that the entity no longer has a license.

Principle # 7: Cross-References

The cross-referencing of requirements is an acceptable form of documentation on the HCFA-2567 only when

it is applicable and provides additional strength to the linked citations. Cross-referencing is most effective when

the linked citations have a direct cause and effect relationship to the deficient practices described in both citations.

In all instances, the linked citation must contain sufficient evidence to demonstrate noncompliance for the

referenced regulation at the linked site.

Principle # 8: Condition of Participation Deficiencies

The COP citation includes deficient practice statements and findings to support the determination of non-

compliance with a condition level requirement. The findings may be incorporated either by cross references to

those requirements which must be corrected to find the COP in compliance or by narrative description of the

individual findings.

Principles of Documentation

Principle #1: Entity Compliance and Noncompliance

When an entity complies with the requirements applicable to the survey conducted, the HCFA-2567 should

consist of an explicit statement that the entity is in compliance for that particular survey. If an entity does not

comply with one or more applicable requirements, the HCFA-2567 includes corresponding citations of

noncompliance. The statutes and implementing regulations are the legal authority for determining an entity’s

compliance with Federal requirements for participation or coverage in Medicare, Medicaid, and CLIA.

The HCFA-2567 is the official document that communicates the determination of compliance or

noncompliance with the Federal requirements. Also, it is the form that an entity uses to submit a plan to

achieve compliance. It is an official record and is available to the public on request.

Exhibit 1-1 illustrates how to give official notice to the provider or any other interested parties of the

compliance status of the entity when the surveyor has identified no deficiencies. The specific requirements

with which the entity must comply, as contained in Title 42 of the Code of Federal Regulations (CFR), are

included.

Exhibit 1-1: Effective Documentation for Principle #1

TAG SUMMARY STATEMENT OF DEFICIENCIES

G000 The [Name] Home Health Agency is in compliance with 42 CFR Part 484, Requirements for

Home Health Agencies.

If a nursing home has no deficiencies identified at the time of the survey, the entry on the HCFA-2567 would

read that the NH is in compliance with 42 CFR Part 483 Requirements for Long Term Care Facilities.

For SNF/NF, if the provider’s noncompliance is isolated and does not pose a risk of more than minimal harm

(S/S=A ), the deficiency is documented on the “A” Form- Statement of Isolated Deficiencies Which Cause

No Harm With Only A Potential For Minimal Harm For SNFs and NFs. (See Appendix C) In addition, the

documentation on the HCFA-2567L would state the SNF/NF is in substantial compliance.

Exhibit 1-2: Effective HCFA-2567L Documentation for Nursing Homes with an A level finding

Principles of Documentation

TAG SUMMARY STATEMENT OF DEFICIENCIES

F000 The [Name] Nursing Home is in substantial compliance with 42 CFR Part 483

Requirements for Long Term Care Facilities

If a nursing home is in substantial compliance but has deficiencies, other than the Isolated Deficiencies which

Cause No Harm with Only A Potential For Minimal Harm (S/S=B, C), the deficiencies are documented on

the HCFA 2567L and no additional language regarding substantial compliance is entered on the HCFA-

2567L.

NOTE: The remainder of the principles of documentation address how to document citations, that is,

situations in which the entity has been found not to comply with one or more requirements.

Principle #2: Using Plain Language

The deficiency citation is written clearly, objectively and in a manner that is easily understood. Each deficiency

citation relates to a requirement within the CFR or the LSC. The deficiency citation should contain only the

evidence to support the determination of non-compliance. Exclude the use of consultation, advice, comments

or directions aimed at the surveyed entity. The deficiency citation should contain only the evidence to support

the determination of non-compliance.

Inclusion of extraneous comments or consultative remarks in citations may lead to confusion. The entity

surveyed and the public may not be able to distinguish between what the survey team would like to see and

what is legitimate evidence of noncompliance. To decrease confusion, documentation in the HCFA-2567

contains only the citation and evidence to support the determination on non-compliance. Extraneous

information that is not relevant to demonstrating non-compliance with the specific requirement should be

avoided.

An example of an extraneous remark would be: When documenting a deficient practice of failure to complete

a care plan, a comment regarding the Resident’s lack of knowledge regarding her Medicaid benefits is

included. The Resident’s knowledge regarding her Medicaid benefits has no relevance to the deficient

practice regarding the care plan and only confuses the reader.

Principles of Documentation

The language used to write a deficiency citation should be as clear as possible. Many styles of writing are

acceptable, and style is a matter of individual preference, however, surveyors should not use slang, unfamiliar

terms and phrases. Best practice is to:

!Put all relevant facts in chronological order.

!Keep sentences short.

!Use simple sentence structure.

!Use the active voice (e.g. “The DON reprimanded the CNA” not “the CNA was reprimanded

by the DON”.).

!Avoid undefined abbreviations, initials and technical jargon.

!Write in layman’s terms.

!Write to inform, not impress.

!Avoid unnecessary words.

!Avoid vague terminology (such as, seems, appears, did not always).

!Avoid words that imply or state conclusions without including the facts to support them (e.g.,

“only”, “just”, “unsatisfactory”, “unnecessary”, or “inadequate”).

!Ensure the accuracy of quoted material.

According to Strunk and White, “When you become hopelessly mired in a sentence, it is best to start fresh;

do not try to fight your way through against the terrible odds of syntax. Usually what is wrong is that the

construction has become too involved at some point; the sentence needs to be broken apart and replaced by

two or more shorter sentences .”

Principle #3: Components of a Deficiency Citation

A deficiency citation consists of (a) a regulatory reference, (b) a statement of deficient practice, and (c)

relevant findings. (For SNFs and NFs, the scope and severity decision is documented in the left column under

the survey data tag number.). Since all relevant information demonstrating non-compliance have been

provided in the deficiency citation, conclusionary and or summary remarks at the end of the deficiency citation

are not necessary and should be avoided.

This principle addresses all of the components of a complete citation.

Regulatory Reference

When the entity’s practice violates a regulation or requirement, determine the regulation that the entity may

have violated. Examine the language of the regulation under which a deficiency could be cited. Determine if

Principles of Documentation

If a LSC chapter references another chapter or NFPA reference document, the

referenced chapter or document should also be cited. For instance, 1985 Life Safety Code, 13-3.5.1: Sprinkler systems

shall be in accordance with Chapter 7 ....7-7.1: Sprinkler systems shall comply with NFPA 13, Sprinkler systems .... , 4-

4.1: Buildings shall be sprinkled throughout the premises.

the requirement addresses the entity’s policies and procedures, actions, or inaction.

A regulatory reference is composed of: 1) a survey data tag number, 2)the CFR or LSC reference, 3) the

language from that reference which specifies the aspect(s) of the requirement with which the entity was

noncompliant, and 4) an explicit statement that the requirement was “NOT MET”. Regardless of the

computer software used to produce the HCFA-2567, essential components of the citation: survey data tag;

CFR or LSC reference, language of the requirement for that reference and an explicit statement that the

requirement was not met are generated automatically on the HCFA-2567. Each handwritten citation should

include all of those components. These components are then followed by the deficient entity practice

statement and the relevant findings.

If the approved HCFA software program for documenting deficiencies does not capture the language of the

requirement being cited at a particular data tag or the specific regulatory/statutory requirement, incorporate

the language for the specific aspect of the requirement being cited as being deficient.

Federal certification requirements are located at Title 42 of the Code of Federal Regulations (CFR) or in the

Life Safety Code (LSC) The requirements are further coded into a series of alpha numeric data tags (e.g.,

F201, A53, G156, etc.) that allow essential survey information to be retrieved and analyzed to determine

trends and patterns of noncompliance. The numerical order of survey data tags approximates the order of the

requirements within the CFR or LSC .

Exhibit 3-1: Regulatory Reference- Principle #3

TAG SUMMARY STATEMENT OF DEFICIENCIES

F 174

S/S=

42 CFR 483.10 (k)

The resident has the right to have reasonable access to the use of a telephone where calls

can be made without being overheard.

This requirement is NOT MET as evidenced by:

Principles of Documentation

Requirements

Federal requirements for participation or coverage can be categorized as follows:

!structure-requirements that specify the initial conditions that must be present for an entity to be certified

to participate and that, in general, are expected to remain as is unless there is a need for major renovation,

reorganization or expansion of services. Some examples of structure requirements include:

The agency has by-laws that or Each bedroom measures

!process--requirements that specify the ongoing manner in which an entity must operate. They do not

allow the entity discretion to vary from what is specified. Examples of process requirements include:

The plan of care must be reviewed by or The physical examination is conducted on an annual basis

!outcome-requirements that specify the results that must be obtained or events that must occur or not

occur following an act. Generally, these requirements are stated in terms of the recipient’s response to

receipt of needed services or conditions that must result from, or are prevented by, implementing one or

more processes. Example of outcome requirements include:

The facility must ensure that a resident maintains acceptable parameters of....

F-314: Based on the comprehensive assessment of a resident, the facility must ensure that a resident who

enters the facility without pressure sores does not develop pressure sores unless the individual’s clinical

condition demonstrates they are unavoidable.

The findings document the outcomes that occurred or failed to occur or failure to assist the individual(s) to

achieve optimal improvement in overall functioning or to prevent avoidable regression or loss of function. The

citation documents sufficient facts to illustrate the level of harm that has occurred or may occur.

Deficient Practice Statement

The statement of deficient practice must be written in terms specific enough to allow a reasonably

knowledgeable person to understand the aspect(s) of the requirement that is (are) not met. They are also

used to identify the levels of scope and severity of the deficiency. It includes what the entity did or did not do

which caused the noncompliance.

The statement of deficient practice must not repeat the regulation, but should state what the facility did that

was wrong or failed to do, to let the reader know what to look for in the findings. The statement of deficient

practice presents the specific action(s), error(s), or lack of action(s) relative to the requirement.

Principles of Documentation

The evidence for a citation begins with a statement of deficient practice that summarizes the issues which led

to the determination that the entity was not in compliance with that requirement and contains all the objective

findings. The statement of deficient entity practice includes: (1) the specific action(s), error(s), lack of action

(deficient practice), (2) when possible, resultant outcome(s) relative to the deficient practice, (3) a description

of the extent of the deficient practice or the number of deficient cases relative to the total number of such

cases, (4) the code of the individuals or situations referenced in the extent of the practice, and (5) reference to

the source(s) of the information through which the evidence was obtained.

Some certification requirements state multiple expectations at a single survey data tag. The entity must

maintain compliance with each facet of the requirement in order to continue participation. The failure to

comply with only one expectation may be sufficient evidence for a citation of the entire requirement. The

deficient practice must be described in concise clear terms so that the entity can determine which part of the

regulation it has NOT MET. The deficient practice statement should be organized and presented in a logical

manner and should relate to each part of the regulation with which the entity failed to comply.

Principles of Documentation

Exhibit 3-2: Effective Documentation of Deficient Practice Statement

F 455 42 CFR 483.70 ( c ) (1)

The facility must provide sufficient space and equipment in dining, health services, recreation,

and program areas to enable staff to provide residents with needed services as required by

these standards and as identified in each resident’s plan of care.

This requirement was NOT MET as evidenced by:

Based on observation, record review and staff interviews, the facility failed to provide a

space and the equipment required for physical therapy services for 4 of 10 sampled residents

(4, 6, 7, and 10) who needed mat exercises, ambulation in parallel bars, and weight training

to improve their physical functioning.

Findings include:

Extent

Extent is the prevalence or frequency of a deficient practice and is a numerical quantification of the deficient

practice. The extent is expressed in a numerical format by identifying the number of deficient cases within the

total number of relevant cases or universe. For example, 4 of 6 residents observed during lunch. The

universe may be all of the recipients provided care and services by an entity, if the failed practice affects all

the recipients, e.g., when a hospital does not provide adequate maintenance of the fire alarm system. When

the failed practice does not affect all the recipients of care and services provided by an entity, the surveyor

must attempt to determine the relevant universe or the total number of recipients who could be affected by the

failed practice. For instance: The ESRD center does not provide adequate monitoring of anti-coagulant

therapy. Only those patients on anti-coagulant therapy would be affected by the deficient practice. Therefore,

the universe would be the total number of patients with orders for anti-coagulants.

The surveyor then determines the number of individuals within the sample or expanded sample on anti-

coagulant therapy who were harmed or could be harmed by the failed practice. Did the ESRD center fail to

monitor all of those patients on anti-coagulant therapy? If not, how many were not monitored? The total

number of patients affected by the failed practice divided by the total number of patients that could have been

affected by the failed practice provides a numerical quantification in percent of the extent of the failed

practice.

Principles of Documentation

The extent of deficient practice will depend upon whether:

(1) the requirement related to all cases or individuals served by the entity

(2) surveyors had knowledge of all cases to which the requirement applied

(3) the requirement related to a subset of all the cases or individuals served by the entity or only a sample of

applicable situations or cases

(4) the deficient practice was determined through only random opportunities for discovery.

Based on observation, the facility failed to maintain appropriate lighting standards for 7 of 12 emergency exits

and failed to test pressure back flows on 2 of 2 water lines. In this example, there are 3 separate expressions

of extent: the deficient practice created a potential hazard/ impact on the entire recipient population, there

were 12 exits and the lighting was insufficient at 7 of those 12, and 2 of 2 water lines were deficient.

!Knowledge of all cases or situations

When the deficiency is based on knowledge obtained about all applicable cases or situations, both this total

and the number of cases/situations that evidenced deficiency should be recorded within the body of the

citation. The following phrases illustrate a variety of acceptable measures:

In an interview with the pharmacist at 2:00 p.m. on 5/29/XX he stated that of 98 residents at the facility for

whom Haldol had been prescribed, 74 had individual program plans that had not been developed with the

participation of ... The hospital’s pharmacy committee minutes dated 01/11/XX confirmed that of the 86

patients to whom medications are administered, 45 (approximately 53%) were identified as being unable to...

Nineteen of the 20 residential living units were observed to need the following repairs: Each of the 5

seclusion rooms used by the facility

!Sample of applicable situations

When the requirement is not applicable to all of the cases or individuals served by an entity, the extent would

be developed by using only the cases or individuals with a negative outcome as a result of the deficient

practice divided by the total number of cases or individuals in the sample that could have been impacted by

the deficient practice. The extent of deficiency should be reported in numeric, quantified terms. For example:

Review of records for 10 of the 60 patients who received transfusions between 7/10/XX and 9/30/XX

revealed that the facility failed to monitor the vital signs for 6 of the 10 patients...

Principles of Documentation

Records for 2 of the 4 surgical patients in the recovery room at 9 AM on 1/7/XX and 3 of the additional 9

records reviewed of patients having had surgery between 12/28/XX and 1/6/XX revealed that no history and

physical had been documented or dictated.

Based on record review, and patient and staff interviews, the facility failed to complete an incident and

accident report for 1 of 8 sampled patients (#6) reviewed and failed to analyze incident reports for

health/safety hazards for 16 of 16 incidents reviewed.

Based on observation, interview and record review, the facility failed to respond to residents’ requests for

assistance in a manner that maintained or enhanced their dignity for 5 of 9 sample residents (#5,9,12,18,24).

Resident Assessments of 5 residents in the sample of 10 had not been evaluated by ...

For 22 of 50 clients in the sample who have current restraint programs authorized, 19 were ...

! Random opportunities for discovery

When the deficiency is based on random opportunities for discovery of the problem, all of the applicable

cases or situations may not be known. Surveyors may quantify their observation but may not be able to

reference a total number of cases or situations that apply. Even though this procedure does not yield as

precise a measure as has been discussed above, the report of measure is valid, particularly when serious

outcomes of the deficiency have been observed and reported. For example:

In 3 of 4 random observations, the facility failed to honor the resident’s requested preference for an alternate

meal choice (RS #1,2,3).

Based on record review, interview and patient observation, the staff did not recognize and failed to assess the

patient for the signs and symptoms of possible fecal impaction.

During the tour of Ward J-7 on XX/XX/XX at 10:00 am, three CNAs were observed addressing residents

about their incontinent and personal hygiene in the solarium using extremely loud voices that could be heard

down the hall. (RS # 1,2,3,4).

Principles of Documentation

Based on observation, on XX/XX/XX the integrity of fire walls located between 1-East and 1-West was

breached by a hole measuring 5 inches....

During tour on unit on XX/XX/XX at 2:15 p.m., RS #1 was observed to be mechanically restrained to his

bed in locked leather cuffs while he was asleep..”.

Identifiers

An individual’s name must not appear in the HCFA 2567. The identity of the recipients of deficient practice

or any persons, including surveyors, who will be referred to in the report, must remain confidential. They are

included in the report by indicating their identifiers, which can be letters, numbers, or a combination or both.

These identifiers also appear in the statement of deficient practice and in the findings.

When the person referred to in the report is an entity staff member, the person(s) may be addressed by their

position, discipline, or job title, or be assigned an identifier.

Identification of each case found to be deficient provides the entity with information necessary to evaluate the

context of the problem. When the evidence refers to individual recipients, the statement of deficient entity

practice should reference by identifiers.

The coding system used to indicate the recipients should be decipherable by the entity, and retrievable by the

RO or SA. Whenever possible, if a revisit or follow-up survey finds noncompliance for the same individual as

in the standard survey, reassign the same identifier code. If it is not possible to use the same identifier, use a

different set of numbers for revisits so that in the event of a hearing, the same identifier is not used for two

different recipients. Every effort should be made to protect a recipient’s privacy especially regarding

information gathered during an in-depth interview. Do not identify recipients or family members without their

permission. If the interviewee does not wish the entity to know the source of the information provided to you,

that information may be recorded on the HCFA-2567 without an identifier. The HCFA-2567 would state,

“During a confidential interview ....” However, the interviewee must be told that there is no guarantee this

information will remain confidential as a court may require that confidential information be disclosed. If the

interviewee’s identity is not disclosed to the entity, the HCFA-2567 must contain sufficient information for the

entity to correct the deficient practice, and to contest the deficiency, if it desires.

When the deficient entity practice references personnel files or staff training, a separate coding system should

be developed to identify the staff affected by the deficient entity practice without using their names.

Principles of Documentation

When random observations or recipients/cases/records beyond the original sample(s) are included in a

citation, an identifier should be given to the individual so that the entity may evaluate the extent of the problem

or patterns and correct the deficient entity practice.

For example: During dining observations in an ICFs/MR, 4 non-sample random clients are observed who

were not given an opportunity for incidental training during their dining experience.

After further investigation focused on the identified concern, if a citation is developed, these randomly

observed clients need to be assigned an identifier so that the entity may address the deficient practice in its

POC.

Examples of identifiers include:

CSample Recipient identifiers:... for 3 of the 5 clients in the sample (Clients 2340, 5496, and 0429)

CStaff identifiers: (Title or Position) Based on interview with the ADON responsible for infection control,

the entity failed OR

Staff Identifier Coding System: 7 of 10 CNAs did not receive the 12 hours of in service training (So, 2,

3, 4, 7, 9, 10)

CConfidential Interview Identifier: Based on record review, the ESRD(entity) failed to allow patient

participation in the development of the long term care plan for 4 of 10 patients (# 2, 4,5, 10). In addition

a confidential interview revealed......

Sources of the Evidence

The source of evidence is the manner through which the evidence was obtained. Sources of evidence may

include: observation, interview, and record review. They contain specific information regarding the who,

what, when, where, and how of the events(s) or situation(s) that contributed to the deficiency. It is best to

utilize supporting evidence obtained from more than one source of evidence.

The sources of evidence are presented in the statement of deficient practice and are described in detail in the

findings portion of the HCFA 2567 report.

Each statement of deficient practice identifies the source(s) through which the evidence was obtained, that is,

from observation, interview, or reviews of records or other documents. Sources identified in the entity

practice statement must be represented in the findings. The findings describe the specifics regarding the

sources.

Principles of Documentation

For example, what was learned from the source; the date, time, and location of the observations; the date and

time of the interviews; titles of the interviewed persons and the types and dates of records/documents used in

the identification of the deficient practices.

Do not identify the recipients or families when using information from the interview. Use a generic term to

identify the person who has been interviewed, e.g., a family member, or a resident. Identify by title those staff

who were interviewed. If more than one of the same type is interviewed, then the number of staff should be

identified.

Observations

Observation is the process by which a surveyor gathers information in accordance with the requirements,

based on input obtained from the five senses. It is what the surveyor sees, hears, touches, smells or tastes

during the survey that evidences an entity’s deficiency. It must answer the who, what, where, when, and how

questions. A surveyor may observe if the actions or outcomes described in a clinical or administrative record

actually occur in the daily operation of the entity. Actions or outcomes that are described in a clinical or

administrative record and observed are also recorded as an observation. The surveyor must note the specific

date and time the observations were made and describe the observation.

Detailed documentation of observations of deficient practice assists the provider in identifying when and

where the deficient practice occurred. Time includes the number of observations in which the deficient

practice was observed and, as appropriate, the duration of each observation. For example, a series of

observations that identify the failure to deliver service from 4:00 P.M. to 6:00 P.M., may help the entity to

identify staffing or supervisory concerns, such as, inadequate supervision or sufficient staffing on a particular

shift. Terms such as “throughout the survey”, “during observation on the second day of the survey”, etc. are

vague, too general and should be avoided.

Exhibit 3-3 illustrates an appropriate manner to document the evidence that was obtained through

observation.

Exhibit 3-3: Effective documentation of observation based findings

TAG SUMMARY STATEMENT OF DEFICIENCIES

Principles of Documentation

K 021 NFPA 101 STANDARD:

LIFE SAFETY CODE STANDARD

Doors in fire separation walls, hazardous area exposure, horizontal exits, or smoke partitions

may be held open only by devices arranged to automatically close all such doors by zone or

throughout the facility upon activation of:

(a) The required manual alarm system and

(b)Local smoke detectors designed to detect smoke passing through the opening or a

required smoke detection system and

(c)The automatic sprinkler system, if installed.

13-2.11.5

Based on observations, the facility used a door wedge (an unapproved device) to hold open

1 of the 9 entry doors included in the facility’s fire safety system.

Findings include

On facility tour between 2:30 and 3:30PM on xx/xx/xx, a door wedge was observed at the

foot of the West entry door holding the door open. The door was being held in an open

position and could not automatically close in case of fire.

Interviews

The interview process largely consists of talking to individuals (e.g., patients, clients, residents, family, visitors,

staff, physicians, ombudsman) to collect information in accordance with requirements about the entity practices.

Information obtained through interviews can provide evidence to support a deficiency.

For example: surveyors talk with recipients to determine whether the entity fulfills the commitments it has made

in records; staff are interviewed to determine their knowledge of the needs of the recipient and of entity polices

and procedures. To the greatest extent possible, the surveyor verifies the information obtained from interview

through observation or record review. In the absence of other objective validation of information, information may

also be confirmed/verified through multiple interview sources.

Principles of Documentation

Exhibit 3-4: Effective Documentation of interview based on findings

TAG SUMMARY OF STATEMENT OF DEFICIENCIES

F252 42 CFR 483.15 (h) (1)

The facility must provide a safe, clean, comfortable and homelike environment, allowing

the resident to use his or her personal belongings to the extent possible.

This requirement was NOT MET as evidenced by:

Based on observation and interview, the facility failed to provide a homelike environment

for 2 of 15 sampled residents (# 5, #6) whose rooms lacked individual decorations and

any personal belongings.

Findings include:

1. Observations made during the tour at 10 AM on xx/xx/xx, noted that Resident 5’s

room was barren of any individualized decorations and personal belongings. During an

interview on XX/XX/XX at 3:00 p.m., Resident #5 stated, “I miss my pictures; they are

all I have left. I want them with me but no one will get them for me. I want my own

toiletries too!”

2. At 10 AM on xx/xx/xx, Resident #6’s room was observed to be barren of any

individualized decorations and personal belongings. During an interview on XX/XX/XX

at 11:00 a.m., a family member of Resident #6 stated,” My (Resident #6) would like to

have a rocking chair. I asked the nurse if I could bring it in and she said she would check

on it and let me know. This was about three weeks ago and she has not yet told me if it

was acceptable or not.”

During an interview with the director of nursing (DON) on XX/XX/XX at 1:00 p.m., the

DON revealed that the facility was aware of the residents’ requests for personal

belongings but had tried to discourage displays of any personal items to reduce theft in the

facility.

Principles of Documentation

Review of Records and Other Documents

Evidence discovered during review of the entity’s documentation is discussed with the staff to determine if

additional documentation or other information exists. Record or document review is the process through which

administrative (e.g., statements of policy and procedure, committee minutes, injury/incident reports) and clinical

(e.g., comprehensive assessments and evaluations, consultations, laboratory reports, plans of care, progress

notes) documents are read and analyzed. Through review of recipients’ clinical records, surveyors determine the

needs of individuals and the extent to which the entity has addressed those needs. Through review of

administrative documents, surveyors assess the entity’s compliance with requirements for the maintenance and

use of those documents.

When using information obtained through record review, identify the record that contained the information. If

the deficiency results from a lack of documentation, make sure the documentation is requested from the staff

member who might or who should know where the documentation can be found.

Obtain copies of the records which show the deficient practice to prove the deficiency, and to show after-

the-fact changes that may be made by the entity.

If the regulation requires a policy on specific issues, ascertain that the policy fails to address the necessary

issues before determining it is deficient.

Examples of documenting information from records and some of the additional investigation necessary,

include:

Patient Y’s medical record contained a urinalysis report dated XX/XX/XX for urine which was sent to a

laboratory on XX/XX/XX. The report indicated the sample had been contaminated and recommended that a

new sample be submitted. The record did not indicate that another specimen had been sent and the staff on

XX/XX/XX were unable to determine if any had been sent.

The medical record did not contain the results of the urinalysis for the sample sent to the lab on XX/XX/XX.

The facility staff were unable to locate the report and reported upon inquiry of the lab that the results had not

been sent to the facility.

The initial Minimum Data Set (MDS), dated XX/XX/XX, documented that a resident was admitted from

home on XX/XX/XX with a reddened area. The nurses notes dated XX/XX/XX, documented a “reddened

area to left ankle.

Principles of Documentation

Exhibit 3-5 Effective documentation of record review based findings

TAG SUMMARY STATEMENT OF DEFICIENCIES

V 321 405.2137(b)(4) STANDARD:

PATIENT CARE PLAN

The care plan for patients whose medical conditions has not stabilized is reviewed at least

monthly by the professional patient care team described in paragraph (b)(2) of this

section. For patients whose condition has become stabilized, the care plan is reviewed

every 6 months. The care plan is revised as necessary to insure that it provides for the

patients ongoing needs.

This STANDARD is not met as evidenced by:

Based on record review, the provider failed to address changes in therapies on the Patient

Care Plan (PCP) for 2 of 7 patients (#1, #4).

1) Review of the admission progress note dated 4/10/XX showed that Patient #1 started

receiving peritoneal dialysis (in the home) on 4/1/XX. Per the 10/2/XX Social Services

note, Patient #1 was switched (at the request of the patient) from peritoneal to

hemodialysis (in the dialysis center) on 9/11/XX. Review of the most current PCP dated

12/2/XX revealed that this change in treatment modality was not addressed in the PCP.

2)Patient #4 started hemodialysis (in the dialysis center) on 2/11//xx per the admission

assessment. The 9/8/XX Physicians Progress note indicated that Patient #4 received a

transplanted kidney on 4/5/XX, but restarted hemodialysis again on 8/1/XX after the

transplant was rejected. Review of the PCP dated 12/2/XX revealed that the patient’s

changes in status were not addressed in the PCP.

Principles of Documentation

Exhibit 3-6 Effective documentation of record reviews

TAG SUMMARY STATEMENT OF DEFICIENCIES

F 225

S/S=

42 CFR 483.13 ( c ) (2)

The facility must ensure that all alleged violations involving mistreatment, neglect or abuse,

including injuries of unknown source and misappropriation of resident property are reported

immediately to the administrator of the facility and to other officials in accordance with State

law through established procedures (including to the State survey and certification agency).

This requirement was NOT MET as evidenced by:

Based upon staff interview, review of medical records, and review of the policy and

procedure manual, facility staff did not report to the administrator bruising of unknown origin

for 2 residents in the sample of 20 (#15,24).

The findings include:

1. A record entry, dated XX/XX/XX, for resident #24 noted that staff had observed bruises

on the resident’s genitals and inner thigh. During an interview at 1:00 p.m. on XX/XX/XX,

the Director of Nurses stated that the Administrator had been ill for 2 months around that

time and she had been acting Administrator. She said, “Staff did not report the bruises to me

... I have not investigated for the cause of the bruises.”

2. A record entry , dated XX/XX/XX, for resident #15 noted that staff had discovered that

the bridge of the resident’s nose was very bruised and no indications of a possible cause

were noted. An interview with the charge nurse on the south wing on XX/XX/XX at 10:00

a.m. confirmed that no one knew how the bruise occurred. The injury of unknown origin had

not been reported to the administrator and had not been investigated.

Principles of Documentation

Exhibit 3-6 Effective documentation of record reviews continued

TAG SUMMARY STATEMENT OF DEFICIENCIES

F 225

S/S=

3. Review of the policy and procedure manual on XX/XX/XX, did not provide evidence that

the facility had established procedures in the manual

that specify how allegations of abuse or injuries of unknown origin were to be reported.

During interview on XX/XX/XX at 3:00 p.m., the administration confirmed that the facility

had no current policy or procedure directing staff regarding when to report possible abuse

or injuries of unknown origin.

The following are examples of complete citations that comply with the Principles of Documentation.

Exhibit 3-7. This example reports the evidence in a way that the entity can understand that the requirement was

not met and how the survey team determined that the requirement was not met. The facts are stated clearly, the

deficient practice is apparent, and there is no extraneous information within the citation that might cause confusion.

All of the components of a complete citation are included.

Principles of Documentation

Exhibit 3-7: Effective Documentation of Principle #3

TAG SUMMARY STATEMENT OF DEFICIENCIES

L 210 418.94 (a) Standard: Supervision

A registered nurse visits the home site at least every two weeks when aide services are

being provided, and the visit includes an assessment of the aide services.

This STANDARD is NOT MET as evidenced by:

Based on review of 4 of 12 medical records (# 5,3,9,12) and interviews in 2 of 4 home

visits (# 5, 12), it was determined that the registered nurse visit did not include an

assessment of whether the aide provided grooming services (shampoo and shower) to the

patients.

The findings include:

1. Review of medical records for Patient #5 revealed that: between 10/20/XX to 12/20/XX,

the records did not contain documentation that any of the registered nurse visits to the home

site included an assessment of the aide services. The son of Patient #5 said, during an

interview on 12/28/XX, “The aide never shampoos my Mom’s hair and the nurse said that

she is supposed to be doing that.” During an interview at 10AM on 12/29 with the nurse

caring for the patient, the nurse acknowledged that the family member had mentioned the

shampoos, the plan of care did indicate the patient was to receive shampoos, but she had

not followed up with the aide about not doing them, nor had she verified what was reflected

on the aide assignment sheet or what the aide had recorded.

2. Review of medical records for Patient #12 revealed that: between 10/28/XX to

12/28/XX, the records did not contain documentation that any of the registered nurse visits

to the home site included an assessment of the aide services. The family member of Patient

#12 said, during an interview on 12/28/XX, “The aide did not give (my family member) a

shower; instead the aide gave (my family member) a very quick bath in bed. I don’t know

why but the aide always comes late and leaves early.”

3. The same lack of documentation regarding registered nurse visits to the home site to

assess aide services was found in medical records for Patients #3 for review period

03/10/XX to 05/07/XX; and #9 for review period 02/11/XX to 03/29/XX.

Each of the three sources may not be necessary to confirm a deficiency. Regardless of the particular avenue(s)

through which information about an entity’s compliance with requirements is gathered, the statement should

include how the information was obtained.

Principles of Documentation

Outcomes

To the extent possible, especially where described or anticipated in the requirement(s), the deficient practice

indicates outcome(s). The statement of findings describes the specific results and consequences of the entity’s

deficient practice for the individual cases reported. Negative outcomes include deterioration, failure to improve

or maintain, etc. Although no negative outcome may be evident from the deficient practice, a failure to comply

with a requirement is a deficiency. Many requirements are not outcome oriented. An example of outcome

requirements includes:

A resident who enters the facility without pressure sores does not develop pressure sores.

Exhibit 3-8 Effective documentation of Deficient Practice Statement

TAG SUMMARY STATEMENT OF DEFICIENCIES

F 314 42 CFR 483.25 ( c )

Based on a comprehensive assessment of a resident, the facility must ensure that (1) a resident

who enters the facility without pressure sores does not develop pressure sores unless the

individual’s clinical condition demonstrates that they were unavoidable: and

This requirement was NOT MET as evidenced by:

“Based on observation, staff interview, and record review, the facility failed to provide services

to prevent the development of a pressure ulcer, to promote healing and to adhere to infection

control measures (universal precautions) designed to prevent cross contamination resulting in

the development of an avoidable Stage III pressure ulcer for 1 of 3 sample residents (R#2)

with pressure sores. Resident #2 experienced ongoing pain, infection and was unable to

continue activities of daily living.”

Findings include:

This example reports the evidence in a way that the entity can understand that the requirement was not met and

how the survey team determined that the requirement was not met. The statement identifies the extent of the

deficient entity practice, includes identifiers for the individuals affected by the deficient entity practice, identifies

the sources from which the information was obtained, and clearly states the outcomes of the deficient entity

practice.

Findings

Findings support or illustrate an entity’s noncompliance with a requirement. Cite only findings attributable to the

entity. Each statement of deficient practice is followed by the specific findings (who, what, where, when, how)

Principles of Documentation

that illustrate the entity’s noncompliance for each case/issue referenced in the deficient practice statement. The

facts are presented in a concise and logical sequence. The findings include the outcomes, descriptions of

actions/situations, identifiers, and sources. Any evidence that supports a finding and affects the deficiency

determination must be incorporated into the deficiency citation. When details for a number of individual examples

have been described to illustrate a particular deficient practice, a final entry may describe additional similar

findings and identifiers to demonstrate the magnitude of the problem.

Facts

A fact is an actual occurrence, something known to exist or have happened. The findings are facts that allow the

entity to compare what it did or failed to do, against what is required. The findings support the deficient practice

statement. For example, if residents #1, 3, 5, and 7, are discussed in the deficient practice statement, the findings

are the facts to support the noncompliance for residents #1,#3, #5, and #7. Without the presence of facts, the

evidence can be construed to mean that an assumption was made, rather than a known conclusion about the

entity’s practice.

Failure to include pertinent facts may prevent the entity from discovering what contributed to the deficient

practice. For example, there may be many reasons for the failure of a patient to receive a needed treatment, such

as: the patient was not scheduled for a treatment; the staff had not been trained regarding how to provide the

treatment; trained staff were not available to provide the treatment; trained staff were available but forgot to

provide the treatment; proper authorization for treatment was not provided; or, the patient refused the treatment.

Identification of the pertinent facts gives the entity the means to examine the failure to comply, in light of the

specific circumstances or contexts which the failure occurred.

When writing a deficiency citation, try to provide answers to basic questions--Who?, What?, When?, Where?,

and How?. Based on the nature of the deficiency, it may be impossible or inappropriate to answer each question.

However, this approach facilitates inclusion of the pertinent facts. Deficiency citations identify:

how the deficiency was determined, and how the evidence relates to the requirement;

what entity practice was noncompliant;

who were the residents or staff involved;

where the deficient practice occurred, e.g., specific locations in the entity or documents; and

when e.g., for how long) the problem occurred. Include the number of observations and the duration of the

observations. Include the specific dates or time period for the noncompliance.

The findings also include documentation of verification or request for additional information through interviews

with facility staff.

Exhibit 3-9. The statement of the findings in this example illustrates how the relevant facts answer the basic

questions of who, what, when, where and how.

Principles of Documentation

Exhibit 3-9: Documentation of Facts

TAG SUMMARY STATEMENT OF DEFICIENCIES

F369 42 CFR 483.35(g))

The facility must provide special eating equipment and utensils for residents who need

them.

This requirement is NOT MET as evidenced by:

Based on record review, observation and interview, “HOW”

the facility failed to provide adaptive fork and spoon “WHAT”

for a resident (R#7) who was assessed to need these items. “WHO”

The findings include:

1. The care plan, dated XX/XX/XX for Resident #7 “HOW”

indicated that R#7, who has suffered from a recent stroke,

needed adaptive utensils to eat meals independently. “WHAT”

2. R#7 was observed in the dining room during “HOW and WHERE” breakfast

on XX/XX/XX and XX/XX/XX, “WHEN”

lunch on XX/XX/XX and XX/XX/XX, and “WHEN”

dinner on XX/XX/XX “WHEN”

struggling to eat, using a regular fork and spoon,

and most of the food was falling off the utensils. “WHAT”

The resident ate only about 25 percent of each meal. “WHAT”

3. During an interview with the nurse aide “HOW”

on XX/XX/XX at 12:00 p.m., the nurse aide

stated, “For a few days R#7 was given special

utensils but I don’t know what happened to them.

I haven’t seen them for a week or so.” “WHEN”

4. R#7 said during an interview on XX/XX/XX “HOW”

at 12:25 p.m., “My right hand just doesn’t work

like it used to since I had this stroke. I was never

good at using my left hand, I don’t understand

why they stopped giving me the special fork “WHAT”

and spoon, I guess they just want me to eat

with regular silverware.”

Principles of Documentation

Organization of findings:

The findings should be organized in a chronological and logical order. Grouping related findings and facts

under applicable statements of the deficient practice statement assists the entity in focusing on the

development of plans to correct its deficient practices rather that on correction of the findings. The

organization of the findings should clearly convey to the reader the sequential order of events that resulted in a

citation. For example, situations or cases are presented in a logical sequence to show individual deterioration

over time or date.

When setting forth a series of facts and events, start by setting out the relevant background facts (e.g.,

“Resident #1 was at risk for weight loss as set forth in the MDS dated XX/XX/XX.) Then, if possible, set out

the events in chronological order.

The following example, Exhibit 3-10 illustrates a citation from the home health requirements. The citation is

written based on two separate requirements contained in the language of the requirement. It includes two

statements of deficient practice and organizes the relevant findings/facts under those statements.

Principles of Documentation

Exhibit 3-10: Effective Documentation of Two Deficient Practice Statement and their Findings

TAG SUMMARY STATEMENT OF DOCUMENTATION

Principles of Documentation

G108 42 CFR 484.10(c)(1) STANDARD: RIGHT TO BE INFORMED AND PARTICIPATE

IN PLANNING CARE AND TREATMENT

The patient has the right to be informed, in advance about the care to be furnished, and of

any changes in the care to be furnished.

The HHA must advise the patient in advance of the disciplines that will furnish care, and the

frequency of the visits proposed to be furnished.

The HHA must advise the patient in advance of any change in the plan of care before the

change is made.

This STANDARD is not met as evidenced by:

Based on observation, interview, and record review, the agency failed to inform 2 of 12

patients (#3 and #9) reviewed about changes of the frequency of care to be furnished, and

the facility failed to inform 2 of 12 patients (#7 and #10) in advance of changes to the plan

of care.

The findings include:

Changes in Frequency of Care:

1. Patient #3 began receiving services on 10/15/XX due to a fractured hip. These

services were to include physical therapy (PT) three times a week for 8 weeks for gait and

balance training to restore ambulation ability. The PT note, dated 11/1/XX, states, "

Increase in case load prohibits three sessions a week of treatment. Frequency to be once

a week for reminder of treatment."

Observation during the 12/7/XX home visit revealed that the patient is not ambulating.

Interview on 12/7/XX during the home visit with Patient #3 indicates that the patient was

not informed of the change of frequency of the PT services. Telephone interview with the

physical therapist on 12/7/XX confirms that this patient is not ambulating due to the

decreased

frequency of treatment and that the patient was not informed of the change

of frequency.

2. Patient #9 began receiving services on 9/10/XX due to a stiff shoulder....

Principles of Documentation

Changes in Plan of Care

1. Patient # 7 began receiving services on 11/20/XX. The plan of care dated 11/23/XX,

indicated that services were to include skilled nursing services for wound care and home

health aide assistance for activities of daily living. On 11/28/XX, the nurse's note states:

"care plan revised as the home health aide can do wound care. Sufficient healing has

occurred so that skilled services are not indicated. Wound needs to be cleansed during

bathing."

Observation on the 12/8/XX home visit indicated that the wound was healed. Interview

with Patient #7 indicated that the patient wondered about the whereabouts of the nurse

who used to come to clean the wound. She had not seen her in a long time. Interview with

the nurse indicated that as the person was progressing well, there was no need to inform

her about the change in the plan of care.

2. Patient # 10 was admitted for service on 11/13/XX. The plan of care, dated

11/13/XX, identified an occupational therapy (OT) consultation to determine if

environmental modifications to the home were indicated.

An OT note of 11/17/XX states: "Consultation not indicated." No additional information

was recorded. Interview with Patient #10 on 12/8/XX indicates that he was satisfied with

the services received, but, "I hope that the person who is supposed to help with the

arrangement of the

house gets here soon. It is difficult for me to get around here."

Interview with the Director of Services on 12/8/XX confirmed that the person was not

informed of the changes to the plan of care."

Principles of Documentation

Principle #4: Relevance of Onsite Correction of Findings

If, during the survey, a deficiency is found, but the entity corrects the situation as soon as they become aware,

a determination of “NOT MET” must be documented on the HCFA-2567. The entity may indicate its

correction in the right-hand column of the HCFA-2567. If, during the survey, the entity initiates corrective

actions that abate a finding of immediate jeopardy, follow the guidance described in Appendix Q. The entity

may indicate its correction in the right-hand column of the HCFA-2567.

If an entity demonstrates practices that cause it to be out of compliance, there may be a system failure. The

findings used as part of the evidence illustrate the result of that failure; the findings are not the cause of it.

Mere correction of the findings reported to the entity prior to the exit conference would not necessarily assure

that the cause of the finding had been addressed. The entity, not the survey team must ascertain the cause and

correct the systems failure that caused the deficient entity practice.

Exhibit 4-1 demonstrates how to document a deficient practice even though the entity may have addressed

the effects of the practice during the survey.

Principles of Documentation

Exhibit 4-1: Effective Documentation for Principle #4

TAG SUMMARY STATEMENT OF DEFICIENCIES

G145 483.14(g) Standard

Coordination of patient services

A written summary report for each patient is sent to the attending physician at least every 62

days.

This standard is not met as evidenced by;

Based on record review and staff interview, it was determined the home health agency failed to

ensure a written summary report which included a compilation of pertinent factors of patient’s

clinical progress had been sent to the physicians’ office for 2 of 2 sampled patients (# 4, and 5)

who required a 62 day summary.

Findings include:

1. Patient #4 was admitted for home health services on XX/XX/XX. The plans of care for the

certification periods XX/XX/XX to XX/XX/XX and XX/XX/XX to XX/XX/XX included goals

which stated “Patient will experience stable cardiopulmonary status as evidenced by clear lung

sounds, no chest pain, SaO2 (saturation of arterial blood) greater than or equal to 92%.”

Summary reports addressing the patients progress or lack of progress were not available as part

of the Patient’s clinical record.

2. Patient #5 was admitted for home health services on XX/XX/XX with the diagnosis of

pressure ulcer and congestive heart failure. The plan of care for the certification period

XX/XX/XX to XX/XX/XX included goals which stated “Patient will have pressure ulcer healed

with no sign or symptoms in 10 weeks”. The summary report addressing the status of the

patient’s wound was not available as part of the clinical record.

Staff interview on XX/XX/XX confirmed the HHA had not sent written summary reports to the

physicians, until after the surveyor inquiry when summary reports were then completed and faxed

to the physician during the survey.

Principles of Documentation

Correction Of Immediate Jeopardy During Survey

Exhibit 4-2 documents noncompliance with a participation requirement that resulted in a situation of

immediate jeopardy. The HCFA-2567 includes the facility’s actions to remove the immediate jeopardy while

the survey team was on-site; however, as stated above, mere correction of the findings does not assure that

necessary corrections, at the systems level, have taken place. Follow the directions for immediate jeopardy

located in Appendix Q of the State Operations Manual.

Principles of Documentation

Exhibit 4-2: Effective Documentation for Correction of IJ during Survey- Principle #4

TAG SUMMARY STATEMENT OF DEFICIENCIES

F223 42 CFR 483.13(b) Requirement

S/S= J Abuse.. The resident has the right to be free from verbal, sexual, physical, and mental abuse,

corporal punishment, and involuntary seclusion.

The requirement is not met as evidenced by:

Based on staff interviews and record review, the facility failed to prevent 1 of 21 sample

residents (#5)from being assaulted by staff and failed to report the assault to the appropriate

authorities in a timely manner and failed to take actions to prevent further such incidents to

residents resulting in immediate jeopardy.

Findings include:

Interviews with 3 CNAs A, B, C, on duty on 7/10/XX, indicated that they observed a

certified nursing assistant (CNA)(E-1) “throw” a resident (R#5) to the ground during a picnic

at the facility on 5/26/XX. The CNA, who observed R#5 becoming agitated, went to the

resident to bring him back into the facility. When the resident became “uncooperative and

irritated” and refused to go into the building, the CNA gave the resident a “bear hug.” The

resident fell to the ground at which time the CNA dragged the resident by the back of his shirt

into the facility, a distance of approximately 30 - 40 feet. Nurses notes on 6/1/XX state that

the resident had abrasions on the lower lumbar and upper left thoracic regions, but was not

able to say how he got them. During an interview with the facility administrator on 7/11/XX,

the administrator said, “I was not aware of the incident until 6/1/XX when a staff member

asked for medication to put on {resident #5's} cuts. I notified the health department on

6/1/XX.” The administrator acknowledged he did not remove the CNA from providing

resident care until questioned by the surveyor on 7/11/XX.

The administrator was notified of the immediate jeopardy at 2:00 p.m. on 7/11/XX. At 3:00

p.m., the administrator notified the survey team that the

involved CNA had been removed from duty and that the CNA would be fired.

Principles of Documentation

Principle #5: Interpretive Guidelines

The deficiency citation demonstrates how the entity fails to comply with the regulatory requirements, not how

it fails to comply with the guidelines for the interpretation of those requirements. Various appendices to the

SOM contain “Interpretive Guidelines” or “Guidance to Surveyors”. These Guidelines were designed to

assist surveyors to develop a better understanding of the requirements, to apply these requirements in a

consistent manner across entities, and to suggest pathways for inquiry.

Although surveyors must use the information contained in Guidelines, they must be cautious in their use.

Guidelines do not replace or supersede the law or regulation, and therefore, may not be used as the basis for

a citation. However, they do contain authoritative interpretations and clarifications of statutory and regulatory

requirements. Interpretive guidelines can include professionally recognized standards and assist surveyors in

making determinations about an entity’s compliance with requirements. When an entity is found to violate a

requirement because of its connection to a professionally recognized standard, the surveyor must indicate

such on the HCFA 2567.

Surveyors should carefully consider how the practices of the entity relate to the illustrations within the

Interpretive Guidelines, and then compare the entity’s practice to the specific language and requirement of the

regulation before determining that a deficiency exists.

Exhibit 5-1: Interpretive Guidelines

REGULATION GUIDANCE TO SURVEYORS

42 CFR 483.35 (h)(2) Hot foods which are potentially hazardous should leave the

Sanitary Conditions.

The facility must (2) store, prepare,

distribute, and serve food under sanitary

conditions; and

kitchen (or steam table) above 140 degrees Fahrenheit, and

cold foods at or below 41 degrees Fahrenheit, etc...

Referenced guidance 1999 FDA Food Code.

Principles of Documentation

Exhibit 5-2 illustrates how material in Interpretive Guidelines can be used to support the citation. The critical

factor is whether or not the evidence relates directly to the language and requirement within the regulation.

Exhibit 5-2: Effective Documentation for Principle #5

TAG SUMMARY STATEMENT OF DEFICIENCIES

W214 42 CFR 483.440 ( c ) (3) (iii)

The comprehensive functional assessment must identify the client’s specific developmental and

behavioral management needs.

This Standard is NOT MET as evidenced by:

Based on observations, staff interview, and record review, the facility failed to include in the

comprehensive functional assessment, the client’s cognitive ability for 2 of the 4 clients in the

home ( #2, #3).

The findings include:

Review of Client #3’s medical records, dated between XX/XX/XX

and XX/XX/XX, revealed 11 evaluations conducted by the professional staff. None of the

evaluations specified any deficits that may have contributed to his diagnosis or his reported

developmental level of functioning. Observations on XX/XX/XX and XX/XX/XX confirmed

that ....In an interview on XX/XX/XX, LPN1 said, “I am unclear about the client’s identified

strengths.”

Principles of Documentation

Principle #6: Citation of State or Local Code Violations

The entity’s failure to comply with State or local laws or regulations is not documented in the HCFA-2567

except when the Federal regulation requires compliance with State or local laws. When the authority having

jurisdiction for that State or local law has made a decision of noncompliance and has effectuated an adverse

action which has been sustained through the hearing process (such as removal of the license to operate), the

HCFA-2567 should note that the entity no longer has a license.

Federal certification requirements are uniform throughout the United States. However, States and localities

may have additional requirements that the entity must meet in order to continue to operate within those

jurisdictions. Some licensing requirements may be more stringent or prescriptive than Federal requirements.

Licensure surveys are conducted to determine an entity’s compliance with specific State or local laws and

regulations. Entities that do not meet the State or local requirements for licensure may not be certified for

participation in the Medicare/Medicaid programs.

In the event of a difference in the stringency of a Federal certification requirement and a corresponding State

or local (e.g., licensing) requirement, the entity is to comply with the more stringent of the two. However,

when enforcement of the more stringent requirement comes from an authority other than the Federal

requirement, the evidence may be recorded on the HCFA-2567 only in the manner prescribed by HCFA.

Failure of the entity to meet State or local requirements is recorded on the HCFA-2567 at a Federal data tag

for one of two reasons:

1) the language of the Federal regulation explicitly requires compliance with State or local laws and codes.

Deficiency citations made under these requirements should include a reference to the particular State or local

code with which the entity is noncompliant. This insures that there is legal authority to describe any conditions

or practices described as deficient. Surveyors always should review their findings relative to the specific

Federal requirement to determine if and when an entity’s failure to achieve compliance with a licensure

requirement is sufficient evidence to cite noncompliance with a Federal certification requirement.

Exhibit 6-1 is consistent with Principle #6. The entity’s practice of using LPNs to conduct the health status

review was deficient specifically relative to the requirement; or

Principles of Documentation

Exhibit 6-1: Effective Documentation for Principle #6

TAG SUMMARY STATEMENT OF DEFICIENCIES

W345 42 CFR 483460(d)

The facility must utilize registered nurses as appropriate and required by State law to perform

the health services specified in this section.

This STANDARD was NOT MET as evidenced by:

Based on record review, the facility for the period between 7/1/xx and 9/30/XX, utilized

Licensed Practical Nurses (LPNs) to review the health status of residents for 4 of 10

sampled records (2, 6, 12, 19) . Section 76543 of the Code of Professional Health

Practices (State Requirement) requires that this function be performed only by Registered

Nurse (RNs).

2) the authority having jurisdiction has made a determination of noncompliance with State or local law, has

taken and sustained an adverse action (See Exhibit 6-2.).

An adverse action is any procedure taken by a State Agency that goes beyond the approval of a plan of

correction, such as, fines, ban on admissions, loss of license, etc. The authority having jurisdiction is the

person or persons who have the authority to make a final determination of noncompliance and are responsible

for signing the correspondence notifying the facility of the adverse action. A final determination means the

determination has not been appealed or is no longer being appealed by the entity.

Principles of Documentation

Exhibit 6-2: Effective Documentation for Principle #6

TAG SUMMARY STATEMENT OF DEFICIENCIES

F492 42CFR483.75(b)

Compliance with Federal, State, and local laws and professional standards.

The facility must operate and provide services in compliance with all

applicable Federal, State and local laws, regulations, and codes, and with

accepted professional standards and principles that apply to professionals

providing services in such a facility.

This requirement is NOT MET as evidenced by:

Based on evidence in the attached notice of determination of non-compliance,

the entity did not meet (state or local) Law # XXX. An adverse action was

taken against the entity by (the authority having jurisdiction.) See attached.

Principle #7: Cross-References

The cross-referencing of requirements is an acceptable form of documentation on the HCFA-2567 only

when it is applicable and provides additional strength to the linked citations. Descriptive evidence (facts and

findings) from one citation may be linked into the evidence for a citation at another requirement. The

evidence being linked into that requirement must support the determination of non-compliance with that

requirement. Each citation must contain all components described in this document independent of the

additional information being linked into that citation. Cross-referencing is most effective when the linked

citations have a direct cause and effect relationship to the deficient practices described in both citations. In all

instances, each citation must contain sufficient evidence to demonstrate noncompliance for the referenced

regulation. Additional guidance for cross-referencing for COP level citations is provided in

POD #8.

Principles of Documentation

TAG SUMMARY STATEMENT OF DEFICIENCIES

G170 42 CFR 484.30 Skilled Nursing Services

The HHA furnishes skilled nursing services in accordance with the plan of care.

This requirement is NOT MET as evidenced by:

Staff interview and review of seven clinical records requiring RN skilled services revealed

that the RN did not comprehensively assess the patients or furnish the frequency of visits

required by the Plan of Care for 4 of the 7 patients (H3 H5, H6, H7). See G174 for

additional information regarding patients H3, H5, and H7.

1.Review of H3's clinical record indicated physician orders for twice daily RN visits from

10/01 to 10/08/XX to administer IV antibiotics, assess the stats of and perform a dressing

change to the Stage 3 ulcer of the left heel. The aide sheet for 10/04 reflected that the aide

had changed the heel dressing that AM. The record shows two LPN visits and an evening

dressing change by the LPN on 10/04 but does not contain information of an RN visit,

assessment or dressing change on 10/04/XX. Interview at 10:30 A.M. on 11/10/XX with

supervising nurse confirmed that on 10/04/XX an aide had performed the AM dressing

change on H3's Stage 3 pressure ulcer of the heel. The supervising nurse reported that

although the RN was ill and had not made the planned AM or PM visits that day, the

agency’s LPN had performed the visits and supervised the aide.

2. Review of H5's clinical record indicated that the Plan of Care for H5 required RN visits

from 4 to 5 times the week of 10/07/XX and 3 times a week for 3 weeks beginning

10/4/XX to assess the patient’s response to changes in the medication to control her angina

and blood pressure. The RN visited only 3 times (10/07, 10/08 and 10/10) during the week

of 10/07 and limited her assessment to checking breath sounds and blood pressure. The RN

did not evaluate for signs and symptoms or complications of either hypo or hypertension or

for compliance with dietary restrictions or known side effects which accompany the use of

calcium channel blockers.

3. Review of H6's clinical record indicated the RN did not visit H6 twice daily as required by

the Plan of Care to monitor the institution of sliding scale insulin for the newly diagnosed

brittle diabetic. The Plan of Care required twice daily visits from --- to ---. The actual visit

frequency was ---.

Principles of Documentation

TAG SUMMARY STATEMENT OF DEFICIENCIES

G170 42 CFR 484.30 (Cont.)

4. Review of H7's clinical record indicated the RN did not assess, record, and report to the

physician the change in the status of the suture line of the hip wound on 10/21/XX. The Plan

of Care required RN visits 5 times a week for 1 week then 3-5 times a week for 2 weeks or

until the wound healed to change the dressing and assess the character of the post operative

wound. The therapist’s progress notes from the therapy visit on 10/21 at 10 A.M. (3 hours

prior to the RN visit) reflect that the patient complained to the therapist of burning and

dampness at the suture line.

Principles of Documentation

TAG SUMMARY STATEMENT OF DEFICIENCIES

G 174 42 CFR 484.30(a) Duties of the Registered Nurse.

The registered nurse furnishes those services requiring substantial and specialized nursing

skill.

This requirement is NOT MET as evidenced by:

As revealed by record review and staff interview, the agency did assure that an RN furnish

clinical services and assess and respond to changes in the clinical status for 3 out of 7

patients whose plans of care authorized/required RN services (patients H3, H5, and H7).

1. Although the physician authorized Plan of Care for H3 required an RN to visit twice a day

for 7 days (10/01 P.m. to 10/08/XX A.M.) To administer IV antibiotics, assess the status

and change the dressing of the Stage 3 pressure ulcer of the left heel, the RN had not

changed the dressing, assessed the wound, or administered the IV antibiotics on the day of

10/04/XX. The supervising nurse confirmed that the RN had been ill that day and that the

LPN had administered the IV antibiotics and an aide had changed the AM dressings under

the supervision of the LPN. The LPN charted an elevated temperature of 100.6 degrees

and a small amount of greenish yellow discharge on the dressing in the PM, but did not

document notification of the physician or RN supervisor regarding the changes in condition.

The record indicates that the RN did not assess the patient’s status at the next visit: the

temperature was not taken again until the evening of 10/05, when it remained at 100.6

degrees; the patient’s temperature at 9 AM on 10/06 was 100.8 an the drainage had

become foul smelling. The physician was not notified about the continued elevation and the

change in character and amount of drainage from the heel until the morning of 10/06. The

State practice code (State code reference) prohibits LPN’s from administering IV

medication and requires RN’s to perform clinical assessments.

Principles of Documentation

TAG SUMMARY STATEMENT OF DEFICIENCIES

G 174 42 CFR 484.30(a) (Cont.)

2. Review of the clinical record for patient H5 revealed that H5 was admitted to the

hospital 10/14/XX. The plan of care required RN visits 4 to 5 times a week for the

week of 10/07/XX to assess the patient’s response to a change in the medication regime.

During the 3 visits for the week of 10/07 (instead of the 4 required by the plan of care),

the RN had not evaluated the patient’s compliance with the dietary restrictions nor

assessed, documented or reported to the physician information about the patient’s

weight, presence or absence of edema, output, or other evidence of response to the

medication. At the visit on 10/14, the patient was noted to have 4+ edema and

moderate unrelieved angina. H5 was admitted tot he hospital for potential adverse drug

reaction to the prescribed NorVasc and uncontrolled angina.

3. ....H7...

Principles of Documentation

Principle #8: COP Deficiencies

The evidence for the citation of noncompliance with a Condition Of Participation explains how the extent or

severity of deficient practices justifies a conclusion of noncompliance at the COP level. The COP citation

includes a statement(s) of deficient entity practice(s) and findings to support the determination of non-

compliance with a condition level requirement. The findings may be incorporated either by cross references

to those requirements which must be corrected to find the COP in compliance or by narrative description of

the individual findings. The COP citation includes ONLY those requirements that must be corrected to

achieve compliance with the COP.

The determination that an entity is not in compliance with an applicable COP is one of the most serious

decisions the RO or SA can make. The decision as to whether there is compliance with a particular COP

depends upon the manner and degree to which the entity satisfies the various requirements and standards

within each COP. If a COP is determined to be deficient, the HCFA-2567 should identify the specific

practices that must be corrected before the entity can be found to be in compliance. If these practices refer

to requirements specified at Standards or other subsidiary requirements, the deficient practices and individual

findings would be cited at the relevant requirements. The findings under these subsidiary requirements may be

referenced under the COP citation.

For certain provider and supplier types, a COP may stand alone at a single survey data tag without

accompanying standards or other requirements. The text of the particular COP may have multiple

components. Based on the evaluation of the evidence, an entity can be cited at a COP level even if it violates

only one component of multi-component regulations.

For example, in the Ambulatory Surgery Center program, 42 CFR 416.43 Condition for Coverage

Evaluation of Quality (tag Q 9) has multiple requirements:

(1) conduct an ongoing, comprehensive self-assessment of the quality of care provided, (2) include active

participation of the medical staff, (3) include review of the medical necessity of the procedures performed and

appropriateness of care, (4) use the findings, when appropriate, in the revision of the center policies and (5)

use the findings, when appropriate, in the consideration of clinical privileges.

There may be entity practices relevant to standards that are deficient, yet not essential for a determination of

compliance with the COP. Most likely it is because the nature of these practices, individually or collectively,

does not justify a conclusion of noncompliance and warrant an adverse action. Such requirements are not

referenced at the COP citation. They are included at the appropriate tag number and corresponding CFR

reference in the HCFA-2567.

Principles of Documentation

Exhibit 8-1: Effective Documentation for Principle #8

TAG SUMMARY STATEMENT OF DEFICIENCIES

Q003 416.41 Condition

Governing Body and Management

The ambulatory surgical center must have a governing body, that assumes full responsibility for

determining, implementing and monitoring policies governing the centers total operation and for

ensuring that these policies are administered so as to provide quality health care in a safe

environment. When services are provided through a contract with an outside resource, the

center must assure that these services are provided in a safe and effective manner.

This Condition is not met as evidenced by;

Based on staff interview and review of administrative records, policies and procedures, and

infection control and quality assurance documentation, it was determined that the ambulatory

surgery center’s governing body failed to assume full responsibility for determining,

implementing and monitoring policies governing the center’s total operation. The governing

body failed to ensure that practitioners had been appointed to the medical staff and had been

granted privileges to practice at the ASC (refer to Q19, Q20, Q21, and Q22), failed to ensure

that a comprehensive quality assurance program was in place (refer to Q9); failed to ensure

that an effective infection control program had been established (refer to Q14). The cumulative

effect of these systemic problems resulted in the surgery center’s inability to ensure the

provision of quality health care in a safe environment.

Principles of Documentation

CONCLUSION:

All requirements are binding. The structures, processes and outcomes required by the regulations are

necessary for the entity to provide quality care, prevent negative outcomes, and facilitate positive outcomes.

Failure of the entity to provide any of the required services or to meet required conditions constitutes

evidence of noncompliance regardless of the presence of outcomes. The purpose of these Principles of

Documentation is to provide structure and consistency to the construction of a citation.

Correctly documenting the Statement of Deficiencies (HCFA-2567) is the key to the success of the survey

and certification process. Effective documentation of the survey signals the provision or denial of financial

participation in the Medicare/Medicaid program, as well as the provision of or lack of quality care in health

care settings.

Keep in mind that one of the roles of the surveyor is to ensure that quality health care is provided by those

entities participating in the Medicare/Medicaid program. It is the surveyor’s knowledge of the regulations and

how to interpret and apply these regulations in a consistent manner during the survey that will produce a clear

description of the entity’s deficient practice. When the deficient practices are resolved by the entity, quality of

care and quality of life can be a reality in health care settings.

COMPONENTS TO BE DOCUMENTED IN A DEFICIENCY CITATION

DOES THE CITATION INCLUDE.....

YES

N/A

Data Tag

In CFR/LSC/CLIA order

CFR/LSC/CLIA Reference

CFR/LSC/CLIA Requirement

Statement that requirement is "Not Met"

Evidence

: Each Statement of deficient practice with

Yes (Y)

No (N)

N/A

corresponding findings (repeat each practice)

NOTES

Statement of deficient practice:

extent of deficient practice

identifiers (confidential)

description of violation of regulation

source of evidence

State/Local code reference, if applicable

Findings/Facts:

who

what

when

where

how

outcome

observations: date, time, location

interviews: date, time, identifier

record/document reviews: date(s), record type

sequential organization of facts

Is the Deficiency Citation......

YES

N/A

Applicable to requirement cited?

Written in plain language?

Free of extraneous remarks and advice?

Principles of Documentation

Compliance with the Life Safety Code, established by the National Fire Protection

Association (NFPA), is mandated by law for certain provider groups.

ATION 2567 Pod 00

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