CLIA Audit Checklist

JANUARY 2022

APHL GUIDE FOR

CLIA INTERNAL AUDITS

RELATED TO HIGH COMPLEXITY TESTING

APHL CLIA Audit Checklist | 2

CONTENTS

Introduction ............................................ 3

Acknowledgments .................................3

APHL Workgroup .............................................................. 3

APHL Staff ....................................................................... 3

CDC ............................................................................... 3

CMS CLIA ......................................................................... 3

List of Assessors by CLIA Regulatory

Requirement ..........................................4

1. Facilities & Safety ............................5

2. Personnel .........................................7

2.1 General CLIA Personnel Requirements (Laboratory

Director Responsibilities Not Covered Elsewhere) .. 7

2.2 Qualiﬁcations ........................................................... 8

2.3 Responsibilities ....................................................... 9

2.4 Training .................................................................. 11

2.5 Competency Assessment ...................................... 12

3. Pre-analytic & Post-analytic

Systems ..........................................15

3.1 Pre-analytic Systems............................................. 15

3.2 Post-analytic .......................................................... 17

4. Analytic—Test Systems, Reagents,

Materials & Supplies ......................21

5. Analytic—Equipment Maintenance,

Function Checks & Calibration .....23

6. Analytic—Testing ...........................26

6.1 Procedure Manual ................................................. 26

6.2 Analytic Systems—Veriﬁcation and Validation

(establishment of performance speciﬁcations) ..... 29

7. Analytic—Quality Control ..............31

7.1 QC—General .......................................................... 31

7.2 QC—Bacteriology .................................................. 36

7.3 QC—Mycobacteriology.......................................... 37

7.4 QC—Mycology ....................................................... 37

7.5 QC—Parasitology .................................................. 38

7.6 QC—Virology ......................................................... 38

7.7 QC—Other than Microbiology ............................... 38

8. Proﬁciency Testing (PT) &

Alternative Assessment ................39

8.1 PT—Enrollment ..................................................... 39

8.2 PT—Testing of Samples ........................................ 39

8.3 PT—Evaluation of Performance ............................ 41

8.4 Comparison of Test Results ................................... 42

9. General Laboratory Systems &

Retention Requirements ...............43

9.1 General Laboratory Systems §493.1230 ............... 43

10. Quality Assessment & Corrective

Action ..............................................44

10.1 Quality Assessment ............................................... 44

10.2 Corrective Action ................................................... 47

APHL CLIA Audit Checklist | 3

INTRODUCTION

This document was developed as a quality improvement tool for internal “self” assessments of CLIA laboratory activities.

Throughout the guide, State Operations Manual (SOM)/Code of Federal Regulations (CFR) numbers are hyperlinked within the

tables for a full explanation of each requirement. Access the full documents:

• SOM: State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory

Services (Rev. 166, 02/03/17)

• CFR: Electronic Code of Federal Regulations (Title 42: Public Health, Part 493 – Laboratory Requirements)

The information and content in this document reects the CFR requirements in place on March 31, 2021. APHL makes no

representations of any kind, express or implied about the completeness, accuracy, reliability, or suitability of this checklist with

respect to ongoing updates to reect amendments to the eCFR website. Therefore, the use of this document is strictly at your

own risk. However, the eCFR website link provided in this document is hyperlinked to the current eCFR website version.

ACKNOWLEDGMENTS

APHL would like to acknowledge the following individuals and organizations for their contributions, feedback and expertise to this

project:

APHL Workgroup

• Hyder Al Janabi

• Mary Bonifas, BS, CQA(ASQ)

• Bonita Bryant, MT(ASCP)

• Leann Covington

• Gillian Edwards

• Laurie Gregg, MT(ASCP)

• Analiza Gross, MBA, MT(ASCP)

• Lydia Mikhail

• Laura Naught, PhD, NRCC(TC)

• Rajesh Parmar

• Kathy Ross

• Deborah Severson, MT(ASCP)

Laboratory Systems and Standards committee chair

• Kimyatta Smith, MS

• Tamara Theisen, MT(ASCP)

APHL Staff

• Kuki Hansen, BVMS, MPH, DACVPM

• Lorelei Kurimski, MS

• Tina Su, MPH

• Andrea Wright

CDC

• Nancy Anderson, MMSc, MT(ASCP)

• Víctor R. De Jesús, PhD

• Marie Earley, PhD

• Meredith Korth, CQA (ASQ), Booz Allen Hamilton

• Atis Muehlenbachs, MD, PhD, FCAP

• Marranda S. Scott, MLS(ASCP)

• Angela Thompson, MS, MT(ASCP)

CMS CLIA

APHL CLIA Audit Checklist | 4

LIST OF ASSESSORS BY CLIA REGULATORY REQUIREMENT

Category of CLIA Regulatory Requirements Assessed Assessor

1. Facilities & Safety

2. Personnel

2.1 General CLIA Personnel Requirements

2.2 Qualications

2.3 Responsibilities

2.4 Training

2.5 Competency Assessment

3. Preanalytic & Postanalytic Systems

3.1 Preanalytic Systems

3.2 Postanalytic Systems

4. Analytic—Test Systems, Reagents, Materials & Supplies

5. Analytic—Equipment Maintenance, Function Checks & Calibration

6. Analytic—Testing

6.1 Procedure Manual

6.2 Verication and Validation

7. Analytic—Quality Control

8. Prociency Testing & Alternative Assessment

8.1 Enrollment

8.2 Testing of samples

8.3 Evaluation of performance

8.4 Comparison of test results

9. General Laboratory Systems & Retention Requirements

10. Quality Assessment & Corrective Action

10.1 Quality Assessment

10.2 Corrective Action

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Facilities & Safety | Page 5

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

1. FACILITIES & SAFETY

# SOM/CFR* Requirement Examples of Compliance Notes

1.1

D3001

§493.1101(a)(1)

Does the laboratory have adequate

space, ventilation and utilities necessary

for conducting all phases of the testing

process?

• Make laboratory floor plans available.

• Observe during laboratory tours

(space: crowded; ventilation: check air

flow strips; adequate lighting; fumes;

availability of electrical outlets).

• Ask about backup power.

• Arrange work areas to minimize

problems in specimen handling,

examination and testing, and the

reporting of test results.

• Place instruments, equipment and

computer systems in locations where

their operation is not adversely

affected by physical or chemical

factors, such as heat, direct sunlight,

vibrations, power fluctuations.

Requirement met?

Yes

Notes:

1.2

D6083, D6084

§493.1445(e)(2)

Laboratory Director Responsibility

(cannot be delegated):

Does the Laboratory Director ensure that

the physical plant and environmental

conditions of the laboratory:

• Are appropriate for the testing

performed?

• Provide a safe environment in which

employees are protected from physical,

chemical, and biological hazards?

• Assure there are quality systems in

place.

• Ask about any safety incident(s) in the

laboratory and what was done.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool.

Notes:

1.3

D3003

§493.1101(a)(2)

Is the laboratory space maintained to

minimize contamination of specimens,

equipment, instruments, reagents,

materials and supplies?

Observe during the lab tour:

• Lab is clean and uncluttered

• Eyewash or hand wash facilities are

accessible

• Ventilation is clear

• Power strips are acceptable to use, but

extension cords are not

Lab bench decontamination log is

available.

Requirement met?

Yes

Notes:

1.4

D3005

§493.1101(a)(3)

Is lab space used for molecular

amplification procedures arranged to

provide unidirectional workflow with

separate areas for:

• Specimen prep, amplification and

detection?

• Reagent preparation (as applicable)?

• Mechanism to detect cross-

contamination of patient specimens?

• Observe unidirectional workflow (no

workarounds)

• Environmental swipe test and blank for

contamination

• Evidence of blank controls (NTCs) from

QC logs or run sheets.

Requirement met?

Yes

Notes:

1.5

D3007

§493.1101(b)

Does the laboratory have appropriate

and sufficient equipment, instruments,

reagents, materials and supplies for the

type and volume of testing performed?

Observe during lab tour or assess

through staff discussions about essential

laboratory equipment, (e.g. autoclave,

centrifuge, scales, correct reagents

for instrumentation, equipment list,

inventory list, etc.)

Is there a purchasing process in place

and is it sufficient?

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Facilities & Safety | Page 6

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

1.6

D3009

§493.1101(c)

The laboratory must be in compliance

with applicable federal, state and local

laboratory requirements.

• Ask for the current certificates or state

licensure documents.

• Ask for the laboratory’s policy on

compliance with these requirement

even if there is no state licensure or

certificates.

Requirement met?

Yes

Notes:

1.7

D3011

§493.1101(d)

Are safety procedures established,

accessible and observed to ensure

protection from physical, chemical,

biochemical and electrical hazards, and

biohazardous materials?

Check that findings from any laboratory’s

safety survey report have been corrected.

Laboratory specific documentation—

including the biosafety manual, waste

management plan, chemical hygiene

plan and, if applicable, the laboratory’s

bloodborne pathogen exposure control

plan and training documents—are

reviewed during the annual safety survey.

Requirement met?

Yes

This includes all types of laboratories

(e.g., permanent, mobile, temporary, etc.)

Notes:

1.8

D3027, 3029,

3031, 3033,

3037, 3039, and

3041

§493.1101(e)

Are records and, as applicable, slides,

blocks, and tissues maintained and

stored under conditions that ensure

proper preservation?

How are records stored? What is your

record retention policy? What is your

policy for the temperature and humidity

control for the records? What is your off-

site archive and retrieval policy?

Check state requirements as applicable—

go with most stringent.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Personnel | Page 7

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

2. PERSONNEL

2.1 General CLIA Personnel Requirements (Laboratory Director Responsibilities

Not Covered Elsewhere)

Refer to the CLIA Personnel Review Worksheet Tool for more information on each of the following requirements/responsibilities:

# SOM/CFR* Requirement Examples of Compliance Notes

2.1.a

D6079

§493.1445

(a)(b)

Note:

Also covered in

2.3.c

Is the laboratory director responsible for

the overall operation and administration

of the laboratory, including:

• Employment of personnel who are

competent to perform test procedures,

record and report test results

promptly, accurately and proficiently,

and for assuring compliance with the

applicable regulations?

• Delegation of qualified personnel

to perform the duties of Technical

Supervisor, Clinical Consultant,

General Supervisor, and Testing

Personnel?

• Ensuring all duties delegated are

properly performed?

If a new CLIA director:

• Ask for educational records,

competency records, transcripts,

certificates, diplomas, laboratory

organizational charts, etc.

• Identify technical supervisors and

policy on delegation of duties.

Requirement met?

Yes

Notes:

2.1.b

D6080

§493.1445(c)

Note:

D6144, D6145

and D6146

§493.1463(a)

(1-2) are covered

in 2.3.e

Is the laboratory director accessible

to the laboratory to provide onsite,

telephone or electronic consultation as

needed?

Documentation addressed in other

sections.

Requirement met?

Yes

Notes:

2.1.c

D6082

§493.1445

(e)(1)

Cannot be delegated:

Does the laboratory director ensure

that testing systems developed and

used for each of the tests performed

in the laboratory provide quality

laboratory services for all aspects of

test performance, which includes the

pre-analytic, analytic, and post-analytic

phases of testing?

Documentation addressed in other

sections.

Requirement met?

Yes

Notes:

2.1.d

D6100

§493.1445

(e)(10)

Cannot be delegated:

Does the laboratory director ensure

that a general supervisor provides

on-site supervision of high complexity

test performance by testing personnel

qualified under §493.1489(b) (4)?

Documentation addressed in other

sections.

Requirement met?

Yes

Notes:

2.1.e

D6101

§493.1445

(e)(11)

Cannot be delegated:

Does the laboratory director ensure the

employment/assignment of a sufficient

number of laboratory personnel with

appropriate education and either

experience or training to provide

appropriate consultation, properly

supervise and accurately perform tests

and report test results?

Documentation addressed in other

sections.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Personnel | Page 8

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

2.2 Qualiﬁcations

# SOM/CFR* Requirement Examples of Compliance Notes

For each person acting in the following

personnel roles, are qualifications

documented?

Since the previous internal audit/

inspection, the items below must be

current for new employees:

• Diploma indicating degree in a

chemical, physical, biological,

clinical laboratory science or medical

technology, if applicable

• Transcript, if diploma does not

specify area of study (transcripts

were requested by CMS inspectors

for degrees in public health, zoology,

epidemiology, forestry and veterinary

medicine)

• Foreign degree equivalency if

educational requirement is from a

foreign institution

• Professional training records

Consult regulations for specifics.

Requirement met?

Yes

Notes:

2.2.a

D6078

§493.1443

Laboratory Director Certificate or (state) license to indicate

qualification to direct the laboratory,

degree (MD or PhD) or other additional

certifications.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool

Notes:

2.2.b

D6111

§493.1449

Technical Supervisor The laboratory director can also be the

technical supervisor.

Someone with a BS and MS degree with

years of experience can be the technical

supervisor with written designation.

Requirement met?

Yes

See CLIA personnel forms:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

2.2.c

D6135

§493.1455

Clinical Consultant MDs: License to practice medicine

from any US state or territory or board

certification by a CMS-approved board.

Note: No further documentation is

required (no need to produce foreign

educational equivalency), but the medical

license must be current and active (must

not be expired).

PhDs: Degree in a chemical, physical,

biological or clinical laboratory science,

plus active certification by a HHS-

approved board (e.g., ABMM or ABB).

Note: Further documentation may be

needed to produce foreign educational

equivalency of the PhD.

Requirement met?

Yes

See CLIA personnel forms:

• CLIA Personnel Review Worksheet Tool

• Clinical Consultant Personnel Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Personnel | Page 9

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

2.2.d

D6143

§493.1461

General Supervisor Documentation of two years laboratory

training or experience is required.

Requirement met?

Yes

See CLIA personnel forms:

• CLIA Personnel Review Worksheet Tool

• General Supervisor Personnel Form

Notes:

2.2.e

D6171

§493.1489

Testing Personnel Documentation of a degree (doctoral,

master’s or bachelor’s) in a chemical,

physical, biological or clinical laboratory

science, or medical technology from an

accredited institution.

Requirement met?

Yes

Notes:

2.3 Responsibilities

# SOM/CFR* Requirement Examples of Compliance Notes

2.3.a

D6107

§493.1445

(e)(15)

Has the laboratory director specified in

writing the responsibilities and duties

for all:

• Clinical consultants?

• Technical supervisors?

• General supervisors?

• Testing personnel?

Written documentation, policies,

procedures or forms for all CLIA

personnel signed by the laboratory

director or designee:

• Clinical consultants

• Technical supervisors

• General supervisors

• Testing personnel

Types of documentation:

• Position descriptions

• Competency documents

• Training records

• SOPs and authorizations

Requirement met?

Yes

See CLIA personnel forms:

• Clinical Consultants

• Technical Supervisors

• General Supervisors

• Testing Personnel

• Supervisor Competency Assessment

Procedure

• CLIA Supervisory Competency

Assessment for General Supervisor Form

• CLIA Supervisory Competency

Assessment for Clinical Consultant Form

• CLIA Supervisory Competency

Assessment for Technical Supervisor

Form

Notes:

2.3.b

D6107

§493.1445

(e)(15)

For testing personnel, is there

documentation that specifies:

• Testing procedures the individual is

authorized to perform?

• Whether supervision is required

for specimen processing, test

performance or result reporting?

• Whether supervisory or director review

is required prior to reporting patient

test results?

Written documentation, policies,

procedures or forms for all testing

personnel signed by the laboratory

director or designee indicating the tests

the individual is authorized to perform

without supervision

Note: supervisory review is required

before patient test results are reported

for all testing personnel.

Types of documentation:

• Position descriptions

• Competency documents

• Training records

• SOPs and authorizations

Requirement met?

Yes

See CLIA Testing Personnel Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Personnel | Page 10

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

2.3.c

D6079

§493.1445

(a)(b)

Note: Also

covered in 2.1.a

Laboratory Director Responsibility:

Is the laboratory director responsible for

the overall operation and administration

of the laboratory, including:

• Employing personnel who are

competent to perform test procedures;

record and report test results promptly,

accurately and proficiently; and

assure compliance with the applicable

regulations?

• Delegating qualified personnel to

perform the duties of technical

supervisor, clinical consultant, general

supervisor and testing personnel?

• Ensuring all duties delegated are

properly performed?

Written documentation of

reapportionments.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool

Notes:

2.3.d

D6136, D6137,

D6138 and

D6140

§493.1457

(a)(b)(d)

Clinical Consultant Responsibility:

Does the laboratory have a clinical

consultant available to provide:

• Consultation to submitters?

• Assist submitters to ensure

appropriate test are ordered?

• Communicate with submitters about

the quality of test results reported and

their interpretation concerning specific

patient conditions?

Communication log that shows the

clinical consultant provides consultation

with submitters.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Clinical Consultant Personnel Form

Notes:

2.3.e

D6144, D6145

and D6146

§493.1463

(a)(1-2)

Note: Also

covered in 2.1.b

General Supervisor Responsibility:

Does the general supervisor:

• Provide day-to-day supervision of high

complexity test performance?

• Remain accessible to testing

personnel at all times testing

is performed to provide on-site,

telephone or electronic consultation

to resolve technical problems

in accordance with policies and

procedures established either by

the laboratory director or technical

supervisor?

Evidence of day-to-day review of records,

such as QC record or organizational

charts that display reporting lines.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• General Supervisor Personnel Form

Notes:

2.3.f

D6080

§493.1445(c)

Note: Also

covered in 2.1.a

Laboratory Director Responsibility:

Is the laboratory director accessible

to the laboratory to provide onsite,

telephone or electronic consultation as

needed?

Overall review of system compliance.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool

Notes:

2.3.g

D6174

§493.1495(a)

Testing Personnel Responsibility:

Is there documented evidence that

testing person-nel limit patient testing to

only those tests which they have been

authorized to per-form by the laboratory

director?

Review test results to ensure performed

by an authorized testing personnel, or

train-ing and competency assessment

records.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Personnel | Page 11

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

2.4 Training

# SOM/CFR* Requirement Examples of Compliance Notes

2.4.a

D6102

§493.1445

(e)(12)

Technical Supervisor Responsibility

(Delegated by LD):

Does the technical supervisor ensure

that, prior to testing patients’ specimens,

all personnel:

• Have the appropriate education and

experience?

• Receive the appropriate training for

the type and complexity of services

offered?

• Have demonstrated that they can

perform all testing operations reliably

to provide and report accurate results?

• Personnel qualification records

(e.g., transcripts, diplomas, foreign

evalutions, equivalency records,

training records, competency

assessment records, etc.).

• LD or designee indicates TS

responsibilities in writing.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

2.4.b

D6120

§493.1451

(b)(7)

Technical Supervisor Responsibility:

Does the technical supervisor ensure

that staff training needs are identified

and that all testing personnel receive

regular in-service training and education?

Note: This responsiblility can be delegated

in writing to GS (see 2.4.c).

Personnel training records.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

2.4.c

D6151

§493.1463

(b)(3)

General Supervisor Responsibility

(If delegated by LD or TS):

Does the general supervisor provide

orientation to all testing personnel?

Personnel training records, onboarding

checklist.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• General Supervisor Personnel Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Personnel | Page 12

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

2.5 Competency Assessment

# SOM/CFR* Requirement Examples of Compliance Notes

2.5.a

D6087

§493.1445

(e)(3)(iii)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that laboratory

personnel are performing the test

methods as required for accurate and

reliable results?

Note: This responsibility can be delegated

in writing to GS (see 2.5.e).

• Competency assessment (CA) records

• Training records

• Quality assurance records

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

• CLIA Testing Personnel Test System

Authorization Form

Notes:

2.5.b

D6103

§493.1445

(e)(13)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor:

• Ensure that policies and procedures

are established for monitoring

individuals who conduct pre-analytical,

analytical and post-analytical phases

of testing to assure that they are

competent and maintain their

competency to process specimens,

perform test procedures and report

test results promptly and proficiently?

• Identify needs for remedial training or

continuing education to improve skills?

Note: This responsibility can be delegated

in writing to GS (see 2.5.e).

• CA records

• Policy and procedure documents

• Documents where staff have

acknowledged that they understand

the policies and procedures (signature

page—digitally, electronically, manually,

attestation, etc.)

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

• CLIA Testing Personnel Test System

Authorization Form

Notes:

2.5.c

D6120

§493.1451

(b)(8)

Technical Supervisor Responsibility:

Does the technical supervisor ensure

policies and procedures are established

to evaluate the competency of all

testing personnel and assure that staff

maintain their competency to perform

test procedures and report test results

promptly, accurately and proficiently?

Note: This responsibility can be delegated

in writing to GS (see 2.5.e).

• CA records:

• Are easy to follow, organized and

standardized

• Have a summary of the schedule for

all personnel in the front of the CA

records (recommended).

• Review policies and procedures

related to compentencies.

• Competency records.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

• CLIA Testing Personnel Test System

Authorization Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Personnel | Page 13

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

2.5.d

D6121–D6126

§493.1451

(b)(8)(i-vi)

Technical Supervisor Responsibility:

Do competency assessments include

each of the following methods:

• Direct observation of testing?

• Monitoring the recording and reporting

of results?

• Review of intermediate results, QC, PT

and PM?

• Direct observation of maintenance and

function checks?

• Assessment of test performance

through repeat, blind or external PT

testing?

• Assessment of problem solving skills?

Note: This responsibility can be delegated

in writing to GS (see 2.5.e).

CA records:

• Are performed by an individual who

has supporting documents and

qualifications to do so (either GS or TS)

• Have details of what test was

assessed, including dates for each of

the six methods of assessment

• Include the results of test performance

and evaluation including worksheets

(if PT was used, specifics for PT event

must be included or a copy of the PT

event records)

• Show evidence of supervisory review

• Include documentation of successful

retraining as necessary

Note: All six competencies must be

assessed within the same calendar year,

but not necessarily at the same time.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

2.5.e

D6151

§493.1463

(b)(4)

General Supervisor Responsibility

(if delegated by LD or TS):

Does the general supervisor annually

evaluate and document the performance

of all testing personnel.

Annual competency assessment records,

to include dates.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• General Supervisor Personnel Form

• CLIA Testing Personnel Test System

Authorization Form

Notes:

2.5.f

D6179

§493.1495

(b)(5)

Testing Personnel Responsibility:

Is there documented evidence that

testing per-sonnel are capable of

identifying problems that may adversely

affect test system per-formance?

• Corrective action reports

• Event logs

• Root cause analysis

• Instrument logs

Note: Documentation may be used as

evidence for competency assessment.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool

Notes:

2.5.g

D6175

§493.1495

(b)(1)

Testing Personnel Responsibility:

Is there documented evidence that

testing personnel follow laboratory

procedures for:

• Specimen handling and processing?

• Test analyses?

• Reporting and maintaining records of

patient test results?

Review of run reports with raw data,

sample rejection logs, quality control

logs, corrective action reports, review of

result reports.

Note: Documentation may be used as

evidence for competency assessment.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Personnel | Page 14

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

2.5.h

D6177

§493.1495

(b)(3)

Testing Personnel Responsibility:

Is there documented evidence that

testing personnel adhere to quality

control policies and document all

quality control activities, instrument and

procedural calibrations and maintenance

performed?

• Quality control records

• Instrument records

• Maintenance records

• Documents where staff have

acknowledged that they understand

the policies and procedures (signature

page—digitally, electronically, manually,

attestation, etc.)

Note: Documentation may be used as

evidence for competency assessment.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool

Notes:

2.5.i

D6127–D6129

§493.1451

(b)(9)

Technical Supervisor Responsibility:

Are testing personnel competency

assessments conducted and

documented:

• Semiannually during the first year the

individual tests patient specimens?

• Annually thereafter?

• When a new method or instrument

change is introduced, individual

is reevaluated to include the use

of the new test methodology or

instrumentation prior to reporting

patient test results?

Competency assessment records—may

be delegated in writing to GS (see 2.5.e).

• Check for new testing personnel CLIA

testing start date and ensure the

laboratory has records of two compe-

tency assessments during the 12

months following this start date, with

at least one assessment within the

first six months.

• Check existing personnel records for

new methods authorized to perform.

• If the testing methodology changed,

retraining will be needed at least once

and documented as necessary.

• Ensure there are records of annual

competency assessment for existing

personnel.

• Records must show evidence of

supervisory review.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

2.5.j

D5209

§493.1235

As specified in the personnel

requirements in Subpart M—Personnel

for Nonwaived Testing, the laboratory

must establish and follow written policies

and procedures to assess employee and,

if applicable, consultant competency.

• Policies or procedures in place to

assess personnel performing pre-

analytical (accessioning), analytical or

post-analytical (reporting)

• Documents where staff have

acknowledged that they understand

the policies and procedures (signature

page—digitally, electronically, manually,

attestation, etc.)

Requirement met?

Yes

See CLIA Testing Personnel Test System

Authorization Form

Notes:

Additional supporting documents for this section:

• Supervisor Competency Assessment Procedure

• CLIA Supervisory Competency Assessment for General Supervisor Form

• CLIA Supervisory Competency Assessment for Clinical Consultant Form

• CLIA Supervisory Competency Assessment for Technical Supervisor Form

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Pre-analytic & Post-analytic Systems | Page 15

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

3. PRE-ANALYTIC & POST-ANALYTIC SYSTEMS

3.1 Pre-analytic Systems

# SOM/CFR* Requirement Examples of Compliance Notes

3.1.a

D5301

§493.1241(a)

Does the laboratory require written or

electronic requests for patient testing?

• Specimen submission/requisition

form should be available for specimen

testing.

• Quality assurance manual.

• Policy or standard operating procedure

addressing the need for orders (how

long does the lab have to order?, turn

around time, etc.).

Requirement met?

Yes

Notes:

3.1.b

D5303

§493.1241(b)

If the laboratory accepts oral requests,

are written or electronic confirmation

requests received within 30 days?

• This may be stated in a policy or

procedure for specimen receipt and

handling, or the lab may have records

of communication that provide

evidence of compliance.

• Quality assurance manual.

• Policy or standard operating procedure

addressing the need for orders (how

long does the lab have to order?, turn

around time, etc.).

Requirement met?

Yes

Notes:

3.1.c

D5305

§493.1241

(c)(1-6, 8)

Do test requisitions contain the following

information?

• Information necessary to identify

the authorized submitter to send

test results and if appropriate, an

individual contact person to enable

reporting of imminently life threatening

results or panic or alert values?

• Patient’s name or unique identifier?

• The sex and age or date of birth of the

patient?

• The test(s) to be performed?

• The specimen source, when

appropriate?

• Date and, if appropriate, time of

specimen collection?

• Any additional information relevant/

necessary for a specific test?

• Review a sampling of specimen

submission/requisition forms for

required information.

• The laboratory may use a

supplemental form to collect

information relevant for specific tests.

• State Operations Manual: Does the

laboratory have a policy/procedure

for what to do when a requisition

is missing required information?

Laboratories must either obtain the

missing information, or report results

and indicate on the test report any

limitations of test results due to the

omission of patient information (See

page 1 of Appendix C for an inspector

and laboratory guide).

Requirement met?

Yes

Notes:

3.1.d

D5309

§493.1241(e)

Does the laboratory ensure that test

requisitions transcribed into a record

system (paper or electronic) are entered

accurately?

• QA monitors in place for requisition

accessioning; the laboratory is

responsible to ensure data is entered

correctly and must have a procedure

to check data entered. This may be

in a policy or procedure for specimen

receipt and handling.

• Demographic change logs, corrective

report logs, QA monthly assessment

or quarterly report, assessment using

LIMS print out, pull metrics from

double data entry from LIMS (error

rates).

Requirement met?

Yes

See Demographic Change Log Example

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Pre-analytic & Post-analytic Systems | Page 16

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

3.1.e

D5311

§493.1242

(a)(1-8)

Does the laboratory establish and follow

written policies and procedures for each

of the following, if applicable:

• Patient preparation?

• Specimen collection?

• Specimen labeling, including patient

name or unique identifier and, when

appropriate, specimen source?

• Specimen storage and preservation?

• Conditions for specimen

transportation?

• Specimen processing?

• Specimen acceptability and rejection?

• Specimen referral?

Information in a test directory should

be consistent with laboratory test

procedures for the following:

• Acceptable sample/specimen type for

testing

• Storage and preservation of specimen

prior to shipping

• Transport medium

• Specimen labeling

• Shipping instructions which include

specimen handling requirements

Documentation:

• Test requisitions

• Test menus

• SOPs (ensure SOPs include

acceptability and rejection)

• Orders

• Containers

• At least two unique patient identifiers

on specimen container labeling,

proper identification of patient

Requirement met?

Yes

Note: Crosswalk all policies and procedures

to all physical evidence.

Notes:

3.1.f

D5313

§493.1242(b)

Does the laboratory document the date

and time of specimen receipt?

Date and time packages/samples are

received is documented (e.g, requisition

forms, sample receipt logs, LIMS sample

logs, etc.).

Requirement met?

Yes

Notes:

3.1.g

D5315

§493.1242(c)

Does the laboratory refer specimens only

to other CLIA-certified laboratories?

Documentation:

• Reference lab CLIA certificates

• Specified in SOP or procedure

Requirement met?

Yes

Notes:

3.1.h

D5317

§493.1242

(a)(1-8)

Does the laboratory provide clients

written instructions to meet the

laboratory’s requirements for the

information outlined in 3.1.e?

• Test menu/test directory

• SOPs, policies

Requirement met?

Yes

Notes:

3.1.i

D3027

§493.1105

(a)(1)

Record Retention: Are test requisitions

and authorizations retained for at least

two years?

Note: Longer retention times might be

in place for other state, local, federal

regulations and must also be followed. The

CLIA two-year rule must be followed at a

minimum.

• Test requisistions available for at least

two years (can be longer)—address

discontinued procedures as well

• SOPs, policies

• Check state requirements as

applicable—go with most stringent

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Pre-analytic & Post-analytic Systems | Page 17

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

3.1.j

D6138

§493.1457(b)

Clinical Consultant Responsibility:

Does the laboratory have a clinical

consultant available to assist submitters

in ensuring appropriate tests are ordered

to meet the clinical expectations?

A CC, other than the LD, is identified.

Note: CC can also be the LD.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Clinical Consultant Personnel Form

Notes:

3.1.k

D6138, D6140

§493.1457

(b)(d)

Clinical Consultant Responsibility:

Is the CC available to assist the

laboratory’s clients in ensuring that

appropriate tests are ordered to meet the

clinical expectations?

CC: Inquire into records of

communication between CC and

submitter on specific patient test

requests or test results (as applicable).

Note: CC can also be the LD.

Requirement met?

Yes

Notes:

3.2 Post-analytic

# SOM/CFR* Requirement Examples of Compliance Notes

3.2.a

D5801

§493.1291

(a)(1-3)

Does the laboratory have an adequate

manual or electronic system(s) in place

to ensure test results and other patient-

specific data are accurately and reliably

sent from the point of data entry to final

report destination in a timely manner?

Including the following:

• Results reported from calculated data

• Results and patient-specific data

electronically reported to network or

interfaced systems

• Manually transcribed or electronically

transmitted results and patient-

specific information

Documentation of result reporting quality

checks, such as:

• Supervisory review of reports (can be

LIS manager)

• Audit log of electronic reports

• Patient test managing report

Requirement met?

Yes

See Patient Test Management Evaluation

Form

Notes:

3.2.b

D5803

§493.1291(b)

Is test report information readily available

to the laboratory and to CMS or a CMS

agent upon request?

Request a random sampling of patient

testing records representing each test

system performed and corrected report

examples if available. Records should

include the specimen requisition, testing

worksheets/data printouts and the final

test report. The laboratory must be able

to retrieve test reports requested during

the CMS inspection.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Pre-analytic & Post-analytic Systems | Page 18

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

3.2.c

D58051

§493.1291

(c)(1-7)

Does the patient test report include the

following:

• Patient’s name and identification

number or a unique identifier and

identification number?

• Name and address of the laboratory

location where the test was

performed?

• Test report date?

• Test performed?

• Specimen source, when appropriate?

• Test result and, if applicable, the units

of measurement or interpretation, or

both?

• Any information regarding the

condition and disposition of specimens

that do not meet the laboratory’s

criteria for acceptability?

Review the sampling of patient testing

records (3.2.b.) requested for required

information.

• If any of the test results were from a

laboratory outside of your laboratory’s

CLIA certificate, check that this is

noted on the report.

• Reports should include a disclaimer, if

applicable. For example, test reports

for laboratory developed tests must

include a disclaimer indicating “The

performance characteristics of this

test were determined by (Laboratory

Name). It has not been cleared or

approved by the US Food and Drug

Administration.”

• Include additional patient identifiers,

ordering physician and date/time of

specimen collection, if available.

Requirement met?

Yes

Notes:

3.2.d

D6139

§493.1457(c)

Clinical Consultant Responsibility:

Has the clinical consultant reviewed

patient report templates to ensure

the test results include pertinent

information required for specific patient

interpretation?

Documentation of review test report

templates.

Documentation that CC has reviewed

reports for each type result reported to

include any interpretation, comments or

disclaimers and test report results are

clear and easy to understand.

Example documentation:

• Mock up test report

• List of disclaimer

• Interpretation comments

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Clinical Consultant Personnel Form

Notes:

3.2.e

D6098

§493.1445

(e)(8)

Clinical Consultant Responsibility

(If delegated by LD): Does the clinical

consultant ensure that reports of test

results include pertinent information

required for interpretation?

See evidence for 3.2.d.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Clinical Consultant Personnel Form

Notes:

3.2.f

D5807

§493.1291(d)

Are pertinent reference intervals or

normal values, as determined by the

laboratory performing the test, available

to individuals ordering the test or

responsible for using the test results?

Note: The result of test performed by

another laboratory must reflect the

performing laboratory’s reference or normal

range, and other interpretation comments.

Reference interval (normal value)

information should be included in each

test procedure (see 6.1.b).

Examples:

• List of reference intervals

• Reports with reference intervals

• SOPs should include reference

intervals—if they don’t, must have a list

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Pre-analytic & Post-analytic Systems | Page 19

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

3.2.g

D5809

§493.1291(e)

Does the laboratory have a means to

provide clients:

• Test methods?

• Performance specifications

established or verified by the

laboratory if applicable?

• Information on interpretation of test

results including interferences?

Are pertinent updates on testing

information provided to clients whenever

changes occur that affect test results or

interpretation of test results?

• A test directory

• SOPs

• Validation/verification data

• Emails or letters to clients regarding

updates

Requirement met?

Yes

Notes:

3.2.h

D6099

§493.1445

(e)(9)

Clinical Consultant Responsibility

(If delegated by LD): Does the clinical

consultant ensure that consultation is

available to the laboratory’s clients on

matters relating to the quality of the test

results reported and their interpretation

concerning specific patient conditions?

If delegated to CC in writing by the LD:

• Look through communication logs for

examples

• Complaints or lack of complaints

• Letter from clinical consultant stating

hours and contact information

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Clinical Consultant Personnel Form

Notes:

3.2.i

D5811

§493.1291(f)

Are test results released only to

authorized persons and, if applicable, the

individual responsible for using the test

results and the laboratory that initially

requested the test?

• Policy statement

• Review data entry if this is auto

reported

Requirement met?

Yes

Notes:

3.2.j

D5813

§493.1291(g)

Does the laboratory immediately alert

the individual or entity requesting the

test and, if applicable, the individual

responsible for using test results when

any test result indicates an imminently

life-threatening condition, or panic or

alert value?

Procedure for reporting alert or panic

values should include:

• Definition for laboratory test results

that have been determined to indicate

an imminently life-threatening

condition, or panic or alert value

• How alert values will be communicated

• To whom alert values may be

communicated (role/qualifications)

Records should include:

• Date, time and to whom test results

were reported

• Method used to communicate (phone,

email, other)

• Acknowledgement of receipt

The laboratory should have a

communication log of alert values.

Requirement met?

Yes

Notes:

3.2.k

D5815

§493.1291(h)

Has the laboratory established

timeframes for reporting test results?

If there is a delay in urgent or timely

requests, does the laboratory notify

appropriate individuals?

The test directory should include

turnaround times.

Records of submitter notification based

on how long delay is and the impact on

patient care (e.g, documentation in the

laboratory information system, call log of

the notification, etc.).

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Pre-analytic & Post-analytic Systems | Page 20

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

3.2.l

D5815

§493.1291

(i)(1-3)

If a laboratory refers patient specimens

for testing, does the laboratory ensure

the following requirements are met:

• Results or information directly

related to the interpretation of results

provided by the testing laboratory are

not revised by the referring laboratory.

• If the testing laboratory is permitted

to send test results directly to the

authorized person who initially

requested the test, the referring

laboratory must retain or be able to

produce an exact duplicate of each

testing laboratory’s report.

• The authorized person who initially

requested the test must be notified by

the referring laboratory of the name

and address of the laboratory where

testing was performed.

• Evidence that you verified reference

laboratory’s CLIA number (via

certificate)

• Copy of all the original reports from the

reference laboratories

• Final report must include testing

laboratory’s name, address and CLIA

number

• Test report does not require CLIA

number

Requirement met?

Yes

Notes:

3.2.m

D5815

§493.1291(j)

Are all test reports or records of the

information on the test report maintained

by the laboratory in a manner that

permits ready identification and timely

accessibility?

Test reports and records maintained

are easily identified and accessible.

Examples:

• Copies of the reports

• Demonstrate retrieval of reports

Identification and accessibility of storage

areas (only appropriate staff have

access).

Requirement met?

Yes

Notes:

3.2.n

D5815

§493.1291

(k)(1-3)

When errors in the reported patient test

results are detected, are the following

accomplished:

• Authorized person ordering the test

and, if applicable, the individual using

the test results are promptly notified?

• Prompt issuance of corrected

report(s)?

• Duplicates of the original and

corrected reports are maintained?

Review corrected report examples from

the requested sampling of patient testing

records (3.2.b).

State Operations Manual: “Corrected

reports, either hard copy or electronic,

must clearly indicate both the corrected

result(s) and the fact that the report is a

corrected report.”

In the event that a corrected report was

issued, the following documentation is

required:

• Non-conforming event (NCE) logs or

documentation

• Documentation of notification

• Copies of original reports are

maintained

Requirement met?

Yes

Notes:

3.2.o

D3041

§493.1105

(a)(6)

Record Retention: Are test reports

(preliminary, final and corrected/

amended) retained for at least two years?

Note: Longer retention times might be in

place for other state, local and federal

regulations and must also be followed. The

CLIA two-year rule must be followed at a

minimum.

Paper or electronic copy of original report

that contains the exact information as

sent to submitter, such as:

• Destruction records

• Record retention policy or procedure

Check state requirements as applicable –

go with most stringent.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Test Systems, Reagents, Materials & Supplies | Page 21

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

4. ANALYTIC—TEST SYSTEMS, REAGENTS, MATERIALS & SUPPLIES

# SOM/CFR* Requirement Examples of Compliance Notes

4.1

D5411

§493.1252(a)

Are test systems selected by the

laboratory?

Are tests performed following the

manufacturer’s instructions and in a

manner that provides test results within

the laboratory’s stated performance

specifications?

• Recent review of package insert

• SOPs

SOM lists specific parameters for:

• Syphilis serology (antigen volume,

incubation time and temperature,

light source, rotator speed and

circumference, and conjugate titer)

• International Normalized Ratio

calculation for coagulation testing

Requirement met?

Yes

Notes:

4.2

D5413

§493.1252

(b)(1-4)

• Has the laboratory defined criteria for

conditions that are essential for proper

storage of reagents and specimens,

accurate and reliable test system

operation, and test result reporting?

• Are the criteria consistent with the

manufacturer’s instructions, as

applicable?

• Are the conditions monitored and

documented?

• If specific conditions apply, do they

include:

• Water quality?

• Temperature?

• Humidity?

• Protection of equipment/

instruments from electrical

fluctuations?

Observe during lab tour:

• Records of reagent and media

storage and handling consistent with

manufacturer’s instructions

• Monitoring records for refrigerator,

freezer and room temperature

(room temperature must be defined

according to method)

• Water quality reports if using water

from a water purification system for

testing procedures

• Humidity if a test procedure or

reagent storage has specific humidity

requirements

• Evidence and maintenance of

uninterruptible power supplies and

power strips or surge protectors

Requirement met?

Yes

Notes:

4.3

D5785

§493.1282

(b)(3)

Does the laboratory document corrective

actions taken when the criteria for proper

storage of reagents and specimens are

not met?

• Temperature monitoring records

indicate whether the temperature

observed is within the defined

acceptable range

• If temperatures are out of range, there

is documentation of corrective action

(e.g., reagents or specimens moved to

another refrigerator)

• Corrective action log

• NCE logs

• Policy/SOP for storage of reagents and

specimens

Requirement met?

Yes

Notes:

4.4

D5415

§493.1252

(c)(1-4)

Are reagents, solutions, culture media,

control materials, calibration materials

and other supplies, as appropriate,

labeled to indicate:

• Identity?

• Titer, strength or concentration, if

applicable?

• Storage requirements?

• Preparation and expiration dates?

• Other pertinent information required

for proper use?

Observe during lab tour:

• Name

• Titer, strength or concentration for

stocks and working solutions

• Preparation date or opened date

• Expiration date

• Storage requirements

• SOP

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Test Systems, Reagents, Materials & Supplies | Page 22

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

4.5

D5417

§493.1252(d)

Does the laboratory prohibit the use

of reagents, solutions, culture media,

control materials, calibration materials

and other supplies that have exceeded

their expiration date, have deteriorated or

are of substandard quality?

• This should be stated in a policy or

procedure.

• The laboratory must assign an

expiration date to any reagents

and media that do not have a

manufacturer-provided expiration date.

The assigned expiration date should

be based on known stability, frequency

of use, storage conditions and risk of

deterioration.

• Physical observation during audit.

Requirement met?

Yes

Notes:

4.6

D5419

§493.1252(e)

Does the laboratory prohibit the

interchange of reagent kit components

of different lot numbers unless otherwise

specified by the manufacturer?

If applicable, this should be stated in a

policy or procedure.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Equipment Maintenance, Function Checks & Calibration | Page 23

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

5. ANALYTIC—EQUIPMENT MAINTENANCE, FUNCTION CHECKS & CALIBRATION

# SOM/CFR* Requirement Examples of Compliance Notes

5.1

D5429

§493.1254

(a)(1)

For unmodified manufacturer’s

equipment, instruments or test systems,

does the laboratory perform and

document maintenance as defined by

the manufacturer and with at least the

frequency specified by the manufacturer?

• Current versions of equipment

manufacturer operator’s manuals

should be available (printed or

electronic).

• Review manufacturer operator’s

manual to determine maintenance,

including frequency defined by the

manufacturer.

• Review laboratory equipment

procedures, maintenance schedules

and records to ensure the lab

is performing and documenting

maintenance as defined by the

manufacturer.

• Maintenance logs/preventative

maintenance (PM) schedule.

• Documentation of repairs and service

requests.

Requirement met?

Yes

See:

• ABI 7500 Semi-Annual Preventative

Maintenance Form

• ABI 7500 Weekly and Monthly

Preventative Maintenance Form

Notes:

5.2

D5431

§493.1254

(a)(2)

For unmodified manufacturer’s equipment,

instruments or test systems, does the

laboratory perform and document function

checks as defined by the manufacturer

and with at least the frequency specified

by the manufacturer?

Note: Function checks must be within the

manufacturer’s established limits before

patient testing is conducted.

• Current versions of equipment

manufacturer operator’s manuals

should be available (printed or

electronic).

• Review manufacturer operator’s

manual to determine maintenance,

including frequency defined by the

manufacturer.

• Review laboratory equipment

procedures, maintenance schedules

and records to ensure the lab

is performing and documenting

maintenance as defined by the

manufacturer.

• QC records and logs.

Requirement met?

Yes

Notes:

5.3

D5433

§493.1254

(b)(1)

For equipment, instruments or test

systems developed in-house, modified

commercially available, or for which

maintenance and function checks are not

provided by the manufacturer, has the

laboratory:

• Established a maintenance protocol

that ensures performance necessary for

accurate and reliable test results?

• Performed and documented the

maintenance activities?

Procedure and/or maintenance schedule

defining maintenance requirements and

intervals for all equipment and records

used for diagnostic testing.

Note: This applies to equipment built in-

house, structurally-modified by the lab or

that is truly without a manufacturer-defined

PM.

See 5.1.

Requirement met?

Yes

See:

• ABI 7500 Semi-Annual Preventative

Maintenance Form

• ABI 7500 Weekly and Monthly

Preventative Maintenance Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Equipment Maintenance, Function Checks & Calibration | Page 24

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

5.4

D5435

§493.1254

(b)(2)

For equipment, instruments or test

systems developed in-house, modified

commercially available, or for which

maintenance and function checks are not

provided by the manufacturer, has the

laboratory:

• Defined a function check protocol that

ensures performance that is necessary

for accurate and reliable test results

and test result reporting?

• Does the laboratory perform and

document equipment, instrument and

test system function checks, including

background or baseline checks as

defined in 5.3?

• Does the laboratory ensure that

function checks are within the

laboratory’s established limits before

patient testing is conducted?

Procedure and/or schedule defining

function check requirements for all

equipment and records of required

function check activities.

If function checks are out of range,

is there evidence that the laboratory

ensures corrected prior to patient

testing?

See 5.2.

Requirement met?

Yes

Notes:

5.5

D5437

§493.1255

(a)(1-3)

Does the laboratory perform and

document calibration procedures:

• Following the manufacturer’s test

system instructions, using calibration

materials provided or specified,

and with at least the frequency

recommended by the manufacturer?

• Using criteria verified or established by

the laboratory?

• Using calibration materials appropriate

for the test system and, if possible,

traceable to a reference method or

reference material of known value

(including the number, type and

concentration of calibration materials,

as well as acceptable limits for and the

frequency of calibration)?

• Whenever calibration verification fails to

meet the laboratory’s acceptable limits?

Generally applies to quantitative assays.

If applicable, records of calibration:

• QC logs

• Equipment maintenance logs

• Run worksheets

• SOPs, including procedure for

failures (QC failures) and supporting

documentation/follow up.

Review of laboratory test procedures to

meet manufacturer requirements.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Equipment Maintenance, Function Checks & Calibration | Page 25

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

5.6

D5439

§493.1255

(b)(1-3)

Does the laboratory perform and

document calibration verification

procedures:

• Following the manufacturer’s calibration

verification instructions; using the

criteria verified or established by the

laboratory?

• Including the number, type and

concentration of the materials,

as well as acceptable limits for

calibration verification?

• Including at least a minimal (or zero),

mid-point and maximum value near

the upper limit of the range to verify

the laboratory’s reportable range?

• Verifying calibration of test systems

at least once every six months and

whenever any of the following occur:

• A complete change of reagents for a

procedure is introduced?

• There is major preventive

maintenance or replacement of

critical parts?

• Control materials reflect an unusual

trend or shift, or are outside the

laboratory’s acceptable limits?

• The laboratory’s established

schedule for verifying the reportable

range for patient test results

requires more frequent calibration

verification?

Generally applies to quantitative assays;

review laboratory test procedures to

determine assays where this applies.

If applicable, records of calibration.

If an assay has a quantitative cut-off

value (e.g., some ELISAs), calibration

verification procedures may be needed

(contact the LD).

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Testing | Page 26

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

6. ANALYTIC—TESTING

6.1 Procedure Manual

# SOM/CFR* Requirement Examples of Compliance Notes

6.1.a

D5401

§493.1251 (a)

Does the laboratory have written

procedures for all tests, assays and

examinations performed available to

and followed by laboratory personnel?

A list of SOPs/test procedures/test

menus available for each CLIA-regulated

test performed may be stored and

accessed:

• Paper-based

• Electronic

Documentation for each test performed

must include:

• The original start date the procedure

was used for CLIA-regulated testing, if

available

• Approval by the technical supervisor

• Approved by the current CLIA

laboratory director.

Requirement met?

Yes

Notes:

6.1.b

D5403

§493.1251

(b)(1-14)

Do procedure manuals include the

requirements laid out in 6.b.i-xiv below,

when applicable, for a test procedure?

SOP/test procedures must include the

required elements specified in 6.1.bi - xiv.

If these items are not found in the SOP,

they must be found elsewhere. May refer

to another procedure, such as:

• Laboratory’s specimen submission

and handling procedure

• Sample rejection policy, to include

information on what labeling is

accepted and not accepted

• Sample collection instructions

• Sample requisition form

• Quality control

• Corrective action/ non-conforming

event

• Laboratory result reporting procedure

Requirement met?

Yes

Notes:

6.1.b.i

D5403

§493.1251

(b)(1)

Requirements for patient preparation;

specimen collection, labeling, storage,

preservation, transportation, processing

and referral; and criteria for specimen

acceptability and rejection as described

in §493.1242.

Requirement met?

Yes

Notes:

6.1.b.ii

D5403

§493.1251

(b)(2)

If microscopic examination is

performed, must include the detection

of inadequately prepared slides.

Requirement met?

Yes

Notes:

6.1.b.iii

D5403

§493.1251

(b)(3)

Step-by-step performance of the

procedure, including test calculations

and interpretation of results.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Testing | Page 27

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

6.1.b.iv

D5403

§493.1251

(b)(4)

Preparation of slides, solutions,

calibrators, controls, reagents, stains

and other materials used in testing.

Requirement met?

Yes

Notes:

6.1.b.v

D5403

§493.1251

(b)(5)

Calibration and calibration verification

procedures.

Requirement met?

Yes

Notes:

6.1.b.vi

D5403

§493.1251

(b)(6)

The reportable range for test results

for the test system as established or

verified in §493.1253.

Requirement met?

Yes

Notes:

6.1.b.

vii

D5403

§493.1251

(b)(7)

Control procedures.

Requirement met?

Yes

Notes:

6.1.b.

viii

D5403

§493.1251

(b)(8)

Corrective action to take when

calibration or control results fail to meet

the laboratory’s criteria for acceptability.

Requirement met?

Yes

Notes:

6.1.b.ix

D5403

§493.1251

(b)(9)

Limitations in the test methodology,

including interfering substances.

Requirement met?

Yes

Notes:

6.1.b.x

D5403

§493.1251

(b)(10)

Reference intervals (normal values).

Requirement met?

Yes

Notes:

6.1.b.xi

D5403

§493.1251

(b)(11)

Imminently life-threatening test results,

or panic or alert values.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Testing | Page 28

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

6.1.b.xii

D5403

§493.1251

(b)(12)

Pertinent literature references.

Requirement met?

Yes

Notes:

6.1.b.

xiii

D5403

§493.1251

(b)(13)

The laboratory’s system for entering

results in the patient record and

reporting patient results including, when

appropriate, the protocol for reporting

imminently life-threatening results, or

panic or alert values.

Requirement met?

Yes

Notes:

6.1.b.

xiv

D5403

§493.1251

(b)(14)

Description of the course of action

to take if a test system becomes

inoperable.

Requirement met?

Yes

Notes:

6.1.c

D5405

§493.1251

(c)

If the laboratory uses manufacturer’s

test systems or operator’s manuals

(e.g., LRN or EUA), does the laboratory

provide supplemental information to

meet requirements of §493.1251

(b)(1-14)?

Supplemental documention may include:

• Laboratory-specific specimen

acceptance/rejection criteria

• Reference (normal) values

• Alert values

Requirement met?

Yes

Notes:

6.1.d

D5407

§493.1251

(d)

Are procedures and changes to

procedures approved, signed and dated

by the current laboratory director before

use?

Documentation of CLIA laboratory

director approval for CLIA regulated test

procedures.

Requirement met?

Yes

Notes:

6.1.e

D6106

§493.1445

(e)(14)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that an approved

procedure manual is available to all

personnel responsi-ble for any aspect of

the testing process?

See evidence above for 6.1.a.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

6.1.f

D5409

§493.1251 (e)

D3029

§493.1105

(a)(2)

Record Retention: Is a copy of test

procedures retained for at least two

years after the procedure has been

discontinued and does the procedure

include dates of initial use and

discontinuance?

Note: Check state requirements as

applicable—go with most stringent.

Are discontinued SOP/test procedures

available if requested and include the

dates of initial use and date testing was

discontinued?

SOPs or testing procedures must be

available from the past two years,

including ones that have been

discontinued.

Longer retention times might be in

place for other state, local and federal

regulations and must also be followed.

The CLIA two-year rule must be followed

at a minimum.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Testing | Page 29

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

6.2 Analytic Systems—Veriﬁcation and Validation (establishment of performance

speciﬁcations)

# SOM/CFR* Requirement Examples of Compliance Notes

6.2.a

D5419

§493.1253 (a)

Has the laboratory verified or established

performance specifications (validated)

all tests put into place or modified on or

after April 24, 2003 prior to reporting

patient results?

Note: Verification or validation for tests

used prior to April 24, 2003 is highly

recommended.

• There is an SOP that includes

verification and validation procedure.

• Validation or verification records for

each test.

Requirement met?

Yes

Notes:

6.2.b

D6085

§493.1445

(e)(3)(i)

Technical Supervisor Responsibility

(Delegated by LD): Does the

technical supervisor ensure that test

methodologies selected have the

capability of providing the quality of

results required for patient care?

See evidence for 6.2.c and 6.2.e.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

6.2.c

D5421

§493.1253

(b)(1)

For unmodified FDA-cleared/approved

test systems, has the laboratory verified

the following prior to reporting patient

results:

• The lab can obtain performance

specifications comparable to those

established by the manufacturer for

accu-racy, precision and reportable

range?

• The manufacturer’s reference intervals

(normal values) are appropriate for

their population?

• Documentation and records of

verification/validation must be

available for inspection.

• Records must include evidence of

review and approval by the technical

supervisor.

Requirement met?

Yes

Notes:

6.2.d

D6086

§493.1445

(e)(3)(ii)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that verification

procedures used are adequate to

determine the accuracy, precision

and other pertinent performance

characteristics of the method?

See evidence for 6.2.c and 6.2.e.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Testing | Page 30

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

6.2.e

D5423

§493.1253

(b)(2)

For all modified FDA-cleared/approved

test systems or a laboratory developed

test system in which the performance

specifications are not provided by

the manufacturer, has the laboratory

established the following performance

characteristics:

• Accuracy?

• Precision?

• Analytical sensitivity?

• Analytical specificity to include

interfering substances?

• Reportable range of test results?

• Reference intervals (normal values)?

• Any other performance characteristic

required for test performance?

• Documentation and records of

verification/validation must be

available for inspection.

• Records must include evidence of

review and approval by the technical

supervisor.

Requirement met?

Yes

Notes:

6.2.f

D6095

§493.1445

(e)(6)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure the establishment

and maintenance of acceptable levels

of analytical perfor-mance for each test

system?

New or modified test procedure

verification/validation studies are

submitted to the LD for review and

approval

See evidence for 6.2.c and 6.2.e.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

6.2.g

D5425

§493.1253

(b)(3)

Has the laboratory determined each

test system’s calibration and control

procedures based upon the performance

specifications verified or established

under §493.1253(b)(1) or §493.1253(b)

(2)?

• Determination of calibration, if

applicable, and control requirements

must be in validation records

• Test procedures

Requirement met?

Yes

Notes:

6.2.h

D5427

§493.1253

(c)

Does the laboratory document all

activities for all method verification

and establishment of performance

specifications?

The laboratory must have documentation

and records available for inspection for

verification/validation activities including

records of the actual measurements

taken, reactions and/or observations.

Requirement met?

Yes

Notes:

6.2.i

D3033

§493.1105

(a)(3)(i)

Record Retention: Are records of test

system performance specifications that

the laboratory establishes or verifies

under §493.1253 retained for the period

of time the laboratory uses the test

system but no less than two years?

Note: Longer retention times might be

in place for other state, local, federal

regulations and must also be followed. The

CLIA two-year rule must be followed at a

minimum.

Verfication/validation procedures must

be available for the period of the time

that the laboratory uses the testing

system, but no less than two years.

Check state requirements as applicable—

go with most stringent.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Quality Control | Page 31

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

7. ANALYTIC—QUALITY CONTROL

7.1 QC—General

# SOM/CFR* Requirement Examples of Compliance Notes

7.1.a

D5441

§493.1256

(a)(b)(c)(1-2)

Has the laboratory established quality

control (QC) procedures for each test

system that monitor the accuracy and

precision of the complete analytic

process?

Does the QC procedure:

• Detect immediate errors that occur

due to test system failure, adverse

environmental conditions and operator

performance?

• Monitor over time the accuracy

and precision of test performance

that may be influenced by changes

in test system performance and

environmental conditions, and

variance in operator performance?

• Comply with the recommendations of

the manufacturer?

Does the QC procedure establish the

number, type and frequency of testing

control materials using, if applicable, the

performance specifications verified or

established by the laboratory?

• Quality Control policy/procedure

• Records

• Logs or worksheets

Note: Specifics for number, type and

frequency needs to be defined in each

individual test procedure.

Requirement met?

Yes

Notes:

7.1.b

D6117

§493.1451

(b)(4)

Technical Supervisor Responsibility: Has

the technical supervisor established a

quali-ty control program appropriate for

the testing performed covering the entire

path of work flow.

QC policies and procedures.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

7.1.c

D6093

§493.1445

(e)(5)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that the quality control

and quality assessment programs are

established and maintained to assure the

quality of laboratory services provided

and to identify fail-ures in quality as they

occur?

QC policies/procedures and records of

review.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

7.1.d

D6148

§493.1463

(a)(4)

General Supervisor Responsibility:

Does the general supervisor monitor test

analyses and specimen examinations to

ensure that acceptable levels of analytic

performance are maintained?

QC is reviewed and failed QC is

documented and investigated.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• General Supervisor Personnel Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Quality Control | Page 32

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

7.1.e

D5445

§493.1256

(d)(1-2)

Does the laboratory perform control

procedures as:

• Defined in this section and/or as

specified in the additional specialty

and subspecialty requirements,

• Recommended by the manufacturer

or established by the laboratory

ONLY when they meet or exceed the

requirement in this section, or

• Developed and customized by the

laboratory using an Individualized

Quality Control Plan (IQCP) to meet

requirements, with IQCP records

reviewed and verified annually as

appropriate to the test methods.

• QC policies/procedures

• QC records, logs or worksheets

includes lot number, date received,

opened or prepared date and

expiration date.

• IQCP documentation reviewed annually

for potential new risks and adequacy

of the QC plan.

• Actual measurements, reactions and/

or observations should be recorded.

• Evaluation of QC failures and, if

applicable, nonconforming event and

corrective actions records that include:

• Retrospective review of patient

results from testing since the last

time the system was known to be

performing within specification

• Issuing corrected patient results or

contacting physicians to notify of

potential error.

• Evidence of supervisory review.

• Check that patient results were not

reported when QC was unacceptable.

Requirement met?

Yes

See Quality Assessment Worksheet

Notes:

7.1.f

§493.1256

(d)(3)

Does the laboratory perform QC

procedures at least once each day

patient speci-mens are assayed for the

following (7.1f.i-v):

See evidence for 7.1.e.

Check QC records to ensure appropriate

controls are performed for each test

procedure.

Requirement met?

Yes

Notes:

7.1.f.i

D5447

§493.1256

(d)(3)(i)

For quantitative procedures, include

two control materials of different

concentrations.

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.f.ii

D5449

§493.1256

(d)(3)(ii)

For qualitative procedures, include a

negative and positive control material.

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.f.iii

D5451

§493.1256

(d)(3)(iii)

For test procedures producing a graded

or titered result, include a negative

control material and a control material

with graded or titered reactivity.

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Quality Control | Page 33

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

7.1.f.iv

D5453

§493.1256

(d)(3)(iv)

For test systems that have an extraction

phase, include two control materials,

including one that is capable of detecting

errors in the extraction process.

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.f.v

D5453

§493.1256

(d)(3)(v)

For molecular amplification procedures,

include two controls and, if reaction

inhibition is a significant source of false

negative results, a control material

capable of detect-ing the inhibition?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.g

D5457

§493.1256

(d)(4)

For thin layer chromatography (TLC),

spot each plate or card with a calibrator

containing all known substances or

drug groups, as appropriate which are

identified by TLC and reported by the

laboratory; and include at least one

control material on each plate or card

which is processed through each step of

patient testing, including extrac-tion?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.h

D5459

§493.1256

(d)(5)

For electrophoresis procedures, include,

concurrent with patient specimens, at

least one control material containing

the substances being identified or

measured?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.i

D5461

§493.1256

(d)(6)

Does the laboratory perform specified

quality control before resuming patient

testing when a:

• Complete change of reagents is

introduced?

• Major preventive maintenance is

performed or a critical part that

may influence test performance is

replaced?

• Quality control policy/procedure

• Records

• Logs or worksheets

• IQCP documentation

• Instrument logs

• Non-conforming event (NCE) log

• Reagent log

Requirement met?

Yes

Notes:

7.1.j

D5463

§493.1256

(d)(7)

Does the laboratory rotate control

material testing among all personnel who

perform patient testing?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.k

D5465

§493.1256

(d)(8)

Does the laboratory test control

materials in the same manner as patient

specimens?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Quality Control | Page 34

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

7.1.l

D5467

§493.1256

(d)(9)

For quantitative procedures, when using

calibration material as a control material,

are different lot numbers used from the

calibration material used to calibrate the

test system?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.m

D5459

§493.1256

(d)(10)

For quantitative procedures, has the

laboratory established or verified the

criteria for acceptability of all control

materials?

• Are statistical parameters (e.g., mean

and standard deviation) defined for

each lot of control materials from

which quantitative results are derived?

• If the laboratory uses commercially

assayed control material values, are

the method and instrumentation val-

ues verified by the laboratory?

• If the laboratory uses unassayed

control material, are statistical

parameters established over time

through con-current testing of

control materials having previously

determined statistical parameters?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.n

D5471,

D5473,

D5475

§493.1256

(e)(1-3)

For reagent, media and supply checks,

does the laboratory perform and

document the following:

• Check each batch (prepared in-

house), lot number (commercially

prepared) and shipment of reagents,

disks, stains, antisera (excluding

bacteriology) and identification

systems (using two or more substrates

or reagents) when prepared or opened

for positive and negative reactivity, as

well as graded reactivity, if applicable?

• Each day of use, test staining material

for intended reactivity? Controls are

to include both positive and nega-tive

reactivity.

• Each time of use, check fluorescent

and immunohistochemical stains for

positive and negative reactivity?

• See evidence for 7.1.e

• See media logs

Requirement met?

Yes

Notes:

7.1.o

D5477

§493.1256

(e)(4)

Before or concurrent with initial use

media, does the laboratory check and

document each batch for:

• Sterility, if sterility is required for

testing?

• Ability to support growth and, as

applicable, select or inhibit specific

organisms or produce biochemical

responses?

• Physical characteristics of the media

when compromised and report any

deterioration in the media to the

manufacturer?

• See evidence for 7.1.e

• See media logs

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Quality Control | Page 35

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

7.1.p

D5479

§493.1256

(e)(5)

Does the laboratory follow the

manufacturer’s specifications for using

reagents, media and supplies?

• See evidence for 7.1.e

• Compare to manufacturer’s package

insert.

Requirement met?

Yes

Notes:

7.1.q

D5481

§493.1256

(f)(g)

Does the laboratory document quality

control testing and evaluate control

results to ensure established criteria for

acceptability are met before reporting

patient test results?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.1.r

D6118

§493.1451

(b)(5)

Technical Supervisor Responsibility:

Does the technical supervisor ensure

that technical problems are resolved

and that remedial actions are taken

and documented when laboratory

test systems deviate from established

performance specifications?

QC policies and procedures documented;

if delegated in writing to the GS (see

7.1.t).

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

7.1.s

D6119

§493.1451

(b)(6)

Technical Supervisor Responsibility:

Does the technical supervisor ensure

that patient test results are not reported

until corrective actions have been

taken and test sys-tems are functioning

properly?

QC policies and procedures documented;

if delegated in writing to the GS (see

7.1.t).

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

7.1.t

D6149,

D6150

§493.1463

(b)(1-2)

General Supervisor Responsibility

(If delegated by LD or TS): Does the

general supervisor assure all remedial

actions are taken whenever test systems

deviate from the la-boratory’s established

performance specifications and ensure

patient test results are not reported

until all corrective actions have been

taken and the test system is properly

functioning?

• Failed QC is documented and

investigated.

• NCE corrective action followed up for

effectiveness, etc.

• Patient results are not reported when

QC out of range.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• General Supervisor Personnel Form

Notes:

7.1.u

D6096,

D6097

§493.1445

(e)(7)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that all necessary

remedial actions are taken and

documented whenever significant

deviations from the laboratory’s

established performance characteristics

are identified, and that patient test

results reported only when the system is

functioning properly?

QC policies and procedures documented;

if delegated in writing to the GS (see

7.1.t).

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Quality Control | Page 36

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

7.1.v

D3031

§493.1105

(a)(3)

Record Retention: Are quality control

and patient test records (including

instrument printouts, if applicable)

and records documenting all analytic

activities (specified in §493.1252

through 493.1289) retained for at least

two years?

Note: Longer retention times might be in

place for other state, local and federal

regulations and must also be followed. The

CLIA two-year rule must be followed at a

minimum.

QC records must be available from the

past two years, including ones that have

been discontinued.

The records must include instrument

charts, graphs, printouts, transcribed

data and manufacturers’ assay

information sheets for control and

calibration materials. If data are

transcribed, ensure that the original and

the transcribed copy are retained for

two years. Printouts from an instrument

that is not directly interfaced with the

laboratory information system must be

retained for two years.

Note: Check state requirements as

applicable—go with most stringent.

Requirement met?

Yes

Notes:

7.2 QC—Bacteriology

# SOM/CFR* Requirement Examples of Compliance Notes

7.2.a

D5501, D5503,

D5505

§493.1261

(a)(1-3)

Does the laboratory check the following

for positive and negative reactivity using

control organisms:

• Each day of use for beta lactamase

methods other than Cefinase

• Each week of use for gram stains?

• When each batch (prepared in house),

lot number (commercially prepared)

and shipment of antisera is pre-pared

or opened, and once every six months

thereafter?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.2.b

D5507

§493.1261

(b)(1-2)(c)

For antimicrobial susceptibility tests,

does the laboratory:

• Check each batch of media and

each lot number and shipment of

antimicrobial agent(s) before, or

concurrent with initial use, using

approved control organisms?

• Test approved control organisms each

day of testing?

• Document and evaluate zone sizes or

MICs for control organisms to ensure

that they are within established limits

before reporting patient results?

• Document all control procedures

performed?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Quality Control | Page 37

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

7.3 QC—Mycobacteriology

# SOM/CFR* Requirement Examples of Compliance Notes

7.3.a

D5511

§493.1262 (a)

On each day of use, does the laboratory

check all reagents or test procedures

used for mycobacteria identification

with at least one acid-fast organism that

produces a positive reaction and an acid-

fast organism that produces a negative

reaction?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.3.b

D5513

§493.1262

(b)(1-3)(c)

For antimycobacterial susceptibility

tests, does the laboratory check each

batch of media and each lot number and

shipment of antimycobacterial agent(s)

before, or concurrent with, initial use

using appropriate control organism(s)?

If so,

• Has the laboratory established limits

for acceptable control results?

• Does the laboratory use appropriate

control organism(s) each week

tests are performed to check the

procedure?

• Are the results of control organism(s)

verified to be within established limits

before patient results are reported?

• Does the laboratory document all

control procedures performed?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.4 QC—Mycology

# SOM/CFR* Requirement Examples of Compliance Notes

7.4.a

D5517

§493.1263 (a)

Does the laboratory check each batch

(prepared in-house), lot number

(commercially prepared) and shipment of

lactophenol cotton blue when prepared

or opened for intended reactivity with a

control organism(s)?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.4.b

D5519

§493.1263 (b)

(1-3)(c)

For antifungal susceptibility tests, does

the laboratory check each batch of media

and each lot number and shipment of

antifungal agent(s) before, or concurrent

with, initial use using appropriate control

organism(s)?

If so,

• Has the laboratory established limits

for acceptable control results?

• Does the laboratory use appropriate

control organism(s) each week

tests are performed to check the

procedure?

• Are the results of control organism(s)

verified to be within established limits

before patient results are reported?

• Does the laboratory document all

control procedures performed?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Analytic—Quality Control | Page 38

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

7.5 QC—Parasitology

# SOM/CFR* Requirement Examples of Compliance Notes

7.5.a

D5523

§493.1264 (a)

Does the laboratory have a reference

collection of slides or photographs

available and, if available, gross

specimens for identification of parasites

and use these references in the

laboratory for appropriate comparison

with diagnostic specimens?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.5.b

D5525

§493.1264 (b)

Does the laboratory calibrate and use

ocular micrometers for determining

the size of ova and parasites, if size is

critical?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.5.c

D5527

§493.1264

(c)(d)

Does the laboratory check permanent

stains each month of use using a

fecal sample control material that will

demonstrate staining characteristics?

Does the laboratory document all control

procedures performed?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.6 QC—Virology

# SOM/CFR* Requirement Examples of Compliance Notes

7.6.a

D5531

§493.1265

(a)(b)

When using cell cultures to isolate or

identify viruses, does the laboratory

simultaneously incubate a cell substrate

control or uninoculated cells as a

negative control?

Does the laboratory document all control

procedures performed?

See evidence for 7.1.e.

Requirement met?

Yes

Notes:

7.7 QC—Other than Microbiology

# SOM/CFR* Requirement Examples of Compliance Notes

7.7.a

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | PT & Alternative Assessment | Page 39

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

8. PROFICIENCY TESTING (PT) & ALTERNATIVE ASSESSMENT

8.1 PT—Enrollment

For all requirements below, refer to the Proficiency Testing and Alternative Assessment Review Worksheet Tool.

# SOM/CFR* Requirement Examples of Compliance Notes

8.1.a

D2001

§493.801 (a)

Is the laboratory enrolled in a CMS-

approved PT program offering three

(3) events per year (two (2) events for

mycobacteriology) with a minimum of five

(5) samples per event for all regulated

analytes tested?

• Compare test lists to PT enrollment

• Records of participation in an

approved PT program for labs testing

regulated analytes

Requirement met?

Yes

Notes:

8.1.b

D6088

§493.1445

(e)(4)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that the laboratory is

enrolled in an HHS-approved proficiency

testing program, if available, for the

testing performed?

See evidence for 8.1.a

Note: Duplicate of 8.1.c if delegated in

writing by the LD.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

8.1.c

D6116

§493.1451

(b)(3)

Technical Supervisor Responsibility: Does

the technical supervisor ensure that the

laboratory is enrolled and participates

in an HHS approved proficiency testing

program commensurate with the services

offered?

See evidence for 8.1.a.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

8.1.d

D5217, D5219

§493.1236

(c)(1-2)

Does the laboratory verify the accuracy at

least twice annually using an alternative

assessment procedure (AAP) such as

other external assessment programs,

blind testing, or split samples for other

testing such as:

• Tests where no compatible PT samples

are offered by a CMS approved PT

program?

• Tests for nonregulated analytes?

• Compare test lists to what is not

covered in PT enrollment and must

perform an AAP

• Procedure and records indicating

at least twice annual alternative

assessment for all other testing

• Records should be easy to follow and

should include a summary page with

expected results, actual results and

evaluation of performance

Requirement met?

Yes

Notes:

8.2 PT—Testing of Samples

For all requirements below, refer to the Proficiency Testing and Alternative Assessment Review Worksheet Tool.

# SOM/CFR* Requirement Examples of Compliance Notes

8.2.a

D2006

§493.801 (b)

Does the laboratory examine PT samples

in the same manner as it tests patient

specimens?

• Policy/procedure to ensure

compliance

• QA manual

• Attestation statements provided by

CAP, other PT provider or created

in-house

Requirement met?

Yes

See the Audit Attestation Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | PT & Alternative Assessment | Page 40

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

8.2.b

D6089

§493.1445

(e)(4)(i)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that proficiency

testing samples are tested as required by

§493.801?

See evidence for 8.2.a.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

8.2.c

D6176

§493.1495

(b)(2)

Testing Personnel Responsibility: Do

testing personnel maintain records that

demonstrate that proficiency testing

samples are tested in the same manner

as patient specimens?

• Worksheets and sample logs

• Policies and procedures

• QA manual

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Testing Personnel Form

Notes:

8.2.d

D2007

§493.801

(b)(1)

Are PT samples examined along with the

lab’s regular workload by personnel who

routinely perform testing using the lab’s

routine methods?

• PT records indicate that testing was

performed by testing personnel

authorized to perform the assay

• Attestation statements

• PT records to confirm testing

personnel are rotated

Requirement met?

Yes

Notes:

8.2.e

D2009

§493.801

(b)(1)

Does the individual testing the PT

samples and the technical supervisor

(delegated by the LD) sign an attestation

statement that PT samples are integrated

into the patient workload using the

laboratory’s routine methods?

• Attestation statements provided by

the College of American Pathologists,

other PT provider or created in-house

• Policies and procedures

Requirement met?

Yes

Notes:

8.2.f

D2010

§493.801

(b)(2)

Are PT samples tested the same number

of times as patient samples are routinely

tested?

• Worksheets and sample logs

• Policies and procedures

Requirement met?

Yes

Notes:

8.2.g

D2011, D2013

§493.801

(b)(3-4)

Does the laboratory have procedures to

ensure:

• No inter-laboratory communication

regarding PT samples/results occurs

until after the result submission

deadline date has passed?

• PT samples are not referred to

another laboratory for analysis, or if

PT samples are received from another

laboratory for testing, the samples are

not tested and CMS is notified?

• Policies and procedures

• QA manual

• Worksheets, sample logs and final

reports for verification

Requirement met?

Yes

Notes:

8.2.h

D2015

§493.801

(b)(5)

Does the laboratory document the

handling, preparation, processing,

examination, and each step in the

testing and reporting of results for all PT

samples?

• Policies and procedures

• QA manual

• Worksheets, sample logs and final

reports for verification

• Attestation statements

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | PT & Alternative Assessment | Page 41

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

8.3 PT—Evaluation of Performance

For all requirements below, refer to the Proficiency Testing and Alternative Assessment Review Worksheet Tool.

# SOM/CFR* Requirement Examples of Compliance Notes

8.3.a

D6090

§493.1445

(e)(4)(ii)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that PT results

are returned within the timeframes

established by the PT program?

PT records are reviewed and complete.

Requirement met?

Yes

Notes:

8.3.b

D5211

§493.1236 (a)

Does the laboratory review and evaluate

the results obtained on PT?

Has the laboratory had unsatisfactory PT

responses? Records should indicate:

• PT result evaluations are reviewed and

signed by the technical supervisor

• Documentation of investigation of

the incorrect result, including any

corrective action or retraining required

• For assays where failed results are

common, results should be logged

for trends that might likely cause the

failed results

• NCEs, self-assessments, corrective

actions

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

8.3.c

D6091

§493.1445

(e)(4)(iii)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that all PT reports

received are reviewed by the appropriate

staff to evaluate the laboratory’s

performance and to identify any problems

that require corrective actions?

PT performance is reviewed with

appropriate staff.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

8.3.d

D5213–D5215

§493.1236 (b)

Does the laboratory verify the accuracy of

any PT result that was not scored for any

reason?

Records of review and evaluation of

ungraded PT challenges.

Requirement met?

Yes

Notes:

8.3.e

D5221

§493.1236 (d)

Are PT evaluations and verification

activities documented?

Note: This applies even if the overall PT

event was successful.

Records available.

Requirement met?

Yes

Notes:

8.3.f

D6092

§493.1445

(e)(4)(iv)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that an approved

corrective actions plan is followed when

any proficiency testing result is found to

be unacceptable or unsatisfactory?

Documentation of review/approval.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | PT & Alternative Assessment | Page 42

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

8.3.g

D3037

§493.1105

(a)(4)

Record Retention: Are records of PT

examination and documentation of

activities retained for a minimum of two

years after the PT event?

Note: Longer retention times might be in

place for other state, local and federal

regulations and must also be followed. The

CLIA two-year rule must be followed at a

minimum.

Obtain signed attestation statements,

PT results and scores from the provider,

documentation of review and records of

any corrective actions, either electronic

or hard copies.

Note: Check state requirements as

applicable—go with most stringent.

Requirement met?

Yes

Notes:

8.4 Comparison of Test Results

# SOM/CFR* Requirement Examples of Compliance Notes

8.4.a

D5775

§493.1281

(a)(c)

If the laboratory performs the same

test using different methodologies,

instruments or testing sites, does

the laboratory have a procedure that

twice a year evaluates and defines the

relationship between test results using

the different methodologies, instruments

or testing sites?

Does the laboratory document test result

comparison?

Procedure and records for comparison of

results when the same test is:

• Performed by another testing site

• Performed using multiple instruments

• Performed by a different methodology.

The laboratory must have written criteria

for acceptable differences in test values.

This comparison must be done twice

a year and must be approved by the

technical supervisor.

Requirement met?

Yes

See examples of instrument comparison

records:

• EVOLIS Instrument Comparability Chart

• PCR Instrument Comparison Example

Notes:

8.4.b

D5777

§493.1281

(a)(c)

Does the laboratory have a system to

assess patient test results that appear

inconsistent with the following relevant

criteria, when available:

• Patient Age?

• Patient Sex?

• Diagnosis or pertinent clinical data?

• Distribution of patient test results?

• Relationship with other test

parameters?

If applicable, documentation within a

test SOP.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | General Laboratory Systems & Retention Requirements | Page 43

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

9. GENERAL LABORATORY SYSTEMS & RETENTION REQUIREMENTS

9.1 General Laboratory Systems §493.1230

# SOM/CFR* Requirement Examples of Compliance Notes

9.1.a

D5787, D5789

§493.1283

(a)(1-4)(b)

Does the laboratory maintain an

information or record system that

includes the following:

• Positive identification of the

specimen?

• Date and time of specimen receipt into

the laboratory?

• The condition and disposition of

specimens that do not meet the

laboratory’s criteria for specimen

acceptability?

• Records and dates of specimen

testing, including the identity of the

personnel who performed the test(s)?

• Records of patient testing including, if

applicable, instrument printouts?

• Unique identifiers to provide positive

identification of specimens from

accessioning through storage.

• Receipt date and time is recorded for

all specimens.

• Condition of specimens and

disposition is recorded.

• Verify procedure for positive specimen

identification, log date, time of receipt

and log rejected specimens.

• Worksheets should indicate date and

time of testing and include the identity

of the individual performing the test

(initials, signature or electronically

logged).

• Instruments printouts maintained, if

applicable.

Requirement met?

Yes

Notes:

9.1.b

D5201

§493.1231

Does the laboratory ensure

confidentiality of patient information

throughout all phases of the total testing

processes that are under its control?

• Controlled access of laboratory

areas where patient info may easily

be viewed in a hard copy format or

electronically.

• Required security awareness training

for all employees.

• Observe during walkthrough if patient

reports are lying out in open view.

• Staff access permissions forms, if

applicable.

Requirement met?

Yes

Notes:

9.1.c

D5203

§493.1232

Has the laboratory established and does

it follow written policies and procedures

that ensure positive identification and

optimum integrity of patient samples

from time of receipt through completion

of testing and reporting of results?

• Policy/procedure to ensure

compliance.

• Unique identifiers to provide positive

identification of specimens from

accessioning through storage.

• Observe during walkthrough how

aliquots are labeled on the bench.

Requirement met?

Yes

Notes:

9.1.d

D5205

§493.1233

Does the laboratory have a system in

place to document all complaints and

problems reported to the laboratory

and does the laboratory conduct and

document investigations of complaints,

when appropriate?

• Log of communications and

complaints including follow up and

date closed, reviewed for trends of

problems and corrective action taken

(NCEs)

• Policy and procedure on how to define

and address complaints.

Requirement met?

Yes

Notes:

9.1.e

D5207

§493.1234

Does the laboratory have a system in

place to identify and document problems

that occur as a result of a breakdown in

communication between the laboratory

and an authorized person who orders or

receives test results?

Review communication logs, NCE logs

and reports for problems that may be

related to communication.

Example: Ongoing inquiries from submitters

for clarification concerning appropriate

specimen, proper collection, transport, etc.

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Quality Assessment & Corrective Action | Page 44

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

10. QUALITY ASSESSMENT & CORRECTIVE ACTION

10.1 Quality Assessment

# SOM/CFR* Requirement Examples of Compliance Notes

10.1.a

D5291

§493.1239 (a)

General Laboratory Systems

Has the laboratory established and

does it follow written policies and

procedures for an ongoing quality

assessment mechanism to monitor,

assess, continuously improve and, when

indicated, correct problems identified in

the general laboratory systems?

SOPs, quality metrics, internal audits,

non-conforming events, corrective action

reports.

QA of general lab systems includes

assessing practices/issues related to:

• Patient confidentiality

• Specimen identification and integrity

• Complaint investigations

• Communications

• Personnel Competency

• Proficiency testing performance

Requirement met?

Yes

Notes:

10.1.b

D5391

§493.1249 (a)

Pre-analytic Systems

Has the laboratory established and

does it follow written policies and

procedures for an ongoing quality

assessment mechanism to monitor,

assess, continuously improve and, when

indicated, correct problems identified in

the preanalytic systems?

SOPs, quality metrics, internal audits,

non-conforming events, corrective action

reports.

QA of pre-analytic lab systems includes

assessing practices/issues related to:

• Test requests

• Specimen submission

• Specimen handling

• Tracking of rejected specimens and

reasons why

• Verification of requisitions

• Patient identifiers

Does the laboratory track problems with

incorrect or incomplete information on

test requisitions?

Requirement met?

Yes

Notes:

10.1.c

D5791

§493.1289 (a)

Analytic Systems

Has the laboratory established and

does it follow written policies and

procedures for an ongoing quality

assessment mechanism to monitor,

assess, continuously improve and, when

indicated, correct problems identified in

the analytic systems?

SOPs, quality metrics, internal audits,

non-conforming events, corrective action

reports.

QA of analytic lab systems includes

assessing practices/issues related to:

• Test procedures

• Accurate and reliable test systems,

equipment, instruments, reagents,

materials and supplies

• Specimen and reagent storage

conditions

• Equipment/instrument/test/system

maintenance and function checks

• Establishment and verification of

method performance specifications

• Calibration and calibration verification

• Control procedures

• Semiannual comparison of tests

results for the same analyte

• Corrective actions

• Test records

• Patient identifiers

Requirement met?

Yes

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Quality Assessment & Corrective Action | Page 45

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

10.1.d

D5891

§493.1299 (a)

Post-analytic Systems

Has the laboratory established and

does it follow written policies and

procedures for an ongoing quality

assessment mechanism to monitor,

assess, continuously improve and, when

indicated, correct problems identified in

the post-analytic systems?

SOPs, quality metrics, internal audits,

non-conforming events, corrective action

reports.

QA of post-analytic lab systems includes

assessing practices/issues related to:

• Accuracy and completeness

• Turn-around time monitoring and

notification

• Notification for abnormal or panic

values

• Tracking corrected reports

• Patient identifiers

Requirement met?

Yes

Notes:

10.1.e

D5293

§493.1239 (b)

General Laboratory Systems

Does the general laboratory systems

quality assessment include a review of

the following:

• Effectiveness of corrective actions

taken to resolve problems?

• Effectiveness of revisions to

policies and procedures to prevent

recurrence of problems?

• Discussion of general laboratory

systems quality assessment reviews

with appropriate staff?

• Management review or minutes from

quality management meetings with

staff.

• Quality management reports.

• Corrective action reports include

actions to prevent recurrence

of problem and plan to monitor

effectiveness.

Requirement met?

Yes

Refer to 10.1.a-d.

Notes:

10.1.f

D5393

§493.1249 (b)

Pre-analytic Systems

Does the pre-analytic systems quality

assessment include a review of the

following:

• Effectiveness of corrective actions

taken to resolve problems?

• Effectiveness of revisions to

policies and procedures to prevent

recurrence of problems?

• Discussion of general laboratory

systems quality assessment reviews

with appropriate staff?

• Management review or minutes from

quality management meetings with

staff.

• Quality management reports.

• Corrective action reports include

actions to prevent recurrence

of problem and plan to monitor

effectiveness.

Requirement met?

Yes

Refer to 10.1.a-d.

Notes:

10.1.g

D5793

§493.1289 (b)

Analytic Systems

Does the analytic systems quality

assessment include a review of the

following:

• Effectiveness of corrective actions

taken to resolve problems?

• Effectiveness of revisions to

policies and procedures to prevent

recurrence of problems?

• Discussion of general laboratory

systems quality assessment reviews

with appropriate staff?

• Management review or minutes from

quality management meetings with

staff.

• Quality management reports.

• Corrective action reports include

actions to prevent recurrence

of problem and plan to monitor

effectiveness.

Requirement met?

Yes

Refer to 10.1.a-d.

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Quality Assessment & Corrective Action | Page 46

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

10.1.h

D5893

§493.1299 (b)

Post-analytic Systems

Does the post-analytic systems quality

assessment include a review of the

following:

• Effectiveness of corrective actions

taken to resolve problems?

• Effectiveness of revisions to

policies and procedures to prevent

recurrence of problems?

• Discussion of general laboratory

systems quality assessment reviews

with appropriate staff?

• Management review or minutes from

quality management meetings with

staff.

• Quality management reports.

• Corrective action reports include

actions to prevent recurrence

of problem and plan to monitor

effectiveness.

Requirement met?

Yes

Refer to 10.1.a-d.

Notes:

10.1.i

D5293

§493.1239 (c)

General Laboratory Systems

Does the laboratory document all

quality assessment activities for general

laboratory systems?

Documented evidence includes:

• Records generated per SOPs related to

QA activities

• Documentation of quality metrics

• NCEs

• Corrective action reports

• Management review presentations

or minutes from quality management

meetings with staff

• Quality management reports.

Records must show evidence of

management or supervisory review.

Requirement met?

Yes

Refer to 10.1.a-d.

Notes:

10.1.j

D5393

§493.1249 (c)

Pre-analytic Systems

Does the laboratory document all

quality assessment activities for pre-

analytic systems?

Documented evidence includes:

• Records generated per SOPs related to

QA activities

• Documentation of quality metrics

• NCEs

• Corrective action reports

• Management review presentations

or minutes from quality management

meetings with staff

• Quality management reports.

Records must show evidence of

management or supervisory review.

Requirement met?

Yes

Refer to 10.1.a-d.

Notes:

10.1.k

D5793

§493.1289 (c)

Analytic Systems

Does the laboratory document all

quality assessment activities for analytic

systems?

Documented evidence includes:

• Records generated per SOPs related to

QA activities

• Documentation of quality metrics

• NCEs

• Corrective action reports

• Management review presentations

or minutes from quality management

meetings with staff

• Quality management reports.

Records must show evidence of

management or supervisory review.

Requirement met?

Yes

Refer to 10.1.a-d.

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Quality Assessment & Corrective Action | Page 47

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

# SOM/CFR* Requirement Examples of Compliance Notes

10.1.l

D5893

§493.1299 (c)

Post-analytic Systems

Does the laboratory document all

quality assessment activities for post-

analytic systems?

Documented evidence includes:

• Records generated per SOPs related to

QA activities

• Documentation of quality metrics

• NCEs

• Corrective action reports

• Management review presentations

or minutes from quality management

meetings with staff

• Quality management reports.

Records must show evidence of

management or supervisory review.

Requirement met?

Yes

Refer to 10.1.a-d.

Notes:

10.1.m

D3039

§493.1105

(a)(5)

Record Retention: Are quality

assessment records retained for at

least two years?

Note: Longer retention times might be

in place for other state, local, federal

regulations and must also be followed.

The CLIA two-year rule must be followed at

a minimum.

Records available for two years.

Note: Check state requirements as

applicable —go with most stringent.

Requirement met?

Yes

Notes:

10.1.n

D6094

§493.1445

(e)(5)

Technical Supervisor Responsibility

(Delegated by LD): Does the technical

supervisor ensure that QC and

QA programs are established and

maintained to assure the quality of

laboratory services provided and to

identify failures in quality as they occur?

• QA policies/procedures and records.

• Competency assessment of the

technical supervisor.

Requirement met?

Yes

See:

• CLIA Personnel Review Worksheet Tool

• Technical Supervisor Personnel Form

Notes:

SOM Appendix C (Rev. 166, 2017)

CFR 42, Part 493

APHL CLIA Audit Checklist | Quality Assessment & Corrective Action | Page 48

Table Key

Laboratory Director (LD)

Clinical Consultant (CC)

General Supervisor (GS)

Technical Supervisor (TS)

Laboratory Director: Date:

Return to

Table of Contents

10.2 Corrective Action

# SOM/CFR* Requirement Examples of Compliance Notes

10.2.a

D5779

§493.1282 (a)

Has the laboratory established

corrective action policies and

procedures?

Are the policies and procedures

available and followed in a manner that

ensures accurate and reliable patient

test results and reports?

Nonconforming event (NCE) and

corrective action procedure and records.

Requirement met?

Yes

Notes:

10.2.b

D5781

§493.1282

(b)(1)

Does the laboratory document

corrective actions taken when test

systems do not meet the laboratory’s

verified/established performance

specifications including:

• Equipment or methodologies are

performed outside of established

operating parameters or performance

specifications?

• Patient test values are outside of the

laboratory’s reportable range for the

test?

• When the laboratory determines

that the reference intervals for a test

procedure are inappropriate for the

laboratory’s patient population?

NCE and corrective action reports show

evidence the laboratory is monitoring and

evaluating laboratory performance and

the quality of services.

NCE documentation should include all

specifics to be able to trace the event.

Example: Temperature-controlled spaces,

equipment and instruments must be

monitored and results documented

for acceptable temperature ranges.

If corrective action is needed when

acceptable temperature ranges are

exceeded, the serial number should be

included in the NCE.

Requirement met?

Yes

Notes:

10.2.c

D6178

§493.1495

(b)(4)

Testing Personnel Responsibility:

Is there documented evidence that

testing personnel follow the laboratory’s

established policies and procedures

whenever test systems are not within

established acceptable levels of

performance?

Documentation of corrective action or

NCE.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool

Notes:

10.2.d

D6181

§493.1495

(b)(6)

Testing Personnel Responsibility:

Do testing personnel document

corrective actions taken when test

systems deviate from established

performance specifications?

Documentation of corrective action or

NCE.

Requirement met?

Yes

See CLIA Personnel Review Worksheet Tool

Notes:

10.2.e

D5783

§493.1282

(b)(2)

Does the laboratory document

corrective actions taken when results

of control or calibration materials

fail to meet established criteria for

acceptability including:

• Evaluation of all patient results

obtained in the failed run and

previous runs since the most recent

acceptable run for acceptability?

• The corrective action necessary to

ensure the reporting of accurate and

reliable patient test results?

NCE and corrective action procedure and

records include:

• Retrospective review of patient results

from testing since the last time the

system was known to be performing

within specification

• Issuing corrected patient results or

contacting physicians to notify of

potential error

• Documentation of review with staff,

including signatures, action items,

follow-up checks for effectiveness and

evidence of trend monitoring.

Requirement met?

Yes

Notes:

Association of Public Health Laboratories

The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the public’s health

in the US and globally. APHL’s member laboratories protect the public’s health by monitoring and detecting infectious and

foodborne diseases, environmental contaminants, terrorist agents, genetic disorders in newborns and other diverse health

threats.

This publication was supported by Cooperative Agreements #NU60OE000103 and NU60OE000104, 100% funded by

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