Summary of Waived

2024 CAP Top 10 Most Common

Testing Requirements*
Checklist Deficiencies

The College of American Pathologists (CAP) updates its 21 discipline-specific

accreditation checklists annually to keep accredited laboratories current with
advancements in laboratory medicine, technology, and regulatory compliance. This
guidance helps laboratories achieve and maintain accreditation.

To promote excellence, CAP compiles the 10 most common checklist deficiencies from
the previous year’s inspections. This list not only highlights frequent deficiencies but
also supports laboratory improvement and ensures quality patient care. Each deficiency
includes Q&As, inspector comments, and other helpful resources.

Additional tools to assist your laboratory are available by visiting our

Accreditation Resources in e-LAB Solutions Suite (ELSS)

cap.org
CHECKLIST REQUIREMENTS

COM.10000 Policy and Procedure Manual

A complete policy and procedure manual is available in a paper-based, electronic, or
web-based format at the workbench or in the work area.
 OTE 1: All steps in a laboratory’s testing, and other technical processes must be defined in written
N
policies and/or procedures. Procedures must be consistent with current laboratory practice.
NOTE 2: The use of inserts provided by manufacturers is not acceptable in place of a procedure
manual. However, such inserts may be used as part of a procedure description, if the insert
accurately and precisely describes the procedure as performed in the laboratory. Any variation from
this printed or electronic procedure must be detailed in the procedure manual.
NOTE 3: A manufacturer’s procedure manual for an instrument/reagent system may be acceptable as a
component of the overall departmental procedures. Any modification to or deviation from the manufacturer’s
manual must be clearly recorded and approved.
NOTE 4: Card files or similar systems that summarize key information are acceptable for use as quick
reference at the workbench provided that:
• A complete manual is available for reference
• The card file or similar system corresponds to the complete manual and is subject to document control
NOTE 5: Electronic manuals accessed by computer are fully acceptable. There is no requirement for paper
copies to be available for the routine operation of the laboratory, as long as the electronic versions are readily
available to all personnel and personnel have been trained on how to access them.
NOTE 6: Procedure manuals must be available to laboratory personnel when the electronic versions are
inaccessible (eg, during laboratory information system or network downtime); thus, the laboratory must
maintain paper copies, electronic copies on CD or other digital media, or have an approved alternative
mechanism to access web-based files during network downtimes. All policies and procedures, in either
electronic or paper form, must be readily available for review by the inspector at the time of the CAP
inspection.
Electronic manuals and electronic copies of policies and procedures are subject to proper document control
(see GEN.20375).

References
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory
improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1251(a) (b) (1-14)
(c)(d)(e)]
2) Borkowski A, et al. Intranet-based quality improvement documentation at the Veterans Affairs Maryland
health care system. Mod. Pathol. 2001;14:1-5
3) Clinical and Laboratory Standards Institute (CLSI). Developing and Managing Laboratory Documents.
Seventh Edition. CLSI guideline. QMS02. Clinical and Laboratory Standards Institute, Wayne, PA; 2024.

Most Common Reasons for Citations

• Not following policy/procedure (eg, changed process but failed to update procedure)
• Failure to archive a procedure not in use
• Printed procedures don’t match electronic documents (version control)

Resources
• Checklist Requirement Q&A—COM.10000 |2
GEN.55500 Competency Assessment Elements - Nonwaived Testing
The competency of personnel performing nonwaived testing is assessed using all six
elements (as applicable) on each test system.
NOTE: Competency assessment records must include all six elements described below for each
individual on each test system during each assessment period, unless an element is not applicable
to the test system. The laboratory must identify the test systems that testing personnel use to
generate test results, including both primary and back-up methods used for patient testing. If a
single test or analyte is performed using different test systems, a separate assessment is required.
A TEST SYSTEM is the process that includes pre-analytic, analytic, and post-analytic steps used to produce a
test result or set of results.
• A test system may be manual, automated, multi-channel or single use.
• It includes instructions, reagents, supplies, equipment and/or instruments required to produce test results.
• It may encompass multiple identical analyzers or devices.
• It may include multiple tests performed on the same testing platform (eg, analyzer), unless tests have
unique aspects, problems, or procedures (eg, pretreatment of specimens prior to analysis). In those
situations, competency must be assessed as a separate test system to ensure personnel perform those
aspects correctly.
The six required elements of competency assessment include but are not limited to:
1. D
 irect observations of routine patient test performance, including, as applicable, patient identification
and preparation; and specimen collection, handling, processing and testing
2. Monitoring the recording and reporting of test results, including, as applicable, reporting critical results
3. R
 eview of intermediate test results or worksheets, quality control records, proficiency testing results,
and preventive maintenance records
4. Direct observation of performance of instrument maintenance and function checks
5. A
 ssessment of test performance through testing previously analyzed specimens, internal blind testing
specimens (eg, de-identified patient specimens) or external proficiency testing specimens
6. Evaluation of problem-solving skills
The competency procedure must outline the practices and procedures used to evaluate competency.
Assessment of the elements of competency may be coordinated with routine practices and procedures if they
are assessed by an individual qualified to assess competency (GEN.55510). Laboratories often use a checklist
to record and track elements assessed. Records supporting the assessment must be retained (copies of
worksheets, maintenance logs, etc. or information traceable to the original record).
The following includes examples of how competency assessment can be coordinated with routine practices
and procedures:
• Assessment of the recording of quality control results and instrument maintenance data in element #3
during the monthly supervisory review process of these records.
• Assessment of test performance in element #5 during reviews of proficiency testing or alternative
performance assessment records.
• Assessment of problem-solving skills in element #6 from monthly reviews of corrective action logs where
problems with quality control or instrument function were investigated.
The CAP provides example competency assessment templates, which can be downloaded from cap.org in
e-Lab Solutions Suite - Accreditation Resources - Templates.

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Evidence of Compliance:
3 Records of competency assessment reflecting the specific skills assessed for each test system and the
method of evaluation

References
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory
improvement amendments of 1988; final rule. Fed Register. 2003(Oct 1):1065-66 [42CFR493.1451(b)],
1053-54 [42CFR493.1413], 1992 (Feb 28) 7184 [42CFR493.1713]
2) Clinical and Laboratory Standards Institute (CLSI). Training and Competence Assessment. 4th ed. CLSI
guideline QMS03. Clinical and Laboratory Standards Institute, Wayne, PA, 2016.
3) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Brochure #10.
What Do I Need to Do to Assess Personnel Competency. November 2012. http://www.cms.gov/Regulations-
and-Guidance/Legislation/CLIA/CLIA_Brochures.html

Most Common Reasons for Citations

• Not documenting all six elements that apply/elements assessed were unclear
• Records supporting the assessment are not documented or available
 onfused about what is considered a test system (eg, lumping all manual tests under one test
• C
system)

Resources
• Competency Templates (find in Templates in Accreditation Resources)
• Checklist Requirement Q&A—GEN.55500

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COM.01200 Activity Menu
The laboratory’s current CAP Activity Menu accurately reflects the testing performed.
NOTE: The laboratory’s CAP Activity Menu must include all patient/client testing performed by the laboratory.
• F
 or laboratories with a CLIA certificate, it includes all testing and activities performed under that
CLIA certificate.
• F
 or laboratories not subject to CLIA, it includes all testing and activities meeting all of the
following criteria: 1) performed under the same laboratory director, 2) under the same laboratory
name, and 3) at the same physical premises (contiguous campus).
The testing and activities must be listed on the laboratory’s CAP Activity Menu regardless of whether it is
also accredited by another organization and regardless of PT provider. This includes remote review and
interpretation of digitized images and data under the laboratory’s CAP/CLIA certificate. The laboratory must
update its CAP Activity Menu when tests are added or removed by logging into e-LAB Solutions Suite on cap.
org and going to Organization Profile - Sections/Departments. In order to ensure proper customization of the
CAP accreditation checklists, the laboratory must also ensure its activity menu is accurate for other related
information, such as methods used and types of services offered. This requirement does not apply to the
instrument list.
Some testing activities are included on the CAP Master Activity Menu using generic groupings or panels
instead of listing the individual tests. The CAP Master Activity Menu represents only those analytes that
are directly measured. Calculations are not included, with a few exceptions (eg, non-waived INR, calculated
hematocrit, estimated hemoglobin).
Testing performed under a separate CLIA certificate must not be listed on the laboratory’s activity menu.
Laboratories are not required to include testing performed solely for the purpose of research on their
activity menus, but may opt to include such testing if the laboratory wants it to be inspected by the CAP.
Testing performed for research is defined as laboratory testing on human specimens where patient-specific
results are not reported for the diagnosis, prevention, or treatment of any disease or impairment of, or the
assessment of the health of, human beings. For laboratories subject to CLIA, if patient-specific results are
reported, the testing is subject to the CLIA regulations and must be listed on the CAP Activity Menu.
If an inspector identifies that a laboratory is performing tests or procedures not included on the laboratory’s
CAP Activity Menu, the inspector must do the following:
• Cite COM.01200 as a deficiency
• Contact the CAP (800-323-4040) for inspection instructions as requirements may be missing from a
laboratory’s customized checklist
• Record whether those tests/procedures were inspected on the appropriate section page in the Inspector’s
Summation Report (ISR)
References
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical
laboratory improvement amendments of 1988; final rule. Fed Register. 2004(Oct 1) [42CFR493.35]
[42CFR493.53],[42CFR493.63].
Most Common Reasons for Citations
 idn’t update activity menu after an instrument change that affected the activity menu (eg, test
• D
went from waived to nonwaived)
• Inspector packet activity menu not matching the laboratory’s current activity menu
• Activities not listed under the correction section unit
Resources
• Master Activity Menu (also found on Activities pages in Organization Profile)
• E
 nsure an “Accurate” Activity Menu and the “Right” Customized Checklists webinar (find in Focus
on Compliance in Accreditation Resources)
• Checklist Requirement Q&A—COM.01200
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COM.04250 Comparability of Instruments and Methods - Nonwaived Testing
If the laboratory uses more than one nonwaived instrument/method to test for a given
analyte, the instruments and methods are checked against each other at least twice a
calendar year for comparability of results.
 OTE: This requirement applies to tests performed on the same or different instrument makes/
N
models or by different methods, even if there are different reference intervals or levels of
sensitivity. It includes primary and back up methods used for patient testing. The purpose of the
requirement is to evaluate the relationship between test results using different methodologies,
instruments, or testing sites.
This requirement is not applicable to:
• Calculated parameters
• Waived methods
• Laboratories with different CAP numbers
• Instruments/equipment that do not provide a reportable result (eg. microscopes, stainers)
The following types of materials may be used to generate data for comparability studies:
• Patient/client specimens (pooled or unpooled) are preferred to avoid potential matrix effects
• 
Quality control materials for tests performed on the same instrument platform, with both control materials
and reagents of the same manufacturer and lot number
• 
Alternative protocols based on quality control or reference materials for cases when availability or pre-
analytical stability of patient/client specimens is a limiting factor. The materials must be validated (when
applicable) to have the same response as fresh human specimens for the instruments and methods
involved.
This requirement only applies when the instruments/reagents are producing the same reportable result.
For example, some laboratories may use multiple aPTT reagents with variable sensitivity to the lupus
anticoagulant to perform different tests, such as aPTT for heparin monitoring and a lupus-like anticoagulant
screen. If these are defined as separate tests, this requirement does not apply unless each type of aPTT test
is performed on more than one analyzer.
For Microbiology testing, this requirement applies when two instruments (same or different manufacturers)
are used to detect the same analyte. Two or more detectors or incubation cells connected to a single
data collection, analysis and reporting computer need not be considered separate systems (eg, multiple
incubation and monitoring cells in a continuous monitoring blood culture instrument, two identical blood
culture instruments connected to a single computer system, or multiple thermocycler cells in a real time
polymerase chain reaction instrument). This checklist requirement does not apply to multiple analytical
methods which identify an organism by detecting different analyte characteristics (eg, antigen typing versus
culture, detection of DNA versus a biochemical characteristic, MALDI-TOF versus phenotypic/biochemical
microbial identification).

Evidence of Compliance:
3 Records of comparability studies reflecting performance at least twice per year with appropriate
specimen types

References
1) D
 epartment of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare,
Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Fed Register. 2003(Jan 24):5236
[42CFR493.1281(a)]
2) Ross JW, et al. The accuracy of laboratory measurements in clinical chemistry: a study of eleven analytes
in the College of American Pathologists Chemistry Survey with fresh frozen serum, definitive methods and
reference methods. Arch Pathol Lab Med. 1998;122:587-608
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3) Miller WG, Myers GL, Ashwood ER, et al. State of the Art in Trueness and Inter-Laboratory Harmonization
for 10 Analytes in General Clinical Chemistry. Arch Pathol Lab Med 2008;132:838-846
4) Clinical and Laboratory Standards Institute. Verification of Comparability of Patient Results within
One Healthcare System: Approved Guideline (Interim Revision). CLSI document EP31-A-IR. Clinical and
Laboratory Standards Institute, Wayne, PA; 2012.
5) Miller WG, Erek A, Cunningham TD, et al. Commutability limitations influence quality control results with
different reagent lots. Clin Chem. 2011;57:76-83

Most Common Reasons for Citations

• Not performed twice a year (eg, due to COVID)
• Lack of acceptance criteria
• Lack of understanding that this doesn’t just apply to identical instruments

Resources
• M
 ethod/Instrument Comparison Template (find in Templates under Instruments/Equipment
Templates in Accreditation Resources)
• Checklist Requirement Q&A—COM.04250

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COM.01700 PT and Alternative Performance Assessment Result Evaluation
There is ongoing evaluation of proficiency testing (PT) and alternative performance
assessment results by the laboratory director or designee with appropriate corrective
action taken for each unacceptable result.
NOTE: Each unacceptable PT or alternative performance assessment result (any result or specimen
not meeting defined acceptability criteria) must be evaluated in a timely manner. The timeframe
for investigation should be appropriate for the determination of any impact on patient results. The
CAP recommends, but does not require, the laboratory to investigate acceptable results that show
significant bias or trends.
For guidance on investigating unacceptable PT/alternative performance assessment results, refer to the
Proficiency Testing (PT)/External Quality Assurance (EQA) toolbox on CAP website (www.cap.org) through
e-LAB Solutions Suite.
Primary records related to PT and alternative performance assessment testing are retained for at least
two years (five years for transfusion medicine). These include all instrument tapes, work cards, computer
printouts, evaluation reports, evidence of review, and records of follow-up or corrective action.
For laboratories outside the US, PT failures relating to problems with shipping and specimen stability should
include working with local customs and health regulators to ensure appropriate transit of PT specimens.

Evidence of Compliance:
3R
 ecords of ongoing review of all PT reports and alternative performance assessment results by the
laboratory director or designee AND
3R
 ecords of investigation of each “unacceptable” PT and alternative performance assessment result
including records of corrective action appropriate to the nature and magnitude of the problem

References
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical
laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 2023 (Dec 28)
[42CFR493.1407(e)(4)(iv)]
2) Steindel SJ, et al. Reasons for proficiency testing failures in clinical chemistry and blood gas analysis. A College
of American Pathologists Q-Probes study in 655 laboratories. Arch Pathol Lab Med. 1996;120:1094-1101
3) Clinical and Laboratory Standards Institute (CLSI). Using Proficiency Testing and Alternative Assessment
to Improve Medical Laboratory Quality. 3rd ed. CLSI guideline QMS24. Clinical and Laboratory Standards
Institute. Wayne, PA; 2016.
4) Shahangian S, et al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43
5) Zaki Z, et al. Self-improvement by participant interpretation of proficiency testing data from events with 2
to 5 samples. Clin Chem. 2000;46:A70
6) Stavelin A, Riksheim BO, Christensen NG, Sandberg S. The Importance of Reagent Lot Registration in
External Quality Assurance/Proficiency Testing Schemes. Clin Chem. 2016;62(5):708-15.

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Most Common Reasons for Citations
• Not having a standardized way to investigate the failure
 isunderstanding about the need to review missed challenges when the laboratory receives an
• M
overall passing score (eg, 80%)
• Inspector disagrees with the level of assessment/corrective action performed

Resources
• Proficiency Testing (PT)/External Quality Assurance (EQA) Toolbox
• P
 roficiency Testing (PT) Failures: Getting to the ‘Root’ of the Causes” webinar (find in Focus on
Compliance in Accreditation Resources)
• Checklist Requirement Q&A—COM.01700

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COM.30600 Maintenance/Function Checks
The laboratory performs and records appropriate maintenance and function checks
for all instruments (eg, analyzers) and equipment (eg, centrifuges) following a defined
schedule, at least as frequent as specified by the manufacturer.
NOTE: Maintenance and function checks may include (but are not limited to) cleaning, electronic,
mechanical and operational checks.
The purpose of a function check is to detect drift, instability, or malfunction, before the problem is
allowed to affect test results.
For equipment without manufacturer’s instructions defining maintenance and function check requirements,
the laboratory must establish a schedule and procedure that reasonably reflects the workload and operating
specifications of its equipment.
It is up to the laboratory to determine how and where records of maintenance checks are recorded.
Equipment not in use does not require maintenance or function checks, but these checks must be performed
before putting the equipment back into service.
References
1) D
 epartment of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory
improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1254]
 linical and Laboratory Standards Institute. Laboratory Instrument Implementation, Verification, and
2) C
Maintenance; Approved Guideline. CLSI Document GP31-A. Clinical and Laboratory Standards Institute,
Wayne, PA; 2009.

Most Common Reasons for Citations

• Missing records (daily, weekly, or monthly function check)
• Not following manufacturer’s defined frequency
• Employees not documenting performed maintenance

Resources
• Checklist Requirement Q&A—COM.30600

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COM.04200 Instrument/Equipment Record Review
The laboratory director or designee reviews and assesses instrument and equipment
maintenance and function check records at least monthly.
NOTE: Appropriate evidence of review includes both the reviewer’s signature or initials and
the review date. If problems are identified (eg, maintenance not performed as scheduled), the
reviewer must record corrective action. The review of the records related to tests that have an
approved individualized quality control plan (IQCP) must include an assessment of whether further
evaluation of the risk assessment and quality control plan is needed based on problems identified
(eg, trending for repeat failures, etc.).

Evidence of Compliance:
3 Records of monthly review

Most Common Reasons for Citations

 issing evidence of review due to staffing shortages (eg, COVID, supervisors pulled to work the
• M
bench)
• Not performed for less frequently used equipment (eg, osmometer)
• Completed several months of review on the same date (not timely)

Resources
• Checklist Requirement Q&A—COM.04200

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COM.30300 Reagent Labeling - Nonwaived Tests
The laboratory labels all reagents, calibrators, controls, stains, chemicals, and solutions,
as applicable and appropriate, with the following elements:
• Content and quantity, concentration or titer

• Storage requirements

• Date prepared, filtered or reconstituted by laboratory

• Expiration date

NOTE: The above elements may be recorded in a log (paper or electronic), rather than on the
containers themselves, providing that all containers are identified so they are traceable to the
appropriate data in the log.
While useful for inventory management, labeling with “date received” is not routinely required.
There is no requirement to routinely label individual containers with “date opened”; however, a new expiration
date must be recorded if opening the container changes the expiration date, storage requirement, etc. For
containers with multiple individual reagent units (eg, cartridges), the expiration date must be recorded on
each unit if stored outside of the original container.
This requirement also applies to the labeling of chemicals used in the laboratory to prepare reagents or during
the preanalytic and analytic phases of the testing process. Requirements relating to precautionary labeling
for hazardous chemicals are included in the Chemical Safety section of the Laboratory General Checklist.
Evidence of Compliance:
3 Properly labeled reagents OR logs traceable to the reagents

References
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory
improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252(c)]

Most Common Reasons for Citations:

• Expiration dates are missing from the label.
• Secondary containers are missing specified information.
• Stain lines are not labelled and logsheets in use are not traceable to the required information.

Resources:
• Checklist Requirement Q&A – COM.30300

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COM.01400 PT Attestation Statement
The proficiency testing attestation statement is signed (physical or electronic signature)
by the laboratory director or qualified designee and all individuals involved in the testing
process.
NOTE: If electronic signatures are used for the PT attestation, the laboratory must be able to show
that they are traceable to the event (eg, electronic record with a date/time stamp for the activity)
and are only used by the authorized person (eg, password protected account). A listing of typed
names on the attestation statement does not meet the intent of the requirement. The signature
of the laboratory director or designee need not be obtained prior to reporting results to the
proficiency testing provider.
Designees must be qualified through education and experience to meet the defined regulatory requirements
associated with the complexity of the testing as defined in the Personnel section of the Laboratory General
Checklist.
• For high complexity testing, it may be delegated to an individual meeting the qualifications of a technical
supervisor or section director (GEN.53400). For the specialties of Histocompatibility, and Cytogenetics refer
to specific requirements for the qualifications of section directors/technical supervisors in the associated
checklists (HSC.40000, and CYG.50000).
• For high complexity testing under the specialty of immunohematology, refer to TRM.50050 for the
qualifications of the transfusion service medical director (technical supervisor) and designees.
• For moderate complexity testing, it may be delegated to an individual meeting the qualifications of a
technical consultant (GEN.53625).

Evidence of Compliance:
3 Appropriately signed attestation statement from submitted PT result forms

References
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory
improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7146 [42CFR493.801(b)(1)]

Most Common Reasons for Citations

• Individual not qualified to sign or delegated to perform this duty
• Missing testing personnel signatures

Resources
• Checklist Requirement Q&A—COM.01400

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 COM.01100 Ungraded PT Challenges
The laboratory director or designee assesses its performance on proficiency testing (PT)
challenges that are ungraded.

NOTE: Examples include, but are not limited to:

• PT challenges that were intended to be graded, but were not, for reasons such as:
 The laboratory submitted its results after the cut-off date
 The laboratory did not submit results
 The laboratory did not complete the result form correctly (eg, submitted the wrong method code or recorded
the result in the wrong place)
 The laboratory’s result was not graded because of lack of consensus
• Educational PT challenges

PT records must show that ungraded PT results are evaluated for acceptable performance with investigation
and corrective action taken for unacceptable results as required in COM.01700. A signature on the PT report
without any notation on the acceptability of ungraded results does not meet the intent of this requirement.
The laboratory must define how it assesses performance on ungraded PT challenges and how the
assessments are recorded.

Evidence of Compliance:
3 Records of review and evaluation of ungraded PT challenges by the laboratory director or designee

References
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory
improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3705 [42CFR493.1236(a)(2)]

Most Common Reasons for Citations

• No policy/procedure to address ungraded PT challenges.
• No review/evaluation of educational challenge (code 26), lack of consensus (code 27 or code 31) or
insufficient peer group (code 20).
• Insufficient data or review of self-evaluation for circumstances noted in #2.
 Compare results to intended response from Participant Summary Report
 If no comparison, perform alternative performance.
 D
 ocument evaluation, investigation, and corrective action. Include acceptability requirements and
signature/date of reviewer.
 Determine if patient result evaluation is needed.

Resources:
Proficiency Testing (PT)/External Quality Assurance (EQA) Toolbox
https://elss.cap.org/lap-reports-ui/#/accreditation-resources?templateLink=proficiencyTestingEQAToolbox

Checklist Requirement Q&A - COM.01100

https://documents-cloud.cap.org/capprd-ccs-acc-resources/COM.01100.pdf

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