How to Prepare for a Lab Inspection (CLIA, COLA and CAP)

Who inspects clinical laboratories?

• CLIA surveys (state survey agency). Labs holding a Certificate of Compliance are surveyed by the state survey agency on behalf of CMS, using the survey procedures and interpretive guidelines in the CMS State Operations Manual, Appendix C.

• Accreditation inspections (COLA or CAP). Labs holding a Certificate of Accreditation are inspected by their accrediting organization against its own standards, which CMS has approved as equivalent to CLIA. See our COLA laboratory consultant and CAP laboratory consultant pages, or compare accreditors in COLA vs CAP vs Joint Commission.

Not sure which certificate you hold? Read CLIA certificate types and test complexity.

30/60/90-day lab inspection timeline

90 days out: gap assessment

• Pull your CLIA certificate, last inspection report, and any previous Form CMS-2567 and plan of correction. Confirm every past correction is still in place.

• Inventory every test on your menu and confirm its complexity, method verification or validation, and written procedure.

• Audit personnel files against 42 CFR 493 Subpart M for every person in a CLIA role.

• Review the last two years of proficiency testing (PT) results and corrective actions.

• Walk the lab with a safety checklist (see below).

60 days out: close the gaps

• Write or update missing procedures; have the laboratory director sign and date them.

• Complete overdue competency assessments and document them.

• Fix QC, calibration and maintenance gaps; investigate and document any QC failures. See QC corrective action documentation.

• Correct safety issues (expired eyewash checks, missing SDSs, blocked exits).

30 days out: organize and rehearse

• Assemble inspection binders or a clearly indexed electronic folder.

• Assign inspection-day roles and brief staff on what to expect.

• Run an internal mock inspection: have someone outside the daily workflow trace a patient result from order to report.

• Re-check that records are complete for the full look-back period.

Documentation checklist

Inspectors review records to confirm the lab follows CLIA. Under 42 CFR 493.1105, labs must generally keep most records for at least two years (longer for some, such as immunohematology and pathology records).

• CLIA certificate (current, posted or available) and, for accredited labs, the accreditation certificate.

• Personnel files for the laboratory director, technical consultant or technical supervisor, clinical consultant, general supervisor (high complexity) and testing personnel: qualifications, diplomas/transcripts, licenses where the state requires them, and signed duty delegations, as required by 42 CFR 493 Subpart M. See CLIA personnel qualifications and CLIA laboratory testing personnel.

• Competency assessment records for each test each person performs, covering the six CLIA elements. See the six elements of CLIA competency assessment.

• Training records for each employee and each test system.

• Proficiency testing: enrollment, results, attestation statements signed by the analyst and director, and documented review and corrective action for every unacceptable result (42 CFR 493 Subpart H). See non-compliance due to unsuccessful PT.

• Quality control: QC logs, review signatures, and corrective action for out-of-range QC; IQCP documents where used. See IQCP.

• Calibration and calibration verification records.

• Instrument maintenance and function checks, including temperature logs for refrigerators, freezers, incubators and room conditions.

• Method verification/validation: performance specifications for each non-waived test introduced (42 CFR 493.1253). For lab-developed tests, see validating an LDT.

• Procedure manual: current, approved, signed and dated by the laboratory director, with retired procedures kept as required (42 CFR 493.1251).

• Patient test management: requisitions, specimen rejection criteria, reports and corrected reports.

• Previous Form CMS-2567 and plan of correction, with evidence that each correction was completed. See CMS-2567 statement of deficiencies and evidence of correction.

Personnel, training and competency

The most common problems are missing qualification evidence, unsigned delegation of duties, and competency assessments that skip one of the six elements or a test the person performs. Confirm each person's role matches the test complexity they perform, and that the laboratory director's responsibilities under Subpart M are documented and carried out. Our page on common CLIA inspection deficiencies lists the patterns we see.

Quality control, calibration and proficiency testing

• QC run at the required frequency, reviewed, and acted on when out of range.

• Calibration and calibration verification performed and documented on schedule.

• PT samples tested like patient samples, by the people who routinely test, with no inter-lab communication about results.

• Every failed or ungraded PT event investigated with a documented root cause and corrective action.

IQCP, if you use it

If your lab uses IQCP for any test system, surveyors will expect to see the risk assessment, quality control plan and quality assessment records behind it. Under CLIA, every lab must have quality control procedures that monitor the accuracy and precision of the complete testing process. The Individualized Quality Control Plan (IQCP) is an optional way to meet those requirements, with QC tailored to your test systems, specimens, environment and testing personnel. IQCP applies to nonwaived testing, and every CLIA specialty and subspecialty except Pathology is eligible. An IQCP has three required parts: a risk assessment, a quality control plan and a quality assessment. See CDC's Individualized Quality Control Plan resources.

• Developing an IQCP - A Step-By-Step Guide: CDC/CMS workbook that walks one example test system through a risk assessment, quality control plan and quality assessment.

• Individualized Quality Control Plans (CMS): CMS's current IQCP page, pointing to SOM Appendix C and the IQCP Workbook.

Related IQCP guides: common IQCP mistakes and inspection citations and IQCP requirements under CLIA, CAP and COLA.

Facility and safety readiness

Clinical labs must meet OSHA requirements as well as CLIA. Inspectors and accreditors commonly look at:

• Bloodborne pathogens. A written exposure control plan, annual training, hepatitis B vaccination offered, sharps containers and engineering controls, per OSHA's Bloodborne Pathogens standard, 29 CFR 1910.1030.

• Chemical safety. A chemical hygiene plan under OSHA's laboratory standard, 29 CFR 1910.1450, plus Safety Data Sheets accessible for every hazardous chemical and labeled secondary containers (Hazard Communication, 29 CFR 1910.1200).

• PPE. Lab coats, gloves and eye protection available and worn; no food or drink in testing areas.

• Safety equipment. Eyewash stations and safety showers where corrosive materials are used (29 CFR 1910.151(c)), with documented checks; spill kits stocked; fume hoods and biological safety cabinets certified on schedule.

• Housekeeping and exits. Clean work surfaces, clear walkways, unobstructed exits, fire extinguishers inspected.

• Waste. Biohazard and chemical waste segregated and labeled.

Our bloodborne pathogen and lab safety course can help with staff training.

Inspection day plan

• Coordinator: greets the inspector, confirms the agenda, and keeps the day on schedule.

• Spokesperson: usually the laboratory director or supervisor; answers technical questions accurately and does not guess.

• Document retrievers: know exactly where each record lives and bring it quickly.

• Note-taker: records every question, document requested and concern raised so you can respond later.

• Work room: a quiet room with a table, power and Wi-Fi where inspectors can review binders and files.

• Keep testing normally; inspectors often observe staff performing tests and ask them to explain procedures.

• Ask for clarification at the exit conference on any finding you do not understand.

What happens after the inspection

For a CLIA survey, deficiencies are documented on Form CMS-2567, Statement of Deficiencies and Plan of Correction. Under the CMS State Operations Manual Chapter 6 (updated by QSO-25-13-CLIA, January 17, 2025), the state agency sends the CMS-2567 within 10 working days of the survey. The form's instructions direct the laboratory to sign it and return it with the proposed corrective action within 10 days of receipt. Each plan of correction should state the corrective action, how recurrence will be prevented, and an explicit completion date. Condition-level deficiencies can lead to sanctions; see CLIA condition-level deficiency sanctions and what to do after a failed COLA, CLIA or CAP survey. COLA and CAP have their own timelines for responding to citations, so follow the instructions in your inspection report.

Printable lab inspection checklist

Documents

• [ ] Current CLIA certificate (and accreditation certificate if applicable)

• [ ] Personnel files complete for every CLIA role (Subpart M)

• [ ] Signed delegation of duties

• [ ] Competency assessments current, all six elements, every test

• [ ] Training records

• [ ] PT enrollment, results, signed attestations, corrective actions

• [ ] QC logs reviewed; corrective actions documented

• [ ] Calibration and calibration verification records

• [ ] Maintenance, function check and temperature logs

• [ ] Method verification/validation for each non-waived test

• [ ] Procedure manual signed and dated by the laboratory director

• [ ] Previous CMS-2567, plan of correction and evidence of correction

• [ ] Records retained for the required period (42 CFR 493.1105)

Facility and safety

• [ ] Exposure control plan and bloodborne pathogens training (29 CFR 1910.1030)

• [ ] Chemical hygiene plan (29 CFR 1910.1450)

• [ ] SDSs accessible; containers labeled

• [ ] PPE available and in use

• [ ] Eyewash/shower checks logged; spill kits stocked

• [ ] Fume hood and BSC certifications current

• [ ] Exits clear; housekeeping done; waste segregated

Inspection day

• [ ] Coordinator, spokesperson, document retrievers and note-taker assigned

• [ ] Work room ready for inspectors

• [ ] Staff briefed

CDC resources on CLIA

• CDC's overview of the CLIA program: CDC explains that CLIA applies to every U.S. site that tests human specimens to assess health or to diagnose, prevent, or treat disease. It also explains that CDC supports the program alongside CMS and FDA.

• CDC on CLIA test complexity categories: CDC explains how FDA scores tests as moderate or high complexity using seven criteria. It also notes that lab-developed or modified tests default to high complexity, and that moderate and high complexity standards differ only in personnel requirements.

Frequently asked questions

How far in advance should a lab prepare for an inspection? Treat readiness as continuous, but start a focused review about 90 days before your inspection window so there is time to fix gaps and document them.

Are CLIA surveys announced? Routine CLIA surveys and accreditation inspections may be unannounced, so records should be inspection-ready at all times.

What do inspectors look at first? Usually the CLIA certificate, personnel qualifications, competency, PT, QC and the procedure manual, and they often trace patient results from order to report.

How long must lab records be kept? Generally at least two years under 42 CFR 493.1105, with longer periods for certain records such as immunohematology and pathology.

How long do we have to respond to a CMS-2567? The CMS-2567 instructions say to return the signed form with your proposed corrective action within 10 days of receipt. Follow the deadline in your state agency's letter.

Does OSHA apply to clinical labs? Yes. Clinical labs are generally covered by OSHA standards, including the Bloodborne Pathogens standard (29 CFR 1910.1030) and the laboratory standard (29 CFR 1910.1450).

Is a COLA or CAP inspection different from a state CLIA survey? Accredited labs are inspected by their accreditor against its own CMS-approved standards instead of a routine state survey, though CMS and state agencies can still do validation or complaint surveys.

Can SLC run a mock inspection? Yes. SLC offers mock inspections and gap assessments for CLIA, COLA and CAP, plus help writing plans of correction.

Sound Lab Consultants. Mailing address: PO Box 2135, Chandler, AZ 85244. Serving clinical laboratories nationwide.

Sources: eCFR 42 CFR Part 493; CMS State Operations Manual Appendix C; CMS QSO-25-13-CLIA; Form CMS-2567 instructions; OSHA 29 CFR 1910.1450; OSHA 29 CFR 1910.1030; OSHA 29 CFR 1910.1200; OSHA 29 CFR 1910.151.