CLIA Inspection Checklist
What a CMS surveyor asks to see, area by area, with the section of 42 CFR 493 behind each item. Mark every item done, open or not applicable, watch the open count fall, then print a clean sheet for the binder. It runs in your browser and sends nothing.
CLIA inspection checklist — assaydeck.com
Inspection checklist
Mark each item Done, Open or N/A. Your marks stay in this browser and are never sent.
Open by area
- Personnel files0 open
- Competency assessment0 open
- Quality control0 open
- Proficiency testing0 open
- Procedure manual0 open
- Records retention0 open
- Test reports0 open
- Temperature and storage logs0 open
- CMS-2567 history0 open
What the checklist covers
The areas are the records CMS tells State Agency surveyors to ask a lab to have "accessible and retrievable at the time of survey", plus what they check once on site (State Operations Manual, Chapter 6, §§ 6102.1 and 6116.4, Rev. 230). In order: personnel files, competency assessment, quality control, proficiency testing, procedure manual, records retention, test reports, temperature and storage logs, cms-2567 history. That is 38 items, each tied to the section of 42 CFR 493 a surveyor would cite.
Where CMS counted an item among its ten most cited standards for 2024, the row carries the D-tag and the number of labs cited (CMS Top 10, Year 2024). The single most cited standard was D5413, storage and operating conditions under § 493.1252(b): 818 labs, 5.0% of all labs. That standard covers temperature, humidity, water quality and power protection, so the temperature log is the first place to look.
An item is open until you mark it Done or N/A. Use N/A for what your menu never touches: pathology report retention in a lab with no pathology, twice-yearly accuracy checks when every test you run has PT. The marks stay in this browser; clearing site data clears them.
Worked example: a physician office lab in its survey window
A moderate complexity physician office lab runs a chemistry analyzer and a hematology analyzer. CMS schedules a recertification survey 6 to 12 months before the certificate expires (SOM § 6102.1), but the notice may come only two weeks ahead. So the office manager runs the list with the technical consultant as soon as the window opens. Six of the rows they hit:
| Item | Cite | What they found | Mark |
|---|---|---|---|
| Written range for the reagent refrigerator | § 493.1252(b) | Daily readings, but no written range | Open |
| New tester's competency | § 493.1413(b)(9) | Started testing in January; no six-month assessment on file | Open |
| Procedures signed by the current director | § 493.1251(d) | Director changed in June; the manual still carries the old signature | Open |
| Director's on-site visits | § 493.1407(c) | February and August visits, each documented | Done |
| Twice-yearly accuracy checks | § 493.1236(c) | Every test on the menu is a Subpart I analyte with PT | N/A |
| Pathology report retention | § 493.1105(a)(6) | No pathology testing | N/A |
Three opens, each fixable before any notice arrives: write the range from the reagent inserts, book the second assessment, and have the new director review, sign and date each procedure. The refrigerator range is the one to fix first, because that row is the most cited standard in the country.
What 42 CFR 493 says
A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection.
Subpart Q also lets the surveyor have you test samples, interview any of your staff, watch every phase of testing, walk every area under the certificate, and take copies of the records it needs (§ 493.1773(b)). Refusing an inspection puts the certificate and Medicare payment at risk (§ 493.1773(g)).
Compliance labs are inspected "on a biennial basis or with such other frequency as CMS determines to be necessary" (§ 493.1777(b)), and CMS bases each visit on the lab's compliance history. That is why the last CMS-2567 is on this list. For an announced survey CMS allows "up to two weeks' notice"; complaint and follow-up surveys come unannounced (SOM § 6106).
Accredited labs are not exempt
How CAP and COLA checklists differ
This list is built from CMS's own survey guidance. It does not reproduce CAP's or COLA's checklists, which are their copyrighted property, and an accredited lab is inspected against those.
CAP says it publishes 21 discipline-specific checklists, updated every year, and that before an inspection it builds a custom checklist from your test menu, the same one its inspectors carry. Accredited labs get them in CAP's e-LAB Solutions Suite; other labs may buy them (CAP checklists). In its 2021 approval notice, CMS found CAP stricter than CLIA in places: PT for waived test systems, detailed LIS requirements, a meeting with the hospital administrator or medical staff for feedback, and a required mid-cycle self-inspection (86 FR 16371).
COLA sends new labs its Accreditation Manual and an information packet, and offers a self-assessment before the on-site survey (COLA accreditation). For the side-by-side, read CAP vs COLA vs The Joint Commission; for what survey day looks like under each, CLIA and CAP inspections: what to expect.
CAP's lines here are CAP's own statements, from its accreditation pages read on 23 October 2026.