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Free CLIA personnel file checklist
A one-page check for each personnel file. It lists the documents a surveyor commonly asks for, with columns for whether each is on file, its date and notes.
Six of the ten condition-level deficiencies CMS cited most often in 2024 are personnel conditions: laboratory director, technical consultant, technical supervisor and testing personnel.
“Specify, in writing, the responsibilities and duties of each consultant”
42 CFR 493.1407(e)(14), opening words
No sign-up. Free to use and edit within your own laboratory or site. Not for resale. Document IR-03 from the CLIA Inspection Readiness Kit.
How to use it
- Complete one checklist for each person who holds a CLIA role, including the laboratory director and any consultants.
- For each line, note whether the document is on file and its date. Where it is kept elsewhere, say where in the notes column.
- Qualification evidence means the document itself: the diploma or transcript, the licence where your state requires one, and proof of training or experience for the route the person qualifies under.
- Review the files before a survey and whenever someone's role changes.
What does the regulation ask for?
42 CFR Part 493, Subpart M sets the qualifications and responsibilities for each role in moderate and high complexity testing. The laboratory director must make sure that, before testing patient specimens, all personnel have the appropriate education, experience and training (42 CFR 493.1407(e)(11) and 493.1445(e)(12)), and must specify each person's duties in writing (493.1407(e)(14) and 493.1445(e)(15)).
For written role descriptions built from those sections, see the Competency Assessment kit. The full list is on the most-cited CLIA deficiencies.
This form is a template. Your laboratory director reviews and approves it before use, and your state or accreditation organization may ask for more than CLIA does.
The rest of the set
The CLIA Inspection Readiness Kit has 6 documents, including this one: self-audit checklist, binder index, personnel file checklist and a plan of correction template.
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Reviewed 12 Nov 2026. General information, not regulatory or legal advice. 42 CFR Part 493 controls.