CLIA Inspection Readiness Kit

Most of survey preparation is finding records quickly. The binder index lists what a surveyor commonly asks for, in the order they ask, so the first hour of the survey goes smoothly.

If you have already received a Form CMS-2567, the plan of correction template sets out the elements a response needs, so the first submission is complete.

Written for: Any laboratory preparing for an initial or biennial survey, or responding to a statement of deficiencies.

First page of IR-01 Self-Audit Checklist, showing the document header, control block and the start of the form — IR-01 Self-Audit Checklist, first page, before personalization. Bracketed fields fill in from the Personalize tool or by hand.

Look inside

What happens after you buy

1
Pay securelyCheckout is run by Lemon Squeezy, which handles payment and any sales tax. Your receipt arrives by email straight away.
2
DownloadThe receipt links to a zip file with every document in Word or Excel, plus a fillable PDF of each one. Open the Start Here guide first.
3
Make it yoursOptional: drop the zip into the Personalize tool to add your name, CLIA number and logo to every file.
4
Review and signYour laboratory director reviews, adapts and approves each document before use.
5
Stay currentWhen we revise a file in the next 12 months, the updated version is available from your original order.

What is in the kit

Doc no.	Document	Format
IR-01	Self-Audit Checklist Questions by subpart: proficiency testing, facility administration, quality system and personnel.	Word + PDF
IR-02	Survey Binder Index The records to have ready, with a column for where each one is kept.	Word + PDF
IR-03	Personnel File Checklist Qualification documents, training and competency records for each CLIA role.	Word + PDF
IR-04	Plan of Correction Template Corrective action, how other affected results were identified, the system change, monitoring and completion date for each deficiency.	Word + PDF
IR-05	Survey Day Sheet Who greets the surveyor, who retrieves records, and a log of what was requested.	Word + PDF

Regulation behind each document

The middle column is our plain-language summary. Read the regulation itself before you rely on it.

Citation	What it asks for	Addressed in
42 CFR 493.1773	Basic inspection requirements for laboratories holding a CLIA certificate.	IR-01, IR-05
42 CFR 493.1105	Record retention periods.	IR-02
42 CFR Part 493, Subparts H, J, K and M	Proficiency testing, facility administration, quality system and personnel requirements for nonwaived testing.	IR-01, IR-03

What the kit does not do

The checklist follows the federal regulation. It is not an accreditation organization's checklist and does not replace one.

Your director stays in control

These are templates, written so your laboratory director can review, adapt and approve each one quickly. Nothing is used until they sign it.

CLIA is a federal minimum. Your state, and your accreditation organization if you have one, may require more. We do not promise a survey outcome, and we do not give regulatory or legal advice. Read the full terms.