CLIA Competency Assessment Kit

Competency assessment is one of the first things a surveyor asks to see, and the usual finding is a form that covers four or five of the six procedures instead of all six for every test system.

This kit gives your technical consultant or technical supervisor a policy to adopt and a form that walks through each of the six procedures, with a place to record the evidence reviewed. A tracker shows who is due and when.

Written for: Laboratories holding a Certificate of Compliance or Certificate of Accreditation, and provider-performed microscopy sites.

First page of CA-02 Testing Personnel Assessment Form, showing the document header, control block and the start of the form — CA-02 Testing Personnel Assessment Form, 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
CA-01	Competency Assessment Policy Scope, who is assessed, frequency, who may assess, written delegation, remediation and record keeping.	Word + PDF
CA-02	Testing Personnel Assessment Form One form per person per test system. Each of the six procedures has its own row for method, date, assessor and evidence.	Word + PDF
CA-03	Role Assessment Forms Separate forms for technical consultant, technical supervisor, general supervisor and clinical consultant, built from each role's Subpart M responsibilities.	Word + PDF
CA-04	Delegation of Competency Assessment The written delegation a director or technical supervisor signs when someone else performs assessments.	Word + PDF
CA-05	PPM Assessment Form The five procedures that apply to provider-performed microscopy.	Word + PDF
CA-06	Due-Date Tracker Semiannual dates in the first year of patient testing, annual dates after that, with overdue items flagged.	Excel + PDF
CA-07	Remedial Training and Reassessment Record What was found, what training followed, and the reassessment result.	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 493.1413(b)(8)	The technical consultant evaluates the competency of moderate complexity testing personnel using six listed procedures.	CA-02
42 CFR 493.1413(b)(9)	Evaluation at least semiannually in the first year a person tests patient specimens, and at least annually after that.	CA-01, CA-06
42 CFR 493.1451(b)(8)-(9)	The same duties for the technical supervisor in high complexity testing.	CA-02, CA-06
42 CFR 493.1235	Written policies and procedures to assess employee and consultant competency.	CA-01, CA-03

What the kit does not do

The forms name the six procedures and the evidence to review. The observation steps for your own analyzers come from your procedures, and you add them.
Accredited laboratories should compare the policy with their accreditation organization's current checklist.

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.