Proficiency Testing Kit

Proficiency testing errors are rarely about the analytical result. They are about handling: a sample run twice when patients are run once, a result discussed with another site, or a missing attestation.

The policy states the handling rules in plain terms that bench staff can follow. The event record documents each step from receipt to submission, and the review form covers every score below 100 percent, graded or not.

Written for: Nonwaived laboratories enrolled in an approved proficiency testing program.

First page of PT-02 PT Event Record, showing the document header, control block and the start of the form — PT-02 PT Event Record, 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
PT-01	Proficiency Testing Policy Enrollment, routine handling, the ban on communication and referral, attestation, review and records.	Word + PDF
PT-02	PT Event Record Receipt, storage, testing, attestation signatures and submission for one event.	Word + PDF
PT-03	PT Result Review and Corrective Action Investigation of unacceptable, unsatisfactory and ungraded results, with root cause and follow-up.	Word + PDF
PT-04	Enrollment and Calendar Tracker Each analyte, the program, ship dates, due dates and scores.	Excel + PDF
PT-05	Twice-Yearly Accuracy Verification Record For tests that have no required proficiency testing.	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 493.801	Enrollment in an approved program, and testing of PT samples in the same way as patient specimens, with no communication between laboratories and no referral of samples.	PT-01, PT-02
42 CFR 493.1236(a)-(b)	Review and evaluation of proficiency testing results.	PT-03
42 CFR 493.1236(c)	Accuracy verification at least twice a year for tests not covered by required proficiency testing.	PT-05

What the kit does not do

Laboratories with a Certificate of Accreditation follow their accreditation organization's PT requirements, which can differ in detail.
The kit does not choose a PT program or tell you which analytes need one. Your program catalog and Subpart I do.

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.