Citations checked against 42 CFR Part 493 on 11 November 2026Independent publisher. Not affiliated with CMS, CDC or any accreditation organization.
CLIA Templates

Kits / Quality Assessment

QA-01 to QA-07

Quality Assessment Plan Kit

A quality assessment plan is easy to write and hard to show in practice. The citation usually reads that the laboratory had a plan and no record of reviews, or reviews with no record of what was done about the findings.

This kit ties the plan to a monthly checklist and to logs that take a few minutes a day. The annual summary gives the director one page to review and sign.

Written for: Nonwaived laboratories that need a written quality assessment program and proof that it runs.

First page of QA-01 Quality Assessment Plan, showing the document header, control block and the start of the form
QA-01 Quality Assessment Plan, first page, before personalization. Bracketed fields fill in from the Personalize tool or by hand.

Look inside

What happens after you buy

  1. 1
    Pay securelyCheckout is run by Lemon Squeezy, which handles payment and any sales tax. Your receipt arrives by email straight away.
  2. 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. 3
    Make it yoursOptional: drop the zip into the Personalize tool to add your name, CLIA number and logo to every file.
  4. 4
    Review and signYour laboratory director reviews, adapts and approves each document before use.
  5. 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.DocumentFormat
QA-01Quality Assessment Plan
General laboratory, preanalytic, analytic and postanalytic systems, with monitors and review frequency for each.		Word + PDF
QA-02Monthly QA Review Checklist
What was reviewed, what was found, what was done and who signed.		Word + PDF
QA-03Occurrence and Corrective Action Log
Event, cause, correction, effectiveness check and closure date.		Excel + PDF
QA-04Complaint Investigation Record
Complaint, investigation, outcome and communication back.		Word + PDF
QA-05Communication Problem Log
Breakdowns between the laboratory and the people who order tests or receive results.		Word + PDF
QA-06Quality Indicator Tracker
Turnaround time, rejected specimens, corrected reports, QC failures and PT performance by month.		Excel + PDF
QA-07Annual QA Summary
One-page summary for laboratory director review.		Word + PDF

Regulation behind each document

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

CitationWhat it asks forAddressed in
42 CFR 493.1239Quality assessment for general laboratory systems.QA-01, QA-02
42 CFR 493.1249Quality assessment for preanalytic systems.QA-01, QA-06
42 CFR 493.1289Quality assessment for analytic systems.QA-01, QA-06
42 CFR 493.1299Quality assessment for postanalytic systems.QA-01, QA-06
42 CFR 493.1233Complaint investigations.QA-04
42 CFR 493.1234Communications.QA-05

What the kit does not do

  • The monitors in QA-01 are common examples. Choose the ones that fit your test menu and volume.

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.