Kits / Waived Testing
CLIA Waived Testing Kit
A waived site has one central duty under CLIA: follow the manufacturer's instructions. Most problems at waived sites come from a procedure that drifted away from the current package insert, or from logs nobody kept.
The procedure template is laid out in the same order as a package insert, so updating it when the insert changes takes a few minutes. The logs cover what the insert asks you to record.
Written for: Physician offices, clinics, pharmacies and other sites testing under a Certificate of Waiver.
Look inside
What happens after you buy
- 1Pay securelyCheckout is run by Lemon Squeezy, which handles payment and any sales tax. Your receipt arrives by email straight away.
- 2DownloadThe 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.
- 3Make it yoursOptional: drop the zip into the Personalize tool to add your name, CLIA number and logo to every file.
- 4Review and signYour laboratory director reviews, adapts and approves each document before use.
- 5Stay 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 |
|---|---|---|
| WT-01 | Waived Test Procedure Template Intended use, specimen, storage, quality control, test steps, reading results and limitations, each tied to the package insert section. | Word + PDF |
| WT-02 | Training and Competency Checklist Initial training sign-off and a periodic observation checklist for each person and test. | Word + PDF |
| WT-03 | Quality Control Log Kit lot, control lot, expected and observed results, and action taken. | Excel + PDF |
| WT-04 | Temperature Log Room and refrigerator readings against the storage range in the insert. | Excel + PDF |
| WT-05 | Kit and Reagent Lot Log Date received, date opened, expiration and the insert revision in use. | Excel + PDF |
| WT-06 | Certificate and Test Menu Record CLIA number, certificate expiration, director, and the waived tests the site performs. | 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 493.15(e) | Laboratories performing only waived tests follow the manufacturer's instructions for each test and meet the certificate requirements in Subpart B. | WT-01 |
| 42 CFR Part 493, Subpart B | Certificate of Waiver application, renewal and the duty to permit inspections. | WT-06 |
What the kit does not do
- CLIA does not require competency assessment for waived testing. WT-02 is included because CMS describes it as good laboratory practice, and some states and accreditation organizations expect it.
- The template does not replace the package insert. Keep the current insert with the procedure.
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.