Kits / Procedures and Verification
CLIA Procedure Manual and Method Verification Kit
Six of the ten standard-level deficiencies CMS cited most often in 2024 fall under four sections of the regulation, 42 CFR 493.1251 to 493.1254: storage and operating conditions, the procedure manual and its content, expired materials, verification of performance, and maintenance.
This kit puts those records in order. The procedure template walks through each of the fourteen items a procedure has to cover and shows which ones the manufacturer's instructions can satisfy. The verification plan and worksheet take a new analyzer from the plan to a signed summary, and the worksheet does the arithmetic.
Written for: Laboratories performing moderate or high complexity testing, especially when adding a test, replacing an analyzer or rebuilding a procedure manual.
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 |
|---|---|---|
| PM-01 | Procedure Manual Policy How procedures are written, approved by the current director, reviewed, changed and retired. | Word + PDF |
| PM-02 | Test Procedure Template Fourteen sections with prompts, and a crosswalk to each item in 493.1251(b) showing what the manufacturer's instructions may cover. | Word + PDF |
| PM-03 | Procedure Manual Index and Review Log Every procedure with its approval date, review due date, discontinuance date and a status flag. | Excel + PDF |
| PM-04 | Method Verification Plan and Summary Plan, results, calibration and control settings, pre-testing checklist and director sign-off for an unmodified FDA-cleared test. | Word + PDF |
| PM-05 | Verification Data Worksheet Four tabs for precision, accuracy, reportable range and reference intervals. Calculates mean, SD, CV, bias, slope, recovery and flags. | Excel + PDF |
| PM-06 | Maintenance and Function Check Log A dated log for each instrument, with a schedule tab that flags tasks due and overdue. | Excel + PDF |
| PM-07 | Calibration and Calibration Verification Record Calibration details, the reason for each verification, three levels across the reportable range and the outcome. | Word + PDF |
| PM-08 | Storage and Operating Conditions Policy Your criteria for each unit and room, what to do when a reading is out, labeling, and expiration and lot rules. | Word + PDF |
| PM-09 | Temperature and Humidity Log Daily readings checked against the ranges you set, with out-of-range entries flagged. | Excel + 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 493.1251 | A written procedure for every test, with the listed content, approved, signed and dated by the current laboratory director before use. | PM-01, PM-02, PM-03 |
| 42 CFR 493.1252(b)-(e) | Criteria for storage and operating conditions, monitored and documented. Labeling. No expired or deteriorated materials. No mixing of kit lots unless the manufacturer allows it. | PM-08, PM-09 |
| 42 CFR 493.1253(b)(1), (b)(3), (c) | Before reporting patient results from an unmodified FDA-cleared or approved test: accuracy, precision, reportable range and reference intervals verified and documented. | PM-04, PM-05 |
| 42 CFR 493.1254 | Maintenance and function checks as the manufacturer defines them, at least as often as specified, and documented. | PM-06 |
| 42 CFR 493.1255 | Calibration, and calibration verification at least every six months and after the listed events. | PM-07 |
| 42 CFR 493.1105(a)(2), (a)(3)(i) | Procedures kept two years after discontinuance. Verification records kept while the test is in use. | PM-03, PM-04 |
Free guides for this kit
What the kit does not do
- The kit does not write your procedures or supply your data. The template shows what each procedure has to cover. The content comes from your manufacturer's instructions and your own practice.
- PM-04 and PM-05 cover verification of unmodified FDA-cleared or approved tests. Modified tests and laboratory-developed tests need performance specifications established under 493.1253(b)(2), which asks for more than these forms.
- The worksheet calculates. It does not decide. The regulation sets no sample numbers or acceptance limits, so your laboratory director does.
- Requirements specific to a specialty, such as microbiology, hematology or immunohematology, are not covered.
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.