Editable CLIA policies, forms and trackers, from $29
Ready-to-sign policies, forms and trackers for competency, proficiency testing, IQCP, quality assessment and survey preparation. Every document comes in Word or Excel and as a fillable PDF, cited to its paragraph in 42 CFR Part 493 and checked again every month.
An example of what the kits help you keep on file.
Cited to the paragraphEvery requirement names its CFR section.
Checked every monthA dated log anyone can read.
Your logo in one clickPersonalize the whole kit in your browser.
Fillable PDF includedType into every blank, in any PDF reader.
How it works
Start with the area that worries you most, or take the complete library and cover everything at once.
Add your name, CLIA number and logo across every file with the Personalize tool, then adjust the wording to your test menu.
Your laboratory director reviews and approves each document. File it, and the binder is in order.
The kits
Each kit is a set of numbered, editable documents. Buy one, or take all six.
Policy, six-procedure forms and a due-date tracker for moderate and high complexity testing.
A procedure template built on the package insert, with training, QC, temperature and lot logs.
Risk assessment worksheet, quality control plan and quality assessment review for one test system.
PT handling policy, event record, result review and a calendar tracker.
A QA plan across all four systems, a monthly review checklist and the logs that feed it.
Self-audit checklist, binder index, personnel file checklist and a plan of correction template.
All six kits, 36 documents in every format, one download. For a new certificate, a new manager, or a manual that needs a fresh start.
Two formats in every kit
Every document comes twice, at no extra cost. Same content, same citations, same version number.
For when you want to make it yours.
For when you just need it done.
Peace of mind
Every file shows the date it was last checked against 42 CFR Part 493. The public verification log lists every check and every change.
Each kit opens with a Start Here guide, and the documents are numbered in the order you will use them.
The Personalize tool puts your laboratory name, CLIA number and logo on every file in one pass, in your browser.
Each section names the regulation behind it, so you or a reviewer can check it against the source in minutes.
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.
Free tool
Enter the date a person began testing patient specimens. The calculator returns the two first-year assessment dates and the annual dates that follow. It runs in your browser and stores nothing.
CMS revised the CLIA application form and set November 9, 2026 as the date from which the new version must be used. Laboratories applying for a certificate, or reporting a change that needs a new application, should download the current form before filling it in.
The proposal would loosen several laboratory director qualification and site-visit requirements, allow remote review of digital data under the testing laboratory's certificate, remove the six-month wait for reinstatement after certain proficiency testing failures, and require the CLIA number on test reports. It is not final. Comments are due December 7, 2026. Read our explainer.
The agencies asked for public input on a wide list of topics, including remote observation for competency assessment, calibration verification for factory-calibrated instruments, software and AI used in interpretation, specimen preparation staff, cybersecurity and whether data-only sites need a certificate. The comment period closed September 14, 2026. A request for information changes no requirements, but it shows where future rules may go.
Questions
Surveyors assess whether your laboratory meets the requirement. They do not approve templates. The kits give you structure and citations. Your signed policies, your records and your daily practice are what get surveyed.
The kits are written to the federal CLIA regulation. Accreditation checklists include items beyond CLIA, so compare each document with your organization's current checklist before you adopt it.
The Waived Testing Kit. CLIA does not require competency assessment for waived testing, and the kit says so. It includes a training and competency checklist because CMS calls it good laboratory practice.
Every document comes two ways. The Word (.docx) or Excel (.xlsx) version is fully editable and opens in Microsoft Office, Google Docs and Sheets, and LibreOffice. The fillable PDF lets you type into every blank, signature line and log row in any PDF reader, including Adobe Reader, Chrome, Edge and Preview. Use the Word version to change policy wording, and the PDF when you only need to fill in a form. Nothing is locked or password protected.
Yes. The Personalize tool on this site adds your laboratory name, CLIA number, address, director and logo to the header of every file, with an optional accent color. It runs in your browser, so your files are not uploaded. You can also edit everything by hand in Word and Excel.
Yes, you can type into the fillable PDFs on a computer or tablet in any PDF reader that supports forms, such as Adobe Reader, Chrome, Edge or Preview. Sign on paper after printing, or with your PDF reader's signature tool if your laboratory accepts electronic signatures.
Each file shows the date it was last checked against 42 CFR Part 493. The verification log on this site lists every check and what changed. Buyers can download revised files for 12 months after purchase.
One purchase covers one CLIA certificate. If you manage several certificates, buy one copy for each.
Yes, within 14 days of purchase. Email us with your order number.
Start with one kit, or put the whole binder in order today.