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

Kits / Complete Library

Complete CLIA Library

All six kits in one download: 36 documents, each in Word or Excel and as a fillable PDF, covering competency assessment, waived testing, IQCP, proficiency testing, quality assessment and survey preparation.

It suits a laboratory opening under a new certificate, a new manager inheriting a thin procedure manual, or a consultant setting up one client site.

Look inside

A page from each kit

Top of CA-02 Testing Personnel Assessment FormCompetency AssessmentTop of WT-01 Waived Test Procedure TemplateWaived TestingTop of IQ-02 Risk Assessment WorksheetIQCPTop of PT-02 PT Event RecordProficiency TestingTop of QA-01 Quality Assessment PlanQuality AssessmentTop of IR-01 Self-Audit ChecklistInspection Readiness

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 included

KitContentsFilesAlone
CLIA Competency Assessment KitPolicy, six-procedure forms and a due-date tracker for moderate and high complexity testing.7$59
CLIA Waived Testing KitA procedure template built on the package insert, with training, QC, temperature and lot logs.6$29
IQCP KitRisk assessment worksheet, quality control plan and quality assessment review for one test system.6$49
Proficiency Testing KitPT handling policy, event record, result review and a calendar tracker.5$39
Quality Assessment Plan KitA QA plan across all four systems, a monthly review checklist and the logs that feed it.7$49
CLIA Inspection Readiness KitSelf-audit checklist, binder index, personnel file checklist and a plan of correction template.5$39

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.