The Joint CommissionOn the public register
- What they do
- Assessor
- Which standards
- On the public register for CLIA, ACHC/CHAP, CMS CoPs.
- Standards
- Pricing
- Not published
CLIA
The Clinical Laboratory Improvement Amendments of 1988 and the regulations at 42 CFR Part 493 govern every laboratory in the United States that tests human specimens for health purposes, about 320,000 sites. CMS runs the program with the CDC and FDA.
A lab holds one of five certificate types depending on test complexity: Certificate of Waiver, Certificate for Provider-Performed Microscopy, Certificate of Registration (a temporary certificate that lets a lab begin nonwaived testing until its first inspection or accreditation), Certificate of Compliance (surveyed by the state agency for CMS), or Certificate of Accreditation (surveyed by a CMS-approved accreditation organization).
Certificates run for up to two years.
For nonwaived testing, a lab needs in writing a procedure manual for every test, quality control and calibration procedures and records, proficiency testing enrollment and results, a quality assessment program, personnel records showing the director and testing staff meet qualification rules with documented competency assessments, specimen handling and reporting procedures, and corrective action records.
Waived labs have far lighter requirements but must still follow manufacturer instructions.
Recent changes: since December 28, 2024, directors of labs doing moderate or high complexity testing (other than labs holding only the microscopy certificate) must be on site at least once every six months, at least four months apart, and document those visits. CMS now sends certificates and fee notices by email only, so labs must keep a valid email address on file.
On July 16, 2026 CMS published a request for information on modernizing the CLIA rules; comments closed on September 14, 2026 and no proposed rule had followed as of September 26, 2026.
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Who has to comply
Any facility that examines human specimens for diagnosis, prevention, or treatment, including hospital labs, physician office labs, independent labs and point-of-care sites. Some testing is excluded, such as forensic testing and research that does not report patient-specific results. The certificate must match the highest complexity of testing performed.
What the assessor asks to see
Surveyors ask for the CLIA certificate and test menu, the laboratory director's qualifications and delegation, personnel qualifications and competency assessments, the procedure manual and test system validations, quality control records and corrective actions, proficiency testing results and investigations of failures, the quality assessment plan and reviews, specimen collection and reporting procedures, instrument maintenance records, and patient test records to trace results end to end.
Where the requirement sits: 42 CFR 493.1251 procedure manual; 493.1235/493.1451 competency assessment; 493.1105 record retention; 493.1256 QC
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AllyMatter is a full system for every internal policy your company keeps, including the ones CLIA turns on. Build the whole library in one place, across every department, and prove who has read what.
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Health Care Compliance Program Policies and Code of Conduct: who needs it, what goes in it, how often it is reviewed and who signs it off. Run exactly that in AllyMatter, alongside every other policy your company keeps.
How it works
Every document is approved by someone other than its author, versioned, distributed to the people it covers and acknowledged by name. Sign it where a signature is what the standard wants, send a set out together as a package, and export a dated record of who read which version when an assessor asks.
The written policies this standard turns on live here, with every version and every acknowledgment on the record.
Who helps with CLIA
Laboratory consultants, medical director services for physician office labs, and accreditation readiness firms; the accreditors themselves publish checklists. Engagements typically cover certificate applications (Form CMS-116), procedure manual development, QC and PT setup, and mock inspections.
Firms that name this framework in their own material. A listing is not a recommendation. Each firm can confirm its own.
Consultants
Be the first CLIA consultant listed here
The people reading this are working out who can help them get there.
Who assesses CLIA
State survey agencies acting for CMS (and CMS regional offices) survey Certificate of Compliance labs. CMS-approved accreditation organizations survey Certificate of Accreditation labs: AABB, A2LA, ACHC, ASHI, COLA, College of American Pathologists, and The Joint Commission.
Washington runs its own CMS-approved program in place of CLIA; New York's exemption is partial, so labs there should check with the state.
Accredited by CMS approves accreditation organizations and exempt state programs under 42 CFR Part 493 Subpart E and reviews them periodically; CMS or state agency surveyors perform validation surveys on a limited percentage of accredited labs.
Public register of assessors: cms.gov ↗
Listed in random order, reshuffled each time the page loads. Firms that pay for a listing are shown at the top, labeled Sponsored.
College of American Pathologists (CAP)On the public register
- What they do
- Assessor
- Which standards
- On the public register for CLIA.
- Standards
- Pricing
- Not published
COLAOn the public register
- What they do
- Assessor
- Which standards
- On the public register for CLIA.
- Standards
- Pricing
- Not published
AABBOn the public register
- What they do
- Assessor
- Which standards
- On the public register for CLIA.
- Standards
- Pricing
- Not published
American Association for Laboratory Accreditation (A2LA)On the public register
- What they do
- Assessor
- Which standards
- On the public register for CLIA.
- Standards
- Pricing
- Not published
Tools for CLIA
Tools that name this framework in their own material.
Grouped by type. Inside each group the order is random, reshuffled each time the page loads. AllyMatter, the publisher of this site, is always first.
AllyMatterPolicy management tool, the policy and acknowledgment layerPublisher of this siteRelated reading
- CLIA for Physician Office LaboratoriesPractical walkthrough of which certificate a practice needs, how test complexity is decided, and what non-waived testing then obliges.American Academy of Family Physicians
- Personnel Requirement Changes in New Checklist EditionDetails the December 2024 personnel qualification changes and how the grandfather provision works for staff already in post.CAP TODAY, College of American Pathologists
- CMS Releases Final Rule Updating CLIA RegulationsSummarizes the CLIA fee restructure, histocompatibility changes and the new laboratory director onsite and continuing education duties.Association for Diagnostics and Laboratory Medicine
Independent third-party explainers, chosen by hand. Not affiliated with this site and not paid placements. All links are nofollow.
Sources
CMS: Clinical Laboratory Improvement Amendments (CLIA)CMS: List of approved accreditation organizations under CLIA (August 2025)eCFR: 42 CFR Part 493 Laboratory RequirementsCDC: About CLIAeCFR: 42 CFR 493.45, requirements for a registration certificateeCFR: 42 CFR 493.1407, laboratory director responsibilities (moderate complexity)
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