The Joint CommissionOn the public register
- What they do
- Assessor
- Which standards
- On the public register for ACHC/CHAP, CLIA, CMS CoPs.
- Standards
- Pricing
- Not published
Framework Healthcare & Human Services
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 several certificate types depending on test complexity: Certificate of Waiver, Certificate for Provider-Performed Microscopy, Certificate of Compliance (surveyed by the state agency for CMS), or Certificate of Accreditation (surveyed by a CMS-approved accreditation organization). All certificates run for 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.
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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, point-of-care sites, and pharmacies. 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
What AllyMatter does here
Controls the procedure manual (approval, versions, review-on-change) and holds competency records as evidence.
AllyMatter publishes this site.
Assessors
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. Exempt states (Washington and New York) run their own equivalent programs.
Accredited by CMS approves accreditation organizations and exempt state programs under 42 CFR Part 493 Subpart E and reviews them periodically; state agencies perform validation surveys on about five percent of accredited labs each year.
Public register of assessors: https://www.cms.gov/files/document/list-accreditation-organizations-august-2025.pdf
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
Consultants
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. Listings we have not verified yet come from public filings and partner lists. Each firm can confirm its own.
No firm has claimed a CLIA consultant listing yet. Claim yours →
Software
Tools for CLIA
Tools that name this framework in their own material.
Related 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 RegulationsSummarises 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.
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From the publisher
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Approve the policies CLIA asks for, keep every version, and record a named acknowledgment from each person who has to read them.
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