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Short answer: COLA accreditation means a clinical laboratory has been surveyed and accredited by COLA, an accrediting organization that, by its own account, is approved by the Centers for Medicare and Medicaid Services (CMS) to accredit laboratories against CLIA requirements. COLA says its surveys run on a two-year cycle and that its approval now covers all CLIA specialties. A lab that says it is “COLA accredited” still needs a CLIA certificate; accreditation is one route to meeting CLIA, not a replacement for it.
General information for laboratory, clinic and supply staff. It is not legal, regulatory or medical advice.
Definition and scope
COLA is a private accrediting organization for clinical laboratories. Its own accreditation page says the program is built to help laboratories meet federal CLIA and state requirements and that COLA operates it under a quality management system certified to ISO 9001:2015. COLA describes the program as reaching physician offices, hospitals, reference laboratories, health systems, pathology and cytology laboratories, public health laboratories, surgery centers, rural health clinics, plasma centers, long-term care and EMS or mobile laboratories.
COLA also states it has been accrediting for more than 35 years, has completed over 100,000 on-site surveys and has approximately 6,000 accredited laboratories. These are COLA’s own figures, not independently audited ones.
How COLA accreditation works in practice
COLA describes a five-step process: enrollment, an optional self-assessment, an on-site survey it calls educational in approach, post-survey corrective action, and accreditation. It says it keeps following a laboratory’s performance afterwards, including by monitoring proficiency testing, and that surveys recur every two years with an accreditation certificate covering that period.
The on-site survey is the point where CLIA obligations such as quality control, personnel and proficiency testing are checked in practice. For the CLIA side of that picture, see CASRAI’s guides on CLIA certification and certificate types, the CLIA inspection checklist and CLIA quality control requirements.
CLIA specialties COLA says it is approved for
COLA’s accreditation page lists nine CLIA specialties for which it says it is approved by CMS to accredit, and a June 11, 2026 COLA press release says it now holds deemed status from CMS for all CLIA specialties, with Histocompatibility the most recent addition. The table below reproduces COLA’s own list; it is the scope you can check against a specific laboratory’s test menu.
| CLIA specialty (as COLA lists it) | Source |
|---|---|
| Chemistry | COLA accreditation page |
| Hematology | COLA accreditation page |
| Microbiology | COLA accreditation page |
| Immunology | COLA accreditation page |
| Immunohematology | COLA accreditation page |
| Pathology (criteria reflect CLIA requirements for histopathology and cytology) | COLA accreditation page |
| Cytogenetics | COLA accreditation page |
| Radiobioassay | COLA accreditation page |
| Histocompatibility | COLA accreditation page; COLA press release, June 11, 2026 |
COLA adds that it has been approved to deem laboratories in California compliant with that state’s requirements.
What “deemed status” changes
CLIA’s provisions on accreditation by private, nonprofit organizations are in 42 CFR Part 493, Subpart E. Per COLA’s press release, its deeming approval was published in the Federal Register on June 10, 2026. Deemed status is the reason a CMS-approved accreditation can stand in for a government inspection route; CASRAI’s CLIA certification guide sets out how this relates to the certificate types.
COLA, CAP and Joint Commission
COLA is one of several CMS-approved accreditors. CASRAI compares them side by side in Laboratory Accreditation Bodies Compared, and explains the Joint Commission program in What Is Joint Commission Accreditation?. The practical difference for a buyer is not which logo is better but which accreditor the supplier or partner lab actually holds and for which specialties.
Checklist: what to confirm when a lab says it is COLA accredited
- Current certificate. COLA issues a certificate for each survey period, so ask for the one in force and its dates.
- Specialty scope. Compare the lab’s test menu against the specialties in the table above.
- Cycle position. COLA describes a two-year survey cycle, so the certificate should show where the lab is in it.
- CLIA certificate. Accreditation sits alongside a CLIA certificate; ask for both.
- Entity. COLA accredits laboratories, so confirm the certificate names the actual laboratory or site you will deal with.
Common misunderstandings
Is COLA accreditation the same as a CLIA certificate?
No. CLIA certification is the federal legal baseline for testing on human specimens; COLA accreditation is one CMS-approved way to demonstrate compliance with it.
Does “COLA accredited” cover every test a lab runs?
Not automatically. Accreditation is tied to CLIA specialties, so check scope against the tests you rely on.
Is COLA only for small physician office labs?
COLA’s own list of facility types includes hospitals, reference laboratories, health systems and public health laboratories as well as physician offices.
FAQ
Who approves COLA to accredit laboratories?
COLA states that CMS approves it for CLIA specialties, and its June 2026 press release says CMS deemed status now covers all of them.
How often is a COLA-accredited laboratory surveyed?
COLA describes a survey experience every two years.
Sources
- COLA, Accreditation (checked 2026-11-01).
- COLA press release, June 11, 2026, announcing deemed status for all CLIA specialties (cola.org, read 2026-11-01).
- 42 CFR Part 493, Subpart E, Accreditation by a private, nonprofit accreditation organization or exemption under an approved State laboratory program (eCFR, general reference, checked 2026-11-01).
