The CLIA Accreditation Organizations

A lab that wants a Certificate of Accreditation instead of a Certificate of Compliance needs an accreditation organization that CMS has approved for CLIA. The regulation defines one as "a private, nonprofit accreditation organization that has formally applied for and received CMS's approval based on the organization's compliance with this part" (42 CFR 493.2). CMS may grant such a lab "deemed status" when the organization's requirements "are equal to, or more stringent than, the CLIA condition-level requirements" (493.551(a)).

Which organizations are approved?

The current Form CMS-116 (03/24) lists seven in Section II, and CMS's September 2026 laboratory statistics show how many labs each accredits for CLIA purposes outside the exempt states:

• College of American Pathologists (CAP): 6,966 labs
• COLA: 5,639 labs
• The Joint Commission: 2,336 labs
• AABB: 192 labs
• ACHC: 149 labs
• American Society for Histocompatibility and Immunogenetics (ASHI): 107 labs
• A2LA (American Association for Laboratory Accreditation): 8 labs

CAP and COLA together account for about four out of five accredited labs. The CMS-116 instructions add: "If your CMS-approved accreditation organization is not listed, contact your local State Agency for further instructions." Older CMS brochures list a different set of organizations, so rely on the current form.

White Glove CLIA is not affiliated with any of these organizations, and naming them here is not an endorsement either way.

Who chooses accreditation over a state survey?

CMS's September 2026 figures show the two nonwaived paths are close in size overall: 15,542 Certificate of Accreditation labs against 15,214 Certificate of Compliance labs. The mix inside each is different. Physician office labs make up 9,104 of the Compliance labs, about 60 percent, but only 4,257 of the Accreditation labs, about 27 percent. Among physician office labs with nonwaived testing, State Agency surveys are the more common route. Neither path is required for any type of facility; the choice is the lab's, made on the CMS-116.

How does accreditation connect to the CLIA certificate?

Accreditation does not replace the CLIA certificate; it is the basis for one. The sequence:

1. The lab files a CMS-116 for a Certificate of Accreditation, checking its organization in Section II and naming it beside each specialty in Section VIII.
2. CMS issues a Certificate of Registration after the $123 registration fee (as of October 2026).
3. The lab provides proof of accreditation, or of application for it, within 11 months (493.57(b); CMS-116 Section II).
4. CMS issues the Certificate of Accreditation once the lab pays the certificate fee and validation fee (493.61(a)).

A lab accredited for some specialties but not others lists each organization beside the relevant specialty on the CMS-116.

What does an accredited lab still owe CMS?

• Fees. A biennial certificate fee by volume schedule and a validation fee of 5 percent of the equivalent survey cost (493.645(a)(1)); the accreditation organization's fees are on top. See CLIA fees in 2026.
• Proficiency testing. Enrollment in a CMS-approved program, with results released to the organization and to CMS when performance is unsuccessful (493.551(b)).
• Access. CMS or its agent may conduct a validation or complaint inspection "at any time during its hours of operation" (493.1780).
• Notices. Ownership, name, location and director changes to both HHS and the organization within 30 days (493.63(a)).

What happens when something goes wrong?

If a CMS validation or complaint inspection finds condition-level noncompliance, the lab "is subject to a full review by CMS" (493.1780(c)(1)). If the organization withdraws accreditation, the lab keeps its Certificate of Accreditation for 45 days after notice, or until the effective date of any CMS action if earlier (493.551(c)). If CMS withdraws an organization's approval, its labs become subject to the Compliance requirements (493.61(g)). See Compliance or Accreditation?

How do you choose among them?

Start with scope: the CMS-116 has a lab name its accreditation organization beside each specialty, so confirm the organization accredits every specialty you perform. Then compare each organization's standards, inspection approach and fees directly with the organization. Ask whether any hospital, payer or partner you work with expects a particular accreditation.

Where does White Glove CLIA fit?

We prepare the CMS-116 for the Accreditation path, including the Section II and Section VIII accreditation entries, and the director's qualification documents (Nonwaived Certificate Application Packet, $1,499; see pricing). The lab applies to and pays its accreditation organization directly, and pays CMS on pay.gov. Accreditation readiness work, such as preparing for the organization's inspection, belongs with the lab's director and laboratory advisers.