Certificate of Compliance or Certificate of Accreditation?

A lab performing moderate or high complexity testing ends up with one of two certificates. CMS's Quick Start Guide (March 2026) says a nonwaived lab "can choose Certificate of Compliance or Certificate of Accreditation based on the agency you wish to survey your laboratory." Labs are close to evenly divided: CMS's September 2026 statistics count 15,214 Compliance labs and 15,542 Accreditation labs outside New York and Washington. Physician office labs lean toward Compliance (9,104 versus 4,257).

What do the two certificates have in common?

More than most people expect. Both allow waived, PPM, moderate and high complexity testing. Both start with a Certificate of Registration. Both require a director who meets subpart M, the consultants and testing personnel subpart M names, proficiency testing in a CMS-approved program, and the quality system in subpart K. Both last no more than two years (42 CFR 493.49(d), 493.61(d)) and are inspected every two years. Neither changes what CLIA requires of the lab at minimum; accreditation organizations "may have more stringent health and safety requirements," CMS says.

How does a Certificate of Compliance work?

• Who inspects: the State Agency or CMS. The certificate is issued "after the State Agency or CMS surveyor finds the laboratory in compliance with all applicable CLIA requirements."
• How often: biennially "or with such other frequency as CMS determines to be necessary," with the nature of later inspections based on the lab's compliance history (493.1777(b)).
• What it costs CMS-side, as of October 2026: a certificate fee by schedule ($223 to $11,801) plus a biennial compliance survey fee. CMS's schedule shows national averages from $446 for a low-volume lab to $5,459 for Schedule J, and says to ask the State Agency for your amount. Follow-up visits for deficiencies, added specialties, substantiated complaints and proficiency testing desk reviews are billed at actual cost (493.643(d)).
• Billing rhythm: a survey fee invoice about a year before expiration and a certificate fee invoice after the survey (Quick Start Guide).
• Notices: changes in ownership, name, location, director or (for high complexity) technical supervisor within 30 days; new specialties and method changes within 6 months (493.51).

How does a Certificate of Accreditation work?

• Who inspects: a CMS-approved accreditation organization. The current CMS-116 lists The Joint Commission, ACHC, AABB, A2LA, CAP, COLA and ASHI. See the CLIA accreditation organizations.
• CMS oversight: the lab must permit "random sample validation and complaint inspections," let its accreditation organization release inspection findings to HHS, and authorize release of its proficiency testing results (493.61(b)).
• What it costs CMS-side, as of October 2026: the same certificate fee by schedule plus a validation fee of 5 percent of the equivalent survey cost, paid "whether the accredited laboratory has a validation inspection or not" (493.645(a)(1)). CMS's schedule lists average validation fees from $22 to $273. The accreditation organization's own fees are separate and set by the organization.
• Notices: ownership, name, location and director changes to HHS and the accreditation organization within 30 days; new specialties and method changes to the organization within 6 months (493.63).

Which one suits a small clinic lab?

There is no rule that favors one, so the decision is practical:

1. Cost. CMS's low-volume survey fee average is $446 per two years for Compliance, against a small validation fee plus the accreditation organization's fees for Accreditation. Ask the organizations for their current pricing before deciding.
2. Standards. An accreditation organization's checklist may go beyond CLIA. Some labs want that structure; others prefer to be measured against CLIA itself.
3. Who else cares. A hospital system, payer contract or partner lab may expect a particular accreditation.
4. Timing. On the Accreditation path, proof of accreditation is due within 11 months of the registration certificate (493.57(b)). On the Compliance path, the State Agency schedules the initial survey, which the Quick Start Guide says typically happens in the first year.

What happens if a lab loses its accreditation?

After an accreditation organization withdraws or revokes accreditation, the lab keeps its Certificate of Accreditation for 45 days after notice, or until the effective date of any CMS action, whichever is earlier (493.551(c)). A lab that fails to meet 493.61 "will be subject to full determination of compliance by HHS" (493.61(c)), and if CMS removes an organization's approval, its labs fall under the Compliance requirements (493.61(g)). A lab in that position should be ready to move to a Certificate of Compliance quickly.

Can a lab switch between them?

Yes. A Compliance lab moving to accreditation does not need a new registration certificate; it provides proof of accreditation "prior to the expiration of the certificate of compliance" (493.57(b)(1)(ii)). An Accreditation lab moving to Compliance becomes subject to State Agency surveys. Either change goes on a CMS-116 marked "Change in Certificate Type," sent to the State Agency.

How can White Glove CLIA help?

We prepare the CMS-116 for the Registration and Compliance or Accreditation path, including Section VIII and the director's qualification documents, in the Nonwaived Certificate Application Packet ($1,499; pricing). The owner or director signs. The lab pays CMS on pay.gov and contracts with any accreditation organization directly; we have no affiliation with CMS, any accreditation organization or any State Agency. For the order of steps, read moving from a waiver to moderate complexity testing.