What’s the difference between a Certificate of Compliance and a Certificate of Accreditation?

Side by side

The core difference: who surveys your lab

Form CMS-116 frames the choice directly: “A laboratory performing non-waived tests can choose Certificate of Compliance or Certificate of Accreditation based on the agency you wish to survey your laboratory” (Form CMS-116 instructions). A Certificate of Compliance is issued after an inspection “finds the laboratory to be in compliance with all applicable condition level requirements.” A Certificate of Accreditation is issued “on the basis of the laboratory’s accreditation by an accreditation organization approved by CMS” (42 CFR 493.2).

Accreditation organizations may hold labs to stricter standards. CMS notes that accredited labs “must also meet their AOs health and safety requirements, which may be more stringent than CLIA requirements” (CMS CLIA Certification brochure).

How each certificate is issued

• Both start with a Certificate of Registration. A lab applying for either certificate first pays for and receives a Registration Certificate, which lets it test until an onsite inspection determines compliance or until CMS receives verification of accreditation (Form CMS-116 instructions).
• Compliance: CMS tells State Agencies to schedule the initial survey at least 90 days after the CMS-116 is entered, and no later than 12 months after (SOM Ch. 6, §6102.1). The certificate’s effective date is the date the lab is surveyed and found in compliance (SOM Ch. 6, §6006.6).
• Accreditation: the lab must give HHS proof of accreditation within 11 months of the registration certificate being issued, or it must meet the Certificate of Compliance requirements instead (42 CFR 493.57(b)). The effective date is the date the accreditation organization verifies to CMS that the lab is accredited (SOM Ch. 6, §6006.6).

Inspections and oversight

Compliance labs must permit announced or unannounced inspections by HHS (42 CFR 493.49(b)(2)). Accredited labs must comply with their accreditation program, permit CMS validation and complaint inspections, and authorize the accreditation organization to release inspection findings and proficiency testing results to HHS (42 CFR 493.61(b)). CMS says “a limited percentage of laboratories with a CoA will receive a validation survey by CMS or a State Agency surveyor” (CMS CLIA Certification brochure).

Fees

Compliance labs pay a fee to cover the cost of routine compliance surveys. Accredited labs do not pay that routine-inspection fee (42 CFR 493.643(a)). Instead, every accredited lab pays a biennial validation fee, “whether the accredited laboratory has a validation inspection or not” (42 CFR 493.645(a)(1)). Fee amounts are set biennially and depend on the lab’s test volume and specialties (42 CFR 493.638(b)), so we don’t list dollar figures here.

Renewal runs on different clocks

CMS bills Compliance labs for the survey fee about 1 year before expiration, and Accreditation labs for the certificate fee about 6 months before (CMS paperless FAQ). The details are in when to submit your CLIA renewal. Both certificates last no more than two years: see how long a CLIA certificate is valid.

Switching from one to the other

• Either direction requires a new Form CMS-116 submitted to your State Agency, and you can’t use the new certificate type until you have paid any fees and received the updated certificate (CMS CLIA Certification brochure; SOM Ch. 6, §6014).
• Moving from Compliance to Accreditation: the lab must be in CLIA condition-level compliance, and it may keep its Certificate of Compliance until it expires and change then. Changing earlier generates a new Certificate of Registration and fees (SOM Ch. 6, §6014).
• Moving from Accreditation to Compliance: a new Certificate of Registration and fees are generated, and the lab then goes through the Certificate of Compliance process (SOM Ch. 6, §6014).

CMS-approved accreditation organizations

CMS lists seven: AABB; American Association for Laboratory Accreditation (A2LA); Accreditation Commission for Health Care (ACHC); American Society for Histocompatibility and Immunogenetics (ASHI); COLA; College of American Pathologists (CAP); and The Joint Commission (CMS list of approved accreditation organizations; CMS CLIA Certification brochure).

The Deadline Desk is an independent service, not CMS, HHS, a State Agency or an accreditation organization. This page summarizes public sources and is not legal or regulatory advice. Your State Agency or accreditation organization has the final word for your lab.