How long is a CLIA certificate valid?

Validity by certificate type

The CLIA statute sets the outer limit: a certificate “shall be valid for a period of 2 years or such shorter period as the Secretary may establish” (42 U.S.C. 263a(c)(2)). CMS summarizes it for labs as “All certificate types are effective for two years” (CMS CLIA Certification brochure; CMS, Apply for a CLIA Certificate). Certificate type descriptions: CMS CLIA Certification brochure.

When your two years start

CMS sets the effective date differently for each certificate type (SOM Ch. 6, §6006.6):

• Waiver, PPM and Registration (new labs): the date the CLIA application, Form CMS-116, is entered into the CLIA Data System.
• Compliance: the date the lab is surveyed and found in compliance with CLIA requirements.
• Accreditation: the date the accreditation organization verifies to CMS that the lab is accredited.

In CMS’s words, “Once the effective dates are established, the laboratory’s 2-year certificate cycle is set.” CMS’s sample certificate in its Quick Start Guide shows an effective date of 12/18/2024 and an expiration date of 12/17/2026, so the expiration date falls the day before the two-year anniversary (CMS Quick Start Guide). Read your exact date from your certificate or from QCOR rather than calculating it: see how to look up your CLIA certificate expiration date.

What happens at the end of the two years

When a certificate is renewed, a new two-year period begins. CMS describes Waiver and PPM certificates as renewed “for another 2-year period” after payment of fees, a Certificate of Compliance as renewed for another 2-year period “after recertification and payment of appropriate fees,” and a Certificate of Accreditation as renewed “with a new 2-year effective date” unless the accreditation organization reports a loss of accreditation (SOM Ch. 6, §§6006.2–6006.5).

The renewal process starts well before the expiration date, and the timing depends on your certificate type. See when to submit your CLIA renewal.

Why the rule says “no more than” two years

• A certificate can end early. The certificate itself says it is valid until the expiration date “but is subject to revocation, suspension, limitation, or other sanctions” (CMS Quick Start Guide, sample certificate), and the regulations provide for suspension, revocation or limitation for noncompliance (42 CFR 493.49(c); 42 CFR 493.61(e)).
• A Certificate of Registration is temporary by design. CMS says it is “valid until the initial survey is conducted and compliance with CLIA regulations is determined” (CMS CLIA Certification brochure). For labs seeking accreditation, proof of accreditation is due within 11 months of the registration certificate being issued (42 CFR 493.57(b)(1)).
• If a lab is appealing a sanction when its certificate expires, CMS may reissue the certificate while the appeal is pending, as long as there is no immediate jeopardy (SOM Ch. 6, §6262).

Two years is also the survey and fee cycle

Labs with a Certificate of Compliance or Accreditation “get surveyed every two years by CMS, the State Agency, or by a CMS-approved AO” (accreditation organization). Waiver and PPM labs are not routinely surveyed. Every certificate type pays CLIA fees every two years (CMS CLIA Certification brochure). If a certificate does lapse, see what happens if your CLIA certificate expires.

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.