CLIA answers for lab managers
Plain answers to the CLIA certificate questions lab managers ask most. Each one is sourced to the federal regulations (42 CFR Part 493), the CLIA statute and current CMS guidance, with links so you can check them yourself.
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When do I have to submit my CLIA renewal?
Routine CLIA renewal starts with a CMS bill, not an application you file. Waiver, PPM and Accreditation labs get a renewal fee coupon about 6 months before expiration and renew by paying it. Compliance labs get a survey-fee bill about 1 year out, then need a recertification survey before the new certificate issues.
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How long is a CLIA certificate valid?
A CLIA certificate is valid for no more than two years. That limit applies to every certificate type: Waiver, PPM, Registration, Compliance and Accreditation. A Certificate of Registration can end sooner, because it only covers a new lab until its initial survey or accreditation is confirmed. Each renewal starts a new two-year period.
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What happens if my CLIA certificate expires?
Federal law says a lab can’t accept specimens for testing unless a CLIA certificate is in effect, and CMS says a lab can’t test or claim Medicare or Medicaid payment without one. If your certificate has lapsed or is about to, contact your State Agency, or your accreditation organization, right away.
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How do I look up my CLIA certificate expiration date?
Search your CLIA number in CMS’s free QCOR CLIA laboratory lookup. Your lab’s detail page shows the certificate type, effective date, expiration date and a link to the certificate PDF. The expiration date is also printed on the certificate itself. QCOR lists active labs only and is updated weekly.
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What’s the difference between a Certificate of Compliance and a Certificate of Accreditation?
Both cover nonwaived (moderate- and high-complexity) testing and last up to two years. The difference is who surveys your lab. A Certificate of Compliance follows a State Agency or CMS survey. A Certificate of Accreditation rests on accreditation by a CMS-approved organization such as COLA, CAP or The Joint Commission.
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Not sure which clock your certificate is on?
Enter your CLIA number and we’ll send you a one-page report showing every date we can find in public CMS records for your lab, and when your CLIA renewal window opens. Free, with no obligation. No patient data.
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.