CLIA Applications and Certificate Updates
Although CLIA is a federal program, State Agencies (SAs) are responsible for laboratory oversight and maintaining CLIA laboratories’ certification records. SAs (PDF) process CLIA applications (PDF), renewals, updates, and requests for certificate copies. Some states also have laboratory licensing laws separate from the CLIA regulations, so please check with your SA before your laboratory begins testing.
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 320,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.
The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.
To report a complaint about a laboratory, contact the appropriate State Agency (PDF) that is found on the State Agency & Regional Office CLIA Contacts page located in the left-hand navigation pane in this section. See the Consumer Complaints FAQ (PDF) on how to file a complaint. Additionally, see the Temporary COVID-19 Testing Sites (PDF) infographic, which advises those receiving laboratory services of things to be aware of to ensure they are receiving quality laboratory testing.
QUESTIONS ABOUT the CLIA PROGRAM
- For Questions regarding a CLIA certificate or fees: If you have a question related to CLIA fees or payment, CMS-116 applications, demographic updates, certificate status or upgrades, and/or Laboratory Director changes, please call your local State agency for assistance. Select the State agency based on the physical location of the laboratory. The State agency maintains the certificate information for new and existing laboratory providers within their state. For a list of our State agency CLIA contacts (PDF), please visit our website at /Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf (PDF)
- All other questions about the CLIA program should be submitted to LabExcellence@cms.hhs.gov.
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Sign up for our CLIA Communications Email List with the link below: https://public.govdelivery.com/accounts/USCMS/subscriber/new?topic_id=USCMS_12461
CLIA Post-PHE Guidance FAQs Only (PDF)
CLIA of 1988 Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355-F) FAQ Sheet 7/7/2022 (PDF)
LDT and CLIA FAQs 10/22/2013 (PDF)
Research Testing and CLIA 12/10/2014 (PDF)
Direct Access Testing 03/22/2019 (PDF)
Partners in Laboratory Oversight 09/2006 (PDF)
Live Blood Cell Analysis Under CLIA 03/17/2017 (PDF)
CLIA Fee, Histocompatibility, Personnel, Alternative Sanction NPRM CMS-3326-P 07/22/2022 (PDF)
S&C-16-18-CLIA FAQs 03/27/2017 (PDF)