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Select the State agency based on the physical location of the laboratory. 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.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. See the Consumer Complaints FAQ (PDF) on how to file a complaint.

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. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. The objective of the CLIA program is to ensure quality laboratory testing. 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. In total, CLIA covers approximately 320,000 laboratory entities. through the Clinical Laboratory Improvement Amendments (CLIA). The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S.

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