Clinical Laboratory Improvement Amendments (CLIA)

The CMS regulates all the laboratory testing (other than research) in U.S. through CLIA, More than 200,000 laboratory covered by CLIA. 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.

How to Apply for CLIA

Form CMS 116 should be completed and mailed to the address of the local state agency for state in which your laboratory resides.

Verification of state Licensure, as applicable

Documentation of qualification

Education (Copy of Diploma, transcript form accredited institution, CMEs)

Laboratory experience

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