General Information Guide

Clinical Lab Improvement Amendment 

CMS regulates all laboratory testing (except research) performed on humans in the U.S. through the 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.

For additional information about a particular laboratory, contact the appropriate state agency or regional office of CLIA, and refer to CLIA regulations and guidance.  Visit Clinical Laboratory Improvement Amendments (CLIA) for additional information.   

Reviewed 10/18/2024