Clinical Laboratory Improvement Amendments

Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.

CLIA Program
In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information (1) for the diagnosis, prevention, or treatment of disease or impairment, and (2) for the assessment of health. An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.

Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, Division of Laboratory Services.

The CLIA Program is funded by user fees collected from approximately 189,000 laboratories, most located in the United States.