Article: Clinical Laboratory Improvement Amendments

The Clinical Laboratory Improvement Amendments (CLIA) are standards that regulate all laboratory testing performed on humans in the United States except clinical trials. CLIA covers approximately 175,000 laboratory entities. The objective of the CLIA program is to ensure quality laboratory testing.

a laboratory

In 1988, the United States Congress passed the Clinical Laboratory Improvement Amendments (CLIA) establishing quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. CLIA defines a laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

CLIA is funded by user fees.

Centers for Medicare and Medicaid Services (CMS), formerly the Health Care Financing Administration, assumes primary responsibility for the operation of the CLIA program. The Division of Laboratory Services, within the Survey and Certification Group of the Center for Medicaid and State Operations implements the CLIA Program.