In 1988, U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) to standardize and ensure the quality of clinical laboratory testing. CLIA applies to all clinical laboratory testing performed on humans, excluding clinical trials and basic research. All clinical laboratories that provide diagnostic services must be approved by CLIA in order to perform testing. CLIA regulates approximately 260,000 laboratory entities across the United States.
To regulate quality laboratory testing, CLIA designates levels of testing and corresponding personnel qualifications, determines how quality control is performed, mandates competency and proficiency testing, and requires inspections.
CLIA regulations were written and are enforced by the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC).
