Definition

Changes to a 1988 U.S. law that sets the standards for all laboratory testing that is done on human tissue, blood, and other body fluid samples used to screen, diagnose, prevent, or treat a disease or condition. The CLIA program makes sure laboratories follow these standards and have quality control programs in place so that patient test results are accurate and reliable. The federal government agencies that manage the CLIA program are the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). Certain types of laboratory testing, such as testing done in clinical trials, research studies, crime labs, and work-related drug testing, are not covered by the CLIA program. Also called Clinical Laboratory Improvement Amendments.