Where the rubber meets the road. Clinical diagnostic testing and new technology

The Clinical Laboratory Improvement Amendments of 1988 ("CLIA 88") established uniform minimum quality standards for all clinical laboratory testing throughout the United States. The intent was to ensure reliability, accuracy and timeless of patient test results regardless of the setting where testing was performed. CLIA\´88 requirements will supersede individual state requirements if more stringent. The Federal Government Centers Medicare and Medicaid Services CMS is responsible for implementing and enforcing CLIA, the Food and Drug Administration (FDA) for test categorization and the Centers for Disease Control and Prevention (CDC) for CLIA research studies.