Which organization is responsible for publishing CLIA rules and regulations?

The Centers for Medicare & Medicaid Services (CMS) is the organization responsible for publishing the Clinical Laboratory Improvement Amendments (CLIA) rules and regulations. CLIA establishes quality standards for laboratory testing to ensure accuracy, reliability, and timeliness of patient test results, which are critical in the delivery of healthcare. CMS oversees the implementation and enforcement of these regulations, ensuring that all laboratory testing meets certain federal standards.

While the Centers for Disease Control and Prevention (CDC) plays a significant role in public health and may provide guidance on laboratory practices and safety, it is not the primary body for CLIA regulations. The Food and Drug Administration (FDA) is involved in regulating the safety and effectiveness of laboratory tests and devices but does not publish CLIA rules. The National Institute of Allergy and Infectious Diseases (NIAID) focuses on research and does not have a direct role in CLIA regulations. Thus, CMS is distinctly positioned as the authoritative source for CLIA-related rules and regulations.