Which regulatory body enforces the Clinical Laboratory Improvement Amendments (CLIA)?

The Clinical Laboratory Improvement Amendments (CLIA) are enforced by the Centers for Medicare and Medicaid Services (CMS). This regulatory body is responsible for ensuring quality laboratory testing across the United States, which includes the oversight of laboratory licensing and certification under CLIA. CMS establishes standards that laboratories must meet to ensure the accuracy and reliability of tests performed on human specimens.

While other agencies listed have important roles in health and safety regulation, they do not enforce CLIA. The Food and Drug Administration (FDA) is involved in the regulation of diagnostic tests but does not handle the certification and operational standards set forth by CLIA. The National Institutes of Health (NIH) is primarily focused on biomedical research and does not have a regulatory enforcement role in clinical laboratory standards. The Occupational Safety and Health Administration (OSHA), on the other hand, focuses on workplace safety and health regulations, which are separate from the quality of laboratory testing as mandated by CLIA. Thus, CMS is the body that directly oversees compliance with CLIA requirements, making it the correct answer.