Which entity administers the CLIA requirements and issues CLIA certificates?

• A. National Institutes of Health
• B. Food and Drug Administration
• C. Centers for Medicare and Medicaid Services
• D. Centers for Disease Control and Prevention

Answer: (C)

The main concept is who oversees CLIA and issues the CLIA certificates. CLIA sets federal quality standards for laboratory testing to ensure accuracy and reliability. The Centers for Medicare and Medicaid Services is the agency that administers the CLIA program, conducts inspections (directly or through state survey agencies), and issues the CLIA certificates of registration, compliance, or accreditation. Other agencies have different roles: NIH handles biomedical research, FDA regulates devices and test kits but does not issue CLIA certificates, and CDC provides public health guidelines without issuing CLIA certificates. So, the center responsible for administering CLIA requirements and issuing the certificates is the Centers for Medicare and Medicaid Services.