Three federal agencies are responsible for CLIA and assuring quality laboratory testing:
The Center for Medicaid Services (CMS) oversees clinical laboratories, issues certificates, monitors proficiencies, and conducts inspections. For more information, see 42 CFR Part 493.
The Food and Drug Administration (FDA) determines the laboratory “Testing Complexity” categorization. For more information, see 21 CFR.
The Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) provide technical consultation, training, and resources.
