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