The Centers for Medicare and Medicaid Services (CMS) is a federal agency within the Department of Health and Human Services (HHS). CMS runs the Medicare program and works with state governments to administer standards for Medicare, Medicaid, and Children's Health Insurance Program.
CMS also oversees and regulates clinical laboratories through HIPAA and CLIA regulations.
CMS assures quality laboratory testing by:
- Issuing laboratory certificates
- Collecting user fees
- Conducting inspections and enforcing regulatory compliance
- Approving private accreditation organizations for performing inspections
- Approving state exemptions
- Monitoring laboratory performance on Proficiency Testing (PT) and approving PT programs
- Publishing CLIA rules and regulations