Understanding CLIA Certification, Accreditation & Test Complexity
The Centers for Medicare & Medicaid Services (CMS) supports the CLIA program to ensure quality laboratory testing in collaboration with the:
Some laboratories may choose to get accredited by an HHS-approved accreditation organization (PDF) that may have more stringent requirements. Additionally, laboratories must be certified for each specialty or subspecialty they test to ensure that they’re meeting the specific regulatory requirements for the types of tests they perform. More information about specialties and subspecialties (PDF), or you can contact the accreditation organization.
Test Complexity Categorization
The FDA categorizes laboratory tests by their complexity:
- Waived tests (simple tests with a low risk of an incorrect result)
- Nonwaived tests (moderate and high complexity tests)
The FDA is responsible for categorizing tests through:
- Interpreting CLIA test complexity categorization rules
- Holding public workshops and meetings
- Developing and issuing rules and guidance
You can search the FDA database to find more information about test categorization.