Clinical Laboratory Improvement Act (CLIA)
Certificate Types
Certificate of Waiver
Tests permitted under this certificate type can found at:
http://www.cms.hhs.gov/CLIA/downloads/CR5600.waivedtbl.pdf
If the test system is not listed, go to:
http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf
This website contains the complete list of tests approved by the FDA and the CDC and includes the complexity of the test.
Certificate of Provider Performed Microscopy
All waived tests and specific microscopy tests are permitted under this certificate type. For a complete list of Provider Performed Microscopy tests, go to: http://www.cms.hhs.gov/CLIA/downloads/ppmp.list.pdf
Certificate of Compliance
The CLIA Program Surveyor inspects laboratories registered under this certificate type every two years. Tests classified as moderate to high complexity are permitted depending upon the personnel qualifications. The surveyor announces all routine surveys. Complaints and revisits are always unannounced.
Certificate of Accrediation
These facilities are inspected by a non-profit agency approved by CMS. The list of accrediting agencies can be found at: http://www.cms.hhs.gov/CLIA/downloads/AO.List.pdf
Tests classified as moderate to high complexity are permitted depending upon the personnel qualifications.
