How can I check on the test complexity for a specific test system?
The complexity designation may be printed in the manufacturer’s package insert or other instructions. In addition, the Food & Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) websites have several resources, including the following:
- FDA’s searchable CLIA database at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm
- FDA’s currently waived analytes at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm
- CMS’s list of tests granted waived status under CLIA at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/waivetbl.pdf
- CMS’s list of provider-performed microscopy procedures (PPMP) at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/ppmplist.pdf.