Test sites will need to apply for a waiver from The Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA), which regulates the quality that all laboratories must meet. For an initial applicant, the CLIA Initial Application must be completed so that testing sites can manage the accuracy, reliability, and timeliness of patient test results.

For more information on obtaining a CLIA waiver and the form to complete, please see: https://www.cms.gov/files/document/cms-clia-laboratory-quick-start-guide-remediated.pdf.