The Clinical Laboratory Improvement Amendments (CLIA) waiver program is a federal program that allows certain laboratories to perform certain tests without having to meet all of the CLIA requirements. This program is designed to make it easier for small laboratories to provide testing services to their patients. To apply for a CLIA waiver, a laboratory must meet certain criteria, including:
Once a laboratory has met the criteria for a CLIA waiver, it can apply for the waiver by submitting an application to the Centers for Medicare & Medicaid Services (CMS). The application must include information about the laboratory’s staff, equipment, and procedures. CMS will review the application and make a determination whether to grant the waiver. Laboratories that are granted a CLIA waiver are subject to certain conditions, including: