Ruby Grantham, Manager
Laboratory and In-Home Services Unit
Bureau of Health Facility Regulation
2727 Mahan Drive - Mail Stop #32
Tallahassee, FL 32308
Florida Relay Service (TDD): (800) 955-8771
Any Laboratory conducting waived tests only must have a valid CLIA Certificate of Waiver. To apply for a CLIA Certificate of Waiver complete a Centers for Medicare and Medicaid Services Form CMS-116 [1.10MB] and mail it to the Agency at the address to the right.
To check a specific test and see if the test is classified as "waived", please visit the U.S. Food and Drug Administration’s (FDA’s) web site at CLIA - Clinical Laboratory Improvement Amendments (fda.gov). A list of currently waived analytes can be found on the FDA’s website at CLIA - Clinical Laboratory Improvement Amendments - Currently Waived Analytes (fda.gov).
Examples of waived tests include:
The Centers for Medicare and Medicaid Services (CMS) administers the CLIA Laboratory certification program in conjunction with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). All facilities performing any clinical Laboratory testing are required to obtain a CLIA certificate. Waived testing laboratories:
NOTE: A Form CMS-116 can be submitted when written notification is required. If the CMS-116 is used in lieu of written notification, it must be completed in it entirety to be accepted. Written notification includes email, fax or hard copy letter.