NOTICE: This page has moved to http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Lab_HomeServ/waived_apps.shtml. This page is no longer maintained and will be removed May 20, 2018. Please bookmark the new page for future use.
URGENT: Medical Device Recall
Alere INRatio PT/INR Professional Test Strips (PN 99008G2)
Please view the Recall Notice [830KB, PDF] for important information
Manager, Laboratory Licensure Unit
Bureau of Health Facility Regulation
2727 Mahan Drive - Mail Stop #32
Tallahassee, FL 32308
Florida Relay Service (TDD): (800) 955-8771
Fax: (850) 410-1511
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.
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:
Federal publication to help Certificate of Waiver providers to perform tests: Ready Set Test Booklet [1.48MB, PDF]
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.