Waived Laboratories

URGENT: Medical Device Recall
Alere INRatio PT/INR Professional Test Strips (PN 99008G2)
Please view the Recall Notice [830KB, PDF] for important information

Dayle Mooney
Manager, Laboratory Licensure Unit

Bureau of Health Facility Regulation
2727 Mahan Drive - Mail Stop #32
Tallahassee, FL 32308
(850) 412-4500
Florida Relay Service (TDD): (800) 955-8771
Fax: (850) 410-1511

LABSTAFF@ahca.myflorida.com

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 to see if a test is "waived", CMS advises that it can be checked on the Food and Drug Administration's web site and provides a PDF file of waived laboratory tests as well.

Examples of waived tests include:

Federal Requirements for a Certificate of Waiver:

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]

Requirements for Laboratories Performing Only Waived Tests:

Applications/Forms

Resources

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