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Clinical 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

*If you are seeking information about professional licenses, please visit the Department of Health's web site at:

All facilities, including physician offices, performing any clinical laboratory testing, are required to obtain a federal Clinical Laboratory Improvement Amendment (CLIA) certificate. Facilities performing any non-waived clinical laboratory testing or testing using a microscope must also obtain a state clinical laboratory license before the laboratory is authorized to perform testing. Tests performed using a microscope are not waived. To determine whether a test is waived, see the List of Waived Tests at the federal web site:, which provides CLIA categorizations.

All applications for State of Florida licensure must be submitted with appropriate fees. State Agencies submitting applications are asked to follow journal transfer procedures.

Although CLIA, CMS116 forms are a part of laboratory applications and are submitted to the state, the CLIA program separately bills the laboratory for payment. CLIA fees should never be sent to the State of Florida.


A notice of workshop was published on 11/18/2016 in Vol. 42/225 of the Florida Administrative Register.

The Agency proposes to amend the rule to provide clarification to the definition of an Exclusive Use Laboratory.

The notice may be accessed at the following link:

Click here for a copy of the agenda.


Non-waived Laboratory Application

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