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Applications and appropriate fees should be mailed to:
Laboratory Unit Phone: (850) 487-3109 |
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| publicrecordsreq@ahca.myflorida.com | |
Clinical Laboratories
[This website provides licensing information related to clinical laboratories, not clinical laboratory professionals. If you are seeking
information about professional licenses, please visit the Department of Health's website at: http://www.doh.state.fl.us/mqa/ClinLab/.]
All facilities, including physician offices, performing any clinical laboratory testing, are required to obtain a federal Clinical Laboratory Improvement Amendment (CLIA) certificate. Facilties 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. The AHCA Laboratory Unit handles applications and changes for both the state laboratory licensure and federal CLIA certification programs. Initial and biennial inspections are required for facilities performing non-waived 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 website: http://www.cms.hhs.gov/CLIA/10_Categorization_of_Tests.asp, which provides CLIA categorizations.
All applications for State of Florida licensure must be submitted with appropriate fees. If the State of Florida application is submitted without a check or money order, it will not be accepted and will be returned. If a check is sent without an application, it will be returned. State Agencies such as the Department of Health, Department of Corrections, Department of Juvenile Justice, submitting applications are asked to follow journal transfer procedures.
Checks should be made payable to AHCA and mailed along with a complete application to:
Laboratory Unit
Agency for Health Care Administration
Bureau of Health Facility Regulation
2727 Mahan Drive, Mail Stop #32
Tallahassee, FL 32308Do not send checks and applications separately; they will be returned if they are not submitted together. "Starter Checks" will not be accepted.
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.
Applications for renewal or change of ownership must be submitted at least 60 prior to the expiration date of the current license, if for renewal, or 60 days prior to the effective date of the change of ownership, if a change of ownership request. Administrative fines will be imposed for late filing.
Requests for duplicate federal CLIA certificates and state licenses: Federal CLIA certificates:
State Licensure
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Links to other websites for Clinical Laboratories:
- CMS CLIA website
- CMS Lab Look-up
- CLIA contractor and payment lockbox address for fee payments
- Federal CLIA information, includes application (FORM CMS-116)
- Waived test information
- FDA website to check the complexity of a test
- List of Provider-performed Microscopy and Waived Tests with CPT codes
- Florida Statutes (See Statutes and Constitution, Chapter 483, Part I for Clinical Laboratory Statute)
- Florida Administrative Code (See Chapter 59A-7 for Clinical Laboratory Rules)
- Florida Division of Corporations
- Florida Department of Health, Board of Clinical Laboratory Personnel
- Clinical Laboratory Personnel lookup
- Health Care Licensing Procedures Act
