Applications and appropriate fees should be mailed to:
Phone: (850) 412-4500
Attention: The Agency held a public meeting June 28, 2012 on amendments to s. 483.245 Florida Statutes for clinical laboratories. Meeting minutes [PDF, 276 KB] and answers to frequently asked questions about this new law are now available.
[This web site 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 web site 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. 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. 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 web site: 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:
Do 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 days 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.
Help Aids for Completing the Clinical Laboratory Application
- Frequently Omitted Items
- Program Overview Brochure [637KB, PDF] Contains How to Complete the List of Tests Performed Section of the clinical lab application.
- Steps in the Application Process
Requests for duplicate federal CLIA certificates and amended or replacement state licenses:
Federal CLIA certificates:
Links to other web sites for Clinical Laboratories:
- CMS CLIA web site
- CMS Lab Look-up
- CLIA_CONTRACTOR_PAYMENT (20KB PDF)
- Federal CLIA information, includes application (FORM CMS-116)
- FDA web site 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
- Florida Society for Clinical Laboratory Services 2010 Symposium [7 MB, PDF]
- First Coast Point of Care Group October 15, 2010 meeting [2 MB, PDF]
- Tallahassee Memorial HealthCare Family Practice Resident Lecture, March 2011 [20 MB, PDF]
- Florida State Society of American Medical Technologists & Central Florida Point of Care Network, November 18, 2011 11th Annual continuing Education Conference [221 KB, PDF]
- The Florida Society of Dermatologic Surgeons, 30th Annual Meeting, December 2, 2011 [1 MB, PDF]