Applications and appropriate fees should be mailed to:

Laboratory Unit
Agency for Health Care Administration
Bureau of Health Facility Regulation
2727 Mahan Drive, Mail Stop #32
Tallahassee, FL 32308

Phone: (850) 412-4500
Fax: (850) 410-1511

PUBLIC RECORD REQUESTS should be sent to:
Public Records Coordinator,
2727 Mahan Drive, Ft. Knox #3,
Mail Stop #3, Tallahassee, FL 32308
850/412-3688 Message Line
850/921-9041 Fax
or via e-mail at: publicrecordsreq@ahca.myflorida.com

publicrecordsreq@ahca.myflorida.com
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2012 Changes to Licensure Law

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.

Clinical Laboratories

[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:

Laboratory Unit
Agency for Health Care Administration
Bureau of Health Facility Regulation
2727 Mahan Drive, Mail Stop #32
Tallahassee, FL 32308

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

Requests for duplicate federal CLIA certificates and amended or replacement state licenses:

Federal CLIA certificates:

  • Upon request for a duplicate CLIA certificate, the Agency will provide the laboratory with a notice indicating the certificate is valid or active. A new certificate will not be issued by the CLIA program. Please call 850.412.4500 to request notice that your CLIA certificate is valid or active.
  • If the laboratory has never received a certificate. Please call the Laboratory Unit at 850.412.4500 and let staff know that you never received your certificate.
  • If the laboratory has changed address or other demographic information, please do not request a new certificate. The laboratory should have documentation indicating it notified the state to update the record as well as the notice from the state that the information was updated.

State Licensure

  • Changes during state licensing period and requests for an amended or replacement state license will be assessed a $25 fee in accordance with section 59A-35.040 and 59A-35.050, Florida Administrative Code. Written notification of changes and requests accompanied by a check made payable to AHCA for $25 should be mailed to: AHCA Laboratory Licensure Unit, 2727 Mahan Drive, MS 32, Tallahassee, FL 32308. Requests must be accompanied by a $25 check made payable to AHCA to be processed. Any request to replace a license must also be accompanied by a $25 check made payable to AHCA.
  • NOTE: Changes of Ownership are not requests to amend or replace a license under 59A-35.040 nad 59A-35.050, Florida Administrative Code and a $25 check and notification will not be accepted. Changes of Ownership must be reported 60 days prior to the effective date of the change with the submission of a Change of Ownership application. [see 59A-7.070, Florida Administrative Code]

Links to other web sites for Clinical Laboratories:

Presentations:

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