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Waived Lab Link

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) 487-3109
Fax: (850) 410-1511

PUBLIC RECORD REQUESTS should be sent to:
Public Records Coordinator,
2727 Mahan Drive, Ft. Knox #3,
Mail Stop #2, Tallahassee, FL 32308
850/414-6044 Message Line
850/921-9041 Fax
850/488-1105, or via e-mail at: publicrecordsreq@ahca.myflorida.com

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 microscopy 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" under the section entitled "Links to other Websites..." below.

 


Steps in the Clinical Laboratory Application Process



Step 1 - Be familiar with the regulations

Step 2 - Ensure that you have the correct application

Step 3 - Know the type of application for the tests you are performing

Step 4 - Ensure that you are correctly completing the application forms

Step 5 - Avoid late fines

Step 6 - Ensure payment is properly sent

Step 7 - Contact us with specific questions after reviewing the information on this website if you are unsure of something

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.

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 prior to the effective date of the change of ownership, if a change of ownership request. Administrative fines will be imposed for late filing.

Look-Up Webpages - Links to the Federal website that allows providers to check the status of their CLIA certificate and to the state website that allows the public and existing providers to check the status of a license. Providers who submitted initial applicaitons that have not yet been approved will not be able to view information on the pending application on this website, but all licensed providers will be able to view the status of the license.

 

Requests for duplicate federal CLIA certificates and 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 progam. Please call 850.487.3109 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 850.487.3109 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. Florida requires such notification to be sent via certified mail. [see section 59A-7, Florida Administrative Code]

State Licensure

Links to other websites for Clinical Laboratories: