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

Out-of-State Clinical Non-Waived and Provider-Performed Microscopy Laboratory Applications:

Out-of-state applicants that transact business in Florida must submit evidence of authority to conduct business in this state. When applying for a license in Florida, please submit a copy of the business’ Certificate of Status or Certificate of Authority issued by the Florida Department of State. If the applicant is unable or not required to obtain a Certificate of Status or Certificate of Authority from the Florida Department of State, please include this information with the application for consideration by the Agency. Each specific type of business entity should refer to the statutes listed below for guidance.

The following Florida Statutes apply to out-of-state businesses seeking a state license and are available on line at: http://www.leg.state.fl.us:

CORPORATIONS

607.0128 Certificate of Status
607.1501 Authority of foreign corporation to transact business required
607.1502 Consequences of transacting business without authority
607.1503 Application for certificate of authority
607.1504 Amended certificate of authority
607.1505 Effect of certificate of authority
607.1507 Registered office and registered agent of foreign corporation
607.1508 Change of registered office and registered agent of foreign corporation
607.15101 Service of process, notice, or demand on a foreign corporation

LIMITED LIABILITY COMPANIES

608.501 Foreign limited liability company; authority to transact business required
608.502 Consequences of transacting business without authority
608.503 Application for certificate of authority
608.504 Amended certificate of authority
608.505 Effect of certificate of authority

PARTNERSHIPS

620.1901 Governing law regarding foreign limited partnerships
620.1902 Application for certificate of authority
620.1903 Activities not constituting transacting business
620.1904 Filing of certificate of authority
620.1910 Amending certificate of authority

CORPORATIONS NOT FOR PROFIT

617.1501 Authority of foreign corporation to conduct affairs required
617.1502 Consequences of conducting affairs without authority
617.1503 Application for certificate of authority
617.1504 Amended certificate of authority
617.1505 Effect of certificate of authority

Operation of a laboratory in Florida requires the provider to hold both a federal Clinical Laboratory Improvement Amendment (CLIA) certificate and State of Florida License for Non-Waived laboratories including those provider-performed microscopy laboratories. Effective July 1, 2009, there is no requirement for a waived laboratory to hold a State of Florida license.

Types of CLIA certificates:

  • Certificate of Waiver
  • Certificate of Provider-Performed Microscopy Procedures
  • Certificate of Compliance -- These laboratories are surveyed by State of Florida CLIA surveyors
  • Certificate of Accreditation-- These laboratories are accredited and surveyed by approved accreditation organizations
    Approved accreditation organizations for clinical laboratories include: AABB (association of blood banks), American Society of Histocompatibility (ASHI), College of American Pathologists (CAP), COLA (was the Commission on Office Laboratory Accreditation), The Joint Commission (TJC)

To check the complexity of a test, CMS advises that it can be checked on the Food and Drug Administration's web site.

Any laboratory that uses a microscope in testing or that is performing a test that is not classified as "waived", must seek a "non-waived" laboratory license and CLIA certificate under the specialty or subspecialty of the tests it is performing . State and federal regulations provide guidance for who may and may not perform these tests as well as what laboratories are required to do to perform these tests.

FEES for Out-of-State Laboratories

ACCREDITED: Please notify your accrediting organization that you are a Florida laboratory. Florida licensure fees for accredited laboratories or those licensed by the states of New York and Washington are $100. Please provide proof of licensure/survey by the states of New York or Washington if you only send in the $100.

NON-ACCREDITED: Fees for non-accredited laboratories are calculated according to section 59A-7.036(2)(e)14., Florida Administrative Code. "Out of state laboratories shall be allowed to count only those tests performed on specimens received from clinical laboratories licensed in Florida. Counting of such tests shall be in compliance with subparagraphs 59A-7.036(2)(f)1. though 13., Florida Administrative Code." The Florida laboratory fee schedule, with a section on how to count tests is available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/fees.shtml.

Florida Requirements for Out-of-State Laboratories Performing Non-Waived Tests:

  • Florida licenses, like CLIA Certificates are renewed every 2 years.
  • Non-Waived and PPM laboratories are inspected at least every 2 years for compliance with state and federal regulations
  • All laboratory directors and Chief Financial Officers must clear a Level II background screening every five years.
FINGERPRINT CARDS are the only option for out-of-state applicants
  • Obtain Fingerprint Card
    You MUST use standard BLUE-LINED FBI applicant fingerprint cards and complete all blocks of the card in black ink, making sure that Name and Address are entered correctly and clearly.
  • Fingerprinting  
     Take the fingerprint card to a local law enforcement agency (or other) to be fingerprinted.  Local fingerprint fees may also apply.
    You must must provide a State or Federal government-issued identification to be fingerprinted.
  • Fees
    The Cogent processing fee for a fingerprint card background check is $55.50 (local fingerprinting fees may also apply). 
    Payment may be made with debit or credit card online during Registration; or
    Payment may be made by Money Order or Cashier’s Check made payable to Cogent Systems
    Do NOT send cash, a personal check, or any other form of payment.
  • Registration & Submission of Fingerprint Card
    Register online at www.cogentid.com, click Florida, click Register Online
    At the completion of Registration you will be given a REGISTRATION ID.  WRITE THIS NUMBER ON THE BACK OF THE FINGERPRINT CARD AND SUBMIT DIRECTLY TO COGENT SYSTEMS (address below).
  • Mail the completed fingerprint card (and money order if applicable) to:
    Cogent Systems
    Attn: Fingerprint Card Scan Florida
    5025 Bradenton Ave, Ste A
    Dublin, OH 43017

Helpful Links:

Laboratory Applications: Application Downloads
Frequently Omitted Items: Non-waived applications
Program Overview Brochure: Includes crosswalk of how Florida regulations exceed CLIA regulations and how to complete the test menu on the Florida application [637 KB]
How to apply: Steps in the Application Process
Who to Contact:  Area maps and unit contacts

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 and 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..
  • Review a recently adopted regulation under Section 59A-7.035, Florida Administrative Code. This rule became effective July 14, 2010.
  • NOTE: Changes of Ownership are not requests to amend or replace a license under 59A-35.040 and 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:


Reporting Medicaid Fraud