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BACKGROUND SCREENING ALERT
Effective 7/1/2008 Background Screening Request
Fees through the Agency will INCREASE.
Level 2 Requests will be $43.25.
Click here for more information

 

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 website and provides a PDF file of waived laboratory tests as well.

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.

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.
  • Changes, including changes of ownership, must be reported timely to the Florida Laboratory Unit [see Chapters 408, Part II, and 483, Part I Florida Statutes, 42 CFR 493 and section 59A-7.021, Florida Administrative Code]

Director’s Qualifications
Documentation required to support the director's qualification must include copies of the director's curriculum vitae.

Director qualifications must be submitted for all physician and non - physician laboratory directors.

The State of Florida requirements for laboratory directors can be found at the Florida Administrative Code website:http://www.flrules.org/gateway/ChapterHome.asp?Chapter=59A-7
CLIA requirements for directors of moderate complexity testing are at the following link: http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1405,

CLIA requirements for directors of high complexity testing the requirements are at the following link: http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1443.

Helpful Links:

Laboratory Applications: Application Downloads
Frequently Omitted Items: From non-waived applications
How to apply: Steps in the Application Process
Who to Contact:  Area maps and unit contacts

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 program. 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: