| Applications and appropriate fees should be mailed to:
Laboratory Unit |
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.
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- 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]
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:
State Licensure
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Links to other web sites for Clinical Laboratories:
- CMS CLIA web site
- CLIA contractor and payment lockbox address for fee payments
- Federal CLIA information, includes application (FORM CMS-116)
- FDA web site to check the complexity of a test
- List of Provider-performed Microscopy
- 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
- General Licensing Rule 59A-35, Florida Administrative Code
