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

Florida Clinical Non-Waived Laboratory and Provider-Performed Microscopy Applications:

Operation of a non-waived laboratory in Florida requires the provider to hold both a federal Clinical Laboratory Improvement Amendment (CLIA) certificate and State of Florida License. Effective July 1, 2009, laboratories that perform only waived testing and do not use a microscope are no longer required to hold a State of Florida license. Waived laboratories must still hold a CLIA Certificate of Waiver.

Types of State of Florida licenses:

  • Clinical Laboratory License for Non-Waived laboratories including those provider-performed microscopy laboratories

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

Provider-Performed Microscopy (PPM) Laboratories

Provider-Performed Microscopy (PPM) Testing Laboratories are laboratories where the examination:

  • the laboratory director is an MD or licensed by the Department of Health as a laboratory director
  • must be performed by a physician or a mid-level practitioner (i.e. nurse practitioners, nurse midwives and physician assistances)
  • where the primary instrument for the test is a microscope
  • the specimen must be labile or a delay in testing could compromise the accuracy of the test
  • control materials are not available to monitor the entire testing process
  • limited specimen handling is required

Examples of PPM Tests:

  • Wet mounts, including preparations of vaginal, cervical or skin specimens
  • Potassium hydroxide (KOH) preparations
  • Pinworm examinations
  • Semen analysis; presence and/or motility of sperm excluding Huhner
  • Nasal smears for eosinophils

 

Non-Waived Laboratories

Non-Waived Testing Laboratories, whether seeking a CLIA Certificate of Compliance or Certificate of Accreditation, are laboratories where the tests, assays, or examinations is categorized by the FDA based on complexity.

The FDA uses seven criteria for categorizing tests of moderate or high complexity which include knowledge, training & experience required, preparation of test material, operational steps, instrument maintenance, interpretation and judgment.

 


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.

Requirements for Laboratories Performing Non-Waived Tests:

  • Both Florida licenses and 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 web site: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:

Non-Waived Laboratory Applications: Frequently Omitted Items and Application Downloads
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

  • Changes during state licensing period and requests for and amended state license will be assessed a $25 fee in accordance with section 59A-35.050 (4), 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.

Links to other web sites for Clinical Laboratories:




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