|Applications and appropriate fees should be mailed to:
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.
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)
Provider-Performed Microscopy (PPM) Testing Laboratories are laboratories where the examination:
Examples of PPM Tests:
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)
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.
Requests for duplicate federal CLIA certificates and state licenses:
Federal CLIA certificates:
Links to other web sites for Clinical Laboratories:
- CMS CLIA web site
- CLIA contractor and payment (20KB PDF)
- Federal CLIA information, includes application (FORM CMS-116)
- FDA web site to check the complexity of a test
- 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