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Clinical Laboratory Licensure: Florida Repeals State Licensure

by admin on June 5, 2018 No comments

clinical laboratory lawBy: Karina Gonzalez

Effective July 1, 2018, Florida’s recent legislation SB 622 repeals the entirety of Chapter 483, Part I of the Florida statutes, and removes the state licensure requirement for clinical laboratories operating in-state and out-of-state. Section 97 of SB 622, approved by the Governor on March 19, 2018, repeals the entirety of Chapter 483, Part I of the Florida statutes, and so eliminates section 59A-7.024(1).

Currently, all clinical laboratories providing services within Florida must be licensed by the state unless the Laboratory was either: (1) a clinical laboratory operated by the U.S. government; (2) a clinical laboratory that only performed waived tests; or (3) a clinical laboratory that was operated and maintained exclusively for research and teaching purposes that did not provide services to patients.  An out-of-state laboratory testing specimens derived from Florida is also required to obtain Florida state licensure if: (1) the out-of-state laboratory maintains an office, specimen collection station or other facility within  Florida (Fla. Adm. Code 59A-7.024); or (2) receives a specimen for examination from a clinical laboratory located within Florida (Fla. Stat. § 483.091).

Beginning July 1, 2018, clinical laboratories will be able to provide their laboratory services in Florida as long as they meet federal CLIA certification requirements.  Florida’s Agency for Health Care Administration (AHCA) expects to roll-out notifications regarding the change in state licensure requirements to currently licensed clinical laboratories in June 2018 and will post notices on its website.

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