October 21, 2018

October 19, 2018

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Florida Will No Longer Require State Laboratory Licensure

The Florida State Legislature has decided to eliminate its state licensure requirement for clinical laboratories.  Effective July 1, 2018, Florida’s recent legislation (SB 622) repeals the entirety of Chapter 483, Part I of the Florida statutes, and in doing so 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 therefore, in tow, eliminates section 59A-7.024(1) and as well as all other corresponding regulations.

Currently, all clinical laboratories providing services within the state of Florida must maintain a state license unless you were 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.  Furthermore, an out-of-state laboratory testing specimens derived from the state of 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 the state of Florida (Fla. Adm. Code 59A-7.024); or (2) receives a specimen for examination from a clinical laboratory located within the state of Florida (Fla. Stat. § 483.091).

Beginning July 1, 2018, clinical laboratories and stakeholders will be able to provide their laboratory services in Florida or to Florida healthcare providers 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 approximately two weeks and will post notice on its website.

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About this Author

Member of the Firm

CHARLES C. DUNHAM, IV, is a Member of the Firm in the Health Care and Life Sciences practice, in the Houston and New York offices of Epstein Becker Green. He provides general counsel and representation to health care providers and health-related entities in a range of matters involving corporate formation and governance, business transactions and acquisitions, and health regulatory compliance. His national health law practice focuses on clinical and anatomic laboratories, hospitals and health systems, physician group practices and networks, long-term...

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Daniel Kim, Epsten Becker Law Firm, Washington DC, Healthcare law
Associate

DANIEL KIM is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. He will be focusing his practice on FDA marketing approval of medical devices and pharmaceutical, reimbursement and compliance matters affecting health care medical device manufacturers, telehealth and telemedicine, HIPAA privacy and security, regulatory health care due diligence, and compliance issues.

Mr. Kim received his J.D., cum laude, from American University Washington College of Law. He obtained an M.A. in Anatomy and Neurobiology from Boston University School of Medicine, where he served as a surgical technician. He also received a B.A. in Biology, with a concentration in Neuroscience, from Boston University.

While attending law school, Mr. Kim clerked at the U.S. Attorney’s Office for the District of Columbia and at the Medicare Operations Division of the U.S. Department of Health and Human Services’ Departmental Appeals Board. Later, he interned at the Commissioner’s Office of the U.S. Food and Drug Administration and at the Office of General Counsel for Doctor on Demand, Inc., where he assisted in researching state telehealth laws and regulations, and developing and implementing HIPAA privacy and security and company compliance policies.

Before going to law school, Mr. Kim worked for six years as a research assistant at Boston Children’s Hospital, studying potential therapeutic treatments for spinal cord injuries.

 

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