On March 20, 2018, Governor Rick Scott signed Senate Bill 622 into law, which made significant changes relevant to clinical laboratories governed by the Agency for Health Care Administration (“AHCA”).  This law became effective July 1, 2018.

Previously, facilities performing any “non-waived” clinical laboratory testing (i.e., testing using a microscope) had to obtain a state clinical laboratory license from AHCA before the laboratory was authorized to perform such testing.  The new law eliminates the state licensure requirement.  Now, clinical laboratories must only be appropriately certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments (“CLIA”) program.

In addition, clinical laboratory personnel are required to meet certain qualifications and licensure requirements.  The new law provides exemptions to these qualification and licensure requirements including:

(1) individuals performing testing in laboratories that are wholly-owned and operated by one or more physicians (e.g., medical doctors, osteopathic physicians, chiropractors, podiatrists, naturopathic physicians, optometrists, or dentists) who practice in the same group practice, and all lab work is for their own patients; and

(2) individuals performing laboratory testing within a physician office practice for patients referred by a health care provider who is a member of the same physician office practice, if the laboratory or entity operating the laboratory within a physician office practice is under common ownership, directly or indirectly, with an entity licensed pursuant to chapter 395 (e.g. hospital).

For more information regarding this Client Alert and how it impacts your clinical laboratory, or if you need assistance with obtaining or renewing your CLIA certificate, contact:

Elizabeth D. Shaw, Esq. |Partner

Florida Bar Board Certified in Health Law

(904) 567-1175 (direct) | (904) 657-9002 (cell) | liz@rezlegal.com