Section 483.801 - ExemptionsThis part applies to all clinical laboratories and clinical laboratory personnel within this state, except:
(1) Clinical laboratories operated by the United States Government.(2) Laboratories operated and maintained exclusively for research and teaching purposes, involving no patient or public health service whatsoever.(3) Persons engaged in testing performed by laboratories that are wholly owned and operated by one or more practitioners licensed under chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, or chapter 466 who practice in the same group practice, and in which no clinical laboratory work is performed for patients referred by any health care provider who is not a member of that group practice.(4) Respiratory therapists and respiratory care practitioners certified or registered under part V of chapter 468.(5) Advanced practice registered nurses licensed under part I of chapter 464 who perform provider-performed microscopy procedures (PPMP) in a laboratory setting pursuant to subsection (3).(6) Persons 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.(7) Registered nurses licensed under chapter 464 who are determined by the clinical laboratory director of a hospital or hospital-based off-campus emergency department licensed under chapter 395 to be qualified under 42 C.F.R. s. 493.1423 to perform only moderate-level or waiver-level clinical laboratory testing in accordance with s. 395.0091 within the hospital or hospital-based off-campus emergency department with a separate federal Clinical Laboratory Improvement Amendments (CLIA) program clinical laboratory certification under 42 C.F.R. part 493.s.32, ch. 92-58; s.21, ch. 93-178; s.6, ch. 97-91; s.163, ch. 97-264; s.136, ch. 2000-318; s.99, ch. 2018-24; s.66, ch. 2018-106; s.1, ch. 2022-37.Amended by 2022 Fla. Laws, ch. 37, s 1, eff. 7/1/2022.Amended by 2018 Fla. Laws, ch. 106, s 66, eff. 10/1/2018.Amended by 2018 Fla. Laws, ch. 24, s 99, eff. 7/1/2018.