2016 Florida Statutes
483.041 Definitions.—As used in this part, the term:
(1) “Agency” means the Agency for Health Care Administration.
(2) “Clinical laboratory” means the physical location in which one or more of the following services are performed to provide information or materials for use in the diagnosis, prevention, or treatment of a disease or the identification or assessment of a medical or physical condition.
(a) Clinical laboratory services are the examinations of fluids or other materials taken from the human body.
(b) Anatomic laboratory services are the examinations of tissue taken from the human body.
(c) Cytology laboratory services are the examinations of cells from individual tissues or fluid taken from the human body.
(3) “Clinical laboratory examination” means a procedure performed to deliver the services defined in subsection (2), including the oversight or interpretation thereof.
(4) “Clinical laboratory proficiency testing program” means a program approved by the agency for evaluating the performance of clinical laboratories.
(5) “Collection station” or “branch office” means a facility operated by a clinical laboratory where materials or specimens are withdrawn or collected from patients or assembled after being withdrawn or collected from patients elsewhere, for subsequent delivery to another location for examination.
(6) “Hospital laboratory” means a laboratory located in a hospital licensed under chapter 395 that provides services solely to that hospital and that is owned by the hospital and governed by the hospital medical staff or governing board.
(7) “Licensed practitioner” means a physician licensed under chapter 458, chapter 459, chapter 460, or chapter 461; a certified optometrist licensed under chapter 463; a dentist licensed under chapter 466; a person licensed under chapter 462; a consultant pharmacist or doctor of pharmacy licensed under chapter 465; or an advanced registered nurse practitioner licensed under part I of chapter 464; or a duly licensed practitioner from another state licensed under similar statutes who orders examinations on materials or specimens for nonresidents of the State of Florida, but who reside in the same state as the requesting licensed practitioner.
(8) “Person” means the State of Florida or any individual, firm, partnership, association, corporation, county, municipality, political subdivision, or other entity, whether organized for profit or not.
(9) “Validation inspection” means an inspection of a clinical laboratory by the agency to assess whether a review by an accrediting organization has adequately evaluated the clinical laboratory according to state standards.
(10) “Waived test” means a test that the federal Centers for Medicare and Medicaid Services has determined qualifies for a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988, and the federal rules adopted thereunder.
History.—s. 4, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 389, ch. 77-147; s. 1, ch. 77-457; s. 21, ch. 79-12; s. 135, ch. 79-164; ss. 2, 3, ch. 81-318; ss. 2, 29, 30, ch. 83-276; s. 77, ch. 85-81; s. 37, ch. 92-58; s. 19, ch. 93-40; ss. 4, 25, ch. 93-178; s. 144, ch. 99-397; s. 135, ch. 2000-318; s. 69, ch. 2009-223; s. 10, ch. 2013-26; s. 1, ch. 2015-119.