483.041  Definitions.--As used in this part, the term:

(1)  "Agency" means the Agency for Health Care Administration.

(2)  "Clinical laboratory" means a laboratory where examinations are performed on materials or specimens taken from the human body to provide information or materials for use in the diagnosis, prevention, or treatment of a disease or the assessment of a medical condition.

(3)  "Clinical laboratory proficiency testing program" means a program approved by the agency for evaluating the performance of clinical laboratories.

(4)  "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station" or "branch office" means a facility operated by a clinical laboratory where materials or specimens are withdrawn or collected from patients or assembled after being withdrawn or collected from patients elsewhere, for subsequent delivery to another location for examination.

(5)  "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.

(6)  "Licensed practitioner" means a physician licensed under chapter 458, chapter 459, chapter 460, or chapter 461; a dentist licensed under chapter 466; a person licensed under chapter 462; or an advanced registered nurse practitioner licensed under chapter 464.

(7)  "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.

(8)  "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.

(9)  "Waived test" means a test that the federal Health Care Financing Administration has determined qualifies for a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988, and the federal rules adopted thereunder.