§1313. Exemptions to licensure

A. This Part shall apply to clinical laboratory personnel performing the practice of clinical laboratory science in a clinical laboratory in this state except those practicing in either:

(1) A clinical laboratory operated by the United States government.

(2) A nonprofit laboratory operated and maintained exclusively for instruction and research involving no individual patient or public health care service, provided the results of any examination performed in such a clinical laboratory are not used directly in the diagnosis, evaluation, or treatment of human disease or disorder.

B. This Part shall not apply to:

(1) Any physician licensed by the board to practice medicine.

(2) Any individual working under the direction and supervision of such a physician in an operating room, theater, emergency room, or intensive care unit.

(3) Any pulmonary function technician acting within the scope of performance of the practice of respiratory therapy.

(4) Any clinical perfusionist acting within the scope of practice of perfusion in the support, treatment, measurement, or supplementation of the cardiopulmonary and circulatory system of an individual patient.

(5) Any individual licensed as a health care provider.

(6) Any other licensed allied health care professional.

C.(1) This Part shall not apply to any individual whose duties may include the performance of routine technical procedures under or eligible for a certificate of waiver in accordance with 42 Code of Federal Regulations Part 493 et seq., whether performed in a physician's office laboratory, a hospital's clinical laboratory or at the point of care, and which do not require the exercise of independent judgment or responsibility.

(2) An illustrative list of such routine technical procedures are:

(a) Dipstick or tablet reagent urinalysis (non-automated) for the following determination levels: bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, or urobilinogen.

(b) Fecal occult blood.

(c) Ovulation tests - visual color tests for human luteinizing hormone.

(d) Urine pregnancy tests - visual color comparison tests.

(e) Erythrocyte sedimentation rate, non-automated.

(f) Hemoglobin-copper sulfate, non-automated.

(g) Blood glucose as determined by monitoring device approved by the Federal Drug Administration specifically for home use.

(h) Spun microhematocrit.

(i) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction providing direct measurement and readout.

(j) Any procedures performed under a certificate of waiver in accordance with the Clinical Laboratory Improvement Amendments of 1988 and the rules and regulations promulgated pursuant thereto.

D. This Part shall not apply to any individual performing phlebotomy or acting as a phlebotomist employed by or acting under the direction and supervision of a physician licensed by the board, a clinic operated by a licensed health care provider, a hospital, a nursing home, or other licensed health care facility.

E. This Part shall not apply to any individual whose duties may include demonstrating or instructing, or both, the use of any automated or digital instrument, device, machine, or similar mechanical equipment and related procedures utilized to assist in the practice of clinical laboratory science, provided the results furnished by such equipment during such a demonstration or instruction are not used in the diagnosis, evaluation, or treatment of human disease or disorder.

F. This Part shall not apply to individuals performing forensic testing and examinations of body fluids, tissues, cells, or blood solely for the purpose of law enforcement and the state's criminal justice system.

G. Any individual who is exempt from the requirement of licensure under this Part, but who meets the qualifications for licensure under this Part, including any individual performing clinical procedures for analysis of non-human specimens, shall be considered actively engaged in the practice of clinical laboratory science and may apply for licensure as provided in this Part.

Acts 1993, No. 396, §2, eff. Aug. 1, 1993.