§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.
(3)A source plasma donation center that performs only nondiagnostic tests for the
purpose of screening source plasma donors.
B. This Part shall not apply to:
Free access — add to your briefcase to read the full text and ask questions with AI
§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.
(3) A source plasma donation center that performs only nondiagnostic tests for the
purpose of screening source plasma donors.
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 or employed by one of the following:
(1) A clinic operated by a licensed health care provider.
(2) A hospital, a nursing home, or other licensed health care facility.
(3) A testing location or laboratory licensed or certified under the Clinical Laboratory
Improvement Amendments of 1988, if the facility provides at least five calendar days of
phlebotomist training and two calendar weeks of on-the-job training.
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.