Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XLV - Medical Professions › Subpart 2 - Licensure and Certification › Chapter 35 - Clinical Laboratory Personnel › Subchapter A - Scope and Definitions › Section XLV-3503 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
A. As used in this
					 Chapter, the following terms are given the following meanings.
Approved Nationally Recognized Certification
						Examination
- an examination prepared and administered by a certifying
						organization approved by the board as satisfying the minimum examination
						qualifications for licensure or certification for each of the classifications
						of clinical laboratory personnel for which successful completion of a
						certifying examination is required as provided by the law and these
						rules.
Approved Professional Organizations
- an
						organization approved by the board to offer continuing education and/or
						training programs, and includes the following organizations:
a. American Society for Clinical Laboratory
						Science;
b. American Medical Technologists;
c. International Society for Clinical Laboratory
						Technology;
d. American Society of Clinical Pathologists;
e. American Society of Cytology;
f. American Society for Microbiology;
g. American Association of Blood Banks;
h. American Association of Clinical Chemistry;
i. Clinical Laboratory Management Association;
j. Association of Territorial and Public Health
						Laboratory Directors;
k. Centers for Disease Control;
l. National Accrediting Agency for Clinical Laboratory
						Sciences;
m. Gamma Biologicals Referred Immunohematology Self
						Evaluation System and Tutorial Program for Continuing Education of Blood
						Bankers;
n. affiliates of an organization identified by the board,
						upon recommendation of the committee, as an approved professional
						organization;
o. accredited colleges and universities;
p. American Society for Cytotechnology;
q. American Academy of Forensic Sciences;
r. Society of Forensic Testing; and
s. other organizations as may be approved by the board
						upon recommendation of the committee.
Approved School
or
Training
						Program
- a school or training program accredited by the Council on
						Medical Education of the American Medical Association, the National Accrediting
						Agency for Clinical Laboratory Sciences, or the Council on Allied Health
						Education Programs and approved by the committee and the board.
Board
- the Louisiana State Board of
						Medical Examiners.
CLIA
- the Clinical Laboratory
						Improvement Amendments of 1988, Public Law Number 100-578, and the rules and
						regulations promulgated pursuant thereto.
Clinical Cytotechnology
- the microscopic
						study or examination of body fluids, tissues, or cells desquamated from a body
						surface or lesion for the practice of clinical laboratory science including,
						but not limited to, detecting malignancy and microbiologic changes and the
						measurement of hormonal levels.
Clinical Laboratory
- any building,
						place, or facility in which an operation and procedure for the biological,
						microbiological, serological, immunological, chemical, immunohematological,
						hematological, biophysical, cytological, pathological, or other examinations of
						materials derived from the human body is performed to provide information for
						the diagnosis, prevention, or treatment of any disease or impairment of, or the
						assessment of, the health of human beings, or for forensic testing.
Clinical Laboratory Personnel
- any and
						all individuals engaged in the practice of clinical laboratory science.
Clinical Laboratory Scientist-Generalist
or
CLS-G
- an individual who performs clinical laboratory tests
						and procedures in all specialty areas of a clinical laboratory which require
						the exercise of independent judgment and responsibility, including but not
						limited to, the performance of all laboratory tests as stated in CLIA. The
						clinical laboratory scientist-generalist may perform the functions of all
						categories of all clinical laboratory personnel licensed or certified in
						accordance with the law, except those of the cytotechnologist, without
						additional licensure or certification.
Clinical Laboratory Scientist-Specialist
or
CLS-S
- an individual performing clinical laboratory science
						in one or more laboratory specialties and who performs functions directly
						related to such particular laboratory specialty or specialties. A clinical
						laboratory scientist-specialist may perform the functions of the laboratory
						assistant and the phlebotomist without additional licensure or
						certification.
Clinical Laboratory Scientist-Technician
or
CLS-T
- an individual who performs medical laboratory tests
						and procedures of high and moderate complexity as defined in 42 Code of Federal
						Regulations, Part 493, within any area of clinical laboratory science, which do
						not require the exercise of independent judgment or responsibility. The
						clinical laboratory scientist-technician shall perform tests and procedures of
						high complexity under supervision as defined in CLIA. The clinical laboratory
						scientist-technician may perform the functions of the laboratory assistant and
						the phlebotomist without additional licensure or certification.
Committee
- the Clinical Laboratory
						Personnel Committee to the Louisiana State Board of Medical Examiners, as
						established and constituted under
						R.S.
						37:1314.
Cytotechnologist
- an individual engaged
						in the practice of clinical cytotechnology which requires the exercise of
						independent judgment and responsibility.
Health Care Provider
- any person
						licensed, certified, or registered by a department, board, commission, or other
						agency of the state of Louisiana to provide preventive, diagnostic, or
						therapeutic health care services.
Independent Judgment
- the performance or
						conduct of clinical laboratory tests and assumption of responsibility for
						determination of the validity and interpretation of clinical laboratory test
						results without intervention by or the supervision of another health care
						provider authorized by law to assume responsibility for the conduct and
						validity of clinical laboratory tests. As respects clinical laboratory
						personnel, the authorized exercise of independent judgment shall not be deemed
						to include or permit the exercise of independent medical judgment in the
						diagnosis of or treatment of, or reporting of clinical laboratory test results
						or their interpretation to, patients except as authorized in accordance with
						CLIA.
Laboratory Assistant
or
LA
- an individual who performs medical laboratory tests and
						procedures under supervision by a licensed health care provider or laboratory
						director as defined in 42 Code of Federal Regulations, Part 493. Laboratory
						tests and procedures performed by the laboratory assistant do not require the
						exercise of independent judgment or responsibility within any area of clinical
						laboratory science. The laboratory assistant may perform high complexity tests
						under supervision as stated in CLIA.
Laboratory Specialty
- any category or
						subcategory recognized as a specialty by a certifying agency for the category
						of clinical laboratory scientist-specialist, including, but not limited to, the
						categories of hematology, microbiology, chemistry and blood bank, and the
						subcategories thereunder.
Louisiana Clinical Laboratory Personnel
						Law
or
the Law
- R.S. 37:1311-1329, as the same may be
						amended hereafter.
Phlebotomist
- an individual performing
						invasive procedures to withdraw blood samples from the human body for the
						practice of clinical laboratory science, including but not limited to, clinical
						laboratory testing for analysis and typing and cross-matching of blood for
						medical examination and human transfusion. A phlebotomist may perform and
						report results of any waived tests.
Practice of Clinical Laboratory Science
-
						the performance by any individual, other than a physician licensed by the
						board, of laboratory testing, analysis, or examination of human
						specimens.
Temporary License
or
Temporary
						Certificate
- a license or certificate issued to an individual that
						qualifies by education, experience, or training that will allow that individual
						to engage in the practice of clinical laboratory science at the appropriate
						level (CLS-G, CLS-S, CLS-T, laboratory assistant, cytotechnologist, or
						phlebotomist).
Trainee
- an individual who has not
						fulfilled the educational requirements to take an approved nationally
						recognized certification examination or who needs to obtain full-time
						comprehensive experience under supervision.
Waived Test
- those routine technical
						procedures performed under or eligible for a certificate of waiver under CLIA.
						An illustrative list of such routine technical procedures includes:
a. dipstick or tablet reagent urinalysis (nonautomated)
						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, nonautomated;
f. hemoglobin-copper sulfate, nonautomated;
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 instrument with
						self-contained or component features to perform specimen/reagent interaction
						providing direct measurement or readout.
AUTHORITY NOTE:
						Promulgated in accordance with
						R.S.
						37:1270(A)(5) and
						37:1311-1329.