La. Admin. Code tit. 46 § XLV-3503
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.
La. Admin. Code tit. 46, § XLV-3503