RS 37:1312

§1312. Definitions As used in this Part, the following terms have the following meanings, unless the context requires otherwise: (1) "Approved school" means an accredited school which offers instruction in any area of the practice of clinical laboratory science approved by the committee and the board. (2) "Board" means the Louisiana State Board of Medical Examiners. (3) "Clinical cytotechnology" means 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. (4) "Clinical laboratory" means 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. These examinations include, but are not limited to, procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the human body. A facility which only collects or prepares specimens, or both, or only serves as a mailing service and does not perform on site testing is not a clinical laboratory. A laboratory that performs workplace drug testing shall be covered under this definition unless such testing is specifically excluded from coverage under the Clinical Laboratory Improvement Amendments of 1988 and regulations promulgated thereunder. (5) "Clinical laboratory personnel" means any and all individuals engaged in the practice of clinical laboratory science. (6) "Clinical laboratory scientist-generalist" or "CLS-G" means 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 the Clinical Laboratory Improvement Amendments of 1988 and the rules and regulations promulgated pursuant thereto. The clinical laboratory scientist-generalist may perform the functions of all categories licensed in this Part with the exception of the cytotechnologist. (7) "Clinical laboratory scientist-specialist" or "CLS-S" means an individual performing clinical laboratory science in one or more laboratory specialties and who performs functions directly related to such particular specialty or specialties as provided for in this Part in rules and regulations adopted by the board as recommended by the committee. The clinical laboratory scientist-specialist may perform the functions of the laboratory assistant and the phlebotomist without additional licensure or certification. (8) "Clinical laboratory scientist-technician" or "CLS-T" means an individual who performs medical laboratory tests and procedures of high and moderate complexity as defined in 42 Code of Federal Regulations Part 493 et seq., which do not require the exercise of independent judgment or responsibility within any area of clinical laboratory science. The clinical laboratory scientist-technician shall perform tests and procedures of high complexity under supervision as defined in the Clinical Laboratory Improvement Amendments of 1988 and the rules and regulations promulgated pursuant thereto. The clinical laboratory scientist-technician may perform the functions of the laboratory assistant and the phlebotomist without additional licensure or certification. (9) "Committee" means the Clinical Laboratory Personnel Committee to the Louisiana State Board of Medical Examiners established by R.S. 37:1314. (10) "Cytotechnologist" means an individual responsible for examining cytopathological preparations which require the exercise of independent judgment and responsibility. (11) "Laboratory assistant" or "LA" means 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 et seq. These medical 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 the Clinical Laboratory Improvement Amendments of 1988 and the rules and regulations promulgated pursuant thereto. (12) "Nationally recognized certification examination" means an examination approved by the board upon the recommendation of the committee. (13) "Phlebotomist" means an individual performing an invasive procedure to withdraw blood from the human body to collect samples for the practice of clinical laboratory science, including but not limited to clinical laboratory testing for analysis, typing and cross-matching of blood for medical examination and human transfusion. (14) "Practice of clinical laboratory science" means the performance by any individual, other than a physician licensed by the board, of laboratory testing, analysis, or examination of human specimens. (15) "Source plasma" means the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use. The definition excludes single donor plasma products intended for intravenous use. Acts 1993, No. 396, §2, eff. Aug. 1, 1993; Acts 2025, No. 60, §1.