Current through Register Vol. XLI, No. 45, November 8, 2024
Section 64-57-2 - Definitions2.1. Certifying agency - means one of the following institutions: 2.1.a. American Society for Clinical Pathology (ASCP);2.1.b. American Medical Technologists (AMT);2.1.c. American Association of Bioanalysts (AAB);2.1.d. American Board of Bioanalysts (ABB);2.1.e. American Board of Clinical Chemistry (ABCC);2.1.f. American Board of Forensic Toxicology (ABFT);2.1.g. American Board of Medical Genetics and Genomics (ABMGG);2.1.h. American Board of Medical Laboratory Immunology (ABMLI);2.1.i. American Board of Medical Microbiology (ABMM);2.1.j. American College of Histocompatibility and Immunogenetics; and2.1.k. National Registry of Certified Chemists (NRCC).2.2. CLIA. -- Clinical Laboratory Improvement Amendments of 1988, Section 353 of the Public Health Service Act, 42 CFR Part 493, last amended September 2, 2020.2.3. Clinical Laboratory. -- Any facility or place, however named, for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease, or the impairment of, or the assessment of the health of human beings.2.4. Clinical Laboratory Consultant. -- A person who meets the qualifications for: 2.4.a. Moderate complexity testing technical consultant found at 42 CFR 493.1411;2.4.b. Moderate complexity testing clinical consultant found at 42 CFR 493.1417; or2.4.c. High complexity testing clinical consultant found at 42 CFR 493.1455.2.5. Clinical Laboratory Director. -- A person who:2.5.a. Provides overall management and direction of a clinical laboratory; and2.5.b. Meets the qualifications for: 2.5.b.1. Moderate complexity testing laboratory director found at 42 CFR 493.1405; or2.5.b.2. High complexity testing laboratory director found at 42 CFR 493.1443.2.6. Clinical Laboratory Practitioner. -- Includes medical laboratory technicians, point of care technicians, cytotechnologists, histologists, medical laboratory scientists, pathologist assistants, and trainees.2.7. Clinical Laboratory Practitioner Trainee. -- A person who is in a training program designed for his or her qualification as a clinical laboratory practitioner or who has successfully completed such a training program and has applied for, but not yet received a clinical laboratory practitioner license.2.8. Clinical Laboratory Supervisor. -- A person who meets the qualifications for: 2.8.a. A high complexity testing technical supervisor found at 42 CFR 493.1449;2.8.b. A high complexity testing general supervisor found at 42 CFR 493.1461; or2.8.c. A high complexity testing cytology general supervisor found at 42 CFR 493.1469.2.9. Cytotechnologist. -- A type of laboratory technologist whose job tasks include specimen processing, test performance, and reporting of cytological examinations supervised by a pathologist or other physician recognized as a specialist in diagnostic cytology.2.10. Department. -- The West Virginia Department of Health and Human Resources.2.11. Grossing. -- The pathological inspection, description, measurement, sectioning, and evaluation of tissue specimens for the purpose of diagnosis or treatment of disease or the assessment of health.2.12. Histologist (CLP-HT) -- A laboratory technologist or technician with the education, skills, and training to perform high complexity pathology specimen grossing, inking, and mapping, and associated special staining procedures or tissue analysis under the direct supervision of a pathologist or pathologist assistant.2.13. Medical Laboratory Technician (CLP-MLT). -- A person whose job tasks include specimen processing, laboratory test performance, or laboratory test reporting in a clinical laboratory which tasks require limited exercise of independent judgment and are performed under the supervision of a clinical laboratory director or a clinical laboratory supervisor.2.14. Medical Laboratory Scientist (CLP-MLS). -- A person who performs a broad range of laboratory tests in a clinical laboratory. Job tasks may include specimen processing, laboratory test performance, or laboratory test reporting and other tasks requiring the broad exercise of judgment and responsibility with little or no direct technical supervision.2.15. Laboratory Test. -- The biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of human beings.2.16. National Accrediting Agency for Clinical Laboratory Science (NAACLS) -- The accrediting organization for laboratory science-related educational programs, recognized by the Council for Higher Education Accreditation.2.17. Pathologist Assistant (CLP-PA) -- A type of advanced practice laboratory technologist who processes a variety of pathology specimens, including comprehensive macroscopic examination and evaluation (grossing) of surgical pathological specimens, under the supervision of a pathologist.2.18. Point of Care Technician (CLP-POCT). -- A type of laboratory technician whose job tasks include specimen processing, laboratory test performance, and laboratory test reporting directly to a physician to review and evaluate the results obtained. These technicians shall perform only tests that have been categorized as moderately complex under CLIA under the personal supervision of a clinical laboratory director or a technical consultant. This supervision shall be available at all times when testing is being performed.