West Virginia Code of State Rules
Title 64 - Health
64-57 - Clinical Laboratory Technican and Scientist Licensure and Certification
§64-57-2 - Definitions.

§64-57-2. Definitions.

2.1. Certifying agency – means one of the following institutions:

2.1.a. American Society of Clinical Pathologists (ASCP);

2.1.b. Amercian Medical Technologists (AMT); and

2.1.c. American Association of Bioanalysts (AAB) formerly known as the International Society for Clinical Laboratory Technologists (ISCLT).

2.2. CLIA. - Clinical Laboratory Improvement Amendments of 1988, Section 353 of the Public Health Service Act, 42 CFR Part 493, Revised October 1, 2006.

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; or

2.4.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; and

2.5.b. Meets the qualifications for directors of:

2.5.b.1. Moderate complexity testing laboratories found at 42 CFR § 493.1405; or

2.5.b.2. High complexity testing laboratories found at 42 CFR § 493.1443.

2.6. Clinical Laboratory Practitioner. - A laboratory technician or a medical laboratory scientist. The term "clinical laboratory practitioner" includes laboratory technicians, point of care technicians, cytotechnologists, and medical laboratory scientists, but does not include: clinical laboratory practitioner trainees; clinical laboratory directors, consultants, or supervisors whose job tasks do not include processing specimens, or performing or reporting laboratory tests; or physicians licensed under W. Va. Code§§ 30-3-1 et seq. or 30-14-1 et seq. who perform laboratory tests only on their own patients.

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; or

2.8.c. A high complexity testing cytology general supervisor found at 42 CFR § 493.1469.

2.9. Contact Hours. - The actual number of hours an individual participates in continuing education. Ten (10) contact hours equal one (1) continuing education unit.

2.10. 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.

2.11. Department. - The West Virginia department of health and human resources.

2.12. Health Care Facility. - An entity subject to licensure as a:

2.12.a. Birthing center under W. Va. Code§§ 16-2E-1 et seq.;

2.12.b. Hospital or extended care facility operated in connection with a hospital, or an ambulatory surgical facility, or an ambulatory health care facility, including a medical adult day care center under W. Va. Code§§ 16-5B-1 et seq.;

2.12.c. Nursing home or personal care home under W. Va. Code§§16-5C-1 et seq.;

2.12.d. Long-term care facility as defined by W.Va. Code§16-5L-2(b);

2.12.e. Hospice under W. Va. Code §§16-5I-1 et seq.;

2.12.f. Clinical laboratory under W. Va. Code §§16-5J-1 et seq.;

2.12.g. Hospital, center or facility for the care and treatment of the mentally ill or mentally retarded, or for the prevention of such disorders under W. Va. Code§27-9-1 et seq.; or

2.12.h. Group residential facility for the developmentally disabled or behaviorally disabled under W. Va. Code§§ 27-17-1 et seq.

2.13. Laboratory Technician or 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. Laboratory Scientist or 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. 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-88, and shall perform testing under the personal supervision of a clinical laboratory director or a clinical laboratory supervisor. This supervision shall be available to the point-of-care-technician at all times when testing is being performed.

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