Wyoming Administrative Code
Agency 048 - Health, Department of
Sub-Agency 0013 - Clinical Laboratories, Licensure of
Chapter 1 - GENERAL PROVISIONS
Section 1-4 - Definitions
Current through September 21, 2024
The following definitions shall apply in the interpretation and enforcement of these rules. Where the context in which words are used in these rules indicates that such is the intent, words in the singular number shall include the plural and vice versa. Throughout these rules gender pronouns are used interchangeably except where the context dictates otherwise. The drafters have attempted to utilize each gender pronoun in equal numbers in random distribution. Words in each gender shall include individuals of the other gender.
(a) "Advisory committee" means the committee established pursuant to Section 33-34-106, W.S. 1977, to assist the state agency with the implementation of this act.
(b) "Approved method(s)" means a method of analysis that is approved for use in diagnostic testing by the state agency. Approval will be based on the general acceptance of the method by laboratory scientists, its accuracy and precision relative to its application, and satisfactory performance on standards, controls, and unknown material, if such a determination is deemed necessary by the state agency.
(c) "Approved reference laboratory" means any laboratory that meets or exceeds the standards established for CLIA-approved laboratories.
(d) "Blood bank" means a facility for the collection, processing, or storage of human blood or blood derivatives, but shall not include such a facility located in a memorial, district, or private hospital.
(e) "CLIA" means Clinical Laboratory Improvement Act of 1967, P.L. 90-174, Section 5 (a).
(f) "Clinical laboratory" means any facility for the microbiological, serologic, chemical, hematological, biophysical, cytological, or pathological examination of materials derived from the human body for the purpose of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of medical condition.
(g) "Inspection" means the on-site inspection of a facility by a qualified, trained employee of the state agency or by qualified individuals employed by the federal government, the College of American Pathologists (CAP), or the Joint Commission for the Accreditation of Hospitals (JCAHO).
(h) "Laboratory Director" means the person who is responsible for the administration of the technical and scientific operation of a clinical laboratory or blood bank, including supervision of procedures and reporting findings of tests, as specified in Chapter II, Section 2.
(i) "Laboratory reference system" means a system of periodic testing of methods, procedures, and materials of clinical laboratories and blood banks, including without limitation the distribution of manuals of approved methods, inspection of facilities, cooperative research, and periodic submission of test specimens for examination.
(j) "Medicare standards" means the regulations found in C.F.R. Title 20, Chapter III, Subpart P, Part 405, that apply to laboratories receiving reimbursement from the Health Care Financing Administration.
(k) "Physician office laboratory" means a clinical laboratory that is part of a single physician or group practice that performs laboratory testing only for the patients of the physician(s) in the practice.
(l) "Provisional directorship" means that certified, reference laboratory director provides scientific, technical, and administrative advice to a laboratory, visits that laboratory at least once a month, and is available for consultation by telephone as needed.
(m) "Qualified, technical personnel" means that the staff hired to perform laboratory testing are trained in laboratory methodology and practice to satisfactorily carry out their duties, as specified in Chapter II, Section 2.
(n) "Reference Laboratory" means any clinical laboratory that accepts specimens referred from physicians or other health officials. This includes hospital laboratories and independent clinical laboratories.
(o) "State-approved proficiency testing program" means laboratory reference system that are the external evaluation programs sponsored by the College of American Pathologists, the American Association of Bioanalysts (also known as the American Society of Internal Medicine Program), and the Centers for Disease Control in Atlanta, Georgia.
(p) "State-run proficiency testing program" means a laboratory reference system that is the external evaluation program sponsored and administered by the state agency.
(q) "State agency" means the Wyoming Department of Health, Preventive Health and Safety Division.
(r) "The (this) act" means W.S. W.S. W.S. 33-34-101 to 33-34-109, Licensing of Clinical Laboratories and Blood Banks.
