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 July 13, 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.