Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0010 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(1) "Accredited college or university" as
			 used in the Act and OAR 333-024-0021  means the accreditation by a nationally
			 recognized accrediting agency or association as determined by the U.S.
			 Commissioner of Education.
(2)
			 "Approved accreditation organization" for laboratories means a private,
			 nonprofit association that has formally received the Health Care Financing
			 Administration's approval.
(3)
			 "Accreditation" means a certificate obtained from a non-profit organization
			 that has met the standards as established by the Health Care Financing
			 Administration and approved by the Division.
(4) "Clinical laboratory" or "laboratory"
			 means a facility where the microbiological, serological, toxicological,
			 chemical, hematological, immunological, immunohematological, cytological,
			 pathological, histological, cytogenetical, or other examinations are performed
			 on materials derived from the human body, for the purpose of diagnosis,
			 prevention of disease or treatment of patients by physicians, dentists and
			 other persons who are authorized by license to diagnose or treat
			 humans.
(5) "CLIA 88" means the
			 Clinical Laboratory Improvement Amendments of 1988 including the rules that
			 implement the law as published in Section 42 Code of Federal Regulations, Part
			 493, Laboratory Requirements, February 28, 1992 and January 19, 1993 as amended
			 and revised.
(6) "Clinical
			 laboratory specialty" or "laboratory specialty" means the examination of
			 materials derived from the human body for the purpose of diagnosis and
			 treatment of patients, or assessment of health, employing one of the following
			 sciences: microbiology, chemistry, diagnostic immunology, toxicology,
			 cytogenetics, hematology, immunohematology, histocompatibility, cytology,
			 histopathology, or oral pathology.
(7) "Clinician" means a nurse practitioner
			 licensed and certified by the Oregon State Board of Nursing, or a physician
			 associate licensed by the Board of Medical Examiners for the State of
			 Oregon.
(8) "Dentist" means a
			 person licensed to practice dentistry by the Oregon Board of
			 Dentistry.
(9) "Director of
			 clinical laboratory" or "Director" means the person who plans, organizes,
			 directs and participates in any or all of the technical operations of a
			 clinical laboratory, including but not limited to reviewing laboratory
			 procedures and their results, training and supervising laboratory personnel,
			 and evaluating the technical competency of such personnel.
(10) "Division" means the Public Health
			 Division of the Oregon Health Authority.
(11) "Health Screen Testing" means tests
			 performed for the purpose of identifying health risks, providing health
			 information and referring the person being tested to medical care.
(12) "High complexity laboratory" means a
			 facility that performs testing classified as highly complex in the specialties
			 of microbiology, chemistry, hematology, diagnostic immunology,
			 immunohematology, clinical cytogenetics, cytology, histopathology, oral
			 pathology, radiobioassay and histocompatibility and may also perform moderate
			 complexity tests, physician performed microscopy procedures and waived
			 tests.
(13) "High complexity test"
			 means a procedure performed on materials derived from the human body that meet
			 the criteria for this category of testing in the specialties of microbiology,
			 chemistry, hematology, immunohematology, diagnostic immunology, clinical
			 cytogenetics, cytology, histopathology, oral pathology, radiobioassay and
			 histocompatibility as established by the Health Care Financing Administration
			 and the Centers for Disease Control and Prevention.
(14) "Laboratory evaluation system" means a
			 system of testing clinical laboratory methods, procedures and proficiency by
			 periodic performance and reporting on test specimens submitted for
			 examination.
(15) "Moderate
			 complexity laboratory" means a facility that performs testing classified as
			 moderately complex in the specialties of microbiology, hematology, chemistry,
			 immunohematology or diagnostic immunology and may also perform any physician
			 performed microscopy procedure and waived test.
(16) "Moderate complexity test" means a
			 procedure performed on materials derived from the human body that meet the
			 criteria for this category of testing in the specialties of microbiology,
			 hematology, chemistry, immunohematology or diagnostic immunology as established
			 by the Health Care Financing Administration and the Centers for Disease Control
			 and Prevention.
(17) "Owner of a
			 clinical laboratory" means the individual(s), corporation, association, firm,
			 partnership, joint stock companies, or a county, state or municipality owning
			 and operating a clinical laboratory.
(18) "Pertinent clinical laboratory
			 experience" or "pertinent experience" as used in the Act and OAR 333-024-0021  and 333-024-0022  means laboratory experience gained in a clinical laboratory
			 performing or supervising the same types of laboratory tests as those in common
			 use for the specific specialty involved.
(19) "Physician" means a person licensed to
			 practice medicine by the Board of Medical Examiners for the State of
			 Oregon.
(20) "Physician performed
			 microscopy procedure" means a test as defined in OAR 333-024-0016(1)(b)  which
			 is personally performed by a physician or other clinician during a patient's
			 visit on a specimen obtained during the examination of the patient.
(21) "Specimen" means materials derived from
			 a human being or body.
(22) "The
			 Act" as used in OAR 333-024-0005  through 333-024-0055  and 333-024-0260  and
			 333-024-0265  means Oregon Revised Statutes, Chapter 438.
(23) "Waived laboratory" means a facility
			 that performs only tests as defined in OAR 333-024-0016(1)(a)  that are so
			 simple and accurate as to render the likelihood of erroneous results
			 negligible.
(24) "Waived test"
			 means tests that are so simple and accurate as to render the likelihood of
			 erroneous results negligible, or tests which are categorized as waived for CLIA
			 laboratories, by the Health Care Financing Administration and Centers for
			 Disease Control and Prevention.
Statutory/Other Authority: ORS 433.017 & 438.010
Statutes/Other Implemented: ORS 438.010-320, 438.430, 438.435  & 438.510