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Code · Oregon · ORS Chapter 438 · Laboratories; Anatomical Material

438.010 Definitions for ORS 438

409 words·~2 min read·/or/ors-chapter-438/laboratories-anatomical-material/438-010·

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438.010 Definitions for ORS 438.010 to 438.450. As used in ORS 438.010 to 438.450, unless the context requires otherwise:
(1)“Authority” means the Oregon Health Authority.
(2)“Certificate” means a certificate issued by the authority or the federal government to a clinical laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a).
(3)“Clinical laboratory” or “laboratory” means a facility where the microbiological, serological, chemical, hematological, immunohematological, immunological, toxicological, cytogenetical, exfoliative cytological, histological, pathological 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.
(4)“Custody chain” means the handling of specimens in a way that supports legal testimony to prove that the sample integrity and identification of the sample have not been violated, as well as the documentation describing those procedures from specimen collection to the final report.
(5)“Dentist” means a person licensed to practice dentistry by the Oregon Board of Dentistry.
(6)“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.
(7)“Operator of a substances of abuse on-site screening facility” or “operator” means the person who plans, organizes, directs and participates in any or all of the technical and administrative operations of a substances of abuse on-site screening facility.
(8)“Physician” means a person licensed to practice medicine by the Oregon Medical Board.
(9)“Specimen” means materials derived from a human being or body.
(10)“Substances of abuse” means ethanol, cannabis and controlled substances.
(11)“Substances of abuse on-site screening facility” or “on-site facility” means a location where on-site tests are performed on specimens for the purpose of screening for the detection of substances of abuse.
(12)“Substances of abuse on-site screening test” or “on-site test” means a substances of abuse test that is easily portable and can meet the requirements of the federal Food and Drug Administration for commercial distribution or an alcohol screening test that meets the requirements of the United States Department of Transportation National Highway Traffic Safety Administration for conforming products. [1969 c.685 §2; 1989 c.776 §1; 1993 c.109 §3; 1997 c.355 §1; 1999 c.739 §1; 2001 c.104 §168; 2001 c.900 §255; 2009 c.595 §698; 2017 c.21 §62; 2019 c.358 §13; 2024 c.73 §89; 2025 c.624 §26]
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