2021 Oregon Revised Statutes
Chapter 438 - Laboratories; Anatomical Material
Section 438.010 - Definitions for ORS 438.010 to 438.510.

(1) "Authority" means the Oregon Health Authority.
(2) "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.
(3) "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: Serology, microbiology, chemistry, hematology, immunohematology, immunology, toxicology, cytogenetics, exfoliative cytology, histology or pathology.
(4) "Clinician" means a nurse practitioner licensed by the Oregon State Board of Nursing, or a physician assistant licensed by the Oregon Medical Board.
(5) "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.
(6) "Dentist" means a person licensed to practice dentistry by the Oregon Board of Dentistry.
(7) "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.
(8) "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.
(9) "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, pathology, radiobioassay and histocompatibility and that may also perform moderate complexity tests and waived tests.
(10) "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, pathology, radiobioassay and histocompatibility as established by the authority.
(11) "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.
(12) "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 waived test.
(13) "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 authority.
(14) "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.
(15) "Owner of a clinical laboratory" means the person who owns the clinical laboratory, or a county or municipality operating a clinical laboratory or the owner of any institution operating a clinical laboratory.
(16) "Physician" means a person licensed to practice medicine by the Oregon Medical Board.
(17) "Physician performed microscopy procedure" means a test personally performed by a physician or other clinician during a patient’s visit on a specimen obtained during the examination of the patient.
(18) "Physician performed microscopy procedures" means a limited group of tests that are performed only by a physician or clinician.
(19) "Specimen" means materials derived from a human being or body.
(20) "Substances of abuse" means ethanol, cannabis and controlled substances.
(21) "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.
(22) "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 conforming products list found in the United States Department of Transportation National Highway Traffic Safety Administration Docket No. 94-004 and meets the standards of the United States Department of Transportation Alcohol Testing Procedure, 49 C.F.R. part 40, in effect on October 23, 1999.
(23) "Waived test" means a procedure performed on materials derived from the human body that meet the criteria for this category of testing as established by the authority. [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]