333-024-0010 Definitions (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 History: PH 65-2024, minor correction filed 06/06/2024, effective 06/06/2024 HD 6-1995, f. & cert. ef. 9-13-95 HD 20-1994, f. & cert. ef. 7-20-94 HD 7-1990, f. & cert. ef. 3-21-90 HD 28-1988, f. & cert. ef. 12-7-88 HB 248, f. 6-30-70, ef. 7-25-70