OAR 333-024-0010
Definitions

(1)

“Accredited college or university” as used in the Act and OAR 333-024-0021 (Qualifications and Responsibilities of Directors for High Complexity Laboratories) 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 assistant 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 (Qualifications and Responsibilities of Directors for High Complexity Laboratories) and 333-024-0022 (Qualifications and Responsibilities for Director of Moderate Complexity Laboratories) 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 (Licensure Categories)(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 (Purpose) through 333-024-0055 (Incompetence) and 333-024-0260 (Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose) and 333-024-0265 (Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure) means Oregon Revised Statutes, Chapter 438.

(23)

“Waived laboratory” means a facility that performs only tests as defined in OAR 333-024-0016 (Licensure Categories)(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.

Source: Rule 333-024-0010 — Definitions, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0010.

333‑024‑0005
Purpose 333‑024‑0010
Definitions 333‑024‑0012
Licensure 333‑024‑0016
Licensure Categories 333‑024‑0020
Licensure for Performance of Laboratory Specialties 333‑024‑0021
Qualifications and Responsibilities of Directors for High Complexity Laboratories 333‑024‑0022
Qualifications and Responsibilities for Director of Moderate Complexity Laboratories 333‑024‑0023
Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories 333‑024‑0026
Equipment and Facilities 333‑024‑0035
Internal Quality Control for Moderate and High Complexity Laboratories 333‑024‑0037
Specialty and Subspecialty Quality Control 333‑024‑0040
External Quality Control (Proficiency Testing Programs and On-Site Inspections) 333‑024‑0043
Quality Assurance 333‑024‑0045
Venereal Disease Testing 333‑024‑0050
Records and Reports 333‑024‑0053
Accreditation Organizations and Accredited Laboratories 333‑024‑0055
Incompetence 333‑024‑0260
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose 333‑024‑0265
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure 333‑024‑0305
Testing for Substances of Abuse: Purpose and Scope 333‑024‑0310
Testing for Substances of Abuse: Definitions 333‑024‑0315
Testing for Substances of Abuse: Licensure 333‑024‑0320
Testing for Substances of Abuse: Qualifications and Responsibilities of Directors 333‑024‑0325
Testing for Substances of Abuse: Incompetence 333‑024‑0330
Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports 333‑024‑0335
Testing for Substances of Abuse: Internal Quality Assurance 333‑024‑0340
Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections) 333‑024‑0345
Testing for Substances of Abuse: Confirmatory Testing 333‑024‑0350
Testing for Substances of Abuse: Equipment and Facilities 333‑024‑0360
Testing for Substances of Abuse: Special Category Laboratories 333‑024‑0365
Testing for Substances of Abuse: Substance of Abuse Registration 333‑024‑0370
Health Screen Testing: Purpose 333‑024‑0375
Health Screen Testing: Definitions 333‑024‑0380
Health Screen Testing: Permits 333‑024‑0385
Health Screen Testing: Testing Site Schedule 333‑024‑0390
Health Screen Testing: Personnel Qualifications and Responsibilities 333‑024‑0395
Health Screen Testing: Tests Performed 333‑024‑0400
Health Screen Testing: Quality Assurance 333‑024‑1000
Newborn Screening: Purpose 333‑024‑1010
Newborn Screening: Definitions 333‑024‑1020
Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted 333‑024‑1025
Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted 333‑024‑1030
Newborn Screening: Timing for Collecting Specimens 333‑024‑1040
Newborn Screening: Manner of Submitting Specimens 333‑024‑1050
Newborn Screening: Religious Exemption from Newborn Testing 333‑024‑1060
Newborn Screening: Improperly Collected Specimens 333‑024‑1070
Newborn Screening: The Newborn Screening Panel and Methods of Testing 333‑024‑1080
Newborn Screening: Result Reporting and Follow-up 333‑024‑1090
Newborn Screening: Use, Release and Retention of Residual Specimens 333‑024‑1100
Newborn Screening: Ordering Specimen Collection Kits and Fees 333‑024‑1110
Newborn Screening: Failure to Comply 333‑024‑2000
Fees for Communicable Disease Tests Performed in the State Laboratory
Last Updated

Jun. 8, 2021

Rule 333-024-0010’s source at or​.us