Oregon Administrative Code

333-024-0010 Definitions (1) “Accredited college or university” as used in ORS chapter 438 and OAR 333-024-0021 means the accreditation by a nationally recognized accrediting agency or association including any foreign institution of higher education that U.S. Health and Human Se…

333-024-0012 Certification (1) It shall be unlawful: (a) For any owner or director of a clinical laboratory to operate or maintain a clinical laboratory without a certificate or without a temporary permit issued under this rule or to perform or permit the performance of any labor…

333-024-0016 Certification Categories (1) The four categories of clinical laboratories are: (a) A waived laboratory which may perform only the following; dipstick or tablet reagent urinalysis (nonautomated), fecal occult blood, ovulation test-visual color comparison tests for hum…

333-024-0020 Certification for Performance of Laboratory Specialties (1) Certification for the performance of surgical pathology, autopsy pathology, exfoliative cytology, and immunohematology (except as provided in section (4) of this rule) shall be granted only to a laboratory w…

333-024-0021 Qualifications and Responsibilities of Directors for High Complexity Laboratories (1) The director shall meet at least one of the qualifications defined by the following: (a) Is a pathologist certified in clinical or anatomical pathology by the American Board of Path…

333-024-0022 Qualifications and Responsibilities for Director of Moderate Complexity Laboratories (1) The director shall meet at least one of the qualifications in OAR 333-024-0021 or one of the following: (a) Is a doctor of medicine, doctor of osteopathy or doctor of podiatric m…

333-024-0023 Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories (1) Moderate complexity laboratory technical and clinical consultants shall meet the minimal qualifications and fulfill the responsibil…

333-024-0026 Equipment and Facilities (1) All equipment shall be maintained in good working order, checked routinely, and precisely calibrated according to manufacturer’s requirements or a minimum of every six months. (2) Work bench space shall be ample, clean, well-organized, we…

333-024-0035 Internal Quality Control for Moderate and High Complexity Laboratories (1) Laboratories that perform testing using unmodified, moderate complexity test systems, cleared by the U.S. Food and Drug Administration (FDA) through the 510(k) or Premarket Approval (PMA) proc…

333-024-0037 Specialty and Subspecialty Quality Control (1) Bacteriology quality control requirements are: (a) The laboratory must check positive and negative reactivity with control organisms: (A) Each day of use for catalase, coagulase, betalactamase, oxidase reagents and DNA p…

333-024-0040 External Quality Control (Proficiency Testing Programs and On-Site Inspections) (1) Physician performed microscopy, moderate and high complexity laboratories shall: (a) At the laboratory’s own expense, be required to participate successfully in a proficiency testing …

333-024-0043 Quality Assurance (1) Each laboratory performing physician performed microscopy, moderate or high complexity testing must establish and follow written policies and procedures for a comprehensive quality assurance program which is designed to monitor and evaluate the …

333-024-0045 Venereal Disease Testing Tests for syphilis approved by the Public Health Division are as follows: (1) Venereal Disease Research Laboratory (VDRL) slide tests; (2) Fluorescent Treponemal Antibody — Absorption (FTA-ABS) test; (3) Rapid Plasma Reagin (RPR) and Reagin S…

333-024-0050 Records and Reports (1) Personnel policies, practices, and procedures that support sound laboratory practice shall be available in written form. A current record shall be maintained on each employee and shall include a resume of training and experience. (2) Complete …

333-024-0053 Accreditation Organizations and Accredited Laboratories (1) Accreditation organizations shall: (a) Provide the Public Health Division (Division) with; (A) Documentation of current deemed status from the U.S. Centers for Medicare and Medicaid Service (CMS); (B) A list…

333-024-0055 Incompetence A clinical laboratory owner or director has “demonstrated incompetence” if there is: (1) Repeated error demonstrated in the performance of laboratory tests or procedures or the results thereof; (2) Failure to comply with the requirements of these rules r…

333-024-0260 Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose (1) OAR 333-024-0260 through 333-024-0265 shall apply to the assay of Maternal Serum Alpha-Fetoprotein (MSAFP), Amniotic Fluid Alpha-Fetoprotein (AFAFP)…

333-024-0265 Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure (1) Prior to performing patient screening, the laboratory shall have available documentation of its expertise with the assays of MSAFP, AFAFP, Serum H…

333-024-0305 Testing for Substances of Abuse: Purpose and Scope OAR 333-024-0305 through 333-024-0365 are for the purpose of carrying out ORS 438.435 regarding substance of abuse testing in order to protect the people of the State of Oregon. OAR 333-024-0315 through 333-024-0350 …

333-024-0310 Testing for Substances of Abuse: Definitions (1) "Benefit" means, but is not limited to, eligibility for insurance or employment, access to or participation in a drug rehabilitation or mental health program, parole or probation, school attendance or attendance in sch…

333-024-0315 Testing for Substances of Abuse: Permits (1) It shall be unlawful: (a) For any owner or director of a substances of abuse (SOA) laboratory or a clinical laboratory to perform medical or automated non-medical SOA screening tests without a permit issued under this rule…

333-024-0320 Testing for Substances of Abuse: Qualifications and Responsibilities of Directors (1) The director of a substances of abuse (SOA) screening laboratory shall meet one of the following qualifications: (a) Is a pathologist certified in clinical pathology by the American…

333-024-0325 Testing for Substances of Abuse: Incompetence A substances of abuse (SOA) laboratory owner or director has “demonstrated incompetence” if there is: (1) Repeated error demonstrated in the performance of laboratory tests or procedures or the results thereof; (2) Failur…

333-024-0330 Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports (1) The specimen container shall be clean, tightly sealed and free of any interfering substance. It shall be transported and stored in such a manner as to preserve the integr…

333-024-0335 Testing for Substances of Abuse: Internal Quality Assurance (1) Laboratory procedure manuals and relevant texts of appropriate current laboratory methods shall be available for the use of the personnel in the laboratory. (2) Each instrument system shall be calibrated…

333-024-0340 Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections) (1) Permitted substances of abuse (SOA) laboratories shall: (a) At the laboratory’s own expense, be required to participate satisfactorily in the proficien…

333-024-0345 Testing for Substances of Abuse: Confirmatory Testing (1) When the substances of abuse screening laboratory obtains a positive test result and the submitter indicates the result is to be used to deprive or deny any person any employment or any benefit, that same spec…

333-024-0350 Testing for Substances of Abuse: Equipment and Facilities (1) All equipment shall be maintained in good working order, checked routinely, and precisely calibrated. (2) Work bench space shall be ample, clean, well-organized, well-lighted, and convenient to sink, water…

333-024-0360 Testing for Substances of Abuse: Special Category Laboratories (1) This rule sets standards for special category screening laboratories, as authorized in ORS 438.435. This rule applies to the testing of inmates within state and local correctional facilities and to th…

333-024-0365 Testing for Substances of Abuse: Substance of Abuse Permit Application (1) It shall be unlawful for any entity to perform any on-site test for non-medical substances of abuse (SOA) screening tests prior to filing an application form with the Public Health Division (D…

333-024-0370 Health Screen Testing: Purpose OAR 333-024-0370 through 333-024-0400 are for the purpose of carrying out ORS 438.010(6), ORS 438.060, and ORS 438.150. The purpose of the rules is to regulate the quality of health screen testing and to govern the issuance of permits t…

333-024-0375 Health Screen Testing: Definitions Except as provided in this rule, definitions in OAR 333-024-0010 are applicable to OAR 333-024-0370 through 333-024-0400. Additionally: (1) "Clinician" means a nurse practitioner licensed and certified by the Oregon State Board of N…

333-024-0380 Health Screen Testing: Permits (1) Any person who operates a health screen testing service must obtain a permit from the Public Health Division (Division). (2) OAR 333-024-0370 through 333-024-0400 apply to all health screen testing services and their personnel withi…

333-024-0385 Health Screen Testing: Testing Site Schedule The health screen testing service shall, in writing, notify the Oregon Health Authority, Oregon State Public Health Laboratory (OSPHL) of the proposed testing site schedule. The schedule must be received at the OSPHL, at l…

333-024-0390 Health Screen Testing: Personnel Qualifications and Responsibilities (1) Each health screen testing service shall have a director who shall meet at least one of the following qualifications: (a) Is a Medical Doctor (MD) or a Doctor of Osteopathy (DO) licensed to prac…

333-024-0395 Health Screen Testing: Tests Performed (1) The health screening testing service may perform only test procedures of waived or moderate complexity, as defined in OAR 333-024-010(23) and (16), from the following list of allowed tests. (a) Blood hemoglobin; (b) Packed r…

333-024-0400 Health Screen Testing: Quality Assurance Quality assurance shall be comprised of internal quality control, test reports and records, quality assurance activities, safety, external quality control, counseling and referral: (1) Internal quality control: (a) Documentati…

333-024-1000 Newborn Screening: Purpose (1) Newborn screening identifies conditions and diseases that may not be clinically evident in the first few days or weeks of an infant’s life but can affect an infant’s long-term health or survival. If these conditions are detected early, …

333-024-1010 Newborn Screening: Definitions As used in OAR 333-024-1000 to 333-024-1110: (1) "Abnormal result" means a laboratory examination result that meets the screening criteria for a newborn screening panel condition requiring additional screening or diagnostic testing and …

333-024-1020 Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted (1) The following, in order of priority, are responsible for ensuring that first specimens are collected and submitted in accordance with this rule: (a) Facilities (h…

333-024-1025 Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted (1) The following, in order of priority, are responsible for ensuring that the second specimens, and when applicable, third or repeat specimens, ar…

333-024-1030 Newborn Screening: Timing for Collecting Specimens (1) The facility or individual responsible for collecting specimens for newborn screening under OAR 333-024-1020 and OAR 333-024-1025 must collect newborn screening specimens from every infant born in Oregon, and sur…

333-024-1040 Newborn Screening: Manner of Collecting and Submitting Specimens A person responsible for submitting specimens to the Oregon State Public Health Laboratory under OAR 333-024-1020 and OAR 333-024-1025 must: (1) Collect the specimens: (a) Using kits available from the …

333-024-1050 Newborn Screening: Religious or Philosophical Exemption from Newborn Testing (1) A parent or legal guardian may opt not to have their infant screened in accordance with these rules because of religious or philosophical beliefs opposed to such testing. To claim such a…

333-024-1060 Newborn Screening: Improperly Collected Specimens (1) If a specimen contains insufficient blood, is contaminated or found to be otherwise unsuitable for testing, the Oregon State Public Health Laboratory will notify the practitioner(s) or facility identified as respo…

333-024-1070 Newborn Screening: The Newborn Bloodspot Screening Panel of Tests (1) Every properly collected specimen submitted for newborn screening will be tested by the Oregon State Public Health Laboratory or, at the discretion of the Oregon State Public Health Laboratory, ano…

333-024-1080 Newborn Screening: Result Reporting and Follow-up (1) Newborn screening results will be reported by the Oregon State Public Health Laboratory to the following persons responsible for the medical care and treatment of the infant, in order of priority: (a) The individu…

333-024-1090 Newborn Screening: Use, Release and Retention of Residual Specimens (1) Residual specimens may be used by the Oregon State Public Health Laboratory for: (a) Quality assurance and method development activities as required to maintain CLIA compliance. (b) Program evalu…

333-024-1100 Newborn Screening: Ordering Specimen Collection Kits and Fees (1) Kits for collecting specimens for newborn screening must be ordered from the Oregon State Public Health Laboratory. (2) Orders must be accompanied by payment for the full amount of the order, based on …

333-024-1110 Newborn Screening: Failure to Comply The Oregon State Public Health Laboratory may refer a hospital, freestanding birthing center or a practitioner to the appropriate licensing entity for failure to comply with these rules. Statutory/Other Authority: ORS 413.014, 431…