ORS 438.040: Clinical laboratory qualifications and certifications.
Edition: 2025 EditionEffective: 2026-01-01Last verified: 2026-09-07
(1) The Oregon Health Authority shall verify the qualifications of each clinical laboratory in this state and shall issue or facilitate the issuance of a certificate to a clinical laboratory that satisfies the requirements of the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a). (2) A clinical laboratory may not operate in this state without a certificate issued by the authority or the federal government under this section. [1969 c.685 §3; 1999 c.341 §1; 2005 c.22 §298; 2025 c.624 §27]
Administrative rules citing this section
- OAR 333-024-0012: Certification — implements
- OAR 333-024-0016: Certification Categories — implements
- OAR 333-024-0016: Certification Categories — authority
- OAR 333-024-0020: Certification for Performance of Laboratory Specialties — implements
- OAR 333-024-0020: Certification for Performance of Laboratory Specialties — authority
- OAR 333-024-0021: Qualifications and Responsibilities of Directors for High Complexity Laboratories — implements
- OAR 333-024-0021: Qualifications and Responsibilities of Directors for High Complexity Laboratories — authority
- OAR 333-024-0022: Qualifications and Responsibilities for Director of Moderate Complexity Laboratories — implements
- OAR 333-024-0022: Qualifications and Responsibilities for Director of Moderate Complexity Laboratories — authority
- OAR 333-024-0023: Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories — implements
- OAR 333-024-0023: Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories — authority
- OAR 333-024-0026: Equipment and Facilities — implements
- OAR 333-024-0026: Equipment and Facilities — authority
- OAR 333-024-0035: Internal Quality Control for Moderate and High Complexity Laboratories — implements
- OAR 333-024-0035: Internal Quality Control for Moderate and High Complexity Laboratories — authority
- OAR 333-024-0037: Specialty and Subspecialty Quality Control — implements
- OAR 333-024-0037: Specialty and Subspecialty Quality Control — authority
- OAR 333-024-0040: External Quality Control (Proficiency Testing Programs and On-Site Inspections) — implements
- OAR 333-024-0040: External Quality Control (Proficiency Testing Programs and On-Site Inspections) — authority
- OAR 333-024-0043: Quality Assurance — authority
- OAR 333-024-0260: Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose — implements
- OAR 333-024-0260: Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose — authority
- OAR 333-024-0265: Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure — implements
- OAR 333-024-0265: Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure — authority
- OAR 333-024-0315: Testing for Substances of Abuse: Permits — authority
- OAR 333-024-0345: Testing for Substances of Abuse: Confirmatory Testing — implements
- OAR 333-024-0345: Testing for Substances of Abuse: Confirmatory Testing — authority
This rule cites
No citations extracted.
Cited by
- ORS 413.550: Definitions for ORS 413.550 to 413.559, 413.564 and 413.565.
- ORS 413.561: Agencies or boards with enforcement authority.
- ORS 438.160: Revocation, suspension, refusal to issue or renew certificates or permits.
- ORS 438.310: Owner or director of clinical laboratory to submit reports and findings on communicable disease.
- ORS 438.435: Substances of abuse on-site screening facilities; permits; rules; fees.
- ORS 438.990: Penalties for ORS 438.040.
- ORS 813.160: Methods of conducting chemical analyses; duties of Department of State Police; reports; costs.
- ORS 830.535: Criteria for chemical analyses.
- OAR 333-024-0012: Certification
- OAR 855-041-1190: Operation of a Laboratory in Drug Outlet Pharmacy
Official source: https://www.oregonlegislature.gov/bills_laws/ors/ors438.html