Rules and Regulations

The Oregon Health Authority (OHA), Public Health Division, Laboratory Compliance Section has permanently amended Oregon Administrative Rules (OAR) chapter 333, division 24 pertaining to clinical laboratories effective May 21st, 2026.

The purpose of these rules is to carry out ORS chapter 438 to ensure the quality of medical laboratory work by establishing a regulatory program. The rule changes are to align with changes to statute from the passage of SB 844 (Oregon Laws 2025, chapter 624) in the 2025 legislative session. The statute changes in SB 844 removed reference to an outdated clinical laboratory licensing program which was replaced in the early 2000s when Oregon adopted the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Subsequently, amendments were needed to administrative rules in chapter 333, division 24 to remove references to this unused clinical licensing program, associated fees, and associated definitions, as well as to update language to align with the federal CLIA terminology.  Statutes regarding Substances of Abuse testing laboratories and Health Screen Testing facilities were also updated with the passage of SB 844 to change the terms ‘registration’ or ‘license’ to ‘permit’ and therefore administrative rule amendments were needed to align with this change. Some references to state and federal entities were also outdated and are being updated to reflect current names.  For more details, including a description of each rule's changes, please see the Permanent Administrative Order.