Laboratory Compliance Rulemaking Activity
Notice of Proposed Permanent Rulemaking: OAR chapter 333, division 24 – Update to administrative rules for Clinical Laboratories
The Oregon Health Authority (OHA), Public Health Division, Laboratory Compliance Section is proposing permanent amendments to Oregon Administrative Rules (OAR) chapter 333, division 24 pertaining to clinical laboratories.
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 proposed 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 The statute changes in SB 844 removed reference to an outdated clinical laboratory licensing program which was replaced in the early 2000s when Oregon adopted the Clinical Laboratory Improvement Amendments of 1988 (CLIA).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 are 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 are 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 Some references to state and federal entities were also outdated and are being updated to reflect current names.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 proposed changes, please see the Notice of Proposed Rulemaking, including the Statement of Need and Fiscal and Racial Equity Impacts, and the full text of the proposed rules:
Persons are invited to review and comment on the proposed rules. There are two (2) options to provide comment:
1) You may provide oral (spoken) testimony during a public hearing scheduled for Tuesday, April 21, 2026, at 11:00 A.M. Pacific Time via video/phone conference using Microsoft Teams.
To provide oral testimony during this hearing:
- Join using the Meeting URL. You can also find the join link for the meeting in the Notice of Proposed Rulemaking under “Remote Meeting Details” using the “Meeting URL."
- You may also contact the Public Health Division Rules Coordinator at publichealth.rules@odhsoha.oregon.gov to sign-up to give oral testimony and receive the link for the Microsoft Teams video conference via calendar appointment.
- To join the hearing via phone (audio/listen only), you may dial 971-277-2343, phone conference ID 305 968 904#
2) Written comments may be submitted before 5:00 P.M. Pacific Time on April 21, 2026:
OHA - Public Health Division
Administrative Rules Coordinator
800 NE Oregon St. Suite 930
Portland, OR 97232
*Comments sent by regular mail must be postmarked by 5:00 P.M. Pacific Time on April 21, 2026.
- Send comments by fax to 971-673-1299
Final rules will be filed after consideration of all comments.
Accessibility Statement: For individuals with disabilities or individuals who speak a language other than English, OHA can provide free help. Examples include sign language and spoken language interpreters, real-time captioning, braille, large print, audio, and written materials in other languages. If you need help with these services, please contact the Public Health Administrative Rules Coordinator at 971-673-1222, 711 TTY or
publichealth.rules@odhsoha.oregon.gov at least 48 hours before the meeting. All relay calls are accepted. To best ensure our ability to provide a modification please contact us if you are considering attending the meeting and require a modification. The earlier you make a request the more likely we can meet the need.