OAR 325-010-0025
Reporting Serious Adverse Events
(1)
The Commission will provide an Event Report form to be used by Hospital Participants for reporting Reportable Serious Adverse Events. The Event Report will include: a summary description of the event; an overview of the Hospital Participant’s complete, thorough and credible root cause analysis for that event; information about plans to implement improvements to reduce risk. The meaning of terms “complete,” “thorough,” and “credible” are explained in OAR 325-010-0035 (Commission Review of Reports).(2)
Hospital Participants must use the Event Report form when reporting Serious Adverse Events to the Commission.(3)
Hospital Participants must submit a completed Event Report to the Commission within 45 calendar days of discovery of a Reportable Serious Adverse Event.(4)
If a Hospital Participant believes the Commission should immediately issue an alert to all Oregon hospitals based on a specific Reportable Serious Adverse Event, the Hospital Participant should provide an initial report to the Commission within 3 business days of discovery of the event, or sooner. The Hospital Participant and Commission will work together to identify information to include in the alert.
Source:
Rule 325-010-0025 — Reporting Serious Adverse Events, https://secure.sos.state.or.us/oard/view.action?ruleNumber=325-010-0025.