OAR 325-015-0035
Commission Review of Reports
(1)
When the Commission receives an Event Report from a Pharmacy Participant, the Commission will determine whether that Event Report is complete, thorough, credible, and acceptable. The definitions for the terms complete, thorough, credible and acceptable are:(a)
A report is complete if it contains all the information requested in the Event Report, or explains, to the Commission’s satisfaction, why that information is not available or not necessary to provide;(b)
A report is thorough if the investigation (e.g., root cause analysis) of the event includes an analysis of all relevant systems issues and shows evidence of an inquiry into all appropriate areas;(c)
A report is credible if it shows evidence that the investigation of the Reportable Pharmacy Adverse Event included participation by leadership within the organization and was internally consistent; and(d)
A report is acceptable if all the above standards are met and the action plans clearly describe meaningful improvement strategies designed to minimize risk.(2)
If the Commission believes that an Event Report received from a Pharmacy Participant is incomplete or unacceptable in some manner, it will inform the Pharmacy Participant’s contact person within 10 business days of receipt of the Event Report.
Source:
Rule 325-015-0035 — Commission Review of Reports, https://secure.sos.state.or.us/oard/view.action?ruleNumber=325-015-0035.