325-011-0001 Definitions As used in OAR 325-011-0001 to 325-011-0055: (1) “Adverse event” means an objective and definable negative consequence of patient care, or the risk of an objective and definable negative consequence of patient care, that: (a) Is unanticipated and usually preventable; and (b) Results in or presents a risk of resulting in physical injury to the patient. (2) “Eligible entity” means an entity eligible to participate in the Patient Safety Reporting Program pursuant to OAR 325-011-0002. ( 3 ) “Health care facility” as defined in ORS 442.015 means a hospital, a long term care facility, an ambulatory surgical center, a freestanding birthing center, an outpatient renal dialysis facility, or an extended stay center. ( 4 ) “Oregon Patient Safety Reporting Program” means the Patient Safety Reporting Program, as defined in ORS 442.837, and operated by OPSC. (5) “Oregon Patient Safety Reporting Portal” means the portal maintained by the Oregon Patient Safety Commission for the purpose of the submission of adverse event reports to the Oregon Patient Safety Reporting Program. This Portal is a component of the Oregon Patient Safety Reporting Program. ( 6 ) “Participant” means an entity that reports Patient Safety Data to the Oregon Patient Safety Reporting Program, and any agent, employee, consultant, representative, volunteer or medical staff member of the entity. ( 7 ) “Patient Safety Activities” include but are not limited to: (a) The collection and analysis of Patient Safety Data by a Participant; (b) The collection and analysis of Patient Safety Data by the Oregon Patient Safety Commission (OPSC) established in ORS 442.820; (c) The utilization of Patient Safety Data by Participants; (d) The utilization of Patient Safety Data by OPSC to improve the quality of care with respect to patient safety and to provide assistance to health care providers to minimize patient risk; (e) Oral and written communication regarding Patient Safety Data among two or more Participants with the intent of making a disclosure to or preparing a report to be submitted to a Patient Safety Reporting Program; and (f) Collaboration between OPSC and participants on patient safety initiatives. ( 8 ) “Patient Safety Data” means oral communication or written reports, data, records, memoranda, analyses, deliberative work, statements, event investigations and analyses or action plans that are collected or developed to improve patient safety or health care quality that: (a) Are prepared by a Participant for the purpose of reporting Patient Safety Data voluntarily to or otherwise working with the Patient Safety Reporting Program, or that are communicated among two or more Participants with the intent of making a disclosure to or preparing a report to be submitted to the Patient Safety Reporting Program; (b) Are collected or prepared by a patient safety organization certified by the United States Department of Health and Human Services under 42 U.S.C. 299b-24; or (c) Are created by or at the direction of the Patient Safety Reporting Program, including communication, reports, notes or records created in the course of a patient safety initiative undertaken at the direction of or in collaboration with OPSC. ( 9 ) “Patient Safety Report” means a form designated by the Oregon Patient Safety Commission (OPSC) to be used for the reporting of Patient Safety Data. ( 10 ) “Serious adverse event” for the purposes of OAR 325-011-0001 to 325-011-0060 means an objective and definable negative consequence of patient care, or the risk of an objective and definable negative consequence of patient care, that: (a) Is unanticipated and usually preventable; and (b) Results in, or presents a significant risk of, the patient’s death or serious physical injury. ( 11 ) “These rules” means OAR 325-011-0001 to 325-011-0060. Statutory/Other Authority: ORS 442.820 & 442.831 Statutes/Other Implemented: ORS 442.819-442.851 History: PSC 2-2025, amend filed 05/16/2025, effective 05/16/2025 PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024