What is written notification, and when should it be provided?
Participants in Oregon’s Patient Safety Reporting Program (PSRP) are required to provide written notification to patients following a serious adverse event 1. Written notification occurs when a physician or healthcare organization provides a written letter about an adverse event to the patient or, if the patient is incapable of receiving the information, to the patient’s next of kin (e.g., spouse, family member, or substitute decision maker). Written notification can clarify a patient’s understanding of an event in a way that may be difficult to achieve through oral notification alone. Written notification can also ensure that information not known or addressed in oral conversations is clearly and accurately conveyed to the patient and family.
The Oregon Patient Safety Commission (OPSC) strongly believes that all patients have a right to know about adverse events that affect their lives (read our Position Statement on Written Notification). When physicians and healthcare organizations are faced with an adverse event, OPSC recommends that disclosure be made first in the form of oral conversation, followed by written notification. Any disclosure should align with your healthcare organization’s disclosure policy.
OPSC recommends that healthcare organizations disclose serious adverse event information as soon as possible after the event occurs. For organizations participating in PSRP, Oregon law states, “After a serious adverse event occurs, a participant must provide written notification in a timely manner to each patient served by the participant who is affected by the event. Notice provided under this subsection may not be construed as an admission of liability in a civil action” (ORS 442.837(4)).
When creating a disclosure policy, organizations should strongly consider the disclosure of non-serious adverse events and near misses. OPSC recommends that physicians and healthcare organizations disclose adverse events regardless of harm level or whether an error is identified. The decision to disclose events that do not fit the definition of serious adverse events should be clearly addressed in an organization’s disclosure policy.
The State of Oregon requires that reporting program participants provide written notification for serious adverse events as defined by ORS 442.819: An objective and definable negative consequence of patient care, or the risk thereof, that is unanticipated, usually preventable and results in, or presents a significant risk of, patient death or serious physical injury.
OPSC has adopted the National Coordinating Council for Medication Error Reporting and Prevention’s harm categories and algorithm for classifying serious adverse events. Harms that fall into categories ‘F’ through ‘I’ are considered serious adverse events, and harms that fall into category ‘E’ may be considered serious adverse events.