The law that established PA-PSRS (Act 13 of 2002, or “Mcare”) contains a provision that allows a healthcare worker to anonymously report a Serious Event directly to the Patient Safety Authority if they know the event has been reported internally according to their facility’s Patient Safety Plan and if they believe the event has not been reported to PA-PSRS.
Anonymous Reports offer a learning opportunity for the facility involved and for other facilities as well. That is the case with an Anonymous Report submitted in November 2004. Following its receipt, the Patient Safety Authority conducted a review involving a site visit to the facility and issued a report of its findings to the Authority Board of Directors. This report was accepted by the Board with a recommendation that the facility’s handling of the event be published in the PA-PSRS Patient Safety Advisory as a case study. The case study is informative because the facility’s management of the reporting process in this case—like the Serious Event itself—contained an error, system weaknesses, a root cause analysis, and corrective action.
Eight weeks prior to the filing of an Anonymous Report, a patient died following injury to the heart from the placement of a chest tube. This event was reported by several healthcare workers through the facility’s internal patient safety system. From the perspective of the individual who submitted the Anonymous Report, it was not evident that any action had been taken. Upon receiving the Anonymous Report, the Authority contacted the facility and confirmed that the event had occurred, that it had been reported to the facility’s Patient Safety Officer, and that the facility had not yet reported it to PA-PSRS. The facility volunteered that it had initiated an investigation of the event immediately upon receiving the initial reports through its internal reporting process.
As required, the facility provided a definitive response to the Anonymous Report within the 30 days stipulated by Act 13. Their letter stated that they had completed their internal investigation, determined that the event was reportable as a Serious Event, and had just submitted the report through PA-PSRS.
The Authority determined that it would conduct its own review of the case. The review team visited the facility, reviewed relevant records, and had a joint interview with the facility’s Patient Safety Officer, risk manager, involved clinical service chief, vice-president for medical affairs, and legal counsel, among others.
It was clear to all involved that the event should have been reported to PA-PSRS in a more timely manner as a Serious Event. Of note, the attending physician reported the event to the patient’s family and the service director at the time of the occurrence. At the completion of its own internal investigation, the facility also followed up with the family.
The Authority’s review team reached the same conclusions as the facility’s internal investigation. This critique of the delay in reporting is presented on the premise that other facilities may find themselves vulnerable to the same weaknesses:
- The first problem was that the decision whether to report the occurrence to PA-PSRS was referred to an individual who had the misperception that a Serious Event, involving patient harm as the result of medical care, also had to involve a medical error. This misperception was ultimately corrected by education from the facility’s counsel, who clarified that the definition of a Serious Event requires that the patient harm is the result of patient care. It does not require that the harm be the result of an error in delivering the care.
- The second problem, identified astutely by the facility, was that it failed to recognize that patient safety reporting, for learning from aggregated confidential reports, is independent of the peer review process. Indeed, the facility was not ignoring the event, but was rather methodically investigating a concern that the event was part of a pattern of behavior by the involved healthcare provider. The delay in reporting to PA-PSRS was caused by the comprehensive, methodical review that ultimately resulted in the individual relinquishing some clinical privileges.
- The third problem, also identified by the facility, was the lack of a tracking mechanism for potential reports requiring investigation. The internal investigation was delayed not only by the desire for peer review, but also by vacations and illnesses of critical decision makers.
- The fourth problem, also recognized by the facility, was that the decision about whether the event was reportable was the responsibility of a single individual, without sufficient input from others involved in the patient safety, peer review, and risk management processes.
Stimulated by the letter from the Authority about the Anonymous Report, the facility conducted a root cause analysis of the breakdown in timely reporting. It recognized in retrospect that it should have reported the event to PA-PSRS at the time it confirmed that the patient sustained the injury from the clinical care.
The facility staff indicated that the process of analyzing the delay in reporting had been a learning experience. They developed an action plan to correct these deficiencies.
The opinion of the Authority’s review team was that there was no intent to hide or minimize the event. The facility likely would have reported it as a Serious Event eventually, if for no other reason than to help justify the peer review action taken. Based on the facility’s record of reporting, the delay in confirming this specific occurrence as a Serious Event appeared not to be part of a pattern to minimize reporting. The facility had wisely conducted a root cause analysis on its perceived failure to report a Serious Event in a timely fashion and changed its Patient Safety Plan to correct the problems.
The site visit team independently came to the same conclusions, and the Patient Safety Authority Board concurred with the lessons learned:
- The definition of a Serious Event requires that the patient harm is the result of clinical care, but does not require that the harm be the result of an error in delivering the care.
- Patient safety reporting, for learning from aggregated confidential reports, is independent of the peer review process.
- A tracking mechanism for potential reports requiring investigation may identify impending delays.
- Decisions about potentially reportable events should be known and reviewed by appropriate team members in the patient safety, peer review, and risk management processes.