Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 2 (June 2005) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority A Different Mindset: One Facility’s Experience with the Anonymous Report Process T he law that established PA-PSRS (Act 13 of 2002, or “Mcare”) contains a provision that allows a healthcare worker to anonymously report a Serious interview with the facility’s Patient Safety Officer, risk manager, involved clinical service chief, vice- president for medical affairs, and legal counsel, Event directly to the Patient Safety Authority if they among others. know the event has been reported internally accord- ing to their facility’s Patient Safety Plan and if they It was clear to all involved that the event should have believe the event has not been reported to PA-PSRS. been reported to PA-PSRS in a more timely manner as a Serious Event. Of note, the attending physician Anonymous Reports offer a learning opportunity for reported the event to the patient’s family and the ser- the facility involved and for other facilities as vice director at the time of the occurrence. At the well. That is the case with an Anonymous Report sub- completion of its own internal investigation, the facility mitted in November 2004. Following its receipt, the also followed up with the family. Patient Safety Authority conducted a review involving a site visit to the facility and issued a report of its find- The Authority’s review team reached the same con- ings to the Authority Board of Directors. This report clusions as the facility’s internal investigation. This was accepted by the Board with a recommendation critique of the delay in reporting is presented on the that the facility’s handling of the event be published in premise that other facilities may find themselves vul- the PA-PSRS Patient Safety Advisory as a case nerable to the same weaknesses: study. The case study is informative because the fa- cility’s management of the reporting process in this • The first problem was that the decision whether to report the occurrence to PA-PSRS case—like the Serious Event itself—contained an error, system weaknesses, a root cause analysis, and was referred to an individual who had the corrective action. misperception that a Serious Event, involving patient harm as the result of medical care, Eight weeks prior to the filing of an Anonymous Re- also had to involve a medical error. This mis- port, a patient died following injury to the heart from perception was ultimately corrected by edu- the placement of a chest tube. This event was re- cation from the facility’s counsel, who clarified ported by several healthcare workers through the fa- that the definition of a Serious Event requires cility’s internal patient safety system. From the per- that the patient harm is the result of patient spective of the individual who submitted the Anony- care. It does not require that the harm be the mous Report, it was not evident that any action had result of an error in delivering the care. been taken. Upon receiving the Anonymous Report, the Authority contacted the facility and confirmed that • The second problem, identified astutely by the event had occurred, that it had been reported to the facility, was that it failed to recognize that the facility’s Patient Safety Officer, and that the facility patient safety reporting, for learning from ag- had not yet reported it to PA-PSRS. The facility volun- gregated confidential reports, is independent teered that it had initiated an investigation of the of the peer review process. Indeed, the facil- event immediately upon receiving the initial reports ity was not ignoring the event, but was rather through its internal reporting process. methodically investigating a concern that the As required, the facility provided a definitive response This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 2, No. to the Anonymous Report within the 30 days stipu- 2—June 2005. The Advisory is a publication of the Pennsylvania Patient lated by Act 13. Their letter stated that they had com- Safety Authority, produced by ECRI & ISMP under contract to the Authority as pleted their internal investigation, determined that the part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). event was reportable as a Serious Event, and had Copyright 2005 by the Patient Safety Authority. This publication may be re- just submitted the report through PA-PSRS. printed and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their The Authority determined that it would conduct its entirety and without alteration provided the source is clearly attributed. own review of the case. The review team visited the facility, reviewed relevant records, and had a joint To see other articles or issues of the Advisory, visit our web site at www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2005 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 2 (June 2005) A Different Mindset: One Facility’s Experience with the Anonymous Report Process (Continued) event was part of a pattern of behavior by the justify the peer review involved healthcare provider. The delay in action taken. Based on reporting to PA-PSRS was caused by the The facility staff the facility’s record of comprehensive, methodical review that ulti- indicated that the reporting, the delay in mately resulted in the individual relinquishing process of confirming this specific some clinical privileges. occurrence as a Serious analyzing the Event appeared not to be • The third problem, also identified by the facil- delay in reporting part of a pattern to mini- ity, was the lack of a tracking mechanism for mize reporting. The facility potential reports requiring investigation. The had been a had wisely conducted a internal investigation was delayed not only by learning root cause analysis on its the desire for peer review, but also by vaca- experience. perceived failure to report tions and illnesses of critical decision makers. a Serious Event in a timely fashion and • The fourth problem, also recognized by the changed its Patient Safety Plan to correct the problems. facility, was that the decision about whether the event was reportable was the responsibil- The site visit team independently came to the same ity of a single individual, without sufficient conclusions, and the Patient Safety Authority Board input from others involved in the patient concurred with the lessons learned: safety, peer review, and risk management processes. • The definition of a Serious Event requires that the patient harm is the result of clinical care, Stimulated by the letter from the Authority about the but does not require that the harm be the re- Anonymous Report, the facility conducted a root sult of an error in delivering the care. cause analysis of the breakdown in timely reporting. It • Patient safety reporting, for learning from ag- recognized in retrospect that it should have reported gregated confidential reports, is independent the event to PA-PSRS at the time it confirmed that the of the peer review process. patient sustained the injury from the clinical care. • A tracking mechanism for potential reports requiring investigation may identify impending The facility staff indicated that the process of analyz- delays. ing the delay in reporting had been a learning experi- • Decisions about potentially reportable events ence. They developed an action plan to correct these should be known and reviewed by appropri- deficiencies. ate team members in the patient safety, peer review, and risk management processes. 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 Page 2 ©2005 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 2 (June 2005) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. ©2005 Pennsylvania Patient Safety Authority Page 3