Overview

Drawing on the experience of the aviation industry, the Veterans Administration tapped NASA to create an external patient safety reporting system that serves as a "safety valve" for capturing information on adverse events and close calls that are not reported to the VA's internal reporting system. Complementary internal and external reporting systems demonstrate the VA's commitment to learning from a full range of patient safety issues and events.

Issue: In the health care field, many "close calls" or "near misses"—incidents that could have resulted in patient injury but, either by chance or intervention, did not—are not formally reported or analyzed. In addition, clinicians may be hesitant to disclose actual adverse events to existing mandatory reporting systems. Hence, valuable information that could be used to diagnose system weaknesses and prevent future errors is often lost.

The aviation industry's systematic approach to passenger safety suggests that an external, voluntary, confidential reporting system could be an effective means of capturing this important information for learning and improvement in health care.

Operated by the National Aeronautics and Space Administration (NASA) in cooperation with the Federal Aviation Administration, the Aviation Safety Reporting System (ASRS) is an important component of the national aviation safety system. For more than 25 years, the ASRS has served as an independent third party to which aviation personnel can voluntarily submit confidential appraisals of safety incidents that they have experienced or witnessed. This system produces timely alerts and research that give "insight into events from the human perspective that can rarely be obtained through other methods," says ASRS director Linda Connell.

Objective and Intervention: To discover and learn from a fuller range of patient safety issues, the Veterans Administration (VA) instituted an external, voluntary, confidential, and non-punitive Patient Safety Reporting System (PSRS) modeled on NASA's Aviation Safety Reporting System. The PSRS is intended to provide a "safety valve" for those who are not comfortable reporting adverse events or close calls to the internal VA patient safety reporting system, which it complements.

Organization: The NASA Ames Research Center developed and operates the PSRS on behalf of the VA. The Ames Research Center is NASA's lead center for information technology and human factors research.

Date of Implementation: The NASA/VA Patient Safety Reporting System became operational in April 2002 following a multi-year planning process.

Target Population: Health care providers in VA medical centers nationwide are encouraged to report patient safety events or concerns (including close calls and actual adverse events) to the PSRS.

Process of Change: Given NASA's expertise and success in managing the ASRS, the VA asked NASA to build and run the PSRS. In turn, NASA sought to strengthen its capabilities through a better understanding of medical issues and safety events that could affect aviation safety. Before implementation, NASA conducted workshops to educate VA facility safety officers and other personnel, including union representatives, on the need for and operation of the PSRS.

All reports to the PSRS are considered confidential and privileged quality assurance documents protected under federal statutes. (The PSRS does not accept reports of intentionally unsafe or criminal acts, which must be reported administratively.) Reporters are encouraged to include identifying information so that they can be contacted in case additional details are needed to fully understand and characterize the incident. Once the information is deemed complete, the record is stripped of all identifying information.

Reports are analyzed by a team of NASA patient safety experts, including physicians, nurses, and a pharmacist. These experts categorize reports and determine their value for identifying deficiencies and discrepancies in systems and procedures. Responses might include issuing a Patient Safety Bulletin on a particular issue, conducting further research, or reporting on problem patterns in monthly newsletters. The VA's National Center for Patient Safety and individual facilities can combine this information with reports from the VA's internal patient safety reporting system and the VA Root Cause Analysis program to determine appropriate actions.

Results: More than 400 reports have been received and 10 safety bulletins have been issued in two years of operation. (These bulletins have not been publicly disseminated outside the VA.) PSRS reports have been used to verify, better understand, and prioritize issues reported to the VA through other means, and have offered insights for improving patient safety systems, practices, and awareness.

Lessons Learned: A voluntary external safety reporting system complements internal reporting systems by providing additional insights into broad system vulnerabilities. The usefulness of such reports does not depend on volume of data collected, but derives from information about human factors affecting patient safety that can be obtained from front-line personnel. Information obtained from root cause analyses initiated through investigations of internal reports is more precisely actionable.

A combination of internal and external patient safety reporting systems helps the VA demonstrate its commitment to a culture of safety and organizational learning, says James Bagian, M.D., director of the VA's National Center for Patient Safety. The external system provides a gauge to assess how well the internal reporting system is working. The relatively small number of reports received by the PSRS—as compared with 140,000 reports submitted to the VA's internal reporting system in the five years since its inception—suggests that the VA has achieved a high level of trust in its internal reporting system (which is also non-punitive and confidential in nature).

A successful voluntary patient safety reporting system requires a guarantee of confidentiality. Time is needed to build trust as clinicians learn that they can report sensitive information without recrimination and can see the benefits of reporting in organizational learning. An independent reporting system that does not have a regulatory or enforcement function enhances the credibility needed to gain this trust.

Implications: The VA's experience with adding an external patient safety reporting option to an already robust culture of internal reporting might not be the norm. From the standpoint of an individual facility, reporting to the agency's internal system is somewhat analogous to external reporting for an independent institution. Hospitals participating in collaborative efforts, such as the Pittsburgh Regional Healthcare Initiative and the Vermont Oxford Network, find that reporting medication errors and nosocomial infections to external databases permits useful analyses of standardized data to support improvement activities. (1)

Widespread adoption of external patient safety reporting nationally depends in large part on whether Congress enacts pending federal legislation that would guarantee its confidentiality, says Don Nielsen, M.D., senior vice president for quality leadership at the American Hospital Association. Meanwhile, six states have established non-regulatory patient safety centers to promote statewide patient safety reporting and analysis, according to a recent article in American Medical News. This June, for example, the Pennsylvania Patient Safety Authority implemented a Patient Safety Reporting System that collects information on both adverse events and near misses at hospitals, birthing centers, and ambulatory surgical facilities.

For Further Information: Visit the PSRS website or contact Linda Connell, M.A., R.N., director, NASA/VA Patient Safety Reporting System, at linda.j.connell@nasa.gov, or James Bagian, M.D., director, VA National Center for Patient Safety, at james.bagian@med.va.gov. For details on the VA's internal patient safety reporting system, see Bagian JP et al. 2001. Developing and Deploying a Patient Safety Program in a Large Health Care Delivery System, Joint Commission Journal on Quality and Safety 27, 522–32.

References:
1. Sirio CA et al. 2003. Pittsburgh Regional Healthcare Initiative: A Systems Approach for Achieving Perfect Patient Care. Health Affairs 22(5), 157–165; Suresh G et al. 2004. Voluntary Anonymous Reporting of Medical Errors for Neonatal Intensive Care. Pediatrics 113, 1609–18.

This study was based on publicly available information and self-reported data provided by the case study institution(s). The aim of Fund-sponsored case studies of this type is to identify institutions that have achieved results indicating high performance in a particular area, have undertaken innovations designed to reach higher performance, or exemplify attributes that can foster high performance. The studies are intended to enable other institutions to draw lessons from the studied organizations' experiences in ways that may aid their own efforts to become high performers. The Commonwealth Fund is not an accreditor of health care organizations or systems, and the inclusion of an institution in the Fund's case studies series is not an endorsement by the Fund for receipt of health care from the institution.