Using Incident Reporting to Improve Patient Safety: A Conceptual Model Peter J. Pronovost, MD, PhD,*Þ Christine G. Holzmueller, BLA,* Jonathan Young, AB,þ Paul Whitney, PhD,þ Albert W. Wu, MD, MPH,§ David A. Thompson, DNSc, MS, RN,* Lisa H. Lubomski, PhD,* and Laura L. Morlock, PhD§ Objectives: The objectives of this paper are to discuss the role of risk analysis and event taxonomies in patient safety reporting systems (PSRSs) and present a conceptual model that supports the use of reporting and analysis to help guide patient safety improvement efforts. Methods: This research involves an analysis of the methodologies being used to use medical incident reports to improve patient safety. Areas discussed are risk analysis, incident-reporting contributions to risk measures, and event taxonomies for health care procedures. Results: Incidents reported in PSRSs are subject to selection bias, have unknown denominators, and require standardized taxonomies for numerators. PSRSs provide a mechanism to identify and learn from mistakes. A conceptual model for using a PSRS to improve safety is proposed. This model includes 4 major elements: (1) recognition and reporting of events, (2) event analysis, (3) analysis of results produced, and (4) process changes developed and implemented. The central themes of this model are education and learning to engage staff and organizations and to affect behavioral change. Conclusions: PSRS is a widely recommended as a strategy to address the important problem of patient safety. Most efforts have focused on developing reporting systems and collecting incident data. We are now faced with deciding how best to analyze and report information back to stakeholders and what process changes will best decrease harm. We outline a comprehensive conceptual model to help realize the full potential of reporting systems in patient safety improvement efforts. Key Words: patient safety reporting systems, adverse, events, incidents, harm, near miss, process mapping (J Patient Saf 2007;3:27Y33) A significant number of people are harmed rather than helped by medical care everyday. 1Y3 The Institute of Medicine (IOM) reported that as many as 98,000 people die in hospitals each year from medical errors. 1 In efforts to reduce errors, the IOM called for the creation of patient safety reporting systems (PSRSs) to focus on serious adverse events and no-harm (near miss) events. In a 2004 report, Patient Safety, Achieving a New Standard for Care, the IOM stated that Bpatient safety systems (should) integrate with clinical information systems.^ 4 Recommendation 1 in this report was that Bimproved information and data systems are needed to support efforts to make patient safety a standard of care^ and that all health care organizations should Bcapture information on patient safety and use this information to design even safer care delivery systems.^ Over the past 6 years, many have responded to these reports by supporting, creating, and implementing PSRSs. Twenty-two states now have legislation requiring PSRS, and Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires that hospitals report mis- takes. In addition, in July of 2005, the US Congress passed the Patient Safety and Quality Improvement Act including incident reporting as a significant component. 5 Despite diligent efforts, most PSRSs are still in their infancy, 6 and the data obtained from these reporting systems are often misinterpreted. Some reporting systems are mandatory, whereas others are voluntary. Nearly all, however, have focused on getting health care organizations to submit reports. Relatively little attention thus far has focused on analyzing the reports and evaluating whether the information received is used to improve patient safety. The following chain of events must occur in the PSRS process to improve patient safety. Medical staff must first submit reports, and the information received must be coded and analyzed. Finally, the results must be sent back to caregivers and administrators for use in reducing harm to future patients. There is debate regarding the goals of reporting. One sector feels that the goal is to improve patient safety, whereas another is pushing for individual and institutional accountability. 7 In addition, there is wide variation in analysis methods. 8 The objectives of this paper are to discuss the role of risk analysis and event taxonomies in incident reporting and present a conceptual model that supports the use of reporting and analysis to help guide patient safety improvement efforts. Understanding Safety, Harm, and Risk A significant component of improving patient safety involves understanding and managing the risks that lead to ORIGINAL ARTICLE J Patient Saf & Volume 3, Number 1, March 2007 27 From the Departments of *Anesthesiology and Critical Care Medicine and †Surgery, ‡The John Hopkins University, Baltimore, Maryland, and §Department of Health Policy & Management, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland. Grant support provided by the Agency for Healthcare Research and Quality (grant no. 1 U18HS11902). Correspondence: Peter J. Pronovost, MD, PhD, 1909 Thames Street, 2nd Floor, Baltimore, MD 21231 (e-mail: ppronovo@jhmi.edu). Copyright * 2007 by Lippincott Williams & Wilkins Copyr ight © Lippincott Williams & Wilkins. Unauthor iz ed reproduction of this article is prohibited.