Cause and Effect Analysis of Closed Claims in Obstetrics and Gynecology Andrew A. White, MD, James W. Pichert, PhD, Sandra H. Bledsoe, RN, ARM, Cindy Irwin, RN, and Stephen S. Entman, MD BACKGROUND: Identifying the etiologies of real or perceived adverse clinical events and undesired outcomes is an im- portant step in improving patient safety and reducing malpractice risks. Systematic analysis of obstetrics and gynecology–related risk management files allows a more complete examination of ways that human and systems factors may contribute to adverse events. OBJECTIVE: To learn the medical complaints of patients who experienced apparent adverse events, the general causes of those adverse events, and the significant specific causal factors involved in obstetrics and gynecology–re- lated risk management cases. METHODS: This was a retrospective analysis of 90 consecu- tive obstetrics and gynecology–related internal review files opened by a medical center’s risk managers between 1995 and 2001. Each file was analyzed to identify factors that may have contributed to or caused unanticipated adverse events. The main outcome was the pattern of contributing factors when they were aggregated into categories. RESULTS: Fifty percent of cases were associated with inpa- tient obstetrics. Factors that may have contributed to ad- verse events were identified in 78% of cases, and most had more than one contributing factor. Thirty-one percent of adverse events were associated with apparent communica- tion problems. Clinical performance issues were identified in 31% of cases, diagnostic issues in 18% of cases, and patient behavior contributed to 14% of adverse events. CONCLUSION: Diagnostic, therapeutic, and communication issues were the most common factors identified. Although the generalizability of these data are unknown, all obstet- rics and gynecology departments face multiple challenges in assuring consistent quality care. Analysis of claims files may help identify opportunities for improvement. (Obstet Gynecol 2005;105:1031– 8. © 2005 by The Amer- ican College of Obstetricians and Gynecologists.) LEVEL OF EVIDENCE: II-3 Specialists in obstetrics and gynecology practice in a liti- gious environment and face pressure to improve health care quality. 1 The Harvard Medical Practice Study 2,3 found that 1.5% of hospitalized obstetrics patients experi- ence an adverse event and that 38.3% of these outcomes were related to negligent care. Recent Institute of Medicine reports 4,5 have also drawn attention to the need for practi- tioners to adopt measures aimed at improving patient safety. Improving women’s health care, assuring patient safety, and reducing malpractice risk are important goals for med- ical centers, physicians, and their insurers. Identifying the reasons for real or perceived adverse events is an important first step toward these goals. Various methods, including autopsy review, closed claim analysis, patient satisfaction surveys, and diagnosis-specific patient chart analysis have been used to develop guidelines for quality improvement or tracking error and malpractice in obstetrics and gynecolo- gy. 6 –12 However, research in this specialty has not concen- trated on identifying common themes or systems contrib- uting to adverse events. Although obstetrics and gynecology departments typ- ically review adverse events in quality assurance activi- ties, analysis of individual cases does not always promote improvements in patient safety. 13 Aggregating data from many incidents may permit more effective identification of recurring or systems errors. 8,12 The objective of this study was to systematically examine obstetrics and gy- necology–related risk management files to assess the presentations, causes, and characteristics of real or per- ceived adverse events. Risk management files were used because they are more numerous than lawsuits 14 and provide richer information than medical records at less cost. 15 These files contain relevant medical records aug- mented by interviews with the care team and, some- times, expert reviews of the case. These interviews and From the Vanderbilt University School of Medicine, Nashville; Center for Patient and Professional Advocacy, Department of Medical Education and Administration, Office of Risk and Insurance Management, and Department of Obstetrics and Gynecology, Vanderbilt University School of Medicine, Nashville, Tennessee. Supported in part by Vanderbilt’s Center for Patient and Professional Advocacy and Vanderbilt’s Center for Improving Patient Safety, Agency for Healthcare Research and Quality grant HS11563. The authors thank Carla Ross, RN, Felicia Vaden, Rachel Garton, and Marlon Fielder for technical assistance during this project. VOL. 105, NO. 5, PART 1, MAY 2005 1031 © 2005 by The American College of Obstetricians and Gynecologists. 0029-7844/05/$30.00 Published by Lippincott Williams & Wilkins. doi:10.1097/01.AOG.0000158864.09443.77