台灣醫院醫療不良事件根本原因分析現況與相關因素探討

Status of root cause analysis in medical adverse events and related factors among hospitals in Taiwan

目標：本研究欲瞭解台灣醫院內部進行醫療不良事件根因調查分析之現況，進一步探討調查員個人經驗與醫院特性等對調查時人為因素掌握之相關性。方法：採橫斷性調查，以自擬問卷匿名普查全國負責醫療不良事件通報窗口及根因分析調查員，以雙變量分析探討醫院對於醫療不良事件之根因調查分析現況及影響因素間之相關性。結果：共調查122家醫院、590名調查員，平均回收率91.6％。醫院97.5％設有專責單位，89.3％採自主通報。91％設有根因分析小組。調查員18.6％未接受過訓練，35.8％自覺訓練不足，49.1％僅一半甚至更少的信心以現行調查工具能有效掌握根因，94.2％表示調查有障礙，前三位為「事後回溯困難，記憶偏差」、「受訪人員排斥」及「調查員經驗不足」。調查員之個人經驗，不論專業背景、調查年資、件數、是否接受調查訓練及時數、自覺訓練是否足夠等皆會顯著影響調查時對人為因素掌握度。結論：台灣醫院內部通報制度普遍已建立，調查員個人經驗為影響調查結果的重要因素，應更加重視與培訓。

Objectives: This study explored the status of root cause analysis (RCA) of adverse events in Taiwan's hospitals. This study also examined the associations between investigator's personal experience, hospital characteristics with human factors consideration when conducting RCA. Methods: This study adopted a large-scale cross-sectional survey featuring a self-developed questionnaire to investigate the status of the RCA of adverse events and RCA investigators in Taiwanese hospitals. Participants were recruited from institutions responsible for medical adverse event and root cause investigation. Bivariate analysis was applied to analyze the RCA for adverse events and its associated factors. Results: A total of 122 units for hospital patient safety and 590 RCA investigators were surveyed. The questionnaire response rate was 91.6%. Of the hospitals from which participants were recruited, 97.5% had dedicated units to handle reports, 89.3% adopted voluntary reporting system, and 91% established RCA teams. Of the investigators surveyed, 18.6% had not been trained in RCA and 35.8% of the trained investigators still felt insufficiently equipped to engage in RCA. Furthermore, 49.1% of the investigators reported having less confidence to obtain root causes by current investigation tools, and 94.2% of the investigators noted obstacles in adverse event analysis and investigation. The experience of the RCA investigators, including years of participation in the analysis, the number of analysis participated in, whether they received RCA training, total hours of RCA training, and the adequacy of conscious training affected investigators' consideration of human factors when investigating adverse events. Conclusions: The internal reporting system in Taiwan's hospitals is well established, and the personal experience of investigators is a key factor affecting the results of RCA investigations. RCA investigators should, therefore, receive attention and high-quality training.