醫療風險管理之預應式分析法的應用缺失探討

Application deficiencies of proactive analysis method for health care risk management

目的：近年來醫院積極採用預應式風險管理方法。本研究目的是探討醫療照護FMEA應用所產生的缺失。 方法：本研究採個案研究法，檢視醫院提供之FMEA/HFMEA 的個案報告，並比對各項質疑點，綜整歸納不 合乎FMEA專有名詞定義、標準作法、以及混淆的缺失。 結果：收到9家醫院資料，研究顯示質疑處的統計，以失效模式與失效原因正確性最多，其次為嚴重度與 RPN/危害指數、決策樹分析、驗證方法。發現有五項缺失順序為: 失效原因大多不是根因、嚴重度不一致、 失效模式與失效原因混淆、決策樹分析不明、失效模式與失效影響未清楚呼應。 結論：FMEA是推動醫院風險管理必要之能力，為增加風險管理的效能，本文建議應加強應用FMEA之系統 思考的訓練以及技術上的熟稔。

 

Objectives: In recent years, hospitals have actively adopted proactive risk management methods such as failure mode and effects analysis (FMEA). The study explored the deficiencies arising from the applications of FMEA and health care FMEA (HFMEA). Methods: By using the case study method, this study reviewed FMEA and HFMEA case reports provided by hospitals and then identified and compared various ambiguities. Finally, the deficiencies were summarized by reviewing the definition of FMEA terms and standard practices as well as through analysis of confusion. Results: Nine hospitals provided the aforementioned case reports. The highest numbers of ambiguities were noted in the correctness of failure modes and causes, followed by that of severity, Risk Priority Number, hazard index, and finally, decision tree analysis and verification methods. The following five application deficiencies were noted, in order of high to low intensity: failure causes were not root causes, failure severity was inconsistently reported, failure modes were mixed with failure causes, decision tree analysis methods were unclear, and failure modes and effects were unclearly reported. Conclusions: FMEA and HFMEA application is essential for enhancing a hospital’s risk management. This study thus recommends FMEA and HFMEA application during training to enhance systems thinking and technical skills.