運用醫療失效模式與效應分析降低急診室動脈內取栓術術前準備缺失率

Using Healthcare Failure Mode and Effects Analysis to Reduce Intra-Arterial Thrombectomy Preoperative Preparation Error Rates in the Emergency Room

背景：動脈內取栓術為治療缺血性腦中風病人並幫助血管再灌流的新穎手術方式；能減少腦損傷和失能的風險。鑑於本單位動脈內取栓術術前準備過程複雜造成缺失率高達100%；雖皆為幾近錯失（near-miss），但仍有病人安全之疑慮，因此選用醫療失效模式與效應分析（healthcare failure mode and effects analysis, HFMEA）檢視單位動脈內取栓術術前準備流程，找出高風險因子，執行預防措施及因應策略，確保病人安全。目的：降低急診室動脈內取栓術術前準備缺失率。解決方案：本專案依照HFMEA之五步驟進行，執行日期2019年4月1日－10月31日，依潛在失效原因進行危害指數計算與決策樹分析並擬定行動方案：製作同意書quick response code、設計醫令套餐、制定查核表、修訂同意書與程序書、舉辦在職教育、建立稽核制度與增購設備。結果：原16項潛在失效原因的有13項危害指數均降低至8分以下進步率為81.3%；持續追蹤本單位2019年12月，動脈取栓術術前準備缺失率為0%，顯示有達成專案之目的。結論：本專案運用HFMEA建構動脈內取栓術執行流程安全策略，執行的結果是完備術前準備過程，且病人沒有發生手術延遲。建議國內各醫院能針對病人安全之高風險流程進行檢測及改善，以提升病人的照護品質。

Background & Problems: Intra-arterial thrombectomy (IAT) is a novel surgery that may restore cerebral blood flow in patients with ischemic stroke and lower the risks of permanent brain damage and disability. Because the process of preoperative preparation for IAT is complicated, error rates for this process have been reported in previous studies to be as high as 100%. Although these errors did not result in serious damage to patients, the risk to patient safety remains. Therefore, reducing the error rate for IAT preoperative preparation is necessary to improve patient safety. Purpose: To reduce the rate of IAT preoperative preparation error in an emergency room. Resolution: This project applied healthcare failure mode and effect analysis (HFMEA) to evaluate the potential risks of IAT preoperative preparation in an emergency room. Based on the resultant hazard score, critical preventive measures were adopted, including creating a quick response code consent form, designing order packages, developing a checklist form, modifying stroke operating procedures and policies, planning suitable education content for staffs, developing criteria for evaluating preoperative preparation procedures, and installing vital signs equipment. Results: After implementation of these measures, the hazard scores of 13 out of the 16 potential failure causes decreased to ＜ 8, and the progress rate was 81.3%. The follow-up error rate for preoperative preparation was 0% in October 2019, which fulfilled the goal of this project. Conclusion: Preoperative preparation for IAT is complicated and time-consuming. In this project, HFMEA was introduced to ensure that preoperative preparation was accomplished in a complete and timely manner. Based on the results, after implementation, preparation work was effectively completed and operations were performed on schedule. Other hospitals may consider using this tool to evaluate potential risks to patient safety and to develop solutions to improve the quality of healthcare processes.