運用失效模式與效應分析評估接受磁振造影檢查之病患安全性

Using HFMEA to Assess the Patients Safety in MRI Examinations

現今醫療院所推動的重點項目，主要是以「病人安全為中心」，且將病人安全之議題列入管理的項目中，醫療照護失效模式與效應分析（Healthcare Failure Mode and Effects Analysis ，簡稱HFMEA） 是醫療界採行的一種前瞻性、預防式的系統風險分析工具，最大的特色是對醫療作業流程做出全面性的風險管理，避免不良及異常事件的發生，同時協助醫療管理者面對問題時處理之優先順序，改善相關之制度與作業流程。本研究以中部某區域教學醫院放射診斷科臨床實例，導入HFMEA 以評估接受磁振造影之病患在執行檢查過程中，潛在之風險因素、人為疏失或醫療錯誤，並提出預防及改善方案。透過HFMEA 步驟進行活動研究與分析，於失效模式分析出共21 個可能失效模式、48 個可能失效原因，經決策樹分析提出需矯正8 個問題點，問題確立後運用品質管理循環（Plan-Do-Check-Action ，簡稱PDCA） 手法提出措施與進行改善。2008-2009 年在未改善前磁振造影檢查異常事件如下：氧氣瓶隨患者進入檢查室、維修用鐵製椅子進入檢查室各1 件，患者使用顯影劑過敏反應2 件，裝心律調節器患者進入檢查室1 件，金屬製品小物帶入檢查室11 件，合計16 件，異常事件百分比0.38% 。2010 年度實施HFMEA 改善後異常事件：金屬製品小物帶入檢查室2 件，異常事件共2 件，異常事件百分比0.1% ，改善幅度達73.7% 。由結果證實HFMEA 的運用，對於流程改善與病人安全的提升是有助益的，故醫療從業人員對HFMEA 應用的普及與熟練度持續努力，透過流程的檢討、分析潛在風險，將能確保醫療照護品質與建立優質的醫療環境。

The most critical item discussed and debated in medical institutions nowadays focuses upon the medical care mode which centers on the patient’s safety that is included in the management project. Healthcare Failure Mode and Effects Analysis (HFMEA) is the medical community to adopt a proactive, preventative system as risk analysis tools, and the biggest feature is to make a comprehensive medical practice risk management processes, to avoid adverse and unusual events while helping healthcare managers deal with priority problem, improve dysregulated systems, and related processes. In this study, Healthcare Failure Mode and Effects Analysis (HFMEA) were used to assess and explore the potential risk factors, carelessness, or medical errors that happened while patients were receiving Magnetic Resonance Imaging (MRI) examination, and proposed ways for prevention and improvement in analyzing the whole process. After putting HFMEA into practice, the researchers found that there were 21 possible failure modes and 48 failure reasons. Through decision tree, eight possible failure reasons that needed to be corrected were brought up, and then Plan-Do-Check-Action (PDCA) was conducted and measures were applied for improvements. In 2008 and 2009 when HFMEA was not conducted, 16 abnormal events (0.38%) happened before carrying out the MRI examination, including one patient with an oxygen bottle, a maintenance chair seen in the examination room, two patients having allergic reactions to contrast media, one patient with a pacemaker entering the examination room, and 11 occurrences of small metal objects carried into the examination room. In 2010, HFMEA was conducted, and at the end of that year, only two (0.1%) abnormal events occurred, that was small metal objects were brought into the examination room, which led to 73.7% improvement rate. HFMEA is significantly advantageous when it comes to improving the process and patient’s safety during the examination. The researchers suggest that in the future, more and constant efforts must be made to promote and efficiently perform HFMEA. Through reviewing the process, a medical team will be able to analyze potential risks in order to ensure the quality of medical care and build up a high-quality medical care environment.