應用「醫療照護失效模式與效應分析」HFMEA評估核醫造影給藥安全並改善作業流程以提升整體醫療品質

Risk Assessment of Radiopharmaceutical Administration and Enhancement of the Safety and Imaging Quality by Using Healthcare Failure Mode and Effect Analysis (HFMEA) Model

陳雅凰(Ya-Huang Chen) ； 賴佳玟(Jia-Wen Lai) ； 汪姍瑩(Shan-Ying Wang) ； 陳佳伶(Jia-Ling Chen) ； 黃兆駿(Zhao-Jun Huang) ； 李柏葦(Bo-Wei Li) ； 吳彥雯(Yen-Wen Wu) ； 陳銘樹(Ming-Shue Chen)

《核子醫學暨分子影像雜誌》 29卷3期 (2016/09) Pp. 105-125

https://doi.org/10.6332/ANMMI.2903.001

摘要

背景：醫療照護失效模式與效應分析，簡稱HFMEA，是近年來醫院管理廣泛運用來評量病人安全相關流程與預防重大病安危害，並成為流程改善依據的一種重要工具，其最大的特色是針對攸關病安作業流程做全面性的風險評估及管理，用以避免異常事件的發生，同時協助醫務管理者改善相關制度與作業流程。材料與方法：本研究以改善某醫學中心核子醫學科之放射性藥物給藥流程為例，透過由核子醫學專科醫師、醫事放射師、護理師、醫療技術員及醫事檢驗師共同組成HFMEA小組，應用HFMEA改善手法，評估病人接受核子醫學檢查中之放射性藥物給藥流程之安全，從原有流程中我們找出31項失效模式及40項失效原因，並利用危害指數矩陣及決策樹分析進行失效原因評估及危害風險分析，確認有7項失效原因須優先進行改善，另外有7項失效原因為嚴重度較高者，也須列入改善項目。結果：研究結果顯示，針對失效原因提出預防及改善方案後，重新評估後呈現流程中31項失效模式降低為21項，危害風險指數也均有顯著下降，在主流程中放射性藥物給予的步驟，也因建立預防措施及嚴格的雙重確認機制，有效降低了放射性藥物給予的風險。結論：研究呈現，有效運用HFMEA手法，能預防核子醫學科放射性藥物投藥錯誤的發生，並提升病人辨識與放射性藥物核對的正確性。

關鍵字

危害指數矩陣 ； 醫療照護失效模式與效應分析 ； 放射性藥物

並列摘要

Background: Healthcare failure mode and effect analysis (HFMEA) is a proactive tool used to analyze risks, identify potential failures before they occur and prioritize preventive measures. The aims of this study were to evaluate the frequency, type, preventability, as well as potential and actual severity of radiopharmaceutical administration errors in a nuclear department in a tertiary medical center, to examine the hazards associated with the process and identify where improvements are needed. Methods: The multidisciplinary teams of nuclear physicians, radiologists, clinical laboratory technologists and nurses were trained to analyze the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure. Probability of occurrence was classified using a six-point scale. Severity was defined according to the HFMEA Severity Scale. The study was to identify higher-priority potential failure modes as defined by RPNs and to plan changes in clinical practice in order to reduce the risk of patient harm and improve safety in the process. Results: In all, radiopharmaceutical maladministration identified 31 failure modes, 40 associated causes and effects were identified. Most errors were preventable and the adverse events to diagnostic radiopharmaceuticals had no immediate adverse effect, and no or little effect on clinical outcome. Seven failure causes were identified to require high-priority improvement; 7 failure modes with high risk should be re-evaluated. The introduction of new activities in the revised process allowed reducing the number of high-risk failure modes from 31 to 21, and resulted in a significant reduction in severity scores. Conclusions: HFMEA is a valid proactive risk assessment tool to aid multidisciplinary teams in understanding the care processes and identifying errors that may occur, prioritizing remedial interventions and possibly enhancing the safety of radiopharmaceutical administrations.

並列關鍵字

hazard scoring matrix ； healthcare failure mode and effect analysis (HFMEA) ； radiopharmaceuticals