背景與目的：隨著醫療水準的進步，放射線檢查類的異常事件，在醫療事件中比重已逐漸增加。本研究利用「醫療失效模式與效應分析」此一預防性工具，應用於放射線病人檢查的作業流程，選出高風險的原因並加以改進，並追蹤其改善成果，來提升放射線檢查中的病人安全。
方法：本研究導入「醫療失效模式與效應分析」工具，共分五大步驟，定義主題，組織團隊，繪製作業流程圖，執行風險分析，行動並測量結果，具體用於提升放射線病人檢查安全個案。
結果：依據「醫療失效模式與效應分析」，找出風險因子有六大項，其相對應改善對策及評量指標為：
一。勤務中心人力不足：加強勤務人員訓練，調整勤務人力配置及賞罰分明。
二。等候區無人照顧：行「走動式服務」
三。多床等候檢查：規劃病房檢查時段，雙軌制申請派工，延遲接回數據回饋。
四。超音波檢查等候時間過久：調整排程時間，調整檢查人力配置，評量平均等候時間。
五。磁振照影未事先評估受檢：更改檢查前準備通知書，回饋檢查失敗比率。
六。醫師報告內容錯誤或不完整： 建立醫師雙重審查機制，建立報告回饋機制，導入結構性報告。
結論：本研究顯示以「醫療失效模式與效應分析」改善放射線病人檢查安全，可系統性地找出作業流程中風險因子，利用團隊共識，提出改善對策及客觀評量指標，望能減少醫療錯誤產生，並定期追蹤其成果，來達到提升病人安全及增進醫療服務品質。

Background and Purpose: With the advancement in healthcare standards, an increasing number of medical errors have been reported in radiology departments. In this study, we applied a proactive tool, Healthcare Failure Mode and Effects Analysis (HFMEA), to study the patient examination in radiology department, in order to identify high risk factors and recommend appropriate improvement. We also followed up improvement outcomes to enhance the patient safety in radiology department.
Methods: In this study, Healthcare Failure Mode and Effects Analysis comprises five steps: Defined the HFMEA topic, assemble the team, graphically describe the process, conduct a hazard analysis, and actions and outcome measures. This was specifically used to enhance the the patient safety in radiology department.
Results: We identified six major risk factors, and, together with the corresponding improvement strategies and evaluation indicators, are listed as follows:
1. Insufficient human resources at the dispatch center: Improve dispatch staff training, adjust dispatch staff allocation, and clarify rewards and punishments.
2. Waiting area left unattended: Implement Management by Walking Around (MBWA) service
3. Multi-bed queue examination: Planning ward examination periods, Dual-track application to send out dispatch staff, and delay data feedback.
4. Excessive waiting times for ultrasound examination: Adjust scheduling, and inspection staff allocations, and evaluate average waiting times.
5. Magnetic resonance imaging not assessed in advance: Changing the pre-examination preparation notice, and the return of feedback on examination failure rates.
6. Faulty or imcomplete radiologist reports: Establish radiologist dual-review system, and report feedback mechanisms, and apply structural reports.
Conclusion: This study indicated that applying "Healthcare Failure Modes and Effects Analysis" to improve examination safety of patients in radiology department, consist of systematically identifying risk factors, using team consensus, and proposing improvement strategies and objective evaluation indicators, in order to reduce medical errors, regularly follow up their outcomes, and achieve enhancement of patient safety and quality of medical services.

論文審定書.......................................................................................................................i
誌謝..................................................................................................................................ii
中文摘要……………………………………………………………………………… iii
Abstract………………………………………………………………………………....iv
目錄……………………………………………………………………………………..v
圖次……………………………………………………………………………………..vi
表次.................................................................................................................................vii
第一章 緒論.....................................................................................................................1
第一節 研究背景及動機...........................................................................................1
第二節 研究目的.......................................................................................................2
第二章 文獻查證.............................................................................................................3
第一節 醫療現況與病人安全...................................................................................3
第二節 醫療錯誤的產生...........................................................................................3
第三節 放射線檢查醫療事件...................................................................................4
第四節 醫療失效模式與效應分析的歷史...............................................................6
第三章 研究方法.........................................................................................................10
第一節 定義HFMEA的主題.................................................................................10
第二節 組織團隊.....................................................................................................10
第三節 繪製作業流程圖.........................................................................................10
第四節 執行風險分析.............................................................................................11
第五節 行動並測量結果.........................................................................................12
第四章 個案研究.........................................................................................................13
第一節 個案背景.....................................................................................................13
第二節 HFMEA於個案醫院提升放射線部病人檢查安全...................................13
一。定義HFMEA的主題.......................................................................................13
二。組織團隊..........................................................................................................13
三。繪製作業流程圖..............................................................................................14
四。執行風險分析..................................................................................................15
五。行動與結果量測..............................................................................................32
第三節 HFMEA於個案醫院提升放射線病人檢查安全之分析與成果...............34
一。分析與改善對策..............................................................................................34
二。實施成果..........................................................................................................43
第五章 討論與建議.....................................................................................................48
第一節 研究討論.....................................................................................................48
第二節 研究限制.....................................................................................................49
第三節 建議.............................................................................................................50
第四節 研究貢獻.....................................................................................................51
參考文獻.........................................................................................................................52
一。中文文獻.........................................................................................................52
二。英文文獻..........................................................................................................53

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中華民國放射線醫學會 (2010) 台灣放射線檢查之病人安全流程與作業指引.2010年5月
台灣病人安全通報系統2012年度報表. (2013). http://www.tpr.org.tw/images/pic/files/台灣病人安全通報系統2012年度報表_10207(Final)_201308131652.pdf
林淑娟. (2004). 運用失效模式與效應分析於手術流程之病人安全評估-以中部某區域教學醫院為例, 中國醫藥學院, 碩士論文.
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郭宜禎. (2008). 運用醫療失效模式與效應分析提升中醫針刺病人安全-以中部某區域教學醫院為例. 中國醫藥大學醫務管理學系碩士班學位論文, 1-66.
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曾耀群. (2009). 應用醫療照護之失效模式與效應分析於醫療流程之改善.(未出版之碩士論文)
劉時佐, 何淑熏, 何子龍, & 李垣林. (2011). 應用 [醫療照護失效模式與效應分析] 於癌症患者電腦斷層與磁振造影檢查之影像報告品質提升. 放射線學雜誌, 36(3), 57-64.
劉泰程. (2012). 應用 RFMEA 提高電腦斷層檢查作業安全性之研究. 中臺科技大學健康產業管理研究所學位論文.
 
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CAC. (1997). HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM AND GUIDELINES FOR ITS APPLICATION. Annex to CAC/RCP, 1(Rev. 3), 1969.
Cheng, C. H., Chou, C. J., Wang, P. C., Lin, H. Y., Kao, C. L., & Su, C. T. (2012). Applying HFMEA to prevent chemotherapy errors. J Med Syst, 36(3), 1543-1551. doi: 10.1007/s10916-010-9616-7
Cochran, S. T. (2005). Anaphylactoid reactions to radiocontrast media. Curr Allergy Asthma Rep, 5(1), 28-31.
DeRosier, J., Stalhandske, E., Bagian, J. P., & Nudell, T. (2002). Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective risk analysis system. Joint Commission Journal on Quality and Patient Safety, 28(5), 248-267.
Habraken, M., Van der Schaaf, T., Leistikow, I., & Reijnders-Thijssen, P. (2009). Prospective risk analysis of health care processes: A systematic evaluation of the use of HFMEA™ in Dutch health care. Ergonomics, 52(7), 809-819.
IOM. (2001). Crossing the Quality Chasm: A New Health System for the 21st Century: The National Academies Press.
Kohn, L. T., Corrigan, J. M., & Donaldson, M. S. (2000). To err is human: building a safer health system (Vol. 627): National Academies Press.
Mattsson, F. (1995). An introduction to risk analysis for medical devices. Compliance Engineering, 11(12), 47-57.
Reason, J., Parker, D., & Lawton, R. (1998). Organizational controls and safety: The varieties of rule‐related behaviour. Journal of occupational and organizational psychology, 71(4), 289-304.
Shebl, N., Franklin, B., Barber, N., Burnett, S., & Parand, A. (2012). Failure Mode and Effects Analysis: views of hospital staff in the UK. J Health Serv Res Policy, 17(1), 37-43.
Swensen, S. J., & Johnson, C. D. (2005). Radiologic quality and safety: mapping value into radiology. Journal of the American College of Radiology, 2(12), 992-1000.
Thornton, E., Brook, O. R., Mendiratta-Lala, M., Hallett, D. T., & Kruskal, J. B. (2011). Application of failure mode and effect analysis in a radiology department. Radiographics, 31(1), 281-293. doi: 10.1148/rg.311105018
Vélez-Díaz-Pallarés, M., Delgado-Silveira, E., Carretero-Accame, M. E., & Bermejo-Vicedo, T. (2013). Using Healthcare Failure Mode and Effect Analysis to reduce medication errors in the process of drug prescription, validation and dispensing in hospitalised patients. BMJ Quality & Safety, 22(1), 42-52.
Wang, C. L., Cohan, R. H., Ellis, J. H., Adusumilli, S., & Dunnick, N. R. (2007). Frequency, management, and outcome of extravasation of nonionic iodinated contrast medium in 69,657 intravenous injections. Radiology, 243(1), 80-87. doi: 10.1148/radiol.2431060554