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系統識別號 U0026-1307201021193800
論文名稱(中文) 以HFMEA改善對癌症住院病人施行化學治療的流程 -以台灣某區域教學醫院為例-
論文名稱(英文) Using HFMEA to Improve Chemotherapy Process for Inpatient of cancer - An Example of a Teaching Hospital in Taiwan -
校院名稱 成功大學
系所名稱(中) 高階管理碩士在職專班(EMBA)
系所名稱(英) Executive Master of Business Administration (EMBA)
學年度 98
學期 2
出版年 99
研究生(中文) 鄭哲舟
研究生(英文) Tse-Chou Cheng
學號 r0796113
學位類別 碩士
語文別 中文
論文頁數 132頁
口試委員 指導教授-張有恆
口試委員-鄭永祥
口試委員-蔡東峻
中文關鍵字 病人安全  用藥安全  化學治療用藥安全  FMEA  HFMEA 
英文關鍵字 Patient safety  Medication safety  Chemotherapy safety  FMEA  HFMEA 
學科別分類
中文摘要 「Do Good, Do Not Harm!」;醫療倫理的首要原則可以說是「不傷害」。然而,病人住院接受治療卻常發生醫療不良事件。自從1999年美國國家醫學研究機構(Institute of Medicine, IOM)提出“To Err is Human:Building A safer Health System”(犯錯乃人之常情:應建立一個更安全的醫療體系)報告書後,病人安全已得到全世界的重視,包括台灣。
行政院衛生署於民國九十二年二月(2003年)成立病人安全委員會;2003年,行政院衛生署、醫策會及國衛院共同辦理「全國醫療衛生政策會議」。會議中提出「病人安全宣言」,其中明言醫院應建構用藥安全機制。
在病人安全議題上值得努力的各個方面,用藥錯誤居醫療誤失之首,所以用藥安全是病人安全最重要的一環。其中,對住院癌症病人施行化學治療具有高危險性的流程,因此,最值得檢討。
檢討醫院內對住院癌症病人的施行化學治療的用藥安全,可由病安事件發生以後,應用根本原因分析來分析錯誤、檢討流程,也可以以預應式的醫療照護失效模式效應與分析,如HFMEA,來預防錯誤事件的發生。
本研究針對台灣某教學醫院的對住院癌症病人施行化學治療的流程實施HFMEA,研究結果發現164個失效模式與199個相對應的原因,並提出各種改善策略,期待更新後的流程,使系統更堅強,能達預防用藥錯誤的發生。
英文摘要 “Do Good, Do Not Harm” is the prime principle of medical ethics. However, patient-safety incidents still occur in hospitalized patients. Ever since 1999, when the Institute of Medicine (IOM) published “To Err is Human: Building a Safer Health System”, patient safety has gained increasing attention all over the world, including Taiwan.
In Taiwan, the Department of Health (DOH), Executive Yuan established the National Patient Safety Committee in 2003; DOH, Taiwan Joint Commission on Hospital Accreditation and National Health Research Institutes held a National Health Policy Conference. “Declaration on Patient Safety” was launched at the Meeting, stating that a mechanism to improve medication safety should be implemented in every hospital nationwide.
Medication errors are the most common incidents among patient safety issues that require ongoing advocacy efforts. Thus medication safety is the primary principle concern regarding patient safety. Especially, delivery of inpatient chemotherapy that carries high risks requires extra vigilance and attention.
To improve the safety of inpatient chemotherapy, Root Cause Analysis(RCA) can be applied after the occurrence of events, or prospective analysis of potential risks, such as HFMEA, can be used to prevent the possibility of errors and mistakes.
The study reviews the results of applying HFMEA on the procedure of chemotherapy for hospitalized patients in a teaching hospital in Taiwan. The results revealed 164 failure modes and 199 counterpart causes. Based on the findings, the study suggests strategies for improving the procedure and enhancing drug delivery systems to prevent future medication errors.

論文目次 目錄
摘要 III
ABSTRACT IV
誌謝 V
目錄 VI
表目錄 VII
圖目錄 VIII
第一章 緒論 1
第一節 研究背景與動機 1
第二節 研究目的 4
第三節 研究步驟 5
第二章 文獻探討 6
第一節 病人安全 6
第二節 用藥安全與藥物錯誤 10
第三節 失效模式與效應分析 14
第四節 健康照護失效模式與效應分析 18
第五節 FMEA和HFMEA於醫療照護產業的應用 23
第三章 研究方法 30
第一節 腦力激盪與要因分析 30
第二節 HFMEA的實施步驟 33
第四章 實例驗證 42
第一節 依步驟實際執行HFMEA 42
第二節 實際執行HFMEA與結果 47
第三節 討論實務面之意涵 119
第五章 結論與建議 122
第一節 研究結論 122
第二節 研究限制 123
第三節 建議 123
參考文獻 125


表目錄
表2-1 嚴重度分數的定義的參考範例 15
表2-2 發生率分數的定義的參考範例 15
表2-3 偵測度分數定義的參考範例 16
表2-4 探討運用FMEA於醫療照護產業的文獻與摘要 17
表2-5 HFMEA的危害指數矩陣(Hazard Scoring Matrix) 19
表2-6 HFMEA工作表單 21
表2-7 應用FMEA於醫療儀器設計與醫用電腦軟體設計的相關的文獻 24
表2-8 應用FMEA/HFMEA於流程改善的文獻 25
表2-9 應用FMEA/HFMEA於給藥安全的文獻 27
表2-10 應用FMEA/HFMEA於對癌症病人施行化療治療的文獻 29
表3-1 HFMEA嚴重度(SEVERITY)分級(1) 35
表3-2 HFMEA嚴重度(SEVERITY)分級(2) 36
表3-3 HFMEA發生的可能機率(probility of occurrence)分類 37
表3-4 HFMEA危害指數矩陣(Hazard Scoring Matrix) 38
表3-5 本研究使用的危害分析表單 41
表4-1 本研究團隊成員 43
表4-2 本研究時程 43
表4-3 以HFMEA改善化療的前置作業 49
表4-4 以HFMEA改善醫囑開立階段的作業 54
表4-5 以HFMEA改善資深護理師執行醫囑輸入階段的作業 61
表4-6 以HFMEA改善醫囑開立後護理人員的作業 66
表4-7 以HFMEA改善醫囑開立後輸送人員的作業 70
表4-8 以HFMEA改善化療調劑室的調劑作業 74
表4-9 以HFMEA改善輸送人員的輸送藥物作業 97
表4-10 以HFMEA改善護理人員給藥作業 104

圖目錄
圖2-1 HFMEA決策樹分析 20
圖3-1 本研究的特性要因圖 32
圖3-2 HFMEA決策樹分析 39
圖4-1 個案醫院對住院接受化療病患的給藥流程(總流程) 45
圖4-2 個案醫院化學治療藥物調配作業與覆核流程圖(子流程) 46
圖4-3 個案醫院病房執行化學治療給藥流程圖(子流程) 47
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