據財團法人醫院評鑑暨醫療品質策進會之報告指出，全臺灣各醫療機構常見的病人安全事件之前五名依序是藥物事件、跌倒事件、管路事件、傷害行為事件、檢查檢驗事件，由於病人因素為個人主觀意識行為，較難有效控制，而藥物事件在過去已有許多研究針對此部分進行改善與討論，因此，本研究將針對檢查檢驗事件深入討論，旨在降低人為失誤的發生、進而提升病人安全。
研究對象為新竹某區域教學醫院檢驗科血液組的日、夜班醫事檢驗師共16名。首先透過從旁觀察並以攝影機側錄，分析其檢驗作業之操作流程，隨後根據2014年與2015年的檢驗報告之統計資料找出發生頻率較高之報告更改原因，並採取根本原因分析（Root Cause Analysis, RCA）追溯事件發生之經過，最後針對根本原因擬定改善策略。另一方面，利用醫療照護失效模式與效應分析（Healthcare Failure Mode and Effect Analysis, HFMEA）進行預應式的風險管理，根據潛在失效模式的行動優先次序擬定改善對策。此外，亦利用NASA工作負荷指標（Task Load Index）評估工作負荷以及其與作業之間的關係。
現況分析之結果顯示：報告更改件數並未隨著月份而有特定的波動趨勢，而報告更改原因則以「醫檢人員檢驗操作步驟錯誤」、「結果輸入錯誤」與「結果判讀錯誤」依序為發生頻率最高之前三位。針對發生頻率最高之報告更改原因查閱詳細的相關資料後，再就此不良事件進行根本原因分析，調查結果為「未明確定義好更換試藥的時間點因而導致報告更改」，透過工程改善即可防止該事件發生。HFMEA之結果則指出「脂血檢體使用氣送系統傳送導致溶血」、「檢體凝固」以及「計數孔阻塞」三項失效模式必須改善，故各自提出方案並透過專家意見予以評估確認成效。
另一方面，醫檢師自覺工作負荷之結果顯示人工閱片、體液檢驗的工作負荷最高，血液沉降速率檢驗、血色素電泳檢驗則為最低，可推論作業項目涉及手工操作時會使醫檢師之工作負荷增加。此外，男、女性醫檢師之間的工作負荷並無顯著差異，但年資較深、日班的醫檢師之工作負荷較年資淺、夜班的醫檢師高。工作負荷與風險評估的一致性分析結果則顯示：隨著操作步驟的增加，工作負荷確實會隨之提高，但風險較高的作業未必伴隨較高的工作負荷，且工作負荷高的作業項目並未反映出較多的報告更改件數，因此工作負荷可能不是造成報告更改的原因。
藉由現況分析、HFMEA、RCA以及NASA工作負荷指標等工具，本研究發現檢驗科血液組的報告更改非與作業的風險及工作負荷直接相關，因此後續宜利用其他分析工具找出更可靠的預測因子；不過，這些分析的結果仍有助於改善檢驗流程，預防失誤的發生。此外，本研究只針對檢驗科血液組進行討論，未來可再延伸至不同的工作組別，提供臨床實驗室更廣泛的改善參考。

According to the report of Joint Commission of Taiwan, the top five patient safety incidents in Taiwan are medication errors, patient fall events, tube incidences, injury behavior events, an inspection events. The factors of patients are mainly due to the behavior of subjective consciousness, so it is difficult to be controlled effectively. Besides, medication errors have been widely studied and improved in the past. Therefore, this study focuses on the inspection events, so as to reduce human error and enhance patient safety.
A total of 16 medical technologists in a regional teaching hospital in Hsinchu were surveyed for their inspection work associated with Hematology in laboratory medicine. The operating processes were observed and recorded by a digital video recorder. After that, according to the records of test reports issued in 2014 and 2015, the most frequent causes of report correction were identified, followed by Root Cause Analysis (RCA) for potential strategies of improvement. On the other hand, the Healthcare Failure Mode and Effect Analysis (HFMEA) was carried out for prospective risk management, which helps formulate improvements according to the action priority of the potential failure modes. Moreover, the relationship between medical technologists’ workload and operations was evaluated by using NASA Task Load Index.
The results of current status analysis showed that there was no monthly trend found in numbers of report correction. Besides, the major reasons for report correction are "inspection procedure error," "result input error," and "result identification error." After that, the most frequent cause of report correction was analyzed by Root Cause Analysis. The result of RCA indicated that unclear instructions of when to change the reagent may lead to report correction, which needs engineering improvement. In addition, the result of HFMEA showed that there were three failure modes requiring improvement, including" lipaemic samples being delivered by pneumatic tube system," " sample clot," and " the aperture of coulter counter being blocked." Thus, the improvement for each failure mode was proposed and evaluated through expert opinions.
According to the results of medical technologists’ subjective workload, "Blood film" and "Body fluid" had the highest workload, while "Erythrocyte sedimentation rate" and "Hemoglobin electrophoresis" had the lowest workload. It can be inferred that medical technologists’ workload increases with manual tasks. In addition, there was no significant difference in workload between male and female medical technologists. But when it comes to work experience and work shift, senior medical technologists’ workload are higher than junior ones, while those on day shift are with higher workload than those on night shift. Further, it was found that as the number of operating steps increases, the workload becomes higher. However, work processes with higher risks are not always accompanied with a higher workload. Moreover, larger number of report correction was not found in work processes with higher workload. Thus workload may not be a direct cause of the report correction.
The overall results of current status analysis, HFMEA, RCA and NASA Task Load Index showed that the reason for report correction is not directly related to the risks and workload of work processes. In order to effectively respond to the frequent causes of report correction, further studies applying other analyzing tools is therefore suggested. However, the analysis results of this study did help identify improvement strategies to prevent human errors. Besides, since this study was limited to Hematology in laboratory medicine, further studies regarding other work groups would be worthwhile for a broader range of clinical improvement.

摘要 6
Abstract 7
一、緒論 9
1.1. 研究背景與動機 9
1.2. 研究目的與範圍 11
1.3. 研究架構 12
二、文獻探討 15
2.1. 檢驗科血液組作業中的人為失誤 15
2.2. 檢驗科血液組中人為失誤的可能原因 17
2.3. 風險評估與管理 19
2.3.1. 根本原因分析（RCA） 19
2.3.2. 失效模式與效應分析（FMEA） 21
2.3.3. 醫療照護失效模式與效應分析（HFMEA） 21
2.3.4. 失誤樹分析（FTA） 22
2.3.5. 小結 23
2.4. 人員之工作負荷 23
2.5. 小結 24
三、研究方法 26
3.1. 現況分析 28
3.2. 醫療照護失效模式與效應分析（HFMEA） 29
3.2.1. 組成團隊 29
3.2.2. 繪製流程圖 30
3.2.3. 執行危害分析 30
3.2.4. 擬定改善策略 32
3.3. 根本原因分析（RCA） 32
3.3.1. 組成團隊 33
3.3.2. 蒐集資料 33
3.3.3. 檢視近端原因 34
3.3.4. 找出根本原因 34
3.3.5. 擬定改善策略 35
3.4. 工作負荷分析 35
3.5. 改善對策之評估 37
四、研究結果 41
4.1. 現況分析結果 41
4.1.1. 作業項目 41
4.1.2. 報告更改資料 47
4.2. HFMEA結果 50
4.2.1. 組成團隊與繪製流程圖 50
4.2.2. 發想失效模式 53
4.2.3. 執行危害分析評分 53
4.2.4. 決策樹分析 64
4.2.5. 擬定改善策略 66
4.3. RCA結果 67
4.4. 醫檢師自覺工作負荷 71
4.4.1. 單因子變異數分析 71
4.4.2. 工作負荷來源 75
4.4.3. 群體之間的比較 76
五、討論 81
5.1. 報告更改資料總數變化趨勢 81
5.2. 風險評估工具改善建議討論 81
5.2.1. HFMEA評估的指標 81
5.2.2. RCA改善 83
5.3. 工作負荷結果討論 86
5.4. 工作負荷與風險評估的一致性分析 87
六、結論 88
6.1. 研究發現 88
6.2. 貢獻與應用 89
6.3. 研究限制與未來方向 89
參考文獻 90
中文文獻 90
英文文獻 90
附錄 93
附錄一 人體研究倫理審查委員會同意臨床試驗證明書 93
附錄二 工作負荷問卷 94

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