醫學檢驗數據為提供醫師診斷及治療的重要依據，準確的檢驗報告能提升醫療品質並維護病人安全。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在評估病人安全的作業流程，並改善醫療品質的一種風險評估工具。
本研究執行期間為2016年4月至10月，採用美國評鑑聯合會(JCAHO)所建議的HFMEA 品質改善手法，導入衛生所檢驗流程作業評估，探討外送檢體錯誤率之高風險操作步驟與原因。研究結果顯示，依據HFMEA五個步驟，組成跨專業的品質改善小組，經團隊分析衛生所檢驗前3項主流程，進一步細分為12個次流程，仔細探究後發現有17項潛在失效模式與24項可能造成失效的潛在原因，透過特性要因圖及5W2H分析，主因可分為三大項人工作業失誤：人工判讀處方箋檢驗項目、人工手寫採血管標籤、人工傳送檢驗處方箋。提出具體改善對策有4項，分別為資訊系統化、採血順序標準化、人員教育訓練、改進採檢標示圖。
研究結果顯示，運用HFMEA改善檢驗流程後，外送檢體退件率由2015年2.14%降至2018年0.49%，有效降低及排除檢體錯誤率發生，進而提升病人安全與醫療品質。

Inspectional data provides an important basis for doctor’s diagnosis and treatment. Precise inspection report can improve the medical quality as well as patients’ safety. Healthcare Failure Mode and Effect Analysis (HFMEA) is a process which generally utilized by the hospitals to evaluate the safety of patients recently and a risk assessment tool to improve the quality of care.
This research was conducted from April 2016 to October, adopting the HFMEA process from Joint Commission Accreditation of Healthcare Organizations (JCAHO), to enhance the inspectional quality of a district health center. The research results showed that the five steps of HFMEA operated by a cross functional team successfully improved the quality. After 3 main procedures of inspectional process were analyzed, it researched 17 potential failure mode and 24 reasons that can probably cause failures. By employing the Cause and Effect diagram and 5W2H technique, the team found 3 main causes of manual work errors, which are manually identify the prescription of the inspectional project, manually write the vacutainer labels and manually deliver inspectional prescription. Solutions to the above three issues: Systemize the information,, standardize the procedure of the blood collection, Train and educate the workers, and Changing the collection signs were also provided. After improvement, return rate of new declined from 2.14%(2015) to 0.49%(2018), which effectively reduced the inspection error rate and enhanced the patients’ safety as well as quality of care.

中文摘要 II
Abstract III
致謝 V
目錄 VI
圖目錄 VIII
表目錄 IX
第一章 緒論 1
1.1研究背景 1
1.2研究動機 2
1.3研究目的 4
1.4論文架構 4
1.5預期研究貢獻與限制 6
第二章文獻探討 7
2.1病人安全 7
2.2檢驗醫療錯誤 8
2.3 FMEA發展歷史與定義 9
2.4 FMEA應用 10
2.4.1設計失效模式與效應分析(Design Failure Modes and Effects Analysis, DFMEA) 10
2.4.2製程失效模式與效應分析(Process Failure modes and Effects Analysis, PFMEA) 10
2.4.3醫療失效模式與效應分析(Healthcare Failure Mode and Effect Analysis, HFMEA) 11
第三章研究方法 15
定義HFMEA主題 15
組成團隊 15
繪製流程圖 15
執行危害分析 16
確認行動與結果量測 18
第四章個案研究 21
4.1 個案機關介紹 21
4.1.1 服務地區人口結構 21
4.1.2 人員編制 22
4.1.3服務內容 23
4.2竹南衛生所檢驗業務 23
4.3委外檢驗檢體退件率 26
4.4檢驗流程HFMEA分析 27
4.5改善方案 43
4.5.1策略一 資訊系統化 43
4.5.2策略二 採血順序標準化 45
4.5.3策略三 人員訓練 47
4.5.4策略四 改進採檢標示圖 47
4.6改善結果 49
第五章結論與未來建議 52
5.1結論 52
5.2未來建議 53
參考文獻 54

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