台灣醫學實驗室面臨成本限縮與醫院評鑑要求，促使實驗室引進自動化設備，門診檢驗智能化系統與全實驗室自動化系統 (Total Laboratory Automation, TLA) 具提升檢驗效率、增加檢驗量能、優化檢體管理、整合檢驗報告、維護實驗室安全、促進作業流程標準化之效用。藉資通訊科技協助導入快速且即時的品管措施來監控檢體品質、自動化軌道、儀器與檢驗報告，並整合至全實驗室自動化流程中，可以創造全實驗室自動化系統更高的效益與優化檢驗流程。
高雄榮民總醫院病理檢驗部臨床檢驗科分別於2019與2021年建置門診檢驗智能化系統與全實驗室自動化系統，來提升醫檢師的檢驗效率、減少病友抽血等待時間、滿足病友與臨床醫護同仁對於檢驗報告在時效與品質上的需求，進而提升病人安全，實踐以病人為中心的照護思維。並於2020年進行組織再造活動，包括全院檢驗項目中央化與醫檢師人力整併，建置成效會因實驗室環境與醫檢師適應力而有所不同，本研究目的是探討門診檢驗智能化系統、全實驗室自動化系統與組織再造活動，在臨床醫學實驗室的結構面、過程面與結果面之影響。
本研究結合「結構－過程－結果」概念模型與平衡計分卡績效評估模型，發展本研究架構與各項評估指標。採用個案研究法 (Case Study)、前後比較研究法 (Before and After Study) 與回溯性研究法 (Retrospective Study)。資料來源包括本院資訊系統資料庫、實驗室資訊系統資料庫，並使用台灣醫事檢驗學會建立之台灣臨床實驗室品質指標系列資料，與全台灣醫院比較。
研究結果顯示醫學實驗室導入自動化、智能化設施與組織再造活動降低醫檢師人力需求50%、降低人員接觸檢體次數74.1%、提高實驗室產能32.4%、提升檢驗前流程效率61% ~ 72%、提升檢驗中流程效率22.3% ~ 91.5%、提升檢驗報告品質1.43%、提升檢驗後流程效益4.5% ~ 72.5%、提高年經濟效益62.1%、提升病人安全、衡量指標檢驗報告逾時率優於台灣醫學中心平均值0.6% ~ 3.0%。亦有未達成衡量指標，包括內部品管CV值超出目標值之檢驗項目比率、成本/收入比率、危急值醫師處置簽收時效與醫師2小時處置簽收率，5項品質指標未優於全國醫院，包括內部品管CV值超出目標值之檢驗項目比率、能力試驗結果不可接受比率、實驗室發出錯誤報告比率、檢驗危急值報告完成時間第90百分位數與檢驗危急值報告60分鐘逾時率。
智能化醫學實驗室藉由軟硬體設施整建、資通訊科技輔助、流程與組織再造，提供高品質與高效率臨床檢驗服務，醫檢師可利用檢驗大數據資料庫分析技術致力於醫學研究，貢獻於疾病診斷，創造價值。本研究結果可為其他希望建立類似實驗室系統的同儕提供有價值的參考。

In the context of cost constraints and hospital accreditation requirements, medical laboratories in Taiwan are increasingly adopting automation technologies. The integration of intelligent outpatient laboratory medicine and total laboratory automation (TLA) has been shown to enhance testing efficiency, increase testing capacity, improve specimen management, consolidate reporting, maintain laboratory safety, and standardize operational processes. Utilizing information and communication technology, rapid and real-time quality control measures can be implemented to monitor specimen quality, automation tracks, instruments, and test reports, thereby optimizing the overall laboratory automation process.
The Department of Pathology and Laboratory Medicine at Kaohsiung Veterans General Hospital established an intelligent outpatient laboratory medicine system in 2019 and a total laboratory automation system in 2021. These initiatives aimed to improve the efficiency of laboratory testing, reduce patient waiting times for phlebotomy, and meet the demands of patients and clinician regarding the timeliness and quality of test reports, ultimately enhancing patient safety and fostering a patient-centered care model. In 2020, an organizational restructuring activities was conducted, which included centralizing laboratory testing and consolidating medical technologists (MTs). The effectiveness of these implementations varies based on the laboratory environment and the adaptability of MTs.
The "Structure-Process-Outcome" conceptual model was integrated with the Balanced Scorecard performance evaluation model to develop the framework and evaluation indicators for this research. A case study approach, before-and-after study method, and retrospective study method were employed. Data were collected from the hospital's information system database, the laboratory information system database, as well as the Taiwan Laboratory Indicators series established by the Taiwan Society of Medical Technology, which were compared with hospitals across Taiwan.
The results indicate that the introduction of automation, intelligent facilities, and organizational restructuring in medical laboratories reduced the demand for laboratory technologists by 50%, decreased tube tough moments of staff by 74.1%, increased laboratory productivity by 32.4%, improved pre-analytical process efficiency by 61% to 72%, enhanced analytical process efficiency by 22.3% to 91.5%, improved the quality of examination reports by 1.43%, increased post-analytical process effectiveness by 4.5% to 72.5%, raised annual economic benefits by 62.1%, enhanced patient safety, and improved the timeliness of examination report delivery, which outperformed the average values of medical centers in Taiwan by 0.6% to 3.0%. However, certain performance indicators were not achieved, including the precission (Coefficient of Variation, CV%) of the internal quality control exceeding the target value, cost-to-revenue ratio, the timeliness of critical value physician interventions, and the 2-hour physician intervention sign-off rate.
Furthermore, five quality indicators were not superior to the national hospital average, including the CV% of the internal quality control exceeding the target value, unacceptable proficiency testing results, the error report rate issued by the laboratory, the 90th percentile of critical value report completion time, and the critical value report exceeding 60 minutes.
An intelligent medical laboratory, through the reconstruction of hardware and software facilities, ICT support, and process and organizational restructuring activities, offers high-quality and efficient clinical laboratory services. Laboratory technologists can leverage big data analytics for medical research, contribute to disease diagnosis, and create value. The findings of this study provide valuable reference for peers aiming to establish similar laboratory systems.

論文審定書 i
誌謝 ii
中文摘要 iii
Abstract v
目錄 vii
圖次 ix
表次 xii
第一章 緒論 1
第一節 研究背景與動機 1
第二節 研究目的 14
第二章 文獻探討 15
第一節 結構、過程、結果概念模型 16
第二節 平衡計分卡 (Balanced scorecard) 18
第三節 組織再造 (Organization Reengineering) 21
第四節 門診檢驗智能化系統 30
第五節 全實驗室自動化系統 32
第六節 檢驗品質 36
第七節 經濟效益 41
第八節 危急值通報 44
第三章 研究方法 47
第一節 研究架構 47
第二節 研究假設 48
第三節 研究設計與方法 49
第四節 研究數據來源 57
第五節 研究變項之操作型定義 59
第六節 資料處理與統計分析 64
第四章 研究結果 65
第一節 門診檢驗智能化系統效能 65
第二節 全實驗室自動化系統效能 71
第三節 全實驗室自動化系統對檢驗危急值報告效率與通報效益的影響 101
第五章 研究討論 115
第一節 門診檢驗智能化系統效能探討 115
第二節 全實驗室自動化系統效能探討 118
第三節 組織再造效益分析 129
第四節 TLA對檢驗危急值通報效益探討 131
第五節 研究限制 135
第六章 結論與建議 136
第一節 結論 136
第二節 建議 138
參考文獻 143
附錄 153

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