目的：本院BSL-3實驗室於2014年檢修，2015年正式啟用進行結核菌之檢驗，並導入CWA 15793國際標準規範之運作。本研究主要之目的是依據CWA 15793國際標準之規範，評估BSL-3實驗室導入CWA 15793規範運作3年的成效結果。材料與方法：依據CWA 15793之規範，(一)成立BSL-3生物安全管理委員會，(二)訂定年度計畫，評估期間為105年至107年，(三)建立符合要求的質性和量性的品質指標；質性指標共計7項，量性指標共計7項，(四)定期檢討與改善。結果：質性指標與量性指標在運作3年後之改善結果，(1)實驗室年度檢測項目合格率達100%，(2)儀器年度定期檢樣項目合格率達100%，(3)實驗室人員緊急應變訓練出席率達100%，(4)實驗室人員生物安全數位學習課程完成率達100%，(5)感染性生物材料潑灑異常事件為0件，(6)感染性生物材料異動確實，每年遺失及未經授權而取走的案件為0案件，(7)影響生物安全之設備異常事件，106年有16件，107年有11件，皆在有效時間內進行矯正與預防措施，後續運作良好。結論：本院BSL-3實驗室導入CWA 15793的3年間，在定期檢討改善、內部稽核及年度管理審查之運作下，逐步達到品質指標的要求，且降低了設備異常事件的發生。本研究結果證實：在符合CWA 15793之規範下，建立相關的品質指標能有效提升國內BSL-3實驗室安全。

Purpose: The BSL-3 laboratory of our hospital was overhauled in 2014.In 2015, it was officially launched for the inspection of tuberculosis and introduced into the operation of the international standard CWA 15793.The main purpose of this study is evaluating the effectiveness of Biosafety Levels 3 Laboratory bio-risk operation for three years in accordance with introducing laboratory bio-risk management CWA15793. Materials and methods: According to the norms, we established our laboratory rules as follows: (1) The BSL-3 biosafety management committee, (2) Laboratory annual plans, which evaluated from 2016 to 2018, (3) Acceptable quality indicators with 7 of each qualitative and quantitative indicators, (4) Regular self-criticism and improvement. Results: After 3 years of operation, the improvement result is shown as follows, (1)The qualified rate of the annual testing project in the laboratory reached 100%, (2)The instrumental annual qualified rate reached 100%, (3)The laboratory personnel attendance rate of emergency response training reached 100%, (4)The laboratory personnel completion rate of biosafety digital learning courses reached 100%, (5)We have 0 cases of infectious biological materials spills in each year, (6)The infectious biological material was changed validly without lost or unauthorized cases every year, (7)The abnormal events affecting biosafety were 16 cases in 2017 and 11 cases in 2018. All the cases were corrected and prevented effectively. The follow-up operation was preceded smoothly. Conclusion: In the three years since the introduction of CWA 15793, our hospital's BSL-3 laboratory has gradually met the requirements of quality indicators and reduced the occurrence of equipment abnormal events under the regular review of improvement, internal audit and annual management review. The results of this study confirm that, under the CWA 15793 specification, the establishment of relevant quality indicators can effectively improve the safety of domestic BSL-3 laboratories.