Regulations Governing Management of Infectious Biological Materials Article 12

Duties of the BSO are as follows:1. Act as the contact person of the entity for external communication of biosafety and biosecurity matters;2. Provide consultation on biosafety and biosecurity matters of laboratories and storage facilities;3. Review the applications of laboratories and storage facilities for possession, storage, use, disposition, or import and export of pathogens in Risk Groups 2-4 or biotoxins;4. Supervise the implementation of biosafety and biosecurity training of personnel by laboratories or storage facilities;5. Supervise the internal audits of biosafety and biosecurity of laboratories and storage facilities every year, and report the audit results to the IBC;6. Supervise the implementation of personnel competence evaluation by high-containment laboratories or laboratories and storage facilities that store or use pathogens in Risk Groups 3-4;7. Supervise the biorisk management system operations of high-containment laboratories or laboratories and storage facilities that store or use pathogens in Risk Groups 3-4;8. Supervise the emergency response drills of laboratories and storage facilities, and report the implementation status to the IBC;9. Supervise the cleaning, disinfection, decontamination, recovery and correction operations of laboratories and storage facilities after a biosafety or biosecurity incident; and10. Investigate biosafety or biosecurity incidents of laboratories and storage facilities, report the findings, and make recommendations to the IBC.
中文原文 感染性生物材料管理辦法第12條
生安主管之職責如下:
一、擔任設置單位生物安全、生物保全之對外事務聯繫窗口。
二、提供實驗室、保存場所之生物安全、生物保全諮詢。
三、審查實驗室、保存場所申請第二級至第四級危險群病原體及生物毒素之持有、保存、使用、處分或輸出入。
四、督導實驗室、保存場所實施工作人員之生物安全、生物保全訓練。
五、督導每年實驗室、保存場所之生物安全、生物保全內部稽核,並向生安會報告稽核結果。
六、督導高防護實驗室或保存、使用第三級、第四級危險群病原體之實驗室、保存場所實施工作人員之知能評核。
七、督導高防護實驗室或保存、使用第三級、第四級危險群病原體之實驗室、保存場所之生物風險管理系統運作。
八、督導實驗室、保存場所辦理生物安全、生物保全應變演習,並向生安會報告執行情形。
九、督導實驗室、保存場所發生生物安全或生物保全事故之清潔消毒、除污、復原及矯正作業。
十、調查實驗室、保存場所之生物安全、生物保全事故,並向生安會報告調查結果及改善建議。

English translation for reference only; the Chinese text prevails. Not legal advice.