Regulations Governing Laboratory Testing for Communicable Diseases and Management of Laboratory Testing Institutions Article 7
The central competent authority, if necessary, may commission institutions that meet the following qualifications as entrusted testing institutions for communicable diseases:1. institutions that use the standard operation procedures approved and regulated by the central competent authority;2. institutions that have passed the proficiency tests;3. institutions that have passed certain level of laboratory biosafety certification cohering with the testing items commissioned and methods used; and4. institutions that are equipped with appropriate laboratory biosafety management manual or regulations brochure agreeing with the biosafety level of the specimens they are operating on.The entrusted testing institutions are authorized to conduct laboratory testing for Category II, Category III, or Category IV communicable diseases specified in the Act only.
中文原文 傳染病檢驗及檢驗機構管理辦法第7條
中央主管機關必要時得就符合下列資格者,委託為受託檢驗機構:
一、使用中央主管機關規定之標準檢驗方法。
二、經實驗室能力試驗合格。
三、通過與委託檢驗項目及方法相當等級實驗室之生物安全檢測。
四、備有與操作檢體相當等級之生物安全管理手冊或規定。
受託檢驗機構以辦理本法第二類、第三類或第四類傳染病之檢驗為限。
一、使用中央主管機關規定之標準檢驗方法。
二、經實驗室能力試驗合格。
三、通過與委託檢驗項目及方法相當等級實驗室之生物安全檢測。
四、備有與操作檢體相當等級之生物安全管理手冊或規定。
受託檢驗機構以辦理本法第二類、第三類或第四類傳染病之檢驗為限。