Regulations Governing Laboratory Testing for Communicable Diseases and Management of Laboratory Testing Institutions Article 6
The central competent authority may appoint institutions that meet the following qualifications as designated testing institutions:1. institutions equipped with biosafety level III or level IV laboratory that meets the standards set by Regulations Governing the Management of Infectious Biological Materials or a level II negative pressure laboratory certified by the Institutional Biosafety Committee;2. institutions that are staffed with laboratory personnel qualified through biosafety training; and3. institutions that have sound laboratory biosafety management measures and good documentation ability for dealing with specimens.The designation mentioned in the preceding Paragraph may be based on, in addition to document review, on-site visit and inspection.During the operation of the Central Epidemic Command Center, the central competent authority may, if it deems that the expansion of testing capacity is necessary for epidemic prevention and control, appoint testing institutions that meet the qualifications for conducting specific tests as designated testing institutions without being subject to the qualification requirements set out in Subparagraph 1 of the first paragraph.
中文原文 傳染病檢驗及檢驗機構管理辦法第6條
中央主管機關得就符合下列資格者，指定為指定檢驗機構：
一、具備符合感染性生物材料管理辦法所定第三等級、第四等級實驗室或經機構生物安全會通過之第二等級負壓實驗室。
二、置有經生物安全訓練合格之實驗室人員。
三、備有與操作檢體相當等級之生物安全管理措施及文件。
前項指定，除書面審查外，得辦理實地訪查、驗證。
中央流行疫情指揮中心成立期間，因應疫情防治而有擴充檢驗量能必要時，中央主管機關得指定具操作特定檢驗方法資格之檢驗機構為指定檢驗機構，不受第一項第一款資格規定之限制。
一、具備符合感染性生物材料管理辦法所定第三等級、第四等級實驗室或經機構生物安全會通過之第二等級負壓實驗室。
二、置有經生物安全訓練合格之實驗室人員。
三、備有與操作檢體相當等級之生物安全管理措施及文件。
前項指定，除書面審查外，得辦理實地訪查、驗證。
中央流行疫情指揮中心成立期間，因應疫情防治而有擴充檢驗量能必要時，中央主管機關得指定具操作特定檢驗方法資格之檢驗機構為指定檢驗機構，不受第一項第一款資格規定之限制。