Audit Report for Laboratories of Biosafety Level 3 and Higher in Taiwan, 2007

Wen-Chao Wu

2008 Vol.24 NO.7

Correspondence Author: Wen-Chao Wu


SARS infection occurred in staff of a biosafety level 4 laboratory in middle December 2003, prompting Taiwan’s Centers for Disease Control (Taiwan CDC) to initiate routine on-site inspection of laboratories of biosafety level 3 and higher in Taiwan in 2005. The Guidelines for Management of Infectious Biomaterials and Sampling of Specimens from Patients of Infectious Disease clearly defined that competent authorities in the central government can perform inspection of laboratories of these levels whenever necessary. In 2007, therefore, Taiwan CDC implemented an audit of one biosafety level 4 and twelve biosafety level 3 laboratories that were in operation. This audit included activities such as pre-audit planning, on-site inspection, compiling audit reports, and deficiency re-audits, with an emphasis on the operation of both the Institutional Biosafety Committees (IBCs) and the laboratories. Deficiencies found in the IBCs are as follows: (1) inappropriate administration framework and position level, (2) failing to thoroughly implement annual internal audits of all laboratories within its institution, and (3) failing to establish procedures specific for adjustment of biosafety level of infectious biomaterials. Deficiencies found in laboratory management are as follows: (1) failing to thoroughly implement qualification reviews of authorized personnel, (2) failing to follow the regulations in handling the adjustment of biosafety level of infectious biomaterials, (3) failing to establish inventories of infectious biomaterials higher than biosafety level 2, held in their laboratories, (4) failing to thoroughly conduct yearly routine safety tests of laboratory equipment. These findings indicated that there are still some room for improvement in the management of biosafety level 3 or higher laboratories by the IBCs at various institutions. Thus, it is necessary to continually supervise and improve the implementation of laboratory safety management.
Keywords:Biosafety Level 3 laboratory, audit, Institutional Biosafety Committee, infectious biomaterial