Laboratory Biosafety Certification of BSL-2 Negative Pressure Laboratories of M. tuberculosis in Taiwan, 2009

Wen-Chao Wu, Shu-Hui Tseng, Jer-Jea Yan

2010 Vol.26 NO.26

Correspondence Author: Wen-Chao Wu


In Taiwan, culture and identification, as well as drug sensitivity test, of Mycobacterium tuberculosis (M. tuberculosis) are mandatory to be performed in biosafety level 2 (BSL-2) laboratory under negative pressure system. In 2009, Taiwan Centers for Diseases Control (Taiwan CDC) conducted an onsite laboratory biosafety certification and inspection on 34 BSL-2 laboratories manipulating M. tuberculosis, including 15 medical centers, 13 regional hospitals, 3 district hospitals, 1 outpatient clinic, and 2 private laboratories. Based on the laboratory safety manual published by World Health Organization (WHO) in 2004, we established our national standards for laboratory biosafety certification, including 15 major categories and 104 items. Each laboratory was inspected by 3 to 4 biosafety commission members and the examination lasted for about 3 hours for each laboratory. The overall failure rate among the 5 different levels of health care facilities was 7.2%. The average failure rate in medical center was the lowest (6.5%) and in outpatient clinic was the highest (11.5%). Individually, one of the medical centers had the lowest failure rate (2.9%) while one district hospital had the highest rate (16.3%). The standard deviation (SD) of failure rate was highest among regional hospitals (3.5%). “General engineering control”, “Laboratory control” and “Facility” were the most common major categories that laboratories failed to meet the standards; the number of failed items in each category were 64, 40, and 30 respectively. As for individual items, laboratories often failed in the following three: “All penetrations in laboratory should be sealed or sealable for decontamination” (16 labs), “Autoclaves should have exhaust filter” (10 labs), and “Access to negative pressure laboratory should be limited to authorized personnel” (9 labs). Through this onsite examination, we urge these health care facilities to take laboratory biosafety issues seriously and to assure that all laboratory personnel are aware of these regulations.