关于高级别生物安全实验室若干管理要素的探讨

Discussion on the Administrative Elements of High Containment Laboratory

目前,我国已有两家生物安全四级实验室和五十多家生物安全三级实验室完成建造并通过实验室认可。生物安全管理体系的技术要素和管理要素是确保高级别生物安全实验室生物安全的关键。本文探讨了高级别生物安全实验室区别于其他体系实验室(如ISO 17025检测和校准实验室与ISO 15189医学实验室)的若干个特征性管理要素,这些要素包括潜在污染的周期性评估、失活验证实验、分子诊断实验的无生物风险的阳性对照、微生物的不同封闭措施及生物安全文化。潜在污染的周期性评估与失活验证实验是高级别生物安全实验室日常管理的强制性措施。分子诊断实验的无生物风险的阳性对照与微生物的不同封闭措施应用于微生物实验(尤其是病毒学实验)从而降低暴露风险。生物安全文化应全面施行,以预防生物安全事件的再次发生。

Currently,two biosafety level 4 laboratories and more than fifty biosafety level 3 laboratories have been constructed and passed the laboratory accreditation in China.The technical elements and the administrative elements of biosafety management system are critical for ensuring the biosafety in high containment laboratory.This paper discusses some of the characteristic administrative elements of high containment laboratory that are distinguished from those of other laboratories,such as ISO 17025 testing and calibration laboratory and ISO 15189 medical laboratory.Such elements include the periodic evaluation of potential contamination,the inviability verification test,the positive control without biorisk for molecular diagnostic assay,different containment measures for microorganisms and the biosafety culture.The periodic evaluation of potential contamination and the inviability verification test are compulsive measures of daily routine management in high containment laboratory.The positive control without biorisk for molecular diagnostic assay and different containment measures for microorganisms were applied to microbiological experiments,especially virological experiments,to reduce exposure risks.In order to prevent the reoccurrence of biosafety incidents,the culture of biosafety should be fully implemented.