Cellular and Molecular Mechanisms in Biological System (CEMBIOS) Research Group, Department of Biology, Faculty of Mathematics and Natural Sciences, Universitas Indonesia, Depok 16424, Indonesia.
Disaster Risk Reduction Centre (DRRC), Universitas Indonesia, Depok 16424, Indonesia.
Int J Environ Res Public Health. 2021 May 11;18(10):5076. doi: 10.3390/ijerph18105076.
Developing countries face various challenges in implementing bio-risk management systems in the laboratory. In addition, educational settings are considered as workplaces with biohazard risks. Every activity in a laboratory facility carries many potential hazards that can impact human health and the environment and may cause laboratory incidents, including Laboratory Acquired Infections (LAIs). In an effort to minimize the impact and occurrence of these incidents, it is necessary to evaluate the implementation of a bio-risk management system in every activity that involves handling biological agents. This study was conducted in an Indonesian higher-education institution, herein coded as University Y. This is a descriptive, semi-quantitative study aimed at analysing and evaluating the implementation of the bio-risk management systems used in laboratories by analysing the achievements obtained by each laboratory. The study used primary data that were collected using a checklist which referred to ISO 35001:2019 on Laboratory Bio-risk Management. The checklist consisted of 202 items forming seven main elements. In addition, secondary data obtained from literature and document review were also used. The results show that out of 11 laboratories examined, only 2 laboratories met 50% of the requirements, which were Laboratory A and B, achieving good performance. Regarding the clauses of standards, a gap analysis identified leadership, performance evaluation, and support as elements with the lowest achievement. Therefore, corrective action should be developed by enhancing the commitment from management as well as improving documentation, policy, education and training.
发展中国家在实验室实施生物风险管理系统方面面临各种挑战。此外，教育机构被认为是具有生物危害风险的工作场所。实验室设施中的每一项活动都存在许多潜在的危害，可能会影响人类健康和环境，并可能导致实验室事故，包括实验室获得性感染（LAIs）。为了尽量减少这些事故的影响和发生，有必要评估在涉及处理生物制剂的每一项活动中生物风险管理系统的实施情况。本研究在印度尼西亚的一所高等教育机构进行，此处代码为 Y 大学。这是一项描述性、半定量研究，旨在通过分析每个实验室所取得的成果，分析和评估实验室中使用的生物风险管理系统的实施情况。该研究使用了主要数据，这些数据是使用参考 ISO 35001:2019 实验室生物风险管理的检查表收集的。检查表由 202 个项目组成，分为七个主要要素。此外，还使用了从文献和文件审查中获得的次要数据。结果表明，在所检查的 11 个实验室中，只有 2 个实验室（即 A 实验室和 B 实验室）满足了 50%的要求，表现良好。关于标准条款，差距分析确定领导、绩效评估和支持是实现程度最低的要素。因此，应通过加强管理层的承诺以及改进文件、政策、教育和培训来制定纠正措施。
