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Abstract：
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.
摘要：
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,教育环境被认为是有生物危害风险的工作场所。实验室设施中的每项活动都会带来许多潜在危害，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件的影响和发生，有必要评估涉及处理生物制剂的每项活动中生物风险管理系统的实施情况。这项研究是在印度尼西亚的一所高等教育机构中进行的，这里编码为Y大学。这是一个描述性的，半定量研究旨在通过分析每个实验室获得的成就来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。该研究使用了使用清单收集的主要数据，该清单参考了ISO35001：2019关于实验室生物风险管理的清单。清单由202个项目组成，构成七个主要要素。此外,还使用了从文献和文献综述获得的次要数据.结果显示，在11个实验室中，只有2个实验室满足了50%的要求，实验室A和B，实现良好的性能。关于标准的条款，差距分析确定了领导力，绩效评估，和支持作为成就最低的元素。因此,纠正措施应通过加强管理层的承诺和改进文件来制定，政策,教育和培训。
