Analysis of Bio-Risk Management System Implementation in Indonesian Higher Education Laboratory

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.

Keywords: ISO 35001:2019; bio-risk management; gap analysis; higher education; laboratory.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Hazardous Substances
  • Humans
  • Indonesia
  • Laboratories*
  • Laboratory Infection*
  • Risk Management


  • Hazardous Substances