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

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.

Implementation of Bio-Risk Management System in a National Clinical and Medical Referral Centre Laboratories.

The increasing threats from biological agents have become a concern in laboratories, and emerging infectious diseases have demanded increased awareness and preparedness of laboratory facilities. Bio-risk assessment is needed to provide a framework for organisations to establish a comprehensive bio-risk management system. The assessment criteria should include both biosafety and biosecurity measures. Laboratories in Indonesia play a significant role in public health interventions in term of disease screening, diagnosis and medical decision making. The National Clinical and Medical Referral Centre Laboratories have the potential of daily exposures to dangerous biological materials. This study aims to identify the gap between bio-risk management system implementation and International Standard Organisation (ISO) 35001:2019 requirements. The 202 items in ISO 35001:2019 are categorized into seven main elements. The findings show that more than half of the elements on ISO 35001:2019 have been implemented in these centres. Good performance was identified at lab 4 and 5 which obtained the highest scores, particularly in the context of organisation, planning, operation and improvement elements. However, the widest gap was found in leadership, support and performance evaluation. One way to address this would be to create written rules and regulations at the laboratory top management level to require all laboratory facilities to comply to the bio-risk policies, rules, and regulations.