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

Abstract

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.

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

“…This ISO standard points out the process used to identify, assess, control and monitor the risks and hazards associated with biological substances in ten clauses, from scope to improvement. The total of 202 checklist items derived from seven main clauses in ISO 35001:2019 were observed [ 23 ] ( Table 1 ). The gathering of data was based on the result of BRM instrument checklist that had been assessed regarding the implementation of each clause.…”

“…This standard also emphasizes the plan-do-check-act (PDCA) system principle, which highlights the sequence process of identification, assessment, controlling and monitoring the available risks and hazards associated with biological substances in laboratories within ten clauses, from scope to continuous improvement. Interestingly, a study conducted by Lestari et al, [ 23 ] applied this standard as the checklist instrument for assessing the implementation of bio-risk management in clinical and medical laboratories in Indonesia. However, studies that utilise this international standard are still limited, particularly in educational settings.…”

Bio-Risk Management Systems: Biosafety Assessment in COVID-19 Referral Hospitals in Indonesia

“…Typically, hospital laboratories are used for testing samples derived from the human body, such as fluids and tissues. Hospital laboratories play a crucial role in disease screening, diagnosis, and medical decision-making [1]. Additionally, hospital laboratories serve as the hub for public health investigations, aiming to provide services to clients and the community in public health programs with reference to evidence-based decision-making [2].…”

“…Additionally, hospital laboratories serve as the hub for public health investigations, aiming to provide services to clients and the community in public health programs with reference to evidence-based decision-making [2]. These activities can pose pathogen-related hazards that could endanger both humans and the surrounding environment [3] due to the types of potential hazards and the magnitude of occupational risk [1].…”

Effectiveness of international virtual training on biorisk management in the context of COVID-19

“…It was not easy to maintain and follow strict laboratory biosafety guidelines ( 10 ). It was very important to find ways to train laboratory workers without exposing them to the virus ( 11 , 12 ). Laboratory biorisk assessment is the backbone of biorisk management according to the Laboratory biosafety manual, 4th edition, and is the basis for implementing effective mitigation strategies ( 13 ).…”