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

Fatma Lestari,Debby Paramitasari,Abdul Kadir,Thariq Miswary,Cynthia Febrina Maharani,Anom Bowolaksono

doi:10.3390/ijerph18052308

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.

Highlights

A laboratory service facility has the function to extract biological materials which are managed globally for certain purposes like education, scientific, pharmaceutical and health-related production
National Clinical and Medical Referral Centre Laboratories have already been certified for International Standard Organisation (ISO) 9001:2015 regarding Quality management system and the National Standard Indonesia ISO 15189 for Clinical/Medical Laboratory, Occupational Safety and Health Management Systems (OHSMS) based on Government Regulation No 50 of
The achievement analysis was based on points applied to each laboratory from the 202 questions adopted from the ISO 35001:2019

Summary

Introduction

A laboratory service facility has the function to extract biological materials which are managed globally for certain purposes like education, scientific, pharmaceutical and health-related production. These facilities are potentially exposed to dangerous microorganisms that will harm people and disrupt the environment [1]. Bio-risk management as a guideline to regulate assets and manage permissions to biological materials requires a comprehensive system to be implemented, which includes policy and management aspects [4].

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Results

Discussion

Conclusion