Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia

Abstract

Latar belakang: Laboratorium Badan Penelitian dan Pengembangan Kesehatan (Balitbangkes) ditunjuk sebagai laboratorium rujukan nasional dalam mendeteksi penyakit infeksi Emerging (EID) dan bertugas dalam mendeteksi pathogen infeksius serta berperan penting dalam sistem penanggulangan wabah. Laboratorium Balitbangkes harus menerapkan sistem manajemen biorisiko untuk mencegah terjadinya penyebaran penyakit yang bersumber dari laboratorium. Penerapan manajemen biorisk laboratorium yang terdiri dari biosafety dan biosecurity bertujuan untuk melindungi pekerja, lingkungan dan produk atau agen biologi. Penelitian ini bertujuan untuk menemukan kesenjangan terkait penerapan manajemen biorisk di Laboratorium Balitbangkes dengan standar.
 Metode: Studi dilakukan oleh Asesor professional pada tahun 2015 dengan mewawancara penanggung jawabLaboratorium BSL-3 (PJ BSL-3) dan Biosafety Officer (BSO) serta pemeriksaan dokumen. Pemilihan respondenberdasarkan jabatannya di laboratorium. Responden dipilih karena sebagai pelaksana teknis dan memilikiinformasi pelaksanaan biosafety dan biosecurity yang mendalam di laboratorium Balitbangkes. Pertanyaandiadopsi berdasarkan CWA 15793: 2011, berisi 160 pertanyaan dari 16 elemen. Analisis skor diinterpretasikanantara 0-2. Skor 0 memenuhi kesesuaian dengan standar dan skor 2 berarti tidak memenuhi standar.
 Hasil: Studi ini menunjukan 3 dari 16 elemen, memiliki kesesuaian penuh dengan standar yaitu teknik mikrobiologi yang baik, alat pelindung diri serta peralatan dan pemeliharaan alat laboratorium. Elemen yang memiliki kesenjangan paling tinggi adalah keamanan dengan skor 1.16. Tidak ada elemen yang dinilai tidak memenuhi kesesuaian standar atau skor2.
 Kesimpulan: Secara keseluruhan, Laboratorium Balitbangkes memiliki sistem manajemen biorisiko yang kuatdan sudah mapan disetiap elemen. Namun, tindakan perbaikan harus segera dilakukan di beberapa elemen untuk memenuhi standard CWA 15793:2011. (Health Science Journal of Indonesia 2018;9(2):70-5)
 Kata kunci: EID Laboratory, biorisk management, laboratory assessment, CWA15793
 Abstract
 Background: NIHRD laboratory was appointed as a national referral laboratory to perform laboratory detectionfor emerging infectious disease (EID). Because of its important role, NIHRD laboratory must implement bioriskmanagement system. A reliable high containment laboratory is crucial to perform laboratory diagnosis forEIDs and to avoid further spread of EIDs. The protection of laboratory workers, environment, and biologicalagents is achieved by addressing laboratory biorisk management consist of laboratory biosafety and biosecurity measures. This study aims to find gaps related the implementation of biorisk management with standard.
 Methods: This study was carried out by Professional Assessor in 2015 by conducting document checking andinterviewing BSL-3 Technical Managers and BSO who were considered to have in-depth information regardingbiosafety and biosecurity activities in NIHRD laboratory. Questionnaire developed based on CWA 15793:2011,which contain 160 questions provided from 16 elements of the standard. Analysis of the scores was interpretedbetween ranges of 0-2. Score 0 means full conformity and score 2 means doesn’t meet the required standard.
 Results: The study showed that only 3 out of 16 elements have full conformity with the standard. Theywere good microbiological technique, clothing and personal protective equipment, laboratory equipmentand maintenance. The highest gap was in security elements with the score: 1.16. No elements has a noncompliance with the standard or score 2.
 Conclusion: Overall the NIHRD laboratory has a strong biorisk management system already establishedwhich is working well in many areas. However, important action is needed in several elements in order tocomply with the standard. (Health Science Journal of Indonesia 2018;9(2):70-5)
 Keywords: EID Laboratory, biorisk management, laboratory assessment, CWA15793.

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

“…The gap analysis carried out in our study found that there were differences or "gaps" between the current state of each clause in each hospital laboratory and the requirements outlined in ISO 35001:2019 regarding the bio-risk management standard. Therefore, there is a need for specialized education, learning materials, and relevant training to enhance capacity in laboratories around biosafety and biosecurity [6,11]. In various industries, including healthcare, pharmaceuticals, and manufacturing, assessing and controlling bio-risk are crucial.…”

National Biosafety Management System: A Combined Framework Approach Based on 15 Key Elements

“…Major international efforts have sought to advance a world safe and secure from infectious disease threats (1)(2)(3)(4), especially as shown through the Global Health Security Agenda (GHSA), an international partnership of nearly 70 countries and major international organizations (such as WHO, OIE, FAO) engaged against infectious diseases (1). This GHSA encourages countries around the world to make new concrete commitments and transform global health security in support of the International Health Regulations (IHR) (5). Composed of 11 "action packages, " including biosafety and biosecurity, GHSA aims to reduce the ability of dangerous pathogens spreading rapidly within and across borders (2).…”

“…BMS is based on a management system approach, which enables an organization to effectively identify, assess, control, and evaluate the biosafety and biosecurity risks inherent in its activity (7). However, they typically have focused only on few key elements of a national BMS, usually due to various constraints, such as budgetary limitations, time, or simply a limited understanding of what is a BMS (4)(5)(6)8). Lessons from our extensive work in Burkina Faso (development of a national biosafety guideline, development of a biosafety and biosecurity assessment tool, conducting biosafety and biosecurity assessments, development of national biosafety regulations, and training of national assessors); other collaborations in Armenia, Burundi, Cameron, Guinea, Ghana, Georgia, Laos, Mauritania (organization of biosafety support, trainings and or assessments); Liberia and India (biosafety training, development of a national biosafety guideline, and specific support); Morocco (development of an laboratory infrastructure guideline); Sudan, Myanmar and Ethiopia (BSL3 assessments and/or trainings) (all unpublished), as well as observed gaps in various project countries which include: inadequate biosafety policies, lack of biosafety cabinet certification programs, lack of pre-service laboratory biosafety training curricula, absence of biosafety training packages and cascade training, and lack of IATA certified international shipment of infectious material capacities, have led us to a comprehensive and systems-based approach for a national BMS that can be sustainable and country-owned.…”

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

“…In the current coronavirus disease 2019 (COVID-19) pandemic, the rapid spread of this virus has become an alert for all laboratories to increase their capabilities in providing fast and precise diagnostic supports as the load of samples from suspected patients is increasing on daily basis [ 17 , 18 ]. In order to improve their capabilities, laboratories need skilled human resources, good microbiological techniques, adequate protective clothing, adequate personal protective equipment and decent laboratory equipment and maintenance [ 19 ]. Regular monitoring and assessment of biosafety will not only promote a safer working environment, but also affect the laboratory’s quality service [ 14 ].…”