Reducing the risk associated with handling dangerous bacterial and viral human pathogens is of utmost importance for the safety of individuals, communities, and EU health security. The publication by the SHARP Joint Action of a new tool for enhancing biorisk management in European microbiological containment laboratories signifies a practical step forward in bolstering biorisk management within European microbiological containment laboratories.
The EBRM-Guidance Tool was spearheaded by Tuija Koivula and Åsa Szekely Björndal from the Unit for Biopreparedness, Department for Microbiology, Public Health Agency of Sweden (PHAS) – a member of the EMERGE laboratory network. It is designed to enable effective management of biological risks.
The document contains vital information that covers the crucial aspects essential for the establishment and maintenance of a robust laboratory biorisk management system. It encompasses essential legislations pertaining to biological hazards and threats within facilities that handle and store infectious agents. Plus, authoritative guidance and standards for laboratory biorisk management best practices at both organizational and operational levels.
One of the key highlights of the EBRM-Guidance Tool is its practical checklist, which facilitates self-assessment of organizational awareness of the with various regulations and guidance. This feature allows for insight on the adherence to pertinent standards, enabling laboratories to identify areas for improvement and implement necessary measures to mitigate risks effectively.
Intended for senior management, laboratory management, biosafety professionals, laboratory supervisors, principal investigators, and laboratorians working in facilities that handle, transport, transfer, and store highly infectious biological materials falling within risk groups 3 and 4, the EBRM-Guidance Tool holds significant value in promoting a culture of safety and responsibility within these sensitive environments. The results of the self-assessment could form the basis of continuous quality improvement planning, or to implement the international standard ISO35001 Biorisk management for laboratories and other related organisations.
This tool complements the previous work from the EMERGE laboratory network, the Integrated European Checklist for Laboratory Biorisk Management in Handling of High Consequence Risk Group 3 and 4 Agents (ECL-Biorisk). Developed under the QUANDHIP project (Quality Assurance Exercises and Networking on the Detection of Highly Infectious Pathogens), the ECL-Biorisk underscores the ongoing commitment to advancing biorisk management practices and fostering a standardized approach across laboratory settings in Europe.
The EMERGE laboratory network
EMERGE – Efficient response to highly dangerous and emerging pathogens at EU level – comprises a European network with about 40 diagnostic laboratories focused on risk group 3 bacteria and risk groups 3 and 4 viruses.
EMERGE aims to provide a common, coordinated, and effective response to infectious disease outbreaks at EU level and abroad.
Embedded in the EU-funded projects and Joint Actions:
- QUANDHIP (2011-2015), EMERGE (2015-2019),
and currently implemented into SHARP (2019-September 2023)
The EMERGE Laboratory Network is a success story and essential for the protection of European citizens against exposure to a panel of high threat bacteria and viruses. Indeed, especially, for emerging and re-emerging pathogens, classified as Risk Group (RG) 3 and 4, the need for an efficient, rapid, quality assured and coordinated response is addressed to prevent and manage major public health emergencies. The EMERGE laboratory network on highly infectious pathogens operates in compliance with the currently revised Decision No 1082/2013/EU. The network is deeply engaged in laboratory capacity and capability building by quality assurance exercises, evaluation of new diagnostics, training
Emerge Network Associated Partners
RKI (Robert Koch Institute), Germany INMI, Italy AGES, Austria CODA-CERVA, Belgium NCIPD, Bulgaria HZJZ, Croatia SUJCHBO, Czech Republic DTU, Denmark TA, Estonia THL (Terveyden ja Hyvinvoinnin Laitos) (Terveyden ja Hyvinvoinnin Laitos), Finland INSERM, France DGA, France BwIM (Bundeswehr Institute of Microbiology),BNITM (Bernhard Nocht Institut für Tropenmedizin)any FLI (Friedrich Loeffler Institut), Germany UMR (Universität Marburg), Germany BNITM (Bernhard Nocht Institut für Tropenmedizin), GermaIZSLER (Istituto Zooprofilattico Sperimentale della Lombardia e dell Emilia Romagna), Greece NCE, Hungary ISS, Italy IZSLENIPH (Norwegian Institute of Public Health), Italy NVSPL, Lithuania RIVM, Netherlands NIPH (Norwegian Institute of Public Health), Norway NVI, Norway NIPH-NIH, Poland NVRI, Poland INSA, Portugal INC, Romania Slovenia BIOEF, Spain ISC III, Spain FoHM, Sweden PHE (Public Health Emergencies), United Kingdom Erasmus MC, Netherlands
Collaborating Partners: IZSPB (Istituto Zooprofilattico Sperimentale della Puglia e della Basilicata), Italy NKUA, Greece SPIEZ, Switzerland FOI, Sweden
For further information email: EMERGE-Coordination(at)rki.de