Risk assessment

Kojima, Kazunobu; Frey, Joachim; Kasloff, Samantha; McKinney, Michelle; Scheel, Christina; Summermatter, Kathrin (2020). Risk assessment. Laboratory biosafety manual, fourth edition and associated monographs. Geneva, Switzerland: Word Health Organisation

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Risk assessment is a systematic process of gathering information and evaluating risks to support a risk management strategy that is informed by the likelihood and consequences of an inadvertent release of and/or exposure to a biological agent. Risk assessment is essential to guide the selection of risk control measures and ensure biosafety within the laboratory when working with biological agents. This assessment requires consideration of many factors including: route(s) of transmission of the biological agent(s), pathogenicity and infectious dose, availability of prophylactic treatment or a vaccine, disease severity and mortality, contagiousness, endemicity, high-risk laboratory procedures (such as work with aerosols, high titres or volumes of the biological agent(s) being produced/handled, sharps, animals), competency of laboratory personnel, susceptibility of individual personnel and biosecurity (potential for misuse of biological agents/use as a weapon for harm). This monograph describes the process of carrying out a risk assessment of work with a biological agent(s) so that an informed decision can be made by a laboratory facility about the risk control measures needed for the work to be safely conducted. The targeted readership for this monograph is biosafety officers, laboratory personnel, laboratory managers and scientists who are doing the risk assessment.The information in this monograph on risk assessment is designed to accompany and support the fourth edition of the WHO Laboratory biosafety manual (core document) and other associated monographs. The manual and the monographs adopt a risk- and evidence-based approach to biosafety rather than a prescriptive approach in order to ensure that laboratory facilities, safety equipment and work practices are locally relevant, proportionate to needs and sustainable. Emphasis is placed on the importance of a “safety culture” that incorporates risk assessment, good microbiological practice and procedure and standard operating procedures, relevant introductory, refresher and mentoring training of personnel, and prompt reporting of incidents and accidents followed by appropriate investigation and corrective actions. This new approach aims to facilitate laboratory design and ways of operating that ensure greater sustainability while maintaining adequate and appropriate control of biosafety.The other associated monographs provide detailed information and help implement systems and strategies on the following specialized topics: laboratory design and maintenance, biological safety cabinets and other primary containment devices, personal protective equipment, decontamination and waste management, biosafety programme management and outbreak preparedness and resilience.This monograph describes selecting a risk assessment team and completing a risk assessment as well as implementation strategies and lessons learnt. Two risk assessment templates, a short and long one, are provided that personnel can use as guides when carrying out a risk assessment. In addition, four examples of completed risk assessments with different scenarios are included

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