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• Biorisk management is a system or process to control safety and security risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities.
• The result of a robust risk assessment can be used for reevaluation of the overall mitigation strategy.
• Biorisk strategies that are not working effectively and measures that are ineffective or unnecessary can be eliminated or replaced.
• A robust risk assessment must be properly recorded, documented, and communicated to all stakeholders of the organization.
• Proper management is necessary to carry out total safety of laboratory workers and patients.
• Laboratory Biosafety Containment principles, technologies, and practices are implemented to prevent unintentional exposure to pathogens and toxins, or their unintentional release.
• Laboratory Biosafety Manual, Third edition (World Health Organization, 2004) provides guidance on biosafety practices.
• Laboratory Biosecurity involves protection, control and accountability for valuable biological materials within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release.
• Biorisk management includes Laboratory biosecurity guidance (World Health Organization, 2006).
• Biosafety is protecting people from dangerous pathogens.
• Biosecurity is protecting pathogens from bad people.
• Risk associated with biological materials is Biorisk.
• Biorisk is the risk associated to biological toxins or infectious agents.
• Infectious agents include Bacteria, Fungi, Virus & Parasites.
• Normal flora is not a biorisk.
• Engineering Controls are the third control measure, which includes physical changes in work stations, equipment, production facilities, or any other relevant aspect of the work environment that can reduce or prevent exposure to hazards.
• Biorisk mitigation measures are actions and control measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins.
• Elimination is the most difficult, most effective, and involves the total decision not to work with a specific biologic al agent or even not doing the intended work.
• Administrative Controls refer to the policies, standards, and guidelines used to control risks.
• Substitution is the second control measure, which involves the replacement of the procedures or biological agent with a similar entity in order to reduce the risks.
• The model ensures that the implemented mitigation measures are indeed reducing or eliminating risks.
• Risk evaluation is the process of determining if risks are acceptable or not, which takes into account the adequacy of any existing controls and deciding whether or not the biorisk is acceptable.
• Performance involves a systematic process intended to achieve organizational objectives & goals.
• The five major areas of control or measures that can be employed in mitigating the risks are Elimination, Substitution, Engineering Controls, Administrative Controls, and Personal Protective Equipment (PPE).
• Personal Protective Equipment (PPE) is the last mitigation control, which are devices worn by workers to protect them against chemicals, toxins, and pathogenic hazards in the laboratory.
• Sources of risk include Unintentional exposure to unauthorized access, Accidental release or loss, Theft, Misuse, Diversion, Intentional unauthorized release of biohazards.
• Biorisk management encompasses the identification, understanding, and management aspects of a system in interrelated processes.
• Biorisk Assessment is the process of identifying the hazards and evaluating the risks associated with biological agents and toxins, taking into account the adequacy of any existing controls, and deciding whether or not the risks are acceptable.
• Biorisk Mitigation involves implementing measures to eliminate or reduce risks to an acceptable level.
• Risk is the likelihood that an adverse event involving a specific hazard or threat will occur followed by the consequences of that occurrence.
• Identified risks can be mitigated, avoided, limited, transferred to an outside entity, or accepted.
• Hazard refers to anything in the environment that has the potential to cause harm.
• To characterize the overall biosafety risks, the risk assessment team needs to compare the likelihood and the consequences of infection – either qualitatively or quantitatively.
• Risk assessment follows a structured and repeatable process: define the situation, define the risks, characterize the risks, determine if risks are acceptable or not.
• The work activities and laboratory environment including location, procedures, and equipment should also be defined.
• Risk assessment includes a review of how individuals inside and outside the laboratory may be exposed to the hazards.
• Risk assessment could either be through droplets, inhalation, ingestion, or inoculation in case a biological agent has been identified as the hazard.
• The risk assessment team must identify the hazards and risks of the biological agents to be handled.
• Threat is a person who has intent and/or ability to cause harm to other people, animals, or the institution.
• In contrast to other risk management models, which typically focus heavily on mitigation measures, AMP focuses on all components with equal attention.