Biorisk Management PDF

Biorisk Management T05 Biorisk Management and the AMP Model working with infectious agents and toxins in In practices and procedures on biocontainment to ensurelaboratories, one must consider the management is necessary to carry out total safety of...

Biorisk Management T05 Biorisk Management and the AMP Model working with infectious agents and toxins in In practices and procedures on biocontainment to ensurelaboratories, one must consider the management is necessary to carry out total safety of biosafety and biosecurity. Proper laboratory workers and patients. Biorisk is the risk associated to risk may be unintentional exposure biological toxins or infectious agents. The source ot to unauthorized access, accidental release or loSs, theft, misuse, diversion, or intentional unauthorized release of biohazards. Biorisk management is the integration of biosafety and biosecurity to manage risks when working with biological toxins and infectious agents (CWA 15793 Laboratory Biorisk Management Standard). According to the CEN Workshop Agreement (CWA) 15793:2011, Biorisk (BRM) is "a system or Management process to control safety and security risks associated with the storage and handling or disposal of biological agents and toxins in laboratories and facilities." BRM encompasses the identification, understanding, and management aspects of a in interrelated processes. It is divided system into three primary components: assessment (A), mitigation (M), and performance (P). These components are collectively captured by what is called the AMP model (World Health Organization, 2010). The model requires that control measures be based on a robust risk assessment, and a continuous evaluation of effectiveness and suitability of the control measures. Identified risks can be either mitigated, avoided, limited, transferred to an outside entity, or accepted. Like a three-legged stool, a biorisk management system fails if one of the components, or legs, is overlooked or is not addressed. In contrast to other risk management models, which typically focus heavily on mitigation measures, AMP focuses on all with components attentien. equal Biorisk Management Figure 7.1 The AMP model  Science 1 Laboratory T06 Principles of Medical of Biorisk Manayement Hey Components Risk Assessment relies on risk assessment a biorisk management process The initial step in implementing that are possibl identification of hazards and characterization of risks which includes the environment that has the potential Hazard refers to anything in the present in the laboratory. that something bad or to cause harm while risk is generally defined as the possibility to occur, there must be a (such an injury or loss) will happen. In order for a risk unpleasant as Guide 51:1999). For example, sharp nedle a situation for the hazard to cause harm (ISO/IEC More specitically, risk needle will not pose any risks. is a hazard, but if no one is using it, the hazard o r threat will o c c u r followed is the likelihood that an adverse event involving specific a o c c u r r e n c e. In performing risk assessment, a structured and by the consequences of that the following steps: repeatable process is followed. It consists of team must identify the hazards and risks 1. Define the situation the risk assessment - who could be humans or of the biological agents to be handled. Next, at-risk hosts, animals inside and outside the laboratory, must be identified. The work activities and laboratoryenvironment including location, procedures, and equipment should also be defined. 2. Define the risks - defining the risks must include a review of how individuals inside and outside the laboratory may be exposed to the hazards. It could either be through droplets, inhalation, ingestion, or inoculation in case a biological agent has been identified as the hazard. 3. Characterize the risks - to characterize the overall biosafety risks, the risk assessment team needs to compare the likelihood and the consequences of infection-either qualitatively or quantitatively. 4. Determine if risks are acceptable or not - this process of evaluating the biorisk arising from a biohazard takes into account the adequacy of any existing controls, and deciding whether or not the biorisk is acceptable. Mitigation Procedures The second fundamental component of the biorisk management model is mitigation. 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 (Salerno, 2015). There are five major areas of control or measures that can be employed in mitigating the risks.  Biorisk Management 107 Hierarchy of Controls Most Difficult Most Effective Elimination Substitution Engineering Controls Administrative Controls Easiest to Implement PPE Least Effective Figure 7.2 Hierarchy of controls of mitigation measurees Elimination, the most difficult and most effective control measure, involves the total decision not to work with a specific biological agent or even not doing the intended work. Definitely, elimination provides the highest degree of risk reduction. Substitution, the second control measure, is the replacement of the procedures or biological agent with a similar entity in order to reduce the risks. For example, a laboratory conducting research with the pathogen Bacillus anthracis, responsible for causing the acute fatal disease anthrax, could potentially substitute a less dangerous experimental surrogate, such as the Bacillus thuringiensis, an organism most commonly used in biological pesticides worldwide. The third control measure, setting of engineering controls, 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. Examples are installation of biosafety cabinets, safety equipment (centrifuge with cover, autoclave, and machines with indicators), facility design enabling proper airflow, ventilation system to ensure directional airflow, and air treatment systems to decontaminate or remove agents from exhaust air, controlled access zones, airlocks as laboratory entrances, or separate buildings or modules to isolate the laboratory. The fourth measure, the setting of administrative controls, refers to the policies, standards, and competency training for laboratory staff and guidelines usedto control risks. Proficiency is considered an administrative control. The displaying of biohazard or warning signages, and worker access, and documenting written markings, and labels, controlling VISitor some examples. Practices and procedures of administrative standard operating procedures are sprays, and acrosols to avoid laboratory-acquired Controls comprise minimizing splashes, (SOPs). The last mitigation control infections or following standard operating procedures neasure is the use of personal protective equipment (PPE). These are devices worn bv and pathogenic hazards in the laboratory. Workers to protect them against chemicals, toxins,  Science 1 Medical Laboratory Principles of 108 considered the least effectie ive PPE. PPE is are all examples of when it is used and respirators and only Gloves, gowns, who is wearing it, the person measure because it only protects correctly. controls or measures ic not one of the mitigation Salerno (2015), of mitigating risks relies As emphasized by or reducing all risks. The effectivity u t i l i z a t i o n of each. It must completely effective at controlling m e a s u r e s and the proper of all the different on the combination because undoing particular m e a s u r e s would not be overdone be ensured that following the controls describes the order of The concept of a hierarchy of m e a s u r e s are definitely costly. measures and implies that least effective) of mitigation effectiveness (from most effective to controls to reduce selecting and implementing this order should be taken into account when risks. Performance Evaluation evaluation that involves pillar of the biorisk management model performance and is The last a systematic process intended to achieve organizational objectives goals. The model measures are indeed reducing or eliminating risks. It ensures that the implemented mitigation and m e a s u r e s that are also helps to highlight biorisk strategies that are not working effectively is ineffective or unnecessary. These can be eliminated or replaced. Performance management simply a reevaluation of the overall mitigation strategy. The diagram below shows the specifie procedures in conducting performance evaluation. identify the Key lssues of Concern Evaluate and Refine Performance Define OUTCOME Indicators Indicators and Metrics Provide Findings from Performance Define ACTIVITIES Indicators Indicators and Metrics Collect Data and Report Indicator Results Figure 7.3 Performance evaluation procedures  The result ot Biorisk Management 109 robust risk assessment a ommunicated all stakeholders of the must be properly recorded, documented, and con to findings could be decided upon, given organization. Only through this final process that elear manifestation of appropriate action, to be able to provide and establish a the laboratory. implementing the fundanmental concept of biosafety and biosecurity in KEY POINTS Biorisk Management (BRM) is an integral part in the of implementation of the conceppt biosatety and biosecurity in a laboratory. It involves the process of assessment, mitigation, and performance evaluation. The AMP model illustrates the balanced role among the components of BRM. A robust risk assessment is the heart of BRM. It ensures safety and security of the people working in the laboratory as well as all the stakeholders in an organization. The different mitigation procedures to be employed depend on the result of a robust risk assessment. It is recommended not to overdo or underdo the measures. Performance evaluation is not a linear process, rather, it is a continuous process to monitor the implementation of existing biosafety procedures and practices. It provides direction for decision-makers to be able to come up with reasonable and justifiable biosafety guidelines. Most importantly, communicating BRM among the members of the organization, way the for interactive transmission and especially to the top management paves the analysis process about risk, risk- exchange of information and opinions throughout risk managers, risk communicators, the related factors, and risk perceptions among general public, and other impacted parties.