ŠĻą”±į>ž’ lnž’’’k’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ģ„Į` šæI(bjbjĖsĖs ?D©©¤¤’’’’’’¤dddddddxĄ!Ą!Ą!8ų!"Lx[2l"|"^Ś"Ś"Ś"µ#µ#µ#žZ Z Z Z Z Z Z$Q\h¹^ĘÄZdč%µ#µ#č%č%ÄZddŚ"Ś"ŪŁZ|)|)|)č%ødŚ"dŚ"žZ|)č%žZ|)|)ś^Uldd¦YŚ"`" °#9ÅrŽĘĄ! &čŹV* Z”ļZ0[ōV²_ˆ'_T¦Y_d¦Ydµ#„9$^|)—$Lć$µ#µ#µ#ÄZÄZ)dµ#µ#µ#[č%č%č%č%xxx|Dxxx|xxxdddddd’’’’ Biosafety Risk Assessment The primary goal of a Biosafety risk assessment is to identify and mitigate risk. A second equally important facet of the process is documentation of compliance to the standards of good science as set by regulatory bodies. Risk analysis involves not only identifying the hazards but evaluating the hazards in terms of probability of occurrence and determining the impact should the hazard not be addressed. The ultimate objective is to implement appropriate measures to reduce the risk, as appropriate. When applied to biological agents (human, animal, zoonotic or plant pathogens) the risk may be increased or reduced, depending on the nature of the experimental work, containment available and a variety of factors as outlined below. The benefits of undertaking a biosafety risk assessment are: Safeguarding the health and safety of lab personnel. Preventing the accidental release or contamination of research samples; and Demonstration of due diligence and compliance. Other benefits include: Identification of training and supervision needs; Evaluation of procedural changes; Justification for space and equipment needs; Evaluating security controls; and Evaluation of emergency planning, including spill response. Frequency of Risk Assessment: The preferred timing of a risk assessment coincides with: planning the research project, a significant change in the project (new employees, a new infectious, or potentially infectious agent, new procedures or technique, new equipment, a relocation of activities, or during/after renovations), or upon BAF renewal(more frequent depending upon nature of risk). Qualifications for a Risk Assessor: The principal investigator and their employees are in the best position to evaluate the potential or existing risk associated with their research and laboratory practices. The qualifications required by these individuals and others mandated to under take a risk assessment are: An understanding of the relationship between personnel, operational procedures, agent specific risk, work flow, and facility design; Knowledge of the hazards associated with the material (pathogenicity, infectious dose, mode of transmission, environmental stability etc.); Knowledge of the procedures and techniques which present risk ; and Knowledge of containment requirements, national standards and guidelines. Activities and tools to assist in a risk assessment are: Reviewing published materials (MSDS, scientific journals, published safety manuals, manufacturer’s bulletins, newsletters, equipment manuals), Reviewing laboratory records (injury or incident, equipment maintenance, training, environmental monitoring), Inspecting laboratories (daily monitoring by employees, periodic walk through, formal inspections), Observing laboratory operations (new procedures, new employees, new equipments, work-flow), Consulting biosafety professionals (biosafety officers, infection control specialists, experts in specific fields (technical/procedural, virologists, bacteriologist etc.), and Reviewing reports of laboratory associated infections (LAI). Factors Affecting Risk: The main areas that need to be considered when undertaking a risk assessment are: agent characteristics personnel experimental environmental equipment Agent Characteristics Not all agents pose the same degree of risk, and depending upon the nature of the risk engineering or procedural changes can greatly reduce the risk. The analysis may become more challenging in the cases of emerging pathogens, genetically modified organisms, or when vectors are involved. There are 11 risk factors that need to be considered, and these address the agent’s characteristics and potential impacts under certain environmental conditions, or when modifications are introduced. These are summarized below, while the “Risk Assessment Associated with Agent Characteristics” (Appendix A) outlines in greater detail the influencing factors.  SEQ CHAPTER \h \r 1 Pathogenicity /virulenceInfectious DoseMode of transmissionTransmissibilityEnvironmental StabilityHost RangeEndemicityEconomic ConsiderationsVectors RecombinantsAvailability of Prophylactic and therapeutic treatments Personnel Although engineering, procedural and administrative controls can help mitigate risk; the degree of understanding, diligence and compliance by the individual can under mind these primary controls. The health status of an individual can greatly influence the outcome of a personally exposure. In order to identify and minimize the risk of human error or exposure a number of factors should be considered. level of training and experience (in general, and specific to the procedure or agent), competency level and demonstration of diligence, health status, (University of Ottawa Biosafety Health Assessment Form (confidential) should be completed for each individual user and discussed with a the Manager of Occupational Health Disability and Leave) use of personal protective equipment, allergies (determines vaccination restrictions), and availability of prophylaxis and first aid. Experimental Factors Numerous experimental procedures can introduce the potential for risk. Often each procedure is viewed as only one step in the process, and not reviewed independently for the potential of risk. These include: aerosol generating activities (pipetting, vortexing, centrifuging…), potential for self-innoculation (recapping needles, disposal of sharps...), concentration of samples. nature of sample (clinical, pure culture, previously manipulated), volume of pathogen, animal use (species, potential viral shredding, bites, scratches), cell line characteristics, toxin production, vector use, contingency plan (exposure, spill, accidental release, equipment failure), techniques (cryogenics, cell sorting …), and decontamination procedures. Environmental The environment can be considered the work area, laboratory, and facility. Should a release of the agent occur which impacts the larger general environment, an additional risk assessment will be required. Factors to be considered are modes of transmission, environmental stability and spread of contaminated material. From a laboratory perspective issues to be considered are: level of containment (required, available) factors affecting containment (air flow, pressurization, certification) impact of external activities (construction, traffic flow, new routes of egress) biosecurity (access and inventory control) lab facility conditions (clean, non-porous benches,..) availability and status of emergency support (first aid,eye wash, spill kits …) housekeeping and trades personnel (trained, procedures) access by public (students, vistors, trades personnel) 5) Equipment The last factor to consider is how equipment may actually increase the risk of an exposure of spill. Factors to consider area: equipment maintenance (frequency and status), periodic decontamination ( incubators, centrifuge etc.), training and correct operation of equipment (compliance to manufactures recommendations), equipment specific hazards (centrifuges, homogenizer, autoclaves), standard operating procedures, ventilation considerations, and location within lab or adjoining labs. The Final Step (Implementation and Documentation): All activities summarized above identify and require risk analysis. To attain the goal of a risk assessment, one must identify and implement changes which reduce the hazard. When the ideal solution is not feasible (due to financial, operation or logistical constrains), and the risk can be reduced to an acceptable level by other means the secondary recommended approach can be implemented. It is important to document your findings for a variety of reasons: To document the steps taken to identify and reduce risk, To provide a point of reference for future assessments, thus will greatly reducing future time requirements, Justifies restricting assessments to just those elements which have changed, and To provide records which demonstrate diligence and compliance.     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