LESSON 8: BIORISK MANAGEMENT

• BIORISK


  Is the risk associated to biological toxins or infectious agents.*The source of risk may be unintentional 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 risk whens when working with biological toxins and infectious agents.The system or process to control safety and security risk associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities
• ASSESSMENT MITIGATIONPERFORMANCE

  3 PRIMARY COMPONENTS (AMP MODEL)
• HAZARD


  refers to anything in the environment that has potential to cause harm
• RISK


  The possibility that something bad/ unpleasant will happen
• Define the situation Define the risk Characterize the risksDetermine if risk are acceptable or not

  STEPS IN RISK ASSESSMENT
• SamplesOperatorReagents Laboratory environment Measuring system


  FIVE MAJOR AREAS WHERE ERROR COULD OCCUR:
• 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
• SUBSTITUTION


  The replacement of the procedures or biological agent with a similar entity in order to reduce the risk
• ENGINEERING CONTROL


  Includes physical changes in the workstations, equipment, production facilities, or any other relevant aspect of the work environment that can reduce or prevent exposure to hazards
• ADMINISTRATIVE CONTROL


  Refers to the policies, standards and guidelines used to control risks
• PERSONAL PROTECTIVE EQUIPMENT (PPE)


  These are devices worn by workers to protect them against chemicals, toxins, and pathogenic hazards in the la
• PERFORMANCE EVALUATION


  Involves the systematic process intended to achieve organizational objectives and goals.
• Performance management


  is the reevaluation of the overall mitigation strategy
• CWA 15793 Biorisk Management System Standard


  *A framework that integrates best practices and procedures*Ensures that an organization can effectively achieve all of its objectives*Frequently build around the PLAN DO CHECK ACT
• robust risk assessment


  The model requires that control measures be based on a ______, and a continuous evaluation of effectiveness and suitability of the control measuresidentified risks can be either mitigated, avoided, limited, transferred to an outside entity, or accepted.
• risk assessment


  The initial step in implementing a biorisk management process relies on ______ which includes the identification of hazards and characterization of risks that are possibly present in the laboratory
• Samples


  (eg. tampered samples, mislabeling)
• Operator


  (eg. wrong test performed)
• Reagents


  (eg. machine giving out erroneous reults)
• Laboratory environment


  (eg. if the lab is messy)
• Measuring system


  (eg. proper amount of samples)
• mitigation


  The second fundamental component of the biorisk management is ___.
• 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.
• PPE


  is considered the least effective measure because it only protects the person who is wearing it, and only when it is used correctly.
• Salerno (2015)


  As emphasized by _____, not one of the mitigation controls or measures is completely effective at controlling or reducing all risks.