Biorisk Management

• Biorisk


  Risk associated to biological toxins or infectious agents
• Source of biorisk


  • Unintentional exposure to unauthorized access
  • Accidental release or loss
  • Theft
  • Misuse
  • Intentional unauthorized release of biohazards
• Biorisk management


  A "system or process to control safety and security risks associated with the handling or storage and disposal of biological agents and toxins in the laboratories and facilities." (CEN Workshop Agreement (CWA) 15793:2011)
• Biorisk management

  • The integration of biosafety and biosecurity to manage risks
  • Manager – conduct judicious evaluation of risk, selecting with mitigation to be improved
  • Parameters & measures na need gawin
  • No actual law
• AMP Model


  Assessment, mitigation, performance
• Influences to management decisions

  • Perception to risk
  • Risk Averse – takot or no power
  • Risk Tolerant – dedma
• Factors influencing perception of risk

  • Financial
  • Political
  • Communication
  • Geography
• PDCA principle


  1. Plan - Identification (development of new concepts)

  2. Do - Testing and optimization by basic means of new concepts

  3. Check - Careful checking of process and obtain result

  4. Act - Standard or protocol
• Risk assessment

  • Includes the identification of hazards and characterization of risks that are possibly present in the laboratory
  • Hazard refers to anything in the environment that has the potential to cause harm
  • Risk defined as the possibility that something bad or unpleasant will happen
• Process in performing risk assessment

  1. Define the situation - Identify the hazards and risks of the biological agents to be handled

  2. Define the risks - Review of how individuals inside and outside the laboratory may be exposed to the hazards

  3. Characterize the risks - Compare the likelihood and the consequences of infection

  4. Determine if risks are acceptable or not
• Mitigation procedures


  Actions and control measures that are put into place to reduce or eliminate the risks associated with biological agents or toxins
• Five major areas of control / measures that can be employed in mitigating the risks

  • Elimination
  • Substitution
  • Engineering controls
  • Administrative controls
  • Personal protective equipment (PPE)
• Elimination


  • Most difficult yet most effective control measure
  • Involves the total decision not to work with a specific biological agent or event not doing the intended work
  • Provides the highest degree of risk reduction
• Substitution


  • The replacement of the procedures or biological agents with a similar entity in order to reduce the risks
• Engineering controls


  • Includes physical changes in work stations, equipment, productions facilities, or any other relevant aspect of the work environment that can reduce or prevent exposure to hazards
• Administrative controls


  • 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 laboratory
  • Considered the least effective measure because it only protects person who is wearing it, and only when it is used correctly
• Performance evaluation


  • Involves a systematic process intended to achieve organizational objectives and goals
  • A reevaluation of the overall mitigation strategy