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Preventing the next Pandemic through
Biosafety
and
Biosecurity Risk Assessment
IFBLSA Biosafety & Biosecurity
Committee
In collaboration with
African Union of Medical Laboratory
Students, AUMLS
Energizing sustainable diagnosis through Research and Innovations
DEFINITION OF TERMS
Hazard:A source, situation, or act with a potential for causing harm
(Source: CWA 15793).
Biohazard:The potential source of harm caused by biological agents or
toxins (Source: CWA 15793).
Risk:A combination of the probability of occurrence of harm and the
severity of that harm (Source: CWA 15793).
Biorisk:A combination of the probability of occurrence of harm and the
severity of that harm where the source of harm is a biological agent or toxin
(Source: CWA 15793).
Risk assessment:A process of evaluating the risk(s) arising from a hazard(s),
taking into account the adequacy of any existing controls and deciding
whether or not the risk(s) is acceptable (Source: CWA 15793).
Definition of terms…..
Biorisk mitigation:Actions and control measures that are put
into place to reduce or eliminate the risks associated with
biological agents and toxins and otherValuable Laboratory
Material (VLM).
Biorisk Assessment:A process of evaluating the biorisk(s) arising
from a biohazard(s), taking into account the adequacy of any
existing controls, and deciding whether or not the biorisk(s) is
acceptable (Source: CWA 15793).
Biorisk management:This is the analysis of ways and
development of strategies to minimize the likelihood of the
occurrence of biorisks.
Energizing sustainable diagnosis through Research and Innovations
Definition of terms…………
Biosafety: This is a set of containment principles, technologies and practices
that are implemented to prevent the unintentional exposure to biological
agents and toxins, or their accidental release.
Biosafety risk assessment:An analytical procedure designed to characterize
safety risks in a laboratory.
Biosecurity:The set of measures aimed at the protection, control and
accountability for valuable biological materials (VBM) and protection of
other valuable items (e.g. equipment) within laboratories, in order to prevent
their loss, theft, misuse, diversion of, and/or unauthorized access or
intentional unauthorized release.
Energizing sustainable diagnosis through Research and Innovations
Definition of terms…………
Biosecurity risk assessment:An analytical procedure designed to
characterize security risks in a laboratory.
Valuable Biological Material (VBM):These are biological materials that
require (according to their owners, users, custodians, caretakers or
regulators) administrative oversight, control, accountability, and specific
protective and monitoring measures in laboratories to protect their economic
and historical (archival) value, and/or the population from their potential to
cause harm.
Valuable Laboratory Material (VLM): It is a material of value to the
laboratory due to its replacement cost and its necessity for the laboratory
operational purposes.
Energizing sustainable diagnosis through Research and Innovations
IMPORTANCE AND BENEFITS OF
RISK ASSESSMENT
Effective allocation of resources to mitigate risks
Identification of training needs and supervision
Advance planning for renovation
Evaluation of procedural changes
Compliance with governmental regulations
Justification for space and equipment needs
Evaluation of emergency plans
Planning for preventative maintenance
Evaluation of exchanges and workflow with other laboratories/units
Energizing sustainable diagnosis through Research and Innovations
WHEN TO PERFORM AND REVIEW
LABORATORY RISK ASSESSMENT
A risk assessment should therefore be performed and
reviewed:
Periodically,
Annually or possibly,
An organization should consider conducting a risk
assessment more often as circumstances warrant, for
example, following the occurrence of problems or if
laboratory practices change.
Energizing sustainable diagnosis through Research and Innovations
WHEN TO PERFORM AND REVIEW LABORATORY RISK
ASSESSMENT………….
A laboratory should perform an initial risk assessment before any work is started and in cases
of:
 new infectious agents, toxins, reagents or other dangerous substances
 new animal species, model, or route of administration of biological agents
 new procedures and practices
 new equipment
 personnel changes
 aging of equipment
 advances in scientific understanding and technology
 a relocation or renovation
 a recent or “near-miss” accident, laboratory-acquired infection (LAI), theft, or security
 violation
 national or regional changes in disease status (endemicity of disease or disease eradication)
Energizing sustainable diagnosis through Research and Innovations
WHO SHOULD CONDUCT RISK
ASSESSMENT?
Biorisk management advisors (biosafety officers or professionals)
Principal investigators/scientists/researchers
External Safety and Security personnel
Laboratory contractors, waste handlers, maintenance staff, and janitorial
crews
Legal consultant or department/public relations/labour safety officer
Upper management
Administration
Community stakeholders
Energizing sustainable diagnosis through Research and Innovations
1. Define the scenario (what can go wrong?)
1a. Identify the hazards
1b. Consider hosts
1c. Define the work activities and laboratory environment
BIOSAFETY RISK ASSESSMENT PROCESS
2. Define the risks (what can go wrong?)
2a. Consider all risks and determine which risks should be defined
• Risk to individual(s) inside the laboratory
• Risk to an individual(s) outside the laboratory (the human
community)
• Risk to animals outside the laboratory (the animal community)
• Risks to humans and animals resulting from a secondary exposure.
BIOSAFETY RISK ASSESSMENT PROCESS…………
3. Characterize the risks (how likely is it to happen & what are the
consequences)
3a. HazardAssessment
3b. HostAssessment
3c.WorkActivities and Laboratory EnvironmentAssessment
3d. Overall Risk Characterization
4. Determine if the risks are acceptable
4a. Discuss with management and other stakeholders
5. Implement risk mitigation measures, as needed
5a. Discuss with management and other stakeholders
Energizing sustainable diagnosis through Research and Innovations
BIOSECURITY RISK ASSESSMENT PROCESS
1. Define the situation
1a. Identify the assets
1b. Identify the threats
1c. define the facility and lab security environment
2. Define the risks
2a. construct a series of potential risks
• risk of a theft of an agent by a technician aiming to make others ill
• risk of an outsider stealing or destroying laboratory information
(specifically test results)
• risk of a criminal stealing laboratory equipment, and
• risk of an environmental or community exposure of an infectious agent
due to theft of laboratory equipment which was contaminated.
Energizing sustainable diagnosis through Research and Innovations
3. Characterise the risk
3a. asset assessment
3b. adversary assessment
3c. facility vulnerability assessment
BIOSECURITY RISK ASSESSMENT PROCESS………
4. Determine if the risks are acceptable
4a. Discuss with management and other stakeholders
Energizing sustainable diagnosis through Research and Innovations
5. Implement mitigation measures, if needed
5a. Discuss with management and other stakeholders
THANKS
NOTE
This plate presents a guide of the steps involved in
biosafety (biological material) and biosecurity
(Personnel) risk assessment processes. As such, it is
permitted to be use for this purpose.
International Federation of Biomedical Laboratory StudentsAssociations
IFBLSA, Energizing sustainable diagnosis through Research and Innovations
https://ifblsa.simdif.com
www.facebook.com/AUMLStudents
ifblsa.net@gmail.com
IFBLSA Desk (mobile contact): (+237) 667 436 766

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Preventing the next pandemic

  • 1. Preventing the next Pandemic through Biosafety and Biosecurity Risk Assessment
  • 2. IFBLSA Biosafety & Biosecurity Committee In collaboration with African Union of Medical Laboratory Students, AUMLS Energizing sustainable diagnosis through Research and Innovations
  • 3. DEFINITION OF TERMS Hazard:A source, situation, or act with a potential for causing harm (Source: CWA 15793). Biohazard:The potential source of harm caused by biological agents or toxins (Source: CWA 15793). Risk:A combination of the probability of occurrence of harm and the severity of that harm (Source: CWA 15793). Biorisk:A combination of the probability of occurrence of harm and the severity of that harm where the source of harm is a biological agent or toxin (Source: CWA 15793). Risk assessment:A process of evaluating the risk(s) arising from a hazard(s), taking into account the adequacy of any existing controls and deciding whether or not the risk(s) is acceptable (Source: CWA 15793).
  • 4. Definition of terms….. Biorisk mitigation:Actions and control measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins and otherValuable Laboratory Material (VLM). Biorisk Assessment:A process of evaluating the biorisk(s) arising from a biohazard(s), taking into account the adequacy of any existing controls, and deciding whether or not the biorisk(s) is acceptable (Source: CWA 15793). Biorisk management:This is the analysis of ways and development of strategies to minimize the likelihood of the occurrence of biorisks. Energizing sustainable diagnosis through Research and Innovations
  • 5. Definition of terms………… Biosafety: This is a set of containment principles, technologies and practices that are implemented to prevent the unintentional exposure to biological agents and toxins, or their accidental release. Biosafety risk assessment:An analytical procedure designed to characterize safety risks in a laboratory. Biosecurity:The set of measures aimed at the protection, control and accountability for valuable biological materials (VBM) and protection of other valuable items (e.g. equipment) within laboratories, in order to prevent their loss, theft, misuse, diversion of, and/or unauthorized access or intentional unauthorized release. Energizing sustainable diagnosis through Research and Innovations
  • 6. Definition of terms………… Biosecurity risk assessment:An analytical procedure designed to characterize security risks in a laboratory. Valuable Biological Material (VBM):These are biological materials that require (according to their owners, users, custodians, caretakers or regulators) administrative oversight, control, accountability, and specific protective and monitoring measures in laboratories to protect their economic and historical (archival) value, and/or the population from their potential to cause harm. Valuable Laboratory Material (VLM): It is a material of value to the laboratory due to its replacement cost and its necessity for the laboratory operational purposes. Energizing sustainable diagnosis through Research and Innovations
  • 7. IMPORTANCE AND BENEFITS OF RISK ASSESSMENT Effective allocation of resources to mitigate risks Identification of training needs and supervision Advance planning for renovation Evaluation of procedural changes Compliance with governmental regulations Justification for space and equipment needs Evaluation of emergency plans Planning for preventative maintenance Evaluation of exchanges and workflow with other laboratories/units Energizing sustainable diagnosis through Research and Innovations
  • 8. WHEN TO PERFORM AND REVIEW LABORATORY RISK ASSESSMENT A risk assessment should therefore be performed and reviewed: Periodically, Annually or possibly, An organization should consider conducting a risk assessment more often as circumstances warrant, for example, following the occurrence of problems or if laboratory practices change. Energizing sustainable diagnosis through Research and Innovations
  • 9. WHEN TO PERFORM AND REVIEW LABORATORY RISK ASSESSMENT…………. A laboratory should perform an initial risk assessment before any work is started and in cases of:  new infectious agents, toxins, reagents or other dangerous substances  new animal species, model, or route of administration of biological agents  new procedures and practices  new equipment  personnel changes  aging of equipment  advances in scientific understanding and technology  a relocation or renovation  a recent or “near-miss” accident, laboratory-acquired infection (LAI), theft, or security  violation  national or regional changes in disease status (endemicity of disease or disease eradication) Energizing sustainable diagnosis through Research and Innovations
  • 10. WHO SHOULD CONDUCT RISK ASSESSMENT? Biorisk management advisors (biosafety officers or professionals) Principal investigators/scientists/researchers External Safety and Security personnel Laboratory contractors, waste handlers, maintenance staff, and janitorial crews Legal consultant or department/public relations/labour safety officer Upper management Administration Community stakeholders Energizing sustainable diagnosis through Research and Innovations
  • 11. 1. Define the scenario (what can go wrong?) 1a. Identify the hazards 1b. Consider hosts 1c. Define the work activities and laboratory environment BIOSAFETY RISK ASSESSMENT PROCESS 2. Define the risks (what can go wrong?) 2a. Consider all risks and determine which risks should be defined • Risk to individual(s) inside the laboratory • Risk to an individual(s) outside the laboratory (the human community) • Risk to animals outside the laboratory (the animal community) • Risks to humans and animals resulting from a secondary exposure.
  • 12. BIOSAFETY RISK ASSESSMENT PROCESS………… 3. Characterize the risks (how likely is it to happen & what are the consequences) 3a. HazardAssessment 3b. HostAssessment 3c.WorkActivities and Laboratory EnvironmentAssessment 3d. Overall Risk Characterization 4. Determine if the risks are acceptable 4a. Discuss with management and other stakeholders 5. Implement risk mitigation measures, as needed 5a. Discuss with management and other stakeholders Energizing sustainable diagnosis through Research and Innovations
  • 13. BIOSECURITY RISK ASSESSMENT PROCESS 1. Define the situation 1a. Identify the assets 1b. Identify the threats 1c. define the facility and lab security environment 2. Define the risks 2a. construct a series of potential risks • risk of a theft of an agent by a technician aiming to make others ill • risk of an outsider stealing or destroying laboratory information (specifically test results) • risk of a criminal stealing laboratory equipment, and • risk of an environmental or community exposure of an infectious agent due to theft of laboratory equipment which was contaminated. Energizing sustainable diagnosis through Research and Innovations
  • 14. 3. Characterise the risk 3a. asset assessment 3b. adversary assessment 3c. facility vulnerability assessment BIOSECURITY RISK ASSESSMENT PROCESS……… 4. Determine if the risks are acceptable 4a. Discuss with management and other stakeholders Energizing sustainable diagnosis through Research and Innovations 5. Implement mitigation measures, if needed 5a. Discuss with management and other stakeholders
  • 15. THANKS NOTE This plate presents a guide of the steps involved in biosafety (biological material) and biosecurity (Personnel) risk assessment processes. As such, it is permitted to be use for this purpose. International Federation of Biomedical Laboratory StudentsAssociations IFBLSA, Energizing sustainable diagnosis through Research and Innovations https://ifblsa.simdif.com www.facebook.com/AUMLStudents ifblsa.net@gmail.com IFBLSA Desk (mobile contact): (+237) 667 436 766