4. To protect employees, the community and the
environment from risks associated with biological agents
handled in the laboratory
The system provides a framework for
◦ assessing and controlling biological hazards & risks in the
laboratory
◦ continually improving the management of biological risks
“Biorisk” = probably (likelihood) and severity (consequences)
of harm from biological agents
5. Based on a “management system” approach
Provide assurance that biosafety and biosecurity
requirements are in place and implemented effectively
Performance-based rather than prescriptive
◦ doesn’t specify exactly how to develop the program, but outlines
what you want to achieve
All individuals are all accountable for managing risks,
safety and health
◦ employees, supervisors, top management, biorisk management
advisor (i.e. biosafety officer, biorisk officer….)
6. Requires leadership and a commitment from top
management
◦ they need to dedicate the human and financial resources
necessary to achieve a successful program
But also requires full participation by all employees in
order to be successful
Biorisk management policies and procedures should
outline the specific roles and responsibilities of all
individuals
7. The approach should also be SMART
◦ Specific – clearly state program requirements
◦ Measureable – results are quantifiable
◦ Achievable – targets are realistic but challenging
◦ Relevant – program has the intended impact on employees,
community, environment
◦ Timely – a clear timeframe
8. Starts with identifying all hazards and risks in the laboratory
Conduct a “biorisk assessment” which is key to managing these
hazards & risks
Risk assessments should involve all employees (biorisk management
advisor, scientists, lab techs, supervisors, security officials)
◦ Should be conducted before work with new biological agents, before new
laboratory activities are carried out, regularly on an ongoing basis
9. Not all hazards are risks
◦ A biological sample is a hazard but it is only a risk if a person
handles that sample and could be exposed
◦ It is how we come into contact with hazards that creates the
“risk”
10. Risk = combination of the likelihood and consequences of an
undesirable event related to a specific hazard
• Likelihood is the probability of an event occurring
Is it possible that an employee could be exposed to this sample in my laboratory?
How possible? Or is it a very remote possibility?
• Consequence is the severity of an event
What would happen if the person was exposed? Nothing? First-aid or
Medical Treatment? Laboratory-acquired infection? Death? Environmental
contamination? Spread to community? Financial loss to institution?
11. How do we determine the risk from a hazard (and assess likelihood
and consequences)?
13. Characteristics of the biological agents
◦ Pathogenicity, virulence, mode of transmission, infectious dose,
stability in the environment, susceptibility to disinfectants, treatment
available
◦ How is it transmitted in the lab (ingestion, blood-borne, aerosol)?
Has a direct impact on the kind of biosafety procedures to be
implemented
◦ Is there a history of laboratory-acquired infections?
◦ What is the assigned risk group of the agent (e.g. RG 1, 2, 3 or 4)
Inherent risk of a biological agent; each country classifies its own list of
agents (e.g. TB Risk Group 3, Ebola Risk Group 4)
14. What activities will be carried out in the lab?
◦ How will the sample be handled in the laboratory?
◦ What tests will be performed?
◦ Diagnostic tests that do not grow up the organism?
◦ Culturing the organism?
◦ Will aerosols be generated by any of the procedures?
Employees working with the biological agents
◦ Are they trained and experienced?
◦ Is it a new procedure for the employee?
◦ Is it boring and repetitious?
15. The risk associated with biological materials has both a safety and
security component
• Biosecurity refers to ensuring the security of
biological materials to prevent theft, illicit use, or
release
- counters deliberate release of materials
• Biosafety focuses on reducing exposure to and
release of biological materials
- counters accidental release
Biorisk encompasses both biosafety and biosecurity
16. Consider security issues in the risk assessment as well
◦ Are there any pathogens that are of interest to bioterrorists?
◦ What is likelihood of theft of pathogens?
◦ Insider/outsider threat – how would they gain access to
pathogens?
◦ What would happen if pathogens went missing?
17. Use the results of the risk
assessment to identify
appropriate risk-based
control measures (biosafety
practices, equipment,
facilities, training, etc…..)
18. Now we need to implement control measures (biosafety
practices, facilities, equipment) to manage the risks
◦ A good risk management approach will develop biosafety
practices and facilities that are proportionate with the specific
risks identified (i.e. the unique biological agents and unique
activities being performed in each laboratory)
◦ Does not completely eliminate risk, but reduces level of risk
to an acceptable level
A “risk-based” approach…
19. “Hierarchy of Risk Management Controls”
◦ Eliminate the hazard by not performing the work with that particular biological
agent
◦ Substitute the hazard with a different biological agent
◦ Controlling the hazard by providing containment equipment (biosafety cabinet)
and appropriate biocontainment facilities (engineering controls)
◦ Minimizing risk by using administrative controls (e.g. training, SOPs, biosafety
manual, lab inspections, accident reporting)
◦ Using personal protective equipment
20. Review all the biorisk management program elements
and results from risk assessment results
Identify “performance indicators” to gather data
◦ Laboratory inspections & audits, laboratory accidents, laboratory-
acquired infections
Success is not the lack of laboratory accidents, or poor
laboratory inspection audits
◦ Success is how organizations are responding to accidents that
might occur (e.g. they use the data to continually improve their
biorisk management system)
21. An effective approach is built on the concept of “continual
improvement” through a cycle of planning, implementing,
reviewing and improving the processes
This is known as the PDCA (Plan-Do-Check-Act) principle:
- Plan: Planning, including identification of hazard and risk and establishing
goals
- Do: Implementing, including training and operational issues
- Check: Checking, including monitoring and measuring
- Act: Reviewing and taking corrective action for needed changes to the
management system
22. Why PDCA?
Proactive approach to identify potential harmful situations and
practices
Improve the system to reduce the risks from these situations
Example
◦ a laboratory accident has occurred
◦ conduct an investigation to determine the “root cause” of the accident and
identify any problems/issues may have led to the accident
◦ Correct those issues/problems to prevent future accidents
◦ Continually monitor accident reports and investigations reports – identify a re-
occurring event, “trend” or “pattern” requiring further changes and
improvements
23. Introduced in the WHO Biorisk Management Train-the-
Trainer Program (follows PDCA approach)
Assessment
◦ Identification hazards and assessment of risks (Plan)
Mitigation
◦ Application of controls using the hierarchy of controls (Do)
Performance
◦ Monitoring of the controls through audits, incident
investigations and identification of non-conformities (Check and
Act to address any non-conformities)
24. In summary the stages include:
1. Hazard identification (biological samples, pathogens)
2. Determination of risk (consequence vs likelihood) from that
hazard (what are we doing with the samples in the lab)
3. Decide whether risk is acceptable
If risk is very low and acceptable – proceed and monitor
If risk is high and not acceptable – identify control measures to
manage that risk
4. Implement control measures (biosafety practices, facilities,
equipment)
5. Review, monitor & measure performance (data from lab
inspections, accident reports)
6. Improve control measures as needed
25. Develop a management system that involves:
◦ Identifying hazards & assessing risks
◦ Implementing risk-based controls to manage those risks
◦ Monitoring the program & measuring performance by
gathering and analzying data
◦ Use that data to continually improve the system
Commitment from top management and participation
by all employees!
