Module 2.

Bio-risk Assessment
Learning Outcomes

By the end of this module, you should be able to:

1. Describe biorisk management system.
2. Explain the key terms used in biorisk management.
3. Describe the importance of conducting biosafety and biosecurity risk
assessments.
4. Describe the concepts of biorisk assessment.
5. Perform basic risk assessment based on the risk assessment framework tool.
Outline

1. Definition of key terms

2. Importance of Biorisk management
3. Concepts/components of Biorisk management
4. Risk assessment framework
a) Gathering information (Biosafety, Biosecurity, Bioethics)
b) Evaluating the risk
c) Develop a risk control strategy
d) Select and implement the risk control strategy
e) Review risks and control measures
5. Risk communication
Definition of Terms(1/3)

Risk: Is a combination of the likelihood of an incident and the severity of the

harm (consequence) if that incident were to occur.

Hazard: Is a source that has potential for causing harm. However, it is not a
risk without a specific environment or situation.

Bio risk: Combines Biological agent risks and Biological security risks.

Biorisk management: Refers to a system or process to control biosafety and

biosecurity risks associated with the handling or storage and disposal of
biological agents and toxins in laboratories, facilities, fields and other areas.
Definition of Terms (2/3)

Risk assessment: The process of gathering information and evaluating

evidence in order to decide whether a person has achieved a standard or
objective.

Biorisk assessment: Is the process of identifying potential hazards and

threats and determining the risks associated with them to minimize risks and
provide a safe working environment.

Risk Management: Is the corresponding process of selecting appropriate

containment measures to ensure that biohazards are properly controlled.
Definition of Terms (3/3)

Risk mitigation: is a systematic reduction in the extent of exposure to a risk

and/or the likelihood of its occurrence.

Performance evaluation: Process of checking how well the biorisk management

system is working and appropriateness of the mitigation measures

AMP = Assessment, Mitigation and Performance

Purpose of Biorisk Management

• To protect employees, the community and the environment from risks

associated with biological agents handled in the laboratory, field and other
areas where applicable.

• To identify vulnerabilities and weaknesses in biosecurity systems and develop

appropriate measures to prevent or mitigate risks.
Components/Concepts of Biorisk Management

Biorisk Management has three key concepts/components:

• Assessment
• Mitigation
• Performance

This is known as the AMP model

Risk Assessment Framework (1/2)

WHO, Biosafety Manual 4th Edition, 2020

Risk Assessment Framework (2/2)

The risks posed by a biological agent cannot be determined only by its

pathogenic characteristics, but also the procedures alongside the
environment and human factors.
Step 1a - Gathering Information (1/2)

1. Pathogen
a. What biological agents are being handled.
b. What are their pathogenic characteristics?
• pathogenicity
• Potential route of transmission
• host range
• severity of infection with the biological agent
• sensitivity to disinfectants
• availability of prophylaxis and treatment
• stability in in the form the pathogen is presented
• what other information is known about it
2. Procedure (laboratory or field activities)
a. what procedures/activities or lack of can lead to exposure release of the
pathogenic agent
b. how can that exposure occur
Step 1a - Gathering Information (2/2)

3. Protective Equipment (PPE and Safety Equipment)

a. Appropriate type
b. Availability
c. Proper use and maintenance
4. Place
a. Does the facility (infrastructural) support the process appropriately?
5. Personnel
a. Training and competence (Compliance with SOPs, GMPP and OSH guidelines)
b. Experience
c. Attitude
d. Vulnerability
6. Other considerations i.e. cultural, religious, socio-economic, that can lead to
exposure
Step 1b - Gathering Information (1/2)

1. Collect information on:

• The type of biological agents (valuable pathogens, chemicals, information
and equipment) available.
2. Evaluating biosecurity risk:
a. What kind of threats and vulnerabilities exist?
b. What is the likelihood of release, loss, theft, misuse, diversion of biological
agent and data or unauthorized access?
c. What is the consequence of release, loss, theft, misuse, diversion of
biological agent and data or unauthorized access?
Step 1b - Gathering Information (2/2)

3. Place (physical location)

a. What security lapses exist?
b. Consider physical and administrative security measures
4. Personnel
a. Evaluating insider and outsider threats and their possible intentions.
b. The personnel required to access the lab and field premises, and those
responsible for the biological agents.
5. Other breaches that may exist from time to time i.e. cultural, religious,
socio-economic, that can lead to misuse, diversion, or theft.
Note: The challenge is how to assess intentions.
Step 1c - Bioethics Risk Assessment

• Identify the hazards that may result from conducting the research
- Risks
- Benefits
• Decide who might be harmed and how
• Evaluate the risks and decide on precautions
• Conflicting values: Promoting good vs. protecting public security
• Review your assessment and update if necessary
• An ethical dilemma (Dual-Use Dilemma)
Step 2a - Risk Assessment Matrix (1/3)

Use the risk assessment matrix to:

1. Determine the likelihood of an exposure and/or release using the variables:
• Unlikely: not very possible to occur in the near future
• Possible: feasible to occur in the near future
• Likely: very possible to occur in the near future
Step 2a - Risk Assessment Matrix (2/3)

2. Determine the consequence of exposure and/or release using the variables: Negligible,
Moderate, Severe.
• Negligible: No injury, and no effect on the environment
• Moderate: Injury requiring medical attention. Average effect on the
environment
• Severe: Serious injury requiring external medical care. Serious effect on
the environment.
3. Compare the results of likelihood and consequences using the risk assessment
matrix to determine the level of the initial or residual risks.
Step 2a - Risk Assessment Matrix (3/3)
Table 1: Risk assessment matrix

Severe Medium High Very High

Consequences
of
Moderate Low Medium High
exposure/relea
se
Negligible Very Low Low Medium

Unlikely Possible Likely

Laboratory Activity/Procedure
Likelihood of exposure/release

Note: A laboratory can adopt a 3 × 3 or 5 × 5 matrix

Step 3 - Develop a Risk Control Strategy

• What resources are available for risk control measures?

• What risk control strategies are most applicable for the resources available?
• Are resources sufficient to obtain and maintain those risk control measures?
• Are proposed control strategies effective, sustainable and achievable in the
local context?
Biosafety Considerations

PPE is the least effective control because it

involves a high level of worker involvement and is
highly dependent on proper fit and correct,
consistent use.
Hierarchy of Controls (1/5)

1. Elimination
•It involves physical removal of the hazard and is the most effective hazard
control.
•This could include changing the work process to stop using a toxic chemical,
heavy object, or sharp tool.
•It is the preferred solution to protect workers because no exposure can
occur.
Hierarchy of Controls (2/5)

2. Substitution
• It is the second most effective hazard control, involves replacing something that
produces a hazard with something that does not produce a hazard or produces a
lesser hazard.
• Substitution is using a safer alternative to the source of the hazard. An example is
using PCR procedure as a substitute for culture based procedures.
• Effective substitutes reduce the potential for harmful effects and do not create new
risks.
Hierarchy of Controls (3/5)

3. Engineering Controls
• These do not eliminate hazards, but rather isolate people from hazards.
• “Enclosure and isolation" creates a physical barrier between personnel and
hazards, such as using remotely controlled equipment E.g. BSC remove
airborne contaminants as a means of engineered control
Hierarchy of Controls (4/5)

4. Administrative Controls
• Administrative controls are changes to the way people work. Examples
include procedure changes, employee training, and installation of signs and
warning labels.
• Administrative controls do not remove hazards, but limit or prevent people's
exposure to the hazards.
Hierarchy of Controls (5/5)

5. PPE
• PPE is the least effective means of controlling hazards because of the high
potential for damage to render PPE ineffective.

• Employers as well as employees should not rely on PPE alone to control

hazards when other effective control options are available.

• PPE can be effective, but only when workers use it correctly and consistently.
Biosecurity Considerations
Step 4 - Selection and Implementation of Control
Measures:
Hazards Associated with Work Practices

• Failure to disinfect the surfaces as required

before and after manipulation of specimen
• Use of inappropriate disinfectant
• Poor waste disposal practices
• Dispensing from pipettes outside of BSC
How to Minimize Exposure via Aerosols

• Pipette at 45° to the base of the tube

• Vortex specimen in capped tubes inside BSC(Only
clotted samples)
• Use barrier ART pipette tips to protect pipettes from
virus contamination
• Use centrifuge rotors with sealed tops and open only
within BSC
How to Minimize Exposure

• Proper use of recommended PPE

• Use BSC when manipulating infectious material
• Heat inactivate sample at 60° C for 1 hour prior
to processing
Risk Mitigation/Risk Reduction

• Risk mitigation is a systemic

reduction in the extent of exposure to
a risk and/or the likelihood of its
occurrence.
• The hierarchy of control is a well
recognized method of risk reduction.
• Workflow should be considered as
one of the areas to reduce risks. air
flow should be from less infectious
area to high infectious areas.
Risk Communication

Risk reporting refers to communicating risks with the

objective of changing or consolidating the recipients
views about the issue
Step 5 - Review Risks and Control Measures
Bottom Line Risk Management Recommendations

• When in doubt, be conservative

• Use Standard Precautions as a starting point
• Complacency and routine can be deadly
• Constantly remind clinicians and pathologists to notify lab personnel if
suspicion exists
• Risk Assessment requires information about the agent and the work along with
good judgment
• Acknowledge and make aware of “close calls”
 Key Messages

• Biorisk management system has three main components namely, biorisk

assessment, risk mitigation, and evaluation of performance.

• Biorisk assessment is a process for hazard identification (biosafety), asset and threat
identification (biosecurity), and benefits and risks identification (bioethics).

• Risk mitigation measures are based on the hierarchy of controls, pillars of

biosecurity, and ethical reviews for biosafety, biosecurity and bioethics respectively.

• The risk assessment framework provides a stepwise guide to performing a

comprehensive risk assessment using specific considerations at every step.
The End

You have come to the end of this Module. Kindly attempt the module quiz and
aim to attain a pass mark of 80%. Remember to participate in the discussion
forum before proceeding to module 3.