Risk Assessment

Module objectives
At the end of this module, participants will be able
•To define risk, vulnerability, and assessment
•To understand the process of biorisk assessment
•To know how to conduct a laboratory
 biosafety risk assessment
 biosecurity risk assessment
 Definitions
Risk:
 the probability that harm, injury, or disease will occur;
 the probability of an adverse effect

Vulnerability
 The degree of susceptibility and resilience of the community and
environment to hazards.

Assessment:
 The process of gathering and judging evidence in order to decide whether a
person has achieved a standard or objective
 Definitions
Hazard
A hazard is an agent which has the potential to cause harm to a
vulnerable target

Threat
a statement of an intention to inflict pain, injury, damage, or other hostile action
on someone in retribution for something done or not done.
 Risk Assessment overview
 Risk assessment is a systematic process of evaluating
the potential risk that may be involved in the projected
activities.
 Risk can be hazard (biosafety) or threat (biosecurity)
 Complete risk assessment when
 Incident/ exposure
 Changes such as moving, renovating or building
new facility
 Working with new infectious agent
 New equipment, technology or procedure
 New scientific information
 Biosafety Risk Assessment: a Deciding Factor

• It is an analytical procedure designed to characterize safety risks in

a laboratory.
• Prior to beginning any procedure, laboratory workers should
gather all available information concerning the agent (s) /
materials they will be working with & perform a risk assessment of
the agent(s).
• “The biosafety level assigned for the specific work is driven by
professional judgment based on a risk assessment”

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 Steps for risk assessment
 Five steps approach to risk assessment:
1. Identify agents
2. Identify laboratory procedure hazards
(Laboratory activity)
3. Determine preliminary biosafety Level
4. Evaluate competency of staff
5. Review the risk assessment (with a biosafety
professional, subject matter expert and the
Institutional Biosafety Committee)
Risk assessment: Step 1

Identify agent

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 Identify Agent

• What is known about the agent (Category, Amount of

agent, Transmissibility)?
• What information is in the literature?

• Is the agent/material known to cause infectious or

toxigenic disease?
• Is the host range limited or broad?
• Is post-exposure treatment, vaccine or prophylaxis available?

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 Identify Agent Cont’d…
• Other agent related questions?
 Potential outcome of exposure?

 Natural route of infection/other routes of infection

(parenteral, airborne, ingestion)
 Stability in the environment

• Laboratory activity (aerosolization, centrifugation, etc.)

• Genetic manipulation

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 Risk assessment: Step 2

Identify laboratory procedure hazards

 Identify laboratory procedure hazards

• Identify laboratory hazards by reviewing protocols,

procedures and guidelines for activities which could
release the organism and expose the worker, co-
workers and/or the environment

• Investigate potential routes of transmission for

Laboratory Acquired Infections

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Identify laboratory procedure hazards Cont’d
Contamination Routes:
Ocular invasion

Inhalation

Ingestion

Skin penetration
 Identify laboratory procedure hazards Cont’d…

1. Needle Hazards 2. Splash and Splatter

3. Animal Bites and Scratches 4. Inhalation Exposure to Infectious Aerosols

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Identify laboratory procedure hazards Cont’d…

Airborne Microbes
Airborne transmission is possible for all
classes of microbes:
• viruses
• bacteria
• Fungi
• protozoans
Identify laboratory procedure hazards Cont’d…
Airborne Microbes Aerosols and Droplets
Aerosols: Airborne particles, either solid or liquid,
about 0.5 to 20 microns in diameter, that remain
airborne for extended periods of time

Droplets: >20 (usually 100+) microns in diameter;

settle rapidly or evaporate to form droplet nuclei
in the aerosol size range
 Identify laboratory procedure hazards Cont’d…

Procedures that Increase Risk

 Non routine activities that require new skills

 Extremely repetitive or boring activities

 Working with high concentration of agent

adds additional risk

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 Risk assessment: Step 3

Determine preliminary
biosafety level

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 Determine preliminary biosafety level
 Establishing a “Starting Point”
Determining the:
preliminary biosafety level
additional precautions
 Requires a comprehensive understanding of the
practices,
 safety equipment, and laboratory facility safeguards
in the work to be undertaken

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 Determine preliminary biosafety level Cont’d …
Identifying Additional Precautions

Intended use of an agent may require greater

precautions than those outlined in the
agent’s scientific literature

agent summary statement

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Risk assessment: Step 4

Evaluate competency of staff

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 Evaluate competency of staff
• Evaluation of staff competency must focus on
identifying gaps:
 Worker experience
 Occupational health and safety (includes prophylaxis and fit
testing)
 Previous training
 Expertise in specific protocols
 Good microbiological practices
 Attitude toward use of safe practices, PPE
 Orientation of new employees on safety and medical
surveillance program

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 Risk assessment: Step 5

Review the risk assessment

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 Review the risk assessment
Use your “team” to ensure all aspects have
been addressed in the assessment
biosafety professional,
subject matter expert,
occupational health provider and
the institutional biosafety committee

Review of the process is often required by

regulatory or funding agencies

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 Risk Assessment Cycle
Identify agent hazards
Review
and perform initial
risk assessment
risk assessment

Reevaluate & Modify

Evaluate staff Biosafety Program
Identify laboratory
proficiencies procedure hazards

Determine
appropriate
biosafety levels
 Prioritization of Risk
General Principles for the assessment:
Identify:
• the (bio)hazard(s) of concern
• who or what is at risk
• where and when the risk is present
• the frequency and intensity of potential
exposure, potential infection/disease
• Assess the proposed procedures (consider both
procedural and worker factors)
• Prioritize the individual risk(s)
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 Prioritization of Risk cont’d….
 A (bio)hazardous agent can be classified as
either
 low
 moderate
 high risk
 The procedures can also be classified in this
manner
 A matrix of the combined level of risks allows
one to prioritize the overall risk

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 Prioritization of Risk cont’d
Points to be considered while
prioritization:
Obtain information on the specific agent
(strain, subtype) to be used

Determine if the strain is well known, newly

isolated, well characterized, unclassified or
rarely used

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 Biosafety Risk Prioritization Matrix

High
High/
High
AGENT

Medium/
Mediu
m Medium-High

Low

Low Mediu High

m
PROCEDURE
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 Risk Prioritization Matrix…
RISK
Likelihood and Very
Consequences, and High

the graph on the right.

Likelihood
High

Moderate
Low

Very
Low

Consequences

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 Risk scenarios
For the following scenarios, draw a STAR where the risk would fall on the graph.
You are in an open field You are in the zoo, You are holding a tiger cub
next to a very hungry , observing a caged adult with a playful temperament in
aggressive, adult tiger. The tiger, which is well fed, your arms.
tiger is unrestrained and and has a mild
sees you as food.0 temperament.

Very Very Very

RISK High RISK High RISK High
Likelihood

Likelihood

Likelihood
Very Very Very
Low Consequences Low Consequences Consequences
Low
 Risk Scenario
You are at the zoo RISK

observing a mellow, Very

tiger cub located High

behind a strong glass

Likelihood
window. High

Moderate

Low

Very
Low

Consequences

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 Risk Characterization
Scenario:
The lab worker discovers his culture of
Mycobacterium tuberculosis is Extremely RISK
Drug Resistant (XDR). Meanwhile, a local
animal rights group has threatened to disrupt Very
laboratory operations and generate publicity High
by breaking in and stealing agents. They
believe taking samples of XDR will generate

Likelihood
the most publicity. High

Moderate
What is the threat in this scenario?
Low
What is the likelihood of a theft?
What are the consequences of a theft? Very
Low
What are some factors that should be
considered? Consequences

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 After completion of the risk assessment
 Generate risk assessment findings summary
 Develop and implement action plan for the identified gaps
 Performance evaluation
 Establish laboratory specific protocols and practices
 Corresponding to the identified level of risk to reduce or
eliminate the chances of exposure and accidents

 Train all personnel

 To know and understand the risk in their particular laboratory

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Laboratory Biosecurity Risk
Assessment
 Definitions
• Biorisk Assessment
– Process of identifying the hazards and evaluating the
risks associated with biological agents and toxins,
taking into account the adequacy of any existing
controls, and deciding whether or not the risks are
acceptable

• Biorisk Mitigation
– Actions and control measures that are put into place
to reduce or eliminate the risks associated with
biological agents and toxins
 Bio-security risk assessment cont’d

Vulnerability Assessment: A systematic evaluation

process used to protect biologic laboratories and
operations from specifically defined acts that can
oppose or harm a person's interest.

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 Bio-security risk assessment cont’d

 Allow management to make informed decisions to

ensure that the cost of protective measures are
proportional to the risk
There are many ways to perform a laboratory bio-
security risk assessment
• 5-step process outlined in the CDC/NIH Biosafety
in Microbiological & Biomedical Laboratories
(BMBL).

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 Five step for
Biosecurity risk assessment

1. Identify and prioritize assets

2. Assess potential threats and vulnerabilities
3. Analyze the risk of specific security scenarios
4. Design and develop an overall risk
management program
5. Re-evaluate institution’s risk posture and
protective objectives

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 Step 1: Identify and prioritize assets
 Identify agents, materials, equipment, personnel
 Evaluate potential misuse or weaponization
 Evaluation consequence of misuse
 Prioritize assets based on consequence of misuse
 Step 2: Assess potential threats and
vulnerabilities
 Identify types of outsiders
 Identify types of insiders
 Evaluate motive, means, opportunity for potential
adversaries
 Step 2: Assess potential threats cont’d…
 Outsider  Insider
 Low Risk  High Risk
 Public access to  Unescorted access
information  Non-violent
 May be armed  Knowledge of facility
 May carry tools  Opportunity

Strategy: Strategy:
Detect/Identify & Know employees
Contain
Step 3: Analyze the risk of specific security scenarios

Develop list of possible security scenarios

Evaluate probability of each scenario
materializing and its consequences
Prioritize or rank scenarios by risk for
management to review

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 Biosecurity Risk Prioritization Matrix
Risk is the likelihood of an undesirable
RISK
event happening, that involves a
specific hazard or threat and has
consequences Very
High

Risk = f (likelihood, consequences) High

Likelihood
or, more simply, Moderate

Risk is a function of both the Low

Likelihood of something happening Very
and Consequences of that occurrence Low

For biosecurity Risk, the threat is the Consequences

potential adversary who is interested in
the biological materials.

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 Risk Characterization
Scenario:
The lab worker discovers his culture of RISK
Mycobacterium tuberculosis is Extremely
Drug Resistant (XDR). Meanwhile, a local
animal rights group has threatened to disrupt Very
laboratory operations and generate publicity High
by breaking in and stealing agents. They
believe taking samples of XDR will generate

Likelihood
High
the most publicity.
Moderate
What is the threat in this scenario? Low
What is the likelihood of a theft?
What are the consequences of a theft? Very
Low
What are some factors that should be
considered? Consequences

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 Step 4: Design and develop
an overall risk management program
 Makes final decision on items that require
protection with advise from committee.
 Oversees, implements, trains, and maintains
biosecurity program
 Develops “Risk Statement”
 Develops “Biosecurity Plan”
 Ensures resources to achieve measures in
biosecurity plan

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 Risk management summary
Communicate and Consult

Establish Identify Analyze Evaluate Treat the

the the Risks the Risks the Risks Risks
Context
Identify
Hazards Review Evaluate options
analysis
Objectives controls risks Select the
best
Stakeholders Likelihoods Rank Risks responses
Vulnerability
Criteria analysis Consequence Develop risk
treatment
Define key s
plan
elements
Level of risk
Implement

Monitor and Review

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 Key Messages
• A biosafety and biosecurity risk assessment allows a
laboratory to determine the relative level of risk its
different activities pose, and helps guide risk mitigation
decisions so these are targeted to the most important risk.

• Risk Characterization is the process of identifying the

factors that contribute to risk and determining the
likelihood and consequences that contribute to risk.

• Complete and thorough analysis of the different hazards,

threats and situations that can affect risk will increase the
robustness of the risk characterization process.

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Any Questions, Comments
and Suggestion