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Risk Assessment
Risk
As defined by Kaplan and Garrick, risk analysis consists of
answering three specific questions:
• what can happen?
• what is the chance that it will happen?
• if it happens, what are the consequences?.
Risk definition
Risks are defined as a function of the likelihood
of infection by the agent and the likelihood of
exposure through an infectious route based on
the procedures and work practices and the
consequences of disease assuming infection
Biosafety risks is a function of:
• likelihood of
– infection by the agent
– exposure through an infectious route
• consequences
Definitions
•
Risk Assessment
– Identifying and exploring, preferably in quantified terms, the types,
intensities and likelihood of the consequences related to a risk. Risk
assessment comprises hazard identification and estimation, exposure and
vulnerability assessment and risk estimation
•
Risk Analysis
– Risk assessment, risk management, and risk communication
•
Risk Prevention
– Measures to stop a risk being realized; typically means stopping the activity
giving rise to the risk
•
Risk Reduction
– Measures to reduce the level of risk, for example by reducing the likelihood
of the risk being realized or reducing the impact of the risk
Risk assessment
strategy
Characteristics
• risk assessment is CAREFUL judgment
• risk assessment is proactive rather than reactive
• assessments can be qualitative, semi-quantitative or quantitative
• risk assessment methodology should be:
– identified
– implemented
– maintained
• risk assessment is first step to control (reduce or eliminate) the
hazards
• risk assessment will provide a guide for the selection of appropriate
- biosafety levels needs
- microbiological practices
- safety equipment
- facility safeguards
Assess the capability of the laboratory staff
to control hazards
- training
- technical proficiency
- good habits of all members of the laboratory
- operational integrity of containment equipment
- facility safeguards
New risk assessment or
review of an existing one when:
• the introduction of new biological agents
• new work or changes to the programme of
work
• alterations to work flow or volume
• new construction / modifications to
laboratories, equipment or its operation
• introduction of altered and unplanned staffing
arrangements
New risk assessment or
review of an existing one when:
• significant alterations to Standard Operating
Procedures (SOPs) or working practices (e.g.
disinfection/waste management
methodologies, PPE provision / usage
entry/exit protocols, etc.);
• unexpected events that may have relevance
for the management of biorisks are observed
New risk assessment or
review of an existing one when:
• actual or potential non-conformity with
internal / external rules and regulations is
identified
• as part of the existing management system
review process (e.g. annually or at another
appropriate and predetermined frequency)
4 scenarios
• Risk to individuals in the laboratory
• Risk to an individual 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
Risk Assessment
• Basis of all biosafety practices
• Professional judgement
• Assessment of:
–
–
–
–
–
organisms
equipment
procedures to be employed,
animal models
containment equipment and facilities available
• Responsibility of Lab Director or Principal Investigator
• Role of Biosafety Committee and Biosafety Officers
Using a Risk Assessment Process
• A standardized biological risk assessment process
allows the risk assessments to be:
– Repeatable
– Quantifiable
• A systematic, standardized approach should
include:
– Accepted criteria for assessing the risk
– A standardized approach for evaluating the situation against the criteria (“scoring
system”)
• Ideally this process results in a system that:
– Allows analysis of the risk to identify driving factors and allow better realization of
mitigation measures
– Enables better communication of risk
• Help to define what is acceptable risk
Identify Key Factors For Assessing A
Biosafety Risk
• Example 1: A laboratory researching resistance
factors for Mycobacterium tuberculosis
• Example 2: A clinical laboratory conducting
diagnostic tests for diarrheal diseases
• What are the key factors needed to conduct a risk
assessment?
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–
–
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What factors define likelihood?
What factors define consequences?
What are the Agent factors?
What are the Procedure factors?
Laboratory Biosafety Risk
•
Risk = F (Likelihood, Consequence)
Likelihood -The likelihood of infection by the agent and the
likelihood of exposure through an infectious route based on
the procedures and work practices
•
• Inhalation
• Percutaneous
• Direct contact
• Ingestion
Consequences - Of disease from accidental exposure
•
Risks - To laboratory workers
–
–
•
•
•
•
Researchers
Animal care workers
Technicians
Engineers
Risk of accidental exposure to community
Risk of accidental exposure to animal community
18
Risk Assesment
• What are you working with?
– Microbe (risk category)
– Chemical (MSDS)
– Equipment (?)
Declaration of International Federation of Biosafety Association on
Advancing Global Biosafety and Biosecurity
2011, the year of building international
biosafety communities
Longer-term goals
• Promoting biosafety education,
particularly of the younger generation,
involving curriculum development within
a common framework and a common
methodology for evaluation.
• Supporting appropriate and practical
legislative framework development.
• Developing a strategy to obtain funding
for applied biosafety research programs
Material Safety Data Sheet (MSDS)
Process
1
2
3
• Assign biosafety level
• Appropriate personal protective equipment selected,
• Standard operating procedures (SOPs) incorporating other safety
interventions developed to ensure the safest possible conduct of the
work
Health and medical surveillance
• The employing authority, through the laboratory director, is
responsible for ensuring that there is adequate surveillance
of the health of laboratory personnel.
• The objective of such surveillance is to monitor for
occupationally acquired diseases.
• Appropriate activities to achieve these objectives are:
– Provision of active or passive immunization where indicated
– Facilitation of the early detection of laboratory-acquired
infection
– Exclusion of highly susceptible individuals (e.g. pregnant women
or immunocompromised individuals) from highly hazardous
laboratory work
– Provision of effective personal protective equipment and
procedures
FINAL REMARKS
Train and RETRAIN and RETRAIN and ..
until good microbiological techniques and safety
precautions become second nature
Inadequate training on :
- PPE use
- correct use and maintenance of equipment
FALSE sense of security