MLSP BIORISK MANAGEMENT
hazard
A ______ is an object that can cause harm
laboratory biorisk assessment
A ____________ is an analytical procedure designed to characterize and evaluate safety and security risks in a laboratory
risk mitigation decisions
A biorisk assessment allows a laboratory to determine the relative level of risk its different activities pose, and helps guide _______________ so these are targeted to the most important risk
BIORISK MANAGEMENT
A system or process to control safety and security risks associated with the handling or storage and disposal of biological agents and toxins in the laboratories and facilities.
A - Assessment M - Mitigation P - Performance
AMP Model COMPONENTS:
Biorisk Mitigation
Actions and control measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins
check
Checking, including monitoring and corrective action
performance
Control Assurance Improvement
Unlikely
Could occur at some time
Catastrophic
Death, toxic release off site with detrimental effect, huge financial loss
PPE
Devices worn by the worker to protect against hazards
PDCA (Plan-Do-Check-Act)
Effective management system approach Should be built on the concept of continual improvement through a cycle of planning, implementing, reviewing and improving the processes and actions that an organization undertakes to meet goals. This is known as the __________
Mitigation
Elimination or substitution Engineering controls Administrative controls Practices and procedures Personal protective equipment
Almost Certain
Expected to occur in most circumstances
Pathogenicity Virulence Host range Communicability Transmission Environmental Stability
Factors that affect Likelihood and/or Consequences? Agent Properties:
PPE Training SOPs Equipment used
Factors that affect Likelihood and/or Consequences? Procedures:
minor
First aid treatment, on site release immediately contained
elimination, substitution
Implementing Mitigation Measures Ideally, you should first consider _________ or __________
do
Implementing, including training and operational issues
Biorisk Performance
Improving biorisk management by recording, measuring, and evaluating organizational actions and outcomes to reduce biorisk
BIORISK MANAGEMENT
Is the integration of biosafety and biosecurity to manage risks when working with biological toxins and infectious agents
Rare
May occur only in exceptional circumstances
moderate
Medical treatment required, on site release contained with outside assistance, high financial loss
Possible
Might occur at some time
insignificant
No injuries, low financial loss
controls: engineering
Physical changes to work stations, equipment, materials, production facilities, or any other relevant aspect of the work environment that reduce or prevent exposure to hazards
plan
Planning, including identification of hazard and risk and establishing goals
administrative
Policies, standards and guidelines
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
practices and procedures
Processes and activities
• Pathogen • Procedures • Personnel PE • Place
RISK ASSESSMENT • Involves team work • identify all the risks : • 5Ps what are the 5Ps?
hazard, threat consequences, risk controls
RISK ASSESSMENT • identify the specific ______ or ______ • determine the _________ of an identified ____ • identify all the existing ______ and any additional ones that need to be applied
elimination
Removing the risk
act
Reviewing, including process innovation and acting to make needed changes to the management system
biorisk
Risk associated to biological toxins orinfectious agents
Biorisk
Risk associated with biological materials _________ = Biosafety + Biosecurity Risks
assessment
Risk identification Hazard/threat identification Likelihood evaluation Consequences evaluation
Likelihood, Consequences
Risk is a function of both the _________ of something happening and __________ of that occurrence
- Unintentional exposure to unauthorized access - Accidental release or loss - Theft - Misuse - Diversion - Intentional unauthorized release of biohazard
Sources of biorisk
substitution
Substitution of a serious pathogen with one this is much less pathogenic
management system approach
This implies that identifying, understanding and managing a system of interrelated processes for a given objective, improves the organization's effectiveness and efficiency
management system approach
This laboratory biorisk management CWA is based on a
activity and procedure
To be comprehensive: A biosafety risk assessment should consider every _________ conducted in a laboratory that involves infectious disease agents
asset, adversary and vulnerability
To be comprehensive: A laboratory biosecurity risk assessment should consider every ________________ in an institution and its component laboratories and units
Likely
Will probably occur in most circumstances
Risk
_____ is the likelihood of an undesirable event happening, that involves a specific hazard or threat and has consequences
1. Define the situation 2. Define the risk 3. Characterize the risk 4. Define if risk are acceptable or not
biorisk assessment steps
major
extensive injuries, loss of production capability, off site release with no detrimental effects, major financial loss5
risk
• A ____ can be based on either a hazard and/or a threat
threat
• A _____ is a person who has intent and/or ability to cause harm to other people, animals, or the institution
performance evaluation
• Involves a systematic process intended to achieve organizational objective and goals. • Model ensures that the Implemented mitigation are indeed reducing or eliminating risk
PERSONAL PROTECTIVE EQUIPMENT (PPE)
•Last control in the hierarchy of controls •Should be used with other controls. •However, in many laboratories it is the first control implemented, and sometimes the only control
