BIORISK MANAGEMENT Flashcards
to ensure biosafety one must do what
must consider the practices & procedures on biocontainment
necessary to carry out total safety of laboratory workers and patients.
proper management
the risk associated to biological toxins or infectious agents.
biorisk
examples of infectious agents
Bacteria, Fungi, Virus & Parasites
Normal Flora is a biorisk
False
sources of risks
Unintentional exposure to unauthorized access
Accidental release or loss
Theft
Misuse
Diversion
Intentional unauthorized release of biohazards
is the integration of biosafety & biosecurity to manage risks when working with biological toxins and infectious agents
Biorisk management
Biorisk management is the integration of biosafety & biosecurity to manage risks when working with biological toxins and infectious agents
(CWA 15793 Laboratory Biorisk Management Standard)
Biorisk Management (BRM) is “a system or process to control safety and security risks associated with the handling or storage, and disposal of biological agents and toxins in laboratories and facilities.”
CEN Workshop Agreement (CWA) 15793: 2011
“a system or process to control safety and security risks associated with the handling or storage, and disposal of biological agents and toxins in laboratories and facilities.”
Biorisk Management (BRM)
three primary components of BRM
Assessment
Mitigation
Performance
Identified risks can be
mitigated
avoided
limited
transferred to an outside entity
accepted
Initial step in implementing a biorisk management
risk assessment
refers to anything in the environment that has the
potential to cause harm.
hazard
generally defined as the possibility that something
bad or unpleasant (injury or loss) will happen.
risk
A sharp needle is a _____, but if no one is using it, the needle will not pose any risk.
hazard
the likelihood that an adverse event involving a specific hazard or threat will occur followed by the consequences of that occurrence.
risk
state the structured and repeatable process of performing risk assessment
1.Define the situation
2.Define the risks
3.Characterized the risks
4.Determine if risks are acceptable or not
second fundamental component of the biorisk management
mitigation procedures
are actions and control
measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins
biorisk mitigation measures
biorisk mitigation measures are actions and control
measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins
Salerno (2015)
state the five (5) major areas of control or measures that can be employed in mitigating the risks (from most effective to least)
Elimination
Substitution
Engineering Controls
Administrative controls
PPE
Most difficult and most effective
Elimination
Involves the total decision not to work with a specific biological agent or even not doing the intended work
Elimination
Highest degree of risk reduction
Elimination
Replacement of the procedures or biological agent with a similar entity in order to reduce the risks
Substitution
Bacillus anthracis → [to what]
Bacillus thuringiensis
can cause acute fatal disease anthrax
Bacillus anthracis
less dangerous experimental surrogate; commonly used in
biological pesticides worldwide
B. thuringiensis
Includes physical changes in work stations, equipment, production facilities, or any other relevant aspect of the work environment that can reduce or prevent exposure to hazards.
engineering controls
examples of engineering controls
- Installation of biosafety cabinets
- Safety equipment (centrifuge
with cover, autoclave &
machines with indicators) - Facility design enabling
proper airflow - Ventilation system to ensure directional airflow
- Air treatment systems to
decontaminate or remove
agents from exhaust air - Controlled access zones
- Airlocks as laboratory
entrances - Separate buildings or
modules to isolate the
laboratory
the policies, standards, and
guidelines used to control risks.
Administrative controls
_____ and _____ _____ for lab staff is considered an
administrative control.
proficiency and competency training
-Displaying biohazard or
warning signages, markings
& labels
-Controlling visitor and worker
access
-Documenting written
standard operating procedures
administrative controls
Devices worn by workers to protect them against chemicals, toxins, and pathogenic hazards in the laboratory.
PPE
why are PPE labelled as least effective
it only protects the person who is wearing it, and only when it is used correctly
the effectivity of mitigating risks relies on:
- combination of all the different measures
- proper utilization
Last pillar of the biorisk management model
performance evaluation
It involves a systematic process intended to achieve
organizational objectives & goals.
performance evaluation
performance evaluation ensures what
ensures that the implemented mitigation
measures are indeed reducing or eliminating risks.
helps to highlight biorisk strategies that are not working effectively & measures that are ineffective or unnecessary –> can be eliminated / replaced
performance evaluation
Reevaluation of the overall mitigation strategy
performance management
state the performance evaluation procedures
- identify the key issues of concern
- define OUTCOME indicators and metrics
- define ACTIVITIES indicators and metrics
- Collect data and report indicator results
- provide findings from performance indicators
- evaluate and refine performance indicators
The result of a robust risk assessment must be properly
recorded
documented
communicated (to all stakeholders of the organization)
