Biorisk Management Flashcards
any microbiological entity that may have able to provoke infection, allergy, toxicity and other adverse effects in human
biological agent
examples of biological agents
bacteria, fungi, virus, viroid, endo-, and ectoparasites
Any material comprised of, containing, or that may
contain biological agents and/or their harmful products
biological material
Potential source of harm caused by biological materials
biohazard
Containment principles, technologies, and
practices implemented to prevent
unintentional/accidental exposure to
pathogens and toxins
Laboratory biosafety
protecting people from bad pathogens
laboratory biosafety
Institutional and personal security measures
designed to prevent intentional release of pathogens
and toxins
laboratory biosecurity
protecting pathogens from dangerous people
laboratory biosecurity
stealing cultures from the laboratory
laboratory biosecurity
examples of biosafety
engineering controls, good laboratory work practices, personal protective equipment
Examples of biosecurity
doors with locks
password/pin
biometrics
cameras
information security
Effect of uncertainty expressed by the combination of the CONSEQUENCES of an event and the associated LIKELIHOOD of occurrence,
where biological material is the source of harm
biorisk
System or process to control safety and security risks
biorisk management
biorisk management strategy
- describe work activities
- identify hazards & identify any threats
- determine risks
- decide whether the risk is acceptable or not
- if yes,
- proceed with work and monitor controls
- if no
- prepare risk control action plan
- implement control measures
- review adequacy of plan
- revise or close project
conduct judicious evaluation of risks, selecting which mitigation measures will be employed
Biorisk Management Manager
supervises the biorisk management
BRM Manager
Influences to management decisions are:
Perception of risk
- risk tolerate vs risk averse influenced by:
- financial
-political
-cultural
- communication
- geography
Biorisk management utilize a _________ approach with a goal of continuous improvement
Plan-Do-Check-Act
It is the pinpoint areas of bio risk management that need improvements
plan
It is the trial and error section of Laboratory Biorisk Management act
Do
It is the section of LBRM of implementation (not full) of test plan or trial
Check
it is the area for full implementation
Act
-identification of potential improvement
-analysis of current situation
- development of new concepts
plan
testing and optimization of new concept
Do
careful checking of process and obtained result
-if successful, full approval
check
full implementation
act
The BRM - AMP Model
assessment
mitigation
performance
Identification of Biorisk
Biosafety risk biosecurity risk
assessment assessment
Performance Measure
Lab BRM
The AMP Model
Identify the specific hazards or threaths
determine the consequences of an identified risk
identify all the existing controls and any additional ones that need to be applied
risk management
it is an object that can cause harm
hazard
it is a person that intent to cause harm to other people
threat
it can be based either on hazard and/or threat
risk
RG 1, RG 2, RG3, and RG4
Agent Risk Group
agents that are not associated with disease
RG1
example of rg1 agent
brewer’s yeast
agents that are associated with disease but rarely serious
RG2
Examples of RG2 agents
herpes virus, streptococcus pneumoniae
agents that are associated with lethal or serious disease
RG3
Example of RG3 disease
Yersinia Pestis, HIV, SARS virus
agents that are associated with serious disease with no therapeutic interventions
RG 4
Examples of RG4 agents
Ebola virus, Marburg virus
Risk Assessment Question
pathogen
procedures
personnel
personal protective equipment
place
Ways of transmission of pathogens
direct
indirect
few-oral
percutaneous
perinatal
is the likelihood of an event/incident with a hazard that has consequences
risk
probability of an event occurring
likelihood
severity of an event
consequence
1 - rare
2 - unlikely
3 - possible
4 - likely
5 - almost certain
determining likelihood of an event
may occur only in exceptional circumstances
rarely
could occur at some time
unlikely
might occur at some time
possible
will probably occur in most circumstances
likely
expected to occur in most circumstances
almost certain
1 - insignificant
2 - minor
3 - moderate
4 - major
5 -catastrophic
consequences
no injuries, low financial loss
insignificant
first aid treatment, on site release immediately contained
minor
medical treatment required, on site release contained with outside assistance, high financial loss
moderate
extrusive injuries, loss of production capability, off site effects with no detrimental effects, major financial loss
major
death, toxic release offsite with detrimental effects, huge financial loss
catastrophic
lab procedures that can cause produce aerosols
pipetting
mixing
shaking
configuration
blending
risk identification
hazards/threat identification
likelihood evaluation
consequences evaluation
assessment
elimination or substitution
engineering controls
administrative controls
practices and procedures
PPE
Mitigation
control
assurance
improvement
performance
a process to identify the hazards and evaluate the risks associated with biological agents and toxins
assessment
actions or control measures that are put into place to reduce or eliminate the risks
mitigation
evaluating and ensuring that the system is working the way it was designed, and identifying opportunities for system improvement
performance
Hierarchy of Controls
elimination
sublimation
engineering controls
administrative controls
ppe
5 major categories in controlling biological risks
elimination or substitution
engineering controls
administrative controls
practices and procedures
personal protective equipment
physically remove the the hazard
elimination
replace the hazard
replace the hazard
engineering controls
isolate people from the hazard
removing the risk
elimination
substitution of a serious pathogen with one this is much less pathogenic
substitution
physical changes -to work stations, any relevant aspect of the work environment that reduce or prevent exposure to hazards
controls engineering
policies, standards, and guidelines
administrative
devices worn by the worker to protect against hazards
ppe
more on equipment, materials, and production facilities
engineering controls
Advantage and disadvantage of engineering controls
Advantage
efficient
eliminates Hazards
significantly reduces the potential and and the level of exposure to pathogens
Disadvantage
Cost
Complexity
Advantage and disadvantage of administrative
Advantage
authority approach
Disadvantage
Indirect approach
Addresses human factor
Advantage and disadvantage of practices and procedures
Ad.
SOP based
Dis.
Training and Supervision Required
Advantage and disadvantage of PPE
Ad.
easy of use
relative cost
Dis.
does not eliminate Hazard
If ppe fails, exposure happens, uncomfortable, limits ability
