PRINCIPLES OF MEDICAL
LESSO LABORATORY SCIENCE
N BIORISK
7 MANAGEMENT
 BIORISK MANAGEMENT AND
BIORISK- biological toxins or infectious agents.
-unintentional exposure to unauthorized
access, accidental release or loss, theft,
misuse, diversion, or intentional release
of biohazards.
BRM (Biorisk Management)- the integration of
biosafety and biosecurity to manage risks
in working with biological toxins and
infectious agents.
- identification, understanding, and
management aspects of a system in
interrelated process.
- CEN Workshop Agreement (CWA), BRM is “a
system or process to control safety and
security risks associated with the
handling of storage and disposal of
biological agents and toxins in
laboratories and facilities”.
AMP MODEL
BRM is divided into 3 primary components:
 ASSESSMENT
 MITIGATION
 PERFORMANCE
AMP focuses on all components with equal
attention.
 KEY COMPONENTS OF
1. RISK ASSESSMENT
-initial step to implementing biorisk
management process.
- includes identification of hazards and
characterization of risks that are possibly
present in lab.
*Hazard- anything in environment that
has the potential to cause harm.
*Risk- the possibility that something bad
or unpleasant (such as injury or loss) will
happen.
-In performing risk assessment, a structured and
repeatable process is followed. This is the ffg.
Steps:
 Define the situation- risk assessment team
must identify the hazards and risks of the
biological hazards to be handled. At risk-
hosts, identify the humans or animals
inside or outside of the laboratory, work
activities and laboratory environment:
location, procedures, equipment.
 Define the risks- includes a review of how
individuals inside and outside the
laboratory may be exposed to hazards.
Could be through droplets, inhalation,
ingestion, or inoculation in case a
biological hazard has been identified as
the hazard.
 Characterize the risks- the risk assessment
team needs to compare the likelihood and
the consequences of infection- either
qualitatively or quantitatively.
 Determine if risks are acceptable or not-
evaluating the biorisk arising from a
biohazard, of any existing controls and
deciding whether biorisk is acceptable or
not.
2. MITIGATION PROCEDURES
-2ND fundamental component of the
biorisk management model is mitigation.
- measures actions and control measures
to reduce or eliminate the risks
associated with biological agents and
toxins.
*There are 5 major areas of control/measures
that can be employed in mitigating the risks.
 Performance management- a reevaluation of
the overall mitigation strategy. These are
procedures in conducting performance
evaluation:
 Elimination- most difficult and most
effective control measure, the total decision
to work or not in a specific biological agent.
Provides the highest degree of risk
reduction.
 Substitution- the second most difficult and
effective. Replacement of biological
procedures or agent with similar entity in
order to reduce the risks.
 Engineering controls- third control
measure, includes physical changes in work
stations, equipment, production facilities, etc
that can reduce/prevent exposure to
hazards.
 Administrative controls- fourth control
measure, refers to the policies, standards,
and guidelines used to control risks.
Standard Operating Procedures (SOPs)
to avoid laboratory-acquired infections.
 Personal Protective Equipment (PPE)-
devices worn by workers to protect them
against chemicals, toxins, and pathogenic
hazards in the laboratory. Gloves, gowns,
and respirators.
3. PERFORMANCE EVALUATION
- last pillar of biorisk management model
is performance evalution that involves
scientific process intended to achieve
organizational objectives and goals. It ensures
that the implemented mitigation process are
indeed reducing or eliminating risks. It also
helps highlight biorisk strategies that are not
working effectively and measures ineffective and
necessary. These can be eliminated or replaced.
KEY POINTS
 Biorisk management (BRM) is an
integral part in the implementation of
the concept of biosafety and
biosecurity. It involves the process of
assessment, mitigation, and
performance evaluation.
 The AMP Model illustrates the
balanced role among the components
of BRM.
 A robust risk assessment is the heart
of BRM. It ensures safety and security
of the people working in the
laboratory as well as all the
stakeholders in an organization.
 The different mitigation procedures to
be employed depend on the result of a
robust risk assessment. It is
recommended not to overdo or
underdo the measures.
 Performance evaluation is a
continuous process to monitor the
implementation of existing biosafety
procedures and practices. It provides
direction for decision-makers to come
up with reasonable and justifiable
biosafety guidelines.
 Communicating BRM among the
members of the organization is the
way for interactive transmission and
exchange of information and opinion
throughout the analysis process about
risk, risk-related factors, etc.