Biorisk Management

RYAN M. PEDREGOSA, RMT

Senior Instructor, NDMU
Medical Technology Department
 Introduction
Risk management systems are common
across many industries, especially those
industries in which accidents can have
significant consequences. The root cause of the
high-consequence accidents extended well
beyond technical or human failure, and almost
always reflected underlying failures in the
management of safety or security. High-
consequence industries that have implemented
proactive risk management systems have
significantly reduced the number and severity of
accidents.

Pedregosa, R.M., RMT Biorisk Management

 Learning Outcomes
At the end of the discussion, students will be
able to:
a. explain the importance of biorisk
management.
b. discuss the AMP model.
c. identify risk assessment, mitigation, and
performance evaluation procedures.

Pedregosa, R.M., RMT Biorisk Management

 Biorisk Management

Biorisk is the risk associated with

biological toxins or infectious agents. The
source of risk may be unintentional
exposure to unauthorized access,
accidental release or loss, theft, misuse,
diversion, or intentional unauthorized
release of biohazards.

Pedregosa, R.M., RMT Biorisk Management

 Biorisk Management

Biorisk management is the

integration of biosafety and biosecurity
to manage risk when working with
biological toxins and infectious agents.

Pedregosa, R.M., RMT Biorisk Management

 Biorisk Management

Biorisk Management 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 or facilities.

Pedregosa, R.M., RMT Biorisk Management

 The AMP Model

The AMP model requires that

control measures be based on a robust
risk assessment and a continuous
evaluation of the effectiveness and
suitability of the control measures.
Identified risks can be either mitigated,
avoided, limited, transferred to an
outside entity, or accepted.

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management

RISK ASSESSMENT
• The initial step in implementing a
biorisk management process that
includes the identification of hazards
and characterization of risks that are
probably present in the laboratory.

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management

• Hazard – anything in the

environment that has the
potential to cause harm.
• Risk – the possibility that
something bad or
unpleasant (such as injury
or loss) will happen.
• Threat – the likelihood of
a person causing harm.

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management

In order for a risk to

occur, there must be a
situation for the hazard
to cause harm.

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management
In performing risk assessment, a structured and
repeatable process is followed. It consists of the
following steps.
1. Define the situation – identify the hazards and
risks of the biological agents to be handled.
2. Define the risks – how individuals inside and
outside the laboratory may be exposed to
hazards.
3. Characterize the risks – compare the likelihood
and consequences of infection.
4. Determine if risks are acceptable or not –
adequacy of any existing controls.

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management

MITIGATION PROCEDURES
• 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.

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management

Salerno (2015), not one of the

mitigation controls or measures is
completely effective at controlling or
reducing all risks. The effectiveness of
mitigating risks relies on the combination
of all the different measures and the
proper utilization.

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management

PERFORMANCE EVALUATION
• The last pillar of biorisk management
involves a systematic process intended
to achieve organizational objectives
and goals.

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management

The model ensures that the

implemented mitigation measures are
indeed reducing or eliminating risks. It also
helps to highlight biorisk strategies that are
not working effectively and measures that
are ineffective or unnecessary. These can
be eliminated or replaced.

Pedregosa, R.M., RMT Biorisk Management

 Key Components of Biorisk Management

Performance management is
simply a reevaluation of the
overall mitigation strategy.

Pedregosa, R.M., RMT Biorisk Management

 Drill

Identify the
hazard, risks,
and threats.

Pedregosa, R.M., RMT Biorisk Management

 Drill

Identify the
hazard, risks,
and threats.

Pedregosa, R.M., RMT Biorisk Management

 Drill

Identify the
hazard, risks,
and threats.

Pedregosa, R.M., RMT Biorisk Management

 Drill

Identify the
hazard, risks,
and threats.

Pedregosa, R.M., RMT Biorisk Management

 References

• Benitez, P.A., et. al (2019). Principles of Medical Laboratory Science I. 1st

Edition. C & E Publishing, Inc.
• Suba, S.C., & Florida, J.S. (2014). Introduction to Medical Technology
with Science, Technology, and Society. Cengage Learning.

Pedregosa, R.M., RMT Biorisk Management

 Questions, Clarifications, or
Violent Reactions??

Pedregosa, R.M., RMT Biorisk Management

 THE END
THANK YOU FOR LISTENING!

Pedregosa, R.M., RMT Biorisk Management