PRINCIPLES IN MLS PRACTICE 1

Title of the lesson: BIORISK MANAGEMENT

Date| Lecturer/Professor: Ms. Arianne Rose A. Lim
Transcriber/s: John Carlo P. de Pedro

 It is divided into three primary components:

BIORISK MANAGEMENT  Assessment (A)
OUTLINE  Mitigation (M)
 Biorisk Management and the  Performance (P)
AMP Model  These components are
 Key Componets of Biorisk collectively known as the AMP
Management
model (World Health
BIORISK MANAGEMENT AND THE Organization, 2010).
AMP MODEL
 In working with infectious agents and toxins in
laboratories, one must consider the practices &
procedures on biocontainment to ensure biosafety
and biosecurity.
 Proper management is necessary to carry out total
safety of laboratory workers and patients.
 Biorisk is the risk associated to biological toxins or
 AMP model requires that control measures be based on a
infectious agents.
robust risk assessment, and a continuous evaluation of
 Infectious agents: Bacteria, Fungi, Virus &
effectiveness and suitability of the control measures.
Parasites
 Identified risks can be mitigated, avoided, limited, transferred
 Normal flora is not a biorisk.
to an outside entity, or accepted.
 S. aureus - skin
 They are collectively known as RISK RESPONSE.
 Lactobacillus – vagina
 Mitigation (reduce impact)
 Sources of risk:
 Avoidance (totally eliminated)
 Unintentional exposure to unauthorized
 Limited (limit one’s exposure)
access
 Like a three-legged stool, a biorisk management system fails if
 No PPE
one of the components, or legs, is overlooked or is not
 Accidental release or loss
addressed.
 Anthrax
 In contrast to other risk management models, which typically
 Theft
focus heavily on mitigation measures, AMP focuses on all
 Bioterrorism
components with equal attention.
 Misuse
 Diversion KEY COMPONENTS OF BIORISK
 Intentional unauthorized release of MANAGEMENT
biohazards
 Biorisk management is the integration of biosafety &
biosecurity to manage risks when working with
RISK ASSESSMENT
biological toxins and infectious agents (CWA 15793
 Initial step in implementing a biorisk management
Laboratory Biorisk Management Standard).
 It includes identification of hazards and characterization
 CEN Workshop Agreement (CWA) 15793: 2011
of the risks that are possibly present in the laboratory.
 Biorisk Management (BRM) is “a system
 Hazard refers to anything in the environment that has the
or process to control safety and security
potential to cause harm.
risks associated with the handling or
 Risk is generally defined as the possibility that something
storage, and disposal of biological agents
bad or unpleasant (injury or loss) will happen.
and toxins in laboratories and facilities.”
 In order for a risk to occur, there must be a situation for the
 BRM encompasses the identification, understanding,
hazard to cause harm (ISO/ IEC Guide 51: 1999).
and management aspects of a system in interrelated
 E.g. A sharp needle is a hazard, but if no one is
processes.
using it, the needle will not pose any risk.

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 Risk is the likelihood that an adverse event involving a  Elimination
specific hazard or threat will occur followed by the  Most difficult
consequences of that occurrence.  Most effective
 In performing risk assessment, a structured and  Involves the total decision not to work
repeatable process is followed. with a specific biological agent or even
 It consists of the ff. steps: not doing the intended work
 Define the situation  Highest degree of risk reduction
 The risk assessment team must  Edward Jenner: vaccine for small pox
identity the hazards and risks of the  Substitution
biological agents to be handled.  Second control measure
 At-risk hosts (humans or animals  Replacement of the procedures or
inside and outside the lab) must be biological agent with a similar entity in
identified. order to reduce the risks
 The work activities and laboratory  Bacillus anthracis  Bacillus
environment including location, thuringiensis
procedures, and equipment should  B. anthracis : can cause
also be defined. acute fatal disease anthrax
 B. thuringiensis : less
 Define the risks dangerous experimental
 It must include a review of how surrogate; commonly used in
individuals inside and outside the biological pesticides
laboratory may be exposed to the worldwide
hazards.  Engineering Controls
 It could either be through droplets,  Third control measure
inhalation, ingestion, or inoculation  Includes physical changes in work
in case a biological agent has been stations, equipment, production
identified as the hazard. facilities, or any other relevant aspect
 Characterize the risks of the work environment that can
 To characterize the overall biosafety reduce or prevent exposure to hazards.
risks, the risk assessment team needs  Examples:
to compare the likelihood and the  Installation of biosafety
consequences of infection – either cabinets
qualitatively or quantitatively.  Safety equipment (centrifuge
 Determine if risks are acceptable or not with cover, autoclave &
 This process of evaluation the biorisk arising from a machines with indicators)
biohazard takes into account the adequacy of any
 Facility design enabling
existing controls, and deciding whether or not the biorisk
proper airflow
is acceptable.
 Ventilation system to ensure
MITIGATION PROCEDURES directional airflow
 Air treatment systems to
 Second fundamental component
decontaminate or remove
 Biorisk mitigation measures are actions and control
agents from exhaust air
measures that are put into place to reduce or eliminate the
 Controlled access zones
risks associated with biological agents and toxins (Salerno,
 Airlocks as laboratory
2015).
entrances
 Five major areas of control or measures that can be
 Separate buildings or
employed in mitigating the risks:
modules to isolate the
laboratory
 Administrative Controls
 Refers to the policies, standards, and
guidelines used to control risks.
 Proficiency and competency training for
laboratory staff is considered an
administrative control.
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  Examples:
 Displaying biohazard or
warning signages, markings
& labels
 Controlling visitor and worker
access
 Documenting written
standard operating
procedures
 Practices & procedures of
administrative controls comprise
minimizing splashes, sprays, and
aerosols to avoid laboratory-acquired
infections or following standard
operating procedures (SOPs).  The result of a robust risk assessment must be properly
 PPE recorded, documented & communicated to all stakeholders of
 Last mitigation control the organization.
 Devices worn by workers to protect  Only through this final process that findings could be decided
them against chemicals, toxins, and upon, given appropriate action, to be able to provide & establish
pathogenic hazards in the laboratory. a clear manifestation of implementing the fundamental concept
 Examples: of biosafety & biosecurity in the laboratory.
 Gloves
 Gowns
 Respirators
 Least effective because it only protects
the person who is wearing it, and only
when it is used correctly
 As emphasized by Salerno (2015), not one of the
mitigation controls or measures is completely effective at
controlling or reducing all risks.
 The effectivity of mitigating risks relies on the combination
of all the different measures and the proper utilization of
each.
 It must be ensured that following the measures would not
be overdone because undoing particular measures are
definitely costly.
The concept of a hierarchy of controls describes the
order of effectiveness (from most to least) of mitigation
measures and implies that this order should be taken into
account when selecting & implementing controls to reduce
risk

PERFORMANCE
EVALUATION
 Last pillar of the biorisk management model
 It involves a systematic process intended to achieve
organizational objectives & goals.
 The model ensures that the implemented mitigation
measures are indeed reducing or eliminating risks.
 Also helps to highlight biorisk strategies that are not
working effectively & measures that are ineffective or
unnecessary --> can be eliminated / replaced
 Performance management
o Reevaluation of the overall mitigation strategy

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