Biorisk Management (Part 1)

What is bio risk management? - 805 of which are caused by human

BIOSAFETY + BIOSECURITY = BIORISK factors
- 205 are caused by equipment
Real – life scenarios
failure
Laboratory acquired SARS outbreaks  Top 4 accidents resulting in infection
- Spillage and splashes
Singapore – September 2003 - Needle and syringe
Taiwan – December 2003 - Sharp object, broken glass
- Bite or scratch from animals or
Mainland China (Beijing and Anhui) – March ectoparasites
2004
The risk associated with biological materials in
2003 – infected over 8,000 people and killed the laboratory has a safety and a security
almost 800 component
Who got infected, where and how? Laboratory biosafety: containment principles,
WHO WHERE HOW technologies, and practices implemented to
SINGAPOR Male BSL3 lab, Inappropriate prevent unintentional exposure to pathogens
E graduat Environmenta lab and toxins, or their unintentional release
e l Health procedures
student Institute and cross- PROTECTING PEOPLE FROM DANGEROUS
contamination
PATHOGENS
of West Nile
virus with
SARS CoV
Laboratory biosecurity: institutional and
personal security measures designed to
TAIWAN Male lab BSL4 lab, Inst. Was working prevent the loss, theft, misuse, diversion, or
scientist Of Preventive on SARS CoV. intentional release of pathogens and toxins
Medicine, Found a
National spillage of PROTECTING PATHOGENS FROM DANGEROUS
Defense material
Medical disinfected
PEOPLE
Center with 70%
ethanol and Laboratory Biorisk Management
cleaned
manually System or Process to control safety and security
risks associated with the handling or storage
(+) SARS - and disposal of biological agents nd toxins in
Environmenta laboratories and facilities
l samples
from handle
The AMP Model of Biorisk Management
of alcohol
spray bottle
and switch
panel of
cabinet

Laboratory Acquired Infections

 Only 20% causative or defined event

 Biorisk Management (Part 1)
Procedures (what are the procedures you will
do in the laboratory)

Personnel (is he or she skilled or trained)

BIORISK MANAGEMENT = AMP
Assessment Mitigation Performance PE (what protective equipment)
Elimination or
substitution Place
-Risk
Engineering Hazard, Threat, and Risk
identification
controls
Hazard/threat
Administrative Control  A hazard is an object that can cause
identification
controls Assurance harm
Likelihood
Practices and Improvement  A threat is a person who has intent and/
evaluation
procedures or ability to cause harm to other
Consequences
Personal people, animals, or the institution
evaluation
protective
 A risk can be based on either a hazard
equipment
and/or a threat

How is hazard different from threat?

Risk Assessment
- The actual process of determining
the likelihood and consequence of a
particular risk.
- The process of evaluating risks to
safety and health from hazards.
- Identify the specific hazard or
threat
- Determine the consequences of an
identified risk
- Identify all the existing controls and
any additional ones that need to be
applied
 Hazard is for biosafety
 Threat is for biosecurity
Risk, Likelihood, and Consequences
 Risk is the likelihood of an
event/incident with a hazard that has
consequences
Risk = f (likelihood, consequences)
 Likelihood is the probability an event
occurring
 Consequence is the severity of an event

Thing to consider:

What could cause injury or harm?

Whether the hazards could be eliminated if not,

What preventive or protective measures are, or

should be in place to control the risks?

Identify all the risks: 5Ps

Pathogen (what type of pathogen you are

working)
 Biorisk Management (Part 1)
Factors in Laboratory Biosafety Risk
Assessment: Agent Properties
Pathogenicity – ability cause disease
Virulence – degree of pathogenicity
Host range – restricted to broad, human,
animals and plants
Communicability – are there reports of
epidemics? Of laboratory infections?
Transmission – means (e.g. direct contact,
vector borne) and routes (e.g. ingestion,
inhalation)
Environmental stability - Is there an alternate
organism that could be used instead with lower
risk associated with it?
Other factors in Laboratory Biosafety Risk
Assessment
What type of equipment is used? – BSC,
centrifuges, containment laboratories
What if PPE is available and used correctly?
Training level of laboratory staff
How often dangerous procedures are
performed?
What types of experiments are done?
What are the waste disposal SOPs?
Is there an incident response plan in place?
What are the consequences if the procedures
are not performed?
What types of disinfectants are available?
Risk Characterization
 A hazard cannot pose a risk without a
specific situation
 Conversely, a situation also does not
represent a risk without a hazard.
 Both a changing hazard and a changing
situation will independently alter after
the scenario being assessed, and thus
change the risk.
 Whereas the hazard or threat can affect
both the likelihood and consequences
of a risk, the situation will usually affect
only the likelihood.
Example adopted from NTCBB Online Biosafety
Training:
If a biological agent is highly infectious through
the aerosol route (hazard characteristic), and a
procedure is being implemented where large-
volume aerosols are being generated in close
proximity to the lab worker, and the protective
equipment such as respirator or biosafety
cabinets are
unavailable
(all
situational
characteristic
) when doing
the
procedures.
Based on your risk assessment?
What is the likelihood of exposure to the
infectious agent? What is the consequence of
the exposure?
 Biorisk Management (Part 1)
Risk evaluation and acceptance can vary with
culture, experience, resources, management
and even current events

Who should perform Risk Assessment?

Laboratory Directors

Principal Investigators

Laboratory staff

Biosafety/Biosecurity Officer

Top management

All stakeholders

The evaluation of risk is highly related to the

concept of Risk Acceptance.