Laboratory Risk

Assessments
LABORATORY BIOSAFETY SEMINAR-WORKSHOP FOR THE ACADEME OF MEDICAL LABORATORY
SCIENCE
Crowne Plaza Hotel, Ortigas
MAY 28-30, 2018
 This course is part of the
Global Biorisk Management Curriculum Library (GBRMC)
2
The GBRMC Library is funded by the
US DOD/DTRA Cooperative Biological Engagement Program

with additional support from the

US DOS Biosecurity Engagement Program

The library is managed by

Sandia National Laboratories
International Biological and Chemical Threat Reduction Program

For more information on the GBRMC Library:

web: biosecurity.sandia.gov/gbrmc
email: GBRMC@sandia.gov
3 Definitions
 Laboratory biosafety: containment principles,
technologies, and practices implemented to
prevent unintentional exposure to pathogens and
toxins, or their unintentional release1
 Laboratory biosecurity: protection, control and
accountability for valuable biological materials
within laboratories, in order to prevent their
unauthorized access, loss, theft, misuse, diversion
or intentional release 2

1Laboratory Biosafety Manual, Third edition (World Health

Organization, 2004)
2 Biorisk management - Laboratory biosecurity guidance (World
Health Organization, 2006)
4
5 What is Biorisk?

Risk associated with biological materials

Biorisk = Biosafety + Biosecurity Risks

6 Key Components of Biorisk
Management
Biorisk Assessment
Process of identifying the hazards and evaluating the
risks associated with biological agents and toxins,
taking into account the adequacy of any existing
controls, and deciding whether or not the risks are
acceptable
7 Key Components of Biorisk
Management
Biorisk Mitigation
Actions and control measures that are put into place
to reduce or eliminate the risks associated with
biological agents and toxins
8 Key Components of Biorisk
Management
 Biorisk Performance
Improving biorisk management by recording,
measuring, and evaluating organizational
actions and outcomes to reduce biorisk.
9 Biorisk Management: the AMP Model
10 Introduction to
Laboratory Risk Assessments
A laboratory biorisk assessment is an analytical
procedure designed to characterize and evaluate
safety and security risks in a laboratory.
11 Introduction to
Laboratory Risk Assessments
To be comprehensive:

A biosafety risk assessment should consider every

activity and procedure conducted in a laboratory that
involves infectious disease agents.
12 Introduction to
Biosecurity Risk Assessment

To be comprehensive:

A laboratory biosecurity risk assessment should

consider every asset, adversary and vulnerability in
an institution and its component laboratories and units.
13 Introduction to
Laboratory Risk Assessments
A biorisk assessment allows a laboratory to
determine the relative level of risk its different activities
pose, and helps guide risk mitigation decisions so
these are targeted to the most important risk.
 Describe work activities
14 Biorisk
Management
Strategy Identify hazards
Identify any threats

Determine risks

Decide whether Proceed with

If yes
or not risk is work and monitor
acceptable controls

If no Prepare risk control action plan

Implement control
Revise or measures
close project

Review adequacy of plan

Source: CWA 15793:2011
15 What is Risk?

Risk is the likelihood of an undesirable RISK

event happening, that involves a specific
Very
hazard or threat and has consequences

Likelihood
High

High
Risk = f (likelihood, consequences) Moderate
Low
or, more simply, Very
Low
Consequences

Risk is a function of both the Likelihood of

something happening and Consequences
of that occurrence
16 What is Risk?

Question:
What is the risk of being attacked by a tiger?

What would you need to know to answer this question?

17 Risk
Let’s consider the RISK
previous question in
Very
terms of Likelihood and High
Consequences, and the

Likelihood
graph on the right. High

Moderate
Low
R = f(L, C)
Very
Low

Consequences
 Risk
18

For the following scenarios, draw a STAR where the risk would fall on the graph.

You are in an open field You are in the zoo, You are holding a tiger
next to a very hungry , observing a caged adult cub with a playful
aggressive, adult tiger. tiger, which is well fed, temperament in your
The tiger is unrestrained and has a mild arms.
and sees you as food. temperament.

Very Very Very

High RISK High RISK High
RISK

Likelihood
Likelihood
Likelihood

Very Very Consequences Very Consequences

Low Consequences Low
Low
19 Risk
RISK
You are at the zoo
observing a
Very
mellow, tiger cub High
located behind a
strong glass

Likelihood
High
window.
Moderate

Low

Very
Low

Consequences
20 Biosafety Risk Assessment

A Risk Assessment is a procedure that analyzes a particular process or

situation in order to determine the likelihood and consequences of a certain
adverse event.

In Laboratory Biosafety, we are concerned with preventing unintentional

adverse events involving infectious disease agents.

To properly conduct a laboratory biosafety risk assessment, it is important

first to gather certain information about the laboratory procedures involving
biological agents and toxins, as well as information on the agents and toxins
themselves.
21 Factors that affect Likelihood and/or Consequences?

Agent Properties
 Pathogenicity
 Virulence
 Host range Communicability
 Transmission
 Environmental Stability

Procedures
 PPE
 Training
 SOPs
 Equipment used
22 Risk Characterization
As you can see many of the factors
regarding laboratory biosafety risk
rely on the agent characteristics and
the laboratory procedures.

The risk of exposure to an agent is

dependent on these factors.
23 Risk Characterization
Exercise:

We will work together,

through a series of examples
to practice determining the
risk of exposure associated
with an experiment.
24 Risk Characterization
Scenario: RISK

Suppose you are working with a seasonal Very

influenza virus, conducting testing on a High
human respiratory specimen, on the

Likelihood
bench-top, with no respiratory protection.
High

Moderate
What is the likelihood of exposure?
Low

What are the consequences of

Very
exposure?
Low
Consequences
What are some factors that
should be considered?
25 Risk Characterization
Scenario: RISK

You are working with a suspect wild-type Very

Ebola virus specimen in a high High
containment BSL 3-type laboratory,
conducting nucleic acid extraction and RT-

Likelihood
PCR. You are working in a BSC and are High
using disposable PPE with respiratory
protection. Moderate
Low
What is the likelihood of exposure?
Very
What are the consequences of Low
exposure?
Consequences
What are some factors that should be
considered?
26 Trigger Points
27 Biosafety Risk Assessment

This exercise should be repeated with every organism and

every procedure conducted in a laboratory or facility.

Doing this in a comprehensive manner is one way to conduct a

facility-wide risk assessment, which would then be, quite
simply, the collection of the individual risk assessments for the
individual procedures conducted in a laboratory or facility.
28 Biosecurity Risk Characterization

Characterizing biosecurity risk includes an in-

depth analysis of laboratory assets, potential
adversaries, and laboratory vulnerabilities.
29 Asset Characterization
Asset Characterization is the process of gathering
information about the biological agents and toxins that
could potentially be targeted by notional adversaries.

These biological agents and toxins will be referred to

as “assets”.
30 Asset Characterization
Determining the ease or difficulty of
malicious use (likelihood) should involve
assessing the following:

The difficulty of acquiring the agent

The difficulty of processing the agent into a
suitable quantity in a suitable form
The difficulty of disseminating the agent to
cause harm
31 Asset Characterization

Determining the potential consequences of the

malicious use (consequences) of a particular agent
or toxin should involve assessing the following:

 The physical impact of an attack on a population

 The impact of an attack on the economy
 The impact of changes in public perception
 The impact on facility operations
32 Adversary Characterization

Adversary Characterization is the process of determining

specific attributes of potential adversaries that enable them to
pose a threat to a biological agent or toxin.

In the security community, Adversary Characterization is also

known as Threat Assessment.
33 Adversary Characterization

Some characteristics of potential adversaries that could help

determine the risk they pose, include:

 Motive
 Means
 Opportunity

Analyzing each of these characteristics in terms of likelihood

and consequences is necessary for a biosecurity risk
assessment.
34 Adversary Characterization

The question of opportunity raises the issue

of insider versus outsider threat.

An insider is a person who has authorized

access to a facility, its units (such as
laboratories), and its assets.

An outsider is a person who does not have

authorized access.
35 Adversary Characterization

Insiders tend to pose a greater

threat than outsiders because they
typically have both greater means
and opportunity than an outsider.

Insiders, however, do not necessarily

have different motives than
outsiders.
36 Scenarios

Another useful tool for Biosecurity Risk Assessment is to work

through possible scenarios to detect any vulnerabilities in the
biosecurity management program.

Each evaluated scenario should involve a specific biological

agent, a specific adversary, and a particular way that
adversary will attempt to steal and misuse the agent or toxin.
37 Scenarios

Keep in mind that it is important to have a screening process to

limit the number of scenarios generated, say by considering
only those scenarios involving biological agents capable of
causing significant harm.

The criteria used for screening should be documented in the

assessment.
38 Scenarios

Exercise:

We will work together, through a

series of scenarios to practice
characterizing biosecurity risk.
39 Scenarios
Scenario: RISK

A facility in a developing country with poor Very

infrastructure and an active, wide-spread insurgency High
conducts diagnostic testing for Bacillus anthracis
and and stores specimens in an unlocked
refrigerator in the corridor.

Likelihood
High
Let’s further expand on this scenario to include a Moderate
specific adversary as well as a particular way that
the adversary will attempt to steal and misuse the Low
asset.

Very
What is the likelihood of theft? Low
Consequences
What are the consequences of theft?

What are some factors that should be considered?

40 Biosecurity Risk Assessment

This exercise could be repeated for every asset and adversary

in a given scenario in a laboratory or facility.

Doing this in a comprehensive manner is one way to conduct a

facility-wide biosecurity risk assessment, which would then
be, quite simply, the collection of the individual risk assessments
for the laboratory or facility.
41 Biorisk Characterization

It is important that the Risk Characterization process be as

robust as possible.

Comparability is the ability trust the accuracy of differences

between assessments, due to similarities in their bases,
assumptions, procedures and protocols.

Repeatability is the ability to conduct the same process in the

same way for the same hazard or threat and situation over a
period of time, or for different hazards, threats, and situations at
the same time.
42 BioRAM

One available tool to aid in the laboratory risk assessment process is the
Biosecurity RAM (BioRAM).

BioRAM is a computerized risk assessment tool developed by Sandia

National Laboratories, in partnership with the international community, to
facilitate laboratory biosafety and biosecurity risk assessments by
simplifying risk characterization.
43 BioRAM

BioRAM uses only one of several possible risk assessment methodologies.

It is based on the input of biosafety experts and validated around the world.
The BioRAM tool helps determine relative risk levels in a comparable and
repeatable way.

http://biosecurity.sandia.gov/BioRAM/
44 Risk Evaluation
Risk Evaluation is a crucial
intermediary step between Risk
Characterization and taking active
steps towards mitigating risk.

Risk Evaluation is the process of

determining, subjectively, whether
a risk is high or low, and whether
it’s acceptable or not.
45 Risk Evaluation

What is “acceptable”
risk?
46 Risk Evaluation

The evaluation of risk is

highly related to the
concept of Risk Acceptance.

Risk evaluation and

acceptance can vary with
culture, experience,
resources, management,
and even current events.
47 Risk Evaluation
Unfortunately, there is no systematic way of
evaluating risk and determining risk acceptability. This
will depend on the perceptions of individuals,
institutions, and the community.
48 Risk Evaluation

Individual Institution
 Professional goals  Legal issues
 Financial goals  Rules/Regulations Compliance
 Educational goals
 Notoriety Community
 Personal health  Health and well-being of the
community
 Educational/professional
opportunities
49 Risk Evaluation
If an institution finds a particular risk
unacceptable, it will either cease the
work resulting in that unacceptable
risk, or it will find ways to mitigate
that risk to a
more acceptable level.
50 Risk Evaluation
The curves on this graph, RISK
called “risk tolerance
curves”, show different Very
High
levels of risk, from Very
Low to Very High.

Likelihood
High

It is important to recognize that the Moderate

precise locations of these risk Low
tolerance curves on the graph Very
are
in fact arbitrary. This is the Low
essence
of Risk Evaluation. Consequences
51 Risk Evaluation
RISK Averse
Overall, two institutions with the Very
same computed risk “values” High

Likelihood
High
for the risk characterization Moderate
process may have different risk Very
Low

evaluations (meanings of risk). Low

Consequences
For example, what is a moderate
risk for one institution could be a RISK Tolerant

high risk for another, depending Moderate

Likelihood
on what each entity decides is Low

moderate or high. Very

Low

Consequences
52 Risk Evaluation

An institution that considers a certain risk high might be

motivated to spend a large amount of resources
mitigating that risk.

Another institution that considers the same risk to be

moderate might decide to spend a small amount of
resources in mitigation instead.
53 Key Messages
 A risk assessment is defined as a procedure that analyzes a particular
process or situation in order to determine the likelihood and consequences
of a certain adverse event and will be unique to each laboratory.

 To be comprehensive, a laboratory biosafety risk assessment should

consider every activity and procedure conducted in a laboratory that
involves infectious disease agents.

 A biosafety risk assessment allows a laboratory to determine the relative

level of risk its different activities pose, and helps guide risk mitigation
decisions so these are targeted to the most important risk.

 Risk Evaluation is a crucial intermediary step between Risk Characterization

and taking active steps towards mitigating risk and is the process of
determining whether a particular risk is in fact acceptable or not to a
facility or institution
54 Key Messages
 A biosecurity risk assessment is an analytical procedure designed to
characterize security risks.
 The results of a biosecurity risk assessment will be unique to each institution
and each laboratory or unity within that institution.
 To be comprehensive, a laboratory biosecurity risk assessment should
consider ever asset, as well as vulnerability in an institution and its
component laboratories and units.
 A biosecurity risk assessment allows an institution and its component units to
determine the relative level of security risk they face, and helps guide risk
mitigation decisions so these are targeted to the most important risks.
Thank You!