FROM THE BENCH
Risk Assessment in Action: Applying Risk Assessment
Concepts to Safely Test Patients with COVID-19
By Drew Fayram, MS, RBP(ABSA), biological threat coordinator and biosafety officer, State Hygienic Laboratory at the University of Iowa
Laboratory science, especially in the
clinical and public health diagnostic
laboratory, includes inherent and
unavoidable risk to the health and
safety of staff performing the work. The
ongoing COVID-19 pandemic presents a
new risk to laboratory staff, one which
causes uncertainty in even the most
seasoned of scientists. While risk can
never be nullified, performing a biosafety
risk assessment can help minimize the
risk as much as possible and facilitate
communication of risks and expected
biosafety behaviors in the laboratory. Here
is an overview of the risk assessment
process to identify and mitigate risks for
handling specimens from patients with
COVID-19.
Identify Hazards
Laboratorians working with specimens
that potentially contain SARS-CoV-2
should be aware of the characteristics
of the virus, including sources of virus,
persistence in the environment, and
susceptibility to chemical disinfectants,
among others. They should also be aware
of the symptoms of COVID-19 so they can
effectively self-monitor after working with
these specimens. Note: it is important to
also assess other biological and non-biological
hazards associated with the work being
performed, but for conciseness I’m focusing
only on SARS-CoV-2.
Evaluate Risk
When evaluating risk, discuss the
likelihood that the scientist will be
exposed based on the procedures that will
be performed, as well as the consequence
of that exposure. For SARS-CoV-2,
exposure to infectious droplets produced
during specimen manipulation, testing
and waste handling is thought to be the
primary route of laboratory exposure. This
may occur during routine procedures, like
vortexing, mixing, centrifuging and other
common laboratory tasks, or during an
unforeseen incident like a splash or spill.
Implement
Controls
Review Risk
Assessment
The severity of COVID-19 can range from
asymptomatic infection to severe illness
and, in a small percentage of cases, death.
In this case, it is essential to consider
the health status of staff who will be
performing testing and tailor the risk
evaluation to the needs of that group or
individual.
Mitigate Risk
BIOSAFETY
RISK ASSESSMENT
CYCLE
Mitigate
Risk
Figure 1. Biosafety Risk Assessment Cycle
Identify
Hazards
Evaluate
Risk
Biosafety risk assessment is a subjective
process that looks different at every
organization, with different personnel, and
when performing different procedures. While
risk assessment guidance is helpful, it is
impossible for anybody outside your laboratory
unit to independently do a risk assessment
for you. Every organization must perform its
own site-specific and activity-specific risk
assessments to determine whether enhanced
biosafety precautions are warranted.
Reduce risk as much as possible by
developing a risk mitigation strategy to
help identify the safety precautions and
control measures needed to mitigate
the risk. The National Institute for
Occupational Safety and Health’s (NIOSH)
Hierarchy of Controls shows how to
prioritize the most effective mitigation
strategies, to ensure we are implementing
the most effective strategies first.
Importantly, elimination and substitution
are almost never realistic mitigation
strategies in clinical and public health
diagnostic laboratories.
For specimens containing SARS-CoV-2,
it is considered best practice to perform
specimen manipulations in a certified
Class II Type A2 biological safety cabinet,
or to use a combination of other
engineering controls (e.g., splash screen)
and PPE to protect the scientist from
exposure via the mucous membranes.
Also, don’t overlook the importance of
administrative controls, which emphasize
biosafety behaviors and habit, like
performing hand hygiene before leaving
the laboratory.
Implement Controls
Controls may need to be procured or
otherwise made available to staff for
implementation. When preparing to
implement controls, it is first essential
to identify whether staff have sufficient
knowledge and training to use the
controls effectively. For this reason, it is
best to assess the biosafety competency
of staff. APHL and CDC’s Guidelines for
Biosafety Laboratory Competency is a
great resource for learning more about
biosafety competency assessment. If
competency is found to be inadequate,
training should be conducted prior to
implementing controls to ensure all
staff are prepared to practice good safety
behaviors.
Review Effectiveness of Controls
and Overall Risk Assessment
Once controls have been implemented,
the effectiveness of the risk mitigation
strategy should be discussed. How
effective does the group feel the strategy
will be? Risk will most commonly be
reduced by decreasing the likelihood
of an exposure, as it is more difficult
to reduce the consequence (severity of
disease). Provide a mechanism for staff
14 LAB MATTERS Spring 2020
PublicHealthLabs
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