Event Description
A comprehensive biosafety plan serves as the backbone for developing a strong biosafety culture. This presentation lays out the components of a comprehensive biosafety plan and how you can adapt your biosafety plan to safely handle an emerging or re-emerging pathogen to help protect the most important asset in your laboratory—your employees.
Event Media
Is it Magic or Simply a Great Biosafety Plan?
I will read two disclaimer statements. The first, again, is the external presenter
[disclaimer], followed by the P.A.C.E. disclaimer. And then I'll introduce our next expert
speaker, Ms. Erin Bowles. Slide decks may contain presentation material from panelists not
affiliated with CDC. Presentation content from external panelists may not necessarily reflect
CDC's official position on the topics covered. Next slide.
CDC, our planners and our presenters wish to disclose that they have no financial
interest or other relationships with the manufacturers of commercial products, suppliers of
commercial services, or commercial supporters.
And now I'm excited to introduce our next expert speaker, Ms. Erin Bowles. Erin is the
Laboratory Network Coordinator for the Wisconsin State Laboratory of Hygiene, Communicable
Disease Division, where she provides outreach and education to more than 125 laboratories in
Wisconsin to ensure a coordinated statewide response to any biological threats of public health
importance. Her background in clinical microbiology and expertise in biosafety serves her well
as a member of APHLs Workforce Development Committee, the Sentinel Laboratory Outreach
and Partnership Committee, and Laboratory Training Special Interest Group.
Some of the committee projects she has contributed to are the revisions of the ASM
Sentinel Level Clinical Laboratory Guidelines and developing risk assessment training and
biosafety tools such as the Clinical Laboratory Preparedness and Response Guide. Our next
speaker is Erin Bowles. Over to you, Erin.
Finally. I found it. Good afternoon. I'll start over again. Good afternoon, everyone. It's a
pleasure to be part of the CDC OneLab Summit and to speak with you today about the value of
biosafety plans. Thank you, Alicia, for inviting me to speak with you today. I want to begin by
sharing a little bit about my laboratory. For those of you who have never been on the University
of Wisconsin-Madison campus, this is a beautiful aerial shot of the campus showing the
shoreline of Lake Mendota in the fall when all the trees display their glorious autumn colors.
And the Wisconsin State Laboratory of Hygiene is part of the University of Wisconsin,
Madison. But unfortunately, most of the laboratory has been moved off campus. And while I
certainly appreciate not having to drive on campus anymore and deal with students who walk
everywhere and don't pay attention to traffic, I do miss being able to take a walk myself to
enjoy the magic of the changing colors. And I think I'm going to turn off my camera.
So before we begin, I do want to say that I have no financial disclosures or conflicts of
interest to disclose today about the content of my presentation. These are the main objectives
for my presentation. I'll discuss the components of a comprehensive biosafety plan and explain
how a great biosafety plan can be a framework of a strong biosafety culture. I'll also talk about
the importance of making your biosafety plan adaptable, so that it can easily be modified for
use with any emerging or re-emerging pathogen to help protect the most important asset in
your laboratory, your employees.
So what do you think of when you hear the word magic? Perhaps it's a fictitious
character like Harry Potter who comes to mind. Maybe you think of a magician like Shin Lim
with his beautiful sleight-of-hand card tricks. Or maybe you think of a magician like David
Copperfield performing complicated feats of levitation or escape.
The word magic is often used when all of the pieces align perfectly and something
beautiful and amazing happens. Who isn't awed by the beauty of a rainbow when sunlight
refracts off of raindrops, creating a prism and we see a beautiful rainbow of colors? And I know
that many people traveled long distances just this past week to areas of the country where the
total solar eclipse was visible, where the moon totally blocked the sun from view for about four
minutes. This was a rare event that only occurs when the sun, the moon, and the Earth align
perfectly.
However, when I think of magic related to biosafety, it is most similar to an athlete like
Simone Biles, who had to adopt the team culture, train relentlessly, and follow a specific plan
that enabled her to achieve a gold medal performance and win the coveted gold medal. In
biosafety, we have the opportunity to assemble a biosafety plan that, when followed and
adjusted as necessary, can build the confidence and skills to enable laboratory staff to handle
any pathogen safely. A great biosafety plan helps protect the people in the laboratory, the
laboratory environment, others working in the building, and ultimately everyone else in our
community.
I want to first ask you what the goal is for your biosafety plan. If the goal is to be ready
to safely handle whatever emerging or re-emerging pathogen comes our way that is a threat to
public health, and if we need to perform our work in a manner that protects our staff and
prevents them from becoming ill with a laboratory-associated infection, then the
comprehensive laboratory biosafety plan and all of the training and preparation that we do
each and every day in our laboratories as part of that plan truly matters.
So where do we start if we want to reach our goal? Dana Perkins, et al., wrote an article
that was published in the Applied Biosafety Journal of ABSA International in 2019. The article
discusses how in 2014, the federal export security advisor panel made a number of
recommendations to federal agencies and stakeholders on how to optimize biosafety and
biosecurity. The working group defined the culture of biosafety, biosecurity, and responsible
conduct in the life sciences as an assembly of beliefs, attitudes, and patterns of behavior of
individuals and organizations that can support, complement, or enhance operating procedures,
rules, and practices, as well as professional standards and ethics.
This culture of biosafety, biosecurity, and responsible conduct is designed to prevent the
loss, theft, misuse, and diversion of biological agents, related materials, technology, or
equipment, and the unintentional or intentional exposure to or release of biological agents. The
article states that a common thread they found is that many laboratory accidents are caused
not by a lack of physical barriers or regulations, but by the absence of a strong biosafety culture
in their labs and their oversight bodies, and by lacking a reliable system for incident reporting,
monitoring, analyzing, and sharing lessons learned.
If you can create a strong biosafety culture and combine it with a comprehensive
biosafety plan, you are prepared to face any biological threats. A strong biosafety culture also
instills a sense of responsibility and care —
not only for our own safety, but for the safety of everyone working in the laboratory.
A strong general safety culture involves seeing safety as a way to work rather than as an
imposed obligation, and it requires that laboratory safety become an integral and apparent
priority to the organization. It must be embraced first and foremost by top management, who
actively support policies and practices that foster safe behaviors among employees. However, it
is critical to get buy in from workers at all levels of the organization.
A key feature of a great biosafety culture is that accidents and near-misses are never
seen as a time for blame and punishment, but they are viewed as teachable moments for all
employees so that they can learn from each other. Biosafety is continually assessed by
everyone in the laboratory, so the plan is continually evolving. And as a result, people feel
valued and safe.
A biosafety plan is a tool every laboratory must have and utilize in order to prepare for
whatever comes their way. In my experience, providing outreach and education to clinical
laboratories in Wisconsin, laboratories often lack a specific plan for the laboratory. Labs often
rely on a general hospital or even broader health system plan. But most hospital plans focus on
patient care and patient care areas, and they lack specific laboratory information that is
necessary for emergency preparedness and response and the biosafety of laboratory
personnel.
Like a jigsaw puzzle, laboratories typically have many of the pieces that should be
included in a biosafety plan, but the pieces are scattered all over and they haven't been
assembled in one place to complete the puzzle, so that everyone can easily view the entire
biosafety plan.
A comprehensive biosafety plan includes all of the components listed on this slide. We
will cover each of these components separately moving forward as if we're turning the pages in
our biosafety plan. Perhaps the most important part of having a biosafety plan is making sure
that all employees know where the plan is kept. Everyone needs to be cognizant of what
information is covered in the plan. It won't serve its purpose if no one knows where the plan is
kept or when it would be useful to refer to it.
And it often seems that the situations when people need to refer to biosafety plans
occur at times when supervisors and managers aren't in the laboratory to ask for help.
Therefore, every employee needs to have initial biosafety training about the biosafety plan.
And a yearly review of the biosafety plan should be required for all employees as part of the
laboratory's annual biosafety competency assessment.
So let's open our biosafety plan to the first section on employee vaccinations. Vaccines
are one of the easiest ways to offer protection to staff. To determine which vaccines to offer, it
makes sense to think about the testing you are performing: what types of specimens do you
work with, and what sources are they coming from. Knowing this can help you determine the
likely pathogens that may be contained in them.
However, always remember to consider pathogens beyond the scope of testing you
perform. You may work in a clinic laboratory and receive throat swabs with requests to test for
strep throat. Just remember, a negative strep group A test doesn't mean there isn't some other
pathogen on that swab. What other pathogens may have the sore throat as a common
symptom of illness associated with them?
At a minimum, laboratories should consider offering their employees vaccines for
meningitis, hepatitis group B, tetanus, diphtheria and pertussis, influenza, and COVID-19.
Additionally, if they haven't had these diseases as children or have been previously vaccinated,
they should also have chickenpox and mumps, measles, and rubella. Public health workers may
also require additional vaccines, such as rabies, salmonella typhi, and smallpox, depending on
the testing they perform.
Turning to the next page of our safety plan, we have biosafety training. This slide shows
just some of the types of biosafety training that should be provided, both initially upon hire and
annually as refresher training. This is not an exhaustive list of biosafety topics employees should
be trained on. But with initial orientation and annual refresher biosafety training and the
establishment of expectations on how we are to perform our work, all of these things are
essential for a strong biosafety culture.
Don't ever assume that new hires or students have had biosafety training. The very first
time that you sit someone down in front of a biosafety cabinet to work, review all of the
biosafety expectations and practices of working safely in a biosafety cabinet with them. Sitting
someone down in front of a computer and having them simply read a procedure on the proper
use of a biosafety cabinet isn't the same as demonstrating the correct usage and then visually
observing and assessing their competency.
We know that from Ebola, the proper training on donning and doffing of PPE is critical in
making sure that we are actually protected from the pathogens we work with. Additionally,
skills that we don't use frequently will be forgotten. So routine practice and observance of
competency in something as basic as donning and doffing is very valuable.
Throughout my laboratory career, I've heard people complain and question the need for
yearly biosafety training. I have to remind myself and them that the longer we work in the
laboratory, the easier it becomes to think, hey, we're experts who do everything correctly and
to become complacent. We may perform our work somewhat mindlessly without paying close
attention to the task we're performing and without really acknowledging the risks in what we're
doing. This is a dangerous situation for ourselves and for others working near us. If I had
magical power like Harry Potter, I'd create a set of goggles that would always let me clearly see
and assess the risks that surround me, so that I would really pay attention to my work and
never become complacent.
After we provide biosafety training, we need to assess biosafety competency. All too
often, competency assessment only looks at whether or not someone is performing a test
correctly and obtaining accurate results. It doesn't always include looking at whether or not the
work is completed in a safe manner and whether or not the individual recognizes biosafety risks
in their work.
That is why every competency assessment should include questions about or
observation of biosafety aspects related to whatever task is being assessed. Impromptu or
regularly scheduled biosafety huddles or small group meetings are also a great way to keep
biosafety foremost on people's minds. One can assess biosafety competence by asking
questions and observing how attentive employees remain to biosafety practices and culture.
One of the most important sections of your biosafety plan is risk assessment. And I want
to take a bit of time to discuss risk assessment more thoroughly, because the ability to identify
hazards in our work and to perform a risk assessment is a critical skill that every individual
working in a laboratory should develop and utilize on a daily basis. This became evident in 2015
when those of us in public health laboratories were working with clinical laboratories to
develop plans and practices centered on how we would safely provide care for potential Ebola
patients.
Some of the questions we asked then, such as, "What are you working with?" and "How
hazardous is the specimen?" are listed on this slide. These basic questions still serve us well and
should be asked for any pathogen that may emerge or reemerge. With Ebola, we knew quite a
bit about the virus and how it is spread, even though we had never seen a case in the US until
2014.
With an emerging pathogen or even a re-emerging pathogen, we may not know all the
answers we ask as part of the risk assessment, and we will only learn them over time, as we did
with SARS coronavirus 2. In the cases where we don't have all the answers, we can start by
looking at risk assessments we've done for similar organisms and modify those assessments,
taking the highest precautions by adding many mitigation measures until we find out more
about the pathogen.
This is why all employees must be able to perform risk assessment, from the bench
scientists performing the testing to the administrator who determines laboratory policy and
work practices. Organisms are constantly evolving and changing, which demands that risk
assessment be a continual process that is constantly reassessed.
When performing a risk assessment, you must consider the routes of infection for each
agent and what mitigation measures you will need to put in place to prevent laboratory
associated infections that I will hereto refer to as LAIs. And the common routes of infection are
pictured on this slide.
Once we have this information, we can go on to identify the hazards in any of the tests
or tasks we perform in the laboratory, such as the production of aerosols, the use of sharps, or
manipulations that can result in splashes and spills. It is critical that all employees are trained in
risk assessment as it is often the employees on the bench who perform the testing that can
best identify hazards associated with the testing.
Once we've identified a hazard, we decide what the likelihood of the occurrence is and
what the consequences of that occurrence will be. The table on the left shows five levels of
likelihood, ranging from rare, where the hazard would occur only in exceptional circumstances,
to highly likely and almost certain to occur. And the table on the right shows five levels of
consequence ranging from insignificant, requiring no treatment, to critical, resulting in
permanent disability or possible loss of life.
Hopefully, many of you are familiar with this table where we plot out the likelihood of
the hazard occurring on the y-axis and the consequence on the x-axis. Where the likelihood and
consequence intersect is the level of risk for the hazard. Then we assign color to the table with
red indicating the highest risk level, and green, the lowest risk level. The bottom table describes
the risk levels and suggest actions that you should take to reduce the risk level.
I've talked about identifying routes of infection, identifying hazards, and how to
determine the level of a risk hazard that is present. Now, I want to address the question of
when you should perform an initial risk assessment. Since risk assessment is a critical tool in our
biosafety plan that we use to prevent LAIs, it must be performed before any work begins in the
laboratory. We also perform an initial risk assessment before implementing any new testing, as
part of validating new equipment, before working with a new infectious agent, and before
working with any new reagents.
Additionally, we know that risk assessment isn't ever a situation where you look at it
once and then think you're done with it and you never need to look at it again. It's a continual
process. You want to repeat your risk assessment after a laboratory move to a new laboratory
location or when there's a renovation to your laboratory space, even just moving equipment to
a different countertop. You want to repeat your assessment when you have new personnel
who may have compromised immune systems or physical limitations. You want to repeat it if
you have changes to your consumables. You always want to repeat a risk assessment after an
accident or exposure resulting in an LAI, or after a theft or security violation, and whenever
there are national or regional changes in disease status.
After you complete the risk assessment, if you have identified new hazards, then you
will want to modify your mitigation measures to reduce the risk of the hazard. And we'll talk
about that more in another slide.
This slide shows a simple form that you can use to do a risk assessment of the tasks or
procedures that you perform in your laboratory. You start in the far left column by listing all of
the steps of the procedure you are performing the risk assessment on. Once you've listed all
the steps, you move on to the hazard column and list all hazards associated with each step of
the procedure. Perhaps step five of your procedure is to vortex the specimen in a tube of liquid.
And then step 6 is to aliquot part of the sample into another tube. Both of these steps could
possibly produce aerosols and/or splashes and spills. So you would list aerosol production and
splashes and spills as hazards.
Next, you would determine the initial risk level for each hazard by asking how likely is
the hazard to occur and what would be the consequence of an occurrence. Aerosol production
and splashes are possible. And the consequences could be serious, depending on what is in the
tube, its route of infection, whether it's inhaled or splashed onto a mucous membrane. I would
assign an initial risk assessment of high in this situation.
You would want to make sure that you put in place mitigation measures such as working
in a biosafety cabinet and wearing eye protection to lower that risk level. And you would list
those measures in the next column. And finally, you will list the residual risk that remains after
implementing the mitigation measures in the last column.
When we talk about risk mitigation, you need to ask, what is your level of risk tolerance?
Different people will have different tolerance for risk. What mitigation steps would you put in
place? There's never a way to lower the risk level to zero unless you can totally eliminate the
hazard. This is a figure that is frequently used to show the effectiveness of various control
measures you can choose from to reduce the level of risk. If you can't eliminate the risk or
substitute something less hazardous to reduce the risk, then you would use a combination of
engineering controls along with administrative controls, and personal protective equipment or
PPE. A common misunderstanding that many people have is that PPE is the most effective
protection, when it's actually the last measure you put in place and the least effective
mitigation measure.
This slide breaks down the various mitigation measures that should be used as part of
your biosafety plan to reduce risk in your laboratory and protect your employees. The most
effective mitigation measures are your engineering controls, which include physical changes
such as having negative pressure airflow from clean areas to dirty areas of the laboratory,
hands free faucets on sinks, and equipment such as biosafety cabinets.
Administrative controls are also highly effective in controlling risk and include the
policies, standard operating procedures, and guidance documents that are included in your
biosafety plan. Common practices and processes that all employees adopt and adhere to in
their work can also be very effective in reducing risk. And finally, adding PPE, such as gloves, lab
coats, eye protection, face shields, etc., can reduce the risk as long as people are trained and
know how to don and doff them correctly.
Unfortunately, there is no way to ensure that accidents and incidents only happen when
a supervisor or manager is in the laboratory to tell people what to do. Directions for when and
how to report accidents and near misses is a critical piece of any laboratory biosafety plan and
something that all employees need to know where and how to reference. Additionally, your
biosafety plan should identify the location of where any forms that will need to be completed
are kept, along with information sheets that employees will need to present to a physician
should they need to seek medical care. Having in place a policy for the transportation of an
injured employee who needs medical care is also something that should be included in your
biosafety plan.
The most important thing to always remember is that if you want employees to report
accidents and near misses, there must be an easy way to report them. And as I've already
stated, there should never be any finger pointing or blame assigned to an individual who
reports an accident or a near miss. Employees need to feel safe from repercussions if they
report an accident or near miss. or they will hide them and not report. Accidents and near
misses must be viewed as opportunities for improvement. They are truly teachable moments
for all to learn from.
A very important document that must be included in your biosafety plan, and it goes
hand in hand with accident reporting, is a list of all the various partners that comprise your
accident or exposure response team. Some laboratories may refer to this as their occupational
health team. The list should provide the names of all the partners, their contact information,
including how to contact them during off hours, and their role and responsibilities when an
accident occurs.
It's important to have established good relationships with the partners that will
comprise your team. If you haven't already established your team, I encourage you to do it
now. You don't want to be scrambling to build a team after an occurrence. Everyone needs to in
advance what is expected of them and what they will be doing.
When I receive a call from a clinical laboratory notifying me that they have isolated a
potential Francisella tularensis, I will ask the laboratory if they've talked to the patient's
physician to determine if the patient's symptoms are consistent with Francisella infection. If it
seems likely, then I immediately start working with the laboratory to make sure that all the
exposure response partners are notified, and I will start working with the laboratory to identify
exposures and then loop in our state epidemiologists, who will work with the hospital infection
preventionist, local public health, and other partners to determine if there may be other
exposures outside the laboratory and what follow up is necessary. Convening a meeting or call
with all the partners to make sure everyone knows what is happening and giving them time to
ask questions is very important early on in a response.
This slide shows a bit of the APHL Exposure Assessment and Monitoring Tool. This is a
really useful tool to reference whenever there's been an accident. I provided a link to the tool in
my references at the end of my presentation, and it may be showing up in your chat, too.
The exposure assessment section pictured on the top left leads you through several
questions, such as what work was being done where, what PPE was worn, who else was
present, and how close were they. If it is determined that there were exposures, then you
would go on to using the exposure event follow-up section pictured on the bottom right to help
determine the appropriate monitoring and/or follow-up treatment that should be taken.
There is also a section that prompts you for additional corrective action and mitigations
that you may want to incorporate into your current policies and procedures to prevent
reoccurrences of the incident. To complete this section, you need to begin by performing a root
cause analysis.
Why should you perform a root cause analysis? I like to use the image of a weed as I
pictured on the slide. If you want to stop dandelions from spreading in your lawn, you can pick
the flowers before they go to seed, which I will admit I've done when I'm in a hurry and don't
have a lot of time. But because the roots are still there, new flowers keep growing from the
root. I have to get out that dandelion digger to get to the roots and pull them up to get rid of
the dandelions. In the same way you often have to dig down to get to the root cause of why
there was a laboratory accident to prevent further accidents.
When you've had an accident in the laboratory, after you've dealt with the accident and
the consequences, it's important to get the group together to perform the root cause analysis,
to identify the biosafety gaps. And there are many ways to do this. This is just one example of a
root cause analysis where you identify the problem and then ask why five times to try to get
down to the root cause of the incident.
Here is an example of how that might work. The problem in this example is that Sam
had an exposure to Neisseria meningitidis in the laboratory when he subcultured a blood
culture bottle on the open bench. You would begin by asking the first why. Why was the
subculture done on the open bench? Sam responds that Michelle was using the biosafety
cabinet when he wanted to use it. Then you would ask, why didn't Sam wait until Michelle was
finished and then take his turn in the biosafety cabinet? Sam explains that he had to pick up his
son from school and he needed to leave work on time to do that. He didn't have time to wait
for Michelle to finish.
Next you would ask, does the lab have an SOP directing employees to always work with
blood cultures in a biosafety cabinet? Sam responds, yes, it does. Then you would ask why,
Sam, didn't you follow the SOP and work in the biosafety cabinet? He's already explained that
he had to leave on time. But couldn't he have asked a coworker for help or even asked Michelle
to stop her work and let him quickly do his subculture, so he could leave work on time to get his
son?
Sam's response: No one pays attention to whether or not people in the laboratory
follow SOPs. People take shortcuts all the time in the lab, and there aren't any consequences
for not following the policy. There is no need to continue to ask the last why, with this example
anyway. Based on what Sam has just told you, you've identified a significant biosafety gap. The
laboratory doesn't have a strong biosafety culture and this poses a huge risk for further
accidents.
What should be done now? Laboratory management needs to promptly address the gap
and put in place mitigation procedures to strengthen the laboratory biosafety culture. They
should provide biosafety training for all staff on why all employees need to follow SOPs and
emphasize how when an employee doesn't follow the SOP, they're putting not only themselves
at risk, but everyone else in the laboratory. They also need to determine how employees will be
held accountable and what repercussions there will be if people choose to disregard the SOPs.
As I've said several times today, there shouldn't be any blame assigned in an accident.
But willfully choosing not to follow biosafety policies and having an exposure as a result is
different than an accidental splash or spill and there must be accountability. In a laboratory
with a strong biosafety culture, all employees monitor themselves and each other and hold
themselves and each other accountable because they act as a family and they are concerned
about everyone's well-being and safety. So whatever method you use to do a root cause
analysis, you will want to put mitigation measures in place to reduce the risk level of any new
hazards you identify.
Another important part of your biosafety plan is the outreach you provide to external
partners and the relationships you need to build with them. I've talked about the importance of
establishing relationships with the members of your occupational health team in advance of
having to respond to an accident or exposure. But what other partnerships do you need to build
that would be beneficial in an emergency situation such as a new or re-emerging pathogen?
Where do you keep their contact information, and how do you protect it from others who may
ask for it? People may be very reluctant to provide contact information if you don't assure them
that you will protect their information and not share it with others without their permission.
I can tell you from my experience as a coordinator of our Wisconsin Clinical Laboratory
Network that regularly investing my time and energy into building and maintaining
relationships with other laboratory colleagues, state and local public health partners, infection
preventionists has benefited our ability to respond in a coordinated manner to the COVID-19
pandemic. We were able to work together collaboratively to share information and help each
other obtain or trade supplies because we had already established trust and respect for each
other.
As Dr. Michael Patella of the Iowa State Hygienic Laboratory once told me, an
emergency is not the time to exchange business cards. After all, establishing and maintaining
relationships with partners is a core function of public health laboratories.
Once you've built the relationships with your partners, you need to maintain and
strengthen them by establishing strong, effective ways to communicate. You want to make sure
you don't ever withhold information but share it in a timely manner. It is important to always
be honest and transparent in your communications. And don't be afraid to admit what you
don't know as well as sharing the things that you do know.
There are many ways to communicate effectively with partners. I send a routine
newsletter to clinical laboratory partners about twice a month via email and fax. At any time, I
can pick up the telephone to call a partner if I prefer urgent 1-to-1 communications. And I'm
currently working to add texting as an option for communicating with clinical laboratory
partners during emergency situations.
We also have a Listserv that provides an easy way for clinical laboratory partners to
initiate communications with their colleagues. And I also communicate with clinical laboratory
partners through monthly or as needed webinars. But probably everyone's favorite way to
communicate is by gathering together face-to-face for an educational event, such as a large
group conference.
We all know that the best relationships with partners are those that are mutually
beneficial. Being able to provide something that your partner doesn't have the ability or time to
easily do is always greatly appreciated. A large part of my outreach is to provide educational
opportunities for our clinical laboratory partners. I spent a significant amount of time training
clinical laboratories on risk assessment and risk mitigation because of the Ebola outbreak in
2014.
But there is always turnover in our laboratories, and there are always new hires to train
and build relationships with. The clinical laboratories may also appreciate getting some basic
biosafety training on topics such as those that I've listed on this slide. And the picture on this
slide illustrates some of the varied ways you can provide training on these topics.
A great biosafety plan should also include information on how and when you gather key
partners after you wrap up an emergency response to a public health threat like the COVID-19
pandemic. Taking the time to review your response, to discuss what worked well and what
didn't work well, is useful. Asking what you would do differently the next time and
documenting everything provides you with a powerful tool that you can refer to when
confronting the next threat that comes your way.
We don't know when we will need the information, but we all know that at some time
there will be another threat that emerges. If it is a new emerging pathogen, you don't need to
start from scratch, simply go find your biosafety plan and then begin by performing a risk
assessment using whatever information you do know about the emerging pathogen. If you
don't have much information, then think about other agents that you do know about and that
seem to be similar to the emerging pathogen. At a minimum, put in place the risk mitigation
measures that you use for the similar pathogen until you learn more about the emerging
pathogen and can make adjustments based on what you've learned.
So in summary, when you're confronting an emerging pathogen, rely on the strong
biosafety culture you've already established in your laboratory. Make sure you use your strong,
effective communication systems to reach out to the network of partners you've built with and
to share what you do and don't know. And finally, refer to and adapt your current biosafety
plan as needed.
Hopefully, I've convinced you that it isn't magic, but it is actually the laboratory
biosafety culture we create and all the hard work we've already done and continue to do in our
laboratories to assemble a great biosafety plan that will serve us well when facing a new threat.
If all the pieces that we've discussed today are contained in your biosafety plan, it will serve as
a strong backbone for you to base your response on.
And because we know that biosafety and emergency preparedness and response are
continually evolving, we can adjust and revise our biosafety plan at any time as we learn more
about how we can best protect our facilities and our valuable employees.
And this slide just lists reference and resource that you might want to look at. And I
want to thank the CDC OneLab group, again, for organizing this Summit. I've really enjoyed the
presentations I've heard. And I also want to send out my wishes for a happy Medical Laboratory
Professionals Week. Great clinical and public health laboratory partnerships are essential. And I
am truly thankful for all of the relationships I have with colleagues who work in both types of
labs. Our collaborations make all of us better. So with that, I'm happy to answer any questions
you may have for me.
Thank you, Erin. We'll take a we'll take a few minutes to answer as many questions as
possible. Again, if we do not answer your question today and you have questions after the day,
you can always email us at OneLab@cdc.gov. So far, we only have a couple coming in. Is a risk
assessment the collective responsibility of everyone in the laboratory?
Ideally. I think that everyone should understand the process. And if possible, give them
a chance to participate in learning how to do that. It's really helpful to have all people in the
laboratory know about risk assessment and what's really involved, how to identify those
hazards. So I would say, if you ask me if I want everybody trained, you bet. So I think it's
important.
This is a really good one. Biosafety plans have a lot of overlap with the OSHA
requirements Bloodborne Pathogens Exposure Control Plan. Do you recommend having a
combined plan or keeping them separate?
That's a really good question. It makes sense to me, if they have similar components to
both plans, that they could possibly be combined into one plan. Part of that may depend on if
OSHA would ever be coming into to look at a plan, do they need to see everything that might
be in a biosafety plan? You might want to have pieces in both places. But the problem is, when I
go into laboratories and they don't have things, they have things all over the place that it's
difficult for somebody when there is an accident.
And truly, these often happen when there isn't the supervisor around on a weekend or a
second or third shift. If there isn't just one place where they go for all the information that they
know and they know what's in there, then they're lost and things happen that shouldn't
happen. So that's why I really try to encourage all the laboratories in Wisconsin to keep it all in
one place. And maybe a combined plan would make the most sense, then.
Well, it seems like that's all the questions that we have. So I want to say, thank you, Erin,
for your commitment to keeping clinical and public health laboratories safe by creating a great
biosafety plan that doesn't happen through magic, but purposefully comprehensive planning.
So again, thank you all. And we'll turn it back over to Blanche.
Thank you.
You're welcome.
Thank you, Erin. Thank you, Alicia. We really appreciate the continued conversation
about risk assessment and biosafety. We are offering one P.A.C.E. contact hour for today's
webinar, the session that you just heard. P.A.C.E. certificates will be immediately available on
the OneLab REACH site in your My Learner Hub for easy access. If you want to receive P.A.C.E.
contact hours after participating in today's session, please log in using your OneLab REACH
account or visit the link in the chat, and you can use the passcode that we've provided to
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As I said, you need to be logged into your OneLab REACH account to access the
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you miss the link and the passcode, that will be included in the email.
Duration
Event Speakers
Erin Bowles, BS, MLS(ASCP)
Wisconsin Clinical Laboratory Network Outreach Coordinator
Wisconsin State Laboratory of Hygiene, Communicable Disease Division
University of Wisconsin-Madison, School of Medicine and Public Health