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 laboratory—your employees.
Event Media
Interconnecting People for Planning and
Preparedness
I'm excited to introduce Dr. Teresa Wolfe.
Teresa is a subject matter expert for Po’okela Solutions.
She's she works for CDC in the Division of Laboratory Systems and the Training Workforce
Development Branch.
She has a long history of working in clinical, academic, and industry laboratories and teaching
laboratory medicine in higher education.
Most recently, Doctor Wolf served as a clinical laboratory consortium coordinator for the
Oregon State Public Health Laboratory during the COVID pandemic.
Our next speaker and final speaker for the 2024 OneLab Summit is Doctor Teresa Wolfe.
Over to you, Teresa.
Thank you, Alicia. Can you hear me?
Ok. Now that's much better.
Is it?
OK, great.
Yeah.
Maybe it was just a bad connection. OK.
Thank you very much, Alicia.
I appreciate the introduction.
As she said, my name is Teresa Wolfe.
If the moderator could go to the next slide, please.
So, today, I want to talk about how laboratories can incorporate interdisciplinary connections to
both assist in an emergency response and with day-to-day operations.
Next slide, please.
My disclaimer, the material I'm presenting here is solely my own.
It does not reflect CDC's, my current, or any former employer's official position on these topics.
Next slide, please.
So, here's an outline of what I will discuss today.
I'm going to talk a little bit about the objectives and the — give an introduction.
I'm going to talk about why engagement is important, how to increase and maintain
collaborations, and then I'm also going to discuss some challenges from some personal
experiences and then action to take, Next slide, please.
So, there are three objectives for today's talk listed here. I'll describe the importance of clinical
and public health laboratories engaging during a strategic response.
I'll present some ways to design methods for increase increasing collaborations, and then I'll
identify some techniques for maintaining those collaborations.
Next slide please.
So, it is well known that a key component of a successful emergency preparedness and
response program is community partners working together.
Pre disaster planning for public private partnerships typically involves some type of strategic
planning.
The strategy can follow something like the graphic that I have here, and I recreated this from
FEMA's planning guides.
The basic premise is that the process focuses on these 4 phases.
So, plan, engage, integrate, assess-refine, shown along this top line while keeping the goals in
mind as the phase activities are developed.
Now in a perfect world, when time, foresight, and funding are abundant, we can't always
predict how and when the next incident, disaster, or pandemic's going to happen.
So, for this talk, I want to focus on just the engage part of this process which you see
highlighted here.
Next slide, please.
So, what do you think of when you see or hear the word "engage"?
Take a minute to think about this. And if you could put your ideas into the Q&A, maybe our
moderator can call out just some of a few of the responses that you might have.
And I'm waiting for responses to come in.
Communicate. Ok, communicate, good. Collaborate, collaborate, listen
OK, next slide, please.
So, I came up.
So, those are good answers.
I came up with words like "participate", "connect", and "associate".
There’re many others that might come to mind.
What about the word "collaborate".
And somebody did come up with the word collaborate.
That one came to mind for me.
So, do we collaborate as part of the engage process or throughout any part of the planning
process?
Well, yes, most of the time we do.
And there's a variety of agencies through whom we might form collaborations within public
health.
Next slide, please.
So, who are these collaborators?
And maybe a better question is who can be the collaborators?
Next slide.
Interestingly, I read an article discussing all of the partners and collaborators that come
together during emergency response, and the article specifically gave the example of an
infectious disease outbreak.
This article mentioned all manners example of manners of federal, state, local, public, private
organizations that might come together in a community partnership, stressing the word
"collaborators."
And while this article focused on the myriad collaborators that could come together during an
emergency response, the authors never mentioned the laboratory.
Despite the theoretical emergency response being an infectious disease outbreak, neither the
clinical nor the public health laboratories were included as target collaborators.
Next slide, please.
So, here are some of those collaborators the article mentioned.
They cite local, state, national, federal partners.
They give examples of public and private agencies for each category.
So, you can see here that there are many agencies like the Medical Reserve Corps, EPA, FDA
who contribute to this collaborative effort.
While this certainly is not an inclusive list, the big takeaway is the article didn't call out the
laboratories.
The article did not mention that the public health agencies lead the response during an
emergency, and we have to assume that the public health laboratory and possible the clinical
laboratories are included in that reference.
So, I'm showing them here at the bottom of the slide since really, they're the focus of this talk.
Next slide, please.
So, coincidentally, you might have noticed the word "collaborator" or maybe not contains the
word "lab" in it.
Next slide.
And, in fact, you can see here if you include Y, next slide, you end up finding the laboratory.
Next slide.
Funny that the laboratory is hidden in plain sight.
That likely comes as no surprise to this audience, that the laboratory work is often unknown or
misunderstood.
And one might think that COVID testing during the pandemic would have brought laboratory
testing into the mainstream dialogue and resolved many of these myths and misconceptions.
But that does not seem to be the case, as apparent in some of the following news articles that I
have.
So, next slide, please.
So, as you can see from these article titles and captions, even during the pandemic, laboratory
testing can still be largely unknown and misunderstood.
So, the picture in the caption of the article on the far left has a really great title, asking who is
doing all the COVID testing. The image is accurate, shows a laboratory professional wearing
appropriate PPE.
The article correctly points out all the nuances of why and how the laboratory is unknown and
misunderstood and why the general public should be informed.
Not surprisingly, this article was written by a laboratory professional.
Now in contrast, the article on the upper right points out that the laboratory profession is
hidden, meaning that most of the general public does not know the laboratory exists nor what
work the laboratory professionals perform.
The tagline states that the laboratory is often considered a hidden profession.
We already saw it in the word "collaborator" despite the fact that almost 3/4 of diagnostic
information gathered on patients comes from the laboratory.
And then lastly, this is kind of my favorite one, is the picture on the far bottom corner that
highlights really the misconceptions that can occur.
This article shows the image of someone holding a multichannel pipette.
The caption identifies the worker as a nurse performing mpox testing.
I would wager that this scenario is happening in a biosafety cabinet within a public health or
clinical laboratory and the work's being performed by a laboratory professional.
Now these articles all came from different sources, and I really don't know how many follow up
articles, if any, appeared in those same sources.
Unfortunately, there's many examples of articles like this in the media, where laboratory
professionals can be misidentified or misinterpreted, or they show workers show images of
workers wearing incorrect or no PPE.
And, of course, we have one here that shows a really great example of proper PPE.
All of these instances certainly could have been an opportunity for engagement and
collaboration.
Whoever initially put those articles out could have followed up with, say, a follow up article
showing, hey, here's, you know, here are more information on this, and this is what the pub
general public should know.
So, now what I want to do is I want to switch gears a bit and talk about the previous work I did
to show how public and private systems engaged and collaborated during the COVID pandemic
in Oregon.
Next slide, please.
So, in mid to late 2020, I was hired by the Oregon State Public Health Laboratory to serve in a
COVID response position as the Clinical Laboratory Consortium coordinator.
That's a mouthful for sure, but the position requirements included a strong clinical laboratory
background with knowledge of laboratory testing.
Some of the responsibilities of this position were to coordinate COVID testing supplies for key
laboratories, helping to handle the bulk of the COVID testing happening around the state and
also to lead a biweekly meeting for several clinical laboratories in the state.
Next slide, please.
So, on this map, I'm showing a or on this slide, I'm showing a map of the state of Oregon.
I've labeled the Consortium members with blue triangles and the Oregon State Public Health
Lab with a Red Star.
So, when I started in this position in 2020, there were a small number of laboratories
participating in a week in the weekly Consortium meetings, which you can see here on the map.
During the meetings, the laboratories would report on the number of COVID tests that they
performed that week along with any issues with COVID testing.
OK, so this is not to say that these are the only labs doing COVID testing at that time.
These are just the ones that were participating in the Consortium calls with the state public
health laboratory.
The laboratories consisted mostly of hospital laboratories along with two private testing
laboratories and two university research laboratories.
So, you can see that most of the participating laboratories at this time are on the west side of
the state, with a few laboratories on the east side of the state.
Next slide, please.
Now on this map, I'm or on this slide, I'm showing a map with the locations of laboratories or
point of care test sites that had joined the Consortium list by mid-2021.
So, as you can see, we achieved quite a wide coverage of participation across the state.
I felt that this was important because many of these facilities are in rural communities.
For those of you not familiar with Oregon, it's not a particularly large state, but there are a lot
of towns and communities in mountainous or remote areas.
Many of the coastal towns have limited road access, and there's often a large distance to the
nearest metropolitan area from that town.
Eastern Oregon, and especially in that lower southeast corner, has a large expanse of range
land with towns spread far apart, and access to medical services and facilities are fairly limited.
So, these connections were helpful for the public health laboratory and being able to assess the
needs of the various communities around the state.
Another thing that these connections also help with is they also help engage the public health
laboratory with laboratories in neighboring states.
So, some of the laboratories that are located along the borders of Washington, Idaho, and
California either have satellite labs in those states or the Oregon location is the satellite
laboratory for a larger system in that neighboring state.
Next slide, please.
So, how did we establish the connections for the Consortium group?
There are several methods, and I have some of the key ones listed here.
I'll run through each of these individually, but — an academic laboratory advisory group.
Meetings with our state epis, our operations and facilities department at the state lab and then
the State Supply Warehouse.
Next slide, please.
So, prior to my position at the state lab, I was the department chair and program director for a
medical laboratory training program.
Now, there's two laboratory training programs in the state of Oregon.
The associate degree program is at Portland Community College, and the bachelor’s degree
program is at Oregon Institute of Technology.
Both of these programs are accredited through NAACLS.
They're state schools, and they have an advisory group of clinical laboratories.
These advisory groups consist of a mix of hospitals and clinics, some of which are shared across
the schools.
I invited members that I knew from these advisory groups to join the Consortium meetings as I
knew that many, if not all, were performing COVID testing in some capacity.
So, this effort really helped and also helped with word-of-mouth spread to other laboratories
around the state.
Next slide, please.
So, the next avenue.
for collaboration was the Operations and Facilities department at the State Public Health Lab,
which is responsible for handling and receiving samples coming into the laboratory. At the
height of the COVID pandemic, this department was receiving thousands of specimens each
week, and staff were working around the clock to process all the specimens coming into the
laboratory.
Occasionally, the laboratory would receive specimens that were improperly packaged, missing
paperwork or specimen identifiers.
These specimens would be routed to me for resolution with the sending laboratory.
At other times, the sending laboratories would call the state lab seeking some type of
information.
Some of these inquiries included questions about testing or reagents, sample collections, and
biosafety concerns.
So, I'll show some examples on the on the next slide.
All of these interactions were opportunities to collaborate with external partners.
Next slide, please.
So, here's an example of two sample issues that came up that allowed me to engage and
develop new collaborations.
So, the picture on the left is a sample that was placed into a specimen bag with wet ice and
shipped to the state lab.
Unfortunately, that specimen was floating in water by the time our receiving department
unpacked it.
The specimen on the right had the opposite issue.
Frozen specimens were placed into a cooler with no temperature control and as a result were
received thawed or were received thawed at room temperature.
So, these samples were both, of course, unusable.
In both cases, this was an opportunity for me to share CDC and APHL's biosafety risk
assessment and packing and shipping guidelines and, of course pertinent job aids.
So, the continued phone conversations like these that I had and others where I was able to
answer questions, help the laboratories find resources, and resolve sample issues were
opportunities for me to engage with the laboratory staff and provide them with needed
information.
It was also an opportunity for me to invite them to the Consortium meetings.
Next slide, please.
The next avenue that was helpful in these efforts was the State Supply Warehouse.
The State Supply Warehouse is not a connection that would immediately come to mind.
I certainly would not have thought of this, but in this case, it became a source to develop new
collaborations.
State Warehouse provided PPE, COVID sample collection supplies, point-of-care COVID test kits,
and some COVID test reagents to local public health departments, corrections, and some
medical facilities and clinics around the state.
The warehouse would receive a myriad of questions about supply expiration dates, reagent
quality control, and swabs for sample collections.
They'd also receive questions regarding laboratory supplies that they didn't carry.
So, when those so, they would often refer those callers to me, to my office, and it and at that
time, I would have a chance to engage with these people calling, asking these questions.
So, it provided another opportunity for discussions regarding laboratory testing and providing
resources for information. When appropriate, it was an opportunity to invite new members to
the Consortium meetings.
Next slide, please.
So, our state epidemiologists met frequently with the state lab to discuss matters related to
COVID.
Occasionally, discussions would involve testing or sample collection issues, often from a point
of-care test site.
So, examples of these point-of-care test sites were long-term-care facilities and community
testing events, but occasionally, they included other state agencies such as corrections.
So, when these sites were referred to me, it was a chance for me to collaborate with a
nontraditional testing environment to assist their staff with laboratory testing.
It was also an opportunity to introduce the staff to CDC and APHL's biosafety, risk-assessment,
and specimen-handling guidelines and job aids.
So, I have an example on the next slide of a call that came from a non-traditional testing site.
Next slide, please.
So, here's a case study of a testing issue that involved a non-traditional testing site and a point
of-care instrument.
The site reported an unexpected outbreak of COVID positive patients.
This facility had had a few positive COVID-patients here and there, but in this case, it was many
patients all at once.
After investigation, the suspicion was that the point-of-care test instrument might be
malfunctioning, and the results were false.
The site manager referred to me — was referred to me for guidance.
So, this was — this was a waived point-of-care testing instrument with few moving parts and an
electronic readout.
The point-of-care instrument does not require daily QC testing, and lot controls are only
required one time per month or with each new lot change.
Next slide, please.
So, the instrument displays these following symbols that I have shown here for the various
possible out result outputs.
There's a red plus sign for a positive result, a green check mark for a past QC check, and a green
bar for a negative result.
I was not familiar with this instrument, so I pulled up its package insert, read through the
documentation to see if I could just get a sense of, you know, how its basic operation should go.
So, for those of us performing laboratory testing, this instrument seems pretty straightforward.
But for someone with no laboratory background, operating a waived point-of-care test
instrument can be a very daunting task.
So, I asked the manager to talk me through all the steps that they had performed.
And remember, this is happening during COVID.
We're not, you know, we're not meeting face-to-face.
I'm doing this all over the phone.
So, after several phone calls, having the manager run, rerun the liquid controls, recheck all the
lot numbers, expiration dates, and storage and materials, it seemed that there was no
resolution.
And to this manager's credit, they were doing everything right.
They had followed the directions, they were logging everything in, they were keeping track of
lot numbers, and you know, their workflow and everything was really spot on.
So, it was still difficult, though, for me because I couldn't be there in person to see how they
were actually performing the test.
The saving grace ended up being that the site had a second waived point-of-care test
instrument from a different manufacturer and that second point of care test instrument also
used liquid controls.
So, I had the manager run the other instrument's liquid controls on the problem instrument,
and here is what happened. Next slide, please.
The manager called me back all excited and was also a bit sheepish because they figured out
the problem. When they ran the other point-of-care test instrument's, liquid controls on the
problem instrument, the instrument gave this new symbol a red X, which indicates an invalid
result.
The manager had not run controls in almost a month because, remember, QC only needs to be
performed once a month or with a new lot change, and so they hadn't had any of that happen
in over a month. And they had not had any positive specimens since the QC was last performed
either.
So, the manager stated that they had forgotten that a positive specimen was a red plus sign and
an invalid result was a red X.
So, for the untrained eye, the red plus sign and the red X look like they mean the same thing, a
positive result.
So, this last, so that last unexpected outbreak actually turned out to be a batch of invalid results
but had been interpreted and turned out as positive results.
Case solved, and this was a really great opportunity to collaborate and educate on the
complexities of laboratory testing.
Next slide, please.
OK, so, how did we maintain these collaborations over time?
There were four key elements for which members expressed appreciation, and I had those
listed here.
The Consortium meeting served as sort of a town hall where attendees could discuss laboratory
testing, supply and resource needs.
It was a place to ask for help and get help, and initially, the Consortium meetings had just been
about COVID testing and positivity rates.
But the meetings discussion, but the meeting discussions broadened over time and were
especially helpful when the mpox outbreak happened in 2022.
On a regular basis, I would attend the CDC Laboratory Outreach Communication Systems call,
the LOCS call and the state, tribal, local, territorial (STLT) calls along with any other meetings
hosted nationally that were pertinent to COVID testing.
And so, other ones could be, you know, ones by APHL, ASCLS, FDA, CMS, etc, anything that
might and also anything that might be hosted by the laboratory or science equipment
manufacturers.
So, this allowed me to provide timely updates to the Consortium members on topics that might
directly impact their work because they're busy doing testing, and they, you know, didn't
necessarily have the time to attend webinars and/or you know, they might not have even
known about them.
I created agendas for each of the Consortium meetings, and these contained sections that listed
links to CDC and APHL's, biosafety and risk-assessment guides, links to any recent health alert
notifications, so the HANs from CDC or the state of Oregon and also any other instrument or
manufacturer recalls or updates.
So, for example, the ever, always updated-by-next now lot number expiration date list. And
then lastly, members were able to meet with staff from other laboratories and nontraditional
testing sites around the state to discuss testing and supply issues.
So, this was a really great networking opportunity for them.
Members could meet regularly with their peers from around the state when they might not
otherwise been have afforded that opportunity.
So, next slide, please.
I mentioned providing timely updates from the CDC LOCS calls.
Here is a link to those calls.
And I also have this on the last slide, in my resources page.
They're held about one time per month now.
During the COVID pandemic, these calls were held weekly.
These calls were invaluable in broadcasting updates from FDA, CMS, and CDC with regards to
COVID testing and positivity rates and then, of course, putting discussing FDA emergency use
authorizations and/or recalls and, CLIA regulations.
The calls started to include mpox topics when that outbreak emerged in 2022.
The calls now continue to include updates from CDC, FDA, and CMS as appropriate that are
pertinent to laboratory testing, any newly released HANs as those come about, and any
advisory bulletins.
The calls also have different speakers at times who present case studies and new outbreaks,
and you can register to sign up to receive notification and meeting invites via the link on the
screen.
And I think that's also been put into the chat.
And you can also access this link on CDC's Division of Laboratory Systems website.
Next slide, please.
So, another CDC initiative that was invaluable to our laboratory consortium is the OneLab
which we are all part of here now.
The OneLab Network started at the beginning of 2021 and provided free webinars and training
on topics relevant to clinical and public health laboratories.
OneLab has greatly expanded since that time, now offers a wealth of resources that are free to
use and share.
The link posted will take you to the main One lab web page, which most of you should know
since you're here on Summit.
But you can also access many more trainings and become part of this national network of
clinical and public health laboratories.
So, the best part about this is all this content is free to use.
So, I encourage everyone to explore the variety of new resources on the OneLab page,
especially the One Lab virtual reality section because those are some new trainings that we
have been developing, and I've been assisting with that.
Next slide, please.
So, collaborations were also maintained through supply chain issues occurring at the time, and
supply chain issues are always a challenge.
And surprisingly, they were also a benefit. Since the Consortium group was an opportunity for
the members to discuss laboratory issues and problems,
they would also often mention critical need items or surplus items.
And surplus items might be laboratory supplies or reagents that they had with short expiration
dates or items in excess that they knew that they might not use up before their expiration date
came up.
So, I saw some examples here of laboratory supplies that were exchanged, borrowed, or
donated between member laboratories during the pandemic.
So, for example, starting on the left, one point-of-care test site had an excess of new, unexpired
butterfly needles that they no longer needed, and those were gladly taken up by one of the
rural hospital clinical laboratories.
Swabs came in a variety of makes and sizes, and we swapped these things around like trading
cards.
The unused blood tubes in the third -to-last picture came from an academic research facility,
and while some of them were expired, many of them were not.
So, this coincidentally happened during the time that there was that shortage of the lithium
heparin green top tubes and also the shortage of the sodium citrate blue top tubes.
So, I sorted through these tubes.
I separated the non-expired from the expired ones.
We were able to find the unused expired tubes homes, and even the expired tubes were taken
up by the academic laboratory training programs that I mentioned earlier in the talk. Pipette
tips.
Were often in short supply due to the plastic shortage.
I don't think anybody could have predicted that one.
The Consortium group was a forum to ask to borrow a particular size or type of tip or find a
home for ones that were not needed.
So, we were able to swap those around as well.
Next slide, please.
Lastly, I would be remiss in not mentioning that this endeavor was not without challenges.
Nothing is without some challenge, but public health funding is always in short supply, so
having sustained and consistent funding would help keep programs operating and evolving in
preparation for the next pandemic or emergency response.
Not sure anyone could have predicted the strange supply chain issues that happened during the
pandemic, but this was certainly a problem.
It not only impacted plastic and material supplies, but also reagents and medical equipment.
Having this networking space for our laboratories to borrow and exchange supplies to keep
tests running for the for the patient population likely saved lives.
The ever-evolving laboratory technologies of course makes it difficult to keep staff trained, as I
showed in that earlier case study example.
It can also impact that supply chain just due to the increased demand or specialty requests.
Interestingly, communication was not as big of a challenge as it might have been, such as in the
case of a disaster where communication methods are disabled.
Spreading the word around about our efforts and taking the time to reach out to other
laboratories was challenging at times, especially when the laboratory is under a large
corporation.
So, calling one of these laboratories invariably ended up with me just getting a 1-800 customer
service line.
Trying to get a direct number or e-mail address for testing personnel now in the laboratory was
nearly impossible.
So, it was only when the customer service line had no idea what I was talking about and
realized I actually really did need to talk to one of the laboratory testing staff and that I was also
laboratory testing staff or if one of the staff called me directly, was I actually able to reach
testing personnel.
When I was able to reach testing personnel, I was always, I always asked to get their direct
phone number and was frequently, frequently told that they were not supposed to give their
number out.
Yet this was lab to lab. This was, you know, I worked in state lab; they're in a clinical healthcare
facility.
We should be able to call one another during a times of crisis or inquiry because we are all
supporting the testing effort.
Next slide, please, So, action gets results.
Encourage everyone to share experiences and knowledge to help strengthen and develop
strategic system partnerships.
Reach out and engage with other laboratory and system partners to create a diverse set of
stakeholders.
Use these partnerships to seek input and spread the word on laboratory needs, barriers, and
goals.
As a parting thought for those seeking to increase their laboratory's collaborations with other
stakeholders, ask yourself the following questions.
Who do you coordinate and communicate with on a regular basis?
How would this change during an emergency, and what activities could you do now to prepare
for the future?
And then what other questions could you ask?
And by having these questions with your stakeholders, they may have questions that you could
not have anticipated that they would ask you.
Next slide, please.
So, here are a few resources that you might find helpful from FEMA, CDC, and APHL I believe
that these will also be dropped into the chat. And next slide, please.
And with that, I thank you for your time and attention.
OK, we'll take a few minutes to answer as many questions as possible.
If you we don't get a chance to answer your question today, we'll do our best to answer via
email.
And if you have a question after today, you can always email it to OneLab@cdc.gov.
Well, it looks like we have no questions.
I'll give it a few minutes to see just in case someone's typing.
Well, looks like we don't have any questions.
So, Teresa, I'll say thank you for sharing your experience and knowledge during the public
during a public health response to interconnect clinical and public health laboratories through
planning and preparedness.
Back to you, Glenn.
Thank you very much, Teresa.
And thanks, Alicia.
We're going to break for just a few minutes before we do closing remarks, and we'll come back
in about 5 minutes.
We'll see you all then.
Duration
Event Speakers
Teresa M. Wolfe, PhD, MLS(ASCP)
Po’okela Solutions, LLC