[Applause]
I was so excited to match to a state assignment, especially one in the heart of bluegrass country
where I Drive past horse farms like these every day on my way to work.
I knew a state assignment would give me the opportunity to explore a variety of public
health topics.
But what I did not know was that within months of arriving to my assignment I would be leading
one of the most unique, confusing, and challenging investigations the health department had ever
seen.
It was December, halfway through Fall Course, when I received a distressed call from my
supervisor.
He was calling to let me know that a physician was reporting three abscess-like reactions
following vaccination.
I could sense the worry in his voice.
To put things in context, it was the middle of flu season and there were a few other things
going on in Kentucky around this time.
We worked with the local health department and identified that these three individuals
received their vaccines from the same business, Business A. We reached out to this business
and their owner - let's call her Ms. Smith - and ask them to cease all vaccination and
set aside any remaining vaccine.
By the end of the week the local health department was onsite.
The local health department collected all remaining vaccine, but all that remained were
six pre-drawn syringes.
Now I do want to clarify when I say pre-drawn I'm referring to the fact that someone has
drawn up vaccine into a syringe from a multi-dose vial, much like the one you see here.
And while use of a multi-dose vial is standard, vaccine should only be drawn up immediately
before administration.
So to collect vaccine that was already drawn up into syringes, this seemed highly unusual.
We scheduled our visit to the business the following week.
Unfortunately we were not able to directly observe any vaccine handling or storage as
when we arrived on site Ms. Smith let us know that she had contacted the CDC nearly one
month earlier to report these reactions and that when she contacted the CDC they advised
her to throw away everything - vaccine, syringes, supplies - all of it.
Thankfully those calls are recorded and interestingly enough no one tells her to discard vaccine
or anything for that matter.
But maybe she was confused?
Unable to directly observe the storage and handling, we asked Ms. Smith to walk us through
her hand hygiene.
Providing vaccines in a variety of settings, she reports that she doesn't always have access
to sink or soap and water so she has to use other methods.
That makes sense.
Ms. Smith proceeds to reach out to a nearby drawer and pull out two alcohol pads, much
like the ones you see here.
I looked on in disbelief as she proceeded to rip open the alcohol wipes and rub the
two-by-twos across her hand.
She said this is how she cleaned her hands most often.
Lack of temperature monitoring, lack of thermostats or thermometers at all, reporting of drawing
up syringes of vaccine days to weeks before administration, and the use of a dormitory-style
refrigerator with no backup power source we had serious concerns on how effective this
vaccine was.
Our next logical question was to ask Ms. Smith about her background and training.
She initially answers with nursing.
It takes multiple follow-up questions to uncover that this background in nursing is no licensed
degree or certification.
No, it's far less.
It's that she was trained by a nurse, once, years ago which now left everyone on our investigation
team wondering who exactly is allowed to vaccinate in the state of Kentucky?
Business A is owned and operated by Ms. Smith's husband - let's call him Dr. Smith - has his
own primary care clinic and reports having minimal involvement in Business A however
all vaccine for Business A is ordered and administered under his medical license.
Business A travels to different company work sites in their area and vaccinates employees
at no cost to the employer, allowing these individuals to receive necessary vaccines
without having to miss work.
Ms. Smith reports that she is the only person who prepares and administers vaccines and
that she alone traveled to seven companies between September and December of 2018 and
vaccinated.
We reached out to these companies.
Six of the seven companies reported one location and that location was in Kentucky.
I remember calling the seventh company and speaking with the HR manager.
He let me know that they had 17 locations.
I had to ask for clarification.
Did he mean to say that Business A traveled and vaccinated at 17 of their locations?
He answered affirmatively.
Two in Indiana, eleven in Ohio, and four in Kentucky.
And just like that our investigation was now multi-state.
In talking with the companies we also found out that there were three other individuals
who would arrive onsite and vaccinate employees, contradicting Ms. Smith's previous claims
to be the one and only person who vaccinated.
It should also be noted that around this time we started to receive positive results.
Individuals who were experiencing reactions and infections were seeking care, and their
physicians and medical providers were testing their infections.
These cultures were coming back positive for a bacteria, non-tuberculous mycobacterium--
or mycobacterium fortuitum.
To be more specific, the significance behind this being that this bacteria tends to be
found in water and has been associated with tap water in previous health care setting
outbreaks.
We had a few ideas on what might have been happening but we didn't want to rush to any
conclusions.
We did however want to re-interview Ms. Smith and we wanted to collect some environmental
samples so we were back at the clinic the following week.
I want to take a pause here because if you are confused, know that you are not alone.
This was easily the most confusing part of the investing for me.
I had so many questions and I went into the second visit wanting answers.
Sure, call me naive but up until this point I was trying to give Ms. Smith the benefit
of the doubt.
For me it was very personal.
As a nurse practitioner I've administered countless vaccines.
I know its complexity and I take it very seriously.
I would be heartbroken to find out that patients of mine were getting sick after I had vaccinated
them and I would be devastated if a health department thought I was to blame.
Sure, Ms. Smith was not a nurse like I was - that was clear - but she was trying to care
for people and I wanted to be wrong.
Unfortunately after this second visit there was no going back.
It was clear that these inconsistencies were more than just a coincidence and two things
made that very clear.
First, when we arrived on site we began a second interview.
Because we knew the names of these three other vaccinators, I asked Ms. Smith who one of
them was.
Staring straight at me she said she didn't know anyone by that name.
Now before this interview our investigation team had looked at Ms. Smith's public Facebook
page and the very person she just denied knowing was all over her account in pictures and in
posts.
But even that would prove only to be the second most important thing we learned that day.
Following the interview we proceeded to prepare to collect samples around the clinic Ms. Smith
went back to her office and advised us to swab anything and everything.
Our team moved from room to room, collecting samples from countertops, sinks, refrigerators
- anywhere and everywhere Ms. Smith reported storing or handling vaccine.
As we moved into the second room something else caught our eye.
Beyond an open doorway in a dark side room there was another refrigerator but this one
was different, dorm-style as well, but Ms. Smith had never mentioned it and up until
this point we didn't even know that it existed.
I was hit with a wave of emotion.
I was terrified but also intrigued.
What is this refrigerator and what is inside of it?
Should I go ask her or should I just open it?
So I opened it.
Paralyzed by what I might have just found, I immediately shut the door.
My chest was tight, I could barely catch my breath, and my fingertips they felt like they
were going numb.
I was in shock at what I might have just seen.
I had to open it again.
I had to know if these boxes contain the very same vaccine that Ms. Smith had reported being
supposedly told to discard.
Sure enough, that's exactly what I found- hepatitis A, hepatitis B, Tdap, pneumococcal,
expired yellow fever, and various forms and amounts of sodium chloride.
Now I would like to say that I played it cool and I knew exactly what to do next, but that'd
be a big fat lie.
I did not expect the visit to go like this, and I most certainly did not know how to handle
this situation.
So I found an empty room in the back corner of the clinic.
I crouched down and huddled against the furthest wall, frantically swiped through my phone
until I found my supervisors number and proceeded to convey my dilemma through whispers.
My mind was moving a mile a minute.
Was I even making sense?
Apparently I was.
I listened as my supervisor ran down the hallway to the health commissioner's office, phone
in-hand, and breathlessly explained the situation.
I was asked to not only swab the newly discovered refrigerator but collect all the vaccine.
After I gave myself a quick pep talk as I'm sure all officers do on their first outbreak
investigation I confronted Ms. Smith.
She was understandably stunned when I told her I had found vaccine.
She ran to the refrigerator claiming it was all expired and needed to be sent back to
the manufacturer for credit, but it wasn't and I told her that.
Our concerns continued to grow as we began to receive results from those syringes that
were collected at the beginning of the investigation.
Two of the six syringes grew multiple organisms, and an additional two of the six syringes
had antigen levels well below what would be expected in a vaccine dose.
One of them was 50-fold less than the control.
On top of that a community provider reached out to the health department and let us know
that he had seen five patients who reported receiving hepatitis A vaccines from Business
A. In caring for these patients he tested for immunity and reported that none of these
five patients showed any signs of immunity to hepatitis A. This was enough.
The Kentucky Department for Public Health issued a press release.
Following this press release and a later interview with one of the additional vaccinators, we
identified 23 companies with over 54 locations across all three states.
We estimate that over a thousand individuals receive vaccines from Business A during the
fall of 2018.
We identified over a hundred individuals who experienced one or more reactions following
vaccinations from Business A, and we identified over 25 individuals who tested positive for
mycobacterium fortuitum - all with indistinguishable PFGE patterns indicating one common source.
Now when I moved to Kentucky I thought I knew what I was going to be getting myself into
- hepatitis A, opioid overdose prevention, surely a foodborne outbreak, and maybe even
try my hand at chronic diseases.
But never in my wildest dreams did I think I'd be out swabbing a refrigerator and persuading
a business to turn over likely contaminated, definitely ineffective, and most certainly
concealed vaccine.
Ready to respond anywhere in the world at a moment's notice takes on a whole new meaning,
and I couldn't be more grateful.
Thank you.
[Applause]