COVID-19 NEWS
Put to the Test
How quickly could the hospital stand
up a process to test for COVID-19?
As the novel
coronavirus began
to rapidly spread in
early 2020, Children’s
Hospital Colorado
infectious disease
specialist Samuel
Dominguez, MD, PhD,
and his team knew it
was likely only a matter
time before it became
a global pandemic.
The hospital would
need to quickly bring
its own assay online to
effectively manage its
patients. It was the first
clinical lab in Colorado
to do so and one of the
first in the nation.
ASSESSING THE
SITUATION
Dr. Dominguez has a
clinical interest in emerging
pathogens. In fact, before
he took over as medical
director of the Children’s
Colorado microbiology lab
in 2016, he worked on basic
science research related to
coronaviruses.
“Our whole team had been
watching this scenario closely
since late 2019,” he says. “In
early January 2020, we went
to hospital leadership and
expressed how we needed
to start thinking about what
our response was going to be
and how we could prepare,
including what it would take to
bring an assay online.”
Then, on January 20, 2020,
Washington State reported
the U.S.’s first confirmed case
of COVID-19. That accelerated
an already unprecedented
preparation timeline. There
were two options.
Dr. Dominguez and his team
could try to build an assay
from scratch — what’s known
as a laboratory developed
test, or LDT. Historically,
though, it takes months to
progress through necessary
government approvals. Labs
have to prove the test meets
appropriate standards for
sensitivity, specificity and
limits of detection. Was that
even possible in weeks?
The other option was to
use the assay already in
development by the Centers
for Disease Control and
Prevention, or CDC, but at the
time, it was only available for
use by state public health labs.
“It really left clinical labs in
a bind,” says. Dr. Dominguez.
“So we went back to hospital
leadership and asked for
guidance on how to proceed.”
Hospital leadership connected
the epidemiology team with
the Children’s Colorado legal
and government affairs teams
to find a way to fast track the
process.
TIME TO TAKE ACTION
The government affairs
team lobbied the governor
of Colorado and members of
congress to speak with the
FDA about lifting regulatory
barriers. As it turned out,
other labs across the country
were doing the same in their
respective states.
Mounting pressure led the
FDA to issue an emergency use
authorization allowing highcomplexity,
CLIA-certified labs
to use the CDC assay, provided
those labs had particular
reagents, extraction kits,
probes and enzymes to run
the assay.
That was another roadblock.
“We got approval to move
forward, but there were
supply chain barriers,” says Dr.
Dominguez. “We didn’t have
access to those resources and
neither did other labs.”
But they had plenty of the
reagents they typically
use, which meant that the
government affairs team
needed to lobby for additional
approval.
“We were willing to do our
own validation and verification
to show that the extraction
agents we had on hand were
equivalent,” he says. “We’d do
whatever was necessary to get
this assay up and running.”
That determination paid off.
They secured quick approval,
and on March 16, Children’s
Colorado was the first hospital
in Colorado to have an assay
up and running. Not only
could they run samples from
team members and patients
in-house, it was a service they
began to offer community
hospitals around the region —
including some from Wyoming
and Montana.
4 | CHILDREN’S HOSPITAL COLORADO