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Pandemic regulatory challenges created public health laboratory collaborations

During a 2021 APHL Annual Conference session, Scott Shone, PhD, director of the North Carolina State Laboratory of Public Health, held up a mini poster that still hangs on his wall that says at the top “States Are Now In Charge of Testing.”

By Melanie Padgett Powers, writer

After the COVID-19 pandemic reached US shores in spring 2020, regulatory requirements, guidance and available assays continued to evolve. This forced public health laboratories across the country to constantly reevaluate and change processes.

But it also created camaraderie and collaboration among public health laboratory professionals from various states, said speakers during the May 18 APHL 2021 Annual Conference session “Regulatory, Accreditation and Staffing Challenges during COVID Times and Strategies to Tackle a Pandemic.”

The session’s four panelists and moderator represented Kentucky, North Carolina, Tennessee and Florida, which are all part of the Southeast ColLABorators Consortium. They are one of seven regional consortia, which allow state and local public health laboratories to share testing services, expert guidance and resources.

The panelists shared their experiences from the past year, as regulatory requirements—and the science—changed month to month, and sometimes week to week. They recalled when they learned that the US Food and Drug Administration (FDA) was handing over regulatory testing authority to the states. Scott Shone, PhD, director of the North Carolina State Laboratory of Public Health, held up a mini poster that still hangs on his wall that says at the top “States Are Now In Charge of Testing.” The FDA shipped the posters early in the pandemic.

However, some state public health laboratories, including in North Carolina, did not have that regulatory power by their state. “The problem was that it created a lot of confusion in our clinical lab community as we became bombarded with emails and requests [for approval],” Shone said.

Needing to deal with that confusion and respond to those requests created an additional staffing burden during a very busy time, he said.

That example represents the “curveballs” that laboratories were constantly forced to deal with, said Marie-Claire Rowlinson, PhD, assistant laboratory director/CLIA laboratory director at the Florida Department of Health Bureau of Public Health Laboratories. “It seemed like a new challenge every two weeks.”

When SARS-CoV-2 diagnostic testing became available—first with a test from the US Centers for Disease Control and Prevention (CDC) on February 4, 2020—laboratories were required to conduct a test performance before using the tests, which were being approved under emergency use authorization. The validation required five positive control tests to always test positive and five negative controls to always test negative. (In June 2020, FDA approved alternatives for processing test validations.)

Public health laboratories stepped up to help their clinical counterparts achieve testing verification quickly. Kentucky and North Carolina were among those that created “blind panels” to ship to other laboratories to help them verify a particular test. Those laboratories would then report their verification results to the FDA. 

Relying on science

The panelists agreed that they faced constant pressure to provide information or institute new processes from politicians, clinicians, journalists and others.

“A lot of the pandemic response decisions are being made by non-scientists, and we have a lot of political pressure,” said Kara Levinson, PhD, MPH, deputy director for the Tennessee Department of Health Division of Laboratory Services. “We found ourselves having to push back with the science: ‘There’s a reason when we say no.’”

For example, public health laboratories were often asked to release their Ct (cycle threshold) values. A Ct value is the number of cycles required for the fluorescent signal to cross the threshold in a PCR (polymerase chain reaction) assay. A PCR assay is used to diagnose a person with COVID-19.

However, Ct values fluctuate depending on the test, temperature, storage, time in transit and more, panelists said. “It took a lot of explaining to folks that without context Ct value isn’t all that helpful,” Levinson said. “For COVID, it’s so new; it’s not quantitative in the way that Ct value for other pathogens, like HIV, is.”

The panelists agreed that it was reassuring that their counterparts in other states were facing the same challenges. They look forward to continuing the collaboration that grew during the pandemic. “The relationships that were built have been extraordinary,” said

Matthew Johnson, division director of the Kentucky Division of Laboratory Services

Melanie Padgett Powers is a freelance writer and editor specializing in health care and public health.

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