Gaps in Pa.’s coronavirus testing procedures led to systemic failure to collect critical data

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HARRISBURG — Pennsylvania has been unable to collect vital information about those who have been tested for the coronavirus due in part to a data collection system that was in the midst of an update when the pandemic started, the state’s top health official said Monday.

The flawed system starts with patients, who may not provide full information, and continues through doctors, who may not pass patient information to laboratories, and finally to the labs themselves, which don’t always send what they’ve collected to the state.

“The collection of samples at drive-thru and rapid facilities is unique to the pandemic, complicates it, and makes it a much larger mess, so to speak,” said Marianne Downes, the incoming head of the American Society for Clinical Laboratory Science’s Pennsylvania chapter.

That information is of vital importance as the state and coronavirus researchers work to respond to the virus and, eventually, figure out the best way to scale back social distancing. Various health experts say the state should be collecting information about age, gender, race, and primary residences of those tested, as well as expanding testing beyond high-risk groups.

“From the standpoint of better understanding the scope of the disease, the more information we have, the better,” University of Pennsylvania epidemiology professor Ebbing Lautenbach said.

Pennsylvania is working to expand its access to demographic information about people being tested for the coronavirus, Health Secretary Rachel Levine said Monday. The “older” data reporting system currently in use requires health-care providers and those conducting tests to input information manually.

“The people doing the testing … are trying to go as fast as they can and they’re not inputting all the data,” Levine said, adding that the state is mandating “that they do that.”

So far, the Department of Health has gathered age and hospitalization data for confirmed patients from hospitals. But consistent and reliable information about those who test both negative and positive outside of hospitals has been a lot harder to come by.

“We have some of that information [about suspected COVID-19 cases] but not as much as we would like,” Levine said, “particularly not about race and ethnicity.”

Laboratories are on the front lines of this race for knowledge but they’re also in the middle of a system struggling to keep pace with demand.

Downes, incoming president of the American Society for Clinical Laboratory Science’s Pennsylvania chapter, said the reporting process leaves many opportunities for useful patient data to be lost — or not reported in the first place.

Many suspected COVID-19 patients are now being seen by health professionals who are not their primary care physicians, she said, and the tests are being conducted at drive-thru testing sites and rapid testing facilities, such as LabCorp or Quest.

In the past, if the disease being tested for wasn’t an urgent matter, lab technicians could wait for full patient information to arrive from the health-care provider who ordered the test. That simply isn’t feasible with COVID-19.

“This is something we’ve never had before,” said Downes, a former lab technician who now teaches at West Virginia University.

Further complicating efforts to expand testing statewide are longstanding staffing shortages and reimbursement challenges at laboratories.

Downes said many smaller hospitals don’t have the capacity to perform nucleic acid testing — one of the ways COVID-19 is diagnosed — which requires a separate room and trained staff. The organization’s most recent annual survey found that among the hospitals who have such facilities, their laboratories were short of at least two full-time technicians.

That staffing shortage, similar to other professions across the health-care industry, could be exacerbated as lab techs fall ill or have to quarantine after exposures.

Given recent advancements in testing science and Pennsylvania’s lack of a certification requirement for lab techs, she said, it’s unlikely that retired or older techs could be pressed into service to fill the gaps.

“A lot of people educated in the ‘80s were not trained to do this testing,” Downes said. “If they’ve not done that training, it’s not something they’d know to do.”

There’s also uncertainty about how insurance companies and health systems will pay for COVID-19 testing, including tests that haven’t been fully vetted by the U.S. Food and Drug Administration. Downes said these tests were approved on an emergency basis so there isn’t a lot of data on false negatives or false positives.

“These can run $200 to $500 per test just because of the expensive reagents,” she said, referencing a key testing substance. “And reimbursement is low and getting lower. We don’t know what’s going to happen: We know insurance will cover it but to what extent? Will it be every test we run a deficit?”

Levine said Monday the widespread shortage of chemicals used to run COVID-19 tests is a key limiting factor to testing more Pennsylvanians. And serology testing, which would determine which people have antibodies that would help protect them from future exposure, is still in its infancy.

While Pennsylvania had made strides in increasing the number of tests conducted daily, the state saw a precipitous drop over the weekend. Pennsylvania had averaged about 7,000 tests per day, which health experts said was already inadequate. That figure dipped below 5,000 on Saturday and Sunday.

Last week, two federally funded testing sites — at Citizens Bank Park in South Philadelphia and a Temple University campus in Montgomery County — closed.

Levine said the Montgomery County site is expected to reopen later this week. State officials are also planning to open a new testing facility in northeastern Pennsylvania, which emerged as a COVID-19 hotspot in recent weeks.

“I can see a time, hopefully over the next number of months, when we’ll have … enough testing capability to do more population-based surveillance testing of the virus,” Levine said. “That will give us a better sense of the true prevalence of the virus in Pennsylvania.”

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