To Stay Ahead of Shifting Science and Regulations, Signature’s COVID-19 Testing Strategy Goes Digital

In the absence of a vaccine or proven treatment for COVID-19, testing will serve as the nursing home operator’s primary weapon against the spread of the virus for an indefinite period.

Widespread baseline testing of nursing facilities was painfully slow to materialize, particularly during the early days of the crisis. But now that operators — bolstered by eventual support from states — have taken great steps forward in that domain, the strategy in nursing homes must shift along with the overall coronavirus response.

For Signature HealthCARE, a major operator with 110 nursing facilities, that shift means a combination of viral and blood tests, tracked digitally under a new partnership with health management firm BASE10 Genetics.

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By compiling information about resident and staff testing into a single database that medical leaders can analyze — and using BASE10 as its testing vendor — the operator can adapt to changing testing mandates as state governments issue new guidance over the coming months, Signature chief medical officer Dr. Arif Nazir told SNN.

“The whole science of testing is not going to be a one-and-done thing — that we make up a strategy, and then we move forward with it,” Nazir said.

While the federal government has made a one-time, baseline test of all nursing home residents and staff a prerequisite under guidelines for reopening facilities to outside visitors, the Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control & Prevention (CDC) have not issued direct testing mandates, largely leaving the matter up to states to decide.

Individual states, in turn, have come up with varying levels of required testing, typically a combination of a one-time program for residents and repeated testing for staffers, who enter the wider community each day and thus have a much greater chance of exposure; early analyses of outbreaks have also revealed that asymptomatic staff contribute heavily to infections of nursing home residents.

Those edicts also are not set in stone: New York, for instance, recently pulled back on its aggressive twice-per-week testing order for nursing home workers, citing falling overall case counts and progression through the state’s wider phased reopening plan.

For larger companies like Signature — which primarily operates in Kentucky, but has locations spread across the South and Midwest — keeping track of the changing mandates across state lines has been just one of the many recurring challenges during the COVID-19 pandemic.

“They’re using multiple labs. Most of the time, they’re using paper,” Nazir said. “It becomes almost an impossible task for somebody to keep track of all those things.”

Further complicating matters: There are multiple types of tests for COVID-19 at present, which work most effectively when used together.

The “gold-standard” polymerase chain reaction (PCR) test provides the most reliable results, but requires an uncomfortable nasopharyngeal swab that’s unpleasant even for the doctors who must take them regularly in order to keep working — and potentially traumatic for nursing home residents with profound cognitive and physical issues. It also presents a single snapshot in time, with multiple tests potentially required to confirm a diagnosis.

Blood-based antibody testing, while much less invasive, generally cannot be used on its own to rule out a positive COVID-19 case, and the science around exactly what antibodies tell clinicians about a resident’s condition continues to evolve.

That’s why, once Signature was able to overcome initial testing hurdles, Nazir started talking to BASE10 CEO Dr. Michael Fang, whom Nazir knew through his work with AMDA — The Society for Post-Acute and Long-Term Care Medicine, a professional organization for geriatricians and other elder-care specialists.

“His company started pursuing an idea: What if they created a digital platform to create science out of this chaos, so that we can create algorithms and evidence on what tests should be used, and how they should be used, and how the two testing strategies go together to give better results?” Nazir said.

With the support of Signature CEO Joseph Steier, the two companies announced their partnership earlier this month. As the COVID-19 pandemic drags through the summer and into the fall, Signature hopes the BASE10 technology will allow it to develop testing plans tailored to individual resident and building needs, while also tracking infections to prevent future outbreaks.

Over time, as government and clinician guidance evolves, the BASE10 system will be able to suggest proper testing frequencies based on emerging science, according to Nazir.

“When the science tells us: Oh, you need to test twice a week, we’ll be able to fix that in the algorithm, so that automation will automatically start creating those cadences,” he said. “It’s not about Signature [coming] up with one strategy and one frequency, I totally believe — and that’s how it should be, that with more evolution of the science, we will be looking at different frequencies.”

The Louisville, Ky.-based Signature this week announced early testing success, celebrating more than 1,100 successful COVID-19 recoveries among its residents — or about 77.7% of its confirmed cases. The shifting tide also prompted Signature to close its flagship coronavirus specialty unit after declaring it COVID-free.

“Much of the media focuses on the negatives of this pandemic that has changed our world. But there are positives, too,” Steier said in a statement. “We must celebrate the victories and let our communities know, this pandemic can be defeated, one person, one resident, one staff member at a time. We’ve got one-thousand plus victories to prove it.”

That success hasn’t come without significant strain: Signature earlier this month laid off 100 corporate workers, citing skyrocketing expenses and a lack of government support. Speaking to a local business publication this week, Steier called the upcoming year to 18 months the “toughest period in our company history.”

And leaders at the company, along with nursing home operators across the country, emphasized that the battle is far from over.

“We have celebrated in our victories and deeply mourn our six beloved residents who have passed during this pandemic,” Lee Rooney, CEO and administrator of Signature’s dedicated COVID-19 facility in Putnam County, Tenn., said in a statement. “We continue to fight in their memory and won’t back down.”

Not backing down, at least for Nazir, means acknowledging that science around testing won’t remain static.

“We knew from the beginning that we will never be in a situation where it’s going to be as simple as a pregnancy test, where you just do one test and then, rest assured, you’ve got the scenario figured out,” he said.

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