By Rachel Roubein, Politico, September 8 2020
The Trump administration’s efforts to scale up rapid coronavirus testing in nursing homes is running into a set of hurdles – just as the White House moves to a new pandemic strategy that stresses shielding the most vulnerable.
Machines that process rapid tests are sitting idle in some nursing homes because of confusion and fears the results are less accurate than widely used lab-based tests. Other nursing homes worry about being able to quickly obtain more of the fast-turnaround tests. And conflicts between state and federal regulations over which tests can be used on nursing home staff are complicating the situation.
“It’s a complete and utter mess,” said Betsy Johnson, the president of the Kentucky Association of Health Care Facilities, which represents nursing homes.
These problems have emerged even as the Trump administration is pushing with increasing urgency to scale up and speed up testing of nursing home workers. The administration last week mandated regular testing of staff, who can unwittingly carry the virus into the homes. By next week, the administration will have sent machines that can do on-the-spot testing to nearly all of the country’s 15,000 nursing homes, completing an effort that began two months earlier.
Infections appear to be yet again on the rise in the facilities, which have been linked to more than 51,000 coronavirus deaths, or over a quarter of the nation’s overall death toll. Some nursing homes also said they’re unsure when they’ll be able to buy more supply for rapid tests. It could be weeks, they have been told.
Questions about the reliability of these rapid tests, known as antigen tests, remain a concern. These antigen tests, which search for proteins on the virus’s surface, promise results within 30 minutes. But they return false negatives more often than tests conducted in labs, which can detect trace amounts of the virus, and there has been confusion over whether they should be used in asymptomatic people. That’s enough to spook some state regulators, who initially required nursing home staff to get more reliable tests processed in labs with longer turnaround times.
The Trump administration and some nursing home operators see the tests as another tool to smother possible outbreaks before they erupt. Federal officials recently clarified that the rapid antigen tests can be used in asymptomatic nursing home staff and residents. And last week, HHS extended legal protections to health providers who administer antigen tests to screen asymptotic people, in an effort to preempt state and local restrictions on their use.
“These concerns were beginning to translate into actions that could have risk in our seniors, and we just could not accept that,” U.S. testing czar Brett Giroir told reporters this last week.
The new federal nursing home policies, however, have sparked confusion among facilities whether they can use the rapid tests without directly contradicting state guidelines, even as the Trump administration insists states can’t bar them.
“There should be no confusion nursing homes are protected and may use these tests to protect their residents and staff,” HHS spokesperson Mia Heck wrote in an email.
About half the states already required regular testing of nursing home staff, often relying on tests conducted in labs – which are highly accurate but can take longer to complete. During the height of this summer’s coronavirus surge, some labs were taking a week or even more to produce results as they struggled to keep up with demand.
The Trump administration’s new guidelines for testing nursing home staff is based on local virus conditions. In counties where less than 5 percent of tests come back positive, staff must be tested once per month. That increases to weekly testing for counties with a 5 to 10 percent positivity rate in the community, and it ratchets up to twice weekly where the positivity rate is above 10 percent.
The administration requires that test results come back within 48 hours, but that could be a tall order if a facility isn’t using antigen tests, as labs are regularly overrun with backlogs.
“This might be an impossible ask” for some California counties where outbreak levels remain high and test turnaround times are slow, said Jason Belden, the emergency preparedness director for the California Association of Health Facilities.
In Maryland, state rules require nursing home staff be tested once a week, but bar facilities with at least one coronavirus case from using the rapid tests. As a result, facilities are wary of relying on quicker antigen tests to fulfill the state’s requirements, despite the new federal protections, and many are largely using lab-based tests, said Joseph DeMattos, the president and CEO of the Health Facilities Association of Maryland.
Maryland’s health department said it’s reviewing the new federal guidance and will “ensure the state’s policies are in line with the new guidance,” a spokesperson said. The state should have more information “in the coming weeks.”
“It does make it really confusing,” said DeMattos, who expressed concern with the varying amount of time it can take to get results back from commercial labs.
New Hampshire health officials continue to recommend that antigen tests only be used for testing people with symptoms. Instead, the state has a system in place that pays for lab-based tests for nursing home staff every 7 to 10 days with a quick turn-around time.
“This may change, but this is where we are today,” said Elizabeth Talbot, a state epidemiologist said on a webinar with state and nursing home officials last week, shortly after the Trump administration updated industry guidance.
The Trump administration is promising more help. Some of the 150 million $5, 15-minute rapid tests the U.S. recently bought from Abbott Laboratories will be sent to nursing homes under more rigorous testing requirements, according to Heck, but the administration hasn’t yet specified how many or when those shipments would begin. These particular tests don’t require additional machinery and are about the size of a credit card.
Meanwhile, nursing homes have had problems refilling orders for rapid tests. The Trump administration last month invoked the Defense Production Act to ensure rapid test manufacturers Becton Dickinson and Quidel prioritize filling the federal government’s order for nursing homes over other customers. BD, which is providing most of the tests, said the government’s order has left them temporarily unable to refill orders for nursing homes and other clients.
As a result, “we cannot currently provide any tests to our distributors to ‘restock’ the nursing homes that already received their government allocation,” a company spokesperson said. BD expects to be able to begin to restock orders within a few weeks.
Quidel’s president and CEO Doug Bryant said its distributors have enough tests to re-supply nursing homes who order more tests.
Heck, the HHS spokesperson, acknowledged that some nursing homes may see delays in receiving more testing supplies, but “we believe this will be rare.” She noted that nursing homes will have priority over other purchasers.
The federal government has been sending between 150 and over 900 point-of-care tests to nursing homes depending on their size, but it’s up to the facilities to procure additional tests.
The head of Lutheran Life Villages, which operates three nursing homes in Indiana, said his first question upon receiving tests from the federal government this week was how to obtain more.
Company president and CEO Alex Kiefer said he’s contacted suppliers and industry groups. But so far, “the best we have right now is the supplies may be available sometime around the end of September, maybe into October,” he said.
One of the company’s homes, an 84-bed facility, received 210 tests from the federal government, just barely enough to test its 180 staff and essential caregivers once. Under Trump’s new testing guidelines, the facility in Allen County, where the testing positivity rate is 7.5 percent, is expected to test those workers once per week.
Kiefer, as well as others in the industry, expressed concern that there still isn’t clear guidance on how facilities are supposed to report their negative test results. He said the labs have been reporting the facility’s Covid-19 test results, and now with the antigen tests, that will be up to the homes.
Some nursing home officials said testing conditions are starting to improve after months of pleas from the industry. And ultimately, some prefer the federal government pushes for more testing now than wait months to finalize the nuances.
While it’s caused confusion, the federal effort to provide facilities with testing equipment is a “move in the right direction,” said one nursing home industry source, who requested anonymity to offer a candid assessment.
David Lim contributed to this report.