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Covid 'Testing Hell': Devices Given to Nursing Homes Bring New Problems - The New York Times

After months of enduring a dearth of protective medical gear and staggering death tolls from the coronavirus pandemic, nursing home operators and employees across the United States experienced something close to elation as rapid-result test machines paid for by the federal government began arriving last month at 14,000 residential facilities that serve the elderly.

The hand-held testing devices, which spit out results in as little as 15 minutes, were intended to quickly diagnose and isolate patients, and alter the deadly calculus of a contagion that has taken the lives of 77,000 nursing home residents and workers, more than 40 percent of the nation’s fatalities from Covid-19.

But the initial sense of relief has been overtaken by frustration as nursing homes have discovered that they must pay for test kits on their own, and that the machines are markedly less accurate than lab-based diagnostics.

Because the devices come with a modest starter-set of test supplies that only last a few weeks, facilities, many of them buffeted by financial losses from the pandemic, must pay roughly $32 for each additional test. In communities with high rates of infection, a typical nursing home can churn through hundreds of tests a week.

Many nursing home operators also say they have been overwhelmed by new federal reporting rules, fines and financial incentives that are associated with the program.

“My initial happiness over the machines has quickly turned to disillusionment,” said Ben Unkle, the chief executive of Westminster-Canterbury on Chesapeake Bay, which operates a skilled nursing center in coastal Virginia. “At the moment we’re in testing hell.”

The machine his company received, made by the medical device manufacturer BD, came with 300 tests but the new rules require Westminster-Canterbury to conduct weekly tests on its 280 nursing employees and residents. BD has said it would be weeks before they could send out additional testing supplies.

The shortages have forced Mr. Unkle to rely on an outside lab that charges $100 a test, an expense that he estimates will add $875,000 to the $1 million in pandemic-related losses that the nonprofit provider expects this year. Rather than the 15-minute turnaround, the lab results take up to four days to arrive, complicating efforts at infection control.

“As far as I’m concerned, this is an unfunded mandate that is not giving us the data we need fast enough to improve either care or protection,” Mr. Unkle said.

Credit...Julia Rendleman for The New York Times

Federal health officials acknowledged problems with the testing initiative, and they have asked for patience as they carry out a herculean effort to provide nursing homes with the diagnostic tools needed to identify infections among their employees and residents and to tamp down outbreaks.

The Centers for Medicare and Medicaid Services, which oversees the nation’s nursing homes, said the agency would exercise discretion before imposing fines on facilities that make a good-faith effort to meet federal testing mandates.

“We understand that some facilities may experience challenges to meet the new requirements,” the agency said in a statement.

The importance of frequent testing is expected to become more critical following a recent decision by C.M.S. to lift restrictions on nursing home visitors.

On Tuesday, President Trump announced a plan to supply nursing homes with 18 million rapid test kits manufactured by the medical device company Abbott. The tests do not require a separate reader, but some experts have voiced concern over their accuracy, and a typical nursing home testing its employees twice weekly would likely run through those supplies in a few weeks.

Even as they expressed appreciation for the free machines, which cost about $300, many nursing home operators said they are overwhelmed by the financial and bureaucratic demands of the testing program, which include up $10,000 in fines for facilities that fail to meet daily reporting rules that sometimes conflict with those from state or local heath agencies. Health departments in some states said they were still trying to figure out how to gather what they described as a tidal wave of new testing data.

“There’s no mechanism in place for reporting,” said Kim Schilling, the vice president of health services at Friendship Haven, which runs a nursing home in rural Iowa. “We were on the phone yesterday trying to figure this out with the department of public health and it was very overwhelming for them too.”

Katie Smith Sloan, the president of LeadingAge, an association of nonprofit providers of aging services, said the Trump administration’s focus on fines and stringent reporting requirements were the wrong approach to addressing a crisis that was aggravated by federal inaction in the early months of the pandemic.

“For seven months, nursing homes have been saving and protecting lives while dealing with staffing shortages, testing and personal protective equipment challenges and growing unexpected costs,” she said.

David Grabowski, a health care policy expert at Harvard Medical School, described the federal rapid-test program as “a positive step but late in the game,” and said Washington should do more to address the systemic financial and staffing problems that have long bedeviled the industry’s efforts to shield vulnerable residents from infectious pathogens. Because federal reimbursements do not cover the full cost of care in much of the country, nursing home operators who serve predominantly Medicaid patients say they often lack the money to hire enough skilled workers willing to take on a grueling job that the pandemic has made increasingly stressful and fraught with risk.

“I don’t have a problem penalizing nursing homes guilty of gross negligence, but my sense is that most of the facilities out there have been doing their best despite dealing with sick workers, a lack of resources and poor guidance from the federal government,” Mr. Grabowski said. “Putting efforts into training workers on infection control, boosting wages and offering paid sick leave would be a better approach.”

The new testing requirements are governed by a complex set of guidelines from the Centers for Disease Control and Prevention that are pegged to the positivity rate of tests for coronavirus infections in the county where facilities are situated. When community positivity rates surpass 10 percent, nursing homes must test their residents and personnel twice a week. The testing requirements drop to once a week when the community positivity rate is between five and 10 percent, and once a month when it is below 5 percent.

As of Sept. 13, more than 3,100 counties across the country reported positivity rates greater than 5 percent, according to CMS data.

Credit...Julia Rendleman for The New York Times

With its community positivity rate above 13 percent, employees at Morningside Manor, a nonprofit nursing home in San Antonio, Texas, quickly burned through the 90 tests kits that arrived earlier this month with their new BD Veritor. Patrick Crump, the nursing home’s chief executive, said that twice-weekly testing of 140 residents and staff required two employees and an outside consultant, an effort that takes more than four hours.

Until more test kits become available, this facility, too, is paying an outside lab a $100 per test, further straining resources at a time when nursing home admissions have been essentially frozen by the pandemic.

“The demands, the stress and the burden on our staff right now are just huge,” Mr. Crump said. “It’s just not sustainable and if we’re going to do our job and take care of our folks, we’re going to need more help.”

Then there is the issue of accuracy. The BD Veritor has a false negativity rate of 15 percent but in recent weeks a small number of nursing homes have reported false positives from it too.

Troy Kirkpatrick, a spokesman for BD, which provided 11,000 of the rapid-result devices to nursing homes, said the company was looking into the matter. Quidel Corp., which is supplying the remaining machines, has not disclosed whether it has received reports of false positives.

Concerns over accuracy, the test kit shortages and the high cost of fresh supplies have prompted some providers to set aside their newly arrived machines, at least for now.

St. John’s United, which received a BD Veritor for its 186-bed nursing home in Billings, Mont., is instead planning to use a state lab for weekly surveillance testing. The tests are free, but the results can take as long as five days. “You can’t make meaningful decisions when results are so delayed,” said David Trost, the president of St. John’s United.

He estimates that test kits for the BD Veritor would cost $19,000 a week for twice-a-week surveillance at the nursing home — money he said would be better spent on an in-house lab that the nonprofit is building for the half-dozen facilities it operates for older adults.

Mr. Trost said that nursing home providers have felt whiplash from new fines and federal rules that land every few days, and it often seems like the government is seeking to blame providers for soaring infections in surrounding communities that often refuse to adopt basic measures like wearing masks.

“When you are forced to do something with absolutely no way to respond, that is oppression,” he said. “Federal agencies were late to provide attention to long-term care even though the pandemic started in a nursing home, and now they’re trying to shift the blame to us for future deaths.”

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