Nevada

Nevada Lifts Block on Rapid Covid-19 Tests in Nursing Homes

The state of Nevada withdrew a directive that blocked nursing homes from using federally provided rapid coronavirus testing equipment late on Friday, in response to an order from the Trump administration.

Nevada told nursing homes on Oct. 2 to stop using the rapid-testing equipment, citing concerns about false-positive results. The back and forth highlights a debate over the proper use of the tests after reports of some false positives.

In a letter to state officials, Adm. Brett Giroir, the Department of Health and Human Services official who has overseen U.S. testing efforts, said the state’s action to ban use of the tests was “inconsistent with and preempted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” The letter was dated Oct. 8 and made public Friday.

Adm. Giroir defended the performance of the federally supplied equipment on a call Friday with reporters, saying the false-positive rate was low and the issue could be managed by using proper procedures to confirm results. The state’s action wasn’t justified, he said. Adm. Giroir declined to say what enforcement action the federal government could take against Nevada, but said he expected the state to comply with the federal order.

“We are very disappointed by the letter received today from U.S. HHS Giroir, as our goal remains united in protecting those most vulnerable in our communities,” Ihsan Azzam, Nevada’s chief medical officer, said. “We too want more testing with rapid turnaround in Nevada, but the results of those tests must be accurate as they affect clinical care.”

“We are not saying the tests have no use, we are just saying pause for further review and additional training,” he added. The health department issued a new bulletin late on Friday, recommending that nursing facilities continue to perform

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Nevada Revokes Halt on Rapid Antigen Testing in Nursing Homes

A week later, however, Admiral Giroir cracked down on Nevada’s “illegal” prohibition on BD’s and Quidel’s tests, which he said had imperiled the residents and staff of nursing homes across the state. “They cannot supersede the PREP Act,” he said.

The false positives that had emerged, Admiral Giroir said, were not only expected but “actually an outstanding result.” No test is perfect, he said.

In the Nevada statement, Dr. Azzam reaffirmed his concerns with the number of false positives that had arisen. “If this laboratory data discrepancy had been reported to Dr. Giroir, we would hope he would have taken the same action as Nevada,” he said. “We too want more testing with rapid turnaround in Nevada, but the results of those tests must be accurate, as they affect clinical care.”

The state’s nursing facilities can resume use of BD’s and Quidel’s products, according to a new Nevada directive issued on Oct. 9. But Nevada’s department of health also recommended that all antigen test results, positive or negative, be confirmed by a laboratory test that relies on a slow but very accurate and reliable technique called polymerase chain reaction, or P.C.R. False negatives, officials noted, risk exposing healthy people in nursing homes to someone who is unknowingly contagious. False positives, on the other hand, could prompt the placement of a person who is well into a unit with sick people, also increasing the chance of infection.

“Both of these scenarios could result in causing harm to a population that we have collectively worked so hard to protect,” the directive said. State health officials, it said, would also continue to investigate the use of BD’s and Quidel’s products.

“We need to better understand the issue before encouraging mass use of such tools among our most vulnerable citizens,” Dr. Azzam said. “We

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HHS Testing Czar Rips Nevada for Stopping Rapid Tests in Nursing Homes

WASHINGTON — Nevada public health officials’ recent actions preventing nursing homes from using rapid screening tests for COVID-19 are “unjustified” and don’t follow the science on testing, Department of Health and Human Services (HHS) “testing czar” Adm. Brett Giroir, MD, said Friday.

The state’s actions are “not scientifically valid. They must cease their prohibition immediately,” Giroir said on a phone call with reporters. “If you need technical support,” he told the nursing homes, “we are enthusiastic to do more. Lives are at stake and our administration is not going to allow action to risk our seniors or any other vulnerable or underserved population.”

Letter Sent to Nursing Homes

On October 2, the Nevada Department of Health and Human Services sent a letter to healthcare providers and long-term care facilities, noting that the Centers for Medicare & Medicaid Services had sent point-of-care antigen tests to nursing homes across the country — specifically, the Quidel Sofia test and Becton Dickinson’s Veritor test. The letter noted that according to the FDA’s emergency use authorization data, Quidel claimed 87% sensitivity and 100% specificity for its test, while Becton Dickinson’s numbers were 97.5% and 100%, respectively.

“However, this was based on extremely limited data,” wrote Ihsan Azzam, MD, PhD, the state’s chief medical officer, and two colleagues. The state conducted its own test after it “started receiving anecdotal reports from SNFs [skilled nursing facilities] that individuals with a positive antigen test were subsequently testing negative” with polymerase chain reaction (PCR) assays, generally considered the most accurate. The state looked at data from 12 nursing homes that conducted 3,725 rapid tests, of which 60 came back positive. Of those, 39 were sent for PCR testing; 16 (40%) came back as true positives while 23 (60%) were false positives.

“Possible reasons for conflicting test results include lack

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HHS testing official warns Nevada must drop antigen testing ban

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COVID-19 widespread testing is crucial to fighting the pandemic, but is there enough testing? The answer is in the positivity rates.

USA TODAY

The U.S. Department of Health and Human Services’ top testing official said Friday Nevada’s ban on rapid coronavirus tests in nursing homes could “endanger lives” and urged state health officials to immediately reverse course.

Assistant Secretary for Health Brett Giroir said Nevada would face unspecified enforcement actions if state health officials did not remove an order instructing nursing homes to discontinue use of point-of-care antigen testing machines made by two companies, Quidel and Becton, Dickinson.

HHS  “expects immediate action from Nevada to reverse its unwise, uninformed and unlawful unilateral prohibition,” Giroir said Friday in a phone call with reporters. “Lives are at stake and our administration is not going to allow actions to risk our seniors or any other vulnerable or underserved population.”

Nevada health officials did not immediately return calls or emails from USA TODAY.

On Oct. 2, Nevada officials ordered nursing homes and other long-term facilities to discontinue use of the antigen testing instruments authorized by Food and Drug Administration “until the accuracy of the tests can be better evaluated.”

 (Photo: Becton, Dickinson)

The Nevada Department of Health and Human Services chief medical officer and two other high-ranking health officials cited a high rate of false positive results at eight facilities that used the antigen tests, according to a bulletin for nursing homes and health-care providers.

But Giroir said Nevada’s ban represents a misunderstanding of the role of testing machines in screening large numbers of people who might unknowingly pass the virus to others.

HHS has purchased and sent rapid antigen testing instruments to nearly 14,000 nursing homes nationwide as part of a strategy to protect vulnerable seniors. Deaths in nursing homes represent up

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Trump Administration Orders Nevada to Allow Rapid Covid-19 Tests in Nursing Homes

The Trump administration ordered the state of Nevada to withdraw a directive blocking nursing homes from using federally provided rapid coronavirus testing equipment, highlighting a debate over the proper use of the tests after reports of some false-positive results.

In a letter to Nevada officials, Adm. Brett Giroir, the Department of Health and Human Services official who has overseen U.S. testing efforts, said the state’s action is “inconsistent with and pre-empted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” The letter was dated Oct. 8 and made public Friday.

Adm. Giroir defended the performance of the federally supplied equipment on a call Friday with reporters, saying the false-positive rate was low and the issue could be managed by using proper procedures to confirm results. The state’s action wasn’t justified, he said. Adm. Giroir declined to say what enforcement action the federal government could take against Nevada, but said he expected the state to comply with the federal order.

Nearly 100 people died during the height of the coronavirus outbreak at the Menlo Park Veterans Memorial Home in April, more than 10 times the number in a typical month. Among those who died were 84-year-old Isabella Kovacs and 86-year-old Joan Williams. Their stories provide a window into what went wrong at the New Jersey facility. Photo: Shari Davis/Julie Diaz

The Nevada Department of Health and Human Services didn’t immediately respond to a request for comment. Nevada told nursing homes on Oct. 2 to stop using the rapid-testing equipment, citing concerns about false-positive results.

The federal government has been supplying equipment from

Quidel Corp.

and

Becton Dickinson

& Co. to about 14,000 nursing homes around the country, which can use the machines to fulfill a federal mandate to test staffers. They perform

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