As cases climb across the country, community spread will send increasing numbers of counties into the so-called yellow and red zones — in turn, requiring more and more skilled nursing facilities to test staffers according to the September guidelines from the Centers for Medicare & Medicaid Services (CMS).
As of the most recent CMS data — from October 15 through October 27 — 991 counties were the so-called red zone, with COVID-19 infection rates above 10% as measured by the 14-day positivity rate of reverse transcription polymerase chain reaction (RT-PCR) tests.
An additional 1,381 were in the yellow zone, with test positivity at 5% to 10%, with some exceptions for smaller counties with lower overall testing data.
That puts more and more providers in a position where they have to test staff multiple times per month under the new rules; SNF providers in yellow counties have to test staff once a week, while those in red counties have to test twice weekly.
The COVID-19 point-of-care antigen tests shipped out by HHS — first the BD Veritor system and Quidel Sofia and Sofia 2 systems, followed by shipments of the Abbott Labs BinaxNOW devices — are intended to make it easier for SNFs to meet those testing requirements. These tests detect the presence of protein antigens from SARS-CoV-2, while polymerase chain reaction (PCR) tests identify the genetic material in the virus itself.
When HHS announced the point-of-care device shipments in July, it noted that the antigen tests were more likely to return false negatives than PCR ones, and later reports would raise the issue of false positives. Though HHS and one of its top coronavirus testing officials, HHS assistant secretary for health Adm. Brett Giroir, have argued that these are not unexpected for any diagnostic test, the reports have raised concerns about the best way to use the government-supplied devices.
Skilled Nursing News spoke with several operators over the course of September and early October to get a sense of how they are deploying the antigen tests in the field. Some are making use of the tests for specific employees; others are using them for staff as supplies permit.
Screening for symptoms
For the Eagle, Idaho-based operator Cascadia Healthcare, the bulk of the testing they were conducting as of September 11 was PCR testing, the method that made headlines in spring and summer for turnaround times so long that any results were meaningless.
Most of Cascadia’s facilities had received their point-of-care testing devices from HHS with test kits, Dee Cross, a special projects resource registered nurse (RN),with Cascadia, explained to SNN in a September 11 interview.
But there were two reasons the operator, which has 21 facilities in Idaho, Montana, Washington and Oregon, decided to make the bulk of its testing PCR, she said.
The first is that at the time of the interview, Cascadia had two laboratory options: the state lab in Idaho, where the company operates 18 facilities, and a new molecular lab — both of which can process the tests free of cost, Cross explained.
The other reason is that at the time of the interview, Cascadia’s order of the refill supplies for the BD and Quidel kits was “on backorder,” Cross said. The two devices require a processing unit and separate testing kits; nursing homes received devices and a round of initial supplies from HHS, but had to make refill orders with the companies on their own.
That necessitated some rationing of the tests, and for most of Cascadia’s buildings, the solution was to use the point-of-care tests for employees presenting with some kind of symptom of COVID-19.
“If we have someone who’s symptomatic that comes into the building, or has not worked in about a week or so, and we need to test them, we’re trying to keep the tests for those instances,” Cross explained. “And we can find out what their status is within those 15 minutes.”
Cascadia’s buildings had not run out of their initial shipment of tests in part because of this rationing; in the weeks since, at least some of the supply issues appear to have cleared up, according to both comments from Giroir and other operators who received the supplies they were waiting on after their initial interview with SNN.
Karen McDonald, vice president and chief clinical officer at Mission Health, which has facilities in Georgia, Kansas, Minnesota, Missouri, Tennessee, and Wisconsin, told SNN on October 2 that Mission ran out of supplies within two weeks.
“In the world [where] we have the supplies, guidance has been to use them on the employees first, for employee mandatory testing, be it weekly, biweekly, or twice a week, or monthly,” McDonald told SNN. “And then use it on symptomatic residents.”
Right now, Mission’s residents are being tested via PCR, since their movement is more limited; staff are being tested through point-of-care testing when it is available. Mission has BD Veritor and Quidel Sofia 2 devices, as well as the BinaxNOW tests; and at the time of the interview, McDonald noted that the Binax tests were being replenished “almost weekly.”
Most of the providers SNN spoke with originally indicated issues with supplies, but also reported upon follow-up a few weeks later that their test refills, which were slow to come in, were starting to arrive. McDonald was among them, telling SNN via e-mail on October 23 that the backordered supplies, which had been ordered through the medical supply distributor McKesson were starting to come through, while “Binax tests seem to be sporadically arriving at communities in all of our states.”
Crystal Packard, the administrator of the Good Samaritan Society-Parsons in Parsons, Kan., told SNN on October 2 that she was waiting for refills of test kits for the BD Veritor device the SNF received.
With about 61 employees, the two boxes of test kits that came was enough for roughly one testing round, she explained on October 2. On October 23, she told SNN via e-mail that her backordered tests, which had been placed through Medline, had arrived, and that she had been able to place another order in the interval. In addition, the supply of Abbott cards for the BinaxNOW have continued steadily.
As of October 2, Good Samaritan-Parsons was testing only its staff — a time-consuming process that could span two days to get all 61 employees tested. But on October 23, Packard reported to SNN that the numbers in her county had begun to spike.
“This week we are at a county percentage of 9.8 and I am afraid we will be at 10% shortly and begin testing staff twice weekly,” she wrote on October 23.
False positive concerns
The question of testing symptomatic individuals is one that comes up repeatedly for the antigen tests. BD and Quidel both have indicated the tests should be used within five days of someone showing symptoms, according to an August report from Kaiser Health News.
But when it expanded coverage of the antigen tests for COVID-19 under the Public Readiness and Emergency Preparedness Act (PREP Act), HHS emphasized that that the Food and Drug Administration (FDA) has indicated in an FAQ that off-label uses of the tests, or uses outside the original authorization, can be considered if other tests are unavailable or taking too long to process.
“For congregate care settings, like nursing homes or similar settings, repeated use of rapid point-of-care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times,” the FDA said in its answer to the question on recommendations for health care providers screening asymptomatic individuals. That answer was last updated September 2.
The instructions for use for the BD Veritor and the Quidel Sofia both note under the section of “Clinical Performance” how many samples were used in the studies for the FDA authorizations of the devices. The Quidel Sofia was used in a study of 209 samples from symptomatic patients suspected of having COVID-19, while the BD Veritor was used in a study of 226 samples from symptomatic patients suspected of having COVID-19.
The clinical performance of the Abbott BinaxNOW, which uses an all-in-one card rather than a separate test kit like the BD and Quidel systems, “was established with 102 nasal swabs collected from individual symptomatic patients (within 7 days of onset) who were suspected of COVID-19,” according to its instructions for use.
When the state of Nevada banned nursing homes from using the point-of-care antigen tests due to concerns about the tests, HHS ordered it to reverse the decision, and Giroir argued that at worst for a false positive, a worker misses two days of work while waiting for a confirmatory PCR test. At best, he argued after the Nevada ban, a true positive was kept out of the nursing home.
“This is a minuscule price to pay [for] identifying and isolating those who are infected, infectious, and who can devastate our elderly in nursing homes,” he said on October 9.
Workers themselves, however, are wary of having their lives shut down over a false positive, especially in rural parts of the country. Holly Noble, the administrator at Attica Long Term Care in Attica, Kansas, told SNN on October 5 that she was down nine staff members because people are wary of being tested and getting a false positive result.
“In rural Kansas, you have to understand, it’s not like Wichita where you work one job,” Noble told SNN. “There’s people that work two or three jobs … I have people that work at hospitals, where they’re not regulated to be tested. So they don’t want to be tested, because it could affect their schedule there.”