Admiral Brett Giroir hedshot
Admiral Brett P. Giroir, M.D., assistant secretary for health at the U.S. Department of Health and Human Services

This week, the U.S. Department of Health and Human Services is shipping 2.6 million COVID-19 test kits to facilities that serve vulnerable populations, including assisted living communities.

Admiral Brett P. Giroir, assistant secretary for health at HHS and lead for COVID-19 diagnostic testing efforts, briefed the media Friday, saying older adults are a priority for the administration. He noted the administration’s efforts to provide 541,000 tests to 5,500 assisted living communities with Clinical Laboratory Improvement Amendment (CLIA) waivers as well as to nursing homes.

The federal government is working with more assisted living communities, he said, but cannot provide tests to them until they secure the CLIA certificate. He added that 13,850 eligible nursing facilities received 13,985 instruments and more than 4.9 million rapid point-of-care tests by Sept. 14. In the coming weeks, additional tests will be shipped to K-12 schools for teachers and students.

The BinaxNOW COVID-19 Ag Card antigen tests initially were shipped to vulnerable nursing home populations in “yellow” and “red” states, which had higher positivity case rates, as well as all to assisted living communities with a CLIA certificate. Production is ramping up quickly in Abbott Laboratories’ two facilities in Illinois and Maine, Giroir indicated, adding that additional distributions will be announced this week.

The government is monitoring testing in a variety of ways, he said, including through business proprietary discussions with manufacturers multiple times a week, to know what was shipped and where, and via weekly state and county-by-county assessments with governors.

Approximately 75% of states are providing the Centers for Disease Control and Prevention with line item reporting on specific types of tests run, Giroir said. The BinaxNOW test comes with an app that automatically reports to HHS. 

“There is no one simple metric because this is not a simple disease. There are a number of factors that we look at,” Giroir said about testing distribution, adding that the White House Coronavirus Task Force looks at trends and shares data with states. “We give  recommendations based on the best information we have from a variety of lenses.”

Although there was a downtick in testing a few weeks ago, he said, the level is back up to between 830,000 and 860,000 tests per day, with the capacity to do much more. In low-prevalence areas, facilities are doing baseline surveillance, symptomatic testing and contact tracing, he said. In hot spots — what he called federal surge sites — up to 5,000 tests are being run each day.

“We’re being very focused in particular ZIP codes of the underserved, multigenerational families” and historically black colleges, Giroir said. 

The HHS official said his job is to increase capacity in types of tests, including point-of-care and highly sensitive lab tests. Three million next-generation sequencing diagnostic tests were used this month, he said, adding that he anticipates growth in point-of-care testing, both molecular and antigen, being conducted. 

In June, the U.S. Food and Drug Administration issued an emergency use authorization to Illumina for the first COVID-19 diagnostic test using next-generation sequence technology. Next-generation sequencing can generate information about the genomic sequence of the virus present in a sample, which can be used in research.

The only way to “get the country back to normal,” Giroir said, is through testing, universal mask-wearing, social distancing and following good hand hygiene practices. 

“Recommended public health practices like wearing a mask, avoiding crowds, especially indoors, and washing your hands combined with smart testing is really the formula to effectively slow the spread, flatten the curve and save lives,” Giroir said. “That’s where we really need to go as we ramp up specific programs, like protecting the elderly and opening up America, primarily through our infrastructure and K-12 schools.”

The federal government used three tools available under the Defense Production Act, including prioritizing point-of-care device production from Becton Dickinson and Quiddel to push out testing to nursing homes, investing in diagnostic testing, and extensive distribution of personal protective equipment, he said.

“We’re doing everything we can to increase numbers of tests as maximally as possible,” Giroir said. “The subtext to that is we are making sure that our investments are in multiple different pools.”

E25Bio, he said, is working through technical and scientific matters to become an authorized manufacturer of rapid diagnostic COVID-19 tests. The company is backed by MIT scientists to introduce an accurate, affordable and fast testing solution, Giroir said.

In other coronavirus-related news:

  • The Missouri Department of Health and Senior Services issued new guidance Tuesday allowing residential care, assisted living, intermediate care, skilled nursing and intermediate care facilities to offer outdoor and indoor visitation. Facilities must be COVID-free for 14 days. The guidance also provides information on “essential caregivers’ ‘ for each resident. The guidelines are called “suggestions,” leaving it up to facilities to decide if they will follow it. 
  • New York Gov. Andrew Cuomo announced the state would review coronavirus vaccines approved by the federal government, saying “Unfortunately, we can no longer trust the federal government.” State officials have no role in the vaccine approval process, but under the current play they would help determine how it would be distributed throughout the state. Officials could delay distribution if they believed the vaccine was not safe.
  • Indiana state leaders announced that the state will move to Stage 5 of its reopening plan for COVID-19. Under Stage 5, assisted living facilities and nursing homes are required to provide visitation opportunities. 
  • Indoor in-person visits resumed Friday at Massachusetts’ long-term care facilities, including nursing homes, rest homes and assisted living. Visitors must wear masks, be screened for symptoms and practice social distancing. Visits can only take place if the facility has proper staffing and no COVID-19 cases in the last 14 days.  Assisted living residences were previously able to resume indoor, in-unit visitation, and can now also resume indoor visitation in a designated shared space.
  • Pennsylvania has expanded its COVID-19 testing. Asymptomatic assisted living and personal care home residents and workers are in Tier 2.
  • Arizona Secretary of State Katie Hobbs and Gov. Doug Ducey are arguing over last-minute voting changes intended to help assisted living residents vote amid visitation restrictions. One county has proposed sending iPads into facilities, with a member of each political party outside to assist residents. The governor, however, said, “the only way we can ensure the integrity of our election system is to refrain from changes in the middle of an election cycle. This isn’t the time to experiment,” reports Senior living community leaders told the media outlet that they can assist residents as they have in the past.
  • New guidelines for COVID-19 testing and visitation in assisted living, personal care and group homes in Pennsylvania appears to be the same as ones issued for skilled nursing facilities, reports. “The new guidance includes a compassionate caregiver designation, which provides special visitor status to a family member or friend of a resident under specific circumstances,” the media outlet said, adding that the guidelines also cover screening and surveillance testing of residents and staff members, expanded visitation policies and more detailed steps for when current restrictions in communities can be lifted.