For COVID-19 Testing to Succeed in Nursing Homes, Lab Access is Critical — But Capacity Hard to Define

Test.

Test.

Test.

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That has been the mantra since the earliest days of the COVID-19 pandemic, the flashpoint of criticism over the early efforts of Centers for Disease Control and Prevention (CDC), and the call from multiple skilled nursing operators and experts. To contain the pandemic and stem its impact on nursing homes across the country, fast and reliable testing for staffers and residents is not an option — it’s a necessity.

In fact, the Centers for Medicare & Medicaid Services (CMS) strongly recommended that nursing homes secure COVID-19 testing for staff and residents before relaxing restrictions on visitors and moving through reopening. Specifically, the agency called for baseline tests of residents and staff to establish that there are no known cases, and then to follow up with screening and weekly testing of staff, with further testing of residents as necessary, according to administrator Seema Verma.

But the guidance for reopening largely left it to states to determine how to proceed. Both Verma and CDC director Robert Redfield called on states to take the lead on testing for COVID-19 in the nursing home setting, describing it as “absolutely imperative” that states develop a comprehensive testing plan and submit that to the Department of Health and Human Services (HHS) in a May 31 letter to governors.

Several states have taken steps to implement testing plans, as NPR reported in mid-May and the Washington Post covered on June 10. But without clear federal guidance and resources, the COVID-19 pandemic will continue to take a devastating toll, as Dr. David Grabowski of Harvard Medical School testified at a recent House of Representatives video briefing.

“Much of the negative impact of COVID in nursing homes could have been avoided,” he told the elect Subcommittee on the Coronavirus Crisis on June 11. “However, rather than prioritizing the safety of the 1.3 million individuals who live in nursing homes and the staff that care for them, we failed to invest in testing, PPE and the workforce.”

One of the most important aspects of any testing plan is the ability of states to pull it off, especially in a time where quantities of swabs, supplies, and the personal protective equipment (PPE) needed to conduct the testing can be extremely short. A key aspect of that is capacity, the amount of tests a state can process.

That’s evident from one of the earliest states to take a stand on COVID-19: Maryland. The Old Line State issued an order for testing among the residents, patients, and staff of skilled nursing and rehabilitation centers on April 29. But at that time, the U.S. and the state were both facing limited testing capacity, Joe DeMattos, the president and CEO of the Health Facilities Association of Maryland (HFAM), told Skilled Nursing News on June 2.

The HFAM is the local affiliate of the American Health Care Association (AHCA), a national trade group for nursing homes.

While the state was “ahead of the curve on testing kits,” many states, including Maryland, struggled with swabs and lab capacity, he explained. So what set the state’s April 29 mandate apart was that Maryland “assisted nursing homes in a very intentional way” by setting aside test kits — and laboratory capacity.

“Certainly the cost of testing is important,” DeMattos told SNN. “But perhaps equally important, as important are two other things. One is the continued supply of the test swabs, and most importantly the lab capacity.”

Defining testing capacity

Providers across the country have reported challenges in securing testing for their residents and staff. Nursing home giant HCR ManorCare reported at the start of May that it was struggling to find enough kits; one nursing home CEO in New York City said the facility was “100% on our own” when it came to securing tests.

The federal government has made multiple calls to prioritize nursing homes for testing, though actual mandates to do so have come from states. CMS, for its part, did take some steps to try to increase laboratory capacity as a means of boosting testing in nursing homes, doubling the payment rate for COVID-19 tests processed with high-throughput technology in mid-April and allowing lab companies to receive reimbursement for tests conducted at nursing homes.

At least according to comments from Verma, the issue was not so much that states could not supply tests as much that there was not enough demand.

“I think that a lot of what we’re hearing is that the states have had some untapped capacity,” she said in a call with reporters in May. “In some of the calls that we’ve had with governors, we’ve even heard them say: ‘It’s not a supply issue. It’s a demand issue.’”

But early reports from one state that set a high testing bar seemed to run counter to that idea. When New York set a mandate for testing nursing home staff twice a week — a mandate that was eased on June 11 because of the success of the order, according to state health commissioner Dr. Howard Zucker — local media reported delays of several weeks.

It’s an issue that Oklahoma, a state with a very different level of COVID-19 cases from New York, ran into as well.

The state announced a push to test all nursing home staff and residents through the month of May, The Oklahoman reported on April 28. Multiple nursing homes in the state had testing conducted in their facilities soon after, using a saliva-based test that the Oklahoma AHCA affiliate, Care Providers Oklahoma, had requested because it was easier for residents than a nasopharyngeal swab, the organization’s president and CEO Steven Buck told SNN on June 4.

But then those nursing homes heard nothing from the lab the state had contracted with to do the testing — a facility based in Lubbock, Texas — for days.

“Apparently they had some malfunctions of machines. They had staffing issues,” Dan Stiles, the administrator of the Dunaway Manor Nursing Home in Guymon, Okla., told SNN on May 27. “As it went on and on, it became very apparent that even if we got the results, they weren’t going to be a true indication of what happened.”

As a result, the senior living community, which includes the 77-bed SNF as well 25 assisted living and 15 memory care apartments, had to do a second round of testing on May 12, with nasopharyngeal swab tests — “the tip of your brain one,” Stiles told SNN. The early results came in on May 15; all the results came in by May 19.

Getting test results back in a timely manner is crucial to any testing strategy. PruittHealth, which operates in the Southeast part of the U.S., emphasized the importance of speed when vetting laboratories when it worked to secure its own testing partners. Getting the results fast is crucial to containing the spread of COVID-19, especially given the dangers of asymptomatic or pre-symptomatic carriers.

But it’s not clear how CMS is defining “lab capacity” when it uses the term. A spokesperson for CMS told SNN on May 28 that the Clinical Laboratory Improvement Amendments law (CLIA) requires that only CMS-certified labs meeting certain quality and safety criteria can perform COVID-19 testing; requiring CLIA certification helps ensure accurate and reliable results, according to the government.

“CMS focuses on a laboratory’s overall performance, such as ensuring that laboratory personnel have the appropriate training, conduct the appropriate performance assessments, properly handle specimens, and report results in a timely manner,” the spokesperson wrote. “CMS CLIA is not responsible for defining laboratory capacity, nor do we measure or determine this for laboratories.”

A follow-up question from SNN about the source of CMS’s definition of testing capacity was not answered as of press time.

Oklahoma has recovered from its initial speed bumps in testing, Stiles and Buck indicated.

One of the labs that helped step up with capacity, for a brief period, to process long-term care tests was the Oklahoma State University diagnostic lab, which added CLIA certification to its existing animal-disease testing capabilities to help accelerate COVID-19 testing.

The lab has a capacity of about 1,200 to 1,400 tests per day; some days it receives more tests than that, while others it receives less, Dr. Kenneth Sewell, vice president for research at OSU, told SNN.

But defining lab capacity is not quite as simple as it might sound, he told SNN.

“It’s not a strange question at all,” Sewell said. “How we, at the state level, are trying to define it is: Assuming you have enough human resources, and assume you have enough consumable supplies. What could your lab process, in a day, of COVID-19 specimens? … What can the physical lab actually do?”

Another way lab capacity could be defined, according to Sewell, is: How many tests could be done today if specimens arrive at the door of a lab? That calculus involves having the supplies on hand and the people to do the tests.

“Sometimes you see these numbers being thrown around, and some of the private labs will report capacity numbers that look absolutely astronomical, because they have a huge amount of equipment and they have the technology to do huge numbers,” he said. “But that doesn’t mean they have the testing supplies.”

Even the fact that the OSU lab is able to process tests highlights how murky lab capacity can get. Adding the ability to test for human diseases to the existing animal disease lab took about 13 days, which led to a significant addition of lab capacity for the state, Sewell noted. But prior to March 31, the lab had not performed a human diagnostic test, though he added that this did not mean the work performed was in any way lesser, given that the equipment used is identical.

In Colorado, a major testing initiative for staffers in nursing homes got its start in a research lab, working in tandem with a CLIA lab. But that lab, at Colorado State University, had the right biosafety level to conduct the research, as well as the personnel.

“It’s not quite as simple as reaching out to a research lab,”Dr. Nicole Ehrhart, director of the Columbine Health Systems Center for Healthy Aging at CSU told SNN on May 18.

‘If they were entirely dedicated to COVID-19 testing’

The strategic testing plan announced at the end of May by HHS included a table with initial testing targets for the U.S. for the month of May and June, alongside data provided by states. While this plan applied to the U.S. as a whole, and not the long-term care population and ecosystem, the structure does still contain some definitions of sorts for how HHS set its targets.

Specifically, the government “determined the number and type of high and low throughput laboratory platforms in each State, including their total capacity to perform COVID-19 tests if utilized to 100 percent capacity,” with each governor receiving location, instrument type, and the actual utilization of that instrument when possible.

“The total capacity of these machines exceeds 200 million tests per month, if they were entirely dedicated to COVID-19 testing,” the HHS report said. “As a result of this analysis, it was determined that each State had capacity to meet its testing goals internally, although four States did not have excess capacity and would likely require outside assistance.”

HHS is the department under which CMS operates, but it is not clear if CMS was using the same parameters when talking about lab capacity for SNF testing.

How states are approaching the issue of testing in SNFs varies considerably. The state of Oklahoma, for instance, is procuring the tests for nursing homes, Stiles told SNN on May 27, and Buck indicated that at least in terms of what he hears from providers, the state has made improvements in conducting testing.

But Stiles noted that while Oklahoma has taken on this responsibility, he’s heard from other administrators across the country, particularly on the East Coast, that SNFs seem to be expected to procure their own testing.

Pennsylvania appears to be taking this approach. SNFs have to complete a baseline universal COVID-19 test for all residents and staff no later than July 24, according to requirements dated June 8.

“In order to be compliant with this Order, a facility needs to enter into a contract with a commercial laboratory to meet testing needs of the facility,” the June 8 order, downloaded by SNN on June 9, said. “A laboratory must have a current Pennsylvania laboratory permit and be approved to perform COVID-19 testing … If timely commercial testing is not available, the State laboratory may be used as a last resort if needed to comply with this Order.”

An update originally issued May 29 from the Department of Health, and updated with corrected contact information on June 1, defines testing or tests as “laboratory tests that detect SARS-COV-2, the virus that causes COVID-19, using reverse transcription polymerase chain reaction (RT-PCR) testing.”

Tests need to come back in one to two days to be considered timely, according to that document. It includes a section on creating a plan for testing logistics, with several questions, including which laboratory would provide collection materials and process specimens.

“While testing can be completed at the state public health laboratory where timely commercial testing is not available, the large scope of the pandemic will require most facilities to use their own resources to obtain testing results more rapidly,” the update said.

Pennsylvania has roughly 700 nursing homes, according to the state, and it’s home to the headquarters of one of the largest nursing home chains in the country, Genesis HealthCare. The Kennett Square, Pa.-based operator, which has hundreds of facilities in multiple states, told SNN that from the perspective of the entire company, that while things had improved by mid-May, testing is not where it needs to be.

“Turnaround times are still — unless you’re in one of these more aggressive testing environments like West Virginia or Massachusetts — well, well north of two days,” Genesis CEO George Hager told SNN on May 11.

In Illinois, long-term care facilities are responsible for ensuring testing as part of their existing infection control policies and procedures, according to a May 28 emergency rule adopted in response to COVID-19.

The Illinois Department of Public Health (IDPH) entered into an agreement with Quest Diagnostics on May 1, with the goal of providing 3,000 tests per day to long-term care facilities that will accept test kits or request them, a spokesperson for the IDPH told SNN.

“IDPH continues to work with long-term care facilities, Quest, and nursing teams to increase the number of facilities and specimen collected for residents and staff,” the spokesperson wrote in an email on June 8. “The State lab initially provided testing and still does for facilities experiencing outbreaks.”

Illinois’ state lab has provided 69,030 testing kits to 217 facilities, while Quest sent more than 9,000 to 39 facilities; some of the 9,000 were returned because the SNFs were able to get supplies from other labs, according to the spokesperson.

Back in Maryland, all nursing home residents, staff and patients were tested from April 29 to May 29, DeMattos told SNN on June 2. The state used the National Guard to help its testing mandates, which was “a huge value-add,” since the Guard would provide the appropriate number of kits and specific instructions on getting those kits to the designated lab once the SNF had collected the samples.

“So there was no issue of: Which lab is the right place for this sample?'” DeMattos told SNN.

That’s especially important because not all labs can process all kinds of tests; specific calibration is needed, as OSU’s work to add CLIA certification indicates. The state has significantly grown and increased its lab capacity, but more work still has to be done to integrate and increase the coordinated daily use of both public and private lab capacity, DeMattos explained.

“We have significantly increased lab capacity across the country during this crisis,” he told SNN. “But some of that lab capacity is purely private, and some of it is purely federal, and some of it is purely state, and some of it’s purely local. And they’re not all calibrated, on any given day, to run the same tests, if different test kits are being used by different by different, let’s say, manufacturers.”

That makes integrated lab capacity across the country and by state all the more essential, as is the coordination of lab use, he said.

It’s why multiple experts have called for federal resources and support for testing. Without it, the guidance from CMS to test staff weekly is “hollow,” Grabowski told SNN on May 20.

And SNFs are looking to CMS for answers. When SNN spoke with Stiles, in Oklahoma, he was due for another round of testing on May 28 with the National Guard, which was likely to be the last test unless any issues surfaced — or until the state reached the point of opening up nursing homes to visitors.

On June 12, Gov. Kevin Stitt issued an executive order indicating that starting June 15, “visitation, outings, group meals and communal dining” could occur in accordance with guidance from the state Department of Health and the CDC.

“When visitation opens, then we’re probably going to see more testing take place,” Stiles told SNN on May 27. “I think everybody’s waiting for guidelines from CMS.”