Asked Wednesday why the state of Virginia couldn’t have contracted with private labs to boost testing capacity, former Health Commissioner Dr. Karen Remley — recently announced as co-director of Gov. Ralph Northam’s new testing task force — said that none were ready at the time when the state needed them most.
“One could have — but those labs were not available to test,” she said. “Four or five weeks ago, everybody was struggling to bring up their laboratories.”
But CEO Bill Miller of Genetworx, a diagnostic lab in Glen Allen, said he approached the Virginia Department of Health in late March with the possibility of taking on some of the state’s testing. A molecular diagnostic center, Genetwork received FDA approval for its COVID-19 test on March 23 and quickly segued to testing patients at Canterbury Rehabilitation and Healthcare in Henrico, a hard-hit nursing home with one of the deadliest coronavirus outbreaks in the United States.
Over the past month, Miller said he’s taken on more cases for Hanover and Henrico counties, as well as the Virginia Department of Corrections. Genetworx has performed testing for other states, including Florida, Massachusetts, and Tennessee. But VDH didn’t take him up on the offer, Miller said.
“We’ve talked to the state,” he added. “We’ve given them our numbers. We could be running a number of tests for them, but we haven’t been assigned, ‘Here’s 10,000 samples per day.’”
At the time, the state lab in Richmond had just recently announced it could test approximately 1,000 people for COVID-19 — a number that experts agreed wasn’t nearly enough. Testing has remained an ongoing struggle in Virginia, even as Northam begins to contemplate lifting social distancing restrictions.
A recent analysis by The Virginian-Pilot ranked Virginia’s testing rate lower than nearly every other state other than Kansas and Arizona. The Johns Hopkins University Coronavirus Resource Center shows that the number of tests administered in Virginia trails nearby states — including Pennsylvania, North Carolina, Maryland, and Tennessee — by several thousand.
Across the country, states have struggled with widespread shortages of testing materials and personal protective equipment, an ongoing challenge when it comes to boosting the rate of testing. But Virginia has appeared uniquely unable to overcome those barriers.
Interviews with state health officials indicate that a sluggish response to testing shortfalls, combined with a continued lack of medical equipment, has stymied efforts to adequately track the spread of the virus. For weeks, large commercial lab companies such as Quest and LabCorp — responsible for the vast majority of testing in Virginia — struggled with backlogs and often more than week-long turnaround times for results.
While the state lab in Richmond has gradually boosted its capacity to about 450 tests a day, its output remains lower than those in other states. In Tennessee, for instance, the public health lab is capable of running approximately 1,000 tests a day, and expects its output to “increase significantly in the coming weeks as we bring on an additional high-throughput assay,” according to Shelley Walker, the director of communications for the Tennessee Department of Health.
In Virginia, there are also days when the state lab tests fewer samples than its capacity allows. Director Denise Toney said staff can only test patients who have been approved by VDH. But the agency didn’t significantly loosen its testing criteria until April 17, limiting the number of samples sent to the lab.
Doctors say the restrictive guidelines were mirrored by many hospital systems, reducing the overall availability of tests. At the same time, personal protective equipment and testing materials — the swabs and transport media needed to sample patients — have been a continued concern, especially for doctors practicing outside large hospitals and health systems.
Dr. Sandy Chung, a Northern Virginia-based pediatrician and president of the Virginia chapter of the American Academy of Pediatrics, said her orders of protective equipment are often taking three to four weeks to arrive. The state’s supply, distributed by the Virginia Emergency Support Team and six regional healthcare coalitions, is largely routed to hospitals, nursing homes, and other health centers.
“Those are being distributed first to facilities,” Chung said. “And rightly so. But then what happens is the primary care providers have no way to get PPE. Especially if they’re not affiliated with a hospital or health system — we don’t have a supply chain to reach out to.”
Those combined factors have made it difficult for doctors to test their patients, limiting the surveillance that Northam has cited as vital to reopening Virginia.
Slow rollout of coordinated testing response
By mid-March, state health officials had formed an ad hoc work group with physicians and hospitals to discuss COVID-19 testing in Virginia, said Michael Keatts, a regional emergency coordinator with VDH’s Office of Emergency Preparedness. He joined in the third week of March to develop a guide for drive-through testing sites, pulling from the state’s previous planning for pandemic influenza.
While the work group discussed the testing issue in phone calls and meetings multiple times a week, Keatts said members weren’t working toward a specific objective. “A lot of those calls were more information sharing,” he added. That didn’t change until more than a month later on April 20, when Northam announced the formation of his testing task force — helmed by Remley and state epidemiologist Dr. Lilian Peake.
A few days later, he set a concrete goal of testing 10,000 Virginians a day in order to reopen the state. Keatts said the task force, along with clearly defined goals, would make it easier to delineate tasks and tackle different aspects of testing, from education and outreach to assessing the variety of new diagnostic tools, such as antibody tests, coming on the market.
“I think it’s going to organize a lot of current pieces and align our efforts more effectively,” he said. “We want to be all in sync and have clear objectives, so how do we work together to achieve those objectives. Like, we have a target testing number — how can we collectively achieve that?”
It’s still unclear how exactly those new objectives will be achieved. In a phone interview on Monday, Remley said one of her goals was to increase outreach and education, encouraging more doctors to test patients through commercial labs as their turnaround times decrease. But she declined to specify other recommendations, saying Northam would discuss testing further in a press conference at the end of the week.
The state has also declined to release its contract with McKinsey, a global consulting firm brought on in early April to secure more testing supplies and protective equipment. The Virginia Department of Emergency Management wrote Tuesday that it would require an additional seven days to respond to a Freedom of Information Act request for the contract.
Performing 10,000 tests a day would be a significant increase for the state. As of Thursday, Virginia had received a total of 90,843 results encompassing a roughly month-and-a-half period. The state lab can currently perform between 400 and 500 tests a day, but Director Dr. Denise Toney said she generally saves a certain number of “buffer” tests in case there’s an outbreak in a specific area or facility.
Keatts said that roughly 70 to 75 percent of testing in Virginia is done through private labs, but officials are still putting together a survey of capacity at commercial labs and university systems.
Heavy dependence on large commercial labs also slowed the rollout of testing in Virginia. While some smaller labs said their free capacity went unused through late March and much of April, doctors and hospitals reported significant delays in the turnaround time for test results from the nationwide labs handling most of the tests.
“Instead of two to four days, they were sometimes looking at 10 days or more,” Keatts said. “This is really problematic for people admitted to the hospital, because until COVID-19 is ruled out, they’re using a lot of PPE to treat those patients.”
The delays also impacted efforts at the state level. Keatts credited the work group with facilitating the flow of information between public and private health experts, including knowledge of the delays at private labs. As a result, VDH stopped emphasizing community testing events, including drive-through clinics and county-level efforts.
“Why push broad-scale testing when we had a group that wasn’t getting their test results quick?” he said. “We didn’t want to further aggravate that system.”
Resource shortages continue to play a role
Virginia, like many other states, has also faced challenges in securing supplies and other assistance from the federal government. Both Remley and Keatts pointed out that other states have opened “community-based testing sites” bolstered by resources from the Federal Emergency Management Agency.
For the first critical weeks of the pandemic, Virginia was also receiving a fraction of the medical equipment it requested from FEMA, including protective gear and swabs. Consistency has been an issue with many shipments from the federal government, Toney said. Earlier this month, the state received and distributed 15 COVID-19 rapid tests to hospitals across the state. But they came with a limited supply of the cartridges needed to run the test.
Toney said the state just received a second order of 30 cartridge kits — enough to test a total of 720 patients. The lab also has to separately order control kits, which are required to validate and run the testing instruments.
“That’s the problem we’re having now,” she said. “We’re ordering the controls and the test kits from the [Centers for Disease Control and Prevention], and they do not have adequate supplies of control kits.”
The state lab ordered 50 controls and received seven, Toney added.
Chung emphasized that there have been several positive developments when it comes to testing. Over the past two to three weeks, private labs have dramatically shortened their turnaround time for test results, often to as little as 48 hours. On Monday and Wednesday, Northam announced that Virginia had received additional test swabs from FEMA, for a total of 214,000.
The state also received its first order of personal protective equipment from Northfield Medical Manufacturing, a Norfolk-based logistics company, in late April — part of an ongoing contract to secure more supplies. What’s still unclear is how frequently those shipments will be delivered and how long the equipment will last.
The state’s current ban on non-emergency elective procedures — implemented to preserve a limited supply of protective equipment — ends Friday. And with many primary care physicians still unable to secure masks, gowns, and gloves, Chung said most are still reluctant to administer the tests, which require taking swabs of a patient’s nose and throat.
“There’s a big risk for exposure there,” she added. “And most of us are using the same N95 masks every day. So, if you want widespread testing, you need enough PPE so physicians can discard it when it gets dirty.”
The same shortages apply to swabs and viral transport media, used to stabilize the samples en route to testing facilities. Dr. Greg Gelburd, a family medicine physician in Charlottesville, said his office depends on LabCorp for test kits. Currently, they’re able to use about five a week.
“Basically, they gave us 30 at the beginning of April and said ‘Good luck,’” he said. UVA Health developed an in-house testing system weeks ago, but Gelburd said they’re still selective in sampling patients.
“I’d say four out of five patients, they won’t screen,” he said. Both UVA and VCU have assisted with testing efforts in other capacities, including point prevalence screening at congregate facilities such as state prisons, according to Toney. But for primary care providers, state and university testing remains widely out of reach.
Without surveillance testing, Gelburd and Chung said there’s no way to safely lift social distancing restrictions. Over the past month, Gelburd said his office has clinically diagnosed at least 25 patients with COVID-19 who haven’t been able to have their results confirmed with a laboratory test. The shortage in testing is even more acute in other areas of the state, particularly rural health districts.
Mount Rogers, for instance, has received a total of 1,330 results — about 0.6 percent of its total population, according to Breanne Forbes Hubbard, the district’s population health manager.
The district has been working to increase the number of tests as availability expands, she said. The local health department has five drive-through clinics in the next two weeks, with enough supplies to test 250 residents. The Richmond and Henrico Health Districts recently launched free COVID-19 test clinics in underserved communities as part of a pilot program to improve health equity.
While capacity is improving, district director Dr. Danny Avula said the testing rate still wasn’t enough to fully understand how extensively the disease is spreading through the community. More importantly, he said, Virginia still doesn’t have the ability to routinely screen health care workers, or conduct extensive contact tracing if there’s a significant increase in COVID-19 cases.
If businesses reopen in the next few weeks, the rate of transmission is certain to rise, he added. And if cases spike, Avula said his district doesn’t have the capacity to test known contacts of positive cases and then isolate those patients if they test positive — a crucial step to containing further outbreaks.
“Right now, we’re getting about 30 new cases a day, and we do have the ability — from a contact tracing standpoint — to get in touch with their contacts and follow up with testing,” he added. “But that number will undoubtedly go up. And if our average number of cases goes from 30 to 50 to 100, we won’t have the staffing, right now, to be able to effectively contact trace. And I don’t know if our supply of test kits will support that degree of follow-up.”