A graduate student in Florida waited 11 days. Positive. A 14-year-old in California waited 24 days. Negative. A writer in New York has waited for four days—and is still waiting.
As the United States struggles to control the COVID-19 pandemic, people across the country are using Twitter to announce the arrival of their virus test results. The point of these tweets is not just to broadcast the result itself, but to point out the absurdity of receiving a result so stale that it’s almost completely useless from a public health standpoint.
Social media posts from July and August make clear a frustrating reality: some Americans are getting their results in mere hours, while others are waiting days, even weeks. To illustrate the problem, TIME set out to create a map showing average test result wait times across the country. What we found instead was that wait times are not just a product of geography, but also of a messy, disparate system of labs and agencies all grappling with supply shortages, logistical challenges, and a lack of federal guidance. The chaos is all but impossible to neatly map and track—but what we learned along the way sheds light on a fundamentally broken system that’s hampering the country’s ability to effectively respond to the pandemic.
When a person gets tested for COVID-19 in the U.S., it’s not always obvious where their saliva sample or nasal swab will end up. Of the more than 700,000 samples taken daily, about half are routed to hospital labs, university labs and public laboratories. The other half are sent to 12 major commercial laboratories, including Quest Diagnostics, LabCorp and Aegis Sciences Corp, which have numerous facilities around the country that serve specific states or regions.
Early in the pandemic, tests were sent from hospitals to the U.S. Centers for Disease Control and Prevention and other public labs, which serve as the first line of defense when there’s an outbreak. But public labs run small operations and cannot handle the type of mass testing that’s required in this pandemic. As the Federal government pushed for more testing and launched drive-through community-based test sites, commercial labs were in an optimal position to jump in. They already had existing business relationships with pharmacies and other retailers that operate the sites, as well as with the hospitals, doctor’s offices, and clinics that lacked their own labs. More than 30 million COVID-19 samples have passed through commercial labs since the federal government began allowing them to do that work on Feb. 29.
But the system as a whole wasn’t ready for such an unprecedented ramp-up. Addressing the shortages of nasal swabs, reagents, trained lab personnel, and testing machines has been a game of whack-a-mole. If supplies can’t be delivered, a lab that’s already receiving as many tests as it can handle will inevitably fall behind. Labs across the country can’t order supplies fast enough and manufacturers can’t make them fast enough.
“It’s The Hunger Games for laboratories,” says Rachael Liesman, director of clinical microbiology at the University of Kansas Hospital. “If we get our supplies, then we can operate, and if we can’t, it grinds to a halt.”
Furthermore, U.S. labs are not set up to easily collaborate, making it hard to predict where the next bottleneck is going to pop up. Nada Sanders, professor of supply chain management at Northeastern University, says that without a national, authoritative body to oversee all the moving parts, every stage of the U.S. testing system, including the testing sites, the labs and the manufacturers, will continue to be overwhelmed.
“It’s extraordinarily uncoordinated,” says Sanders. “We completely left it up to the open markets. When we talk about public health, that’s not something you leave to the forces of the free market.”
The Federal Emergency Management Agency (FEMA) is working with states in an attempt to allocate resources as needed. But because the national stockpiles have run dry, FEMA is buying supplies from the same vendors as the labs, creating extra competition for those resources. FEMA sends supplies it receives to the states, which then send them to the labs. But health policy experts and lab directors interviewed by TIME say it’s unclear how many supplies FEMA is procuring and how the states are distributing them.
That haphazard system has led to the nationwide delays we’re currently grappling with. In mid-July, only 37% of tests across the country came back in one or two days, according to a recent report from researchers at Northeastern, Harvard, Rutgers and Northwestern Universities. As for the remaining tests, 21% took three days, 29% took four to seven days and the remaining 13% took more than a week.
Data from the Department of Health and Human Services also show delays. In the month of July, only 45% of lab tests were completed in three days or fewer. Turnaround time began to improve in the last week of July, with 56% of tests completed within three days. But times vary by lab, which explains why people in the same region are experiencing different wait times: a person who gets tested at a medical facility working with a hospital lab is simply in a different queue than a person who goes to a chain pharmacy working with a commercial lab.
The shortage of testing equipment has left lab directors scrambling. “The supply chain for diagnostic manufacturers can’t keep up with the demand,” says David Dexter, chief executive and president of Sonora Quest Laboratories, a joint venture between Banner Health and Quest Diagnostics. The company’s five locations in Arizona collectively conduct 70% of the COVID-19 testing in the state. “We don’t want to be out seven to 10 days. That’s unacceptable to us.”
What happened to Sonora Quest demonstrates the fragility of the system. Back in April, when stay-at-home orders were still in place and testing was reserved for inpatients and health-care workers, demand was relatively low; the company only received about 1,000 tests a day that month. Dexter lobbied the state’s health department to expand testing to more patients, such as those in long-term care facilities, knowing his labs could support the load.
Then, on May 15, Arizona ended its stay-at-home order. The number of cases soared from about 40,000 to 100,000 over the July 4th weekend. During that same period, the positivity rate jumped from 6% to 23%. At its peak in early July, Sonora Quest was receiving 14,000 samples a day, when its capacity was 10,600. The company needed more supplies, but Sonora’s three vendors were already stretched thin. Making matters worse, Sonora’s reagent supply was reduced to 6,000 tests a day—possibly a result of FEMA allocating the nation’s supply of reagents to hotspots around the country.
Sonora attempted to offload tests to Quest labs in other states, but they were already at capacity. Labs on the east coast, not affiliated with Quest, offered to take about 1,000 tests, but Dexter says that wouldn’t have made a dent in Sonora’s backlog, especially because it would take time to make the labs’ back-end technology systems compatible with each other.
The challenges Sonora faced during this period are still haunting the company. On August 5, the state sent Sonora a cease and desist letter for failing to disclose accurate turnaround times to consumers and health care providers. The letter indicates, however, that “the situation seems to be improving.” Sonora says it has provided accurate information about its turnaround times but declined to comment further on the letter.
Sonora Quest isn’t unique. In addition to competing for tests and supplies, labs across the country are also competing for market share and money. In May, the New York Times reported on a number of smaller labs that were operating under capacity while large labs were reaching their limits. “Large companies are not going to just say, ‘We have extra business, we’ll send it over to you,’” says Sanders, the supply-chain expert.
Even if labs had a way to distribute the load more evenly without losing revenue, other hurdles stand in the way. For instance, whenever a lab uses new equipment—say, a different type of swab or reagent—it has to prove that the results are reliable. Since the supply shortages started, labs have diversified their testing tools because their usual vendors are swamped. The upshot is that variations in supplies make it much harder to collaborate without introducing more regulatory slowdowns. (Also, as Dexter’s experience shows, labs’ systems are designed to communicate with their typical clients, like doctor’s offices and pharmacies, not necessarily with each other.)
Some labs, like the University of Kansas Hospital where Liesman works, are trying to collaborate using their existing technology. When her lab receives tests from hospitals that have different patient-tracking tools, employees at both hospitals have to enter all the information manually. This allows COVID-19 samples to get shared around, but it also slows everything down at a time when labs are racing against the clock. “The pandemic has revealed a lot of weaknesses in the system,” says Liesman. “It’s a nightmare from a lab perspective.”
Alarmingly, testing issues have become so severe across the U.S. that people are simply not getting tested, likely out of frustration with delays. In the first week of August, when 50,000 new cases were being reported nationwide each day, testing demand in the U.S. actually fell 9.1%, the equivalent of about half a million tests, from the week earlier. That marked the first decline in demand since early March, according to the COVID Tracking Project. Some of the drop can be attributed to Hurricane Isaias, which forced some state officials in the Southeast to temporarily close testing sites. But the bulk can only be blamed on a failing system. California, for instance, has been hampered by unreliable computer systems that report the state’s results. And several states, in an effort to clear the backlog, have put restrictions on who can get tested. The rules often exclude asymptomatic people to reduce the overall number of tests coming in—but, given that as much as 40% of COVID-19 cases are asymptomatic, failing to test people who seem healthy risks missing a huge number of cases.
In Arizona, Dexter says Sonora Labs is now ready for more samples, but they just aren’t showing up in the same quantities—the company is receiving 60% fewer tests from its peak a month ago. “That’s a function of the fact that people waited in line for 13 hours in really high heat and then they don’t get a result for 7 to 10 days,” says Dexter. “People don’t want to go through that.”
None of this bodes well for containment efforts. Widespread testing, including testing of asymptomatic people, is crucial to curbing infection rates. But testing is only useful when results are available in one or two days, according to July 16 study by researchers at universities in the Netherlands, the U.K and Portugal. The results, published in The Lancet, found that complementary virus-control efforts, like contact tracing and containment, become far less effective after three days of delayed test results.
If the U.S. backlog is a result of a patchwork system, it shouldn’t be surprising that many solutions look like administrative duct tape. Last week, a group of seven states banded together to implement a new testing strategy altogether. The bipartisan agreement, spearheaded by the governor of Maryland and joined by the governors of Virginia, Louisiana, Massachusetts, Michigan, North Carolina and Ohio, will allow the states to jointly purchase rapid coronavirus testing kits. These tests take about 20 minutes to process, which means that much larger swaths of the population can get immediate results. The downside to these tests is that they are less accurate. But experts have reasoned that identifying even just 50% of cases from the whole population is better than the roughly 10% of cases likely being identified in the current process.
For its part, Sonora Quest in Arizona spent $10 million on new equipment from Euroimmun, a German supplier, and hired and trained 200 employees—investments that Dexter hopes will allow Sorona to dodge some of the constraints in the U.S. supply system. He says that, by the end of this month, Sonora will be capable of processing 60,000 COVID-19 tests a day—a sixfold increase. He’s also optimistic that he’ll be able to collaborate with Quest labs serving hotspot regions that are still dealing with backlogs of their own.
“This was a risk but I had to do it,” says Dexter. “The only way out was to dig ourselves out.”
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Contributor: Emily Barone