'States duking it out for supply': Lack of federal plan leads to coronavirus testing delays
Cris Julian and son Ethan emerged Friday from their two-week coronavirus quarantines in New London, Iowa.
It took less time to wait it out than it did to get their results back. As of Friday night, they were still waiting.
Youngest son Alexander was tested at the same time but got his positive test results back within 48 hours. He was exposed by another student during an open gym workout at his school. Because the state lab was closed July 3, Julian's doctor's office sent the tests to Quest Diagnostics.
The Centers for Disease Control and Prevention said COVID-19's incubation period is up to 14 days, so Julian said that means her test is "worthless now."
"We will never stop the spread if we can’t get reliable and timely results," Julian said.
She wants the federal government to provide incentives for labs to provide a faster turnaround, and some leading public health experts agree. They said the Trump administration needs a national strategy for testing and a way to prod, penalize or otherwise enable laboratories to pick up the pace in processing.
Here's the rub: Labs are performing more COVID-19 tests than ever, lab workers are strained and states are bidding against one another for the same, limited supplies.
"It's the Wild, Wild West," said Blair Holladay, CEO of American Society for Clinical Pathology. "There's been no national testing strategy ... so states are duking it out for supply chains. That's a problem."
In mid-April, when labs completed about 150,000 COVID-19 tests a day, the federal government dangled a major incentive to increase testing output. Medicare would pay labs $100 for each “high-throughput” test, nearly double the $51 per test paid in the early days of the pandemic, as a way to get labs with machines that process lots of tests to increase capacity and deliver faster results to combat the spread of the virus.
The labs reached an all-time high of more than 831,900 COVID tests Thursday, according to the COVID Tracking Project, but the prolific expansion has led to a bottleneck, slowing results for families such as the Julians.
Quest Diagnostics said this week the average turnaround time for nonpriority patients was seven days or more. Patients in hospitals, those preparing for acute surgery and health care workers with symptoms get results within a day.
The laboratory giant warned it won't be able to deliver COVID-19 test results faster as long as cases continue to rapidly escalate. The situation is "complex and not easily fixed" and affects the entire laboratory industry, Quest said in a statement.
LabCorp, citing increases in testing demand and supply and equipment constraints, said average turnaround time for non-hospital patients was four to six days, according to a company spokeswoman.
"We’ve gone way backwards" in testing, said former New York health commissioner Nirav Shah.
Shah, a senior scholar at Stanford University's Center for Clinical Excellence, and other public health experts said the delay in results renders many of the tests irrelevant and increases the virus's spread.
Dr. Joshua Sharfstein, a former health commissioner for Baltimore and the state of Maryland, said commercial and federal insurance programs could penalize labs that didn't produce results within 48 hours or pay extra if they do.
"It's the failure of a federal strategy that led us to this point," said Sharfstein, a professor and vice dean at Johns Hopkins Bloomberg School of Public Health. "Financial incentives would help to get more tests done quickly. Additional funding to guarantee the market would also help to grow capacity for testing over time."
In the short term, states that can't build more capacity should set priorities for who can be tested, he said. The "best case scenario," Sharfstein said, would be "more timely and therefore more meaningful tests."
"I'd rather have fewer tests that are timely than more that are too late," he said. "It is a worthwhile trade-off."
Former Food and Drug Administration Commissioner Scott Gottlieb favors a focus on lab capacity.
"It’s an infrastructure issue and a question of whether you’re going to undertake a huge capital investment for a business that will go away in six months," he said.
Whatever the solution, epidemiologist Brian Castrucci called shifting testing responsibility to states the "worst misuse of federalism ever" and "a national leadership disaster."
"When you look at that (in some places), everyone who wants a test can get a test, was that the right thing to do?" said Castrucci, CEO of the de Beaumont Foundation.
"Did we take any steps to prepare to do that? This could have been forecasted. This was never an 'if' but a when."
As of Monday, Johns Hopkins University reported there have been more than 3.7 million U.S. cases of COVID-19, the disease caused by the new coronavirus, and more than 140,000 deaths.
No incentive for quick results
Anthony Morelli, 21, of Winchester, Virginia, had a fever for nine days while he and his family waited for the results of his COVID-19 test this month. It took 13 days for the positive results.
His mother, Allison Lowry, had symptoms when she went through a CVS drive-thru line near her home June 30. She got her positive results back July 8.
She was sick for about three days, and the whole family self-quarantined. She would have taken Morelli to the emergency room if she was sure it was COVID-19.
“It’s really kind of a disgrace and irresponsible on the part of CVS and Quest to take on testing that they do not have the capacity to process," Lowry said. “I can see how that would contribute to the crisis that’s going on if people don’t have symptoms anymore and they just get tired of waiting for results and just go out and infect more people.”
CVS sends test samples to third-party labs that process kits and return results, which CVS shares with customers, said Mike DeAngelis, senior director of corporate communications for the company.
"The increase in cases of COVID-19 in certain areas of the country is causing extremely high demand for tests across the board," DeAngelis said. "This has caused backlogs for our lab partners and is delaying their processing of patient samples. Currently, during times of high demand, it may take six (to) 10 days for people to receive their results, and in some instances, our lab partners may take even longer to return results."
Actual delivery of the results to patients further extends the process. Some patients said they had to wait until Monday because medical offices were closed on the weekend.
Ramin Bastani is CEO of Healthvana, which says it has delivered fast and private HIV results since 2015. The company contracted with cities, counties and labs in mid-April to do the same for COVID-19 tests.
He said the process of calling, then mailing printed results to thousands of people is labor-intensive. Some health departments have eight workers calling patients for up to 12 hours a day. His company can deliver results in five minutes via text message, he said.
"It can take up to a couple days, and some people fall through cracks," Bastani said.
Under fire for the testing delays, Assistant Secretary for Health Brett Giroir said the U.S. Department of Health and Human Services is expanding testing options at surge sites where rapid turnaround is needed and getting more tests into doctors' offices. The federal government procures and sends testing supplies such as swabs to every state once a week, according to Giroir.
Shah blames a U.S. health system that prioritizes tests for nonemergency surgeries over people who could be spreading the virus.
“The system is perfectly designed to deliver the results it incentivized," Shah said. "It has not incentivized public health but profit. At what point does public health ever get in ahead of the line?"
Lab industry officials said the problem is more complex than paying labs to process tests more quickly. Doctors and clinics need swabs to collect mucus samples from patients' nasal cavities. Labs require chemical reagents to run tests on machines.
The absence of a national testing plan means there's little federal coordination to steer pivotal supplies to regions where the virus thrives, Holladay said.
New York labs busy with the pandemic's initial surge months ago are now well-equipped, while some labs in the Southeast and Southwest cannot turn around tests quickly enough. Labs in New York can probably finish tests in 12 hours, Holladay said, while labs elsewhere report results can take more than a week.
In Phoenix, results for three-quarters of COVID-19 tests are ready within one week, and one-quarter of tests take up to 10 days, Sonora Quest Laboratories, the metro region's dominant lab, reported Thursday.
Further complicating matters is a mismatch of state policies on reopening restaurants, bars and gyms, as well as mask wearing.
Holladay said the lack of federal coordination and varying state reopening policies would mean less if the virus was under control and fewer Americans were dying.
"Deaths are going back up, and it’s clearly related to opening the states before this virus was under control," Holladay said.
Smaller labs ready to help
While large labs and hot spot cities report delays of a week or longer, consumers in other states get quick results. Some smaller labs say they have untapped capacity.
Loveland, Colorado-based Warrior Diagnostics gained the FDA’s emergency-use authorization for the lab’s molecular COVID-19 test.
Founder and President Jake Rice said Warrior can handle 1,500 tests each day and deliver results within 48 hours of receiving a specimen from a clinic, nursing home or other provider. But the lab does only about 200 tests per day.
“We’re here. We’re open. We’re ready to rock,” Rice said.
He reached out to state government officials to offer his company as an overflow lab, but that has not translated to new business. Nursing homes turn to other labs, and some hospitals develop their own testing or send samples to overwhelmed national labs.
Rice sees even more demand on the horizon from large employers screening workers returning to offices or factories.
He said turnaround time is critical to make tests meaningful. A test that takes more than seven days to process makes it difficult to isolate and trace the contacts of infected individuals. Rice favors paying labs incentives to guarantee faster results.
“They should reimburse a lot more for faster turnaround time,” Rice said. “We are banking on doing these tests as fast as possible instead of a five- (or) seven-day turnaround time. What is that going to help?”
Other labs prioritize testing by need. High-priority patients get access to quick-turn testing while less urgent cases, such as asymptomatic patients with no known exposures, are pushed back to the testing line.
Dr. Yvonne Maldonado, director of infection control at Stanford Children’s Hospital, said sophisticated labs must run multiple machines simultaneously to process tests as quickly as possible.
Some patients need immediate results. She gave the example of a patient on life support awaiting a liver transplant. Among the tests doctors run to ensure a donor kidney is the right fit, they must know whether the organ is infected with COVID-19.
For such urgent cases, Stanford uses a Cepheid rapid-testing machine – one of four major testing platforms the academic lab uses. The rapid test can deliver results in as little as 30 minutes but typically no more than two to three hours, Maldonado said.
"We don't have very many of those tests ... so we save them for that reason," said Maldonado, a professor of pediatric infectious disease and health research and policy. "It’s not I want to get on a plane pretty soon. That’s trivial compared to the person who’s going to die if you transplant an infected organ into them."
She said the nation's testing logjam won't be easy to quickly resolve. Labs need more machines, more trained personnel to run the machines and, in particular, more chemical reagents to run tests.
The American public should be prepared to wait longer for results, wear masks to protect others and socially isolate themselves when appropriate.
"The real problem right now is getting the platforms freed up to do the work that they’re supposed to," Maldonado said. "Right now, they are just so backlogged with a surge of people who want to get tested. There’s just not enough supplies or people to do the tests."
In Iowa, after two weeks of sheltering in place, Cris Julian is cautiously venturing out again with a mask and social distancing. As she and son Ethan pass the two-week mark since their tests, she wonders if she'll ever hear.
"I would be surprised if anything comes back now," she said.
O'Donnell is on social media as @JayneODonnell and can be emailed at jodonnell@usatoday.com. Alltucker is on Twitter as @kalltucker or can be emailed at alltuck@usatoday.com.
This article originally appeared on USA TODAY: COVID testing delays worsen as labs struggle to keep pace with demand
