Falling through the cracks: Overwhelmed system leads to coronavirus tests mishandled, delayed
Two hours after getting in line, with the Atlanta sun beating down on the hood of her car, Andrea S. Mitchell pulled up at the drive-thru test site. Rolling down the window, she took her uniquely barcoded kit from a volunteer.
But there was someone else's name on the bag.
"I got the lady's attention that, 'Hey, you gave me the wrong person's test,'" Mitchell, 42, told ABC News. "We had the same initials, but I was like, 'This isn't my name, this isn't my number, this isn't my birthday. This isn't me.'"
As the demand for testing surges with the rise in COVID-19 cases, major labs tasked with delivering results to the entire country have explicitly warned they're overwhelmed. Quest, one of the largest testing companies in the U.S., cautioned Monday that the urgent need for testing "continues to outpace [their] capacity," especially in the regions now facing rising numbers of cases: the South, Southwest and West.
Forced to confront the rapidly spreading virus, a strapped health care system is straining to keep up -- fomenting communication breakdowns, clerical oversight, mislabeled, mishandled and misplaced samples, experts say.
"There are multiple steps where mistakes can happen," Dr. Carmen Wiley, president of the American Association for Clinical Chemistry, told ABC News. "We have so many manual and quite frankly ad hoc processes in place, it's human error."
"It's like trying to jump out of an airplane, and build a parachute that works, and land safely all at the same time."
The U.S. has struggled to roll out efficient and timely testing from the start of the pandemic, scientists and clinicians say. A federal review confirmed that early test kits produced by the Centers for Disease Control and Prevention in January were likely contaminated -- and likely what delayed the CDC's distribution of tests during those early days of the domestic pandemic -- while a Department of Health and Human Services report cited "time pressure" to launch testing, and "lab practices that may have been insufficient to prevent the risk of contamination."
Instead of initially enlisting the private sector to develop tests from the start, the U.S. health officials relied on CDC's tests. Insufficient supply of testing from the CDC along with an originally narrow testing criteria, meant that not enough Americans could get tested. The U.S. has conducted over 51 million tests; as the pandemic has worn on, turnaround time for big commercial labs has gotten longer, Health and Human Services' Assistant Secretary for Health Adm. Brett Giroir told reporters Thursday.
On Sunday, Giroir emphasized the importance of faster turnaround times.
"I started out by saying that we are never going to be happy with testing until we get turnaround times within 24 hours and I would be happy with point-of-care testing everywhere," Giroir told CNN. "We are not there yet. We are doing everything we can to do that."
LabCorp and Quest both have now received emergency authorization to begin "pool testing" their samples in an attempt to "ensure testing is available" amid such inundation, LabCorp said in a statement Saturday.
Since then, even as the burden of testing has shifted to state-run, local and private labs, neither that "time pressure" nor the scramble to alleviate it, have ebbed, health officials say.
"Something as simple as the lid comes off the specimen, and it's not preserved," Dr. Phillip Coule, vice president and chief medical officer of Augusta University Health System, told ABC News. Georgia now faces some of the latest case surges, reporting almost 3,800 new cases on July 25. "I can think of one example where [in transit] the specimens were placed directly in the ice, and it soaked through all the labels. So, labels came off. And rather than run the risk of misreporting those, you have to discard them."
Labs responsible for tests nationwide now find themselves pummeled two-fold, Dr. Dwayne Breining, executive director of Northwell Labs, told ABC News.
"You've got more demand for tests from pushes to reopen -- plus a whole bunch of states now with increased demand because everybody's getting sick," Breining said. "It's like a double whammy. And unfortunately, I don't think we've hit the worst part of it yet."
'A delicate matter': Compromised tests cast doubt
Mitchell had already weathered a bout with coronavirus. Her first results returned "inconclusive." As her symptoms worsened, a retest confirmed what she already felt and feared: She was positive. Still in the process of recovery, she went back a third time to get tested.
"The mistake of another person like what happened with mine -- you want to extend grace to people, because they're trying to get as much done as fast as possible. But it's your life," Mitchell said.
"If a person is not getting their results, usually, there's a reason," Quest spokesperson Kimberley Gorode told ABC News. "And sometimes the reason is lost in translation. There are instances where a test can't be performed, or the specimen isn't collected properly, but we are double and triple-checking everything to make sure that we're on top of it, working 24/7 to get people results and to be accurate because we do understand how important this is."
LabCorp did not respond to specific questions regarding lost or mishandled tests, but a spokesperson emphasized in a statement there has been a "significant increase in demand and constraints in the availability of supplies and equipment," and that the company "continues to be committed to doing everything we can to respond to the health crisis."
Cases of compromised samples casting doubt on tests' validity have also emerged in Florida, where Saturday, total coronavirus cases statewide surpassed New York.
In late May, the Florida Division of Emergency Management announced they had been "made aware" that more than 1,700 coronavirus tests administered across the state had been damaged in transit.
"These individuals will be prioritized for retesting at the site where they were originally tested," the Division said a statement.
It directly followed AdventHealth, which operates 45 hospital campuses across the country, announcing they had canceled a contract with one of their partnered labs, citing a failure to fulfill its obligation and impacting over 25,000 tests in Central Florida. Another statement from the same day noted another 8,000 people had been impacted by a lab's issues throughout their West Florida division.
"This situation has created unacceptable delays, and we do not have confidence in the reliability of the tests," AdventHealth's statement read.
Behind the scenes, collecting and processing samples is an intricate process, trusted to and passed among multiple sets of hands, and often shipped cross-country, experts describe.
"It's a delicate matter," Dr. David Reich, president of Mount Sinai Hospital, told ABC News. "There are so many links in the chain and it's very easy for one of them to fail. It's logistically complex to do this well."
Samples must be kept in highly controlled conditions and shielded from any outside, compromising circumstances -- like extreme temperatures, said Wiley. As hotspots now flare in some of the hotter spots in the nation, keeping samples intact for hours and sometimes even days has proved challenging. In mid-June, more than 400 COVID-19 testing samples were not able to be processed after being exposed to heat, according to the D.C. Department of Health, Washington ABC affiliate WJLA reported.
"We apologize for the inconvenience and are taking steps — such as the addition of more refrigeration at each testing site — to ensure the issue does not arise again," the health department wrote in a statement.
Playing telephone and tracing the case
Cases where tests go missing or mishandled don't make up an overwhelming majority of errors, experts told ABC News, but rather a disconnected system can prove troublesome.
"It feels like we're swimming upstream," Dr. Umair Shah, executive director of Harris County Public Health in Texas, a state hitting its record-high one-day COVID deaths, and hospitalizations.
"We're constantly having to pivot," Shah said. "It's been the incompleteness and delay of the lab information. And it's honestly started to really impact local communities."
Shah knows the challenges of the at-times antiquated data-sharing systems across the nation, between major labs and hospitals. Recently when one lab tried to send its test results in bulk, his office's fax machine kicked into hyper drive, spewing papers uncontrollably onto the floor.
Health care professionals from across the country repeatedly described to ABC News frustrations with the lagging, often-muddled flow of good information impeding their work.
"So it'll turn out we'll only have your date of birth. Or we'll have your address, but not your phone number. Or we'll have a number, but it's wrong," Shah said. "Now the name is misspelled, but everything else appears to be the same or maybe not quite. Now we've got to go back and figure out, 'Is it the same person that we've already reached out to?'"
"So we're trying to figure out how to interrupt the virus's transmission, but first we had to go trace the case," Shah continued. "Then it's too late to do meaningful contact tracing because you've missed that window. That's a systematic issue across this country, and that is a real shame."
In Washington, D.C., Ursula Sandstrom waited over two weeks for her results. She went for testing in late June, but hadn't heard anything through the first week of July. Finding it difficult to know who to ask about the delay, she called the city's hotline. She was told her results had been ready for a week, but her name was recorded as "Sandstron Sandstron" in her file. Her results were negative, but by a mid-July phone conversation with ABC News, Sandstrom says her patient file still had not been fixed.
"It took extra work to figure out, 'Who do I, how do I, figure out what's going on?'" Sandstrom said. "These are high stakes because it's COVID and people need to know."
Those on the front lines fighting the virus tell ABC News they're worn out.
"We're all burnt out, just varying levels of burnt crisp," said Dr. Saskia Popescu, an infectious disease epidemiologist and infection preventionist in Arizona, one of the most recent hotspots. "We've had an entire ICU full of COVID patients since like, March, April. So this is a marathon, not a sprint. And yet we're having to do a marathon and a sprint at the same time."
Popescu has a background in pandemic preparedness, and is among those responsible for reporting all the data on COVID patients, point by point, input manually, while relying on inundated labs. She fears the delays in testing will impact the numbers she's able to report.
"This is what we trained for, but that doesn't make it any less exhausting or the challenges any less," Popescu continued. "I see it as, you know, this keeps people safe -- and it has to get done."
ABC News' Matt Mosk contributed to this report.
