Flawed work by the TestUtah initiative run by Nomi Health poses an imminent threat to public health and safety, federal investigators concluded earlier this month.
At one TestUtah site in January, an inspector saw a “pile” of processed rapid tests ignored for an hour and a half, even though results are only valid for a 5-minute window.
At another, an inspector found “contaminated” test kits sitting on a laboratory table right next to yogurt, rice cakes and a bag of Cheez-Its.
At a third, a regulator noticed swabs with patient samples and unused swabs stuffed together in a cart outside in below-freezing temperatures.
According to documents obtained by The Salt Lake Tribune, those are just three of more than two dozen mistakes and complaints that federal and state health officials have documented in recent weeks at TestUtah, which has been testing Utahns for the coronavirus under contracts with the state since the early days of COVID-19.
In an interview Wednesday about complaints investigated by the Utah Department of Health, Nomi Health co-founder and chief operating officer Josh Walker said many of the state’s recent complaints were “hearsay or anecdotal” and difficult to run down.
Though Walker acknowledged the increased demand for testing during the omicron variant surge had stressed TestUtah, along with other care providers, he said his company followed up on each state concern and defended his company’s overall performance during a health crisis that didn’t come with a playbook.
“I still believe that we did a wonderful job, and we worked together with the state in a great way, given the odds that we had in tackling an unsolvable new problem,” he said.
But just hours after that interview, The Tribune obtained records showing that federal regulators had notified Nomi — more than two weeks ago — that inspectors found the company’s testing sites had committed the most serious level of violation a health lab can: “Immediate jeopardy.”
“It was determined that the deficient practices of your laboratory pose immediate jeopardy to patient health and safety,” inspectors with the Centers for Medicare and Medicaid Services wrote.
Immediate jeopardy, they explained, means “immediate corrective action is necessary because the laboratory’s non-compliance ... has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.”
As a result, Nomi Health no longer met the requirements to perform coronavirus testing under federal law, according to the March 16 letter. However, the federal agency did not require the TestUtah sites to close — and it did not issue any warning to the public.
The Utah Department of Health said Thursday it was not immediately informed about the federal finding of “immediate jeopardy.” The department participated in the federal investigation, but it is not immediately clear when the department learned of the finding — and it also has not alerted the public.
Thursday was the final day for residents to be tested at TestUtah under state contracts, though some sites are scheduled to remain open for testing for private insurance companies.
A Centers for Medicare and Medicaid Services (CMS) spokesperson said federal regulators are continuing to review their investigative findings as they decide what to do next.
Federal inspectors had demanded that the company rectify the documented deficiencies and demonstrate it had come into compliance by March 26 — or else face nearly $22,000 per day in fines, among other possible sanctions.
In a prepared statement Thursday, Nomi Health said it responded “quickly and with rigor” to the federal determination and noted that the compliance process is still underway. The company sent the federal government a response March 25, a spokesperson said.
The CMS spokesperson said laboratories in cases like these can continue testing during the federal agency review, as long as they submit “a credible allegation of compliance” and “acceptable evidence documenting that the immediate jeopardy has been removed” and that they’ve corrected their deficiencies.
The state’s complaint logs, obtained by The Tribune, show patients, site employees and health officials have been raising concerns about TestUtah for months, while the state poured millions into its contracts with Orem-based Nomi Health.
UDOH officials said the state has paid Nomi more than $33.2 million since September, when most of the reports of problems began. They are negotiating with Nomi Health over invoices for the company’s work in January and February, officials said.
State health officials credited Nomi Health for bolstering Utah’s capacity to meet a deluge of testing demand during coronavirus surges. Nomi was responsive when state officials flagged potential problems, they said.
A letter Nomi emailed to the state March 11 asserts that the company had addressed 38 of 40 concerns logged by UDOH. They included complaints that TestUtah staffers had given patients incorrect information about testing, flawed testing practices and delayed, missing or conflicting test results.
One of TestUtah’s site supervisors was so alarmed by what she witnessed at work that she was willing to step forward as a whistleblower, and submitted a 20-page report of concerns to the Utah Department of Health in early February.
The employee told The Salt Lake Tribune that she wants to see her company succeed, but she felt that the testing initiative was falling short of its aspirations and was largely ignoring her when she called attention to problems. Testing site operations often felt chaotic and “super messy,” she said, especially during the omicron surge, when she and her staff were overwhelmed with patients.
The Tribune has obtained her report and verified her identity, but agreed to not publish her name due to her concerns about professional repercussions for speaking out.
Miscommunication and misinformation
State officials recorded several reports of problems at TestUtah sites starting in September, when the state shifted nearly all of its community testing to Nomi, according to logs compiled by the Utah Department of Health.
At that time, the state-run mobile testing teams that had been providing much of Utah’s free community testing were reserved for school testing — but not many districts requested them. Meanwhile, TestUtah sites were overrun as schools reopened and the delta variant of the coronavirus spread through the state. Patients reported hourslong waits, and Nomi said it planned to ramp up hiring.
But some of the new employees seemed to misunderstand even basic details of testing, according to a complaint dated “Sept.-Ongoing.”
“New staff do not know the difference between antigen and antibody testing and PCR testing,” a UDOH staffer wrote — a problem that apparently persisted until December, when a doctor told UDOH that her son had registered for a PCR test at the Draper site but received a less-accurate rapid antigen test, the log states.
Some staffers were turning away cars before closing time, according to the logs. Others were telling patients they couldn’t receive both a rapid antigen and a lab-processed PCR test.
Problems continued throughout the fall. One patient reported he was denied a test because he didn’t have a smart phone. Agents operating Nomi’s call center and online chat feature also were providing inaccurate information, UDOH employees wrote, citing “issues ranging from the call center not knowing what kinds of tests are available at given sites, to misinformation about schedules of sites, along with not knowing where or how to pronounce certain site names.”
A symptomatic patient who got conflicting results from two different tests said he called the hotline and was told he did not need to isolate. And an agent on the chat feature claimed TestUtah did not accept walk-up patients, and those without cars should hire a taxi, the logs state.
“I’m not thrilled that their staff is apparently recommending symptomatic people without vehicles would expose some poor cab driver rather than just let them come on foot,” the complaint states. In mid-October, a UDOH staffer wrote: “We’ve tried to email anyone at Nomi multiple times over the last week without one response. Any other suggestions please?”
The communication failures affected inventory, too. UDOH employees reported hearing that two major TestUtah sites were repeatedly running out of nasal swabs but didn’t seek more from UDOH.
“We were not notified where we could have helped,” the log states.
In late November, a family reported that staff at TestUtah’s Bountiful site told them that if they tested positive, they should visit the website of the Front Line COVID-19 Critical Care Alliance — a nonprofit that exhaustively promotes ivermectin and hydroxychloroquine but downplays the use of vaccines.
“This is totally unacceptable,” one of the family members wrote. “Vulnerable people getting tested for COVID should be able to trust healthcare professionals to provide scientifically backed information.”
Many of the log entries were labeled as having a “high” degree of severity.
But Walker said some anecdotes included on the complaint tracking sheet had little grounding in reality. For instance, he said, TestUtah had an open-door policy and never instructed employees to turn away walk-up patients or people without smartphones.
He also said he believes the patient who reported being referred to the Front Line COVID-19 Critical Care Alliance was confused and that the person was actually directed to TestUtah’s monoclonal antibody facilities.
TestUtah was originally promoted by Utah’s tech sector as a way to streamline and transfer health data during COVID-19. But several of the recent complaints deal with flawed data.
In mid-November, local health departments reported that they “frequently hear about missing test results from TestUtah sites in Davis County and Southwest [Utah],” the log states.
A couple of weeks later, UDOH recorded local health agency “complaints about delayed reporting of results, resulting in delayed case investigations and linkages to schools.” Results were being reported in “batches,” health officials wrote, “so several days of results get dumped all at once.” Local health officials also complained that results were often mislabeled: parents’ names would be linked to their childrens’ birth dates, with “mixed/duplicated” information and “misreported labs.” Those errors could prevent cases from being imported into the state’s data-tracking system, UDOH staff wrote.
Salt Lake County health officials began complaining about data errors in September, the log states — an issue Utah County health officials also described as “a continuing problem” and state contact tracers encountered “a lot” when they worked at a TestUtah site, according to a Nov. 3 note.
“Originally they were told it was a technical issue that had been resolved. When it continued to occur, they were then told that it was a data entry/human error,” UDOH staff wrote, noting that the state-run test teams require two people to verify each result as it’s entered into the system, while Nomi teams don’t have anyone verify them.
UDOH staff wrote that they had contacted Nomi twice in late October and early November about the data problems, but received “no response.”
And the problems continued. In February, UDOH wrote that patients were reusing their scannable codes for multiple tests, potentially receiving results from the original test rather than the new one.
“These instances have occurred and likely happen often,” the log states.
In one case, a TestUtah staffer got tested at a TestUtah site after receiving three positive results on at-home tests. Other employees at the site called her directly to let her know she tested positive and should isolate — but she replied that she’d already been notified that her test was negative. Her coworkers double-checked her result to confirm it was entered correctly, and it was; the problem was that she had reused an old QR code to register for the test, and the timestamp on the result showed TestUtah had re-sent the results of the earlier test rather than the new, positive one.
“I can’t help but wonder how many of our patients were in a similar situation … but never found out they were positive,” a TestUtah staffer was quoted as saying.
Walker said those concerns are the product of a misunderstanding and that the QR codes are only used to register for tests and not to share results, which are sent to patients in the form of a secure link.
A few days earlier, five TestUtah staffers were recorded as testing positive at a TestUtah site even though they hadn’t ever been tested there, the log states.
TestUtah staff also complained of data problems affecting their own work. One employee told UDOH that their test site computers remained logged into the same staff account throughout a shift, making it impossible to trace errors or other actions back to the correct person; one staffer had already been disciplined for a data error made on a shared account, the employee said.
“I don’t want my medical license to get revoked because of someone else’s mistakes,” the worker added.
In response, Walker said each staffer has an individual account and that the TestUtah system automatically logged a person off after a certain period of inactivity.
“There wouldn’t be a scenario where someone would be forced to log into an account the entire day,” he said.
Perhaps of most concern, UDOH received multiple complaints that samples were being collected and processed incorrectly.
In mid-December, UDOH received a report that patients at one site received their results just eight minutes after being swabbed, even though the test takes 15 minutes to process.
About a week later, patients at two separate TestUtah sites reported they received negative results, but were found to be positive in follow-up tests they sought elsewhere because they were worried about how the TestUtah sites had collected their samples.
“The person doing the testing at Nomi Health barely put the thing in her nose and took it back out,” one mother wrote after her daughter tested negative at the Roy test site but positive at a community clinic. “I think they need to be investigated. Getting false negatives because they don’t do the test right is very dangerous and likely contributing to the spread of the virus.” Another patient said they tested positive after receiving a negative result at the Park City High School site, where the test “barely touched inside their nose,” the log states.
A few weeks later a woman said she and her friend group got tested together at a TestUtah site in Salt Lake County after they developed symptoms, and they received negative results — but then they got tested elsewhere and all were positive.
A caller from a Utah County site said on Feb. 1 that a staffer there “had a handful of half a dozen swabs and was just walking down the line of cars handing them out/picking them up and it looked like he was mixing them all up.”
“I’m hoping the swabs have some kind of labeling and everything is being processed correctly but I wanted to let you know,” the log states.
UDOH also reported that staff were not changing gloves between patients. Not only that, staffers from the state-run mobile teams who volunteered at TestUtah sites to help manage crowds told UDOH “that they were told specifically NOT to swap out gloves in between testing individuals in the same vehicle.”
“This is likely happening across multiple sites,” the log states.
As the omicron variant swept through Utah in late December and early January, UDOH increasingly reported problems with test timing.
A UDOH employee visited the TestUtah site in the health department office parking lot on Dec. 26 to help with long lines and noticed “a number” of unprocessed Abbott ID Now samples were waiting in a stack. Abbott’s instructions require the tests to be processed within two hours. Meanwhile, some PCR samples had not been sent for processing even though they had been collected a full day earlier, the log states. A TestUtah employee reported a similar backlog of tests at another site.
On Jan. 8, a UDOH employee visited a TestUtah site in West Valley City to help with the five-hour line there. Nomi staff quickly explained how to process a backlog of about 150 swabs that had been collected. But when the UDOH employee asked for a timer and for someone to input the results, “the employee was instructed to just lay the processing test out on a box and not to worry about tracking time.”
In fact, the instructions for the test require the user to read the results 15 to 20 minutes after processing begins.
“Caution,” the instructions warn. “False positive or false negative results can occur if test device is read before 15 minutes or after 20 minutes.”
The UDOH volunteer processed tests for an hour and a half, during which no one recorded the results of the tests, “and more rapid tests kept getting added to the pile.”
Less than a week later, another TestUtah site volunteer reported there still were no timers for rapid tests.
“This has been brought up multiple times. Nomi has said they track time based on clocks on iPads,” the log states — but Nomi ultimately “purchased some timers.”
Walker attributed some of these complaints to misinterpretations by onlookers unfamiliar with the testing process. The report from the Utah County caller concerned about swab mixups is a “great example of how an observer in a line of cars who doesn’t understand the processes on the ground” might see things, he said. Each swab and its associated packaging has a barcode and labeling that ties it to a specific patient, he said.
He asserted that TestUtah had no policy discouraging employees from changing gloves and relied on a software system for tracking test times, rather than using individual timers.
However, inspectors for the federal investigation also documented numerous testing deficiencies, in one case noticing that a TestUtah staffer had put patient swabs back into their open plastic sleeves and then stuffed them into a box. The sheathed samples were lying “directly on top of each other,” the inspector wrote.
“This is a possible patient test contamination,” a collection worker acknowledged in an interview with the inspector.
The report also notes the lack of temperature monitoring in storage areas for samples and tests — which are only supposed to be used inside specific temperature ranges. TestUtah staffers were using makeshift methods for heating up the extraction solutions, such as by cramming hand warmers and tests inside a roll of duct tape, according to the investigation records.
Inspectors said the solution had heated up to about 143 degrees. The appropriate window was 59 to 86 degrees.
The whistleblower’s worries
The TestUtah site supervisor who stepped forward as a whistleblower, submitting a 20-page report of concerns to state health officials in February, told The Tribune that some employees were working 13-hour shifts every day of the week while the omicron variant was racing through the state. She would sometimes stay onsite processing tests for hours after the 7 p.m. closure, she said.
Her site was chronically understaffed, she said, recalling one day when a single employee showed up to assist her through the afternoon and cars were lined up to the nearby main road.
“She had never been on the site, so I explained everything in like two minutes, and the poor girl was shaking,” she said. “I’m like, just get out there, just get a car, it’s fine.”
With these inadequate staffing levels, it felt to her like Nomi was always trying to plug holes, whether by moving workers from site to site or even recruiting temporary workers from Florida, the supervisor said.
She started to get burned out from constantly having to train new people — and from her concerns about how the work was being done, she said.
Nomi leaders pressed employees to collect samples from each car within five minutes, a goal that she said at times verged on the impossible, especially when multiple people in a vehicle needed testing. “It was stressful and it’s brutal,” the employee said.
Walker acknowledged that Nomi monitored the pace of work at its sites and believed that testing each patient should only take a “few minutes” under normal circumstances. “We believe that tracking those types of metrics is not unusual in organizations where operational excellence is top of mind,” he said.
The employee also said Nomi’s call centers were persistently giving out incorrect information, she didn’t always have the supplies she needed and the company shifted to using a rapid test that she didn’t trust.
With that test, made by GenBody America, it was often nearly impossible to detect the pink line that signaled someone was positive for coronavirus, she said.
And she started suspecting there were broader accuracy problems with the rapid tests, she said, one evening after her site had closed and her staff was processing the mountain of samples left behind. She was shocked when her co-worker reported that of the hundreds of GenBody tests they’d collected, only a few had come back positive for COVID-19.
Frustrated with her supervisor’s lack of response to her concerns, she said, she shared her worries with a health department employee who showed up at her site. At the official’s suggestion, she wrote the report formally outlining the issues for UDOH, she said.
The whistleblower said she knows TestUtah has helped many people over the course of the pandemic, but she is angered by the times “we aren’t giving correct patient care.”
What caused the flawed GenBody results?
It’s not clear whether any of the processing missteps described by state employees and patients played a role in the problems with GenBody test results that state officials discovered earlier this year.
After officials reviewed results from the GenBody test that was used at many community testing sites in December and January, they paused all rapid testing at state sites in early February. An analysis of results showed it appeared to be yielding a large number of false negatives.
For the review, UDOH looked at results from 18,000 Utahns who’d received both a GenBody test and a PCR test on the same day. Of the people whose PCR results came back positive for COVID-19, more than half had a negative rapid test result.
“We are telling a lot of people that they are negative and can go to the Jazz game or see grandma when they are in fact positive,” a UDOH epidemiologist wrote to a colleague on Feb. 1.
However, the distributor who was supplying the state with rapid tests insisted that the high rate of false negatives was due to user error, rather than a fundamental flaw in the product.
The vice president for Zaymat Distributors said he’d identified “several red flags” with Utah’s rapid testing process, critiquing the state for exposing “the swab to three distinct climates” as the sample traveled from a patient’s car to the outdoors and finally to a mobile testing truck. He also faulted the state’s teams for moving the testing strips during processing.
He even offered to fly out to Utah to train its teams in how to administer the GenBody test.
While Walker said he’s confident Nomi was following all the proper protocols for using the tests, state health officials initially also suspected TestUtah might be to blame for the rapid testing problems.
“I could see it possibly being Nomi total incompetency,” Dr. Leisha Nolen, state epidemiologist, wrote in a message to colleagues.
But the analysis showed that both Nomi and the state’s mobile testing teams were having similar problems with GenBody.
Officials also found the rates of false negatives were much higher for GenBody than for other rapid tests the state’s teams were using.
David Yoo, CEO and founder of GenBody America, said the company is “investigating several potential variables which may account for these findings,” including that exposing the tests to the frigid outdoors might have impaired accuracy.
The GenBody rapid tests must be at room temperature to perform accurately, “as stated in its instructions for use,” Yoo wrote in a response to the Tribune. Company experiments have also found that the lower the temperature, the fainter the test lines become, he added.
In addition to suspending the use of rapid tests at state sites, UDOH also sent a letter to the U.S. Food and Drug Administration (FDA) detailing its concerns about the GenBody tests, records show. Yoo said the FDA scheduled a time to discuss Utah’s concerns with GenBody but canceled the February meeting and hasn’t yet rescheduled it.
Officials expressed interest in getting a refund for the $6.6 million it spent on the tests. But according to UDOH, they haven’t yet gotten the money back and are still “exploring options” with the distributor.