Federal officials worried that more than 174,000 coronavirus patient test results from an Orem lab used by TestUtah were potentially wrong — but none of the people who were tested early in the pandemic were told, documents obtained by The Salt Lake Tribune show.
Testing at Timpanogos Regional Hospital may have produced accurate results. Or its lab may have produced false negatives or false positives, according to documents and interviews with people familiar with the matter.
State health officials knew for months that federal regulators were questioning whether the hospital’s lab was following requirements designed to ensure tests are processed accurately, according to interviews and documents. Public officials knew as early as May 2020 about problems at the lab, which did not suspend COVID-19 testing until Aug. 23, 2020.
In the hospital’s plan for correcting deficiencies, submitted to regulators the day after it halted its processing of coronavirus tests, it acknowledged:
“Once it was determined that verification and validation had not been properly performed, Timpanogos Lab suspended the processing of COVID-19 specimens on the non-validated and non-verified instruments.”
For the hospital and health officials, “the ethical thing is to let people know the potential they were given bad health information,” said Dr. Robyn Atkinson-Dunn, former director of the Utah Public Health Laboratory who was demoted after expressing concerns about TestUtah.
Otherwise, she added, “you’re messing with people’s health and livelihood.”
Timpanogos Regional Hospital prepared a letter in August 2020 to 100,993 patients that would have let them know the lab may not have followed protocol. Another 73,523 patient tests — which were among the TestUtah results — were also called into question, but because sample collectors had not obtained all of the patients’ identifying information, such as mailing addresses, the hospital said it didn’t know how to reach them.
Days before the letter was to be sent to patients, federal officials who oversee lab certification reversed course. David R. Wright, a director at the Centers for Medicare and Medicaid Services, or CMS, instructed the hospital that notifying those affected did not further “the public health imperative.”
Timpanogos had voluntarily suspended COVID-19 testing, a CMS spokesperson noted last week, and the federal agency “was primarily focused on ensuring the lab corrected their policies and procedures to provide accurate testing.”
Dr. Angela Dunn, executive director of the Salt Lake County Public Health Department and state epidemiologist during the first year of the pandemic, said there’s an ethical obligation for a health provider to tell people the test results they received were wrong or even possibly wrong.
“That goes to trust — 100,000-plus people were trusting this entity with their health information, and if what they got back was wrong, they deserve to know the truth,” Dunn said.
The failure to notify patients potentially endangered thousands more who were at risk of being exposed to the virus or forced to stay home from work when they weren’t infected.
[If you think you received test results from Timpanogos between April 1, 2020, to August 23, 2020, please share your experience by emailing email@example.com.]
The decision to not inform patients came three months after a May 2020 inspection by CMS found poor laboratory practices at the hospital and the agency said it was “not in compliance” with federal regulations. The problems identified by regulators from the Division of Clinical Laboratory Improvement & Quality ranged from how patient specimens were handled to how tests were performed, according to past Tribune reporting, records and interviews.
Regulators asked in June 2020 why the lab was using different practices in handling tests for hospital patients and tests used with TestUtah patients. They also repeatedly point out in documents that the hospital lab was not processing the Co-Diagnostics test kits that were being used at TestUtah sites exactly as the manufacturer and federal regulations called for; the hospital defended its practices as reliable and allowed.
The hospital eventually notified regulators that its lab would no longer perform COVID-19 tests and submitted evidence of corrections that CMS considered “credible,” which appears to have resolved the matter. CMS did not impose any sanctions against Timpanogos Regional Hospital, according to a Sept. 15, 2020, letter. CMS said the hospital had returned to compliance with federal requirements, known as CLIA (Clinical Laboratory Improvement Amendments) as of the day before, and its lab continues to be accredited.
“If others in Utah could scale to meet the needs of Covid hot spots in all corners of the state, they would have. They could not,” said a spokesperson for Nomi Health, which runs TestUtah under a contract with the state. “If CMS and CLIA regulators believed the Timpanogos lab was a danger to public health, they would have shut it down. They did not.”
Timpanogos Regional Hospital, which is owned by national hospital chain HCA Healthcare, did not dispute that 174,516 patients were to be notified but emphasized that no sanctions were imposed.
The hospital believes “its efforts and expertise as part of the TestUtah program helped to crush the curve, support a restart in our communities and protect families and individuals in Utah,” spokeswoman Brittany Glas said.
Nomi Health, the company that operates TestUtah, did not have the required federal certification to operate a lab when it started offering testing. But Timpanogos Regional Hospital did, and its laboratory was in good standing.
The hospital lab was not investigated or sanctioned for at least 10 years, said Janette Case, a former state CLIA program manager who retired in April 2020 after nearly a decade in the role. The small regional hospital conducted testing for hospital patients but it had little experience processing large numbers of tests from outside referrals.
The hospital agreed to host TestUtah. Nomi and its partners provided equipment and services that helped automate processing of COVID-19 tests, though regulators emphasized it was ultimately the hospital’s responsibility to make sure federal processing requirements were met.
A total of 88,435 tests were processed through TestUtah at the lab between April 1 and Aug. 24, 2020, the Utah Department of Health said.
Among the state officials who knew that the test results were possibly flawed, records and interviews show, were Richard Saunders, then the executive director of the Utah Department of Health and now the state’s chief innovation officer under Gov. Spencer Cox, and Nate Checketts, who at the time was the state’s testing coordinator and is now the executive director of the Utah Department of Health.
“While the UDOH was not a party to the CLIA review, the UDOH required Nomi Health to ensure its subcontractor, Timpanogos Regional Hospital, resolved any concerns identified during the CLIA inspection,” Checketts said in a statement.
When Dunn, the former state epidemiologist, learned the tests were potentially invalid, she said it was clear what needed to be done.
“If that’s the case, we need to notify everybody,” Dunn recalled thinking during a conference call with other state officials on Mother’s Day in 2020. “My recommendation was to inform people they needed to retest, if the tests were wrong or invalid. Whether they were positive or negative, there are huge public health implications, let alone individual well-being.”
Even if it was too far past potential exposure or infection to prevent virus spread or to know if someone was truly positive, it was important to notify people so they could have better information for future health decisions, she said, such as being vaccinated.
“We have no way of knowing how that result has influenced their life,” Dunn said.
In May 2020, state health officials met to discuss what to do about the lab results, said Atkinson-Dunn, the former director of the state Public Health Laboratory.
She recalls telling Saunders, Checketts and Jefferson Burton, then the director of UDOH and now a state lawmaker, that the ethically responsible thing to do was to notify patients. Instead, she said, “They swept it under the rug.”
“I said, ‘Let’s get ahead of this thing. You know now this is bad,’” Atkinson-Dunn recalled. “Burton and Saunders said, ‘We need to wait and see what CLIA tells us to do.’”
Timpanogos responded to regulators’ concerns in writing in early June, but at the end of the month, CMS warned the hospital that it had not provided credible evidence of its compliance and corrections of identified violations. Timpanogos responded again in July — but CMS again criticized the hospital’s explanations in a blistering seven-page August letter, obtained by The Tribune.
“Your latest submission provided additional evidence of poor laboratory practice beyond what was cited at the survey, which leads us to question the effectiveness of the laboratory’s oversight mechanisms and the competency of personnel,” wrote Karen Fuller, a San Francisco-based regional manager with CMS. “The submission also fails to provide assurances of the laboratory’s ability to provide accurate and reliable patient results.”
In the letter, dated Aug. 13, 2020, federal health officials outlined proposed sanctions, including fines, suspending Medicare payments, revoking the laboratory’s certificate and its ability to operate the lab for two years.
Another sanction would have required the hospital to compile a list of all patients, physicians and other clients that had used some or all of the lab’s services since May 18, 2018, and to then notify them that their tests results may not have been performed according to regulation. The hospital had until August 24 — 10 days — to respond to the letter.
The sanctions were sent to the hospital’s CEO, Kimball Anderson, and the laboratory director at the time, Dr. Blair McGirk.
Over the next week, the lab’s leadership scrambled. They met at least three times with state officials, hospital executives and TestUtah partners, interviews and calendar invites show.
By Aug. 20, Timpanogos had a letter ready, from Anderson to the affected patients. In it, Anderson informed patients that from April 1, 2020, to Aug. 20, 2020, test results “may not have been performed” according to legal regulations.
“While this does not necessarily mean your tests [sic] results were inaccurate or unreliable, we understand and apologize for any worry or concern this news may cause you,” the draft letter stated.
The hospital had hired a mailing company to prepare the letters, documents show. By Aug. 21, 2020, the lab had its list of identified patients, with the exception of the addresses of patients who had provided specimens collected by the Utah National Guard, for testing for COVID-19.
That same day, Cheryl Dobbe, a CMS inspector who had conducted the May 2020 inspection, notified the hospital that the proposed sanction of notifying patients was lifted. The letters were returned to Timpanogos Regional Hospital from the mailing house, and “sequestered.”
The night before the hospital’s response was due, Anderson, the CEO, received the confirmation from Wright, at CMS, that the proposed sanction requiring patient notification was lifted.
“We do not believe this notification furthers the public health imperative for CLIA due to the short cycle of the testing involved with COVID-19,” wrote Wright, director of the Quality, Safety and Oversight Group that includes enforcement of CLIA regulations. Wright’s message to Anderson was distributed in an email sent by Stephany Seuell, a vice president of quality, risk and emergency management at HCA Healthcare.
In the hospital’s Plan of Correction, submitted on August 24, 2020, officials acknowledged they had suspended all COVID-19 testing the night before at 9:05 p.m, after it had been “determined that verification and validation had not been properly performed.”
The action, they added, “eliminates the risk of specimens being performed until adequate verification and/or validation can be completed in order to resume patient testing.”
Within days of hospital officials delivering the corrective plan, Utah state officials announced new state contracts for testing. Timpanogos Regional Hospital was out, although it has resumed other COVID-19 testing.
But Nomi, the startup based in Orem, navigated the fallout, continuing with the TestUtah contract. The company has won millions in state and local contracts in Nebraska, Iowa, Florida, Texas, Colorado, Maryland and elsewhere. In December 2021, the company announced it had raised $110 million in funding, making it another Utah tech unicorn with an estimated valuation of $1.47 billion, according to ForgeGlobal.