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TestUtah lab officials defend accuracy, decry ‘undue’ extra scrutiny

MountainStar official questions if public scrutiny has been a ‘competitor-driven issue’

Katlyn Langston, medical lab technician, does RNA extraction for COVID-19 testing in an oKtopure at Timpanogos Regional Hospital in Orem on Thursday, May 28, 2020.
Katlyn Langston, medical lab technician, does RNA extraction for COVID-19 testing in an oKtopure at Timpanogos Regional Hospital in Orem on Thursday, May 28, 2020.
Kristin Murphy, Deseret News

COTTONWOOD HEIGHTS — MountainStar Healthcare officials say they’re running out of patience with ongoing criticisms and misinformation that continue to circulate about the provider’s COVID-19 test procedures and note that, in some cases, those issues are being raised by direct competitors that are embedded in the state’s pandemic response teams.

Criticisms first surfaced when an April 14 email written by Intermountain Healthcare infectious disease physician Dr. Bert Lopansri was released publicly that took aim at the COVID-19 tests being performed at Timpanogos Regional Hospital.

“I worry about having tests routed to a small community hospital lab inexperienced with highly complex molecular testing that uses a test from an unknown company without much in vitro diagnostic experience that has a higher limit of detection compared to tests offered by more established vendors,” Lopansri wrote. “A pandemic is not the time for amateurs to learn.”

In a wide-ranging interview Thursday, MountainStar Chief Medical Officer Dr. Michael Baumann responded directly to that claim, noting Timpanogos Regional is one of eight MountainStar facilities which themselves are part of the largest health care system in the nation. That parent company, Nashville-based HCA Healthcare, operates over 180 hospitals in 21 states and two countries. Baumann noted that Utah MountainStar facilities are providing health care to almost a quarter of all Utahns.

Dr. Michael Baumann, MountainStar Healthcare’s chief medical officer, answers questions about TestUtah COVID-19 testing at the MountainStar Healthcare office in Midvale on Thursday, May 28, 2020.
Dr. Michael Baumann, MountainStar Healthcare’s chief medical officer, answers questions about TestUtah COVID-19 testing at the MountainStar Healthcare office in Midvale on Thursday, May 28, 2020.
Kristin Murphy, Deseret News

“To call a system with over 180 hospitals with labs ... ‘amateurs’ in management and direction of labs is ridiculous,” Baumann said.

‘Built-in prejudice’

Dr. Heather Signorelli, who oversees laboratory operations at all of HCA’s facilities, said the network’s facilities have collectively processed tens of thousands of COVID-19 tests across the U.S. and have the advantage of being able to share insight and best practices across and between its member hospitals and labs.

She said the ongoing scrutiny has been baseless and ill-timed.

“It’s one thing to have a moment where you want to verify that the appropriate steps are being made in order to evaluate a methodology,” Signorelli said. “But to keep going after it time and time again ... it is really disappointing.

“We’re in the middle of a pandemic and there are plenty of other things we could be spending our time doing.”

Baumann, who said MountainStar’s No. 1 priority is its patients, said if there were any issues at all with the lab’s COVID-19 testing accuracy, “I’d be all over it.”

But, Baumann said, TestUtah’s tests have now cleared multiple accuracy tests with flying colors — and yet he said there continues to be “undue” additional scrutiny that isn’t equally applied to other labs conducting COVID-19 testing in Utah.

“There is almost a built-in prejudice in favor of these other labs,” Baumann said. “We’re all developing and using new tests, so all of these labs should have the same level of scrutiny, and I think the scrutiny is being generated because this lab is a new entrant into the environment and a direct competition site for ARUP and IHC.”

Timpanogos Regional has been processing COVID-19 tests both for its own patients and those who get tested via the TestUtah program using a test kit manufactured by the Salt Lake-based medical diagnostics firm Co-Diagnostics. Both the Co-Diagnostics test and the lab that processes them in Orem are authorized under U.S. Food and Drug Administration emergency use authorization guidelines.

The efficacy of those tests was called into question by Lopansri who, in his correspondence, noted the low rate of positive tests being run by the Timpanogos lab was evidence that something was wrong with the testing process.

Lopansri is a member of the Utah COVID-19 Task Force, assembled by Gov. Gary Herbert, as well as an employee of Intermountain Healthcare, a competitor of MountainStar and the largest health care provider in Utah. While Intermountain, U. Health and other providers are represented on the task force, no representatives of MountainStar were invited to participate on the board, according to Baumann.

Lopansri’s concerns, according to his correspondence, stemmed from data reflecting that tests being processed by Timpanogos Regional, under contract with the company leading out on the TestUtah effort, Nomi Health, were showing a lower rate of positives than tests being conducted by other entities, including Intermountain Healthcare and ARUP, another competitor of both Mountainstar and Co-Diagnostics.

“What alarms me the most is that they are expanding collection and testing with these unknowns about how their test performs,” Lopansri wrote. “If correct, I urge you to halt their testing until we understand why their results differ so much from what other labs are reporting as this is a potential public health disaster that will be compounded by the fact that they are constantly promoting themselves publicly while we are not.”

Baumann said two batches of random sample testing assessments done in a side-by-side comparison with the state’s testing lab both returned results that were 100% accurate.

There was also data available at the time that showed that while test results from those who tested at TestUtah drive-thru testing sites were notably lower than results from other testers, the tests processed by Timpanogos Regional of HCA’s own patients was within a percentage point or two of the stats from other providers.

Lab assistant Andrew Sheffield plates patient samples for TestUtah COVID-19 testing at Timpanogos Regional Hospital in Orem on Thursday, May 28, 2020.
Lab assistant Andrew Sheffield plates patient samples for TestUtah COVID-19 testing at Timpanogos Regional Hospital in Orem on Thursday, May 28, 2020.
Kristin Murphy, Deseret News

Baumann said the lower positive rates coming from TestUtah testing tents are easily explained by different patient populations being tested. He pointed out that the positive rate for in-patient tests — those who had visited doctors due to symptoms — versus the lower rate of TestUtah results from those who only filled out an online assessment with lower barriers for referrals for testing, were a clear reflection of that contrast.

Those MountainStar patients as well as individuals who scheduled tests through the TestUtah site all were assessed for COVID-19 using the Co-Diagnostics test kit processed by the Timpanogos Regional lab.

“All of our labs should have the same level of scrutiny,” Baumann said. “Given what I think is undue level of scrutiny, in part started with an email from one of our competitors, puts this issue of ‘Is this a competitor-driven issue?’ on the table, and makes us have to consider that as part of what we look at when we see all that’s transpired since we became a part of TestUtah.”

Lopransri, after discussing the issue with Co-Diagnostics and Timpanogos lab officials, sent an email May 1 addressing his “private” email to state officials, which he said was meant to “encourage prompt action to resolve concerns.”

“Since my email was sent on (April 14), we’ve had a number of discussions about these differences,” he said. “The concerns remain, and we are committed to continuing the dialogue in order to resolve them.”

Lopransri added: “As I stated in my conversation, I regret that the impassioned language that I used was made public. My goal was to spur action and was not intended to harm the reputation of the parties involved. We are all in this unprecedented battle together. It is important to the health of Utah citizens that we are all successful in providing accurate and timely testing.”

Abandoned test

If their tests had no accuracy issues, why, then, would MountainStar refuse to participate in a larger proficiency test other major Utah labs conducting COVID-19 testing had agreed to join in order to verify each others’ accuracy?

To MountainStar officials, it was a matter of process and fairness. They didn’t like the idea of the test being run by one of their competitors, ARUP, without an independent reviewer.

“We all along would have been happy to participate in a proficiency test that was fair, balanced and adjudicated by an independent third party,” Baumann said. “The proficiency test that was being offered was being, actually, designed and run by one of the lab directors at ARUP, which is one of our competitors.”

So, instead, MountainStar agreed to a compromise. They worked out a smaller sample exchange, where MountainStar agreed to exchange three batches of samples, for a total of 130 samples, with the state’s lab to compare test accuracy.

But those results were never released by the state health department. Instead, Gen. Jeff Burton, acting director of Utah’s Department of Health, said he decided against releasing the results because of problems with the samples, including a batch from the state’s lab that were not randomly selected, and some samples that were 10 days old, or too old to produce accurate test results.

“That’s not really a fair assessment, and that’s not an accurate assessment,” Burton said. “So that’s why we said, ‘We want to do this again.’”

Burton said state officials are planning to set up another proficiency test with a third-party review — but he’s also waiting for the results of a federal audit on Timpanogos lab (a Clinical Laboratory Improvement Amendments audit).

Burton and MountainStar officials note that if federal regulators had found anything major in their initial review of the Timpanogos lab, they would have shut it down. That didn’t happen.

“Once I get that (audit), then we’re going to hammer out how we revalidate, and how to make them feel comfortable with how we do it so it doesn’t feel like an attack or hit on them,” Burton said.

‘Inaccurate information’

Burton last week received a letter from a MountainStar attorney outlining concerns that the Timpanogos lab had been the subject of excessive scrutiny that had led to “inaccurate information” and a “distraction” from COVID-19 response.

“We need your help to correct the public record regarding the tests and the lab, so that the Utah health care community can return its focus to providing our fellow residents with the high-quality health care they need and deserve during this critical time,” wrote attorney Kristy Kimball, in the letter dated May 21.

Kimball wrote the state health department’s multiple reviews — requested despite the Timpanogos lab completing a testing validation recommended by the FDA in late March — “clearly confirm the accuracy of the tests processed by the Timpanogos lab.” She also listed a slew of reasons why “no further (state health department) reviews of the lab are now warranted.”

In March, the Timpanogos lab completed FDA-recommended testing validation, she continued. “This required Timpanogos to send correlation samples (split samples over multiple days) to the Utah Public Health Laboratory, and UPHL’s test rests were 100% consistent with Timpanogos’ test results.

“To be clear, this validation process confirmed that UPHL and Timpanogos had the same test results when testing the same samples,” Kimball wrote.

But that didn’t assuage concerns.

“Despite the universally positive results of that FDA-recommended validation process, the DOH raised concerns about ‘false negative’ test results from the Timpanogos lab,” Kimball wrote. “Although it vehemently disagreed with those concerns, Timpanogos agreed to work with the DOH to assuage those concerns and exchanged three additional sets of correlation samples with UHPL for a total of 130 samples.”

The results of those tests included a 100% consistent test result with the first set of 40 samples randomly selected by Timpanogos. The second set of 50 samples, however, “unfortunately, due to conflicting instructions” from the state health department, were not tested by the state lab until about seven days after they were collected, Kimball wrote.

“That delay increased the likelihood of unreliable test results, and not surprisingly, six of the 50 variances did not support the DOH’s stated concern of ‘false positives’ since five of the six variances showed that the Timpanogos lab results were ‘positive’ while the UPHL lab tests were ‘negative’ or ‘inconclusive,’” Kimball wrote.

Then, a final set consisted of 40 frozen state lab samples sent by the state health department to the Timpanogos lab. Of those, “only three of the 40 samples showed a variance between the results reached by Timpanogos and UPHL,” Kimball wrote.

“The Timpanogos lab has now completed four rounds of validation testing and none support the still-vague suggestion that it produces ‘false negative’ results,” Kimball wrote. “Moreover, Timpanogos’ results have matched UHPL’s results 98% of the time.”

In a footnote, Kimball noted that “high correlation rate is even more impressive, considering that the ‘second’ and ‘final’ sample sets were chosen by the DOH, without any input from Timpanogos, and that 40 of the 50 ‘second’ set were ‘negative’ patient samples.”

“We believe the DOH now has all the information it needs to feel confident about the testing work performed at the Timpanogos lab,” Kimball wrote, though she added if state officials want additional reassurance, the lab is participating in the College of American Pathologists’ first national survey on COVID-19 testing proficiency, and the results of the survey will be available in a few weeks.

Kimball, concluding her letter, “respectfully” asked state health officials to “pause” reviews of Timpanogos lab, at least until the end of the College of American Pathologists’ survey.

“The DOH’s reviews are unnecessary and distracting to the lab employees, and they will result in a further erosion of the otherwise good relationship between DOH and Timpanogos,” she wrote.

Kimball also asked state officials to “cease any inaccurate and/or public criticism of the Timpanogos lab.”

“That criticism is perpetuating a false narrative about Timpanogos, both generally and in the context of COVID-19 testing,” she wrote. “More importantly, however, it is undermining public confidence in Utah’s COVID-19 testing efforts.”

Burton, asked about that letter on Thursday, said MountainStar’s concerns were fair.

“They want a level playing field,” he said.

However, Burton said that “additional scrutiny” has come because MountainStar, through the state’s TestUtah contracts with Nomi Health, are contracting with the state, and any concerns about accuracy need to be vetted.

“When I’m the contractor, I have the right to know that the processes are valid and things are going well and so we need to do periodic review of that,” he said. “So I don’t apologize for it.”

However, Burton credited the TestUtah tests for helping Utah expand its testing capacity to be in the top five states in the nation with high testing capacity.

“They’ve helped us tremendously,” he said. “We couldn’t have done it without them.”