TestUtah’s lab for COVID-19 testing is not in compliance with federal requirements, regulators find

(Trent Nelson | The Salt Lake Tribune file photo COVID-19 testing at Timpanogos Regional Hospital in Orem on Tuesday, April 14, 2020.

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The hospital lab that has been processing COVID-19 tests for TestUtah is "not in compliance" with federal certification guidelines, according to regulators who inspected the lab in May.

But the lab at Timpanogos Regional Hospital in Orem is still performing coronavirus tests for TestUtah, despite lingering questions as to the accuracy of the statewide testing system operated by Utah tech companies.

And Jeff Burton, director of the Utah Department of Health, said Thursday he would rely on Timpanogos Regional to alert patients as to whether they should be retested for COVID-19.

As Timpanogos Regional works now to come into compliance, Utah is seeing a continuing statewide spike in coronavirus cases, with 316 new diagnoses announced Thursday. It’s the eighth day in a row that the state has reported jumps of more than 200 cases.

No deaths were reported between Wednesday and Thursday, and the state’s death toll stands at 117 people.

The state’s latest public health order — which has most of the state, outside Salt Lake City, at the low-risk “yellow” status — is set to expire Friday. The state’s Public Health and Economic Emergency Commission is urging Gov. Gary Herbert to move to a “modified yellow” and what it calls “smart green” safety levels across most of Utah.

Meanwhile, a Salt Lake County resident filed a request for an injunction in state court Thursday, arguing Herbert’s coronavirus orders have overstepped his authority and seeking to block their enforcement.

In May, regulators from the Centers for Medicare and Medicaid Services inspected the lab at Timpanogos Regional after they received a complaint, according to a letter to the hospital last week.

“We find that your laboratory is not in compliance with all applicable CLIA Conditions,” the letter stated, referring to the Clinical Laboratory Improvement Amendments, which govern medical labs nationwide. “Laboratories that do not meet the ... requirements of CLIA may not be certified to perform laboratory testing under the CLIA program.”

MountainStar Healthcare, which owns the hospital, described the report as “part of the ordinary review process."

”We appreciate the feedback as we advance our lab in support of our community. The written report we received was consistent with verbal recommendations provided by CLIA," administrators wrote in response to an inquiry from The Salt Lake Tribune. “We are actively implementing the suggested changes.”

The state health department has “not seen the details of the CLIA audit," Burton wrote in a prepared statement in response to The Tribune’s questions. But, he said, “[we] understand the audit returned findings that some areas of the lab did not meet CLIA compliance requirements.”

“... Non-compliance findings are not out of the ordinary for CLIA audits. CLIA has provided the laboratory with the opportunity to come into compliance, and we fully expect it to do so," he wrote.

"If CLIA had reason to believe any TestUtah results should be invalidated, or that individuals should be re-tested, we would expect that information to be relayed to those individuals from the lab,” he added.

The regulators’ letter to the hospital does not identify the person whose complaint initiated the unannounced inspection in May, but public health officials have said they heard the complaint came from out of state. The Tribune obtained the letter through a public records request.

Regulators did not provide the report that identifies the violations they found. Instead, the letter notes general areas where the number or severity of “deficiencies” were enough to imperil the lab’s certification:

  • "General laboratory systems," or how the lab monitors and evaluates its overall function.

  • "Preanalytic systems," or how it handles test requests and specimens before they are processed.

  • "Analytic systems," or how it conducts the tests.

  • "Postanalytic systems," or how it reports the results of tests.

  • Qualifications or performance of the lab director and the general supervisor.

Federal inspectors issue two levels of citations; those described at Timpanogos Regional are “Condition-level,” or the more serious of the two.

“The determination that a laboratory is not in compliance with an applicable Condition is one of the most serious decisions the (regulators) can make,” CMS administrators wrote in their enforcement guidelines for lab inspectors

However, the regulators did not take their sternest action: a finding of “immediate jeopardy,” which is reserved for labs whose violations threaten serious harm to patients, or the health of the general public. That would have required immediate corrective action.

“The lab at Timpanogos Regional Hospital has remained functioning throughout the pandemic and continues to provide accurate COVID-19 testing results through the Test Utah initiative,” MountainStar’s statement read.

In their letter, federal regulators note that their inspections “may not find every violation that the laboratory may have committed” because they are conducted through “random sampling.”

But the letter doesn’t specify whether the lab’s COVID-19 testing was specifically evaluated, or whether inspectors were apprised of a now-scrapped state review of TestUtah’s accuracy.

While federal regulators were conducting the audit, state health officials were comparing coronavirus results for batches of samples tested by Timpanogos Hospital and by the Utah Public Health Lab. The state undertook the experiment in response to questions about the accuracy of TestUtah, whose operators have secured more than $60 million in no-bid contracts in Utah and two other states.

Data collected in April showed that the positive rate for TestUtah’s symptomatic patients was less than half that of other test providers. And in Nebraska, where the same companies have contracts, their rate of positive results has been less than a third of the overall positive rate.

TestUtah agreed to compare results with the state as a “compromise” after its operators refused to join Utah’s other labs in a formal proficiency experiment to check the sensitivity of each others’ coronavirus tests. Then, after weeks of review by state health officials and MountainStar’s parent company, HCA, health officials decided to throw out the results.

There were “questions about the validity” of the samples used in the experiment — particularly those supplied by the state, Burton said. Health officials have declined The Tribune’s request for the results, saying they remain in “draft” form only.

But a May 21 letter from MountainStar’s attorney to Burton provides some detail about the results. For the first 40 samples, which were “randomly selected” by the Timpanogos Regional, the hospital’s results were the same as the state’s, according to attorney Kristy Kimball.

Then the state provided 50 samples — but did not test them until they were seven days old, by which time they produced negative results in several samples where the hospital lab had detected the virus. “That delay increased the likelihood of unreliable test results,” Kimball wrote — the same explanation Burton gave for throwing out the experiment.

But, Kimball wrote, the state then sent a third batch of samples, this time frozen, to the hospital for comparison. On three of the 40 samples, the state and the hospital got “variances,” or different results, she wrote.

Because the state will not release the full results, it hasn’t disclosed whether the three samples with differing results were positive or negative — or how many of each type there were. That information affects what those results could reveal.

For instance, say a batch of samples includes six positive samples and all three of a lab’s variances were negative — that would mean a virus went undetected in half of the samples where it was present. If a lab detected a virus 23 times in a batch that only included 20 positive samples, that would mean 13% of its positive results were false.

But, Kimball argued, in all of the sample comparisons between Timpanogos Regional and the state lab, the hospital’s results matched the state’s 98% of the time — though to arrive at that figure, she excludes all of the mismatched results from the flawed second batch while still including those where the labs agreed.

It’s not clear why Burton threw out the results even though the state replaced the flawed batch of samples. He has said the state hopes to launch a new experiment.

But Kimball said the state has “all the information it needs."

”We respectfully ask that the DOH agree to ... pause its ongoing reviews of the Timpanogos lab," she wrote. “... 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 the DOH and Timpanogos.”

It’s unclear whether public health employees agreed that the results proved no further review was needed — but health department emails obtained on Thursday by The Tribune show that the day after they received the results, several employees were called to a Saturday afternoon meeting to “discuss TestUtah talking points.”

Two days after that, state lab staff requested documentation of Timpanogos Regional’s testing and equipment evaluations, as well as personnel records. Most discussion of the sample comparison is redacted.

Descriptions of the samples that led to the federal violations and other details of the inspection will not be available until Timpanogos Regional has responded to the report later this month.

In order to keep its certification, the hospital lab has to show, among other things: How it identified patients who may have been affected by each “deficient practice;” how it corrected the problem for patients who were affected; what measures it took to make sure the problem doesn’t happen again; and how it will monitor that solution’s success.

If the fixes pass regulators’ muster, inspectors may return to the lab for a follow-up visit. If not, the lab could face fines of more than $6,000 per day or lose certification and Medicare payments. “These investigations ... may well identify violations that may not have surfaced during a routine survey using random sampling, but for which the laboratory and its director will still be held responsible,” regulators warn.

In the meantime, MountainStar spokesman Mike Graul, said the hospital lab is operating as usual, and will continue to process samples for TestUtah. TestUtah had conducted more than 26,000 tests as of mid-May.