OREM — Timpanogos Regional Hospital officials have submitted responses and remedy plans to a lengthy audit of a COVID-19 test processing lab it operates as part of the state-administered TestUtah program.

While highly technical, the audit results appear to be mostly focused on procedural issues with some citations raising questions about confirmation of test accuracy as well as personnel/lab management policy.

A letter from the Centers for Medicare and Medicaid Services sent to Timpanogos Regional Hospital two weeks ago indicated a “complaint survey” conducted at the hospital’s lab May 18 found “your laboratory is not in compliance with all applicable CLIA conditions,” or conditions required for the lab to be certified under federal Clinical Laboratory Improvement Amendments.

The audit listed six federal conditions the laboratory did not meet during the survey. In a statement, hospital officials said they “are actively implementing appropriate, suggested changes” and noted none of the issues rose to the level of requiring the lab to cease operations.

“If there were any major concerns discovered during the CLIA audit, the lab would have been immediately shut down,” the statement read. “This was not the case. The lab at Timpanogos Regional Hospital remains open and has been fully functioning throughout the pandemic.

“We continue to provide accurate COVID-19 testing results through the TestUtah initiative while we implement the recommended suggestions to improve our lab.”

The state of Utah, which owns and oversees the TestUtah effort including the TestUtah.com assessment website, appears to also have confidence in how the lab is functioning.

According to Nomi Health, the lead contractor for the TestUtah program, state officials asked last weekend if the lab could take on an additional 900 tests a day that the Utah Public Health Laboratory was unable to process, due to increased volumes of COVID-19 testing.

Auditors wrote that while standards require the lab director to be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed, that person “was not accessible to the laboratory between March 27-April 27, when the COVID-19 tests procedures were implemented and later modified.”

Timpanogos officials said the lab director, Dr. Blair McGirk, is “in the high-risk category for COVID-19 and has been following guidelines to isolate at home” but was “always accessible to the lab” throughout the period noted both telephonically and electronically.

Results from the tests processed by the Timpanogos lab have been under scrutiny since the program launched, with critics claiming low rates of positive tests as evidence of accuracy issues. But, hospital officials have defended the veracity of the work, noting the lower positive rates coming from TestUtah testing tents are easily explained by different patient populations, geography and accessibility of those tests.

They also decried “undue” extra scrutiny the lab has received compared to other labs conducting COVID-19 testing in Utah, and they questioned whether it’s been a “competitor-driven issue.”

Accuracy issues were also raised in the lab audit, with one citation noting that verification procedures to determine accuracy and precision were “not met because the ... laboratory modified a COVID-19 test that received an emergency use authorization from the FDA and failed to establish performance specifications before reporting patient test results.”

Timpanogos’ response detailed that “in late March, prior to commencing COVID-19 testing, the lab completed the testing validation for the Logix Smart test, in the manner recommended by the FDA.

“This required the lab to send correlation samples (split samples over multiple days) to the  Utah Public Health Laboratory ... and UPHL’s test results were 100% consistent with the lab’s test results. To be clear, this validation process confirmed that UPHL and the lab had the same tests results when testing the same samples. No other validation of the test was required.”

The issue of differences in the results from the Co-Diagnostics test processed at the Timpanogos lab and results from other Utah lab facilities was also addressed in a white paper authored by Co-Diagnostics Chief Scientific Officer Brent Satterfield.

Satterfield wrote that TestUtah results prior to May 2 were a reflection of “a TestUtah consortium including the Utah Department of Health, the Governor’s Office of Management and Budget, the Leavitt Group and a consulting group of epidemiologists (that) created a more lenient online assessment to proactively encourage Utahns to be tested in an effort to ‘crush the curve.’”

The “broad and nonspecific definition of ‘symptomatic’ allowed large numbers of people to be tested as per the goals of the consortium,” Satterfield wrote. “However, shortly after implementation differences in the rates of positives between those recruited through TestUtah’s online assessment and those referred by physicians through a stricter set of criteria became apparent, Gov. Herbert said the question of how the rates of positives are affected by who gets tested was “a concern to reconcile so we make sure the results are accurate.” 

Satterfield wrote that a department of health revision of the assessment on May 2 that narrowed testing parameters to six more serious symptoms “brought the assessment more in line with the same definition of ‘symptomatic’ that is used in a health care provider’s decision to refer a patient for testing during an actual office visit, changing the population of people who were being screened by TestUtah.”

In a statement, Co-Diagnostics noted federal auditors did not question or cite the performance of the COVID-19 test kit the diagnostics company manufactures at its Salt Lake City facility.

“The audit letter is an evaluation of the testing process and does not comment on the quality or performance of the diagnostic assay,” the statement read. “The Co-Diagnostics test continues to demonstrate exemplary sensitivity and specificity (the benchmarks for accuracy) in multiple, independent evaluations of its clinical performance.”

Several issues raised in the audit highlighted communication and reporting issues that appear to be tied in to the Utah Department of Health’s oversight of the software, developed under contract by Provo-based Qualtrics, behind the TestUtah program. One item in the audit cited the lab for missing information in a required test report.

The hospital’s response pointed out that the software behind the TestUtah program was solely under the control of the health department and that requested changes to help Timpanogos come into compliance had not been addressed at the time of the audit.

In another portion of the report, Timpanogos noted that those changes had been implemented by the health department on June 8.

In response to a Deseret News request for comment on the audit results and the responses provided by Timpanogos Regional Hospital, Utah Department of Health acting director Gen. Jeff Burton said his agency had not yet completed its review of the findings, but would work to help the TestUtah lab maintain compliance with federal regulations.

“We will be conducting this review over the coming days, including areas where we can make adjustments to help the laboratory maintain compliance,” he said.

Burton also noted that most audits result in findings that need to be addressed by lab operators and his department had received confirmation from Timpanogos Hospital that the issues were being resolved.

“As is the case with nearly all CLIA audits, findings of noncompliance were identified and the laboratory has been afforded the opportunity to address those findings and to become compliant,” Burton said. “The laboratory has assured the UDOH it will address all of the findings.

“We look forward to working with Timpanogos Regional Hospital to address the audit’s findings and to ensure Utah residents continue to have access to the best possible COVID-19 testing.”

Nomi Health also weighed in on the audit and its ongoing role in the state’s response to the COVID-19 pandemic.

“We’re glad we could step up yet again for the state of Utah in a moment of need,” a company statement read. “If the state doubted the capabilities of the lab, they would not continue to partner with TestUtah.