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174,000 people in Utah weren’t told their coronavirus test results could’ve been wrong

FDA flags accuracy issue with widely used coronavirus test
Posted at 7:26 PM, Jan 30, 2022

OREM, Utah — 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.”

Read the full report on The Salt Lake Tribune's website.

The Utah Department of Health sent the following statement to FOX 13 News:

“In March 2020, the state of Utah contracted with Nomi Health to operate the TestUtah program. The state did not have a contract with Timpanogos Regional Hospital or Co-Diagnostics. Later that Spring, the Utah Department of Health (UDOH) assumed more direct responsibility for the TestUtah contract.

“The UDOH was not a party to the CLIA audit. However, our contract with Nomi Health requires that Nomi Health ensure any concerns raised in the audit are resolved. The final audit results from CLIA did not include a requirement or recommendation that any entity notify any patients of potential issues with their test results.”