Federal officials worried that more than 174,000 coronavirus patient test results from an Orem lab used by TestUtah were potentially wrong.
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.
“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.”
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.
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.
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.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.
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