Federal officials worried that more than 174,000 COVID-19 test results from Timpanogos Regional Hospital in Orem, Utah, were wrong, but those patients were never notified, The Salt Lake Tribune reported Jan. 30.
Public officials knew as early as May 2020 that the hospital's lab, which was being used by TestUtah to perform COVID-19 tests, wasn't following requirements designed to ensure tests are processed accurately, the report said. The lab didn't suspend COVID-19 testing until Aug. 23, 2020.
"[The] ethical thing is to let people know the potential they were given bad health information," said Robyn Atkinson-Dunn, PhD, former director of the Utah Public Health Laboratory who was demoted after expressing concerns about TestUtah.
The hospital prepared a letter in August 2020 to notify 100,993 patients about the errors, but another 73,523 patients were left out because sample collectors hadn't obtained the necessary patient information, including mailing addresses.
But days before the letters were to be sent out, David Wright, quality safety and oversight director at CMS, told the hospital it didn't need to notify those affected, the report said. The letters were then returned to the hospital from the mailing house and sequestered.
"We do not believe this notification furthers the public health imperative for [CMS' Clinical Laboratory Improvement Amendments] due to the short cycle of the testing involved with COVID-19," Mr. Wright said in an email distributed by Stephany Seuell, BSN, a vice president of quality, risk and emergency management at HCA Healthcare, according to the report.
Among the state officials who knew the test results were possibly flawed, the report said, 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.