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.”
For the hospital and health officials, “the ethical thing is to let people know the potential they were given bad health information,” said Dr. Robyn Atkinson-Dunn, former director of the Utah Public Health Laboratory who was demoted after expressing concerns about TestUtah.
Otherwise, she added, “you’re messing with people’s health and livelihood.”
Timpanogos Regional Hospital prepared a letter in August 2020 to 100,993 patients that would have let them know the lab may not have followed protocol. Another 73,523 patient tests — which were among the TestUtah results — were also called into question, but because sample collectors had not obtained all of the patients’ identifying information, such as mailing addresses, the hospital said it didn’t know how to reach them.
Days before the letter was to be sent to patients, federal officials who oversee lab certification reversed course. David R. Wright, a director at the Centers for Medicare and Medicaid Services, or CMS, instructed the hospital that notifying those affected did not further “the public health imperative.”
