SALT LAKE CITY — “Immediate jeopardy to patient health and safety.” That’s how federal lab inspectors are describing TestUtah in documents obtained by the Salt Lake Tribune, content sharing partners of FOX 13 News.
Reporters at the Salt Lake Tribune published an article Thursday, saying the feds visited TestUtah sites and allegedly told the company they committed the most severe level of violation a health lab can reach.
Erin Alberty, reporter with the Tribune, told FOX 13 News that it was the state who reached out to federal health officials to look into the labs.
“They considered what they found to be ‘immediate jeopardy,’” explained Alberty. “Immediate jeopardy is the highest designation for a violation under the federal lab regulation.”
She and fellow Salt Lake Tribune reporter, Bethany Rodgers, obtained both state and federal documents detailing TestUtah lab practice concerns dating back to September.
“Tests being kept to process much longer than the five minute window that the results are valid for, tests being left in a pile somewhere, staffers not changing gloves between tests,” listed Alberty.
Josh Walker, chief operating officer of Nomi Health, the company that operates TestUtah, said Utahns have nothing to worry about in the handling of their tests.
“Your viewers should feel rest-assured that the sites that were being operated were being done really well with seasoned professionals in the healthcare industry who were able to oversee and make sure that the policies and protocols that we were using at the site are the very best,” he told FOX 13 News.
The Utah Department of Health sent FOX 13 News the same statement they shared with the Salt Lake Tribune, writing, “By contract, Nomi Health is required to: “Ensure that all collections are conducted in accordance with [the Clinical Laboratory Improvement Amendments program].” UDOH regularly monitors performance and when concerns are raised, we inform Nomi of the concerns and implement a resolution process. We have not seen the CMS report you referenced and have requested it from CLIA. Since state-sponsored testing is paused for all vendors, effective close of business today, we will use the time during this pause to review the issues raised in the CLIA report and Nomi’s response once we receive them and determine appropriate actions.”
These aren’t the first questions about the reliability of Nomi Health’s testing.
In 2020, about 174,000 patient test results were potentially wrong according to documents earlier obtained by The Salt Lake Tribune and FOX 13 News. Neither Nomi Health nor the testing laboratory at Timpanogos Regional Hospital opted to tell patients.
When it comes to concerns and complaints, Walker says the company takes them seriously.
“Whether grounded or ungrounded, we chase them all down with urgency and treated them all seriously where they were or weren’t,” he said. “We found many of them were individuals who were misinformed or confused but at the end of the day we still treated those with the utmost urgency.”
According to the Salt Lake Tribune, Nomi Health was given a letter on Mar. 16, saying the company no longer met the requirements to perform COVID-19 testing under federal law. Agencies did not require TestUtah sites to close and there was no public announcement.
Reporters with the Tribune wrote that inspectors with the Centers for Medicare and Medicaid Services asked Nomi Health to show it was complying with standards by Mar. 26, or else it’d be fined nearly $22,000 a day.
The Salt Lake Tribune reported that “the current status of Nomi Health’s compliance is unclear.”
Walker told FOX 13 News that he can’t comment on this part of the investigation, but said the company is working with the proper agencies and feels “confident” about the communication.
“We see this as a standard part of the process to ensure that the programs that we’re running are running the way they should,” he said.
In a response to the article, Nomi Health also shared this statement with FOX 13 News: “CLIA engaged us with specific improvements. Our clinical and quality team responded quickly and with rigor. It’s a federal process that is still underway, and we look forward to working together in this process. We reject any implication or insinuation by certain people inside the Utah Department of Health that the lack of efficacy of certain antigen tests is somehow unique to Nomi Health. It is not. Our national findings on antigen test efficacy were consistent with the State of Utah’s findings for certain tests, leading the state to halt antigen testing. The State of Utah Epidemiologist Dr. Nolen herself acknowledged as much in our many meetings with her as evidenced by her briefing to us the day after the Department’s press conference about their concerns.”