Name: ‘Interesting coincidence’: Lab director removed same day response to federal COVID-19 testing inquiry turned in
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‘Interesting coincidence’: Lab director removed same day response to federal COVID-19 testing inquiry turned in

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Posted: Jul 22, 2020 / 10:11 PM MDTUpdated: Jul 24, 2020 / 10:46 AM MDTSALT LAKE CITY (ABC4 News) – In early June, top state health officials essentially demoted Utah’s Public Health Laboratory Director Dr. Robyn Atkinson-Dunn.The move came as state health officials witnessed a rapid increase in positive COVID-19 cases, as the demand for increased testing surged.&nbsp;Dr. Atkinson-Dunn was removed from her post at the time when she was not comfortable sending COVID-19 samples to a lab found out of compliance by federal inspectors.&nbsp;In May, federal regulators cited Timpanogos Regional Hospital’s Lab for not being in compliance with the Clinical Laboratory Improvement Amendment of 1988, or CLIA Compliance.&nbsp;It’s basically a federal certification for all labs in the United States.&nbsp;At the time, the hospital, operated by Mountain Star Healthcare, a client of ABC4 News, had been enlisted to help with the state’s coronavirus testing.&nbsp;ABC4 News obtained the federal audit conducted by the Centers for Medicare and Medicaid Services or CMS, a division of the Department of Health and Human Services.&nbsp;In the audit, investigators found, among other deficiencies, that the lab at Timpanogos Regional Hospital, “Failed to ensure positive identification and optimum integrity of patient specimens from time of collection through completion of testing and reporting of results”&nbsp;In one instance auditors were told by a lab worker that, “leaking referral specimens have been tested for COVID 19,” and that “Collection sites responsible for leaking specimens were not identified or contacted.”The report also found the laboratory failed to follow the manufacturer’s instructions for sample storage and transport, like refrigerating the specimen at two-minus eight degrees celsius, and shipping overnight on an ice pack.&nbsp;Two lab employees told investigators that, “All referral specimens sent to the laboratory for COVD-19 testing, the samples were shipped to the laboratory on a refrigerator pack, and not an ice pack.”At the time of the inspection, the federal inspector found fault with six lab processes and procedures or the lack thereof.&nbsp;Those were:“I think the results are valid that there were some discrepancies, you know the question always comes down to why were those discrepancies are there, and that was part of the conversations we were having was to try and delve into those discrepancies. Whether it was on Timpanogos or on the Public Health Lab,” said former Utah Public Health Laboratory Director Robyn Atkinson-Dunn.&nbsp;In a response dated June 8th, Timpanogos Regional Lab Director Doctor Blair McGirk told federal auditors that, “It is our understanding that the State of Utah, via the Utah Department of Health developed all of the public testing processes and protocols.”Public testing is carried out by Test Utah, a statewide testing initiative launched by several Utah tech companies to help the state perform 3,000 tests a day.&nbsp;The Test Utah project came under fire in early May when infectious disease experts began questioning the accuracy of their tests because their positive test results were far below the states and other labs.&nbsp;“The Public Health Lab at the time was trying to work with Timpanogos to try to understand some of the allegations that have been made as far as lower positivity rates from their testing, things of that nature,” said Atkinson-Dunn.Timpanogos Regional Hospital officials declined an on-camera interview, but say there were daily and weekly meetings while Test Utah was in its early stages of development.&nbsp;In a statement hospital spokesperson, Mike Graul told us, “The attendees of those meetings included hospital and lab representatives involved in COVID-19 testing, representatives from the various Silicon Slopes partners, and representatives from the Utah Department of Health, including Robyn Atkinson Dunn and other representatives from the state lab on many occasions.”ABC4 News Investigator Jason Nguyen asked Atkinson-Dunn if she gave the hospital any type of guidance on how to perform COVID-19 tests for Test Utah.&nbsp;“It is interesting that’s how they would portray it. You know in my opinion the only guidance we gave was statewide and it was mostly guidance from our laboratory regarding how to collect samples, how to do testing. It is my opinion that what they are driving at in this document that because of the way the testing was set up with Test Utah, with all the different players, that they feel somehow the lab, myself, even others within the Department of Health were responsible for setting up their procedures and their policies,” she said. ” But no, at no time did I give them any type of guidance on how to do testing, how to set it up, how it should be processed. And I frankly have no authority to do that.”&nbsp;ABC4 News asked the State of Utah Department of Health about this.&nbsp;Officials would not go on camera but we were provided a statement.“Robyn was involved in helping to establish guidance and protocol for all COVID testing in Utah, including through the Test Utah Program,” said Utah Department of Health Director of Communications Tom Hudachko.&nbsp;Timpanogos Lab Director Dr. Blair McGirk in a response to the audit states, “Thus, procedures established and governed by the Utah Department of Health (here, an agent of CMS) for the Public COVID-19 Testing, have driven the processes for which the lab is now being cited.”&nbsp;Atkinson-Dunn tells ABC4 News, “There are some claims that because we are an agent of CMS, which the laboratory is not, that we were somehow driving their procedures and policies and that is just not true.”The Orem hospital’s response to the federal audit also indicated their lab had issues inputting COVID-19 data into the state’s system because of a software program.&nbsp;Graul tells us, “This access was granted on June 08, 2020. In order to meet the concern raised in the CLIA report, the Utah Department of Health granted permission for the Lab to gain access to additional information.”June 8th was also the day Atkinson-Dunn was removed from her duties, but state officials say it was a personal matter.&nbsp;“I think it is an interesting coincidence. I think it is interesting that they state in their response that the, you know Public Health Lab, i.e. me, was in any way responsible for their process and their procedures when clearly we were not. I was not,” Atkinson-Dunn said.&nbsp;We asked if she could respond to some who might say the former lab directors may be a disgruntled employee by coming forward and talking.&nbsp;“I mean, I think disgruntled is a strong word. I’m obviously hurt by the way things happened. To be shockingly and abruptly removed from a position I’ve had for eight-and-a-half-years with pretty glowing performance reviews prior to this, not having any documented evidence that anything had gone wrong, it was hurtful,” she said. “And so it does leave you to question why? And, so you just try and put the dots together and try to understand what happened.”&nbsp;In another statement, Timpanogos Regional Hospital Tells ABC4 News:As the state sees record numbers of COVID-19 cases, the Test Utah lab at Timpanogos Regional Hospital continues to provide accurate testing results for patients in our community. The accuracy of the COVID-19 testing done at Timpanogos Regional Hospital has now been verified on multiple occasions. Most recently, the lab provided 100% accurate results in a College of American Pathologists (CAP) proficiency challenge of 1,480 COVID-19 labs across the country.&nbsp; &nbsp; &nbsp;The Test Utah lab at Timpanogos Regional Hospital is in full compliance with federal standards and has responded to the recommended suggestions identified during its recent lab audit. Such reviews are standard practice and corresponding feedback for improvement are part of the ordinary review process. We appreciate the feedback as we advance our lab in support of our community.Acting Executive Director Jefferson Burton of the Utah Department of Health also provided a statement,TestUtah was envisioned and implemented early in our state’s response to the COVID-19 pandemic as a means of increasing access to testing for Utah residents. The public-private partnership was initiated at a time when testing was scarce not only in Utah, but across the nation. To date, the initiative has resulted in nearly 50,000 Utahns being tested.&nbsp;As is the case with nearly all CLIA audits, findings of non-compliance were identified and the laboratory has been afforded the opportunity to address those findings and to become compliant. The laboratory has assured the UDOH it is addressing all of the findings.Laboratory testing is a critical element of the COVID-19 response, and ensuring the accuracy of Utah’s testing programs is a top priority. We are always exploring opportunities for improvement in all facets of our COVID-19 response.ABC4 News found out there was another round of questioning from federal auditors.After talking to CLIA inspectors, they tell us they should have all their findings within a month, which could include fines of more than $6,100 per day and possibly the loss of Timpanogos Regional Hospital CLIA Certification.&nbsp;Below are all the reports ABC4 News was able to obtain on this story.Click here to for the first alerts on your phone. Sign up for the and daily newsletters.Thanks for signing up!Watch for us in your inbox.Subscribe NowThanks for signing up!Watch for us in your inbox.Subscribe NowThanks for signing up!Watch for us in your inbox.Subscribe Now✕× Close Ad

Posted: Jul 22, 2020 / 10:11 PM MDTUpdated: Jul 24, 2020 / 10:46 AM MDTSALT LAKE CITY (ABC4 News) – In early June, top state health officials essentially demoted Utah’s Public Health Laboratory Director Dr. Robyn Atkinson-Dunn.The move came as state health officials witnessed a rapid increase in positive COVID-19 cases, as the demand for increased testing surged.&nbsp;Dr. Atkinson-Dunn was removed from her post at the time when she was not comfortable sending COVID-19 samples to a lab found out of compliance by federal inspectors.&nbsp;In May, federal regulators cited Timpanogos Regional...

‘Interesting coincidence’: Lab director removed same day response to federal COVID-19 testing inquiry turned in

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