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TestUtah lab ‘not in compliance,’ federal letter says

By Katie McKellar, KSL | Posted - Jun. 4, 2020 at 7:36 p.m.



OREM — A federal audit of the Timpanogos Regional Hospital lab that has been processing COVID-19 tests for TestUtah found that the lab is “not in compliance” with all federal regulations.

But it wasn’t clear Thursday specifically what those violations are.

The Centers for Medicare and Medicaid Services sent a letter dated Friday to Timpanogos Regional Hospital notifying it that a “complaint survey” conducted at the hospital’s lab May 18 found “your laboratory is not in compliance with all applicable CLIA conditions,” or conditions required for the lab to be certified under federal Clinical Laboratory Improvement Amendments.

“You must take steps to bring any unmet conditions into compliance immediately,” states the letter, signed by Karen Fuller, manager of the division of Laboratory Improvement and Quality.

The letter comes after the lab, overseen by MountainStar Healthcare and contracted with Nomi Health to conduct COVID-19 testing for the state of Utah, has been under scrutiny, as some have questioned the accuracy of TestUtah’s tests.

MountainStar officials last week defended the tests’ accuracy, saying the lower positive rates coming from TestUtah testing tents are easily explained by different patient populations, geography and accessibility of those tests. They also decried “undue” extra scrutiny the lab has received compared to other labs conducting COVID-19 testing in Utah, and they questioned whether it’s been a “competitor-driven issue.”

MountainStar officials said the audit is a “standard practice.” Last week, they welcomed the audit, noting that if federal regulators had found any major violations in their initial review of the Timpanogos lab, they would have shut it down immediately. That didn’t happen.

“The purpose of any hospital-based review process is to identify opportunities for improvement,” MountainStar spokesman Mike Graul said in a statement Thursday. “Such reviews are standard practice and corresponding feedback for improvement are part of the ordinary review process.”

Graul said the written report is “consistent with verbal recommendations” given by federal auditors.

“We appreciate the feedback as we advance our lab in support of our community,” Graul said. “We are actively implementing the suggested changes.”

The Timpanogos lab has “remained functioning throughout the pandemic and continues to provide accurate COVID-19 testing” for TestUtah, Graul added. “The recommendations in this report will make the lab better than ever as we continue to serve our patients and our community.”

The letter lists six federal conditions the laboratory did not meet during the survey, labeled “general laboratory systems,” “preanalytic systems,” “analytic systems,” “postanalytic systems,” “laboratory director” and “general supervisor.”

The full audit report and more details of those violations were not publicly available Thursday. Hospitals are typically given 10 days to review and respond to the report before it’s released.

However, the Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services available on the Centers for Medicare and Medicaid Services website list the conditions cited in the letter.

For a lab to be cited under the “general laboratory systems” guidelines, “significant deficiencies cited under this condition may indicate deficiencies under personnel responsibilities,” and the condition cited in the letter is used when “significant deficiencies are identified that have the potential to adversely affect patient testing, are systemic and pervasive throughout the laboratory, and are not limited to any one specialty or subspecialty.”

The “preanalytic systems” condition refers to “all steps taken prior to the actual testing of a patient specimen from the test request to the actual testing of the specimen,” according to the Centers for Medicare and Medicaid Services guidelines. Deficiencies cited under the “analytic systems” and “postanalytic systems” may also indicate “deficiencies under personnel,” the guidelines say.

The guidelines the letter cites for the “laboratory director” also state the lab must have a director who meets the qualification requirements, and the “condition of laboratory director is not met when the laboratory director” position “is not filled,” “is not qualified,” or “does not fulfill the laboratory director responsibilities.”

For the “general supervisor” condition, the guidelines state the lab must have a qualified general supervisor, and that condition isn’t met when the general supervisor position “is not filled,” “is not qualified” or “does not fulfill the general supervisor responsibilities.”

The letter doesn’t list more details about why the lab was cited under those conditions. The lab was given 10 days to submit documentation to show compliance.

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