Lab supervisor: Northshore’s COVID tests ‘terribly wrong’

The Nevada public health laboratory supervisor who detected that a Chicago-based lab’s COVID-19 testing was missing most positive cases said the operation’s data was so flawed as to suggest it had not even run the tests.

Skeptical that Northshore Clinical Labs’ COVID-19 testing operation on the University of Nevada, Reno campus was providing accurate results, a university official sent specimens to both the Chicago lab and the Nevada State Public Health Laboratory.

The Nevada state lab determined that Northshore’s PCR testing had missed 96 percent of positive cases, a finding reported in a ProPublica investigation, which said officials never arrived at a clear explanation for the unreliable results.

Andrew Gorzalski, molecular supervisor at the Nevada public health lab, said last week he couldn’t say with certainty whether the lab was running the tests incorrectly or simply not running them at all.

From a scientific perspective, which explanation would be most likely? “Probably that they weren’t running the tests, honestly,” Gorzalski told the Review-Journal.

Northshore, which declined to comment to ProPublica, did not respond to a request for comment for this story.

Northshore, which the state licensed in November, conducted most of its testing in the northern part of the state: for UNR, the Washoe County School District and eventually for Washoe County at its public sites. In January and February, it also conducted testing operations at public sites in Las Vegas and Henderson.

Data ‘terribly wrong’

In mid-January, when Gorzalski detected the operation’s inaccurate results, he contacted Northshore, taking the approach of “Let me help you figure this out,” he recalled.

Inaccurate results could stem from any number of issues, from improper shipping and storage of specimens to instrument calibration. To get a clearer picture, he asked Northshore for data, which it provided for some of its samples.

“It was terribly wrong, it wasn’t accurate,” he said.

The data Northshore generated didn’t correspond with its test results, Gorzalski said. Samples with the highest levels of virus came back as negative.

“If they can’t call positive on those samples, then they have no business doing PCR testing,” he said.

Northshore had identified two of 51 positive cases from among 150 samples. Gorzalski asked for the operation’s quality control measures, which it would not provide.

“They weren’t interested in fixing their issues,” he said, adding “there was no scientific basis” for the results the company was providing.

Northshore expands into Southern Nevada

By November, Northshore had testing agreements with UNR and the Washoe County School District, and by December, with Washoe County for public sites. It would soon also expand into Southern Nevada though it did not have the proper licensing to operate statewide, ProPublica reported.

The city of Las Vegas confirmed that earlier this year, it had contracted with Northshore to provide limited COVID-19 testing.

“This was when demand for testing was at its highest levels, and the city was trying to help meet that demand,” city representative Jace Radke said in an email this month to the Review-Journal. “The city has not entered into any other contracts with Northshore Clinical Labs, and is no longer affiliated with the company.”

The city provided testing locations at Las Vegas Fire & Rescue, 500 N. Casino Center Drive, on Jan. 21-23 and on Jan. 28-30, Radke said.

“This clinic had extremely low volume and was closed January 30,” Radke said.

Northshore also operated a drive-thru location at Veterans Memorial Community Center, 101. S. Pavilion Center Drive, on Jan. 22-23, Jan. 29-30, Feb. 5-6 and Feb. 12-13.

“This clinic was demobilized February 13 due to significant reduction in community demand,” Radke said.

The city of Henderson also provided space for a testing operation.

“Northshore operated their testing site in the parking lot of Whitney Ranch Recreation Center under a standard facility use agreement without any involvement from the City,” Henderson representative Kathleen Richards said in an email.

Although the agreement was for the year, testing was limited to roughly the January and February time frame, according to Richards, who said she did not know the exact dates of operations.

“The city of Henderson did not have any kind of contractual agreement to provide COVID testing services with Northshore Clinical Laboratories,” Richards said. “The entity obtained a Henderson business license after it was licensed by the Nevada Department of Health and Human Services, which oversees the licensing requirements for diagnostic testing labs, to operate a COVID testing site.”

Meghin Delaney, a spokeswoman for Gov. Steve Sisolak’s office, said in a statement this month, “The State’s COVID-19 response coordinator worked with Northshore Clinical, which was set to start a testing program with the City of Henderson, to ensure services would remain uninterrupted and to connect Nevadans to testing during a time of great need.”

Southern Nevada Health District representative Jennifer Sizemore said that Clark County’s health agency did not use Northshore for its testing operations.

‘Immediate jeopardy’

By late December, the Centers for Medicare and Medicaid Services had cited the Northshore lab in Chicago for deficiencies that put the public in “immediate jeopardy,” word of which did not immediately reach Nevada officials, ProPublica reported.

In mid-January, following the Nevada lab’s findings, the state Department of Health and Human Services with CMS launched an investigation into Northshore operations in the state, finding several deficiencies.

By Feb. 1, UNR had terminated its contract with Northshore, citing dissatisfaction with its service. Washoe County limited Northshore’s operations to rapid antigen testing, which had proved generally reliable.

Neither state nor local nor federal government informed residents of concerns that Northshore testing results might be wrong.

As demand for testing dwindled, Northshore abandoned its operations in Nevada and asked that its license be closed. The state ultimately rescinded its license.

The CMS investigation is ongoing. “We continue to review our investigative findings to determine appropriate actions under our authorities,” a spokesman said.

Contact Mary Hynes at mhynes@reviewjournal.com or 702-383-0336. Follow @MaryHynes1 on Twitter.