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Investigation finds lab accused of giving false COVID test results did not meet federal requirements

Lab accused of giving false COVID test results did not meet federal requirements
Lab accused of giving false COVID test results did not meet federal requirements 03:09

CHICAGO (CBS) -- With COVID-19 outbreaks continuing to pop up, we are revisiting a question we first dug into last year – is your negative COVID-19 test really negative?

Last year, the CBS 2 Investigators exposed complaints against a west suburban medical lab accused of giving false results. Back in March 2022, we contacted the Illinois Department of Public Health about the testing complaints.

The state launched an investigation, which Medstar said would prove they did nothing wrong. But as CBS 2 Investigator Megan Hickey reported Thursday, we just learned the probe found that the lab did not meet federal requirements. 

We spoke to two COVID-19 testing site employees who said they were concerned about "suspicious negatives" coming out of the Hillside lab Medstar, which processed their tests.

"I started just testing the theory myself, by just sending positive COVID swabs," said former testing site employee Patricia Sasso.

In front of our very eyes, one worker showed us how she sent COVID-19 positive control swabs, tubes with no samples at all, and tubes with non-samples - like two pen caps wrapped in paper and stuffed into a vial.

While they should have been positive or invalid, all of them came back "negative."

"It needs to be talked about instead of brushing it under the rug, because this is something very serious," said former testing site employee D'onte Thomas.

Medstar took the allegations seriously, and to our surprise, even welcomed us into the lab and tried to explain the test results. Medstar's team pointed out that positive controls can degrade over time, which is why they say they have questions about the quality of the COVID samples that were submitted.

But what about the negative results for empty vials? In our report last year, Medstar couldn't give us any explanation for that.

The Illinois Department of Public Health launched an investigation after our story aired, which Medstar said would vindicate them.

But in a letter we received this month, the state told us: "The IDPH's investigation revealed that Medstar Laboratory Inc. did not meet the federal CLIA (Clinical Laboratory Improvement Amendments) requirements in the areas related to your complaint. Therefore, the facility will be required to take corrective actions."

At this point, we don't have specifics about what was wrong, because our Freedom of Information Act request for more information was denied.

But when we asked Medstar for a comment on the problem and what the company is doing to correct it, that question was completely ignored.

A spokesperson called us out for our "advocacy journalism," and touted their recent accreditation:

"Since CBS2 filed this complaint in its advocacy journalism inspired by a collection site worker –unaffiliated with MEDSTAR– who tampered with the testing process during unprecedented times, MEDSTAR has earned significant peer review recognition," a spokesperson said, in part.

Medstar went on to say they recently completed a very thorough, 18-month accreditation process. We will keep pushing for answers.

Medstar, founded in 1974, provides a vast array of extensive diagnostic testing across the Chicago metropolitan area, Wisconsin, and Indiana.  

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