CHICAGO — The list of Chicago-based companies that operate COVID-19 testing sites now under investigation is growing, with a third company under scrutiny after collecting more than $154 million from the federal government amid a sea of consumer complaints.
Northshore Clinical Laboratories, which is not affiliated with NorthShore HealthSystem, worked with third-party pop-ups all over the United States before ending its partnerships with them in late December. It’s also partnered with schools, nursing homes, politicians and other groups on testing and vaccinations. It’s processed at least 5 million tests, according to a federal report.
But the federal agency that regulates labs has cited Northshore at its highest level — immediate jeopardy — in three areas, with an inspection saying the lab failed to follow steps to ensure it got reliable results.
The Illinois Department of Public Health is investigating the lab, a spokeswoman said. The Illinois Attorney General’s Office has received more than 40 complaints about Northshore Clinical Labs and is contacting consumers to get more information, a department spokeswoman said. Nevada’s and California’s health departments are also investigating.
And the Better Business Bureau, a nonprofit business watchdog group, has received 13 complaints about Northshore Clinical Labs. The group has given the lab an “F” rating.
The complaints are similar to ones lodged against two other local companies: Center For COVID Control and O’Hare Clinical Lab. Numerous customers said they’ve had issues getting results from Northshore, with results being delayed by weeks or never coming.
One woman said she was sent another person’s results, while another woman said she was sent different results for the same test.
“We have done everything we can to support public health efforts around testing and vaccination to keep the community safe,” a Northshore Clinical Labs spokesman said in an emailed statement.
Northshore Clinical Labs has cut off its work with third-party pop-up testing sites, and it “regrets” customers have had delays in getting results or haven’t heard from the lab, the spokesman said.
The lab is working with a consultant to ensure it’s in compliance with the law, the spokesman said. The Omicron variant — which drove up COVID-19 cases and testing around the United States — and other factors have put strain on the lab, the spokesperson said.
But customers were reporting problems long before Omicron hit.
Hope Zawaski, of suburban Homewood, said she was tested at a pop-up Aug. 20 and then waited four days to get PCR results from Northshore Clinical Labs, calling multiple times only to be told her sample was still being processed. The lab sent a result as Zawaski was sitting in the home of her mother-in-law, who was receiving treatment for cancer, putting her at higher risk from the virus. The result said Zawaski’s test was positive for COVID-19.
Zawaski immediately walked out of her mother-in-law’s home, contacted people with whom she’d been in contact and quarantined.
Four days after the positive result, Northshore sent another result — this time saying Zawaski was negative, she said. The result was otherwise identical to the initial email sent to Zawaski, she said.
Zawaski also tested negative at her doctor’s office, and she did not have symptoms of COVID-19, she said. She contacted Northshore Clinical Laboratories, concerned about the “strange results,” she said.
“And they said, ‘Oh, yeah, sometimes you just get a positive that turns into a negative,'” Zawaski said. “They just said, ‘Have a nice day,’ and that was it.
“I was at a point where I was like, you just have to laugh.”
Getting different results from the same test concerned Zawaski, she said — but the response when she called made her even more worried.
“I tell everyone I know that has even mentioned maybe going there to please find somewhere else to go,” she said.
‘No Confidence At All’
Northshore Clinical Laboratories is a Chicago-based testing company that’s received more than $154 million from the federal government for testing and treatments. The lab is not affiliated with NorthShore HealthSystem, a local hospital and health care system.
The lab is headquartered at 4751 N. Kedzie Ave. in Albany Park and is registered with the state under the name of Meena Mohindra. Former employees said Meena Mohindra is the mother of Hirsh and Gaurav Mohindra, who help lead the company.
Hirsh Mohindra has a history in real estate, and Gaurav Mohindra is an attorney and blogger, according to their websites and online profiles. In 2017, the Federal Trade Commission banned the brothers from doing debt collection business, with a court finding they’d participated in “deceptive and unfair acts or practices.” The brothers were ordered to hand over tens of thousands of dollars, multiple properties and a 1-kilogram gold bar, with the assets worth more than $9 million.
Now, Hirsh Mohindra is Northshore Labs’ director of operations, helping it “partner with organizations all across the nation,” while Gaurav Mohindra is its director of business development and partnerships, according to Hirsh Mohindra’s website.
Northshore Clinical Laboratories partnered with a variety of independent pop-up businesses, processing the PCR tests that were gathered at sites across the United States.
The lab also partnered with summer camps, nursing homes, schools, cities, companies, shops and event venues and organizers, providing testing and vaccinations. It lined up a long list of clientele and partners: state senators, Chicago aldermen, Pride Fest, the Bulls and White Sox, City Colleges of Chicago and others.
It has worked with more than 100 summer camps for testing, according to Hirsh Mohindra’s website.
But there have been issues, some customers said.
The suburb of Berwyn worked with Northshore Clinical Laboratories on testing events for residents — but it cut off its partnership in December 2020 after neighbors reported issues in getting their results.
“After exhausting all opportunities to resolve the delays in response to patient testing delays inquiries, Northshore Testing Labs was dismissed from service to the Berwyn community” and a testing event was canceled, the town announced in a Dec. 8, 2020, Facebook post.
At the time, Northshore said it was facing delays due to a number of reasons, including a supply shortage.
Customers said they have had trouble getting accurate, timely results from the lab — and encountered issues at the pop-ups with which Northshore formerly partnered: dirty sites, unmasked workers, people telling them to not put down insurance or not providing instructions for correctly testing themselves.
Zawaski got her double results in August. She said the pop-up workers were not wearing masks, and when she asked for instructions on how to use a swab, a worker told her, “I don’t know. Put it up as far as you want.”
“I don’t know if I ever administered it correctly,” Zawaski said. “I definitely know that one way or another, the results were very inaccurate.”
Another woman was tested in suburban Riverside in September, and Northshore Clinical Labs sent her another person’s results — allowing her to see the person’s name and when and where she had tested, the Riverside woman said.
The woman called Northshore, concerned about a potential HIPAA violation, and the lab sent her the correct result — but the time of the test on the result was incorrect, she said. She said she’s not confident it is actually hers.
The woman had gotten tested because she had a fever and chills, and she works in a hospital where she is exposed to COVID-19, she said.
“But then, after, this, I had no confidence at all” in the testing at the site, she said.
A St. Charles man was tested Dec. 28 at a pop-up where a worker told him he’d get results back in two to three days, though the holidays could delay that “a bit,” he said. Northshore didn’t send the man’s results until Jan. 18, he said; when he contacted the owner of the pop-up, the owner blamed Northshore on the delay.
“I had symptoms, but I couldn’t tell whether it was Chicago winter symptoms … or COVID,” the St. Charles man said. “I kinda plugged along. It was disheartening to be left kind of in limbo.”
Joshua Bergeron said he went a testing site on Dec. 23 where workers had masks under their noses and told customers to not put down their insurance information. There was no social distancing at the facility, and a worker told Bergeron he only needed one swab to process both a rapid and PCR test, he said.
The worker read patients’ results out loud in front of other customers, Bergeron said. They told him he’d get PCR results in about 72 hours, but he didn’t get results until Jan. 5, he said.
The results said Bergeron’s sample had been collected in the morning, when he hadn’t tested until later, he said. And the result said Bergeron’s sample hadn’t been received by Northshore until Jan. 4, he said.
“If I went to any place I didn’t recognize, I would look it up to see if they were affiliated first with that place,” Bergeron said. “And if they were, I would tell everyone to stay clear.”
Brittany Miller, of Bridgeport, went to a pop-up that partnered with Northshore on Dec. 2. Workers gave her swabs, but they didn’t tell her how to do self-administer the rapid and PCR tests, she said. Miller asked if she should put the swab in her mouth or nose, and a worker told Miller to swab her mouth — while other customers were swabbing their nose, she said.
Miller gave the workers her swabs and they put them directly on a table, then put the rapid test swab in a container with solution, she said. About 10 seconds later, they Miller her she was negative for COVID-19, she said.
Miller got her PCR results from Northshore about four days later, and it was negative, she said. But she’d taken another PCR test at a hospital the same day she went to the pop-up, and that result was positive, she said. She also had COVID-19 symptoms.
“I just wasn’t sure if they didn’t even send them to the lab, or if the lab just sent me back anything — but then I also thought it could have possibly been an issue on my end from swabbing because I didn’t receive guidance,” she said. “While I was there, no, I didn’t really have any concerns, because I thought, ‘Oh, this place is affiliated with a lab. I should get correct results back.'”
A Northshore Clinical Labs spokesman said the company is “committed to communicating with all patients,” though some test samples might have been damaged or improperly stored, meaning some patients might not get a result.
“Despite facing enormous challenges outside of our control, our technical and clinical teams have been working tirelessly to make things right,” the spokesman said.
Northshore is “completely separate” from the companies that ran pop-up testing sites, apart from its agreement to process the PCR tests they collected, the spokesman said.
The lab started working with the third-party sites in June, the spokesman said; the sites were supposed to outfit workers in personal protective equipment, have a valid business license and get a certificate from the federal agency that regulates labs, among other requirements. They were also supposed to follow “proper procedures when asking patients about their insurance,” the spokesman said.
Northshore “regularly audited” the pop-up operators and terminated contracts with those that didn’t meet Northshore’s standards, the spokesman said. It audited sites by having staff randomly call 250-500 people who had been tested at a pop-up; if they had concerns about a site, the staff called more people who had been tested there.
Patients’ information was also reviewed daily to ensure it complied with state, federal and Northshore requirements and all information had been collected, the spokesperson said.
Northshore heard complaints about the pop-ups and was facing a backlog of PCR tests, so it terminated its contracts with the pop-ups Dec. 31, the spokesman said.
“It’s totally unacceptable to us for patients to have had those experiences, and further validation that we made the right decision in terminating our contracts with those sites,” the spokesman said.
The lab does not plan on bringing back its work with those pop-ups in the “foreseeable future,” the spokesman said.
The spokesman declined to say how many pop-ups Northshore had worked with.
The Illinois, California and Nevada health departments have gotten complaints about Northshore Clinical Labs and are investigating, spokespeople said. KSNV news in Nevada first reported that state’s investigation.
The Illinois Attorney General’s Office has gotten more than 40 complaints about the lab and is talking with customers to learn more, a spokesperson said.
The federal Centers for Medicare and Medicaid have also cited the lab for “immediate jeopardy” — the highest level of infraction — when it comes to Northshore’s general laboratory systems, analytic systems and laboratory director, according to a report from Dec. 29.
The lab did not have complete, written procedures in its manual to ensure more than 1.7 million tests were processed correctly, according to the report.
And Northshore’s laboratory director did not meet the federal agency’s requirements — like being a licensed doctor in Illinois — potentially affecting 5 million tests that have been done at the lab, according to the report.
Northshore defends its laboratory director in a Jan. 22 statement, saying he has “been stewarding our lab since 1994” and previously worked as the laboratory supervisor for Cook County Hospitals before retiring in November.
A surveyor at the lab’s Kedzie Avenue location said staff there confirmed they did not provide training to people working at Northshore’s “collection sites,” according to the report. An inspector also noted multiple instances where test tubes were not labeled properly with a person’s information.
The lab also failed to ensure its patients’ information was kept confidential, as an inspector saw “numerous” documents with patients’ information kept in uncovered containers in an unsecured hallway at the lab, according to the report.
At an off-site Northshore lab in Ohio, an inspector saw a worker improperly use a rapid test on a customer, with the worker not following the test’s directions to have the customer blow their nose and not using a timer to ensure the test was checked at the right time, according to the federal report.
The inspector also saw the worker throw away testing materials in a garbage bin, and the worker verified the facility didn’t have a container for hazardous waste, according to the report. The worker couldn’t provide documentation people had been trained on testing, according to the report.
Northshore has cooperated with the Illinois Department of Public Health and worked with the “country’s leading lab consultancy” to create a plan of correction, the lab’s spokesman said. The lab is working to ensure it is in “total compliance,” he said.
“… We’ve already acknowledged that many patients experienced delays in getting their result or have yet to receive a result,” Northshore’s spokesperson said. “This is the exact situation we’re working round-the-clock to address.”
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