Is Pritzker Steering School COVID-19 Testing Contracts To U of I?

CHICAGO — This story about coronavirus saliva tests might make you mad enough to spit.

It boils down to this question: Is Gov. J.B. Pritzker's administration trying to rig the market for coronavirus testing in public schools to favor University of Illinois' budding COVID-19 testing operation, Shield Illinois?

That's difficult to answer, apparently.

Pritzker's administration didn't respond to queries related to the "very interesting" timing, as one school district administrator put it, of a policy change on surveillance testing in schools. The change effectively made districts ineligible for reimbursement through federal coronavirus relief funds if the tests were conducted by SafeGuard Surveillance, a Shield Illinois test contract competitor.

SafeGuard Surveillance was started by Dr. Ed Campbell, a suburban virologist who set out to help his kid's school get back to in-person learning.

Shield Illinois is the U of I's in-state prototype testing operation that launched its saliva test and contact tracing app nationally through a for-profit company, Shield T3 LLC.

Shield officials pitched President Joe Biden's administration in December on a plan to make its coronavirus saliva test developed at the University of Illinois "broadly available as the backbone national testing," according to confidential documents obtained by Patch.

In August, Gov. Pritzker praised the Shield team for putting Illinois on the "cutting edge of testing innovation on a national level," and made it public that his administration was all in for Shield.

"The State of Illinois looks forward to being [Shield's] biggest customer," Pritzker said.

Things didn't go as planned. Shield's saliva test didn't win emergency use authorization from the U.S. Food and Drug Administration, stalling the testing expansion that was expected to help schools return to in-person learning.

That's where Campbell's company stepped in. SafeGuard inked contracts to provide school districts surveillance testing. At least three times, SafeGuard won testing contracts while in direct competition with Shield Illinois.

Interviews and public records, including hundreds of pages of emails obtained by Patch, show Pritzker's administration has quietly kept watch on SafeGuard Surveillance, which won contracts with nearly two dozen school districts to provide weekly saliva tests that determine if asymptomatic participants should be referred for diagnostic COVID-19 tests.

Illinois Department of Public Health officials say anonymous tipsters inspired an investigation targeting SafeGuard. The investigation results were referred to the state's top law enforcement officer, Attorney General Kwame Raoul, and federal public health agencies.

At the same time that the Illinois Department of Public Health asked county health department officials about the use of SafeGuard tests in suburban schools, top Pritzker administration officials and the head of Shield Illinois traded emails about school districts contracted to use the "surveillance" testing, according to public documents obtained by Patch.

In an email, Deputy Governor for Education Jesse Ruiz even opined surveillance testing going on in suburban schools could present an "opportunity for Shield."

Since then, state officials have edited public health guidance to discourage use of the kind of tests provided by SafeGuard, which are permitted by federal regulators without requiring laboratory certification or emergency use authorization, according to public information and emails obtained by Patch.

Plus, the Pritzker administration has informed some school districts that they won't be reimbursed through federal coronavirus relief packages — which Shield Illinois has identified as its primary funding source — to pay for testing provided by SafeGuard, which costs taxpayers about half as much as the U of I tests, school officials said.

The governor's office and state public health officials did not respond to an interview request or written questions related to decisions made related to SafeGuard tests.

"The state, in my opinion, is taking steps and actions to steer school districts to Shield," New Trier School District Associate Superintendent Chris Johnson said.

"The state is saying that you can't get federal reimbursement for [SafeGuard's] test through the state of Illinois, but you can get it through Shield. It's the timing that seems very interesting to me, I'll say that."

Creating "Opportunity For Shield"?

In the fall, LaGrange School District 102 board member and HIV virologist Ed Campbell set up a coronavirus surveillance testing effort for his kids' school modeled after a University of Wisconsin saliva test used to refer asymptomatic people for follow-up COVID-19 testing.

At the time, there was neither a state nor national effort to roll out coronavirus testing at schools. When word got out about Campbell's testing strategy in LaGrange, nearby school districts asked him to conduct surveillance testing for their staff and students, too.

Here's how Campbell's SafeGuard surveillance testing works: Instead of using polymerase chain reaction, or PCR, technology, the testing uses a molecular test called loop-mediated isothermal amplification, or RT-LAMP, which is faster, cheaper and more accessible, according to researchers.

But unlike PCR tests — the so-called gold standard in coronavirus testing — federal guidelines don't allow SafeGuard test results to be used to provide patients with a COVID-19 diagnosis.

In response to the coronavirus crisis, the U.S. Centers for Medicare and Medicaid Services decided that lab certification and emergency use authorization are not required to conduct surveillance testing so long as the results are not used to diagnose COVID-19 status in individuals.

Scientists have used RT-LAMP surveillance testing to conduct COVID-19 surveillance on asymptomatic people at Colorado University Boulder and the University of Wisconsin.

Campbell says he mirrored those testing efforts in the Chicago suburbs.

SafeGuard's COVID-19 surveillance effort is used to alert its school district clients that people who provided test samples, identified by a barcode, should be referred for follow-up diagnostic testing.

In response to a demand for testing, Campbell launched SafeGuard Surveillance LLC to expand the saliva testing effort to elementary and high school districts in the north and west suburbs, most notably New Trier High School.

By September, the suburban dad's coronavirus test had gained national notoriety.

Months later, Illinois public health officials began scrutinizing SafeGuard.

An IDPH spokeswoman told Patch last week that "in December, a couple local health departments reached out to IDPH about schools using SafeGuard Surveillance LLC for testing. IDPH looked into this and alerted the federal Centers for Medicare and Medicaid Services (CMS) who stepped in."

Emails obtained by Patch, however, show that starting in November, IDPH communicable disease section chief Judy Kauerauf began inquiring about how school districts were using SafeGuard tests. This occurred after Cook County's top epidemiologist, Palak Panchal, requested clarification on whether to count someone as receiving a positive test result from SafeGuard's saliva test at New Trier High School if follow-up testing comes back negative for COVID-19.

The emails show state public health department officials were interested in how school districts were using SafeGuard Surveillance's coronavirus tests to flag potential asymptomatic students. The inquiries came around the time Gov. Pritzker's office was engaged in discussions with Shield Illinois about pushing saliva testing to elementary schools statewide — a move delayed by Shield's lacking federal emergency use authorization.

Campbell said he wasn't notified that IDPH had concerns about his company's surveillance testing. The only time he was contacted by the state public health department was to schedule a Zoom meeting on Dec. 8 that he says was billed as a friendly effort to learn about the tests and offer help.

"I was happy to talk," Campbell said. "I did not know at the time I was the target of a secret investigation."

An IDPH spokeswoman said the state investigation was launched after a complaint was filed related to "concerns about test results being provided to schools," but the spokeswoman did not provide details, a timeline or the origin of the complaint.

"IDPH consulted with federal Centers for Medicare and Medicaid Services (CMS) and the CDC. CMS issued a letter to SafeGuard at the end of December 2020 alerting SafeGuard to the requirements of CLIA certification," the spokeswoman said in a statement.

Campbell received an email from CMS on Dec. 28 saying it had been alerted that SafeGuard was conducting COVID-19 testing, which would require the company to obtain certification to conduct coronavirus testing to report "patient-specific results." The federal agency that oversees coronavirus testing, however, wrote that it is temporarily "exercising enforcement discretion" on COVID-19 tests that "do not report actual test results, but only refers to an individual" for follow-up testing at a certified lab.

Since SafeGuard provides referrals, not results, federal regulations didn't require the company's lab to be CLIA certified. Campbell said he later applied for and received CLIA certification in the event that CMS were to change its guidance on the kind of testing his company provides.

All the while, SafeGuard continued testing at suburban schools. The company stopped describing test results as having "potential clinical significance." Instead, schools were informed that test participants identified by barcode numbers should be referred for follow-up diagnostic tests at a certified lab.

On Dec. 28, the same day Campbell was contacted by CMS, top Pritzker administration officials and the head of Shield Illinois traded emails referencing SafeGuard's testing at schools, according to public documents obtained by Patch.

That's when Deputy Gov. Jesse Ruiz suggested the controversy might have a silver lining for U of I's testing effort in schools statewide.

"Perhaps an opportunity for Shield as well?" he wrote.

Ron Watkins, Shield's managing director, replied in the affirmative. "If we had the capacity in place we could help K-12. It is not a matter of IF but WHEN. ... The faster we can get to ISU and SIU [School of Medicine] going, the faster we can help K-12," he wrote.

As of Wednesday, neither Watkins nor Ruiz agreed to be interviewed.

"If The Governor Could Find Time …"

In December, certified labs expressed reluctance to conduct Shield Illinois saliva tests until the Food and Drug Administration extended emergency use authorization, which would limit a laboratory's exposure to potential civil litigation.

That slowed Shield Illinois' efforts to roll out testing to universities and schools statewide.

Watkins emailed Ruiz asking if Gov. Pritzker could be persuaded to get personally involved in lobbying laboratories on behalf of Shield Illinois.

On Dec. 18, Watkins emailed Ruiz asking if Gov. Pritzker would use his influence to encourage testing labs at Loyola Medical Center and Northern Illinois University to ramp up staffing that would allow Shield Illinois to begin using the saliva test at universities.

"If the Governor could find the time to call two of the labs, it would make a difference. We have a new CEO starting in Decatur and this is critical to our ability to start testing right away for EIU, ADM and many other schools. We also need Loyola Medical to go fast for the Chicago area and schools such as NIU and many others. If he could call those two it would be a difference maker," Watkins wrote.

Watkins also asked Ruiz to leverage his "good relationships" with the SIU medical school and Illinois State University to ramp up staffing at labs in preparation for launching testing as Shield Illinois submitted its application for Emergency Use Authorization for its saliva test.

Three days later, on Dec. 21, Loyola University Chicago government affairs director Philip Hale emailed top Pritzker administration officials and then-state Sen. Heather Steans explaining that they weren't able to have a Shield lab network up and running because the saliva coronavirus test had not yet received emergency use authorization. Hale also wrote that Loyola didn't have staff to conduct a "lab developed test," a proposal suggested by Shield officials as an alternative to waiting for federal approval.

Watkins wrote in a Dec. 28 email to top Pritzker aides that certified labs "need to stop looking for every blanket coverage or we need to find a way to give them some liability 'coverage.'"

'What You're Telling Me Sounds Concerning'

In the fall, Shield Illinois officials, Pritzker and Sen. Dick Durbin (D-IL) falsely claimed in public statements and news releases that the test had won emergency use approval from the Food and Drug Administration.

At the time, Shield Illinois was allowed to continue using its testing system at the Urbana-Champaign campus. But plans for a statewide rollout of saliva testing remained delayed because the federal government hadn't authorized the test for emergency use.

Despite the setback, Shield Illinois officials continued trying to sell school district officials on using their brand of saliva tests at the same time SafeGuard pitched its surveillance testing that was already up and running.

Both saliva testing providers, for instance, made their pitch to New Trier High School.

Johnson, New Trier's associate superintendent, said SafeGuard was prepared to begin testing at New Trier in October for $11-a-spit-sample. Shield Illinois officials said their saliva tests — which couldn't be rolled out without federal emergency use authorization — would cost the school district $20 each with testing expected to start in November, Johnson said.

Ultimately, district officials inked a deal with SafeGuard to avoid paying nearly double for testing that would delay getting students back to in-person learning.

"Shield said, 'We're not up and running, and we're twice as much money.' And if we had taken them on at their word that they would have been ready in November, we wouldn't have had kids back. Dr. Campbell's process allowed us to get kids back," Johnson said.

"Deerfield and Highland Park (high schools) are using Shield. They didn't have kids back until the spring. We've had kids in the building since November."

Other suburban districts also picked SafeGuard over Shield Illinois for school testing. Oak Park River Forest District 200's school board, for instance, rebuffed Shield Illinois' pitch in favor of SafeGuard's surveillance testing.

On Jan. 23, Watkins, Shield Illinois' managing director, emailed Ruiz a link to a Wednesday Journal report on Oak Park River Forest School District 200's decision to select SafeGuard's $11 test over Shield Illinois' $20 test to the tune of a $400,000 contract.

"Please see link below and I'm up for any suggestions you have," Watkins wrote.

Replies to emails between Watkins, Ruiz, Assistant Deputy Gov. Lizzy Whitehorn and IDPH Director Dr. Ngozi Ezike, her chief of staff Justin Dewitt, Deputy Gov. Sol Flores and head of testing, Charles H. Williams, were redacted by the state citing Freedom of Information Act exemptions related to "predecisional, deliberative communication" between government agencies.

On Jan. 26, Kauerauf proposed changes to public health guidance that states IDPH does not recommend surveillance testing at schools, according to documents obtained by Patch.

On the same day, IDPH's investigation into SafeGuard appeared to intensify.

Kauerauf emailed Cook County public health officials on Jan. 26 asking them to provide "a copy of what the [SafeGuard] lab is providing to the school, whether the test is "FDA approved" and whether test results are being "provided to the school in any form, including presumptive positive?" emails show.

A Cook County public health official responded with information provided by a New Trier High School nurse who said SafeGuard only reports barcodes of testing participants that should be referred to a certified lab for a diagnostic coronavirus test.

A state public health laboratory quality specialist, Brandon Rakowski, replied in an email saying SafeGuard "is complying with [federal] guidance issued to them during the complaint but the school seems to be taking that information and making broader assumptions that if they show up on the list they are positive. From the CLIA side I don't think we can do anything but maybe IDPH can inform the schools that they are making a jump by assuming these recommendation to seek testing is equivalent to a result of 'clinical significance' or 'presumptive positive.'"

On Jan. 27, Kauerauf emailed DuPage County health department officials asking if they oversee any school districts using the SafeGuard saliva test and to "inquire with a few to see how the lab is sending them results and what they are communicating to the families. We are meeting with the AG's office today to see what steps we may need to take."

An IDPH spokeswoman did not respond to questions about the decision to involve Attorney General Kwame Raoul's office in the SafeGuard investigation.

But Kauerauf told DuPage County officials in a Jan. 27 email that the state's legal team was preparing documents for the attorney general's office, and wrote it "seems like the AG has what it needs to pursue." She also wrote: "We are also on a call with CDC right now who may also intervene."

Campbell said he has been contacted by neither the attorney general's office nor the CDC. He said follow-up conversations and emails with CMS and state public health officials confirmed that SafeGuard's operation is allowed to continue so long as the surveillance tests are only used to refer individuals to a diagnostic test as permitted by federal regulators.

After being told about the timing of Watkins' email about the Oak Park River Forest school district testing contract and Kauerauf's investigative inquiries about SafeGuard's surveillance practices, Campbell paused.

"I don't have all the information," he said. "But what you're telling me sounds concerning."

A Cautionary Tale?

On Feb. 9, a New York Times reporter emailed IDPH officials inquiring about SafeGuard.

"I know that the Illinois DPH is aware of this company and that the AG's office is perhaps going to get involved. … Essentially, the company and the school are both telling me that they have spoken with people at the Illinois DPH and were told what they are doing is fine. I'd like to confirm that," the reporter wrote.

The email was forwarded to Pritzker's chief of staff, press secretary, Ruiz and other top gubernatorial aides. Ruiz's email, which the administration partially redacted citing exemptions cited in public information laws, states: "Yes, aware of this, and believe …"

A March 30 story published in The New York Times described school districts contracting with SafeGuard as a "cautionary lesson about what happens when educators are asked to take on public health responsibilities."

Since the story was published, several school districts have issued public statements to address "inaccuracies" in The New York Times' reporting that SafeGuard was "flagging individual students who might be infected" with coronavirus, a process called "screening" that requires federal emergency use approval.

MORE ON PATCH: SafeGuard Saliva Testing Program Certified After State Scrutiny

New Trier district officials said the news report contained inaccuracies and omissions.

"New Trier has also met with local and state health authorities to review our use of the program and they have not directed us to change our use of it," district officials said in a statement. "From the time the program began, New Trier has been clear that the saliva program is non-diagnostic and must be confirmed by a lab test. To suggest otherwise is false."

IDPH spokeswoman Melaney Arnold is quoted in the New York Times story saying, "The investigation [into SafeGuard] and follow-up continue."

Last week, an attorney general's office spokeswoman told Patch investigators have had conversations with IDPH and are "monitoring the issue," but declined further comment regarding whether the agency has jurisdiction over testing regulated by the federal government.

Last week, a state public health department spokeswoman told Patch that IDPH received two anonymous complaints in March about SafeGuard testing. "CMS reviewed the complaints and did not recommend an investigation. SafeGuard has since received a CLIA Certificate. Per CMS/CLIA, at this time, there is no further recommended action," she said in a statement.

Campbell said his company has never been notified of those anonymous complaints.

"From all of my understanding, CMS has acted in a way consistent with the guidance that has been provided at a federal level," he said. "No one contacted us about any of these complaints or offered any guidance to remedy anything stemming from the complaints."

Pritzker Administration Does Not Recommend SafeGuard

On Feb. 26, three days before Shield Illinois received federal emergency use authorization for its saliva tests, the state public health department published new public health guidance related to COVID-19 testing.

The "interim guidance" states that because surveillance testing from a non-certified lab is not diagnostic a positive result, that "can delay procedure for notification and other mitigation measures. For this reason, IDPH does not recommend schools utilize surveillance testing."

That public health policy seems to contradict President Joe Biden's national coronavirus response strategy that instructs the secretaries of Health and Human Services, Education and the Federal Emergency Management Agency to "provide support for surveillance tests for settings such as schools."

Earlier this month, CNN reported the Health and Human Services Department has earmarked $10 billion to help states implement coronavirus surveillance testing in schools.

SafeGuard's owner says he found the state's new stance on using surveillance testing in schools confounding, given the guidance provided by federal testing regulators.

"This guidance from IDPH does not seem to be accepting of the guidance from CMS. It seems to suggest it is inappropriate to refer specific individuals to diagnostic tests, which is inconsistent with CMS guidance regarding surveillance which clearly demonstrates this is allowed," Campbell said.

"I do not understand how referring an individual to a diagnostic test that would not have otherwise sought a diagnostic test can delay anything. That is very difficult for me to wrap my head around, given that the majority of people we refer to diagnostic tests are asymptomatic when they are referred, based on feedback from the school nurses and administrators I have received."

Pritzker administration officials did not respond to questions seeking comment.

Shield Illinois officials, however, made it clear in a confidential pitch to the Biden administration that they're pushing to make the group's saliva test a national standard funded by federal coronavirus recovery cash made available to local health departments that stand up Shield testing programs, according to the confidential document obtained by Patch.

Shield's pitch to the Biden administration also called for the federal government to not pay reimbursements for any test that takes more than 24 hours to deliver results, a move that "will force more local deployment of testing."

Coronavirus Relief Denied By Pritzker Administration

This year, school districts hoping to get reimbursed by the state for SafeGuard testing through the federal coronavirus relief package have been getting bad news from the Pritzker administration, officials told Patch.

New Trier officials submitted a request for SafeGuard testing reimbursement that got approved by the state — by accident.

"We got a call saying, 'We made a mistake. We should have said, No.' We were told that SafeGuard's test isn't done in a CLIA lab and it doesn't have [emergency use authorization] so the state was not able to reimburse it," Johnson said. "They said that because they already paid us, we will receive the funds. But they said that other districts will not be able to obtain these funds for [the SafeGuard] screening program."

One of those other districts unable to get federal reimbursement for SafeGuard testing is Glenbard School District 87.

Glenbard School District officials reached out to Shield Illinois representatives and had discussion about using the saliva tests as a COVID-19 mitigation effort to resume in-person learning at the west suburban schools.

Shield Illinois' tests were more expensive, were not yet available, and spit sample collection had to be observed by a medical provider, which created a logistical problem at a time when schools were under capacity limits compared to SafeGuard's test that allows at-home saliva collection, Assistant superintendent Chris McClain said.

Ultimately, Glenbard officials decided to start SafeGuard testing in January.

"Our thought was since this was such a strong safety mitigation and there has been such a huge emphasis on schools going back in person and the President saying schools need to do testing, that's exactly what we are doing," McClain said. "We're doing everything we can to make our students, staff and community feel safer about this."

McClain said the school district did not receive any guidance from state public health officials to steer clear of SafeGuard testing and was not told the surveillance testing effort would not be eligible for reimbursement through federal coronavirus relief funding.

McClain said state officials last month denied a request for $742,500 in federal coronavirus relief reimbursement for SafeGuard testing because the company's test has "not been approved for emergency use and is not FDA approved, and therefore is not a reimbursable expense."

Pritzker administration officials did not respond to questions about the decision to block reimbursement for SafeGuard tests.

Health insurance companies are not required to pay for the kind of non-diagnostic surveillance tests being used by SafeGuard, according to federal guidance. But there is nothing that stops states from using federal coronavirus relief funding to reimburse schools for surveillance testing as a COVID-19 mitigation measure, experts say.

McClain said he's hoping state officials come to a new conclusion on funneling federal dollars to his district as reimbursement for SafeGuard testing.

"After being told there would not be a reimbursement, I asked to go through an appeal process to understand details [about why the request was denied.]," McClain said. "This is a lot of money to us."

And for local taxpayers.

After learning that some of his school district clients had been denied access to federal funding for SafeGuard tests, Campbell called the state's opinion on his saliva test "curious" and "disappointing."

"Some of the things I have seen make it appear that the state has a preferred vendor. And if this is an effort to ensure that only their preferred vendor can provide [testing] services to schools, that is very frustrating and unfair to schools relying on our services," he said.

"What is driving the decision not to allow our clients and school districts to be reimbursed?"

As of Wednesday, Pritzker's administration wouldn't say.

Mark Konkol, recipient of the 2011 Pulitzer Prize for local reporting, wrote and produced the Peabody Award-winning series, "Time: The Kalief Browder Story." He was a producer, writer and narrator for the "Chicagoland" docu-series on CNN, and a consulting producer on the Showtime documentary, "16 Shots."

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