SHIELD Slow To Deliver COVID Testing, Blames School Districts?

CHICAGO — In May, Gov. J.B. Pritzker handed his pet coronavirus testing operation, SHIELD Illinois, exclusive access to $225 million in federal cash through no-bid contracts to provide the saliva test free to every Illinois school that wanted it.

Now, more than a month after the start of school, nearly 70 percent of 477 public school districts and "non-public agencies" that took Pritzker up on the "free" testing offer got what they paid for it. Nothing.

Why the delay? Despite being promised nearly a quarter billion dollars from federal coronavirus relief funding, SHIELD Illinois didn't have the operational capacity to run their own testing program to meet demand when kids returned to school.

When I asked about the slow roll-out of testing last week, a SHIELD spokesperson suggested that the blame lies on school district administrators tardy signing up for testing.

"More than 40% of those schools signed up after Aug. 23, although IDPH began offering free testing in April," Ben Taylor wrote in an email.

SHIELD officials also told the Tribune they were having trouble getting permission slips from parents and collecting rosters of students allowed to be tested. The testing operation's software needs an upgrade. And SHIELD doesn't have enough staff to respond to school district questions and concerns, according to the Tribune report.

On Friday, the feds had to step in to bail out SHIELD's overwhelmed testing program and help ensure there's a virus-mitigation strategy in in place in Illinois schools.

The folks running the University of Illinois coronavirus saliva test are "not interested in an interview at this point," Taylor wrote to me when I asked to chat about the testing hold up.

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But a parent watchdog group with a healthy suspicion about the Pritzker administration's effort to fund SHIELD Illinois' testing operation with public money has been filing Freedom of Information Act requests for documents and emails all summer long.

James F. Holderman III of Protect Parents' Rights sometimes sends me the fruits of his group's FOIA labor, and details about his failed attempts to get straight answers from the folks at SHIELD.

What the emails show is SHIELD faced harsh realities while scaling up the operation to deliver the services the Pritzker administration promised when he steered enough funding for SHIELD testing at as many as 4,000 schools.

Staffing shortages and lacking leadership at laboratories topped a list of trouble in April — before Pritzker set aside funding for free SHIELD testing at state schools including a Loyola laboratory, lacking laboratory leadership affected "quality of work: duplicate errors and contamination issues," according to SHIELD lab operation director Yoni Merid 's emailed report.

"Yesterday they pulled the wrong patients to give 380 results. The lack of leadership is now affecting the quality! It's the 2nd time this happened. A process was put in place to prevent this, but they get lazy and sloppy. Without a lead, there are too many opinions and no lab hierarchy," Merid wrote in reference to the Loyola lab.

The email details concerns about the lab's two top scientists resigning at Illinois State University without experienced replacements ready to step in, and there weren't enough employees to staff the third shift. And a lab in Rockford lacked a properly certified lab supervisor.

In other emails, SHIELD Illinois officials expressed concerns about the ability of partner labs to process specimens fast enough, including a debate with a scientist at odds with SHIELD over protocols for confirming positive results.

Dr. Sam Ho, a scientist at Gift of Hope laboratory, inquired in emails whether SHIELD was collecting data and verifying positive patients with repeat testing or clinical diagnoses, which he said are "paramount in gauging how the assay performs in real world setting."

"Regardless of living in a COVID pandemic world or not, maintaining high quality standards for laboratory performance and patient care is and has always been the utmost priority of the Gift of Hope laboratory and our laboratory professionals," Ho wrote in an April 13 email.

Other emails obtained through FOIA included a chart that showed when positive results are re-tested, SHIELD's test accuracy is near perfect.

But in May, SHIELD Illinois boss Ron Watkins sent an email saying, "We moved away from retesting positives due to the increased time for resulting and the potential of increased spread."

Dr. Ho refused to stop re-testing positive results to better ensure accuracy. The SHIELD team initially pushed back — including a suggestion of taking legal action — before relenting, according to emails.

When SHIELD senior director Andrew Greta emailed Dr. Ho to ask how to explain how accurate the saliva test would be when school communities experienced a high prevalence of COVID-19 infections, the scientist replied that the test accuracy could be less than 50-percent.

"As an example, if we anticipate that 20% or ~2,500,000 Illinoisans will be screened routinely at maturation of this project, at 2% prevalence, the PPV will fall below 50% at 98% sensitivity or less. In other words, we will be telling 96,500 people that they have COVID when in fact only 47,500 do," he wrote.

In that scenario, Dr. Ho wrote, "the chance of predicting the positive results to be accurate (i.e. as positive) is worse than flipping a coin." He wrote that since there is no perfect test, it's better to have a false positive than a false negative, because it "causes less harm to unnecessarily quarantine" people who don't have COVID-19 for two weeks than "not doing anything."

But, in April, the perception that school kids were being unfairly quarantined became "a very real issue and I believe the biggest threat to the Illinois SHIELD program," according to Dr. Scott Morcott, CEO of Passport Healthcare, which collects SHIELD test saliva samples at 23 north suburban school districts.

Morcott wrote in email to SHIELD officials: "We are rapidly losing the confidence of our community members." Attached was a letter from a parent complaining of the "complete insanity" that her daughter had been quarantined three times without testing positive for COVID-19.

When I talked to Morcott about that email on Thursday, his company has had fewer complaints from clients and parents about the over-quarantining of students based on SHIELD's testing system.

"I know people feel strongly on both sides of this, which is completely understandable. I encourage you to keep reporting on the value of keeping kids in school. That's why I'm interested. I'm a father of four kids. I really believe kids need to be in school," he said. [Over-quarantining] is a concern. That's a reasonable thing to ask about. ... I don't think that's an irrational concern."

Morcott said SHIELD's "test-to-stay" program that started in August has proven to be an effective way to allow students who otherwise would be quarantined for having close contact with a COVID-19 positive case to remain in classrooms.

Dr. Ho didn't respond to my request for an interview about his email assessment of the SHIELD test's reliabilty. He forwarded my email to Watkins, assuring the SHIELD boss he didn't plan to answer my questions.

Watkins replied to Dr. Ho, "If you would like to speak with him about the test, please do. It appears he is trying to discredit the test. Too bad this is happening."

And Watkins also turned down a request for an interview. It's too bad, really.

Because Pritzker handed SHIELD a monopoly on coronavirus testing in Illinois school districts, parents deserve more transparency — and straight answers – about the state-funded coronavirus testing program beyond what's used in sales pitches to school district officials and testing testing program summaries found online.

And there's a lot of questions, frankly.

For instance, Watkins should have to explain why officials at Chicago Public Schools — the only public school district in the state that doesn't have to rely on the Pritzker administration to dole out federal coronavirus relieve dollars — turned down the offer of federally funded SHIELD testing.

Emails show that Watkins was eager to make a huge push to get CPS as a big-money client.

"Things are moving quickly with Chicago Public Schools. They want assurances over the test. The head of the school health care would like 15 minutes with one of you. It that possible? We try hard to protect your time, but this one is big. She is not going to get technical, she just wants assurances," Watkins wrote in January.

"She asked for anything that shows our sensitivity and specificity. Her and many others ask for the data. I let them know that I do not have it to provide. I show the covid dashboard and send the pre-print. What I really need is something to share that proves the 99.8-.9% specificity and gives a sensitivity. I tell them 8-fold better than the Yale test on sensitivity, but they all want something in writing with some science behind it."

Top city sources told me CPS turned down the spit-test pitch due SHIELD's inability to provide assurances about accuracy, including the ability to scale up the testing operation to accommodate the state's largest school district that receives federal funding through City Hall.

It seems CPS officials were right about the latter, given SHIELD's severely delayed school testing roll-out statewide. And as for SHIELD officials' claims the tests delivers near perfect diagnosis, their numbers don't match what's in the FDA's Aug. 26 summary of SHIELD's emergency use authorization report.

The FDA reported results of "usability study" produced results that don't jibe with either Watkins' email claim of 99.8-percent specificity or the assessment of test effectiveness in the program's frequently asked questions brochure.

Indeed, the SHIELD test's sensitivity — how often the test accurately identifies samples actually positive — was calculated at 95.8 percent. The test's specificity — how often a negative sample produces a negative result — of 98.9 percent, according to the FDA report.

The difference in specificity means SHIELD's test could produce over five times as many false positives as they claim. And the "limitations" of those calculations have "only been established with saliva specimens from symptomatic individuals," according to the FDA.

None of this is shocking to me given the Pritzker administration's entire coronavirus response — from testing in poor minority neighborhoods to vaccine distribution at the United Center and even the federal approval of SHIELD's test — hasn't lived up to its over-hyped billing.

So far, the massive roll-out of SHIELD Illinois testing doesn't seem to be much different from the Pritzker administration's broken promises for a testing boost in poor Black neighborhoods or the untrue prediction that making vaccine jabs to all Illinoisans at the United Center would boost inoculations in Chicago's Black and brown enclaves.

And now that Pfizer has applied for FDA approval to vaccinate all school-aged kids — a move that could allow kids to start getting jabs before Halloween — the continued need SHIELD's saliva surveillance testing might more expensive than it's worth.

Still, when SHIELD officials are given the chance to be transparent about the governor's pet coronavirus testing operation, they're not interested answering questions.

That's a shame.

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" docuseries on CNN and a consulting producer on the Showtime documentary "16 Shots."

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