Less than one week after a New York Times article claimed New Trier High School’s saliva screening program “ran afoul of regulators,” district officials are calling on the national outlet to issue a retraction because of “inaccuracies and omissions.”
New Trier Superintendent Dr. Paul Sally issued a detailed statement Saturday, April 3, calling the Times’ article “misleading” and “inaccurate,” and saying it omitted relevant information while asserting that the district violated federal regulations with its COVID-19 screener program from Safeguard Surveillance.
Those assertions, however, are not accurate, according to local and federal officials contacted by The Record.
The Times article originally stated that Safeguard Screening is under investigation by the Illinois Department of Public Health. IDPH confirmed to The Record on Friday, April 9, that it is not investigating Safeguard; however, over the past four months it received multiple complaints against Safeguard that it referred to two federal agencies: the Center for Disease Control and Center for Medicare & Medicaid Services.
A spokesperson from CMS told The Record it reviewed the complaints against Safeguard and declined to pursue a full investigation.
“We have been unable to substantiate any findings pertaining to the allegations received against this laboratory,” the spokesperson said via email.
CMS oversees Clinical Laboratory Improvement Amendments certification, which is a precursor to offering COVID-related testing. The Times‘ article states neither Safeguard nor New Trier pursued a certificate.
Safeguard’s founder Dr. Ed Campbell told The Record he followed guidance from the CMS that reportedly allowed the company to screen for COVID-19 as long as it did not offer a diagnosis, but instead flagged samples for diagnostic testing.
The CMS spokesperson said that Safeguard was issued a CLIA certificate on March 23, a week before The Times article published.
IDPH’s Melaney Arnold told The Record via email that Safeguard is “permitted to conduct screening testing” and “per CMS/CLIA, at this time, there is no further recommended action.”
In response to Sally’s retraction request, The Times made two corrections to the story but stood by its reporting as a whole.
“Our editors have carefully reviewed the points raised in the letter from Dr. Sally, the Superintendent of New Trier High School,” The Times told The Record. “We haveappended two correctionsto the story. One regards the name of the federal agency to which SafeGuard applied for lab certification. The other, in response to Dr. Sally’s letter, notes that the state health department ended its investigation of SafeGuard in March.
“As our response to Dr. Sally explained, our story provides a fair and accurate account of the school’s testing program.”
As first reported by The Record, New Trier’s board of education approved in October 2020 a plan to offer students and staff members weekly COVID-19 screening tests that return same-day results.
The unanimously greenlighted contract with SafeGuard Screening provided saliva surveillance screening — or RT-LAMP (Reverse Transcription Loop-mediated Isothermal Amplification) — for which participants would collect samples at home and return them to specified dropoff areas at the school.
At the time, the screening was already in use by an elementary district in the western suburbs.
In mid-December, district officials announced plans to mandate participation in the screening program for students learning in-person and taking part in an extracurricular activity, which was also reported first by The Record.
Participation was never mandated for staff members.
Campbell, a professor at Loyola University Chicago’s Stritch School of Medicine, launched SafeGuard in September of 2020 to aid schools in safely providing in-person learning opportunities.
While New Trier was one of the first school districts to use Safeguard’s program, now around 30 districts do, including Wilmette District 39 and Glenbrook High School District 225; though, New Trier D203 was the only district identified in The New York Times article.
The tests cost New Trier $11 each and are offered to district families free of charge. Officials first earmarked $1.26 million for the cost of the program this school year, but have said they will spend less.
Sally’s 2,600-word statement decries multiple points in Mandavilli’s article, including the story’s assertion that the process being used by New Trier and through Safeguard violates state and federal regulations and is not cleared with local health departments.
“I recognize Ms. Mandavilli is an admired and award winning science journalist, but I am asking for a full retraction of the article based on the grossly unprofessional standards used as evidenced by the narrative below and the harm done to our school district and community by the baseless allegations made by the author that were knowingly incorrect,” Sally said in the statement.
Safeguard did not initially receive the certificate because, Campbell said, it followed guidance provided by the CMS late last year.
Neither New Trier nor Safeguard provide COVID-19 test results or diagnostic results to participants in the screening program.
Campbell claimed that the guidance from the CMS has been reaffirmed by a majority of law firms focused on education in the Chicago area.
“The logic that any referral to a diagnostic test is somehow a de facto diagnosis, which is the premise of the author’s article, would mean — if you were to follow this logic — that there is no way to conform to the very clear CMS guidance that allows for diagnostic referrals using surveillance,” Campbell said.
“Using that logic, there is no way to conform to the guidance. So then why did CMS issue guidance if it’s impossible to conform to? Obviously they didn’t — obviously they believe what we’re doing is appropriate.”
According to Sally, district officials “provided evidence that those at CMS who directly oversee these programs said that CLIA certification is not needed if diagnostic results are not provided — which they are not.”
Campbell said that neither he nor Safeguard was ever contacted by IDPH officials or asked any questions related to what the company was doing, or the way it was doing it.
Campbell said the only time he or Safeguard was contacted by IDPH was in early December for a meeting that was called by the department.
According to Campbell the meeting invitation stated it was to “discuss testing protocol and learn from the methods being implemented. “The topics presented were specimen collection, tests performed, results provided, actions based on results, how results are reported and any opportunities for support,” he said.
“At that time, no one indicated there was any problem with the process we were using,” Campbell said. “No one told us to change what we were doing and the meeting was called under the (premise) of learning what we were doing and trying to provide assistance, and I felt that meeting was productive and gave me no reason to believe there were any problems with our approach.”
In the months since the implementation of the saliva screening program, New Trier officials have continually praised the benefit they believe it provides not only the district but also the community at-large.
“This saliva screening just helps everyone,” Board president Cathleen Albrecht said at a January meeting. “It helps the school, it helps the community, it helps individual families and it helps everyone taking it.”
According to a statement from New Trier, the program has identified 120 cases of COVID-19 since its launch at the district in November.
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Martin Carlino is a co-founder and the senior editor who assigns and edits The Record stories, while also bylining articles every week. Martin is an experienced and award-winning education reporter who was the editor of The Northbrook Tower.