WASHINGTON (SBG) - An internal investigation at the Department of Health and Human Services into why the Centers for Disease Control and Prevention (CDC) shipped defective coronavirus test kits to public health laboratories in February – a failing some experts have cited as a hindrance to America’s critical early efforts to combat the outbreak – has concluded, according to a final report obtained by Sinclair, that CDC scientists likely used a component in the kits that was “contaminated.”
A three-page summary of findings issued on official letterhead on June 19 by the office of HHS General Counsel Robert P. Charrow, who opened the investigation on orders from HHS Secretary Alex Azar on March 1, found that an “initial batch” of test kits produced by CDC relied on a “reagent” that was likely contaminated.
Reagents are substances introduced into chemical tests to produce reactions that scientists can study to learn about other substances.
The report said the faulty kits represented the second of two sets of test kits that were developed by the CDC starting in late January. The first set shipped off in limited numbers to public health authorities and was apparently used without incident.
However, the review acknowledged that it was the second, defective batch for which CDC leadership harbored more ambitious plans. The faulty kits, the report stated, were “developed to be manufactured by CDC as a first wave of testing to be shipped to public health laboratories across the country until commercial laboratories and diagnostic companies were able to come online” with mass-produced kits of their own.
“One of the three reagents in this initial batch of manufactured test kits was likely contaminated,” the general counsel’s office concluded. “These tests are so sensitive that this contamination could have been caused by a single person walking through an area with positive control material and then later entering an area where tests reagents were being manipulated.”
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In a footnote, the general counsel’s office cautioned that the report’s use of conditional terms and phrases, such as “likely,” stemmed from the highly technical nature of the investigation. “We state our conclusions in likelihoods, rather than with absolute certainty,” the report said, “due to the inherent complexities of this presumptive contamination and of the underlying science.”
In a statement to Sinclair, Michael R. Caputo, the assistant secretary of HHS for public affairs, defended CDC’s conduct, saying the agency began working to produce viable testing within days of receiving the genetic sequence of the coronavirus from China. “As a result of President Trump’s strong leadership, the United States now has the world’s most robust public-private testing system and is better prepared to respond to future global health threats,” Caputo said. “The CDC and our public health labs were not intended to bear the weight or capacity of nationwide testing on this scale. While it is possible that this contamination may have delayed the CDC’s ability to supply tests to the public health labs for a short time, we never had a backlog of tests in this country.”
A CDC Spokesman declined to comment, directing Sinclair to the statement from Caputo.
Dr. Emily Rose Smith, an epidemiologist affiliated with Harvard University’s T. H. Chan School of Public Health, agreed with critics of CDC who said the agency’s use of contaminated test kit components hindered the early U.S. response. “Anyone who's worked in a lab knows that contamination can happen, and certainly working under time pressures, that's more likely,” Dr. Smith said in an interview with Sinclair after the report was made public by HHS. “On the other hand, it does seem like a careless mistake that cost us a few weeks' time in terms of getting testing up and running.”
The probe was led by a pair of HHS attorneys with scientific backgrounds, who reported to the general counsel. Their investigative team collected documents from various agencies and interviewed nearly a dozen officials, scientists, and consultants at CDC and the Food and Drug Administration who participated in the early development of coronavirus test kits. The interviews were transcribed, senior officials said, but the witnesses were not sworn because the general counsel’s office believed existing statutes already make it a crime for anyone to provide false statements to federal officials conducting an official investigative inquiry.
Sources at HHS said the report was being circulated to key lawmakers on Capitol Hill, where CDC officials are certain to face renewed questioning over its conduct in combating the worst pandemic in a century.
An aide to Rep. Anna Eshoo, D-Calif., chair of the House Energy and Commerce subcommittee on health, did not immediately respond to a request for comment.
CDC acknowledged in February that the core issue was a defect “in the manufacturing of one of the reagents,” adding that the agency was “remanufacturing the reagents with more robust quality control measures.” CDC Director Dr. Robert Redfield said in a statement the following month, issued in response to reporting by Sinclair on the agency’s early problems with test kit development: “CDC rapidly developed a diagnostic test for CDC and the nation’s public health labs... CDC and our U.S. government partners are working 24-7 to protect Americans, their families, and their communities.”
It was in January, amid early reports of the coronavirus emanating from China, that the Respiratory Virus Diagnostic Lab (RVD), an arm of CDC, undertook the task of developing a genetic test. RVD scientists designed genetic sequences for the reagents to be used in the process and asked another branch of the agency, the Core Facility Branch, known as “the Core Lab,” to manufacture them.
However, RVD personnel also requested that the Core Lab shorten its sequences of positive control materials, in order that the agency might remain competitive with an outside private firm that had indicated its scientists might be able to produce such sequences within ten days. “The Core Lab initially declined” this request, the report found, citing “the time pressure,” but ultimately agreed to comply, producing three different reagents.
A final set of reagents, requested by RVD, manufactured by the Core Lab and provided to RVD by January 28, arrived at a point when the diagnostic lab had already worked with positive control gents so intensively that it created “increasing opportunities for contamination.” It was at this point, when RVD processed and tested the latest reagents constructed by the Core Lab, that the components “were most likely exposed,” the report found.
Once the defective test kits were received from CDC in early February, public health laboratories sought to gauge their accuracy before using them on what the report called “real specimens.” These performance tests of the test kits “could not validate” the results they produced, with the outcome, the report said, that “a negative control gave a positive result.” Following this discovery, the laboratories across the U.S. shelved the test kits. “No patient received an inaccurate test result” because of the lapse, the report concluded.
Confronted on February 8 with the dismal findings of the validation experiments, CDC scientists alerted top agency officials, who reported the bad news to Secretary Azar “shortly thereafter.” Azar ordered CDC to identify the problem and fix it.
The chronology established by the HHS investigation revealed that within two weeks, CDC recognized that the relevant tests “could be run without the contaminated reagent,” which in any case “was not designed to be specific to the COVID-19 virus.” At that point, CDC scientists engaged colleagues at the Food and Drug Administration to devise tests that excluded the contaminated reagent. “New, uncontaminated reagents manufactured by private laboratories for CDC,” the report said, “were distributed to public health laboratories beginning in late February.”
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In March, a former HHS official for Preparedness and Response in the Trump administration, Christopher Meekins, told Sinclair in an on-camera interview that CDC’s early test kit failings were compounded by “lies” that agency leaders allegedly told to Secretary Azar and, by extension, President Trump, about CDC’s ability to rectify the problems. HHS and CDC officials denied that allegation at the time, saying Meekins was causing the public to be “misinformed.”