CDC Shut Down a Lab Involved in Making Faulty Coronavirus Tests

With no public notice, the Centers for Disease Control and Prevention in October shut down a key lab involved in making faulty COVID-19 tests for state and local health authorities early in the pandemic. The move came less than six hours after ProPublica published an investigation that detailed for the first time the chain of mistakes and disputes that unfolded inside CDC labs, which culminated in one of the biggest fumbles in the agency’s 74-year history.
A CDC acting branch chief told the staff of the Respiratory Viruses Diagnostics Team lab on Oct. 15 that the closure would be for two to four weeks while the CDC investigated and the staff worked on corrective action plans, according to internal sources. But more than two months later, the lab still is not performing tests.
ProPublica’s investigation revealed that Stephen Lindstrom, a respected CDC veteran who led the lab and was in charge of the production of tests in the early days of the pandemic, made a fateful decision in January 2020 to use an internal CDC manufacturing process that was fast but risked contamination. Lindstrom then released tests to state and local public health labs the following month even though one of his staff’s quality checks showed that plain water tested positive for the virus, according to CDC lab records.
Complaints poured in from the state and local facilities shortly after the tests arrived. At that time, Lindstrom’s CDC lab was the only one in the country that could confirm whether a patient had COVID-19, and the scarcity of working tests at state and local public health labs had serious consequences in the early days of the pandemic.
The roots of that early public failure had remained largely a mystery, even to those within the CDC. ProPublica’s account of what transpired inside the lab was news even to some senior CDC officials. The story, based on interviews and exclusively obtained lab records, detailed the mounting pressures on the lab staff, the mystifying appearance of contamination at every turn and the three-week scramble to fix the tests.
Since then, work in the lab has been intermittent, with tests diverted for a time in March and a temporary closure in May. In October, the lab, which by then was no longer managed by Lindstrom, was faulted for making what higher-ups considered an error while handling materials for a new test designed to detect both the flu and the coronavirus, according to people familiar with the matter. It’s not clear whether that issue, the revelations in the ProPublica investigation or a combination of both led to the Oct.15 shutdown.
The CDC media team declined to answer questions about the reasons for the closure or the ongoing efforts to bring the lab back into compliance. Lindstrom referred a reporter to the media team, which did not make him available for an interview.
Debate has simmered within the CDC about whether the flawed tests were due to contamination, which can happen in the best of labs, or a faulty design. Two CDC labs were involved in making ingredients for the flawed tests in January and February last year, and a report by lawyers at the Department of Health and Human Services last June said Lindstrom’s lab was the likely source of contamination.
Lindstrom had created well-regarded tests for the flu, including the first test for H1N1 during that pandemic in 2009. Records show he was adamant that the COVID-19 test design was not flawed and that evidence showed the contamination happened at the other CDC facility that made testing components, not his own lab. In July he was reassigned to a new job with no official title and few responsibilities.
A different CDC scientist familiar with the Oct.15 lab closure said Lindstrom’s lab made mistakes. But the scientist, who asked not to be identified, said there was a sense among some CDC staff that Lindstrom and his team were being scapegoated and unfairly blamed for contamination that may have involved another CDC lab. The scientist believes that shutting down the lab on the day of the ProPublica story was to protect top CDC officials, including the task force in charge of labs during the COVID-19 response. “When something bad happens and it goes public, heads have to roll, and they pick people to take the fall,” the scientist said.