Despite intense scrutiny of lab safety lapses at the Centers for Disease Control and Prevention, workers at an agency lab earlier this year failed to confirm and certify a supposedly killed virus specimen was dead before shipping it across the country, a top CDC official said this week in response to questions from USA TODAY.
The specimen of chikungunya virus, which turned out to still contain some live virus, was shipped without required testing in May from the CDC’s high containment lab facility in Fort Collins, Colo., to a lab that uses lower-level safety precautions at the agency’s Atlanta headquarters.
The incident is the first known failure of CDC staff to follow a key safety certification process put in place after series of lab incidents in 2014 that included dozens of agency workers in Atlanta potentially exposed to live anthrax that hadn’t been fully killed before it was shipped to a lower-level lab. In another incident that year, a different CDC lab mixed up specimens from an Ebola experiment and sent an un-killed sample to a lower lab.
“To my knowledge this is the only example where this has happened” since the reforms were put in place, Steve Monroe, CDC’s associate director for laboratory science and safety, said in an interview.
Monroe said the May shipment of chikungunya virus posed no risk to workers of the public. The shipment occurred in conjunction with emergency efforts to create tests for the more dangerous Zika virus. The CDC would not say whether disciplinary action was taken against workers involved in the shipment.
“We are gravely concerned that a conscious decision was made to ship this pathogen before confirmation because of urgency,” said U.S. Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee, which this week held the latest in a series of hearings on safety lapses in U.S. labs.
“It is precisely at this height of operational demands where CDC needs to provide clearer guidance and leadership on balancing its mission and safety," Upton said Friday. "Everyone needs to get on the same page – now – before people are needlessly harmed, or worse.”
U.S. Rep. Diana DeGette of Colorado, the ranking Democrat on the committee’s investigations subcommittee, said that while members are still looking into the incident “what we know for certain is that safety procedures weren’t followed as they should have been.”
Under CDC’s safety reforms, when a killed specimen is moved out of a biosafety level 3 or 4 lab – the highest safety levels where workers wear respirators and other special equipment to protect against infection – it must be accompanied by a signed certificate detailing how it was killed and verifying that additional tests showed the kill-step effective.
Yet in the May incident, CDC lab staff in Fort Collins, Colo., neither waited for confirmation tests to show the sample was fully killed, nor filled out the required certificate, Monroe said. Chikungunya virus, which is spread by mosquitoes, can cause fever and joint pain. While it is not often fatal, the illness can be "severe and disabling," according to the CDC's website. In some people, the joint pain can last for months.
The incident occurred as CDC staff were responding to the spread of Zika virus, which can cause babies to be born with abnormally small heads, incomplete brain development and other serious health problems -- yet cause no symptoms or minor symptoms like fever or joint pain in many of the people infected.
Scientists at the CDC’s headquarters in Atlanta were creating a new “Trioplex” test kit to allow state and local health departments to test for Zika and two other similar mosquito-borne viruses: dengue and chikungunya. The agency asked its biosafety level 3 lab in Fort Collins to prepare a specimen of killed chikungunya virus and send it to Atlanta for use in the kits, Monroe said.
The Fort Collins lab prepared the specimen and treated it with a heat process that had been effective in the past with thoroughly killing the virus. “Because they recognized the urgency of trying to put together these kits for use by the state and local health departments,” Monroe said staff in the Fort Collins lab called their colleagues in Atlanta and said they were shipping the specimen before testing had confirmed it was killed – and to not open the package until the results were completed.
When the package arrived in Atlanta, it was put into a lab refrigerator, then destroyed after the Fort Collins tests ultimately showed “some low-level residual infectivity,” Monroe said.
Monroe said the agency is reinforcing with lab workers that killed specimens must be confirmed dead before shipment. The agency also is reminding workers that “nothing is transferred – even within CDC facilities – unless accompanied with a material transfer certificate,” he said.
The "Trioplex" test involved in the May incident has been the subject of whistelblower claims by a top agency scientist that the CDC has promoted the three-virus test despite it being nearly 40% less effective in detecting active Zika virus than a Zika-only test. This week, the U.S. Office of Special Counsel sent a letter to the White House calling for additional review of concerns raised by Robert Lanciotti, a microbiologist who is chief of CDC's Diagnostics and Reference Laboratory at the Arbovirus Diseases Branch in Fort Collins. The CDC's internal investigation found there is not sufficient evidence to show the Trioplex test is less effective, according to records released by the Office of Special Counsel, an independent federal investigative agency.
In May, the CDC demoted Lanciotti to a non-supervisory position within his lab after he raised concerns about the Trioplex test internally -- and also in an email to state public health officials, according to the Office of Special Council. After Lanciotti filed a whistleblower retaliation claim, the office said got CDC to agree to reinstate him as chief of his lab.