Congress probes lapses at high-containment labs

In the wake of three recent incidents involving dangerous pathogens, members of Congress today had tough questions for federal health officials about high-containment lab safety, which revealed systemic problems, along with worries about the safety culture of lab employees.

The hearing took place before the US House of Representatives subcommittee on oversight and investigations, with US Centers for Disease Control and Prevention (CDC) Director Tom Frieden, MD, MPH, at the top of the witness list.

The tone of the hearing reflected deep bipartisan concerns about current events involving possible anthrax exposure, cross-contamination of an avian flu sample, and the discovery of decades-old smallpox samples in another federal lab, as well as past events and reports that have underscored shortcomings at the labs.

Late last week the CDC announced that it temporary closed two of its labs and barred the movement of dangerous pathogen samples as it investigates the incidents. It also said its lab used a method that may not have inactivated the Bacillus anthracis samples—the causative agent of anthrax—before handing them off to a lower-containment lab, where about 80 workers may have been exposed to the pathogen.

So far no illnesses have been detected.

Legislators seek answers

Rep Tim Murphy, R-Penn., subcommittee chairman, in his opening statement said that, in spite of several red flags over the years, such as earlier lab safety problems and several concerns raised by federal inspectors, the same problems seem to be occurring over and over again.

"There is a pattern of reoccurring issues, which is sloppy and inexcusable," he said. "Reports over the years appear to be systemic."

Rep Diana DeGette, D-Colo., ranking member of the subcommittee, said, because of briefing materials the subcommittee has received from federal officials, that the CDC had ample warning before the anthrax incident occurred.

"What we all need to know is whether there will be a safety culture change," she said. "We can't legislate that—it has to come from CDC."

Frieden told the subcommittee that the recent events point to "deeply troubling" problems and an insufficient culture of safety. He said the CDC has missed critical patterns, having approached safety problems in the past on an incident-by-incident basis.

He added that CDC researchers do some of the most rigorous scientific work in the world. "We have to apply that same rigor to improving safety in our labs."

He listed several steps the CDC is taking to address the issue, and he added that one of the key steps is to identify critical control points, such as inventory control. "A trust-but-verify approach and empowering staff to report."

The recent events showed that the CDC should use an emergency operations center approach for breaking down tasks to streamline its response to internal events such as the anthrax lab event—similar to what it uses to speed response to external events, Frieden said.

USDA, GAO input

Jere Dick, DVM, associate deputy administrator for the US Department of Agriculture's (USDA's) Animal and Plant Health Inspection Services (APHIS) signed a memorandum of understanding with the CDC in 2012 to inspect its labs, which it has now done seven times, including recently in the wake of the anthrax incident.

APHIS regulates the domestic possession, use, and transfer of select agents and toxins that can pose a severe threat to public health or the US food supply.

Dick said that, among the findings of those inspections, the lab didn't use an adequate inactivation protocol, the protocol wasn't validated, some employees didn't have proper training, and there were problems with oversight. The CDC's own preliminary investigation has identified similar findings.

Several subcommittee members raised concerns about the country's number of high-containment labs—estimated to number about 1,000—not just in federal agencies, but in academic and corporate settings, as well.

Nancy Kingsbury, PhD, managing director for applied research and methods at the Government Accountability Office (GAO) said so far the federal government doesn't have a baseline to determine how many of the labs the country should have. The number increased after the September 11, 2001, terror attacks and the anthrax attacks that followed. "We don't have a good answer, but it's worth keeping on the table."

Kingsbury told the committee that the CDC and APHIS are only two of the federal agencies that are involved with work in high-containment labs. She said there is guidance, but nothing in place to ensure that labs are following through. Currently, there are no national standards for high-containment labs, she said.

And while it would be an extremely complex task to have standards that would be appropriate for all type of lab work, a better framework for oversight seems warranted, she said. She added that competing interests of different types of labs would make it difficult to come up with national standards, but the strategy should be discussed.

Questions on procedures, delays

Alluding to a recent APHIS report that said some anthrax samples were transported in Ziploc bags, Murphy held up a prop showing bacterial plates in a Ziploc bag and asked Frieden to explain.

Frieden said many of the issues in the APHIS report applied to procedures that are done for killed anthrax samples.

Murphy also asked if a 6-week delay in reporting that a CDC unknowingly sent a sample to a USDA lab that was cross-contaminated with highly a pathogenic H5N1 avian influenza strain amounted to a cover-up.

Frieden said so far the CDC has found no evidence of a cover-up, with preliminary information indicating the failure may have resulted from a lack of recognition that the situation was an emergency. He added that it's clear that the agency needs to encourage reporting such incidents.

Rep Henry Waxman, D-Calif., pressed Frieden about whether the closures of the two labs is hampering the CDC's response to other disease threats. Frieden responded that other labs have been able to handle the overflow and that work related to public health response and individual patient case has been prioritized. He said the tasks the flu lab does in preparing materials for next season's flu vaccine should be completed on time.

Subcommittee members asked federal officials if the lab problems were related to government budget cuts, and they responded that they weren't.

Dick said the problems identified in the APHIS inspections ranged from simple things like unlocked refrigerators to more serious ones, such as inactivation protocols not being up to date.

Frieden said, "The primary issue isn't lack of funding.

House members also wondered if some lab workers might have become complacent about safety, given their years of experience working with certain pathogens.

Jan Schakowsky, D-Ill., said of the system-wide changes that Frieden alluded to earlier, "Whenever I hear the word 'culture,' I know we have a real problem on our hands," she said. She likened routine and important safety steps to hospital workers washing their hands. "These are small steps that deal with attitude and awareness."

Experts weigh in

During the second part of today's hearing, Congress members heard from two outside experts, Sean Kaufman, MPH, president and founding partner at Behavioral-Based Improvement Systems, a training firm based in Woodstock, Ga., and Richard Ebright, PhD, professor of chemistry and chemical biology at Rutgers University.

Kaufman told members that one of the organization's toughest challenges is to accept and control human error. "As a former proud CDC worker, I'm disappointed by what I'm hearing."

He also noted that the events highlight the need for more evidence-based biosafety research.

Ebright said in his opening statement that the CDC didn't learn biosafety lessons from a nearly identical anthrax incident in 2004 when lab workers at Oakland Children's Hospital were exposed to B anthracis in samples sent from a Frederick, Md., lab.

"This is part of a pattern that should have been identified a half decade ago," he said.

He added that three reports from the Department of Health and Human Services Office of Inspector General over the past few years have revealed major violations in areas such as physical access, inventory documentation, and training.

Congress and the administration should take two steps, Ebright said: Reduce the number of select agent labs to about 50 to ease the task of monitoring safety, and appoint an independent group that can regulate the labs.

See also:

Jul 16 House subcommittee press release

House subcommittee hearing testimony and background materials

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