Significant safety lapses in 2014 and 2015 in laboratories handling some of the world’s deadliest pathogens continue to raise concerns over the need for improved federal oversight of hazardous biological agents in high-containment laboratories, according to a recent Government Accountability Office (GAO) report.
High-containment laboratories deal with biological agents, such as the bacteria that causes anthrax or the virus behind smallpox, which can cause potentially lethal infections in humans and animals.
“Given the threat that hazardous biological agents pose to public and animal health and the US economy, federal departments and agencies need to strengthen oversight of their high-containment laboratories,” the report stated.
Over the past several years, the Departments of Defense (DOD) and Health and Human Services (HHS) reported multiple lapses in laboratory safety that could have exposedpersonnel and other individuals to dangerous biological agents.
In early 2014, CDC cross-contaminated a benign strain of bird flu, H9N2, with a deadly one, H5N1. The contaminated specimens were sent to a US Department of Agriculture lab (USDA), which discovered the contamination issue after chickens in their research became seriously ill and died.
In June 2014, Homeland Security Today reported that approximately 75 Atlanta-based CDC staff were unintentionally exposed to live Bacillus anthracis—a bacteria that can cause severe infectious disease— after established safety practices were not followed.
The incident occurred in a biosafety level 3 laboratory at CDC where the laboratory used a procedure that may not have adequately inactivated the B. anthracis samples. The samples were sent to lower biosafety level laboratories for experimentation where the proper protective equipment for handling infectious samples was not used, since the researchers were unaware that the samples may not have been inactivated.
CDC determined the scientists’ failure to follow an approved, written study plan that met all laboratory safety requirements led to dozens of employees being potentially exposed to anthrax. There was also a lack of standard operating procedures to document when biological agents are properly inactivated in laboratories.
Although the after-action review of the incident determined it was unlikely any workers were exposed to B. anthracis, CDC concluded that, “Response to the incident should have been better organized from the outset” and “this was a serious and unacceptable incident which should never have happened.”
Since then, DOD and HHS have made substantial progress in implementing recommendations from the reviews held in the wake of these safety incidents. As of November 2015, HHS agencies—the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA)—reported implementing 91 and 6 recommendations, respectively, and were taking steps to implement others, and the National Institutes of Health (NIH) reported implementing all of its recommendations. DOD reported implementing one recommendation from its review and was taking steps to implement others.
GAO’s recent investigation of the oversight at high-containment laboratories determined, however, that CDC’s, DOD’s, and Army’s plans lacked implementation time frames for some of these recommendations. The federal investigators explained, “Without implementation plans that include time frames, their ability to gauge performance and track progress toward implementing these important improvements will be hampered.”
The investigation also revealed that most of the 8 departments and 15 agencies they reviewed had policies for management of their high-containment laboratories. However, the policies lacked key safety elements or did not apply to all high-containment laboratories.
Furthermore, these departments and agencies use inspections and audits as their primary oversight activity, but do not routinely report the results to senior officials. Specifically, senior officials at 5 departments and 8 agencies did not routinely receive inspection results; and senior officials at 4 departments did not routinely receive incident reports.
These departments and agencies did not report this information, since there was no requirement for them to do so.
“Absent routine reporting of the results of inspections and trend analyses, senior department and agency officials are hindered in their ability to recognize when individual safety lapses that appear to be isolated incidents point to systemic weaknesses and thus to identify needed improvements and corrective actions,” GAO explained.
The federal investigators made 33 specific recommendations intended to help ensure that all the federal departments and agencies they reviewed have comprehensive and up-to-date policies and stronger oversight mechanisms for their high-containment laboratories.
The recommendations include updating missing policy elements and ensuring that senior officials receive inspection and audit results. Six departments—DOD, HHS, USDA, Department of Homeland Security, Department of the Interior, and Veterans Affairs—generally agreed with all of the recommendations.
The remaining two departments, the Department of Energy and Environmental Protection Agency, did not believe that further action was needed to respond to some of the recommendations. GAO maintains its recommendations.