CDC Sizes Up Laboratory Safety Post-H5N1 and Anthrax ‘Incidents’

Following an inadvertent cross-contamination of influenza virus samples and an unintentional release of “potentially viable anthrax,” in CDC labs, the agency released a discussion of recent findings and actions related to laboratory safety. The CDC discussion covered reports of both incidents that were released by the Animal and Plant Health Inspection Service’s (APHIS) as well as the CDC’s own findings based on internal reports. The CDC Director Tom Frieden announced that the implementation of changes identified in the reviews will continue as the “CDC is working intensively to make our labs to be models of not only scientific rigor but also of safety.”

H5N1 Flu Lab Incident

In May of 2014, the CDC recognized that an “inadvertent cross-contamination of a low pathogenic avian influenza (LPAI) A (H9N2) virus sample with a highly pathogenic avian influenza (HPAI) A (H5N1) virus and the subsequent shipment of the contaminated culture to an external high-containment laboratory” had occurred in a CDC lab in January of 2014. An internal CDC report found that while the incident did not “appear to have posed a safety risk,” since the contaminating product was handled in accordance with proper laboratory and shipped with proper permits and packaging, “the contamination most likely happened due to the failure of a laboratory scientist to adhere to established best practices and the absence of an approved laboratory team-specific protocol.” The report also noted a failure to completely understand reporting requirements, which “contributed to the delay in reporting this incident.” An APHIS report mirrored many of the findings of the CDC report regarding this incident including “gaps in laboratory protocols,” and failure to adhere to best practices and reporting procedures.

In response to these findings, the CDC announced its intention to “enhance laboratory performance and safety in the influenza laboratories,” through the execution of the following steps: (1) review and modification of existing protocols and development of new protocols, if necessary; (2) improvement of documentation processes; (3) implementation of standardized testing of cross-contamination samples before transfer or shipment; and (4) identification of existing skills and knowledge of staff and development of new training, if needed.

Anthrax Incident

A CDC report described the anthrax incident as one involving “an unintentional release of potentially viable anthrax within its Roybal Campus in Atlanta, Georgia,” on June 5, 2014. In the wake of this release, the CDC states that it instituted an immediate “moratorium on the movement (i.e. transfer inside or outside the agency) of biological materials from [biosafety level(BSL)] BSL-3 or BSL-4 facilities,” and that this moratorium would remain in place “pending lab-by-lab review of policies and procedures.” Additionally, and in response to the APHIS summary of findings on this incident, the CDC announced these steps taken to further guard against the potential for a similar incident in the future: (1) the creation and appointment of a CDC Director of Laboratory Safety, which will serve as the single point of accountability for lab safety; (2) the establishment of a Biosafety Working Group, which will function under and at the direction of the new Director; (3) the establishment of an external group of researchers and experts to advise the Biosafety Working Group; and (4) the development of example protocols for the inactivation of anthrax and refresher training for laboratory staff with access to anthrax.