Trouble in the World’s Best Cleanroom?

In the contamination-control industry, we all understand the importance of and difference in ISO classes. These global standards were devised and adopted when the U.S. General Service Administrations standards – then known as FS209E – were no longer adequate in categorizing the growing specifications in cleanroom technology. From the original six classes of the FS209E, an additional two ‘cleaner’ standards were incorporated into the new ISO system, along with one ‘dirtier’ standard, and the system of ISO Classes 1 through 9 in use today was born.

But did you know that there is a standard of cleanroom that is superior to even the cleanest ISO cleanroom? Welcome to the world of the National Emerging Infectious Diseases Laboratories, or NEIDL…

NEIDL is more than just a lab. It’s a national network of high-security facilities with one sole remit: to study emerging (or reemerging) infections with an aim of developing diagnostic tests, treatments and eventually vaccines to combat them. As the most advanced incarnation of the cleanroom in existence, NEIDL facilities are designed to operate as fully self-contained units. Not only do they boast their own air filtration systems but also incorporate self-contained decontamination and waste disposal systems. According to one facility based at Boston University in Massachusetts, the air leaving the NEIDL facility is actually cleaner and more pure than when it came in. And, of course, it goes without saying that all of these critical systems have backups and redundancies, making failover a piece of cake.

What could possibly go wrong?

Given that the aforementioned NEIDL unit at BU was engaged in research on strains of the highly virulent tuberculosis bacteria, this should be a rhetorical question. When dealing with pathogens like tuberculosis or indeed ebola (see our earlier article on ebola and the issue of strike-through in contamination-control garments) there simply is no room for mistakes or errors. It should go without saying that quarantining the bacteria within a confined, secured area is critical to public safety. Unfortunately for the researchers involved on the Boston campus, however, it did need to be said…

In a singularly concise piece published in the Boston Herald on June 2^nd, we were interested to see a report of a partial shutdown of the NEIDL’s ventilation monitoring system which resulted in a suspension of research.(1) Per university guidelines, an external engineering contractor was brought in to perform a review and BU was forced to acknowledge what could have become a catastrophic malfunction. In what might seem a mundane incident were it not for the potential consequences, a malfunctioning network switch led to a restriction in air flow between two of the labs actively working on the live TB pathogen. Given that the problem also caused exhaust fans to power down, air pressure increased within the labs to a dangerous level, necessitating an immediate suspension of activity. As of publication date research in these two labs has not yet recommenced. According to a report in the Boston Globe, the secure freezers housing the TB pathogens were not affected by the malfunction and Boston’s public health commission was quick to issue a statement that public health was at no time compromised.(2) Boston University is awaiting a full report into the incident but preliminary findings seem to indicate a need for improvement of the system that controls air supply in the event that exhaust fans cease working.

News of this recent incident was of grave concern in many sectors. Flags were raised within the contamination-control industry and those living close to the university’s medical school which houses the NEIDL also shared an understandable level of concern. But it is what this incident revealed on a broader level that was of particular interest to many observers. Although Boston University followed the correct protocol in its immediate response, it chose not to inform the public of the incident for some time.

And this decision echoes what appears to be a disturbing trend in the bio-medical research industry. According to a Center for Disease Control (CDC) advisory committee report issued in 2015, many research personnel feel increased pressure to keep accidents or mistakes secret. Even from their immediate supervisors. Co-chaired by Dr. Kenneth Berns, the committee’s report noted a shift towards regarding protocol lapses and safety breaches as constituting a danger to the continued operation of a lab, with both individuals and teams reluctant to report them for fear of causing trouble. In a statement by Local 2883 American Federation of Government Employees representative Pam Gilbertz, concerns were raised that research personnel who reported safety issues risked being branded as ‘troublemakers.’ She went on to comment that “once you’re identified as a troublemaker your career is shot at CDC.”(3)

And another troubling picture emerged from the report – a culture in which the greatest safety threats are perceived as coming solely from outside the agency. To illustrate this point, when a CDC lab accidentally shipped a contaminated flu virus to Athens, Greece, the greatest concern was not that a researcher had failed to clean their workstation between handling two strains of flu virus, resulting in the cross-contamination of a relatively benign strain with the deadly H5N1 avian flu. Nor was it that – in feeling pressured to produce results – workers had taken shortcuts. But rather, the main worry was the potential violation of federal select agency rules – protocols put in place to ensure that such materials do not fall into the hands of unfriendly agents. In other words,  the hands of terrorists.

In a report by the Atlanta Journal-Constitution, Dr. Joseph Kanabrocki, Associate Vice President for Research Safety at the University of Chicago, is on record as saying that in the post 9/11 reality, emphasis has shifted from lab safety to protecting against theft: “Safety concerns are secondary,” he’s quoted as saying.

And given the types of material housed at the CDC – an agency considered the nation’s greatest authority on the correct handling of deadly pathogens – this complacency is ominous. In the aftermath of the critical review and concerned statements by Members of Congress it remains to be seen what steps the agency will take to dismantle the creeping culture of reticence to speak out. Promises have been made and we will be interested to see what changes are put into place.

Do you have thoughts on the challenges faced by the CDC? If so, we’d love to read them here!

References:

1. http://www.bostonherald.com/news/local_coverage/2016/06/tuberculosis_research_on_hold_at_boston_university_biolab
2. http://www.bostonglobe.com/metro/2016/06/01/lab-temporarily-halts-research-after-safety-lapse/9wwMlaePCqKapvzRdyW65L/story.html
3. http://www.myajc.com/news/news/experts-criticize-cdc-safety/nkf4Q/
4. http://www.bu.edu/neidl/resources/faq/