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Ebola Vaccines Study Lab Shut Down by CDC for Safety and Quality Violations and Turn up on ‘SiteWatch Challenged’

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The scientist experimented in the laboratory

A U.S. Army lab that supports Ebola virus and other infectious disease research has been shut down due to reported violations in June by the Centers for Disease Control and Prevention. The Army lab at Fort Detrick goes into the TrialSite News SiteWatch database.

Apparently, the lab was involved with the investigation into dangerous pathogens when the government agency suspended the research due to lapses in biosafety as reported by Heather Mongilio at the Frederick News-Post on August 2. The local newspaper reported that they were told by a spokesperson for the US Army Medical Research Institute of Infectious Diseases (USAMRIID) that no disease-causing materials have been found outside of the authorized areas at the research site.

USAMRIID has been the US Department of Defense’s lead laboratory for medical biological defense research since 1969. The News-Post reported that the facility has both level 3 and level 4 biosafety labs and has worked on studies such as Ebola, Yersinia Pestis (plague) and Francisella tularensis (tularemia). These types of pathogens are considered “select agents and toxinsby the Department of Health and Human Services, which only allows authorized labs to work on such studies.

Cease and Desist Order

According to Ms. Mongilio, the suspension occurred due to multiple material issues such as failure to follow local procedures and a lack of periodic recertification for workers in the biocontainment laboratories according to spokesperson Caree Vander Linden of USAMRIID. Moreover, there were basic failures with the wastewater decontamination system.

The lab’s teams were studying among other things, agents are known to cause tularemia (deer fly or rabbit fever), the plague and Venezuelan equine encephalitis—all of which were worked on in a biosafety level 3 laboratory according to spokesperson Linden.

Quality and Government

The U.S. taxpayer expects that the monies allocated to various governmental endeavors are done so in such a way that we receive quality outcomes. Nowhere is this more important than in dangerous infectious disease research programs in support of our national defense. In addition to federal and state law, various industry quality standards must be not only adhered to but embraced and mastered. Quality, safety, and excellence are not just part of a strategy—they are a state of mind inherent in a culture of excellence. We expect that excellence to become a driving force moving forward.

Accountability is in order. USAMRIID’s registration with the Federal Select Agent Program which oversees disease-causing material use, possession was suspended. Those responsible for the lab’s quality and safety cultural degradation need to be held accountable. The lab is responsible for mission-critical research of significant national security interests. Of such paramount concern, why would management let conditions degrade just so the CDC would send them a cease and desist? The number one goal list on lab collateral reads “to ensure research is conducted in a safe and secure environment.” A quality culture lives up to this edict.

Repositioning or Reordering?

USAMRIID notes it will be back up and running when its again meeting benchmark requirements for biosafety. This means a thorough root cause analysis and corrective and preventative measures that support the organizations transcendence of how it operates today. Cultural change (and leadership) support an authentic investigation into true root cause—not what we have seen in the past in some environments–a cursory and “CYA” approach which only keeps the underlying problems around to surface for another day.

Quality requires talent, capital and time. If there are budget cuts, for example, the USAMRIID teams need more talent and time. If there are talent shortages it is very difficult to achieve requisite quality levels. “Vocational certainty” is of paramount importance in such highly regulated, risk-prone research endeavors.

This is a critically important laboratory—for basic science; for our understanding of infectious disease; to support translational research and for the U.S. national defense. TrialSite News will monitor and update on the situation.

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