Thursday, July 17, 2014

APHL Statement Regarding Biosafety Incidents At Federal Labs




# 8840



The Association of Public Health Laboratories (APHL) is a non-profit organization of long standing that represents local, territorial, county and state public health laboratories of all types, including medical, environmental, agricultural and veterinary with the goal of promoting the safety, training, and excellence of public health laboratories across the United States.


With the recent revelations of hundreds of improperly stored vials of potentially deadly pathogens (see FDA Statement On Additional 300 Vials Discovered At NIH Campus Lab) – including smallpox – and reports of serious lab mishaps involving anthrax and bird flu (H5N1) at a CDC lab (see Subcommittee Hearing On CDC Lab Incidents), there are understandably concerns over what other bad biosafety news might be in the offing.


Yesterday in his testimony, CDC Director Dr. Thomas Frieden indicated that all CDC, FDA, and NIH labs were conducting (or about to conduct) full inventories to ensure there were no more improperly stored pathogens in government labs, and said it was possible that additional lapses could be discovered.


But these federal labs are far from the only research or testing facilities where lapses in protocol, or judgment, could produce potentially serious consequences.  During yesterday’s hearing, the GAO’s managing director for applied research and methods, Dr. Nancy Kingsbury, admitted the government didn’t have a good feel for how many high containment bio labs were were in the United States. 


Other panel members suggested that - between Federal, State, academic, and corporate labs - that number could reach as high as 1,000 labs.  And that there is no single regulatory agency in charge of creating safety protocols, and inspecting labs for compliance, across the nation.



Which brings us to a statement (my thanks to Marion Koopmans for tweeting the link), posted by the APHL that commends the CDC on their quick response to the recent lab incidents, and urges that all labs take immediate steps to `review their protocols and procedures immediately and thoroughly’ and work to `instill a culture of quality and safety’ in labs around the nation.


APHL Response to Biosafety Incidents at CDC and Other Federal Laboratories

The recent series of incidents in federal laboratories serves as a wake-up call for all laboratories--governmental, academic and those in the private sector.

APHL commends the CDC for its swift and assertive response to the biosafety incidents discussed in its conference call and report of July 11. We believe that the agency has taken the appropriate steps to improve the culture of safety and quality across CDC laboratories. APHL will work closely with the agency as it hones its biosafety processes and procedures and strengthens its quality management systems to assure that all aspects of laboratory management are administered effectively.

These changes will require sustained effort on the part of CDC leadership, staff, funders and partners. Enhanced federal support may also be needed to bolster oversight systems.

Because CDC is the sole provider of many materials used by public health laboratories to monitor and detect diseases and other health hazards, the moratorium on movement of all biological materials from BSL-3 and BSL-4 laboratories will have an impact on their operations. In the coming week, APHL will be in contact with CDC to determine how and when these materials – which are essential to public health services at the state and local level – can be delivered.

Lastly, the recent series of incidents in federal laboratories serves as a wake-up call for all laboratories--governmental, academic and those in the private sector. APHL urges its members and partner laboratories to review their protocols and procedures immediately and thoroughly. Having strong quality management systems in place, and a culture of quality and safety, is essential to retaining the public’s longstanding trust in laboratory results. The public deserves, and rightly expects, laboratory systerms that merit this confidence.




The sobering revelations from the CDC and FDA regarding biosecurity – while undeniably bad – are at least known problems that have been (quite commendably) publicly identified, and are being dealt with. More troubling are those hidden biosafety lapses – large and small - that are likely lurking in hundreds of other labs in the Untied States (and around the world).


One hopes that every lab in the country will heed the APHL’s advice and will go over their procedures and inventories  with a fine toothed comb looking to prevent incidents such as we’ve just witnessed at the CDC and FDA. 


Whether we will hear about all of the lapses uncovered, or whether some (perhaps, many) of them will be handled `discreetly’, is something I suspect we will never truly know.  


But either way, this summer is a wake up call for labs – both public and private - across the country.  

They need to either find that much vaunted `culture of safety’  within themselves, or some group of politicians and bureaucrats will surely do for – or to -  them. 


And that’s a `fix’ that I doubt many of these researchers would want to see arbitrarily imposed. . 

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