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American Red Cross Violations
Sidney M. Wolfe, M.D.
There is little dispute that the American Red Cross (ARC) provides many valuable services, including disaster response and community services that help the needy. One of its most well-known functions involves the collection, processing and distribution of blood and blood components. Serious deficiencies in this important function have been the subject of decades of investigations by the Food and Drug Administration (FDA), with repeated findings of widespread, long-standing and dangerous ARC practices.
In 2000, Public Citizen asked that the ARC be held in contempt of court for repeated violations of a 1993 court-monitored Consent Decree ARC had signed with the FDA. Recent violations, according to the FDA, had included “a deficient quarantine system that does not prevent release of unsuitable products; improper release by ARC of cytomegalovirus (CMV)-positive blood products; donors being associated with incorrect histories; [and] inadequate ARC oversight of system problems.”
In 2003, a strengthening of the previous Consent Decree was agreed upon, in an effort to further ensure the safety of the nation’s blood supply, because of continued violations of many of the important steps of the collection, processing and distribution of blood and blood products. Since that 2003 agreement was signed, ARC has been forced to pay a total of $47 million to the government as a result of hundreds of adverse findings during a series of FDA inspections.
The most recent example of these massive violations, which resulted in a $9.6 million fine, was discovered in a fall 2010 inspection of ARC facilities that documented hundreds of further violations of the 2003 agreement.
These violations included failing to notify health departments when a blood donor has been determined to have infectious diseases, such as HIV, hepatitis B or C, West Nile virus or syphilis; failing to review donors whose blood donations needed to be quarantined in the past; failing to promptly add people with known problems, such as infections, to the national list of deferred donors; and delays in logging donations more than five days after their discovery.
The substandard performance of critical ARC blood-handling functions continues. Too many lives are at risk if the ARC continues violating the important 2003 Consent Decree it long ago agreed to abide by.