American Red Cross Could Face Criminal Charges for Failing to Keep Blood SafeJul 21, 2008 | Parker Waichman LLP
The American Red Cross has been under a court order for the past 15 years to improve the way it handles the nation's blood supply. Since 2003, the Red Cross has been fined more than $21 million for failing to do so. Yet critics of the organization claim the Red Cross is still not doing enough to make sure donated blood is safe. Now, frustrated at the Red Cross' apparent unwillingness or inability to do its job, federal regulators are said to be considering filing criminal charges against the organization's board members.
The list of fines assessed against the American Red Cross over the past several years is long. Just this past June, the Food & Drug Administration (FDA) fined the organization $1.7 million after the agency found that the Red Cross had washed six units of red blood cells with hypertonic saline solution. Sterile normal saline solution should always be used for this purpose. The defective red blood cells were transfused to three patients in 2006 and 2007 at three Red Cross chapters in the Northeast and Southeast.
The June fine followed another in February, when the FDA ordered the Red Cross to pay $4.6 million after the agency discovered 113 incidents in which the organization collected blood from an ineligible donor, failed to undertake proper testing, or shipped the collected blood at wrong temperatures.
In September 2006, the Red Cross was penalized $4.2 million for non-compliance with federal and FDA regulations concerning the collection of blood products. In that incident, the fine was levied for the American Red Cross’s “failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products.” The FDA said that the fines were “assessed under an amended 2003 consent decree that called for significant financial penalties when” the American Red Cross “fails to comply with FDA regulations and consent decree provisions designed to ensure the safety of the nation’s blood supply.”
The 2003 consent decree required the American Red Cross to “establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions; enhance training programs; and improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions.” Between the conception of the consent decree and the September 2006 fine, the FDA levied another $5.7 million in fines against the American Red Cross.
Despite the consent decree and subsequent fines, apparently not much has improved at the American Red Cross. According to The New York Times, the FDA has become so frustrated over the situation that in January, agency commissioner Andrew von Eschenbach attended a meeting of the Red Cross board of directors. The commissioner warned meeting attendees that they could face criminal charges for their continued failure to bring about compliance.
The Red Cross controls 43 percent of the country's blood supply. According to FDA records, some of the safety lapses at the Red Cross that resulted in fines put patients in danger, and exposed them to diseases like hepatitis, malaria and syphilis. Despite repeated incidents, the FDA says the Red Cross has failed to investigate the results of its mistakes, so no one knows for sure if any of the incidents resulted in patient injuries.