According to the Food and Drug Administration, the Red Cross failed to follow proper safety procedures when collecting blood between 2008 and 2009. Specifically, the non-profit organization violated federal safety laws during the collection and processing of donor blood including mislabeling blood, failing to record complete information about donors, and exposing blood donations to air contamination. Consequently, the FDA fined the Red Cross $16 million on Wednesday.
The FDA warned the Red Cross of the problems associated with its blood collection practices in October of 2009 and ordered the organization to take the appropriate steps to prevent future problems. Furthermore, the $16 million fine is only the latest in a series of fines levied against the Red Cross since 2003.
In 2003, an amended consent decree required that the Red Cross pay significant fines if they failed to comply with the FDA regulations and other consent decree provisions to protect blood donors from contamination and to protect potential blood recipients from infectious diseases. It is particularly important that the blood industry complies with the safeguards put in place since blood products always contains some degree of risk. The consent decree requires the American Red Cross to comply with the following guidelines:
- Establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions;
- To enhance training programs; and
- To improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions
However, since the 2003 consent decree was issued, the Red Cross has failed to fully comply with these requirements and the FDA has issued 12 warning letters and at $21 million in fines, not including the fine announced on Wednesday.