FDA fines American Red Cross $4.2M for Donor Violations

The American Red Cross (ARC) is the largest single agency involved with collecting blood for our nation's strapped supply of blood products used in transfusions. Today, the FDA fined the organization $4.2 million, the largest single fine, for violations of FDA rules. These rules include formal regulations regarding the collection of blood, as well as amendments in the form of consent decrees, of which the most recent was in 2003.

It's important to note that the FDA goes out of its way to say that no "serious health consequences" have been found to have resulted from the violations. In fact, they state "Improvements in donor screening procedures and the use of a variety of new tests in the last few years have made the national blood supply safer from infectious diseases and other risks than it has been at any other time. However, because there is always some degree of risk in receiving blood products, each individual safeguard is considered critical to minimizing that risk." It's the broaches of individual safeguards committed by the ARC that the fine today was due to.

This underscores the importance of well trained employees and volunteers in every institution collecting blood for use in our nation's blood supply. Only 10% is collected by hospitals, whereas smaller private local agencies make up the difference, with these agencies providing collections of an amount equal to that of the ARC's. This fine should be a warning to each of these smaller agencies to maintain and improve compliance with the careful screening questionnaires required by the FDA.

I'm hoping that the technologies used in testing also improves such that tainted blood can be discarded before it enters the nation's blood supply. We may never reach 100% safety, but the closer we can get, the better.

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