New Fines for the American Red Cross

Earlier this month, the Food and Drug Administration slapped the Red Cross with a $9.6 million fine for unsafe blood management practices. This fine follows a June 2010 fine of $16 million for similar offenses.

The latest fine stems from the investigation of 16 Red Cross facilities from April 2010 to October 2010. According to the FDA, investigations revealed “significant violations” including poor managerial oversight and inadequate record-keeping that may have led to the release of potentially contaminated blood.

While there is no current evidence that any blood recipients have fallen ill, Patricia El-Hinnawy, an FDA spokeswoman, points out that the “FDA cannot definitively say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences.”

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J. Chris Hrouda, the executive vice president of Biomedical Services for the Red Cross, received a 32 page letter regarding the violations on January 13, 2012. The issues discussed in the letter included a backlog of about 15,000 records in Charlotte, North Carolina, indicating that the organization failed to either process or examine records relating to donor reactions. It was also discovered that some sites neglected to maintain a list of donors who were banned from giving blood due to infections or other issues. Other locations bypassed “lookback” investigations, which serve to notify donors who tested positive for infections and also to notify patients who may have been given infected blood. Many locations also failed to follow-up on other issues in a timely manner. For example, in 2010 inspectors witnessed a phlebotomist at a Red Cross center stick herself with a need and then use the same needle on a patient. The issue went unreported for a month. Other concerns include improperly trained staff members and mishandled and misplaced blood.

According to Evelyn Bonnin, the director of FDA's Baltimore District, these and other issues have been brought the attention of the American Red Cross before but more needs to be done to rectify the situation.

The Red Cross, however, insists that the issues outlined in the most recent letter have been resolved since the inspection was conducted more than a year ago. “We are disappointed that the FDA believed it necessary to impose a fine for an inspection conducted so long ago. We are not aware of any adverse donor reactions or patient issues due to the problems in the FDA report,” said Stephanie Millian, the director of biomedical communications.

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Despite assertions that it has cleaned up its act, the Red Cross says that it does not have access to more recent investigations to prove its claims. The organization has said that it cannot access new investigations because they are still considered to be “open.”

According to the Director of Public Citizen's Health Research Group, Sidney Wolfe, the fines have not been imposed in a timely manner, thus complicating the situation. “The longer the FDA waits to impose fines, the more opportunity the Red Cross has to say: ‘That was then. This is now. Everything is fine,'” said Wolfe.

However, that is not to say that the Red Cross would amend its practices even if the FDA presented the fines in a more immediate manner. According to Daniel Borochoff, president of CharityWatch, the Red Cross may determine that it's easier and more cost effective to pay the fines and continue to as is.

If taken at face value, statements made by the Red Cross would suggest otherwise. According to the organization, it is “fully committed to meeting all FDA standards, has made significant progress in working with the FDA to comply with their regulations and requirements, and continues to work on improving its performance.”