Fines for Blood Safety Violations

By Brian Scoles

The American Red Cross made the news in a big way this week and last when the FDA fined the Red Cross $4.2 million due to a voluntary recall of 12,000 units of blood and blood products produced by the Red Cross' Biomedical Services.

It is important to know that not all Red Cross chapters are involved in collecting 45 percent of the nations blood supply. The Upstate South Carolina Chapter is one that is not involved with blood collection.

Let's take a look at the issue for a moment: non-compliance with FDA regulations (Consent Decree). The FDA has established guidelines with which blood collection agencies must comply, such as pre-screening of donors, collection of blood and blood products, testing and storage, and delivery of blood to hospitals. The Biomedical Services division of the Red Cross discovered that it had not fully complied with the pre-screening phase during a limited period of time. When the error was discovered it was reported to the FDA.

Does that mean that Red Cross blood is unsafe? No. The FDA states that the Red Cross blood supply is safer than ever. The Red Cross has many layers of safety in place to help protect the blood supply which includes self-deferrals, completion of the blood donation record, health history screening, confidential unit exclusion, testing, and post donation information.

The Red Cross is not aware of any adverse events associated with ARC blood products, which is the good news. Now we must pay the fine and will do so. The funds will not come from donor money. They will be taken from the Biomedical Services' operating funds. The American Red Cross will never use the public's generous monetary donations to pay penalties associated with the Consent Decree.

I hope this helps to clarify the issue over the fine. Please respond with any questions you may have. Remember, the Upstate South Carolina Chapter is not involved in blood services.