American Red Cross

The American Red Cross (chartered as the American National Red Cross) is a humanitarian organization that provides emergency assistance, disaster relief and education inside the United States, as part of the International Federation of the Red Cross.

Court ordered consent decree

The Food and Drug Administration (FDA) took court action against the American Red Cross in response to deficiencies in their tracking and proceedures for ensuring the safety of the blood supply. The consent degree outlines some of the violations of federal law that the American Red Cross engaged in before 1993. Fines were imposed in the millions of dollars.

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In response to the decree, Red Cross Biomedical Services now has: a standardized computer system that efficiently maintains our blood donor database; a network of eight, state-of-the-art National Testing Laboratories (NTLs) that test about 6 million units of blood collected by the Red Cross's 36 blood regions; the Charles Drew Biomedical Institute, which allows for the Red Cross to provide training and other educational resources to Red Cross Blood Services' personnel; a highly qualified Quality Assurance/Regulatory Affairs Department, which helps to ensure compliance with FDA regulations in every Red Cross Blood Services region; and,

Related Topics:
Computer - FDA

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a centrally managed blood inventory system to ensure the consistent availability of blood and blood components in every Red Cross Blood Services region throughout the country.

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In an http://www.fda.gov/ora/frequent/letters/1000123507_ARC/consent_decree_100023507.pdf agreement with the American Red Cross] the Consent Decree was amended in 2003 with penalties for specific violations.

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The FDA can impose penalties after April 2003 up to the following maximum amounts:

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• $10,000 per event (and $10,000 per day) for any violation of an ARC standard operating procedure (SOP), the law, or consent decree requirement and timeline
• $50,000 for preventable release of each unit of blood for which FDA determines that there is a reasonable probability that the product may cause serious adverse health consequences or death
• $5,000 for the release of each unit that may cause temporary problems, up to a maximum of $500,000 per event
• $50,000 for the improper re-release of each unsuitable blood unit that was returned to ARC inventory
• $10,000 for each donor inappropriately omitted from the National Donor Deferral Registry, a list of all unsuitable donors