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For the second time in less than 2 years, FDA has levied fines of more than $9 million on the Biomedical Services arm of the American National Red Cross.

The fines are due to violations by the Red Cross of a 2003 Amended Consent Decree of Permanent Injunction. FDA and the Red Cross entered into the 2003 Consent Decree after FDA inspections of various Red Cross biomedical facilities found numerous deviations from FDA law, regulations and the requirements of an earlier (1993) Consent Decree. The biomedical facilities are responsible for ensuring the safe collection, screening, handling and distribution of the nation’s supply of donated blood.

On June 17, 2010, FDA informed the Red Cross that the non-profit organization was to be fined $9,776,000 for violations of the Consent Decree that occurred from 2003 to 2008. The second series of fines, announced on January 13, 2012, covers violations that were documented during a series of inspections carried out from April 2010 through October 2010.

All told, FDA has fined the American National Red Cross $19,368,200.

A number of the violations that were documented during FDA inspections of 16 different Red Cross Blood Services facilities threaten the potential safety of the nation’s donated blood supply. Here are just a few of the more egregious lapses:

  • Failure to establish, implement and continuously maintain managerial control over QA in all regions and laboratories…
  • QA programs were not adequate to ensure that all regulated donor management operations were being performed effectively at the Philadelphia DCSC…
  • Failure to comply with reporting requirements…
  • Inadequate National Donor Deferral (high-risk donor screening) Register…
  • Failure to promptly implement adequate corrective actions to prevent recurrence of the failure to control suspected blood or blood components…
  • Failure to follow Standard Operating Procedure…
  • Failure to establish and maintain a distribution and receipt procedure that includes a system by which the distribution or receipt of each unit of blood can be readily determined to facilitate its recall, if necessary…
  • Failure to ensure that supplies are used in a manner consistent with the manufacturer’ s instructions, and failure to prepare the phlebotomy site using a method that gives maximum assurance of a sterile container of blood…

FDA also underscores in its most recent letter to Mr. Chris Hrouda, Executive Vice President of Biomedical Services for the American National Red Cross that many of the violations enumerated in the January 13, 2012 letter are “virtually identical” to violations reported in previous letters.

As of March 2010, the adult population (15 years of age and up) of the USA was approximately 242 million people. According to the Red Cross web site, 3 out of every 100 Americans – that’s roughly 7.25 million people – are blood donors. I wonder how those 7.25 million people feel about the way the Red Cross is handling their precious Gift of Life.

The American National Red Cross depends on the good will and generosity of millions of people who donate their time, money, and blood to save the lives of total strangers. It’s time that the organization was held to account, not just by FDA, but also by the people on whose generosity it relies for its very existence.

Next time the Red Cross contacts me to ask for a donation, I plan to demand an accounting of how they propose to clean up their act. I suggest that everyone do likewise.

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