Hasty Ruminations

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Tuesday, November 28, 2006

More Red Cross Problems


Now, I am mad!

The FDA is citing the American Red Cross – again – for blood safety violations.

Recent inspections found major problems in quality assurance, inventory management, control of off-spec blood products, donor screening and blood component manufacturing problems. These are repeats of previous Red Cross problems, in violation of the 2003 consent order between the Red Cross and the FDA, and in spite of Red Cross claims of training and assist visits. The American Red Cross had such “persistent and serious violations” (FDA’s words) for 17 years that it “settled” with the FDA in the 2003 consent order.

The Red Cross handles 40% of the nation’s blood supply. They sell blood to health facilities.

This is a horrible state of affairs.

We are not talking about rocket science here – nothing as complicated as controlling organ transplants, mapping genes or diagnosing cancer. What the Red Cross does requires simple, written procedures; training; supervision; quality assurance and quality control; and accurate specifications. There are consultants who know how to set these things up. That the Red Cross has not done this after three plus years – and $15,000,000 in fines (yes, fifteen million) – means that their management and their much-discussed board of 50 governors does not want to do it.

This outfit operates under the charter of the United States Congress.

The Red Cross put together a plan in 2004, with FDA’s blessing. The inspection in 2005 of the West Henrietta, NY, blood facility was the first test of that plan. It was that inspection which resulted in 207 deviations from the plan and the regulations and violations which resulted in the recent $5.7 million fine. I work under those regulations in the pharmaceutical, medical device and biopharm industries; and I must comply just as the Red Cross must comply.

It means that the Red Cross is not even trying. In my book, that is contempt, and it deserves some jail time.

They claim that they do not use donated money to pay these fines. I don’t believe that, either. The fines will increase if the new compliance plan does not meet FDA requirements.

Your kids and mine have a 40% chance of getting some Red Cross blood into their systems.

Who knows where it’s been, how it’s been handled, or where it came from?!

Let's establish another source for the blood supply, disband the Red Cross, and put them all in prison. Start with each of the 50 governors to a Fed Pen in each state.


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