Red Cross Is Faulted Over Blood Supply

[mcablue]

Source: Wall Street Journal

By JARED A. FAVOLE

The Food and Drug Administration on Thursday said it has found widespread and persistent problems with the storage and distribution of blood supplies by the American Red Cross.

An FDA investigation in 2008 found more than 200 significant violations at 12 Red Cross facilities across the U.S., according to a report posted to the FDA's Web site. Violations include blood components that were distributed with incorrect references to the donor's gender, and blood distributed in cases where a donor wasn't properly cleared to give blood.

"FDA regards the violations discussed in this letter to be significant," the agency said in an Oct. 30 letter to the Red Cross. The FDA said it may levy fines of up to $5,000 for every unit of blood or blood component that was distributed and may have put the public's health at risk.

It's unclear from the documents whether anyone was injured by the blood distributed from the Red Cross facilities.

Read more: http://online.wsj.com/article/SB125807531639846383.html

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I don't mind them sometimes confusing the gender of the donor. Does that even make a difference? What scares me is the bit about "blood distributed in cases where a donor wasn't properly cleared to give blood."

[cutlassmama]

1. Great way to get Hepatitis or AIDS

[Rhiannon12866]

2. K&R. No, gender doesn't make a difference.

I used to give blood quite frequently and this isn't exactly reassuring. I was given a transfusion once, but I dodged a bullet, gave blood for myself and it was given back to me after surgery.

How will they cover these fines? Donations? :shrug:

[brewens]

4. Failing to correctly identify the gender means you didn't accurately determine the identity of the

donor so they will discard that unit if the mistake is caught. Even with the mistakes the ARC made those units still cleared testing no doubt. They were probably all good units. Good to know the FDA is catching those and making them tighten things up.
The ARC blood services is a not for profit corporation so they will pay the fines with revenue from blood sales.

[Rhiannon12866]

5. Thanks for an answer from an expert.

What I meant was that gender didn't matter as far as donating/receiving blood is concerned. But, of course, it's essential to determine where it came from. And what a terrible waste if good blood is discarded. It's not easy to get people to give, even if the need is great. :-(

When I was very ill, back in the '90s, there was a lot of fear about transfusions, like the Ryan White case. I was severely anemic and considered myself very fortunate that I somehow avoided receiving a transfusion, except when I received my own blood. Excellent news that they're tightening these things up... :scared:

And a belated welcome to DU, brewens! It's great to have you with us! :toast:

[brewens]

3. It is easier than you think to screw those up at a blood drive but reviews

afterward and during processing should catch the mistake. I've made both mistakes registering donors. You accidentally type in F for gender with a male donor probably because you've been registering women all day. You ask the donor to review his own registration form to point out any errors and he doesn't notice it. Then the people doing the blood draw don't notice it either. At a busy blood drive it can happen. My blood center has never been fined for distributing such a unit since I have been there. It always gets caught by the reviewers or lab techs. Usually because the name is obvious.
There are more ways to fail to establish eligibility to donate than you would think. The only way I have ever screwed that one up is by registering a duplicate donor. I registered someone as a new donor that was already registered with us. One where the previous registrar had reversed the first and middle names. I could have spotted him in the data base but didn't. That screw up means you couldn't tell if he had possibly donated more recently than is allowed (56 days) or possibly been deferred for some reason.
I had another one one time where an elderly woman with a common name had registered with us when she lived in another state. I spotted her in the data base and she swore that was not her at that address. When the reviewers spotted that and called her she confirmed that it had in fact been her at that address. That one really pissed me off.
I only know about those because the mistakes were caught.
The good thing is that people at high risk for HIV and hepatitis already know they can't donate and don't try. If they do and lie to us on the questionnaire the blood is tested for that.

[katkat]

6. what?

you say "The good thing is that people at high risk for HIV and hepatitis already know they can't donate and don't try. If they do and lie to us on the questionnaire the blood is tested for that."

That's some lie detector you have. Plus ar least with AIDS a person can be infected but test negative for some time.

As to the Red Cross, they have been screwing up blood handling for years.

[vadawg]

7. thought that if you have hiv or hep, or suspect you may have been in contact then you wouldnt want

to give blood, i know my blood is no good so i dont even try to donate, i just give rides and collect names when they have blood drives here.

[brewens]

11. That is mostly true.

We don't get people lying on the questionnaire to try and get away with donating blood. They have no incentive to do so. In the last two years we had one unit test positive for HIV. That was a donor that suspected he might be positive and admitted donating to use us for a free HIV test. One out of almost 80,000 units collected.
http://www.redcross.org/en/eligibility
There are the eligibility guidelines published by the ARC. The FDA mandates that all blood services use about the same criteria.
One thing a lot of people don't realize is that we cannot pay for blood donations. People sell plasma to the plasma centers but that cannot be transfused to patients. It's for research and manufacturing.

[rasputin1952]

8. The fines should be waived if the ARC gets to fixing the

problem. They have enough problems w/the economy as it is.

I don't agree w/fines as a punitive measure for errors of this type, fines don't fix the problem, better training and paying attention to detail fix this specific problem.

Since they are working on it now and will fix the problem, the fine won't do anything positive for the ARC.

[katkat]

9. rasputin

The Red Cross has had pretty horrifying problems with its blood supply for years. Apparently only fines will get their attention. Or a big lawsuit.

[rasputin1952]

10. The first thing they need to do is change managemnet, especially if

this is an ongoing problem. Get people in there that will ensure that will institute policy and ensure said policy gets done.

I think the ARC is a fine organization, they and the Salvation Army are always at disaster sites helping where they can, but there needs to be a change from the top to as deep as where the problems lie.