FDA Fines Red Cross For Bad Bookkeeping, Labeling This past week, the Food and Drug Administration fined the American Red Cross more than $5 million dollars for bad bookkeeping and labeling problems. It's the latest in a series of FDA actions against the Red Cross.
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FDA Fines Red Cross For Bad Bookkeeping, Labeling

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FDA Fines Red Cross For Bad Bookkeeping, Labeling

FDA Fines Red Cross For Bad Bookkeeping, Labeling

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DEBBIE ELLIOTT, host:

This past week, the Food and Drug Administration fined the American Red Cross more than five million dollars for blood safety problems. The agency levied the fine after inspecting one of the nation's largest blood processing centers in New York State. This is just the latest in a long series of actions by the FDA against the American Red Cross. Here to talk about the situation is NPR's John Hamilton.

John, this sounds bad. What did they find?

JOHN HAMILTON: Well, the biggest thing they found was that the Red Cross has really not implemented a plan it was supposed to have implemented to improve its safety procedures and bookkeeping. This has been several years in the works and this is the first time that the FDA was really checking to see how it was going, and they saw a number of procedural problems and bookkeeping problems and that sort of thing.

ELLIOTT: Can you give us an example of the type of problems that they found?

HAMILTON: Yeah. One of the worst things that they found was an example where they went in and looked at this blood processing center and they found that a unit of blood that had been marked contaminated was in a bin with blood units that were not contaminated or had been marked safe. So you have the potential then for bad blood to get to somebody at the other end. Now, that's not likely to happen because there are a whole series of checks along the way and any unit that was marked that it was contaminated, there would be so many steps where somebody could catch it and the chances of getting to somebody are almost infinitesimal. But it's still the possibility.

ELLIOTT: Does this mean that people should be concerned about the blood supply from the Red Cross?

HAMILTON: Well, the FDA itself has gone out of the way several times in the past few years to say that they do not believe that the nation's blood supply is unsafe, and the failures they've found on inspections have not been linked to people actually getting hurt.

ELLIOTT: So they sound like a lot of management issues.

HAMILTON: Yeah. The blood banking industry is sort of a cross between Federal Express and a hospital. You're trying to make millions of deliveries every day, but every one of them has to be certified safe. So if you think about that, you can imagine all of the procedures that have to go on to make sure that everything gets to the right place and is correctly labeled and so on. And so when you find errors, it's not usually that the blood that eventually got there was dangerous, it's usually that somewhere along the way there was a problem, but the blood was allowed to go to the next step before that problem was acted on. That sort of thing.

ELLIOTT: Now, this was a five million dollar fine. That sounds like a pretty hefty fine.

HAMILTON: It sounds like a lot. On the other hand, the blood banking business in this country is billions of dollars. So as a percentage of that, you know, five million dollars is not that big.

ELLIOTT: Now, I understand that this is not the first time that the FDA has had some problems with the way the Red Cross operates.

HAMILTON: Not at all. These problems go back to at least 1993, which is the first time that the FDA and the Red Cross entered into agreement to try to fix some of these problems with the way they were dealing with blood. They went back and revisited those in 2003, and what's happened here suggests that even now, the problems are not solved.

And this all gets to a larger problem, which is that the Red Cross itself has been in a state of turmoil, if you will. They've gone through a number of presidents. They're acting under an interim president right now. They're talking about reforming their board. They're talking about changing their charter. It's clear that this is an organization that is having trouble figuring out exactly how it needs to run itself.

ELLIOTT: Now, what happens if the Red Cross fails to remedy these bookkeeping and labeling problems that the FDA has cited it for most recently?

HAMILTON: The FDA could shut down individual blood centers, or all of them, if they wanted to. It has regulatory control over them. However, the Red Cross provides more than 40 percent of all of the blood that is supplied in this country. This is a country where we don't have enough blood. There are continual shortages, so losing 40 percent is really not an option.

ELLIOTT: NPR's Jon Hamilton, thank you.

HAMILTON: You're welcome.

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