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Why Aren't Hospitals More Concerned About Blood Safety?

 |  By cclark@healthleadersmedia.com  
   April 14, 2010

After my father's heart bypass operation 18 years ago, he suddenly spiked a fever, started quivering with chills and seemed to suffer terribly. His wife and I were horrified.

His bedside nurse calmly said his symptoms looked worse than they were. He'd be fine, she said. He'd just had a sudden, rare and surprising reaction to a blood transfusion.

His wife and I weren't reassured. If asked to fill out a patient satisfaction scorecard, I might have given the hospital a D.

The nurse explained, and the doctor repeated, that he'd developed an allergic reaction to components in the white cells of the donor's blood. Either dad's blood and tissue perceived the donor as foreign, or the donor's cells were attacking my father's, they believed.

They didn't know for sure but they'd keep him a few more days until he recovered, which he did.

If they could have known something like this might happen, "the blood we gave him would have gone through a process called washing." It was expensive; dad was low risk. That many years ago, maybe they didn't quite know what was wrong.

Having worked as an AIDS reporter for the prior eight years, I thought we knew pretty much how to keep the blood supply safe. But I'd never heard that blood that wasn't infected with viruses or bacteria could cause this much havoc to human health.

That's why the new Hemovigilance Project, a joint effort between the American Association of Blood Banks and the Centers for Disease Control and Prevention launched Feb. 18, is so intriguing.

The project is funded with roughly $1.7 million from the private sector, some blood banking organizations, and federal support for software development. Hospitals and their transfusion services are being recruited to use standardized definitions to rigorously count the number of adverse transfusion reactions in their patients–just like the one that happened to my dad–to score them, and report them on a computer database so they can be quantified and analyzed.

Most other developed countries around the world have been doing this for years. But, not the U.S. Apparently, here, hospitals and the non-government run blood system have been reluctant. To date only 20-25 hospitals are contributing, with another 40 saying they are in preparation.

Why the hesitation to participate, I wonder? Why aren't the other 4,000 or so other hospitals in the U.S jumping on board? The American Hospital Association and the California Hospital Association didn't respond to requests to discuss the issue.

Paul Ness, MD, editor of the journal Transfusion, and director of transfusion medicine at Johns Hopkins Hospital in Baltimore, suggests two reasons.

First, he says, "the transfusion service in a hospital is undervalued, often regarded as a cost center, not a revenue generator. So hospital administrations often put up significant pressure on hospital labs to reduce costs. Something that is being asked of the transfusion service to do, that is voluntary in nature, is given less importance than it really deserves."

Second, physicians and hospital officials "assume that all these transfusion reactions are trivial and benign. But they are part of a spectrum–some of them are not so trivial and benign."

Ness says "it's critically important that the U.S. develop this system with this kind of data. These are important, potentially preventable and treatable (adverse reactions). But the only way to muster support is to get a better idea of their true incidence."

The healthcare community in Great Britain offers a perfect example of how this data can be so useful, he says.

It wasn't until they launched their SHOT (Serious Hazards of Transfusion) surveillance project, that the cause of a most severe complication from transfused plasma was identified.

"They were able to determine that most of the plasma that was causing the problems of Transfusion Related Acute Lung Injury (TRALI) was coming from female donors who were previously pregnant," Ness says.

The problem is that some women had developed antibodies after exposure to fetal blood. These antibodies from the donor can react with transfused patients' white blood cells, causing pulmonary reactions.

Now, to guard against TRALI, plasma for transfusion is more commonly made from whole blood cells available only from male donors, Ness says.

In interviewing several blood transfusion experts for a story we posted on Monday, I got the sense that for most hospitals, these bad reactions are a lot more common than hospitals want to admit. Often, the reactions are erroneously blamed on the underlying illness that necessitated the transfusion in the first place.

The landmark 1999 Institute of Medicine Report "To Err Is Human" identified errors associated with the process of getting the right blood product to the right patient as "the error of greatest concern."

Such reactions, according to the CDC, can occur quickly, during the transfusion as in the case of my dad, or within hours. Or, even more confounding, it can occur days to months following transfusion.

Blood transfusions cause "tens of thousands" of non-infectious adverse reactions in hospitalized patients annually and many of them are quite serious resulting in longer, more costly care, explains Matthew J. Kuehnert, MD, director of the Centers for Disease Control and Prevention's Office of Blood, Organ, and Other Tissue Safety.

Sometimes they are minor, hives, rashes or itching. But sometimes they are as severe as, in the case of my dad, hypotension and fevers or bronchospasms, anaphylactic shock, renal failure and pain at the IV site.

And fatality is rare, with rates estimated at one per million to one per eight million transfused components.

Since each transfused patient receives on average 2.7 units, that risk falls to between one per 370,000 or one per three million.

We don't know exactly how many non-infectious adverse reactions occur in the 5.3 million Americans transfused each year, but there are some good guesses.

One survey conducted in 2004 of 1,322 medical facilities (one-fourth of the nation's acute care hospitals) reported 32,128 transfusion reactions that were so severe, they required diagnostic or therapeutic intervention.

That's an average of 24 per hospital, but in all probability, some hospitals may have more transfusion reactions as they perform more surgeries, where as other facilities may have fewer incidents.

"While any transfusion-associated adverse reaction is considered rare, the general consensus in the United States is that there could be considerable underreporting based on surveillance reports of similar events from national surveillance programs in the United Kingdom and Canada," says a recent CDC report.

If those estimates are correct, they might just be rare enough for risk managers to overlook, unless of course it's your patient, or your loved one.

Barbee Whitaker, director of data and special programs for the AABB which has long pushed for this project, wants hospitals to sign up for another reason, "One thing that the (Hemovigilance) system allows you to do is see whether any change that is made in a hospital, (such as) a change to a process, a device, a technology, a procedure, (is having) an impact on patients," she says.

As it turns out, the nurse in my father's hospital 18 years ago was correct. He recovered just fine, and doesn't even remember what happened to him. He lived another 18 years until he died of a ripe old age this February.

I hope more hospitals do get on board with Hemovigilance to identify these kinds of problems in transfusion medicine. After all, the British discovered the major cause of TRALIs. Who knows what other sorts of mysteries information like this might solve?


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