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FDA AND TRANSFUSION FATALITIES


mollyredone

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If a patient has a transfusion within 72 hours of death, what is the proper workup?  I've mentioned it several times to my medical director, but she is unsure of whether it has to be investigated.  I don't get notices when a patient is deceased (although probably I could get a list) to be able to follow up on it.  

Would the pathologist just look at the patient's report and other comorbidities and decide the transfusion didn't cause the death?  I saw a QI report from years ago where nursing investigated such deaths and decided they were not transfusion related, so I don't know if they reported the deaths to the FDA.

Thanks!

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Agree with AMcCord, we recently had this occur and FDA stated that unless the death can be directly linked to the transfusion, we do not need to report. We did investigate as a potential reaction, and our Medical Director reviewed the chart and wrote up a conclusion that indicated that the transfusion reaction was not likely. In case it's reviewed, we did our homework.

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As a side note, when a death occurs while a patient is getting a blood product, we always keep copies in the BB of pertinent chart data that shows the cause of death was not related to the transfusion.  When the FDA shows up they usually want to see records of anyone who died while getting transfused.

Scott

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Thanks everyone!  I have emailed the QI coordinator.  Who in your hospital investigates causes of death and decides whether the transfusion contributed to the patient's demise?  Since most of the time there was no transfusion reaction initiated, I wouldn't even know that the patient had passed, unless I happened upon it.  

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20 hours ago, mollyredone said:

I saw a QI report from years ago where nursing investigated such deaths and decided they were not transfusion related, so I don't know if they reported the deaths to the FDA.

I do have a Hell of a lot of respect for nurses, but I often wonder why we pay for doctors, or, indeed, why doctors put themselves through years of training, when all we need to do to find out why a patient did or didn't die is ask a nurse.  I seem to recall a discussion on here, which got quite heated, when it was suggested that nurses were quite competent at running a blood transfusion laboratory.

As I say, I have huge respect for nurses, but that huge respect is for their nursing - NOT their deep knowledge of all aspects of blood transfusion and medicine.

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Malcolm,

What was even more amazing was that they reviewed every transfusion and it was a rare one that didn't meet criteria!  Simply amazing!  But blood bank really can't review these deaths if there was no transfusion reaction called and no post specimen to work with and we don't know that the patient has even died.  What can we do?

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5 minutes ago, mollyredone said:

Malcolm,

What was even more amazing was that they reviewed every transfusion and it was a rare one that didn't meet criteria!  Simply amazing!  But blood bank really can't review these deaths if there was no transfusion reaction called and no post specimen to work with and we don't know that the patient has even died.  What can we do?

I agree 100% mollyredone, but, in the UK, such decisions as to whether or not the transfusion is involved in a death would ONLY be made by a doctor, and, if the death is unexpected, would go to a coroner and would certainly involve a post-mortem.  The say so of a nurse would not be considered for one moment (as, indeed, the say so of a laboratory technician/Biomedical Scientist would not be considered, however experienced they may be - and quite correctly so too).

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There seem to be two issues here. One, that deaths during a transfusion are not getting reported to a responsible party, and B, that it is not determined just who that responsible party is.  I would think that any transfusion service would have to have policies covering both of these.  I think the FDA, at the least, would be interested if this is not the case for any regulated institution.

Scott

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