IgA deficient autologous dilemma

[bmarotto]

We have a rather unfortunate patient who has a hematalogic problem (I do not recall what), Hepatitis C, and IgA deficiency with ant-IgA. The IgA deficiency was found when she had an anaphalactic reaction to red cells years ago at another institurion. She has a history of GI bleeding. It gets worse...she is A Negative, has anti-Kell, anti-s, anti-Do( and a warm auto antibody. When she needs blood, it means a nationwide search. Over the past two years, she has not had any bleeding and her hct is just high enough for autologous donation. We freeze her red cells for 10 years, We are also freezing her plasma since she is IgA deficient. Her hematologist wants us to save all products until she uses them or dies. Two of her plasma units have exceeded 12 months and are no longer FFP. They are being relabeled as PLASMA.

Considering this difficult situation, what is the maximum dating you would give these products? We are FDA registered but not licensed.

What would you do if she was admitted to her local hospital with a GI bleed and they ask for the products to be transferred? She is known Hep C pos but we do no testing on our autologous units as our policy is they are for in-house use only.

Her hematologist is also the head of medical ethics at our facility. I know he is going to make this a topic at one of their meetings. He has already asked our medical director what we would do if another patient "somewhere in the world" has the same antibodies and is in emergent need of blood. The fact that the blood is untested, from a patient with Hep C, and we are not FDA licensed for shipping across state lines wasn't enough for him. No matter what answer he is given, he comes back with a "but what about......."

I welcome any and all opinions regarding this case

[Mabel Adams]

Wow. Wouldn't some other patient desparately in need of blood be better off with washed antigen negative cells? Giving cells with a pos DAT and Hep C sounds like a bad idea to me. Maybe if recipient was Hep C pos. Still, do we know how DAT pos cells would survive if transfused (I am assuming stronger or different than a usual DAT pos donor)?

The FFP might be another deal, but the Hep C seems like a huge block.

If it were her at another hospital, I would either find out from the FDA what it would take to do this (is she across a state line?) or wing it at the time using the best medical and ethical advice available. Easier to ask forgiveness than permission theory. Can't a medical director approve about anything as an emergency measure as long as he can justify it?

[bmarotto]

I think he was getting at the fact that setting aside her IgA deficiency, it took days to find compatible blood because of the Dombrock. This one is a non-issue as far as I am concerned. I think he just wants as many issues as possible to toss out to his ethics committee for debate.

She lives in the same state but on the border of another state so the need to transport across a state line is possible. I agree that shipping her blood in an emergency would be something we would do under medical necessity after an authorization from the BB medical director of the receiving faclility.

What about holding her frozen units past their expiration as he has requested?

As for his ethics issues...he has brought two other BB issues to his committee in the past. One was whether to notify the recipient of blood products from a donor who subsequently died of CJD. The other was a case where we were asked to continue to transfuse massive amounts of blood products (during a holiday shortage) to a no hope of survival accident patient to keep her alive long enough for her family to fly into the country to see her before she died. I find it interesting that in both cases the committee was split evenly on what to do.

[David Saikin]

If you don't do testing on the blood you cannot ship it anywhere. If you did do testing, you could ship across state lines or to another in-state institution in a documented emergency, but would have to notify the FDA (include the documentation) - your quality plan should have some contingency statement for situations like this. The other pt's doc would have to approve using a unit with a positive marker . . . I think the best folks to ask this question to would be the FDA since you will have to answer to them if you are in violation of guidances/statutes/CFR. In my experience, physicians will try to do whatever they want to regardless of regulations - even if is dangerous for the patient (from our perspective).