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Texas Lynn

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About Texas Lynn

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  • Birthday 08/22/1953

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  1. For the Ortho Vision users: are you using certified blood bank saline or the NERL saline on the Vision? I don't see any specification in their manual.
  2. this is what I found from AABB "ask the FDA' estion 29: When is a transfusion service required to be FDA registered? Do the following processes require the facility to be registered? These examples were received from 4 different facilities. thaw plasma and split RBCs receive washed red cells from the blood supplier and then add plasma for an exchange transfusion divide red cell or platelet products for pediatric use re-label thawed fresh frozen plasma to thawed plasma MS. CIARALDI: There's an easy answer, which is no, yes, no, no, but what I'd like to do is just take some time to explain why. The regulation that states who must or who is required to register is 21 CFR 607.20. It says specifically any establishment that manufactures a blood product must register, and there are some other criteria, but that's the main one that applies here. Additionally, there is a regulation 21 CFR 607.65(f), that lists some exceptions under which a transfusion service does not need to register, but that's a very limited and specific list. Now, to go on to the specific examples here, what I'd like to do is bunch bullets one, three, and four together. In those three situations, a transfusion service would not need to register. Thawing plasma to prepare it for a transfusion we don't consider the manufacturing of a product. So that is why that particular practice is exempt. In addition, splitting or dividing units for whatever reason, usually pediatric reason, is also not manufacturing a product. The end product is the same as the starting product. It's just smaller volumes. So that is the rationale behind why that would also not need registration. However, in the second bullet, washed red blood cells has plasma added to it, and the final product, which is sometimes called reconstituted whole blood or reconstituted red cells, is used for exchange transfusion. The answer to this is that, yes, registration is required, because the transfusion service is making a new product. The reconstituted whole blood is the new product. The final product, the whole blood product, is different from the two original starting products. So there is manufacturing of a product going on in this particular situation.
  3. We may start doing panels here also. Where do I get these programs to ID the antibody?
  4. We switched last year from a local supplier to ARC. The big downside is not being able to return RBC or frozen products. We have tried to transfer PLTPH to our sister hospitals, but we quit doing that also. I throw away units that before I would have returned to our supplier. I also hate unpacking the units (they come in boxes) and having to throw those big bags of ice into the sink. Our local supplier would put the units in the frig or freezer if we wanted them to do that.
  5. How are deciding if it is a real antibody or if it is from the RhIg shot? to mollyredone: If patient has Anti-K and we crossmatch K neg units, we still do the IgG crossmatch. So, we do the IgG crossmatch on the patients with Anti-D. Like someone else said; sometimes to have a rule and no exceptions is easier for the generalists.
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