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Whole Blood
Thank you very much for your thoughtful response! As for my other question, I asked it because at the blood center I worked at, they did start testing the RBC supernatant on antibody positive donors and labeling them as regular unrestricted RBC units. I figured this was sort of related since the argument they made to the FDA was that the additive solution dilutes antibodies to an undetectable level. I've attached a document of exceptions to the CFR from 2018. In section 7d of this document they say as long as they test the supernatant by an "approved method" and it's negative they are allowed to do it. I don't know what studies the blood center did to get this exception granted, but it's been the way this blood center has been doing it for at least 6 years now. Exceptions-and-Alternative-Procedures----Approved-Under-21-CFR-640.120 (1).pdf
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Whole Blood
Thank you everyone for the replies! I definitely have a lot of reading to do. @Bet'naSBB I definitely agree that the patients have to live to have a problem. I appreciate the info about your facility. I hope to read more research about the WB that's being done at hospitals like yours! I am also curious about studies going on that involve obstetrics and cardiac LTOWB MTPs. @Neil Blumberg Thank you very much for the articles. I am also worried about the incompatible plasma in the regular red cells for sure. I feel like I'm in between a rock and a hard place. Just to make sure I've understood, even if a patient just got their total plasma volume replaced with Group O albeit Low titer plasma, we should switch all products to their blood type the second we get a result? (I am also curious what you think of blood centers labeling red cells from antibody positive units as regular red cells and don't treat them as antibody positive units needing a minor crossmatch. The blood center claims that the Additive Solutions dilute the titer "enough." I admit I haven't looked for any research on this yet. I don't know if they titer the supernatant or what to prove this. Maybe this also needs to be brought up in paradigm shifts alongside rethinking out of group ABO compatible red cell transfusions.) @jshepherd Right now, I would like to limit it to 4 LTOWB and then switch to components until more research is done, but my hands are tied. No amount of articles or concerns has changed our Trauma department's mind. They want unlimited LTOWB in their perfect world, but we were able to limit it to 10 to match the "model" facility's protocol. Maybe a retroactive study can be done here at some point. To be clear, thankfully I have no evidence that any of our patients have experienced harm because of the LTOWB specifically. This is more of a proactive worry. We are unfortunately not accredited by AABB, but CAP has a similar standard and I outlined our policy as no limit for LTOWB, but if more than 4 transfused, give Group O red cells. After getting Dr. Blumberg's insight, I may be editing it again!
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Whole Blood
I work at a trauma center that uses Low Titer Group O Whole Blood. This year we have basically been forced to copy another facility's protocol where they transfuse up to 10 units of whole blood during MTP. From a logistics perspective, it's great for the blood bank and the trauma team since there are fewer bags to manage. However, is there any guidance about how/when you can safely switch back to type specific products for non Group O patients? It's "low titer" but it's not zero. If a patient gets more than 4 LTOWBs we add a Use Group O RBC's instruction. We do this because the only articles that I can find about evaluating LTOWB show that it's probably ok if non group O patients get up to 4 LTOWB. So far, it hasn't been a huge deal to do this. We're not transfusing a ton more O RBC's since the bulk of the transfusion already happened during the MTP. I'm new to trauma and have kind of been blindsided about how people aren't more concerned about going off on a limb with 10 units like this. I've seen some older accounts from the military where they tested the patient's reverse at IAT to evaluate safety of switching back, but I don't know if that's clinically relevant. It feels like the wild west. Thank you in advance!
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Temp indicators for blood products
Our Blood Bank uses Hemotemp II's but they are only good applied to the bag for about 2 days. They also have to be activated with a 40C incubator. We use those for units in OR coolers and trauma. If you want tracking for the life of the unit, Safe-T-Vue's are pretty much the only option. I second everyone's frustration with the Timestrip BT10's. We tried them for our trauma bay and they fell off all the time despite prepping with alcohol and wiping condensation off the bag. They'd also activate if you looked at it wrong. Our rep said the lots we got might be bad because they were in her hot car. @RRay I think the decline might be due to hospital networks going single source and racing to the bottom to get the cheapest things. There's no incentive to make a higher quality instrument/reagent/etc. if the hospital networks are only going to look at upfront costs and ignore the issues caused by low quality/bad service/insufficient supply.