jshepherd

The FDA Guidance on Computer Crossmatching calls out that patients with an ABO typing discrepancy should not be allowed to qualify for computer crossmatches. " If ABO typing discrepancies exist, you should not rely on a computer crossmatch. This is particularly important if there is mixed field red cell reactivity, missing serum reactivity, or apparent change in blood type following hematopoietic stem cell transplantation. Under those circumstances, your procedures should provide for compatibility testing using serologic crossmatch techniques." I wrote our policy to include any non-straightforward ABO types for any reason will be required to get an IS or IAT crossmatch.

Is this for emergency transfusion, or routine transfusions?

Bad news: we use the MaxQ EMT cooler for our cold stored platelets, and for room temp platelets. We validate them the same way we would any cooler process, once at 1-6 and once at RT. The small coolers are perfect for 1 unit of platelets, and waste has dropped. Since regs say to validate coolers at min and max capacity, we take that as needing to do both temps for each cooler. We have 2 of the EMT coolers. We have 10 of the MaxQ OR12 coolers for other products, but they are so huge (can hold 8 units) that we didn't want to use them for our CSPs. Giant box for one little platelet. If we had used them, I would still have made staff do cooler validations for 1 unit of RBC, 8 units of RBC, and 1u of platelets. We also use these coolers for transport of tissue on dry ice, and we validate for that as well - we have 4 designated coolers that are validated for dry ice storage, that way we we're not validating forever! I would suggest picking one or two of your coolers and validating them for CSPs. Its odd that the platelets get too cold....it shouldn't be much different than 1unit of RBCs in those coolers. Maybe for platelet cooler (and its validation) there is a gel pack added or something else that will maintain temp?

Same! We were AABB accredited long ago, so still follow the standards, just not quite to such a rigorous degree. We are now TJC and FDA inspected. To my knowledge, FDA doesn't require an associated procedure the way AABB does. As long as there is document control for everything, I think you're covered. I've been in my job 10 years with this inspection setup and not had any issues with my procedures or policies with FDA.

The FDA's Guidance for inspections is super cumbersome to get through, and is very much written for inspectors, not those looking for info on what is to be inspected. I went through it once a few years ago....never again. Lol. I agree that there isn't a clear direction on if forms are controlled documents, but I've always handled forms as an attachment or part of an SOP/document, so they also get the document control revision dates and such, including retention of old versions for the same timeframe that old procedures are retained. Implied best practice, I guess? Hope that helps!

Hey Randi, I would push back on your medical director if you can. To Dr. Blumberg's point, low-yield platelets are an FDA approved product, so there's no real reason to require notification to providers, especially if half the infusions are just topping up people for a procedure, but I won't rant about that one right now. Agreed that Vitalant was not clear about how often they expect to have these, and their cost being the same. We don't order from Vitalant much, but we haven't seen any of the new E-codes for low yield. Janine

Well, there are several things you can reference, besides AABB standard 5.29.1, which nursing won't care about. Joint Commission (Hospital): PC.02.01.01 Ep 10. Before initiating a blood or blood component transfusion, the hospital follows a process to correctly identify patients that includes the following: - Matching the blood or blood component to the order - Matching the patient to the blood or blood component - Using a two-person verification process or a one-person verification process accompanied by automated identification technology, such as bar coding By logic, you can't match the blood component to the patient or order without documenting the "lot number", in this case the DIN. eCFR :: 42 CFR 482.27 -- Condition of participation: Laboratory services. See (b)(5) on this page regarding recordkeeping. For lookbacks, the HOSPITAL must maintain records, therefore a DIN must be documented from receipt to final disposition, including in the transfusion record. eCFR :: 21 CFR Part 606 -- Current Good Manufacturing Practice for Blood and Blood Components this is a general list of all the required records, but you can say that (c) is the most helpful for requiring a DIN documentation Hope these help!

My facility is not AABB accredited, just Joint Commission and FDA, and I have an individual membership. I am the supervisor, and we are a large level 1 metropolitan trauma hospital. I have gained so much from my membership. Everything Cliff mentioned about resources is true, and I can't tell you how many times we've taken advantage of the discount on books for my pathologists (none of whom are transfusion medicine specialists). AABB membership also opened up all the subcommittees and sections, and I now sit on 9 subsections and lead one of them. I am also a mentor in the program Cliff mentioned above. I would say it's worth it for at least one year, so you can try it out and see what you get from it. Pro tip: if you love it, they do offer a 3 year membership option that knocks some of the cost down.

AABB Standard 3.5 looks the closest to what you're looking for: The BB/TS shall have a process for scheduled monitoring and maintenance of equipment that at a minimum is in accordance with manufacturer's written instructions. The AABB Technical Manual has recommended maintenance frequencies, but that clearly states "recommended". I do know that AABB has just put out a request for input on the 35th Ed. of Standards, and it was already brought up that quarterly alarm checks need to be gotten rid of, so I know they will be looking at that closely. Though, upon looking for where it states quarterly checks are needed, I agree with Randi that I can't find that anywhere.....and I feel dumb for continuing to have done quarterly checks.....I've only got 10 fridges/freezers though, so it's not as burdensome as larger blood collection centers! Would love to hear what others have to say on this!

It may not be quite in half, but we get 150ml transfer bags that are singly packaged. They are from Charter Medical. They might have other sizes that will suit you. Good luck!

My organization has a Leadership Development program, which can provide very basic info for people wanting to move into leadership roles. As for lab leadership, I would recommend that people see what AABB has to offer. There are subsections and committees, one of which is the Leadership and Administrative section, and I am the chair of that section. We have a great group of members, and anyone who is an AABB member can join. We discuss and present on many leadership topics, and it's great to be able to bounce ideas off peers.

I'm with Dr. Blumberg, we cap our LTOWB for trauma MTP at 4 units. This is due to inventory as well as not wanting to give non-ABO identical as little as possible. We have had zero adverse events thus far. The more O you give a non-O patient, the harder it is to determine their true type as well, especially if you don't get a sample drawn ASAP. Switch to patient's ABO type as soon as you can, and only fall back to type O red cells if inventory is in trouble. Also agree with Bet'na - the patient has to live to have a problem, but we can mitigate the problems by capping how much potentially incompatible plasma we give. There is an AABB standard 5.27.2 that states that your SOPs must indicate the maximum volume/units allowed per event. You can define that yourself, there isn't really a guide as to how much is too much. There are facilities out there that have no limit and some that have a limit, as evidenced by the responses in this thread. Standard 5.15.4 applies to this as well, which states that you have to have a policy concerning transfusion of significant volumes of plasma containing incompatible ABO antibodies, ie type O plasma to non-O patients. I've been doing level 1 trauma for almost 20 years, and it can feel like the wild west, reach out if you need clarification or real-life examples of things. Happy to help.

Same as sgoertzen - we got rid of keep ahead when we moved to Epic. I didn't even know there was a keep ahead function available in Epic! The blood bank may keep ahead by doing crossmatches on downtime for difficult crossmatches, but that's it.

We have Epic and Soft and this is how our system functions as well. The orders for specimens are collected in a tube that Soft considers to have a 3 day expiration, so they get a new order number and a new Aux number. The Aux number for us is the instrument ID from Epic. To my knowledge, there is no solution to this, this is how the system is designed. Only one active TYSC order should be allowed. When a sample is drawn before midnight on the third day, we have to manually go in and inactivate/expire the existing TYSC sample so that product orders will flow onto the new TYSC.

The caveat for using expired cells is if you are a reference lab and the cell is rare. You do have to QC it before using it for rule outs, and I've always been told that you should QC it based on an antigen that is known to evanesce over time, like Fy. We stopped using expired panel cells more than 10 years ago when this became part of the IFUs. We just stock more options of panels in order to do all rule outs. (Also a large academic center that performs 95+% of ABIDs. ) To Randi's point, you might be able to write an IQCP and get away with it that way, it will probably depend on your inspector, and if your medical director is okay with blatantly going against the IFU.