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.

We have the Helmer HB105 undercounter fridge with Access Control, so the Access Control panel allows 100 codes to be pre-programmed. We have those in a list that we just keep on rotating which code is used.

With BiologID, there is an option to add an interface so that your BBLIS data adds to Biolog's data, which means that once you assign the units to the patient they were removed for, it will also show up in Biolog. We still have to issue the units in our BBLIS, they're not connected in that way. Our ED charge nurses call the BB with the patient MRN, we give them a code to access the fridge, and they take what they need. Yes, we basically emergency issue the units in Softbank with that MRN we are given, and use Biolog to know exactly which units were removed from the fridge for that patient. I am actually working with Biolog to set up a system to remove that phone call to us, so that the RNs can enter the patient MRN on a tablet, it will give the fridge access code, and there is more streamlined access to the blood products, but we still get all the info we need for our tracking and systems.

Hey Mabel! We have a regular Helmer undercounter in our ER, as we can't afford a Haemobank, but we did put the access control on the fridge, so it is locked by a 4 digit code 24/7. Only nurses who are trained know how to open the fridge. We are a level 1 trauma center, so we limited the people trained on the fridge to just the ED Charge nurses. Keeps things secure, and ensures that we know when the fridge is opened and units are removed and for whom. The fridge has RFID shelves installed (Biolog ID), and each shelf contains either O pos reds, O neg reds or liquid plasma. Shelves are labeled, and we have long used a Flintstones system to ID male or female blood, Fred and Grandma Flintstone for O pos, and Wilma for O neg (we do females over 50 get O pos in emergencies). Utilizing a picture system we found helped the nurses with the O pos/O neg thing for red cells. We don't allow return privileges for units from the fridge. If they decide they don't need it, they have to run it back upstairs to us. We are directly above the ED, so not a long trek, but they definitely need to make a decision fast. They are good stewards of our blood, and have been great about not pulling out units unless they really need them and if docs change their mind they do physically run the unit up to us for a temp check so we can accept it back! Hope that helps! If you need more details I'm happy to share more of our process.

Thanks for the info. I trialed the Zipthaw a few years ago, and they are still in business. Its downside is only thawing 2 units, and when we trialed it, the Zipthaw took longer to thaw than the microwave.....but since I don't have the microwave to compare to anymore, the Zipthaw may be a decent backup for small orders. I'll have to look at that again. Thanks for making me think about that!

Hi everyone, All the old threads about plasma thawers are several years past, so let's start it up again. We have a Helmer 8 slot water bath, and we had a plasma microwave from ArkBio/Tropitronics as well. The problem I'm running into is that the plasma units being manufactured by ARC lately are pheresis units, and the bags are too small and not folded the right way to use in our plasma microwave. It's been this way for years now, and ARC does not seem to change their manufacturing plans just because of us, so I'm looking for a new plasma thawer as a backup to my Helmer DH8. I'm very interested in the Barkey Plasmatherm and the Sarstedt Sahara, but there are precious little details in their brochures about thaw times and maintenance. These are clearly not the most popular thawers, but a dry one is very intriguing. Smaller footprint is also a necessity for me. Anyone have recent experience with a thawer OTHER than Helmer? I love our Helmer, but I need a decent back up, as we are a Level 1 Trauma that must ensure we can thaw at all times. Thanks!

Yup. What Neil said. We do not give RhIg prophylaxis for women of childbearing age if they have received Rh Pos red cells, but will offer it for Rh pos platelets. Once a full unit of red cells is in, it's a lot to mitigate, and if they're getting 1 unit of Rh pos red cells, they're usually getting MTP and many more Rh pos products. Plus, treatment for anti-D in pregnancy has gotten pretty sophisticated, it's certainly not pleasant for mom, but it can be done. The patient has to survive first!

My old supervisor would antigen type a patient sample for something AHG, like Fya. Once we had patient sample that was Fya positive, she'd remove all the plasma, and add a ton of Anti-Fya sera (usually stuff that was about to expire). Let it sit in the fridge for several days so the Anti-Fya antisera bound to the patient cells that were Fya pos, then she'd check that the DAT was coming up pos at IgG, and make us do an eluate on that sample. The caveat here is that it's not a very stable sample, and it only worked well sometimes. Also, what I describe above comes from my memories of 10 years ago, so I may have missed a step. I haven't had to attempt to make this myself in my current facility. I need a whiz like @Malcolm Needs to check that this could work in theory......

Yes, agree with Cliff, the product code reflects the frozen or thawed status of the unit. It needs to be relabeled as well as the expiration date/time changed.

I've seen anti-D come stronger or weaker in the same patient, and when we've sent them for molecular they come back as some form of weak D usually. We use Immucor reagent here, so tube typing, and it's the same reagents on the instrument as in our tube, but we do see some variability from the two methods, likely because of the RT incubation the instrument does on all blood types. The weaker D can "unbind" it seems, and the instrument will call something Rh negative when in tube we get weakly reactive or 1+.

Typically, when you have a limited blood inventory, the BB response to a mass casualty incident depends on the inventory and the incident. We have two stages here (500+ bed level 1 trauma urban hosp): an ED surge where they are expecting many patients to the ED at one time that are expected to be critically/severely injured, and the actual MCI which is when they expect more than 10 patients. The BB response to an MCI is to get 5 coolers of uncrossmatched products ready and have them available to be picked up, and basically keep that amount at the ready until we are cleared. We do 4 rbcs and 2 plasma per cooler, so this is a good amount of product. As a smaller community hospital, you may not have 20 O pos red cells to set aside like that, so you have to make up what works for you. Once initial coolers are ready, we start calling our local suppliers to get as much product to us as possible as soon as possible. If things go awry you'll need to be restocked sooner than later, so better get those people mobilized and couriers on their way to you! That can be difficult if the hospital is in lockdown due to the emergency, so we also work with our Security team to let those couriers in the doors. These are the first things I think of, hope this helps!