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I would treated the patient's own red cells with papain or ficin (whichever is used by the manufacturer to make their enzyme treated red cells), and then test them against autologous plasma. My guess (and from this far away, it is just a guess) is that they will be positive. I think that there is a "cold" reacting auto-antibody there. I would also suggest performing an IAT panel in tubes, bringing the reactants to 37oC before mixing them, and using isotonic saline, rather than LISS as the red cell diluent, and then washing the tests in pre-warmed isotonic saline. This should show i

You have to change your refrigerator alarm settings to activate at 2.2C (or whatever you choose). It doesn't matter that your refrigerator never gets too cold; if you are going to store reagents (and RhIg) in a BB refrig, it has to be able to alert you when then temp is out of prescribed range.

Somebody was sure digging through the archives to find this one! Glad to see. This was probably one of my first posts. To be honest, I don't remember if we ever went with the second type but I imagine we did knowing the corporate QA team at the time. I do believe that anything short of a second draw is little more than smoke and mirrors to show compliance with some mandate.

I would just be a bit suspicious if say there was a + reaction with A1 cells and 4+ with B cells in an apparent group O - or vice versa; or very weak reactions in a young healthy adult.....a bit of common sense required, that's all

It drives me nuts when I go to a talk and the person speaking says we all make competency too hard. It is hard, it's really hard. I don't care if you have 5 staff or 50, it's hard. That said, we've tried to make it as simple as possible while still trying to make it a value-added process. First, follow the CLIA rules, period. (<-- link and attached) Next, follow the rules of all your inspectors / surveyors... We are FDA, AABB, and TJC, and DPH for NRC. For TJC they define annual and 6 months... Follow their rules. DPH says AABB is law in my state, follow their rules

Nope. Positive is positive.

Our requirement (at Blood Bank insistence) is that the infusion has to begin within 15 minutes of checkout. We had problems with nurses checking out blood products before they made sure that the IV was good and without taking vitals, then wanting to bring the unit back 45 - 60 minutes later. Their policy says check IV and vitals before coming to Blood Bank to pick up units and the short time allowed to start the infusion kind of reinforces that. The number of wasted units dropped significantly after this policy was in place. We also use the policy shared by slsmith. If there is a dela

We are going to put a hang tag with a fluorescent green label on our pathogen reduced platelets using the language suggested by Cerus - FDA approved as a substitute for irradiated product, meets AABB requirements for CMV neg, etc. etc. I'm not optimistic about many people actually reading the education materials.

Just a question - along with mrmic - What is the average daily temperature in your lab? If this antibody is, at least partially, a "Cold" and you have a LOT of reactions like this, as you stated, it just may be too cold in your lab. Try a strict Prewarm test, as suggested by Malcom and if that helps, consider reducing the amount of Room Temp exposure your average specimen encounters and see if you can cut the reactions down. We have almost no RT exposure in our testing anymore (Immucor ECHO) but we used to have more extraneous reaction problems in the winter when our lab grew colder (think

I highly suggest you change the 6 month Competency to "Semi-annual." Our lab got dinged several years ago by a "by the book" inspector. Some of the leads had the 6 month evaluation at 6.5 or 7 month. If you have a OCD inspector with no grace, you could get cited for every competency that is one day over 6 months. I had an inspector a few years ago that was going to cite me for completing the thermometer checks 10 days later than the year before. She took "annual" literally. To her, 10 days later than the year before was past due. I protested and told her the lab performs all thermometer c

We require another sample of a different collection event, prior to transfusion. Believe this is in the new AABB standards. The computer automatically orders a no charge forward and reverse retype, if the pt has "No Hx". We actually found a mislabeled BB specimen, once. Discovered when tech did the rpt on a diff sample and got a diff aborh.....

That's a new one to me. I'm with Kelly, positive is positive as long as it matches the forward type. If not, let the investigation begin!

Agree with Kelly

You cannot use E2121 for all of them. Each of those frozen products have a corresponding thawed 24hour and a thawed 5 day plasma code of their own. You have to use those. We go straight from frozen to 5 day thawed so we only use those two. Here is a screen shot of our database.

Personally I don't see a problem here but I sure can't site any regulations, rules or even precedence that would help. Of course it bothers all the blood bankers, I would be very surprised if it didn't. It involves a change and that always makes us uncomfortable. I suggest sitting down and trying to come up with what, exactly, makes everyone uncomfortable if you haven't already. Then weigh those concerns on the real vs imagined scale and see what you come up with. Just thoughts from an old guy that's been there.

I am getting ready to install an ECHO Lumina. Just had our initial set up meeting yesterday. Switching from gel to solid phase. Looking forward to a bit more standardization in this department. We use DI but the ECHO also comes with its own middleware (or so I believe).

For the second ABO we use a specimen collected at a different time like a CBC but we won't use one collected at the same time as the type and screen. It's rare for us to request a specific draw for this testing but it does happen. We're a level 1 Trauma in a Children's Hospital but can take adults during disasters and pandemics (new one for me). We just changed our emergency issue and MTP policies adding in liquid plasma to start the MTP and we gave our computer the ability to give Rh POS to Rh NEG RBC and plasma products to males (policy stated if >1 year old with prior approval fro

Dave Saikin and JeanB. My policy actually lists that the MaxQ coolers are validated to hold a storage temp for X hours and a transport temp for X hours (dependent on each cooler) but we choose to call them transport coolers. All the coolers are back in 12 hours and their ice packs changed which is within the validated storage and transport temp so we should be safe. Also, FDA and AABB have both reviewed our policies prior to the use of MaxQ coolers multiple times and never said a word. I think it's the very lengthy validation we do at RT and >30C monitoring the temp inside the cooler, u

I found this on the 2012 AABB Ask the FDA and CLIA Transcript. Kind of old but I think still relevant. I saved because I once had an inspector that stated I had to be registered with the FDA to thaw FFP. (??!?) I knew it wasn't right but I didn't want to argue in the middle of an inspection and I didn't have anything in writing. Basically if you don't make a completely new different product, you don't have to register. If you take a product and make something completely different, you do have to register, e.g irradiating a unit creates a totally different product. Hope this helps Que

Ahhh.....the unanswerable question. My personal favorite: Even if the first and second tubes were collected from different patients, there's still a good chance they'll still match ABO group (~40% group O, ~40% group A, etc.). If one were a gambler, those would be good odds. But, that being said, I still think two tubes are better than one.

Finish the unit.

And if the blood in the tube was taken from the wrong patient?

Forgive my ignorance, but are the above stuck to the outside of the bag, and therefore measuring/indicating the surface temperature of the blood product ? The "storage vs transport" hairball will be debated well after we're all dust.

"2.7.6 Ael Under usual conditions Ael cells are not agglutinated by anti-A or -A,B, although they do bind these anti bodies, as demonstrated by adsorption and elution [298,337–339]. Saliva from Ael secretors contains H, but no A substance. Serum from Ael individuals usually contains anti-A1 and may also contain an anti body that agglutinates A2 cells [337,339]. No A transferase has been detected in Ael serum or red cell membranes [232,287–289]. Serum H-transferase is weaker than that found in A1 or A2 serum [289]. No example of Ael

If you store blood in the coolers when they get to their destination,they cannot be considered transport (if blood stays in them wherever you send them and no matter what your consideration is). This per the FDA. If you are CAP and/or AABB your assessor/inspector should remind you of this.

We apply this custom label to all PR platelets and PR platelet aliquots (see attached picture). We're a children's hospital and we've been giving PR platelets to neonates since March 2017 with no problems. PR Platelets.docx

As David said there isn't a BB standard for time frame a transfusion needs to be started but for some reason this time frame is in the nursing policy, theirs is 20 minutes. Where they got this information I don't know. Anyway if blood is sent to the floor and it isn't going to be started in 20 minutes and the floor asked calls the BB (before they actually return it) we tell them if they are going to transfuse and it is will be completed within the 4 hours that it was issued to the floor keep it, otherwise it will be discarded (if temp is greater than 10 degrees)

as a former AABB assessor and CAP team leader I would say there is nothing to cite with a mixed match reagent refrigerator in principle.

I would get more history first. Transfused when? How much and/or how often? With what, rbcs, plasma, platelets, Immunoglobulin? Why? Diagnosis? Meds? Age of patient? Pregnancies if female? Previous antibody test results and methods utilized? Any results of extended rbc testing previously done available? Any other lab results suggesting rbc destruction or decreased rbc survival of transfused red cells? DAT negative but autocontrol positive? Could transfused red cells be present? Early production of cold reactive auto or allo antibodies showing up? As previously suggested try prewar

I agree with John. I cannot think of a reason why not (except it goes against the grain for blood bankers).

Sounds like a couple of the FDA inspectors I've experienced.

On a roll Arno!!!!!!!!!!

I just answered this question. My Score PASS  

We have been using a Bio-Rad IH-500 (and a SAXO as backup) for about a year now. Very happy with them. They work with the IH-Com that serves as a command centre for both and as middleware. We also use the antibody software and upload our QC to Unity. (We were manual gel/tube prior). sandra

or mum is a surrogate or baby is the result of an ivf with external donors

I'm chuckling reading all of this because it's like the question, 'If the parents are both Group O, can they produce a Group A baby?' Ask a student, they'll say 'No way!'. Ask a BB fanatic, they'll say, 'Sure it could happen ... and here's how ...' And in this forum, there is never a simple answer!

I suggest you try any high potency IgM anti D which these days is a monoclonal and thus not high protein. The anti D on your bench right now ( immediate spin) should work.

Here is our aliquoting procedure, hope it opens okay. I may be a good Banker but when it comes to computer uploads, downloads or whatever not so much. Sheri SKM_C55821040507520.pdf

I wish we could get some of our physician's (heart transplant mostly) to understand that leukoreduced = CMV safe and that it should be equivalent to CMV NEG but they insist we keep giving CMV NEG RBCs. We still mostly get CPDA-1 RBCs (fresh, < 6 days old) but we added AS-3 to the list of what neonates can receive a couple of years ago when there was the shortage on CPDA-1 collection bags. So now we use CPDA-1 interchangeably with AS-3. It's weird because our HPC (including bone marrow out of ABO and/or Rh type) transplants don't get CMV NEG but our heart transplant candidates and recipie

At one of my facilities we had a group of O neg donors that would come in on a regular basis and these folks were designated as out Neonate Donors. I think at the time we would set them aside exclusively for the neonates for a week and if they were not needed during that week we would move them to the general population. We would ask regular O neg donors if they could come in on a schedule so they could be used for the babies. When most understood that their blood would be designated for the newborns little else had to be said to get them on board.

Easy, give group O only. We used to allow directed donations and we would do a back type on the baby. We stopped allowing directed donations years ago and only give O Neg to our neonates.

I'm also wondering how one manages to validate that all units of blood remain within temperature range when the ambient temperature and handling is not consistent. We can't even validate our coolers for the same reason ... and one never knows if the cooler is left open or the units are removed then replaced. Are you using 1-10oC or 1-6oC? FDA instructed us to use 1-6oC for the coolers because they are really 'in storage'. If not in a cooler, we can go up to 10oC because they are 'in transit'. I haven't implemented that part yet, but I will be soon.

We crossmatch the A or B cells(the red cell itself) to the babies plasma, using the IgG gel card.

Since we have both manual procedures and QC and automated procedures and QC, we have left our manual QC with just the recommended "positive" controls. Since the ECHO runs 3 QC reagents and winds up with a "positive" and a "negative" for all of the reagents (usually the same lot numbers in both sets) we thought that was enough. We are FDA and Joint Comm. and they have been happy so far.

Perhaps the monoclonal anti-D reagents had been taken out of the fridge, and not allowed to come to room temperature before being used. Most, if not all, monoclonal anti-D grouping reagents will detect an I-like or i-like antigen on D Negative red cells (see Thorpe SJ, Boult CE, Stevenson FK, Scott ML, Sutherland J, Spellerberg MB, Natvig JB, Thompson KM. Cold agglutinin activity is common among human monoclonal IgM Rh system antibodies using the V4-34 heavy chain variable gene segment. Transfusion 1997; 37: 1111-1116, and Thorpe SJ, Ball C, Fox B, Thompson KM, Thorpe R, Bristow A. Anti-D

Personally, I never had a problem receiving in blood like you described as long as it met all the requirements that we required from out supplier. On the other hand I knew facilities that would discard any and all blood that was received from outside with out any thought. I considered this a dreadful waste of a precious resource! Just curious but did the blood have any of the temperature monitors attached to the units? If so, that could help you make the decision. Having said all that, I have been out of the world for a while and many things have changed since I was intimately invo

You do not need to register with the FDA if you are just pooling, thawing, changing FFP to Thawed Plasma or splitting units like for pediatric use. The end product is basically the same as the beginning product. However, if you take a product and make a new product then you would need to register with FDA. An example would be combining RBC with FFP to make whole blood for an exchange transfusion. The end product is different from the starting product. I found a good explanation for this on the AABB site. 2012 ASK THE FDA and CLIA Transcript question #29. You can access and print thes

If non-Group O red cells are transfused, verify that there isn't demonstrating anti-A, anti-B or anti-A,B in the baby. Test reverse cells through Coombs phase or crossmatch the red cell unit. To avoid the need to do this testing, transfuse Group O, Rh compatible red cells. In my experience, it's best to limit donor exposure to the infant, if possible, for small volume transfusions. Most facilities I have worked in dedicate a unit to the neonate from the first transfusion request until the unit expires or is used up. CPDA or AS-, AS3 anticoagulant preferred - the fresher the unit when

I disagree with the statement that if the donor center retypes that the receiving transfusion service does not need to. I think the transfusion service must retype red cell products received into their inventory from an outside source.

Hi Bertie, I'll do my best. The very best way to adsorb out an auto-antibody is to use autologous red cells (i.e. auto-adsorption). Such an adsorption will take out any auto-antibody, leaving behind any alloantibody, however rare the specificity of the alloantibody may be. To put it another way, if the auto-antibody is panreactive, but underneath that is, say, an anti-Lan (an antibody directed against a very high frequency antigen), however many times you adsorb the patient's plasma with autologous red cells, you will not remove the anti-Lan because the patient is, by definition of the fact