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Under routine circumstances, we do not prepare an eluate from positive DAT cells from a neonate because identity of the antibody can be determined from the mother's sample. Of course, if a neonate with a Positive DAT arrived without a mother, no maternal sample, or from a Group AB mother with a Negative Antibody Screen, we would likely prepare and test an eluate to aid the pediatrician with his/her care plan. (For the latter case we would request a sample from the father to determine if the mother is producing an antibody to a low incidence (aka private) antigen passed on to the infant by the father.) But, that's a whole 'nother conversation!

And you will fix what they cite - no worries. They expect to find things to cite you for, so don't plan on going through the inspection w/o getting nicked for something, Do the best you can, but don't be hard on yourself when you are cited. Look at it as a learning experience and an opportunity for improvement.

Our lab also transitioned to treating our own cells for adsorptions for complex workups but for only a short time of a few years. Our hurdles forced us to discontinue this level of service again as mentioned keeping staff competency, TATs without 24/7 coverage and limited flights for samples to arrive. We had the advantage of our sister IRL to provide absorbing units for us on a regular basis otherwise it would have been very difficult. It was fun while it lasted but if there is any question in the long term viability and ROI this route isn’t for everyone and of course the main concern is providing the best patient care if you don’t have a team that can staff a schedule as well as handle the 8+ hrs one sample may take to finish....this may not be for everyone. Hope this helps Let us us know how this goes !!

Hello Eva, The thawed codes for E1624 are listed below. I have included the codes for products with a 24 hour expiration and 5 day expiration, in case you need both. You can use the ISBT 128 Product Lookup Web Application to look up the full descriptions. 24 hour expiration: E2284 5 day expiration: E2121 The division codes (A0, B0, C0, etc.) would also use the same 5-character thawed Product Description Codes. I also wanted to clarify that the second character of the division code is a “0” (zero), and not the uppercase letter “O”. Section 5 in the Implementation Guide: Use of Product Code [Data Structure 003] - Blood (IG-021) document further discusses division codes. (Please note, you will need to be logged in to view the document). I hope this helps, Eva! Please let me know if you would like some more help with finding additional codes. Kind Regards, Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)

Following the ICCBBA document it would appear this is the correct label;

We check it off on the Maintenance log and document review on the log. Since you cannot run the Echo unless the QC passes and the QC is on the instrument or archive disks, we never felt the need to print off the paper and keep it.

I am just wondering if anybody (any Blood Centers) has been labeling units with historical antigen typings since 2017 FDA guidance came out. For those who are doing these, I am also curious to see what kind of processes you have in place and which antigens you are labeling using historical antigen typing. *FDA guidance document attached* UCM534978.pdf

Our collection facility is going to start sending out patient samples and donor units for RBC genotyping on the Immucor Bioarray HEA system and I'm curious as to what this could mean. Will they be able to label units based on the HEA results since it's FDA licensed? will they still need to confirm serologically? Will they need to run more than one donation from the donor to confirm the genotype ("predicted phenotype") before labeling it or confirming serologically? How would this differ if they were using a non-licensed platform like the Grifols ID Core from Progenika? Thanks for any guidance!

As an inspector I would be satisfied with this for compliance. It's always nice to see the RadSure label but I do not believe that it is required.

Hello Steve, You’re very welcome! Also, apologies for the long response below: It looks like you will need to submit a request for a new code to be added to the database to reflect the description you need for your products. If you can verify that the following description describes your final product, you can go ahead and submit a request for this to be added to our ISBT 128 Product Description Code Database via the ISBT 128 Product Lookup Web Application (please note that you need to be logged into the ICCBBA website to use the program). RED BLOOD CELLS|CPD>SAGM/450mL/refg|RBC irradiated|ResLeu:NS|Supernat rem/Plasma added You can also use a code that does not indicate irradiated. In the US, the FDA does not allow coding and labeling a partially irradiated product (e.g., only RBCs were irradiated) as a fully irradiated product. A product description code with the “RBC irradiated” attribute or a non-irradiated code can be used. If you wish, you can request the following description – currently there is no non-irradiated code in our database that reflects the description you provided. RED BLOOD CELLS|CPD>SAGM/450mL/refg|ResLeu:NS|Supernat rem/Plasma added In the meantime, your facility may assign a local code for the description you need until the description is added to our database. The reconstituted red cell guidance (also linked here) briefly mentions using local codes. For more details regarding local codes: section 2.4.3 of the ISBT 128 Standard Technical Specification (ST-001) document and section 3.7 of the Implementation Guide: Use of Product Code [Data Structure 003] - Blood (IG-021) document discusses and provides guidance for using locally assigned codes. If the codes provided above do not fit your needs, please let me know and we can adjust the description accordingly prior to your request submission. Kind Regards, Kaytee

Hi Steve, Products for exchange transfusion or “reconstituted” products are encoded as red blood cells with the plasma added attribute. When selecting an appropriated ISBT 128 code for these products all applicable core conditions, attributes, and modifiers still apply. For help with the terminology, section 2 of the ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002) document contains the current blood component terminology and definitions that is used for ISBT 128 product descriptions. I would be happy to work with you to narrow down the appropriate ISBT 128 product description. If you are able to provide more information about your product, we should be able to determine an appropriate product description code for your product or initiate a request for a new code to be added (if necessary). Please feel free to DM me or contact the ICCBBA office with a description of your processing steps if you wish not to make such information public on these forums. I also see that the reconstituted red cell guidance was shared earlier in this thread – the short document (also linked here) reflects the current thinking on labeling these products in the US. You may need to refer to your national/local authority for any coding/labeling guidance and requirements for such products in the UAE. You may also need to reference your accrediting organization for any additional requirements. Kind Regards, Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)

I have found this to be true regardless of the inspecting/assessing agency. Whenever you are dealing with people personal bias will be involved at one level or another. Some are better at controlling it while others make no effort in that direction. Good luck with your inspection. Do the best you can to prepare but always remember....... They can't kill and eat you, it's against the law.

Welcome srichar3.

Wlecome

NO! The whole point of column agglutination technology is that the ionic strength has to be the same, otherwise you will end up with either false positives or false negatives (see the inserts).

I have never seen a need for an exclusive blood bank arm band. If the universal hospital arm band provides the needed info and is used appropriately then why needlessly complicate a process with a blood bank exclusive arm band? Complicating process never makes it better. To answer the original question we required Patient's full name, DOB, and MR # along with the phlebotomist's initials and date/time of the collection. Utilizing the biologics arm band system (pre barcode tech) the 1st three were provided on the label made directly from the patient's armband. The last 3 were hand written by the phlebotomist. I'm certain the technology has changed but I'm confident the bar code systems function very much the same. As far as regulations go I believe that CAP or maybe JACHO required 3 identifiers and 2 of them had to be full name and DOB. I may be mistaken in this but that's what I seem to remember.

Well, yes and no (I realise that is not helpful, so I will expand!). The patient's do wear arm bands that have both eye readable identification (full name, hospital number, date of birth, etc), but also a bar code that can be read by a scanner, with the same information (at least, if not more). The bar code can be used to produce sticky labels at the bedside that can be used to label sample tubes for blood bank - but no pre-printed sticky labels are allowed. The blood bank also can produce labels for the units of blood/blood components and blood products, and so these can be scanned at the bedside (against the arm band) before administration. This is the "yes" bit! Having said all that, the arm bands are not exclusive to blood bank; they can also be used to identify the patient for the administration of, for example, medication, to ensure correct patient identification. Therefore, the arm bands are not exclusive to the blood bank. This is the "no" bit!

Except that we are talking about patients here that have anti-B in their own plasma already. We are not talking about patients who have no detectable anti-B in their plasma. So we are talking about a patient who groups as an A in the forward group and has a ++ reaction in B cells, due to anti-B. So if he receives group A plasma, yes, he will receive some anti-B - which will be diluted out by his own plasma which already contains anti-B……….. Realistically, I think it is a question of comparing risks, benefits and the amount of work. In this case, what are the chances that this is an ABwk patient? - Very low What is the risk, if this patient is an ABwk, of transfusing this patient with group A blood? None. On the contrary it is better than transfusing with group AB What is the risk, if this patient is an ABwk, of transfusing this patient with group A plasma? very little as the patient already has a considerable amount of his own anti-B in his plasma What is the risk, if this donor is an ABwk, of transfusing to a group A patient? Very little as the amount of B antigen present is so small How much work do you need to do to be 100% sure that this type of reaction belongs to a patient who is really a group A and not ABwk? As an absolute minimum genotyping, possibly complete sequencing. Long delays and $$$$$$$$$$$$$$$.

I agree with Cliff and AMcCord. I suggest to first determine if your lab can afford the time, i.e. do you have enough techs to work-up warm autos that require allo adsorptions in addition to your current work load. If you can and do then look for the answers to your list.

I recently learned that the Echo QC could be backed up onto one of our hospital's servers, instead of onto a disc. I'm going to check that out.

Being a generalist with Microbiology experience, here is my take on this: The unit should be reported as positive for bacterial contamination. I would not, though, report the gram stain as "positive" because that is changing the result that the microbiologist reported. They did not see any organisms on the gram stain, so it is negative. If the transfusion reaction workup only allows for a positive or negative result of a gram stain, with no place to report the culture result, then maybe report it as negative with a comment that the culture was positive. Ultimately, the culture shows that the unit was most likely contaminated, and that needs to be part of the transfusion reaction workup report. If the report doesn't allow for both the gram stain and culture report, maybe it should be changed to being positive or negative for "bacterial contamination" as opposed to "gram stain" (which, technically, isn't really reported as positive or negative).

I am unable to answer your questions about the staining of Kleihauer slides, as this most definitely NOT my area of expertise, but I will have a crack at the bonus question (but with a comment about terminology thrown in!). Yes, a transfusion certainly will have implications on the FMH screening/quantification, and it will lower the results, but only if the transfusion is given for an ante-partum haemorrhage very close to birth, or a post-partum haemorrhage soon after birth, but before the sample has been taken to estimate the FMH. If you think about it, the only reason for the woman to have a transfusion at these times is if she, herself, has had a haemorrhage. The ratio of "adult" red cells to foetal red cells she loses will be identical to the ration in her circulation, but as soon as she receives a transfusion, the ratio of "adult" red cells to foetal red cells in her circulation will rise. The reason for this is that those red cells being transfused to her would contain no foetal red cells, and so, in effect, these transfused "adult" red cells will "dilute" the mixture of maternally-derived "adult" red cells and foetal red cells in her circulation. Of course, and also in effect, this means that the amount of "adult" red cells will be concentrated (maternal red cells + transfused red cells), meaning that the ratio of foetal red cells to "adult" red cells in the circulation will be lower (if you like, it is a bit like the more saline you add to an antibody, the weaker will be the reaction, as is the case with an antibody titration). Now, it may be argued that the ratio of foetal red cells to maternal red cells that are bled out during the haemorrhage will be the same as that of the original blood in the maternal circulation, which means that the actual volume of foetal red cells in the maternal circulation (as opposed to on the Labour Ward floor) is reduced, and I would find it difficult to gainsay this, so it may well be that the calculated amount of anti-D immunoglobulin required to prevent sensitisation to the D antigen, and so the dilution of the foetal red cells remaining in the maternal circulation, versus the actual volume of the foetal red cells in the circulation is irrelevant, and will still be adequate, but I would err on the side of caution, and give a slightly higher dose of anti-D immunoglobulin. Now for my comment! There is no such thing, and never has been such a thing as the Rhesus Blood Group System. Rhesus with an upper case "R" was an ancient King of Thrace. rhesus with a lower case "r" is a monkey. As I have said many times, neither Rhesus, nor rhesus worked (directly) in blood transfusion. The correct terminology for the Blood Group System is Rh. However, the gene is RHD, the protein carrying the red cell antigen is RhD, but the antigen itself is just plain D (not Rhesus D, not rhesus D and not Rh D), and so the pregnant women of which you are talking are D Negative. The wrong name has come about because Landsteiner and Wiener injected rhesus monkey red cells into various animals (rabbits and guinea pigs) in an effort to discover more antibodies against antigens expressed on human red cells. They managed to do so, and the antibody they found was thought to be identical to the anti-D described in a human by Levine and Stetson, but in the early 1960's it was found that the antibody described by Landsteiner and Wiener, and that described by Levine and Stetson were far from identical (and, indeed, the genes encoding the antigens are found on different chromosomes). As a result, the antibody described by Landsteiner and Wiener was designated as anti-LW, and this particular Blood Group System is now designated as LW.

You can't elute complement from the red cells - besides which it is non-specific (though I wonder if there was an ab that fixed complement - Jk comes to mind - if it might be possible to elute it off even if the IgG DAT was neg. Just a thought. Whenever I have dealt with a reaction on a patient with a pre and post + DAT we routinely performed the complete (ahg) xm on the pre and post specimens just to be thorough. There is not much else you can do.

Same as Dankset. First void collected and kept - examined for haemoglobinuria & bilirubinuria only if other work-up is positive. Would be looking at Haptoglobins then as well. Cheers Eoin

Pretty much the same here as Molly, above. We would run a serum haptoglobin, plasma hemoglobin, and urine for Hgb only if we were sure it was NOT just a febrile reaction. Here, a urine Hgb is done by testing a strip on the spun supernatant. Scott