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I will quote (one of my favourite quotes) from Issitt Peter D and Anstee David J. Applied Blood Group Serology. 4th edition, 1998, Montgomery Scientific Publications, pages 63-64 (only because I cannot get to my copies of earlier editions at the moment - as while looking for them, a large number of my text books almost knocked me sideways, as they fell off the top of my wardrobe, and my wife nearly "brained" me too for making our bedroom look a mess!). "Reading Methods for In Vitro Tests. Now that most routine tests are carried through to an antiglobulin reading the question of how to read them does not often arise. They are usually read macroscopically in order that the cells and serum are left in the tube for progression of the test. A few cells may, of course, be removed and examined microscopically at any stage if this type of reading is required. However, one of us (PDI) has believed for years that routine use of the microscope in the blood bank creates far more problems than it solves. Almost any cell suspension, including those in which washed cells have never been exposed to antibody, if examined carefully enough under the microscope will be found to contain a few small clumps of red cells. Thus, while reading aids such as mirrors or hand lenses are acceptable, routine use of the microscope is not condoned. This reasoning also applies to the reading of antiglobulin tests. Again if agglutination cannot be seen with the naked eye, a hand lens, a convex mirror, or the type of microscope in which the contents of the tube are viewed while still inside the tube by placing the tube itself on the microscope slide, IT IS NOT THERE. Were it not for special tests, such as those in which mixed-field reactions may have occurred or when a small percentage of fetal cells might be present in a maternal sample, the microscope should be banned from the blood bank. Enzyme tests for agglutination or following conversion to antiglobulin reading, should NEVER be read microscopically." Several things should be noted about this quote. Firstly, there is NO distinction here between the indirect and direct antiglobulin test. Peter Issitt (see PDI, although I happen to know that Dave Anstee agrees with him) talks about reading antiglobulin tests. Secondly, this quote was originally written well before 1998. Since that time, there have been huge steps made in improving the sensitivity of tests within blood transfusion and blood group serology (often at the expense of specificity, and certainly at the expense of making diagnosis from the results of these tests straightforward - see the introduction of the term "delayed serological transfusion reaction", when there is laboratory evidence of a transfusion reaction, but no clinical evidence of a "delayed haemolytic transfusion reaction" (Petz LD and Garratty G. Immune Hemolytic Anemias, 2nd edition, Churchill-Livingstone, 2004). Thirdly, both Peter Issitt (1986) and Dave Anstee (1997) have been awarded the AABB Emily Cooley Memorial Award and Lectureship (amongst numerous other international awards - Dave was the President of the British Blood Transfusion Society, the Kenneth Goldsmith Award in 1985 and the James Blundell Award in 2003; these two are far from idiots! Lastly though, looking down a microscope is no panacea to detecting a transfusion reaction. I would draw your attention to Sachs UJH, Röder L, Santoso S, Bein G. Does a negative direct antiglobulin test exclude warm autoimmune haemolytic anaemia? A prospective study of 504 cases. British Journal of Haematology 2006; 132: 651-661. This paper talks about the production of de novo antibodies and anamnestic antibody production post-transfusion, as well as WAIHA. It comprehensively debunks the fallacy that a mixed-field reaction can, in all cases, be detected by the use of a microscope. So, perhaps the question should be, if the DAT is negative to the naked eye, should we perform an elution in each case? I REALLY, REALLY hope that nobody (seriously) answers YES to that suggestion (believe me, it was made with my tongue very firmly in my cheek)! Sorry about the rant!

And never EVER , under ANY circumstances look at gel tests under a microscope or a magnifying glass - unless you want to call absolutely everything positive and waste everybody's time

I would read the actual OSHA regulations, there are a lot of statements in there about "reasonable expectation of exposure". https://www.osha.gov/SLTC/bloodbornepathogens/bloodborne_quickref.html Be sure to read the definitions and don't implement rules for a research lab or micro/viro lab that don't apply to blood bank. This whole subject is one of my pet peeves, I would vote for common sense and don't lick anything in the lab!

OK, I"ll admit it. I'm stubborn. I won't give up on this sort of problem. Even though I really don't have time for it. So here's how I've persisted over a lot of years, with some success. You really need to report all deficiencies you find, through whatever incident reporting system your facility utilizes, hopefully to quality, so that risk management comes into play. A lot of work for you, but it's the only way to get their attention sometimes or to get the attention of someone higher up who can make changes. Do your research - check out their references, which will be nursing manuals, articles, etc. and see if they are compliant with those. Nursing standards of care and practice are everything to nursing management. They aren't much impressed w/ lab references unless there are regulatory teeth behind them. If you can throw specific regulatory references, do so. I tell them that if I'm cited during a CAP inspection, we're going to have an issue with TJC (truthfully) and that gets action here. Sometimes I have to use a back door approach. If there isn't a specific checklist item directly pointed at the problem, can you find something else that will help. Don't forget CLIA regs. As David says, sometimes compromise is helpful. Are the expectations greater than the nursing standard of practice? If they are, that's not necessarily a bad thing, but you might get better compliance if you uncomplicate things a bit. Nurses do have heavy workloads. If you can give a little, they may meet you part way. Education can be helpful - can you get the cooperation of your nursing education staff? CAP requires annual education for transfusion and recognition of reactions (which means I can say that we've got to do it to pass TJC). I ask them to stress that attention to vitals is a very important way to catch reactions and that adverse events have to be documented. And if you don't document, you can't prove one way or the other whether or not a reaction occurred. Whoever your inspectors are, check out the requirements for documentation and education. My experience is that it will take a lengthy period of time for improvement and that 'continuous quality improvement' is going to be the mantra. Staff comes and goes so there are always new people to be educated and good habits will slip over time. It took me years to get buy in that we had a problem. Our first electronic flowsheet for transfusion documentation didn't have mandatory entry fields - I pushed for that and didn't get it because nursing management thought that it would 'set staff up for failure'. I found that puzzling, but had to work with what I got. I looked at patterns of deficiencies and looked for failures to follow policy and reported multiple examples. I directly emailed nurses for followup - 'Hi "name", I noticed that the "whatever was missing" was not documented on the flowsheet for your patient. Please be sure to document "whatever was missing" because it is important for regulatory compliance or patient safety or whatever reason sounded impressive. I cc'd their managers on these emails. Sometimes I cc'd an education staff member I work closely with and she makes sure that common problems are addressed as part of new nurse orientation. We now utilize a flowsheet (Epic) that does have mandatory entry fields (Yippee!). Once they've had time to settle in with the new Epic version and I've got our new blood bank system up, I'll start looking at data again and reporting problems. Can you ask someone in the lab to help you with the chart reviews or delegate some of the reviews? There are some young techs in my lab who are eager for extra responsibility - perfect project for them.

Yes, that's true, Malcolm. On the other hand, if you test with 2 different monoclonal anti-A reagents (and an anti-AB for good measure - a real one not an A+B) and they all come up 4+, I think it's fairly safe to say that the patient is a group A. I think that giving group O blood in this case is both wasteful of group O blood (unless you are swimming in it) and overkill

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 $$$$$$$$$$$$$$$.

'Use common sense, and don't lick anything in the lab' - now that's my kind of policy!

I would just like to add another comment to this discussion. CAT is NOT the best method for looking for weak ABO antigens or antibodies.

We do have a NICU and have still had cases where they couldn't wait for the aliquot to be prepared, so we gave them the freshest O Neg that we had on the shelf.

Here's a easy read version of the Transfusion Safety Officer job description at our facility. Hope it gives you an idea of what might be possible at other facilities. TSO JOB DESCRIP.doc

And don't forget that you will have to maintain competencies. You will probably have to send out some split samples to your reference lab or find some other means of proving that your methodology and process are good for regulatory purposes. I stopped doing even autoadsorptions because it just got too complicated and spendy to deal with those kinds of issues. Not saying don't do it, just keep an eye on the details.

We have a pretty active NICU, we only use AS cells.

I ain't dead yet!!!!!!!!!!!!!! The Lewis Blood Group System.pptx

As long as idiots exist in the world, they will thwart any solid plan we put in place to mitigate their recklessness.

We also used to do electronic checks quarterly, but now that there is specific guidance to standard 3.7, we have reverted back to the old water/ice alarm check. This is from the AABB portal on the guidance for standard 3.7 in the 31st edition - "An electronic alarm test that merely increases or decreases the electronic digital readout to determine if the audio alarm sounds, would not meet the intent of the Standards." The full checklist item and guidance are attached. AABB Standards 3.7 and guidance (31st edition April 2018).docx

Happy Thanksgiving to all my PathLabTalk friends across The Pond!

and you would - I hope - transfuse with group A, so if you wrongly called it a group A, rather than an AB, it would actually be better for the patient. I know of at least one case where an ABel was transfused with group AB blood and died as a result of a transfusion reaction. And if this is a donor, the amount of B antigen present MIGHT cause a minor reaction if transfused to a group A patient but would not do any serious harm. An what percentage of those weak reactions with B cells will actually be caused by this phenotype anyway? Probably less than patients having antibodies against LFAs that are not picked up in the antibody screen and who have a minor reaction due to the incredible bad luck of receiving a unit of blood that just happens to have the antigen

I had an FDA inspector hit us with the same thing. I asked what her expectation would be for the night shift with one tech on duty. Her response was...well you don't transfuse anyone at night, so that would solve the problem. I guess she thought that a 180 bed hospital in rural American didn't practice medicine or something. I told her that we certainly do transfuse patients at night. Her response was that we should decline to transfuse patients at night. I asked her what we were supposed to do about the trauma patient in the ER or the OB who goes bad or the active GI bleeder admitted with the 5 Hgb. Well, we would have to review the unit prior to distribution. I asked...so you are saying that we have to call someone in to perform that task? Response...isn't there someone that could do that? I asked her (with sarcasm in mind, but not in voice) what she though about a phlebotomist or an RN doing that. She said she didn't think that they would be qualified. I asked her again if she was expecting us to call someone in every time a transfusion was needed on the night shift, possibly multiple times per night. At this point she called someone back at the office and nothing more was said. We now have two techs on the night shift and no FDA registration, so this whole thing no longer applies. Your inspector may have been a little overly zealous or misinterpreting something. Many of the inspectors I saw had no medical background and did not understand the distinction between transfusion service and blood center (though technically that doesn't really matter as far as the regs are concerned). My advice would be to contact the FDA directly - email or phone - and discuss the situation with them. I have found them to be helpful. They may have a useful suggestion. My strongest piece of advice would be to drop your registration - if you are not irradiating product and doing nothing fancier than thawing plasma or pooling cryo, you don't need it. No registration, no inspection. Meet CLIA regs and whatever standards are required for whoever else inspects your facility and you should be fine.

I would do a bit more work on it. There are two things I would do. Firstly, I would incubate a 4oC (but would include a group O cell in the reverse in case there is a "cold" auto- or allo-antibody there). Secondly, I would papain or ficin treat the reverse red cells (including a group O cell again as a negative control). As long as the group A and group O red cells remain negative, and the B cells react more strongly, but not as strongly as normal, I would be happy to call it a group A.

We just finished with our JCAHO inspection Oct 2018 and nothing was said about how we handled Rhogam. Our pharmacy orders the Rhogam inventory since Rhogam is given in the MAR (has a NDC #) and pharmacy gets the revenue when administered. Blood Bank stores the Rhogam and determines who is a candidate. Blood Bank calls the pharmacy when we need them to order more inventory.

They obviously do! Patty, PLEASE do not think I was getting at you. As you will guess from John's post above, this is (just) one of my pet hates. It was nothing personal!

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.

But Malcolm, there is a very subtle but important difference between what is "possible" and what is "realistic". Personally, I would say that going through an exchange transfusion simply to prevent the formation of anti-D is not reasonable but then I'm married to a nurse who has an anti-D along with an anti-K and an anti-S so my view may be a little jaded. Oh ya, the D was provided by the birth of our son. Our daughter was effected by it to the point of needing a double exchange transfusion which, I should mention, is not quite as dramatic in an infant as it is in an adult. The daughter is now 31 and has three children of her own. I relate this to remind folks that having an anti-D is not the automatic kiss of death. Ok, enough of my semiannual philosophical drivel.

We had our Rhophylac stored in Pharmacy as we thought this was a JCAHO requirement. We had nothing but problems. The OB floor would bypass us and call the pharmacy for Rhophylac along with the ED department. It was causing havoc for us. After 3 years when a new pharmacy director came along we finally got our Rhophylac back in the blood bank. We just had AABB and JCAHO inspections and nothing was said about us stocking Rhophylac in our department.

I posed the question to JCAHO online and this is their response: No, this is not a mandatory practice. Rho Immune Globulin is a "blood derivative". Our practice is to survey blood derivatives (albumin, Rhogam, factor concentrates, etc.) under either the Immunohematology or Medication Management standards, depending on which of the two hospital departments is overseeing it. Specifically, if managed by the blood bank, we would survey it under our Immunohematology standards in the laboratory manual. If managed by pharmacy, we would survey it under the Medication Management standards in the hospital manual . The former has stringent tracking requirements (see QSA.05.01.01 and AABB standards 5.1.6.1 & 6.2.3) ; the latter requires sufficient tracking to determine who may be impacted in the event of a recall (MM.05.01.17). Note that full compliance with the intent of the standards can only be assessed during an onsite survey. Please feel free to contact me directly with any further questions or discussion for clarification purposes.Megan SawchukJoint Commission