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Many years ago, Peter Issitt stated that microscopes should be banned from Transfusion Laboratories (I think it was in the orange edition of his book) except for such tests where cells are being counted (such as the Kleihauer). Many years after his wise words, I still follow his advice, and have not (yet) been involved in a missed weak antibody that has caused a clinically significant haemolytic transfusion reaction (43 years in the job), and many of those tests were performed in opaque tiles and then, as we "modernised", tube techniques.

I wish CAP would put all 1 specimen results all together, then move on to the next specimen. Doing all the ABO, then all the Rh, then ABS... THAT'S what causing all the clerical errors I've seen. We're supposed to test and report just like a patient spec - and that isn't it!

It's a bit ironic that CLIA has so many regulations and requirements to insure laboratory testing quality and then flips it on it's head and grants non-laboratorians purview.

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM425952.pdf This is in Draft status, but should be finalized this year. Once finalized, FDA will give 2 years for implementation. Transfusion services should not be mandated to make changes until some time in 2019 or later. There are some misstatements in some previous posts that should be clarified. PAS apheresis platelets can be stored up to 5 days and must have a "safety measure" test within 24 hours of transfusion if transfused on Day 4 or 5. The use of platelet additive solution does not confer any protection against bacterial proliferation. Plasma-stored apheresis platelets can be stored up to 7 days and must have a "safety measure" test within 24 hours of transfusion if transfused on Day 4, 5, 6, or 7. Pathogen reduced apheresis platelets can be stored up to 5 days and can be transfused up until expiration without additional testing.

I think that after you use them for a long time.....running panels and seeing which "positive" reactions pan out to be something, and which do not; you start to get an "eye" for what is a true positive vs. a few red dots that are not going to give you anything (or, you learn the "look" of a cold agglutinin; rouleaux; warm auto; vs. clinically significant antibodies). I think it just takes time and experience (going after the questionable reactions long enough to know "when" to go after them) to feel comfortable (and in the end, you could still be wrong; but there is also a good chance that if it is so weak that you can't decide whether to call it Positive or not, you probably won't find anything anyway). Just my opinion. Brenda Hutson, MT(ASCP)SBB

I see your point SMILLER/Scott. It's a fair argument. I'm not advocating "less oversight", but merely acknowledgement that an immunohematology work-up often has a lot more "grey/gray" than the other pathology disciplines. As we all know, "antibodies don't read books" and sometimes it takes all of your resources and experience to resolve a serological problem, including the prudent use of expired materials (or frozen inventory). One could argue that absolute prohibition of using expired reagents in such cases could potentially put a patient at more risk by leaving an issue unresolved. Using all of your tools, in-date or otherwise, to get a good answer might outweigh the regulatory implications. As I alluded to earlier......I don't recommend front-line techs use expired reagents willy-nilly - they should be used surgically and by those skillful enough to recognize the limitations.

I've been pretty much off the grid for the past month and thought I would check in. We're driving around Alaska enjoying retirement. Hope all you folks are holding down the fort. I'm sure you are doing a great job.

Well, in a way, yes. They will not waste time on trying to perform alloadsorptions (as these don't work) and will probably perform genotyping from the word go, rather than trying to get a phenotype. To be honest, the submitting hospital should give the Reference Laboratory as much information as they can about ANY patient, whether they be on ANTI-CD38 (gagpinks, they are on a monoclonal antibody - not a monoclonal antigen!!!!!!!!!!!) or not.

I agree with the above post. Case in point: We had someone call for emergency release blood and then someone came to get emergency release for a different patient. Thinking it was the patient they had called about, the tech issued the blood. It gets worse (nobody died) but suffice it to say that this went to risk management and the results were not pretty for the employees! A few days later, the nurse got upset because a different tech would not give her any emergency release blood without a name and DOB. They want it both ways! This final case was dropped as the tech was correct.

I quite fancy an expedition to Loch Ness - with or without the monster......

I have retired from active clinical laboratory - for what it is worth.

Well, that would make my decision to retire very very easy!

Sometimes I think that the "regulators" feel obliged to fix problems that don't exist. Does anyone recall a rash of patient morbidity/mortality due to the use of expired reagents in the blood bank arena? That being said, the use of such material should be restricted to those with the appropriate knowledge and expertise.

You may be referring to trypsin-treatment of the red cells (screening cells). Apparently CD38 is destroyed/inactivated (along with Lutheran system determinants) but Kell system antigens remain intact. Other blood group antigens are also affected by trypsin, so I think the modified approach involves testing the patients' samples against both DTT-treated and trypsin-treated cells. To further complicate matters.....manufacturing a reliable, consistent trypsin reagent is VERY difficult. The enzyme activity of source material varies immensely and, as with other enzymes, stability is a problem.

Almost zero, because of the effect of immunosuppression, followed by the accommodation effect.

We have been using Cerner Millennium Pathnet since 2005 and our amazing Lab Informatics team has set up QC entry for each test in Pathnet with parameters that we defined. Each test group has an established relationship with a QC group. When opening the result entry worksheet, an appropriate QC group for the tests being resulted must be chosen. If the QC has not been satisfactorily resulted in the established time period, a warning displays and result/interpretation verification can not proceed until QC has been satisfied. This way we are always confident that QC is current for tests being resulted. If computer downtime is expected, we print copies of QC so we know when it has been performed and when it will expire. If unexpected downtime, we perform and record QC as indicated per procedures and enter it into Pathnet during downtime recovery. This process has served us well for the past 12 years and always satisfies AABB, CAP, FDA, and internal auditors.

We have been doing this for years. We only only have to use the mom's IAT results if they think they might give blood products to the infant. We do not use the cord blood for baby transfusion because they could be contaminated with mom blood. They must order a specific test for the baby transfusion workup. We use a current baby hemo specimen to perform the baby ABORh off of a "clean " specimen and use the mom's IAT results. The DAT would have already been performed on the cord. Our computer is set up to enter MOM IAT results when we enter the baby's results. They baby is spared being stuck again. Our baby transfusion population has dropped off to almost nothing in the last year or two. Any baby that might need blood is shipped off. I'm not too sorry about that either.

Hi Amy, We are the transfusion service for three hospitals in our area that don't have blood banks. They follow our blood draw and patient identification requirements, send us the specimen and we perform the type and crossmatch and transfer the blood. We have contracts spelling out exactly what is required of them, as well as us. It is their responsibility to arrange for transport of both specimens and RC units. Two hospitals send the specimen with couriers and someone from their facility will pick up the blood later, while another sends the sample with a hospital employee who then waits "in the Big City" for an hour (usually they shop!) while we get everything ready. I have never been to any of their hospitals but they are required to send the transfusion paperwork back so I can review and make sure they are following policy for transfusion. They also have protocol for how to what is needed for a transfusion reaction and we would work it up here. We have been doing this for many years and no inspectors have questioned the process. They just want to see the contracts and transfusion documentation. We are a non-profit hospital.

If the patient is AB, and the anti-A1 does not react at 37oC, I cannot see for a moment why you don't give the patient cross-match compatible AB.

The AABB TM, 18th edition, states in Chapter 22, Perinatal Issues in Transfusion Practice, Serology and Mechanism, "Administration of RhIG during pregnancy may produce a positive antibody screening result in the mother, but the titer is rarely greater than 4 and thus poses no risk to the fetus." If we ID anti-D in prenatal sample, we perform a 1:4 dilution and if the results are non-reactive we have two statements in our report, "The antibody demonstrated a titer of less than 4 in saline at AGT indicating that it may be due to recent administration of RhIG." and "Due to the recent administration of RhIG, the antibody may have been passively acquired. To establish this as the sole cause of the antibody's presence, repeat testing six months post-delivery should demonstrate a negative antibody screen."

Thank you for mentioning this important concept which few know of. I presented accommodation at the meeting to decide whether to transplant or not. The literature is limited on iABO KT with A2B and AB but sufficient. We will transplant. They considered this case ABO mismatched but compatible as anti-A1 is absent. May end up publishing they said. But I am just happy that he found a kidney. He is a young man and the live donor is his mum. Will keep you posted. Thank you.

Hi Cliff. We do 4 hours from the time the unit leaves the blood bank. We use a electronic time stamp to document this time on the blood administration tag that is attached to the unit. We teach the nurses that they have 4 hours from this time to complete the transfusion. This does not apply if we send products in a cooler.

What Malcolm? No anti-weak D antisera available in the U.K.? (There is such a thing as an auntie weak D, however.) My father's sister was a terrible center-back when playing for Suffolk. Scott

Coming from a reference lab perspective, we couldn't do our job if we didn't use some expired reagents. We have 2 LN2 tanks that hold our library of rare cells. It has taken our lab over 40 years to accumulate these resources. In some cases, our cells are from the propositus the antibody/antigen was named after and the donor is no longer alive. You can't get most of these cells commercially. In some instances, it appears that regulating groups try to control something just for the sake of control. Control of a service/technique doesn't necessarily make it better quality, it just makes it more expensive or prohibitive to provide. Immunohematology isn't like chemistry, hematology, urinalysis, etc. It's not as easy to put this part of the lab in a box. At least, that's my opinion. And there is no such thing as a "mere generalist". There is much to keep track of when you are working in several different departments; that's no "mere" feat.

The results are in from our testing... DARA is not adsorbed out by RESt. Thanks for the replies!

You are quite correct. I don't actually think that it is in most guidelines, but what one should remember is that a foeto-maternal haemorrhage is just another form of transfusion for the mother, and she is capable of being sensitised by the baby's blood right up until the baby is born. Therefore, the mother's sample should be as fresh as is possible for use as a "baby's sample".

1. We will perform an elution with a positive DAT within 3 months of a transfusion, BUT, will also perform elutions on other cases (even if the DAT is negative) if the clinical symptoms give us reasons to suspect that an elution may be of help. Nothing in the world of blood transfusion is pure black or white. 2. Normally, we use the acid elution technique, but will, occasionally use the Lui technique. 3. Usually, but not exclusively, gel IAT. 4. Full panel, as a minimum, but may include A1 and/or B cells, and others as required partner's red cells in the case of a suspected case of HDFN due to an antibody directed against a low prevalence antigen). 5. I can't think of any - YET!!!!!!!!!!!!!!!!

I am a little worried about the fact that there is no serological cross-match if the mother has made an atypical antibody. The reason I say this is because it is well-known that when a person makes one antibody, they often make more than one. If a mother makes, for example, an anti-K, which is easily detected, she may well also make another antibody specificity, such as an anti-Dia. As the Dia antigen is a low prevalence antigen in most populations, it could well be that the Dia antigen is not expressed on either the screening cells or the antibody identification panel cells - in other words, it may not be detected. Even if the baby does not express the Dia antigen on its red cells, the maternal anti-Dia will still go through the placenta, and so this anti-Dia will still be in the baby's circulation. If, the unit to be transfused is K-, but Di(a+), the baby could well have an unexpected haemolytic transfusion reaction, which could be avoided by a serological cross-match against the mother's sample. Once the unit has been cross-matched, and found to be compatible, then aliquots from the same unit of blood can be safely transfused without a further cross-match, but I feel that, for the first transfusion from any unit of blood, a serological cross-match should be performed.

Don't reference labs/hospital labs use many things outside of IFU? These things are used to aide in the identification of antibodies. They are not used solely for ID, as that would be ridiculous. Just like using expired panels, only, to ID antibodies. Expired panels are only used to help rule in/out. It seems that validation would be the fact that DTT works when the controls work.

Yes, there are some hospitals in the UK that do not keep group AB red cells. The original excuse/reason was that they did not have that many group AB patients, and so the units expired. As a result, group AB units were, essentially, made "free", in that, if they were not used, the cost was refunded. Still some hospitals did not want to stock them and, privately, I was told this was because they were frightened that they would be given in error to a group A, B or O patient (which is a huge worry, if they think that they and their staff cannot perform accurate ABO typing on patients). In your case, it is different, as you know that you have a "tame" group AB patient who will be, presumably, be using the blood on a regular basis. If you still don't want to transfused group AB blood, I would go for A first, as the anti-B in those units tend to be of lower titre and avidity than does the anti-A in either group B or O units, but, in my opinion, it would be better to give AB red cells. There was a paper recently, I think in Transfusion, but I'm not certain (and I am just about to rush out for an appointment, so I can't check now) that highlighted the fact that ABO antibodies can cause clinical problems other than haemolytic transfusion reactions. Sorry this was written in such great haste.

Sorry for the delay in replying. I am not receiving this newsletter in my email anymore for some reason. Yes we use Cerner. I don't think the baby and mom are linked. If they are, the lab can't see it on our side. We used to put the cord blood workup under the mom's number. That changed when the EMR came along to foul things up. Now the baby is ordered under their own medical record number. We have L/D wrap a mom's chart label sideways on the top of the cord blood and the baby label is placed up and down in the normal way. That way we have the mom's name and number when we are putting in the baby results. We look up the mom to make sure we have a current blood type. If current, we type the mom's type into the results. If it is not current, we get a new specimen. Blood Bank history is not always reliable. Unfortunately, the computer doesn't compare the baby type to the mom type, we have to do that. Talking about the history is not always reliable..... a patient came in to have a baby. The blood type didn't match the history. Had her collected again. It still didn't match her history. Started digging in the computer. Turns out, she had a baby 3 months earlier. (???) Called L/D to see if this was some type of weird OB case. No, it turns out the one that gave birth 3 months earlier had a Medicaid card and it worked so well when she gave birth that she loaned it to her friend. Just a little bit of fraud. Go figure. Never rely on computer history

We pick up admission errors in Blood Bank on a fairly regular basis, especially with outpatient registrations. Patients with language barriers can cause admission problems - the name may change because someone misunderstood what the patients name actually is because it is unfamiliar in spelling or from a different culture. Similar names, clerical errors with spelling and birth dates, patients who self-identify differently one visit to the next, etc. It is important to be very careful - admissions staff are not uniformly diligent about carefully confirming patient ID and making sure that the correct historic record is selected. Simple human error because of distraction or interruption happens. It can be a big problem for reference work because the only patient info we have at that time is what was received from the patient's clinic registration. When the patient is admitted through our doors later on we have to decided...same patient with errors or different patient. I preach to staff that we must never assume, always check.

My opinion: Why are we recording vital signs? The person recording them has to be able to interpret them in regards to the transfusion taking place. They must be trained to recognize changes that are indicative of a reaction regardless if they are an RN or not.

We went with the second blood type but only on patients we are not giving group O blood to. Between that policy removing about half of the need, allowing use of another lab specimen from Hem or Coag and a lot of historical types on record, it hasn't been too bad. We are AABB and TJC but not CAP inspected. We made the change for patient safety at the time. Now I think AABB is requiring something similar to CAP.

When I was in the hospital, we had an instance where a patient was in the ER and the admitting individual "picked" the wrong patient from a list of names only distinguished by different middle initials. Frozen plasma was ordered and when the tube from ER arrived in the BB, the type on the tube didn't match what we had on record. After investigation, it was discovered that the wrong patient record had been initially selected. New type on each encounter/admission is a good idea.

I agree MaryPDX, but, unless the Reference Laboratory is made aware that the patient has been on Dara, time and reagents can be wasted by trying to sort out the problem by more "traditional" means.

After all these preparation patient delivered at home. Baby and Mum didn't need any blood.

We go with 4 hours from the time they spike the bag.

Most of our reconstituted whole blood is made using washed RBCs (to remove the residual anti-A/anti-B/anti-A,B), which necessitates the 24 hour outdate.

I agree with Dansket. There is too much insurance card swapping and sharing going around to rely on a historical type, even if andministration of Rhogam would not necessarily be that harmful. We require a current type for everything except emergency release/massive transfusion and even then we would like to a specimen sooner than later so we're not pouring out ON for child-bearing females.

I would review some of these references with your pathologist. It's definitely not an exhaustive list. Judd, W. J., Butch, S. H., Oberman, H. A., Steiner, E. A. and Bauer, R. C. (1980), The Evaluation of a Positive Direct Antiglobulin Test in Pretransfusion Testing. Transfusion, 20: 17–23. doi: 10.1046/j.1537-2995.1980.20180125036.x Judd, W. J., Barnes, B. A., Steiner, E. A., Oberman, H. A., Averill, D. B. and Butch, S. H. (1986), The evaluation of a positive direct antiglobulin test (autocontrol) in pretransfusion testing revisited. Transfusion, 26: 220–224. doi: 10.1046/j.1537-2995.1986.26386209372.x Stec, N., Shirey, R. S., Smith, B., Kickler, T. S. and Ness, P. M. (1986), The efficacy of performing red cell elution studies in the pretransfusion testing of patients with positive direct antiglobulin tests. Transfusion, 26: 225–226. doi: 10.1046/j.1537-2995.1986.26386209373.x Domen R.E. and Grattan J. (1986). Efficacy of performing red-cell antibody elutions in patients with a positive direct antiglobulin test, Vox Sang, 51:324-326. Johnson, M.F.M. and Belota, M.K. (1988). Determination of need for elution studies for positive direct antiglobulin tests in pretransfusion testing, Am J Clin Pathol, 90(1):58-62. doi: 10.1093/ajcp/90.1.58 Perkins, J.T., Arruza, M., Fong, K., Sosler, S.D., and Saporito, C. (1990). The relative utility of the autologous control and the antiglobulin test phase of the crossmatch, Transfusion, 30: 503-507. doi: 10.1046/j.1537-2995.1990.30690333479.x Richa, E., Benidt, G., Tauscher, C., Stowers, R., Bryant, S., and Stubbs, J. (2007). Eluate testing following microscopically positive direct antiglobulin tests with anti-IgG, Ann Clin Lab Sci, 37(2):167-169. Yazer, M. H. and Triulzi, D. J. (2009), The role of the elution in antibody investigations. Transfusion, 49: 2395–2399. doi: 10.1111/j.1537-2995.2009.02304.x

See attached validation. For thawing the FFP, we saved units of FFP that were thawed and not used. We refroze them and kept them on the quarantine shelf until we did our validation and used them. Validation of Microwave Plasma Thawer.doc

Let me spin this differently. I'm unlikely to detect an anti-A1 or any other weakly reactive (1-2+) IgM antibody in routine room-temperature gel testing. Secondly, I have eliminated the immediate-spin crossmatch in favor of an electronic crossmatch to detect ABO incompatibility between donor and recipient. Lastly, by adopting the electronic crossmatch, I have accepted that any reactivity (limited to room-temperature) between donor and recipient (not demonstrated to be due to anti-A and/or anti-B) is rendered clinically irrelevant!

Sorry Scott, but could I just jump in here? The strength of the reaction of the DAT is not a measure of anything really. It is rather like saying that, if a reaction with anti-D from a pregnant woman is weak, the foetus is not in danger, but I have seen a few cases over the years where the reaction with R1R1 and R2R2 screening cells and panel cells has been weak because the D antigen sites are swamped. The same sort of thing can happen with the DAT.

We have a process to extend the crossmatch that has worked for several years. It is complicated and involves 3 departments. Everything has to be exactly right. The patient comes in to pre-test. We have a form that is put with the pretest packet. On the top part of the form is the patients info along with today's date and expected date of surgery. The nurse asks the patient two questions- have you been pregnant or transfused in the last 3 months? The nurse signs her credentials and sends the form to us along with the specimen. We perform a T/S and write our info into a section for the BB. There is a spot on the form that we put whether we need a second type on the morning of surgery. We put a sticker on top of the tube to signify the tube has to be saved when specimens are thrown away. Two days before surgery, the night shift faxes the form to surgery holding so they can put the forms in the charts. The morning of surgery, the nurse scans the form to see if they need to collect the second specimen and they ask the patient if they have been pregnant or transfused since pretest. Nurse signs form and faxes to us and sends the 2nd specimen if required. We get the form, do the second ABORH, find the original specimen, look at form for all signatures, etc. If all the stars are alligned, we order a specific test in the computer which extends the crossmatch for 3 days, answer the specific things in the computer and perform an electronic crossmatch if the physician wanted blood set up. If the patient had an antibody, we request a new specimen on the morning of surgery to do a new T/S and crossmatch the units we antigen typed before the patient arrived. Works great. Most are only T/S done 3-5 days before surgery with the occasional cancelled surgery that tries to get in at the end of the month. We tried to do 14 days but extended to a month (30/31 days hard stop) because the physicians kept pushing the envelope. We did 30/31 days because it is easy to see if the surgery was canceled for too long. If there is any question about ANYTHING, a new specimen is collected and we start over. It works well for us and we have had very few problems after the nurses realized it helped them

Better make certain you validate the heck out of Epic, esp if you are using Beaker. My most recent experience with Epic/Beaker and HCLL made me want to call the FDA. I'd run my own validation protocols rather than the Epic ones. Not enough training for staff , though this could have been a vagary of the institution rather than the system.

This is from The Joint Commission 2011. I don't think it has changed, but, I don't have the latest edition of the Laboratory Accreditation Program for Blood Transfusion Service. "The laboratory has written policies and procedures for the blood transfusion service that are consistent with AABB standards."

The Circular of Information for the use of Human Blood and Blood Components has information regarding transfusion within 4 hours. Here is an excerpt: "Transfusion should be started before component expiration and completed within 4 hours." And another, "The initial portion of each unit transfused should be infused cautiously and with sufficient observation to detect onset of acute reactions. Thereafter, the rate of infusion can be more rapid, as tolerated by the patient’s circulatory system. It is undesirable for components that contain red cells to remain at room temperature longer than 4 hours. If the anticipated infusion rate must be so slow that the entire unit cannot be infused within 4 hours, it is appropriate to order smaller aliquots for transfusion."

June 17 I will run up it again, then I am doing the ride up it in August.

Nicely done. Often, a little strategic word-smithing will save the time and effort of revising a procedure or policy.