Linda0623

Ah.....the joys of analyzers....... This is why we do correlations between analyzers every 6 months in Chemistry. The intent is to prove that at any given time, you can run a patient on any available analyzer, and expect the same results. The 50-50 prospect you share is SCARY!!!! though can happen more than you think.....anything with a probe + variables can spell discrepancy, so trouble shooting is the way to go......(speaking as a former chemistry lab supervisor).......BUT>>>>>>>> Interestingly, you said you found a JKA......so, dosage could come into play here, and could wreak havoc in real life too.....if all available machines are not operating optimally, this scenario could occur, and easier because of doasge......just another consideration, and leads back to the first paragraph, stating that proving consistent performance between analyzers periodically is crucial.:cool:

I am in the process of setting this up myself, and I admit I will be "cheating" a little as I have previously been a chemistry lab supervisor. My interpretation for this rule in Blood Bank is to be able to prove that your validated use of each method performs as expected, so, that if you use a manual back-up method to your automation, you can be reasonably assured of getting the same results. In this case, it's not necessarily about the individual grading reactions, it's about interpretations, and tolerance between the methods. For example, in Chemistry, we had whole blood sample testing for analytes such as glucose and electrolytes performed in Blood Gas, and plasma testing performed on a different set of analyzers. A ten sample comparison between methods was run. SD applies, it's not about matching exactly. WB testing does range differently than plasma testing, therefore, you build accomodations into it for tolerance in the method comparisons. For example, reproducibility is defined at 10% between runs for glucose. Any outliers are documented and investigated. This general principle will apply in Blood Bank,. My intent is to run KNOWN patients (10 of them), both positive and Negative, on Both my ECHO, and in tube(PEG). My tolerance, or acceptability range, will be determined based on the acceptable concordance we achieved during ECHO validation. This will be for Group/Screen, and Panel only, as those are the only processes we routinely run on our ECHO. In the future, when we purchase a 2nd machine, the correlation would be run method vs. method, and analyzer #1 vs. Analyzer #2. The goal was to show that regardless of which method or analyzer was used, the reported results were as expected, or in the case of the analyzer, either one could run a patient and the outcome would be the same....... I don't know if that helps any, but if anyone has any suggestions, I'd love to hear them!!!

One of my techs told me the story of how a nurse had ordered platelet pheresis on a patient, and after picking up the unit from the Blood Bank, called to say that the order requested the platelets be "packed". So the tech asked them to bring the unit back and he would pack them. The nurse then replied "i've already transfused the unit, but it still needs to be packed." The tech then said to her, well, she could bring the patient down to the Blood Bank to be centrifuged. When she replied, "You can do that?" The tech burst out laughing.....Can you believe, he was written up for saying that to her???????

Also, if you have other cost centers that will potentially benefit from the switch to automation, you need to include those potential savings: how many less tubes will you need to buy? how much less waste biohazardous/sharps waste removal will be necessary? One process I am looking at is using the IgG crossmatch assay to "pre-screen" units for phenotyping. If you are only phenotyping compatible units, the likelihood of using expensive antisera only to discover that the unit is antigen positive, should net savings in both reagents, tech time, and TAT for finding units for patients with antibodies. Lastly, instead of using the anticipated "saved" FTE's to allow for attrition or other staff reduction, I proposed using the available tech time to bring back in-house eluates and absorptions....this will save thousands of dollars off of my reference testing cost center. The best part????? They really went for this one as I currently have a large budget line for that cost center..........Hope this helps, Linda

Happy Belated Birthday Cliff!!! Cool present!!!! Loved doing Legos with the kids......enjoy!!!

Hi Rashmi, Good thought about lots, I did consider it. However, we have been on the same lot number for several weeks since the service call, and still saw the decline in occurrence....in fact, not ONE case within that scenario has occurred......we will be switching lots in the next week or so......we'll see what happens... I guess I am wondering about the potential of carryover/cross contamination and it's affects on the assay should any problem, however minor, take place in the fluidics (can't help myself, I was a Chemistry supervisor before coming to Blood Bank).....please also note that during this whole time of errors and troubleshooting, WB corQC reacted as expected, and there were no QC errors attributed to this issue. Thus begs the question, is there a testing result pattern that can clue one in to the potential malfunctioning of the ECHO????

hi Rashmi, I think the answer to your question is.....sort of.....I'm thinking possibly both.....Here is the scenario...... in March/April, I noticed several patients that were presenting as DAT negative, probable warm auto antibodies when run on the ECHO, but if I had them repeated in tube, (both PEG and LISS, and also did complete tube DAT), all was negative. After much back and forth with Immucor Tech support, who were quite insistent that nothing was wrong with the assays, I finally got them to dispatch service because we started to get random errors during testing which indicated the system was not delivering or detecting reagents/specimens that had plenty of volume for processing. After 2 days of going over things, the ONLY concerning finding was that during one of the test cycles of priming the fluidics, PBS was dropped onto the plate deck where the stripholders are lined up for pipetting. This was with both the current and a brand new probe. After long thought out consideration by field service, several parts were ordered. One was a tiny board that controls the probe pipetting mechanism. This stopped the errors we were receiving regarding the level sense....... Now, why do I think this is relevant? Since this part was replaced, I have not seen any more of these solid-phase related DAT negative, all screen/panel cells positive cases, that were negative in tube (PEG and Liss.....)....thus removing cross contamination and this type of false positive ID's......What do you think? Linda

Hi Rashmi, I am intrigued by the retrospective analysis your wk antibody qc prompted, that there was a problem with inadequate plate washing. In retrospect, you feel that the inadequate washing caused missed antibodies, correct? Could you tell me a bit more about what Immucor actually did to improve the plate washing for you, and have you observed any connection between issues with plate washing and false positive results?????? Thanks, linda

ok.....here's a 2yr follow-up question if I ever suspected one..... We are looking at reducing/making more efficien/eliminating archived storage of paper records among the entire organization. HIM is leading the way with EMR, and are currently scanning all the backlog of patient medical records that the hospital has.... My question is this....I have a donor room in addition to the normal transfusion records kept by most hospital blood banks.....if I were to scan these documents that are supposed to be held indefinitely, can the paper be destroyed? Or, does it only allow me the flexibility to shift records to archived storage offsite sooner? Does it depend on the record type? The hospital has been told that their chosen system is acceptable per joint commission to allow for them to destroy the old records once they have been scanned to the EMR(we would create our own indexed files, not add these documents to any EMR).......Does that apply to us? Can anyone tell me if they are doing this and how inspectors feel about their process? and lastly, is there any specific regs about this that anyone can point me towrd????

I am in the process of reinstating our MSBOS.....We are a predominently orthopedic surgery based hospital, and what we found over the last couple of years is that without an effective MSBOS, blood management has become a nightmare. Most of the blood set-up for surgery, 85-90%, is currently not used peri-operatively. Because these units are "tied up" for the surgical suite, inventory for routine medical or post-op requests have become an issue. We could (and do) double- crossmatch and then issue based on need, but that has it's own problems. What I chose to do was to create a Blood Bank/OR Services PI project, that looked at/for inefficiencies in the services the Blood Bank provides to the OR. This project has the backing of the Hospital Performance Improvement Commitee, as well as is sponsored and monitored by the Transfusion Committee. One piece of this project was to strentghen the use and basis for the MSBOS. It has meant a lot of work up front to try to ensure 3 basic things: 1.) Standardize Ordering practices across the hospital system for pre-op patients, 2). Reflects the Dept. Of Anesthesia's expectations of blood needs for each procedure, and 3.) Patient Safety: Nothing worse than an inpatient being sent down for an add-on procedure where bleeding is encountered and no clot let own any blood products are available.The MSBOS has a guideline attached that allows for MD discretion for patients' with higher acuity. This has been well-received by anesthesia, and the in-patient floors find it helpful as a guideline for what a patient might need if no updated order has been written and the OR calls them to add on their patient to that day's schedule. It takes a lot of team building outside of the Blood bank to make this a success, and I can see that being difficult in larger institutions that service multiple critical areas, but with enough dedicated people to the process, it can be done. Our chief of anesthesia has played a pivotal role in the development of this, and has gotten consensus from the Dept. of Surgery. It is now going to our Medical Executive Committee for final implementation and approval. The buy-in from the surgical dept is, in my opinion, the key to this. If you get the consensus, and put the proper monitors in place, I think the MSBOS can serve a facility well. I know that thus far, our cross-departmental team building on this project has helped to give the Blood Bank a presence in the clinical team, as opposed to being a 'back-ground' ancillary service. Only time will tell how successful this will be long term, but at present, I have hopes of actually seeing a more efficient streamlined process so that the Blood Bank can provide even better service than in previous years.......we'll see...... Oh, and I almost forgot......the regulatory basis that I used to get all the parties together was the CAP TRM question regarding service agreements between the BB and the clinical areas such as ER, OR, L&D, where communication of patient problems, dept. expectations, and TAT are expected to be outlined..........sorry I don't have the checklist question # right handy!!!!

I don't know for sure, but my sister hospital has the Galileo....I can ask their experience.......

Thank you for the help!!! I think I am going to present a combination of the two of your guidelines to my medical directors....we do occasionally have the auto donor who wants to donate allo as a directed or community, hence the need to make some CA deferrals to guard against in apppropriate future allo collections...hence some confusion for my techs handling deferrals.....

Hi All- Any help on this subject I would be so-o-o-o appreciative!!!! We have a moderate donor program that is predominently autologous donors. We struggle a bit with cancer deferrals. Sometimes my staff become confused because the medical directors ar not as clear cut as I would like them to be:cries:. Can anyone help me with locating some general guidelines on deferring potential donors with + Cancer hx or are willing to share how they do it? Many thanks in advance, Linda

HI Rashmi, You are right in saying that I am fortunate to have time in most cases.....but that is not to say that this method is difficult to interpret in general.....I just meant to indicate that I am an advocate of making all of my techs able to perform at a high level, and I do my best to encourage that whether they are students, new grads, or veterans like like my 30and 40+ yr blood bankers...... Overall, this method does what I need it to do.......detect clinically significant antibodies with more sensitivity and specificity than PEG in tube....we have caught more weak antibodies, even with the ? or having to visually call positive cells that the ECHO called neg, than what we have missed and know about...... Several times we have taken these weak antibodies and tried to demonstrate them in tube, and get everything completely negative. Would we do better with gel? I cannot say either way with certainty, as we have never used gel here. What I can offer you from the technical perspective, is this: When I investigated the idea of automating, I asked both Ortho and Immucor to come in and demo their methods for all of my staff, some of whom had no appreciable knowledge or understanding of either method. Overwhelmingly, the techs preferred solid phase, and my 40+ year blood banker just simply said "when do we get this"...... That has gone a long way in helping everyone along, and I am happy with my 85% independence of work-up completion at this point as we have only been LIVE with the method for about 3 months now...... Regards, Linda

Well....this is a whole topic in itself...... I am doing my best to "bring everyone along" with me as I gain better experience and understanding of how Capture works.....or doesn't. Daily I go over the current workups and their statuses and next steps with my day shift, and as feasible with my evening shift. We are predominently a specialized hospital and donor center serving Orthopedics with some neurology, oncology and cardiology thrown in for good measure, but only on adults, and we don't have a general Emergency Room or OB services. What that does, generally speaking, is to give us time to figure things out, as most surgeries performed are elective, and planned....although we do take "stable" orthopedic traumas....(snicker)......what we do get however, are some pretty complicated cases, as we get people from all over the country and beyond that come here because of our world renowned surgeons. I've had a Bombay patient, several cartwright a patients, and a patinet withan IgG reactive York with 4 other allo antibodies for that used 12 units of blood before we gave him the York and the Fya......... The ECHO, specifically Capture methodology, in my opinion overall has made us a better transfusion service. My techs, including myself, have to think, and evaluate what we get much more thoroughly than previously, because we have to get comfy with what the ECHO is telling us..... many things are alot harder to dismiss as ACARO (our term for all clinically significant antibodies ruled out). We have had instances where because we had done previous work in tube that was negative (pre admission screening) that when we ran the OR sample on the ECHO we would get positives we were not expecting that were sometimes strong, sometimes weak, but generally very significant. Nothing like those to inspire confidence, hee-hee---but it's part of the learning curve...... That being said, I would say that about 85% of the time at this point, my techs complete and enter the results of the work-up without my intervention. If they get a positive screen and a negative panel, they have to go over it with myself or my other super user before final decisions are made. I try to make sure as I said above, that I bring them along with me.....it doesn't benefit me to have them lag behind...... An example of this was while I was on vacation last week, they got a RS3 that was 2+ on cell 2, but the panel was negative. I had them run the Extend I panel, and one cell came up positive. I looked at the Masterlists, and had them run the third panel I had available. It also came up one cell positive. The common thread, they were the only 2 Kpa positive cells I had available. The catch?: why was the antibody screen positive? Cell #2 on the RS3 they ran was Kpa Neg........Hmmm.........Still working on this one!!!(Lucky she doesn't go to surgery until next month!!) Did I mention the learning curve????? Best Regards, Linda

Hi Rashmi..... I talked about this a little bit on a different ECHO thread, but I am not considering using the IgG crossmatch assay for crossmatching purposes per se...... and the reaction I got on the AG + unit was 1+..... I am using the crossmatch assay on the ECHO to "pre-select" units for antigen typing.....if it's not compatible, I don't screen it for the required antigen, as it is actually faster and cheaper to crossmatch than to screen ransomly for certain antigens. In the instance I mentioned, I purposely "crossmatched" known E or K units for validation purposes. I wanted to see if in fact on questionable or cannot rule-out situations, could I pick up incompatibility on the ECHO that could be potentially missed if I didn't notate the antibody specifically E or Kell. The positive E unit that I tested, would not have been normally selected to crossmatch, and our computer system would not have allowed it's selection due to the antigen typing results entered on that unit, so they couldn't have easily inadvertently used this unit for the patient. Also, as I mentioned above, we do IS and IGG crossmatches on all patients with + antibody screens in tube on the bench.....luckily, on a daily basis we do not do that many IGG crossmatches and therefore do not see the value of having either 2 techs do one crossmatch or see the efficiency of doing only the IGG crossmatches on known Ag Neg blood for efficiency purposes. Hope this isn't too confusing...... Linda

Hi all-- One little thing I thought I would throw in the mix for all to consider....... The fact that the ECHO has some difficulty in interpreting reactions of 1+, sometimes even 2+, applies to screens and panels as well...... What I have found, is that scrutiny of the "0" reactions compared to the negative control background on the ECHO, helps give you a clue as to what is going on........ When I was trained on manual Capture by Immucor, they specifically taught that you should compare the backgrounds on the panels to the negative control. Any shading of color that is different in the background, or fraying edges of the cell button beyond the amount evidenced in the negative control, should be suspected as a weak +. Several times already, we have seen this, especially with Anti E's, but I recently also saw this with a Kell. A ? reading is given if the camera determines a reading greater than 5....the reading the ECHO gave was a 7.....I compared that answer to the cell that read 1+, and it was a reading of 20. Visually, comparing the 2 wells was not all that different. comparing the ? cell background to the negative control background indicated that there was indeed a weak reaction. These are difficult, because everyone's eyes are different, and I suppose you could say that we wanted to make this work....but in several instances, for validation purposes, I would run IGG crossmatches of known E pos/neg or Kell pos/neg cells to check compatibility. The Ag neg cells, (so far) were always compatible, and the Ag pos. cells were incompatible in all cases except one........ Not too shabby...... Sorry so long, but I think part of the concerns stem from the time needed to read this methods weaker reactions with confidence and experience....like everything else.........

Hi Cornelia- In my experience, the longest it would take to get an emergency- "STAT" group and screen would be 22 minutes plus the remaining time on a Ready ID or Extend Panel.....so, it depends on what your run is comprised of when you put the stat on. If you are running a batch of group screens, and then request the Stat, the ECHO will start the testing on your sample "next", in place of the subsequent routine sample it would have picked up if no STAT was requested. After the STAT has been begun, it returns to where it left off in the routine run. I have not as of yet lost any processing of routine samples due to "interruption" by a STAT. The one thing to note about the ECHO's timing is that the timing of the pick up of the next sample is dependent on where the previously started test run is in the sampling/testing process, because there is only one transport arm. Therefore, the timing is spaced between activities, controlled by the software such that the transport arm does not need to move multiple strip holders at the same time to different places, (such as the wash station at the same time it needs to move strip holders in the incubator or centrifuge). Hope this helps and I wasn't too confusing........ Regards, Linda

Hi- We have consent for blood and tissue included in our surgical consent form. We set the stipulations similarly for tissue that we had on our blood informed consent form, just added tissue where appropriate and at our last JC inspection, they received good marks for how tissue was handled. I do not have responsibility for the tissue program, but I do serve as a liason to the OR director for these compliance issues. It was our suggestion to streamline and include wherever possible to cut down on the number of forms to maintain and manage.....

Hi Barr, Wow---you packed alot in a paragraph...I'll do my best to keep this concise.....(I'm getting better at it the longer I'm a supervisor!!) One way for me to keep this "simple" is that I am validating this process with "known" antibodies needing routine crossmatch. This allows me to request 2 tubes for the validating, as it is the lab phlebotomist who will be drawing the patient. This gives me plenty of plasma to work with. We are a predominently orthopedic specialty hospital, so I don't have as many "unexpecteds" as those of you in a general community hospital setting. So, for my patient pop. what we are doing is: If patient has known history of antibodies (not Anti-D), they need to run the Ready ID panel with the Antibody screen. If they have a history of auto antibodies or one is suspected, I have them run the IGG DAT with the Ready ID to serve as the autocontrol. If the patient has history of Anti-D, they are to run Extend II only, to rule out anything else. If the patient is not known to be Anti-D, but is rh neg. with no prior blood bank hx, the rule is to do the Ready ID followed by the Extend II if anti D is proved but they need to rule out anything else. If beyond that more rule outs are necessary, or if there is the need for pre-warm techniques, as well as the full DAT kit, we have liquid cells and panels for rule outs. I have been off for the Holidays, but I did receive via email the tech comm from Immucor regarding this QC issue and a possible resolution. Do you need them?? I would be happy to help...... Regards, Linda

Thanks John..... I am actually pretty new to the BB supervisory realm, so it's nice to know I have some ideas to share that others might find useful, and not just feel like I have alot to learn...... To dingalls2: Yes, we did experience what I would call a two-fold difference in sensitivity when we validated the Capture manual workstation, and then proceeded to the ECHO. I was very fortunate in that during my last AABB inspection, my surveyor was a Beta tester for both capture and then more recently, the ECHO. He gave me a "heads up" about the potential to see this, and I took his recommendation to validate the Capture workstation to validate the "method", which would be Solid phase Red Cell Adherence, to the reference standard, which for me was PEG in tube, and then validate manual method to automation when the ECHO arrived. When the ECHO arrived, the major validating was the ECHO itself, and their validation guide for that is very thorough in testing ECHO functionality, but I did parallel studies to validate the change in our Work Flow Processes. However, we did do an additional 40 samples, tube vs. Capture vs. ECHO, to cover all bases. All told, it took about 2.5 months, as the total validation was 10% of our monthly volume. It did show further sensitivity the further in the Process we went, especially with E's, Kidd, and Duffy antibodies.

Hi all We are in the process of interfacing the ECHO with Meditech Magic 5.6. With Meditech, as you know, getting "new" services in the way that is logical to us vs their way of thinking is a challenge to say the least. My understanding from my own LIS person, is that the antibody screens will cross, and he is able to have the criteria line up with how we manually resulted with tube testing. It seems to be a matter of how you build your rules to coincide with what is sent over from the ECHO. We are going to be using rules to "reflex" Ready ID's. Because you still have to write your results on the master list and read the antigerams to determine what Ab you have, we are opting to have the Echo send a "complete'" message to the interface to result;Antibody screens will send over cell 1,2and 3 reactions, plus pos ctrl. We were able to set up 2 rules/calcs that will reflex our usual comments and markers, same as in tube. To actually result an antibody ID, we will be using our ABID as before, but it will only be a reportable, not chargeable test. The ReadyID, extend II, etc. will result as complete, but will only be a charge, not reportable test. this will help us in reflecting how many panels we need to do in order to get the antibody ID, and have the billing coincide better than our prev. set-up. We are in validation of this process, so will update if anyone's interested as we go along.......

Hello Dr. Pepper-- We too perform cell saver......any chance we get. We are predominently orthopedics, but have some neuro cases as well, and unless the patient is deemed unfit for cellsaver (ie. infection at the surgical site), they are considered for the process if there is any significant EBL anticipated. So far this year, it has been used in ~900 cases! (imagine the cost savings on allogeneic blood....) We used to completely control the whole process, but now the OR "owns" it themselves. They report on it to me for Transfusion Committee review, but all cases where it is used, PM's training, etc. are maintained by the Anesthesia Department Director, with blood bank oversight. We do not currently include this on our AABB accreditation, as the OR has the day to day responsibility, but we do remain the oversight body for stats and reporting purposes. Hemonaetics is the vendor who provides our training, PM's, equipment etc. It has really helped us keep cases moving during blood shortages as well.....

Hi all, We have just implemented the ECHO, and although we would have low use of the IGG crossmatch as it stands, what we are in the process of validating is using the IGG crossmatch assay to "prescreen units" for patients with antibodies. As an example, I just had a patient that had E, Kell, and Fya antibodies. When we needed to screen more for routine crossmatch, I ran the patient against 8 donor cells for IgG crossmatch. Only one was compatible. We then took the one donor and antigen typed it....negative for all 3 antigens....not too shabby for 1/2hour's ECHO time plus antigen typing.....not to mention the potential cost savings on antisera....we only phenotyped one unit instead of 3....(well, if we were validated....because I am in the process of validating, I did have the techs go back and determine which antigens the other 7 donor units had which caused the ECHO incompatibility......)

Thanks K.....as they say, there is NO perfect blood bank method, and in our specialuzed scope of practice (predominently orthopedic), we miss most problematic Rh issues, such as those involving OB.....but, the techs were confused by this, and so it's great to be able to attribute this to assay limitations......