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Joanne P. Scannell

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Everything posted by Joanne P. Scannell

  1. We dropped our AABB Accreditation last year ... and no, I do not see that the quality of our department has suffered. If anything, I have more time to spend on the REAL stuff. I still buy the Standards and will continue to buy the Technical Manual and other books from them ... but the 'non-member' prices nowhere near make up for the thousands of dollars they are requesting for membership nowadays. Yes, missing 'the feather', but it was just getting to be a very expensive, heavy feather ...
  2. Please stop listening to 'hearsay' and 'old adage' and learn about the different types of plastic tubes and method of manufacturing (extruded vs molded) ... yes, Wescott Labs will explain it all to you. We've been using the polystyrene 12x75mm plastic tubes very successfully for a few years now ... for EVERYTHING done in tubes.
  3. Just so happens we've been collecting data so we can see if it is safe to cut down on the number of elutions we prepare/test. Currently, we prepare/test an elution only if the patient has been transfused during the past 3 months (using that old rule ... an rbc can survive 120 days ... IF it is healthy and left alone! What were we thinking?) For the 971 elutions we reviewed, only 4 of them yielded a positive eluate with the 'offending' antibody 'missing' in the plasma ... and all of those were within the 14 day window. (We are using MTS for our Antibody Screens, btw.) To support the converse: We had 3 inconclusive eluates but were able to define the antibody using the plasma and 38 cases where the results were the same whether using eluate or plasma. So, guess what I am going to be presenting! Cut it down to 14 days as the literature and a lot of you are suggesting in here. Thanks for the support!
  4. I know and I agree ... multiply transfused people do tend to develop more than one antibody is well documented and seen day to day in Blood Banks around the world ... but for one particular antigen, and a highly immunogenic one at that ... who knows how many mls it takes to evoke an immunoresponse.
  5. Ok, so 'if we have the time, the staff, the resources, we'll seek out c-neg'? Once exposed to c antigen, the game is over ... wait 3-10 days to see if the patient makes Anti-c. If not, don't worry about it anymore. If so, now you can continue to give c- negative. Unless there is some literature out there that states the more units you give, the higher the incidence the antibody will be produced ... and how many units will that be? Too many if, ands, and buts ...
  6. The 3 day rule for patients who have been pregnant or transfused within the past 3 months is there for a reason: Did the patient start making new antibodies or have old antibodies that were previously below detectibility now evident? To answer that question, we don't need to re-identify known antibodies, we need to seek others, so run panel cells that will give you that information, e.g. If you have a patient who is known to be producing Anti-D and Anti-C, run D-neg, C-neg reagent cells from the panel. So, yes, it is important to run a 'panel' every 3 days if the patient has been pregnant or transfused within the past 3 months.
  7. Bags are discarded at the infusion site as soon as the transfusion is over. To address the issue of having samples for TXRX workups, when RBC's are initially entered into our system, we take 2 segments from each unit and place them in a plastic tube labeled with the donor number. These tubes are placed in a container and kept in the refrigerator for 2 months. This allows for 'time until outdate' with time to spare (in case a unit gets transfused on the expiration date, we need to keep the segment for 10 days after that). If there is a TXRX, we go find the segments.
  8. Soooo ... you are automatically seeking out and transfusing only c-neg RBC's 'now' to anyone who is making Anti-E to avoid having to do so in the future in the event a patient actually starts making the antibody ... ... ... think about that. :/
  9. Interesting and SCARY replies! I see serious issues here: 1. 'Rule of Thumb' here in the USA, 3 positives or 3 negatives to put you on the cautious side of the statistical probability that the identification is correct. If two are working for you 'across the pond', that's wonderful. This does not mean you need 6 cells. It means if you have an antibody to a high incidence antigen, you need 3 negatives to make the ID ... likewise in reverse for the lower incidence antigens. e.g. We don't call it an Anti-E unless we have 3 positive (and you know there are plenty of negatives around). We don't call it an Anti-k unless we have 3 negatives (again, with plenty of positives around). Besides, if you insisted on 3 pos and 3 neg to rule in/out ... ummm, how do you get around calling an Antibody Screen negative? 2. Zygocity: We have met many antibodies (eg. Anti-D, -E, Jka) on many occasions that react with ONLY homozygous cells. You CANNOT rule out with heterozygous cells as a general rule! There have been articles and lectures over the years about the dangers of doing this. However, there are a few that can 'sneak' by, eg. Anti-K1, because they generally do not succumb to dosage effects. Caution: Kkeep in mind that cells that may 'look' homozygous on the panel, eg. Fya+b-, may not be homozygous ... that 'second seat' may be occupied by an alternate antigen, e.g. Fy3. 3. 'One Homozygous Cell is Enough' : When we run an Antibody Screen, we are 'ruling out' using ONE homozygous cell all day, every day and we feel safe saying there are no antibodies and perform immediate spin crossmatches. Why should this change when running a panel of cells, then? So, no ... we don't rule anything out (except Anti-K1) unless we have a homozygous cell that is not reacting with our 'unknown antibody'. Those that cannot be ruled out using a homozygous cell are listed as 'possble Anti- ___' until presence is either proven or dismissed. And yes, we 'honor' them as if they were there until proven otherwise ... with educated prudence, of course!
  10. Mary h's Post is very interesting! I'd like to say 'overthinking', but then ... there's a lot of overthinking out there that suddenly turned into a vip hot topic complete with inspection citations. Having read that and having said that ... in this day and age of 'validate everything', I'm going to go validate my gel packs. They are 'constantly' at room temp (from incubator to cooler back to incubator), so I imagine they'll 'recover' to 20-25oC very quickly ... but it never hurts to have some data proof when that inspector asks.
  11. Yikes! Don't you think a validated cooler with gel packs would be a lot cheaper ... and smaller ... and the surgeons wouldn't have to be fighting over them. And if your concern is the rotating part: Platelets and remain 'unrotated' for 24hrs ... you aren't leaving them up there longer than that, are you?!
  12. Let's look at 606.60 a) .... Again, I cannot find using an NIST as a requirement ... This inspection report you posted sounds like this BB hasn't been checking their thermometers at all which is indeed a violation of CFR 606.60. Doesn't matter how, you just have to check them periodically according to how you wrote your SOP. Yes, the FDA Inspector will determine if what you've written is acceptable ... this inspector is obviously stuck on the NIST method. There are other ways to assure thermometers are acceptable ... one is to use indated certified thermometers.
  13. We used to use RESt routinely, but then woke up and realized we really didn't have to. It's expensive and time consuming and doesn't really give you much more information that prewarming would do. Yep, she's using that word again ... !
  14. Are you a Blood Banker? Your posting looks and reads like you are a representative who pulled something out of the manufacturing regulations. We don't do the actual calibrations out here in the field ... we just check our thermometers against a thermometer that has been calibrated, and certified as such, by a manufacturer.
  15. Unless you get a lot of returns, its probably overkill to issue every unit on ice. We actually issue units a number of ways: Single units in a plastic bag; if units are returned to the BB, we take it's temperature. Rule Say: Unit must be maintained at prescribed temperatures. So, if a component that is supposed to be 'refrigerated' is less than 10oC, it can be returned to inventory. If not, it is a discard. However, Rule Say: the transfusion must be completed within 4 hours. So, if they pick up a unit at say 12n, they have until 4pm before they have to discard that unit. That's 4 hours to do whatever adjustments/troubleshooting they have to do that may delay the initiation of the transfusion. If they return it 'immediately', chances are it will be still under 10oC, otherwise, we say to keep it up there and let us know whether it was discarded so we don't inadvertantly record it as 'transfused' in our LIS. Multiple Units go in iced coolers (yes, validated) with thermometers and temperature record tags.
  16. Call Helmer back! I've gotten quotes from them within hours! If you need a contact, let me know. I agree, the i-Series are GREAT refrigerators! You will not be disappointed!
  17. I disagree ... and that citation was short-minded, not addressing the actual intent of the requirement. Again, the requirment is for a PROCESS ... if it works for you and you don't mind all the doubted specimens/mislabeled specimens/questionable hospital bands/extra footwork/extra sampling/delays/questionable patient identification at transfusion time, then I can't say anything about your process if I'm inspecting you, can I? Time will tell which system works ...
  18. An opaque white zip lock bag. The opaque bag is for privacy ... these are being carried throughout the hospital (elevators, hallways, staircases) ... patient confidentiality issues.
  19. I'm reading all this wondering 'why?'. (Again!) No matter what the antibody specificity is, it is a cold agglutinin and therefore clinically 'insignificant' and you are not going to seek I-neg, Pr-neg, M-neg, Lewis-neg, etc. RBC's. The fact of the matter all this 'clearing' is only to make the BBer feel better, the patient still has this cold agglutinin in his/her system when the seemingly 'compatible' blood is transfused. So, let's stop fooling ourselves and wasting our time and money. Reactivity at RT = 'Compatible by Blood Type' and use a blood warmer. No Reactivity at 37oC = patient has no clinically significant antibodies = no 'AHG' crossmatch is required. You are done! Yes Reactivity at 37oC = Measures are needed to circumvent the cold agglutinin ONLY to see if there is something clinically significant 'under it'. We have found that prewarming will help us see our way clearly in most (if not close to all) of our cases. (Face it, high titer, broad thermal amplitude, persistent 'cold agglutinins' are not common ... and we are using Anti-IgG now so we don't see these 'colds' as much as we did with Poly AHG.) YES, I know that 'prewarming' is to be use with caution! Gone are the old days where all we had was albumin (requiring a 37oC spin/reading) and 'Poly AHG' (and it was indeed very POLY in those days!). Contrary to popular belief, 'Prewarm' does not mean 'no enhancement medium' (although sometimes, that's what it takes). So, you CAN prewarm PEG or Gel, therefore you will be 'circumnavigating' without sacrificing sensitivity. It's very simple really.
  20. Again, a lot of talk and extrapolation and we get all befuddled. Back to reading the actual requirement(s) ... I could not find any reference in the FDA CFR requiring the use of an NIST certified thermometer. If someone can find that reference, please post it! We purchase certified thermometers and use them as our 'standard' to check all other thermometers that are either not formally certified or have past their certification deadline. This is done Quarterly. It's simple ... line them all up in a waterbath (or incubator) just make sure at least one thermometer is indated certified and use that one as the 'correct temperature' to which others are allowed to vary whatever your tolerance is. btw: Anyone hear that story about why mom cuts the ends of the ham before she cooks it?
  21. I agree ... reactions do indeed 'go away' due to dissociation over time (or temperature!) and yes, patient is weakly positive with the Anti-IgG portion of your AHG(Poly) and negative for the Anti-Complement portion. To check this 'theory' ... run them separately using Anti-IgG and Anti-Complement. Do note that sometimes the AHG(Poly) is positive when the monospecific reagents are negative ... it's impossible to 'calibrate' them to match up exactly.
  22. All over the place here ... yikes. Back to the facts at hand: Yes, retraining is definitely in order here ... mainly about prewarming but also about using one's intelligence. Prewarm should only be used when one is certain there is a cold agglutinin AND the method used in Prewarm Technique is not going to miss any clinically signficant antibodies (and yes, you CAN prewarm anything, including gel). Unless there was some indication that there is a cold agglutinin in the mix (eg. reaction at RT with pooled O cells and/or mixed field/cell reactivity with gel), then prewarm is NOT the way to 'automatically' go! Gel is more sensitive ... don't expect tube testing to correlate with gel 100% of the time. The patient could indeed have a weak clinically significant antibody that is only detected in gel. Be careful when changing enhancement/procedures. Unexpected results, ie. positive antigen typing for Jk(: The tech should have stopped, taken a breath, looked at his/her reagents carefully and repeated the tests ... we are human, we make mistakes. Anti-M: Gel is well known to be super sensitive to Anti-M because of the acidity of the system. PLUS, I do remember reading somewhere years ago that if you looked hard enough, you'd find Anti-M in many plasmas. It's clinical significance needs to be determined ... enter 'prewarm' here. The clinical significance of Anti-M is up for discussion anyway. Furthermore, patients producing Anti-M sometimes do type 'M-pos' ... most often because they are actually 'Mg-pos' (which is detected by your Anti-M reagent). So, we don't type patients for M at all ... in fact, I don't even stock the stuff.
  23. Given these facts:: 1. Gel is known to enhance Anti-M because it is more acidic than tube testing; that's why we are seeing more of them now. 2. Anti-M is not considered clinically signficant although there is debate how signfiicant the antibody is if it has a high thermal amplitude, eg. reacts at 37oC. Having these in mind, we do the following (as I see some of you in here also do): If we identify Anti-M using gel, we repeat using Prewarm Technique using TUBE testing, eg. PEG, with a 'homozygous' M-pos cell. If this is negative, it is a cold agglutinin and treated as such (let's not go there right now). If it is positive, it is a warm antibody and treated as such ... that is, full crossmatch using pre-warm with TUBE testing (gel will enhance!) and issue the crossmatch compatible units. No reagent Anti-M testing is done ... as expressed in here earlier, it is not necessary. I agree with the note about 'Open Hearts' ... we do the same ... just as for any cold agglutinin. But, like I said, that's another thread to unwind!
  24. Ditto! Helmer is the way to go!
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