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exlimey

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Everything posted by exlimey

  1. That sounds like a reasonable approach, if the process is actually required by regulation. Kathyang's original post mentioned "competency", but it's possible we're talking about the same thing.
  2. Is this a one-time thing or is there annual refresher training, a.k.a. competency ?
  3. This is an interesting topic. Disclaimer: I am not intimately familiar with the complexities of the regulations. Obviously, couriers are not involved in testing and are therefore not technically subject to the CLIA regs. On the other hand, they are involved in the quality chain from lab. to patient. I don't know if this is overseen by AABB/CAP, but more probably it's under the "Joint Commission" umbrella. I suppose one could argue that a facility should require competency/training for persons delivering blood to the hospital - other driver/couriers, even FEDEX drivers, if that's how you get your inventory.
  4. Next question: What does the package insert say ? The Immucor insert for anti-A1 lectin requires "A1 or A1B and A2 or A2B cells".
  5. It must be a very interesting policy/procedure that allows falsification of information.
  6. Agreed. It is very easy to fall down the "What if?" rabbit hole and get lost in the details. Complicated systems lend themselves to failures and unofficial shortcuts. The various regulatory agencies were supposed to be incorporating a risk-based approach to their inspections. One could argue that it worked for a while, but now in the absence of big issues, the inspectors are back to the minutiae.
  7. Since anti-A1 lectin is used to differentiate between A1 and A2 (plus other weak subgroups), I would think it important to prove that the reagent does that. Question: Do you use group O cells as the negative control for anti-A and/or anti-B ?
  8. Are you talking about "vacuum" blood collection tubes or just regular test tubes ?
  9. Just to clarify......you have "validated" test tubes ? What was involved ?
  10. I don't know if/how silica might affect testing, but I think that might only apply to the stopper, not the tube proper. You could certainly use regular 16 x 100mm (borosilicate) tubes, rather than the "vacuum" versions. We get generic tubes from VWR, cat # 47729-576.
  11. An excellent question. In theory, there is no such thing as "too cold" for a freezer, so the low temp. alarm setting seems to be pointless. However, if such a unit does activate a low temp. alarm, it may indicate that the unit is malfunctioning in some way. It might just give you time to intervene before the unit goes "bang". I hope I've sufficiently emphasized the low probabilities of the above happening. Our facility still checks the low alarm points for our walk-in freezers (-20 C). Luckily, we have access to liquid nitrogen (LN2) which is very convenient and quick. In the past, we've very awkwardly used a sludge of alcohol and dry-ice to get a very low temperature (-60 C), but this doesn't help with ultra-colds (-80 C). For physical science reasons, we are unable to activate the low alarm on our liquid nitrogen tank !!!! We actually had an inspector challenge us on this issue a number of years ago.
  12. I just answered this question. My Score PASS
  13. The Rh typing reagents are designed to react that way. These days, the reagents are monoclonal, IgM in nature and give direct agglutination in a very short amount of time (similar to anti-A and other ABO reagents). Centrifugation is also usually part of the process. Antibodies to Rh antigens in patients (or donors) are typically IgG and require incubation and an antiglobulin phase. Most manual tube testing systems these days also use a potentiator to enhance reactivity and/or reduce incubation times. In the "bad-old-days", Rh typing reagents were human-source, IgG in nature and usually required incubation and an antiglobulin phase.
  14. I like that ! None of this wishy-washy, barely reactive stuff.
  15. I agree with Malcolm. In theory, there may be examples of anti-K that only react with K+k- cells, but in practice it's a very rare event. One of my former colleagues/mentors once said that one shouldn't worry about missing a weak antibody. If the patient were unfortunate to be transfused antigen-positive blood, the former weak antibody would be super-strong next time around !!! Problem solved.
  16. I just answered this question. My Score FAIL
  17. It sounds as if the "real", actionable result is the 24-hour reading - this should be recorded in the medical files. The "quick-and-dirty" initial test, while not very sensitive, may still be useful in some cases of extreme contamination. It may give the physicians a leg up on treatment. Perhaps a two-field record could be designed? Test #1 = Immediate; Test #2: 24-hr. The interpretation algorithm would include both results.
  18. It's probably all tangled-up in training, competency and proficiency. Maybe an administrative nightmare?
  19. Yeah, I know. I was just being silly, pointing out that sometimes what sounds like a reasonable idea is often impractical and mostly useless. Proposed new policy: Type them once every week for the duration.
  20. Very good point. One could argue that ALL pregnant women should be phenotyped specifically to look for mixed fields.
  21. I'm assuming....yes, that gets me into trouble all the time......that you're worried about antigen suppression in pregnant women? Antisera licensed in the USA should have been tested extensively with samples from such patients. If they were unable to correctly phenotype samples from pregnant women, it's unlikely that they would have been approved. As Malcolm points out, the only real troublemakers are the Lewis antigens.
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