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Everything posted by exlimey

  1. Fascinating.....voluntary, but, it appears, strongly encouraged. I wonder in how many institutions this has been translated to "mandatory"? I lean toward R1R2's position - don't do it, especially if it is indeed a "doozy" or a "stinker". We're all busy enough already. Unless the survey organizers (FDA) are going to provide funding for such an exercise......
  2. While it is not impossible, it can be extremely ticklish to extend an expiration date (of anything) beyond that of the manufacturer. You may find that the burden of proof required exceeds the value of the theoretical savings. You also have to remember that the manufacturers of the products put on that expiration date for a valid reason - presumably their testing indicated some deterioration/deficiency over time. Certainly microbial contamination is an issue and culturing may provide useful data. However, and this is a BIG HOWEVER, most BB saline products do not contain preservatives and don't claim sterility after opening. Therefore, you will undoubtedly end up at some point with positive cultures on opened containers. The question then becomes "How much contamination can our test system tolerate ?" - a very difficult question to answer satisfactorily. Perhaps more importantly for BB testing is stable pH and any plan to extend the expiration date of saline should include pH testing.
  3. One presumes that the FDA know what they want you to do. Perhaps you should ask them......? I know, my advice is not very enlightening, but second-guessing what hoops the regulatory agencies want you to jump through is an exercise in futility.
  4. I'm sure you sent them a card.......
  5. I agree with the sentiments above. Wiggle room is always a good idea when creating ranges for any activity/process. The art is in defining the range - certainly you don't want to be too strict that an unexpected event throws you out-of-compliance. Neither do you want ranges that are so broad that they are effectively meaningless. For maintenance, a good idea is to have a target date and then add your wiggle factor (+/- days, weeks, months, etc).
  6. An excellent idea ! No need to re-invent the wheel.
  7. No worries, perhaps I was just a little sensitive. May I presume that your detailed knowledge of the reagents and platform (and the Swiss flag) is a result of an association with the company (formerly know as DiaMed) ??
  8. No need to get so snippy. Unlike you, I am not intimately familiar with the state of things in the UK - that's why I asked.
  9. Food for thought: Are the reagents licensed/approved for use on the instrument ? If "Yes", then minimal validation is required (and is perhaps better called "verification"), but 10 samples is probably too small (even if you select/cherry-pick the phenotypes). You would have a very hard time covering all of the most common Rh haplotypes/phenotypes with such a small sample size. If "No", then you're definitely in the validation realm and 10 samples is way too small to achieve appropriate statistical confidence levels. If you have a pet statistician, it might be worth talking to them. BTW, if the phenotypes of the selected test samples are already known, there is no need to re-test them manually as part of this process. As Malcolm suggests......there are some not-so-secret ways to collect that information. A final brain-dripping: You will need a plan to deal with discrepancies. No two techniques are the same, nor are the formulations of the reagents (monoclonal cell lines and other secret ingredients).
  10. I was wondering if the probe was able to be moved, but probably not. I'm sure the manufacturers don't want the end users monkeying with their delicate electronics. If the probe could be moved, it might be possible to angle it into liquid nitrogen (LN2) - that would set off the low/cold alarm ! That's what we do in my facility, but our probes are accessible/flexible enough that we can move them around fairly easily. May I assume that you're only doing a one-point calibration/certification of the freezer probes ?
  11. How do you calibrate or verify calibration of your freezer temperature probes ?
  12. Patty, you may be getting your markers mixed up. Daratumumab reacts with CD38 (not CD47). It is an IgG1 antibody and reacts nicely with Immucor's reagent.
  13. Who's responsible for training and tracking, etc. - nursing or the Blood Bank ? How does one know that the body that turns up to collect the blood has been trained ?
  14. 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.
  15. Is this a one-time thing or is there annual refresher training, a.k.a. competency ?
  16. 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.
  17. Next question: What does the package insert say ? The Immucor insert for anti-A1 lectin requires "A1 or A1B and A2 or A2B cells".
  18. It must be a very interesting policy/procedure that allows falsification of information.
  19. 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.
  20. 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 ?
  21. Are you talking about "vacuum" blood collection tubes or just regular test tubes ?
  22. Just to clarify......you have "validated" test tubes ? What was involved ?
  23. 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.
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