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exlimey

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Posts posted by exlimey

  1. 20 hours ago, AMcCord said:

    I have a stick thermometer with a current calibration certificate in the ultra-low freezer. When maintenance is done, the temp of the thermometer is documented along with the temp on the freezer LED display and the chart temp.

    You can indeed test the circuitry of the freezer by pressing a button for an alarm check (love that feature!), but how do you perform a physical test of the low alarm to make sure that your circuitry is functioning correctly?

    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 ?

  2. On 12/10/2017 at 10:56 AM, EAB81 said:

    Okay... my question is this: In order to do a low alarm check on your freezer, how would you go about getting the temp low enough to do the testing? Like most BB refrigerators, for example, ours has the wands that we can "trick" the fridge into triggering the low and high alarms. How would you trick the fridge? Currently, our plasma fridge is at -60. How could you fake the temp lower than that or am I thinking about this wrong? We've never been cited here for alarms on the freezer as long as I've been a tech.

     

    6 hours ago, AMcCord said:

    I'm not sure how you could trigger a low alarm in an ultralow freezer when it runs at about -80C. I don't even try.

    How do you calibrate or verify calibration of your freezer temperature probes  ?

  3. 1 hour ago, Patty said:

    I am not familiar with the Immucor AHG that does not detect IgG4.  When using Immucor's AHG for testing patients after Dara treatment do you still see pan-agglutination?  We are currently sending patients treated with Daratumumab  to ARC reference lab for DDT treatment and transfusing K- blood if no antibodies are identified.  After a molecular phenotype has been done we consider transfusing phenotypically similar blood without an antibody workup which requires a signed deviation form per patient.  Both options are time consuming and expensive.

    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.

  4. 16 hours ago, Cliff said:

    @SMILLER, we have always been able to determine who received our products, including all emergency release products.  We have a form the physician signs that lists the units.  The blood bank issues those products (when they have time) to that patient and we can track where every product goes.

    What I take exception to is the inspector insisting that we also put the patients name and MRN on the product.  They again insisted this made the process safer.  It does not in any way make it safer, especially if it's a system assigned name / MRN and more importantly, when it takes a modest amount of time to generate these labels.

    We have done a tremendous amount of planning to ensure we can give out emergency release coolers, almost on demand.  It takes us very little time to give the requester their products, these labeled units have put a significant delay on that, and in my opinion, has deceased patient safety.

    Well said, Cliff !

  5. 9 minutes ago, R1R2 said:

    I think upon hire.   Not really a competency, more like training.

     

    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.

  6. 18 minutes ago, R1R2 said:

    I implemented training for the couriers.  It was a PPT that their boss gave them to read and sign off on.   Basically, go directly to department promptly, avoid hot or cold temps, give to responsible person. 

    Is this a one-time thing or is there annual refresher training, a.k.a. competency ?

  7. 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.

  8. 29 minutes ago, Kathyang said:

      Actually with our QC that we do in tube, the negative control for Anti A and Anti B is O Pos cells. That is CorQC from Ortho.

    Next question: What does the package insert say ?

    The Immucor insert for anti-A1 lectin requires "A1 or A1B and A2 or A2B cells".

  9. 21 minutes ago, John C. Staley said:

    Over the years I came to realize that a lot of what we did was geared toward simply passing inspections and meeting requirement that, in reality, did little or nothing to aid the patients.  Smoke and mirrors to confound the masses. 

    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.

  10. 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 ?

  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. 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.

  13. 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.

  14. 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.

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