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exlimey

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Posts posted by exlimey

    41 minutes ago, bldbnkr said:

    Hello - We went to the smaller containers years ago because the large ones were too heavy to comfortably lift and move.  It is worth the extra cost to save a tech's back/neck/shoulders!

    Perfect ! Throw in a risk of workers' comp. and the argument is won quickly. Nicely played.;)

    27 minutes ago, John C. Staley said:

    I have always wondered what is done with the information from such surveys.  Are decisions made and action taken or simply are heads scratched and eyes rolled?  Are they undertaken simply for the "that's interesting" factor of the information?   :confuse:

    I agree too.

    I find it additionally perplexing that that information from these types of surveys usually takes a few years to be compiled and published. Not much use after the fact.

    On 12/27/2017 at 7:56 PM, R1R2 said:

    Are you sure that the survey is required by the FDA?

    I remember one from a few years ago and it was from the AABB and not required so I did not do it.

     

    20 hours ago, AMcCord said:

    If its the survey I'm thinking of, it is actually a biennial survey for HHS (I think) and yes, AABB sends it out/has a link for it. It is a voluntary survey to collect information on transfusion practices in the US. Its still a stinker :omg:.

    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......

    1 hour ago, kblewett said:

    I work in a small rural lab that does minimal BB each month. Our 10L box of saline from Cardinal indicates it should be used within one month, so we are discarding about 9L of saline each month. The smaller containers are more expensive, so.. can saline be validated for use for longer than the manufacturer recommends? We also use this saline for micro testing. Can showing no growth and negative Coombs reactivity each month be considered validation? Any help is appreciated!

    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.

    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).

    On 12/16/2017 at 8:03 AM, galvania said:

    sorry Exlimey, didn't mean to be snippy.

    anna

    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) ??

    3 hours ago, galvania said:

    Exlimey - Yes, of course the reagents are licensed to use on the instrument.  This is BioRad reagents in the UK.  And there are already LOTS of labs in the UK working with these reagents on this instrument.  And the cards used on the Instruments are the SAME cards that are used manually; and the Diluent is the same in the two techniques too, so no differences there to worry about.

    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.

    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).

    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 ?

    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  ?

    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.

    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 !

    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.

    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 ?

    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.

    ·

    Edited by exlimey

    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".

    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.

    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 ?

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