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Popular Content

Showing content with the highest reputation on 06/29/2016 in all areas

  1. First of all, I would read the package insert very carefully. I do not know this particular reagent, but I do know that sometimes panel cells, depending on what they are suspended in and their concentration, just are not suitable for use as controls with some reagents. Secondly, a Ee cell had been chosen to test the antiserum. Some of the posts above were worried that this cell might have been used to rule out an anti-e. Well, I hope nobody is using Ee cells to rule out the presence of anti-e with ee cells being in such abundance. Thirdly, you have probably got a second lot of panel cells. You should test the anti-e with the Ee cell on the other panel. If that is reacting strongly, then it is possible that the original Ee cell was in fact a previously undetected RH:CE variant and the manufacturer should be notified. That should not stop you using the cell, however, as you would look at the panel results as a whole, and not just this cell in isolation, and the other antigens (outside the Rh system) would not be affected. On the other hand, if none of your Ee cells are reacting and you are following the instructions in the package insert to the letter, then you probably do have a problem with you anti-e. You should stop using it and contact the manufacturer. They may well need examples of the cells that you are finding negative to see if they can reproduce your reactions on their retained samples.
    2 points
  2. Well, I prefer to apply the methods as a standard... Here are the forms I have created, I do this once a year... Cell washer verification form.doc Centrifuge calibration form.doc
    2 points
  3. DebbieL

    Lot to lot testing

    I listened to the same webinar. Basically what I heard is.... if the kit has positive and negative controls, then the new kit will have to be compared to the old kit. If the kit does not have controls, then they will not have to be compared. So according to that, we must compare Fetal kits but do not have to compare Elu-kits (no internal controls.) I have my people take the old controls and run with the new kit and the new controls to run with the old kit. This is supposed to be done while the old kit is still in-date, in that week of overlap. (We have had a few bumps in the road on that part). I made up a form showing the results for current kit with new controls and new kit with the current controls. Both tests should be about the same. Acceptable or not acceptable. I would attach the form but I think I am blocked here from attaching forms and procedures.
    1 point
  4. We do the same here s
    1 point
  5. Thank you for these forms.
    1 point
  6. It has been a work in progress. As with everything else, accountability makes all the difference! We audit the charts of patients who used uncrossmatched blood to ensure the patient information was documented. At first, it was problematic....but with time, they have gotten much better. Now it is very infrequently that they are not labeled (and when that occurs, we notify them that they need to go to the chart and label the Form). We don't have any requirement about what stage of the process they have to label the Form. We are not even an official Trauma Center (moving towards a Level 3) but have rarely had >1 "trauma" patient at a time.....and I understand your concern! Once there was a male and female and they said they only needed a cooler for the male.....so we took O POS; then found out later they really wanted it for the female and moved it to her room! We have spelled all of this out to them so why these things occur is beyond me! And once they place an order in the computer, we can print them Forms with the patient information on them. I can tell you what happened at a large (well known) Medical Center (Level 1 Trauma) when they used the same system we do and had a bad FDA inspection (though I can certainly see how this would be a much bigger risk at a large, Level 1 Trauma Institution than our little 180 bed Hospital). Unfortunately, when the FDA audited those patient charts (which the Blood Bank had not been doing....not that they are required to), they found: Missing Chart Copies; Chart copies on wrong patient charts; Chart copies w/o patient information on them. Obviously they were cited. So the Hospital "fix" is that now, the Transfusion Service will not issue blood to anyone/ anywhere until an Order has been placed in the computer and they can print Transfusion Forms that have all information on them (patient and unit). Surprised they were able to push that through at a Level 1 Trauma Center.....but FDA citations can certainly help a cause, right?! I have threatened our ER and OR with that if they don't ensure these Forms are completed (which is part of why the improvement we have seen), and/or if they don't start putting orders in the computer more promptly (a battle I am still waging). Brenda
    1 point
  7. Yeah, and then there is the ongoing headache question of QC for Antibody ID panels... Scott
    1 point
  8. There is every chance that the UK may be to blame for this. The MHRA, our equivalent of CAP (for want of a better way of putting it - maybe Mafia is the correct word, I don't know) have had high level meetings with people in the USA, and they have exchanged ideas as to how to make our job even more difficult and beaurocratic (sorry, "safer", and with a higher degree of "quality", I meant to write), and we have had this rule in the UK now for some years. I would not be surprised, therefore, if they have infected your Quality System.
    1 point
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