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Gloria

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Posts posted by Gloria

  1. We validate our Igloo Playmate coolers twice a year and we do it in the Blood Bank.

    On another note, I have recently heard that FDA considers coolers going to OR as storage and as such they have to be monitored every four hours. Has anyone else heard that? does that mean that coolers can only be out up to 4 hours unless they have some way of being monitored continuously? would we have to check on the blood every 4 hours if not? Since it is storage, does the blood also have to be maintained at 1-6C?

  2. Human source ABO reagents have not been available in the US market for several years. Currently, there are reagents that are just a mixture of anti-A and anti-B, some that contain anti-A,B in addition to anti-A and anti-B and some that are actually anti-A,B. Check the direction insert of the reagent to find out which one you are using.

  3. I have recently joined an institution that does electronic x-matches. Specimens for blood bank are witnessed by a second person that also verifies patient ID. If there is not a previous blood type on the patient a retype is done on the same sample; only after the second type is done are patients with no history of antibodies candidates for electronic crossmatching.

  4. I look forward to seeing some clarification on this issue. If CLIA wants QC to test the limits of the reagent, we aren't meeting that either, since we do not dilute antisera or use weak cells to challenge the reagent in our ABO/Rh QC.

    Thanks for your response!

    Testing the limits of the reagent would include testing it against cells with the weakest expression of the corresponding antigen, however, it would not include diluting the reagent since they are not routinely used diluted, doing so would be not following manufactures' directions.
  5. In addition to all the good things Elaine suggested I will also take the "check list" and note all the applicable SOPs for each question. That way I can get to the references immediately and not fumble around. I've fumbled around and it is not fun. I always hated telling an inspector/assessor; "I know it's here somewhere!!" As far as preparing the staff, I just tell them it is business as usual, answer any questions in a freindly yet short and consise manner and for heavens sake don't do more than just answer the question. If yes or no works use them.

    I agree with this suggestion. Last year when were inspected by CAP, I downloaded the CAP checklist and added the applicable SOPs, as a reference, to each question. When the inspector came in, I handed the checklist with the references to him, this way he knew exactly where to go if he had a question. It worked great.
  6. I recently joined an institution that relies on the blood center using the swirl technique: we are not AABB, but the CAP checklist does not say this is not acceptable. As a matter of fact, they were inspected by CAP last year and did not have that counted as a deficiency. However, I contacted CAP and was told that the new checklist will have a revision of the question of testing for bacterial contamination and the swirl technique will not be acceptable.

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