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Showing content with the highest reputation on 04/30/2021 in all areas

  1. If you store blood in the coolers when they get to their destination,they cannot be considered transport (if blood stays in them wherever you send them and no matter what your consideration is). This per the FDA. If you are CAP and/or AABB your assessor/inspector should remind you of this.
    1 point
  2. I'm also wondering how one manages to validate that all units of blood remain within temperature range when the ambient temperature and handling is not consistent. We can't even validate our coolers for the same reason ... and one never knows if the cooler is left open or the units are removed then replaced. Are you using 1-10oC or 1-6oC? FDA instructed us to use 1-6oC for the coolers because they are really 'in storage'. If not in a cooler, we can go up to 10oC because they are 'in transit'. I haven't implemented that part yet, but I will be soon.
    1 point
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