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Quality control on Radsure stickers


velliott

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While I can't answer who requires it or why it is required, we perform these steps:

  • When a new lot number is received, record the date received on each box and place the boxes into a Quarantine area until QC has been performed on the lot.
  • When you open a new box of RAD-SURE® labels, record the date opened and your initials on the box.
  • Verify that the Temperature History Card color is blue/black. If an orange colour is on the card, the box of RAD-SURE® labels should not be used. Contact a supervisor immediately for instructions on how to proceed.
  • Place a RAD-SURE® label from the new lot number on an expired blood product (red cell or platelet) and irradiate the unit. QC is acceptable if the window of the RAD-SURE® label turns black and the word “NOT†is no longer visible.

Looking at the references for our SOP, these steps are probably called for in the Instructions for Use for the labels.

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I rechecked the Rad Sure Instructions for Use and there are no recommendations for QC other than to verify that the temperature indicator should be "blue", indicating that unacceptable temperatures have not been reached during shipment or storage.

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  • 6 months later...

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