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Thread: Blood Component Donation Number Check Digit

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  1. #1
    The Council of Europe Guidance talks about numbers throughout whether donation numbers, batch numbers, in relation to labeling, etc. At no time does it talk about part-numbers or incomplete numbers

    https://www.edqm.eu/sites/default/fi...cember2016.pdf

    e.g.

    6.2.5. Systems of sterile blood bags used for the collection of blood and blood components and theirprocessing must be CE-marked or comply with equivalent standards if the blood and bloodcomponents are collected in third countries. The batch number of the bag must be traceablefor each blood component (Directive/2005/62/EC/Annex 6.2.2).

    I would argue a batch number isn't traceable if it isn't complete.

  2. #2
    Forum Member
    Join Date
    Jun 2017
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    4
    Thanks Chris

  3. #3
    Forum Member
    Join Date
    Nov 2016
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    42
    So the requirement for this is under the BSQR ; The person responsible for the management of a hospital blood bank shall—
    section 9 (1) (e): maintain, for not less than 30 years, the data needed to ensure full traceability of blood and blood components, from the point of receipt of the blood or blood component by the hospital blood bank;

    If your colleagues still don't accept this affecting the unambiguous traceability of the units, then they have the responsibility to inform your CEO (as they are the responsible person for the hospital blood bank compliance) with reasons for deviating from the regulations and placing this at risk.

    This is really interesting, please keep us updated on how things go as many of us are not getting the IT support we need for improvement projects.

    bw

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