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Thread: Updated Good Practice guide

  1. #1

    Updated Good Practice guide

    Hi Everyone

    I have just received this email you will be interested in



    The 21st edition of the Guide to the preparation, use and quality assurance of blood components, providing state-of-the-art guidance for healthcare professionals, has just been published by the European Directorate for the Quality of Medicines & HealthCare (EDQM).
    Also known as the Blood Guide, this gold-standard compendium offers quick and easy access to a comprehensive overview of the most recent advances in the blood field, technical standards to ensure the quality, safety and efficacy of blood and blood components, and guidance concerning blood donation and collection. It is a must for blood establishments, hospital blood banks and healthcare and regulatory professionals.
    The Good Practice Guidelines (GPGs), included in the Blood Guide, offer additional guidance, with standards for the implementation of quality systems in blood establishments and, where applicable, hospital blood banks. The GPGs are referred to directly in European Commission Directive (EU) 2016/1214, saying they should be taken into account by EU member states in the implementation of quality systems in blood establishments.

    New in the 21st edition
    For the first time, all changes with respect to the previous edition are compiled in a change log, accompanied by supporting background documents, both published alongside the 21st edition. The terminology used has been standardised, harmonising in particular the use of the terms must and should, and inclusive language has been introduced.
    Other highlights of the latest edition include:

    • new and updated standards on data-processing systems in the GPGs;
    • changes in donor selection criteria related to haemoglobin, iron stores, allergy and anaphylaxis, cancer and malignancies, interventions and treatments, acupuncture, tattooing, body piercing, and aesthetic medical procedures, surgery and dental treatment;
    • the recommended frequency for monitoring of donor IgG levels has been reduced while the permitted annual donation frequency with regard to plasmapheresis remains unchanged from the previous edition;
    • the recommendation of glucose measurement instead of pH as a more appropriate quality indicator for platelets in additive solution.

    Find out more at the EDQMs dedicated web page and download the 21st edition of the Guide to the preparation, use and quality assurance of blood components.

    Where to get your copy
    The Blood Guide can be downloaded for free from the EDQMs free publications platform, FreePub: download the 21st edition of the EDQM Blood Guide.
    Printed copies can be purchased at the EDQM WebStore.

    Kind regards,
    The EDQM Blood Transfusion Team

  2. #2
    Hi all - I was wondering if anyone had a gap analysis tool available for this edition of EDQM?

  3. #3
    There is a Change log you can download with the updated guidance

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