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Thread: Visibility of SLAs to complete annual BCR

  1. #1
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    Visibility of SLAs to complete annual BCR

    At a recent TADG there was some discussion that staff completing/ submitting the annual BCR don't always have access to SLA's (Contracts) that are in place and that they donít get to see the SLA for annual review and to ensure these comply with the GPG. Individuals signing off the BCR without having sight of these documents may unwittingly leave themselves open to a non-conformance, especially if they have been told they cannot see them.

    Please see relevant references below:

    1.2.2. The Quality System encompasses quality management, quality assurance, continuous quality
    improvement, personnel, premises and equipment, documentation, collection, testing and
    processing, storage, distribution, quality control, blood component recall, and external and
    internal auditing, contract management, non-conformance and self-inspection (Directive
    2005/62/EC/Annex 1.1.2).

    1.2.17. A product quality review may also be considered as an instrument for surveying the overall
    quality status of a blood component and its manufacturing processes, including the collection.
    Such a review should normally be conducted annually and should be documented. It may
    include:

    1.2.17.6. review of technical agreements and contracts;

    In addition please see Section 8 of the GPG.

    For any further info- please contract Mike Dawe at MHRA : Michael.Dawe@mhra.gov.uk

    Many thanks.



  2. #2
    Further to Rashmi's post, I've been asked by Mike to post some additional info




    4.7. Control of equipment and materials

    4.7.1. General principles

    4.7.1.1. Documented systems for purchasing equipment and materials should be available. These
    should identify the specific requirements for establishing and reviewing contracts for the
    supply of both equipment and materials.

    In addition please see Section 8, Outsourced Activity Management, of the GPG.

    When a hospital sign the BCR regarding Sections R, sub section ‘is there a Service Level Agreement/Technical Agreement in place to describe the responsibility for these function’?, and S you are signing to say, that to the best of your knowledge, the site is compliant with the above references and therefore access to these agreements is key in ensuring that you are meeting your regulatory requirements.

  3. #3
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    I think there isnít always a full awareness of responsibilities with the Hospital BCR at all levels, from BBM upwards. The BCR guidance notes are also a little ambiguous and should be improved.

    Some sites developed their own technical agreements over the years rather than relying on others within pathology to ensure these were in date, signed by both parties, etc, as this was a sure way to fail having valid documents. Unfortunately this created additional burden to the BBM role.

    The BCR really needs everyone in pathology to work together to ensure compliance is met- this includes contracts staff/ path managers. Perhaps itís time for BBMs to let go of these responsibilities of propping up a poor system. The rest of Path will need to get their act together to meet the regulations.
    Last edited by Rashmi; 1st Oct 2018 at 12:36 AM.

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