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Thread: Blood Compliance Reports 2019

  1. #1
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    Blood Compliance Reports 2019

    The compliance report and declaration forms for Hospital Blood Banks and Blood Facilities (01st April 2018 to 31st March 2019) are now available on the MHRA website as below and must be completed and submitted by 30th April 2019.

    https://www.gov.uk/guidance/blood-authorisations-and-safety-reporting

    Please note that late submissions increase the risk score applied to the site.

    Changes have been made to the submission process for 2019 BCR and Blood Facility Declaration Form to have separate mailboxes. Please read below.

    For hospital blood banks, it is a requirement to complete the compliance report and the declaration form. A change in approach to blood compliance report assessment was introduced during 2015 which saw a removal of the majority of questions requiring free-text responses. You will note that some sections are not available or some question numbers do not appear to be in order in some sections. Please ensure all the available questions on the BCR are answered and submit your completed BCR as outlined in the 2019 Hospital Blood Bank Compliance Report Guidance Notes. The guidance notes have been revised to include detailed instructions and clarification to some of the questions. Please read the guidance note prior to completing the BCR.
    Hospital blood banks should submit their completed BCR and Hospital Blood Bank Declaration Form to bcr@mhra.gov.uk with email subject heading ‘Full Hospital Name – BCR 2019’.
    (Please ensure the email includes 1 BCR and the declaration form for that hospital name, with additional information related to the blood bank ONLY. Do not send multiple BCR and declaration forms within the same trust in one email)

    For blood facilities, the blood facility declaration form must be completed and sent to the MHRA at a separate mailbox BCRBF@mhra.gov.uk with email subject heading ‘Full facility name – DEC 2019’.
    (Please ensure the email only includes 1 Blood Facility Declaration Form for that facility name. The Declaration Form should be signed and dated, and submitted after 01 April. This is to confirm the reporting year of 01st April 2018 to 31st March 2019 is covered. Any declaration form submitted before 01 April will be deleted, resulting in no submission.)

    Following the BCR assessment, Hospital Blood Banks will be provided with a BCR Assessment Confirmation Letter to confirm that assessment has been completed, without indicating the outcome (i.e. inspection or no inspection). The level of compliance determined will be used to inform the inspection programme for 2019/2020. The Hospital Blood Banks selected for inspection will be contacted by the inspectors to arrange a date. All inspections will be performed with a maximum of 7 days’ notice.

    A compliance letter, confirming the operations are accepted as in general compliance with the requirements of the BLOOD SAFETY AND QUALITY REGULATIONS 2005/50 as amended, will be sent to the “no inspection” sites in April 2020.

  2. #2
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    Hello
    Just seeking some clarification relating to the requirement to complete the Facility Declaration form. Given that only 111 out of 808 for last year were completed suggests we are not alone.
    Our Trust supplies a number of other organisations with blood components etc, so classed as a facility, but conversely we have within our SLA that we control the monitoring of the temp controlled storage device, do their SABREs and also maintain records of transfusion. Do our "facilities" therefore need to complete a form? If so does the form need to be completed and directly sent by them or do we pursue with them?
    Could the questions in Section R be worded in such a way that if yes is answered to any of the questions, then a prompt appears to complete the facilities form.
    Thanks in advance.

  3. #3
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    This is a good question that I would like to know more on.
    From our SLA with these locations I have always had this in place

    • "Site A" will pay the agreed fee to "Hospital" for carrying out key tasks (as above in "Hospital" responsibilities) which will exempt "Site A" Hospice from being classified by the MHRA as a Blood Facility



    “HOSPITAL” responsibilities:


    • “HOSPITAL” will ensure that "Site A" is provided with a copy of the current Trust Transfusion Policy (XXXX) and that "Site A" will be informed in a timely manner of any changes to blood transfusion practice
    • “HOSPITAL” will report all serious adverse reactions and events to the Serious Adverse Blood Reactions and Events (SABRE) scheme on behalf of "Site A"
    • All cold chain and traceability records will be maintained by “HOSPITAL”
    • “HOSPITAL” will temperature map all blood transport containers once per annum
    • “HOSPITAL” will complete the annual Blood Compliance Report (BCR) for submission to the MHRA on behalf of "Site A"



    Regards

  4. #4
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    Hi All,
    I have to confess that I was somewhat confused by this too. However, if you look at this as a 'quality improvement' activity then it makes sense in that responsibilities for compliance is shared with the SLA sites and relies on timely communication etc .Its all very well having SLAs in place but does anyone actually remember or understand their part? I think its a good move for sites to submit a declaration and I have asked mine to copy me in when they finally return their forms, not sure if this is the correct approach, but we are all learning. One of my sites had enthusiastically completed their declaration last week and were a little disappointed when it was mentioned the declaration had to be dated and sent in April as per the guidance notes- you have to smile! but at least they are trying.
    I'm sure an email to Mike.Dawe@mhra.gov.uk would help clarify further.
    bw
    Last edited by Rashmi; 19th Mar 2019 at 11:44 PM.

  5. #5
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    Dear All
    Hopefully the Q&A below will be helpful in answering your queries.

    The MHRA have recently contacted blood facilities to request the completion of a Blood Facility Declaration form; this should be filled in after 01 April and sent to the MHRA by 30 April 2019. Feedback from hospital blood banks and facilities has alerted us to some confusion over the definition of a blood facility and highlighted some issues with the Facility Declaration Form. To this end we have corrected and clarified the form and provided some clarity on the responsibilities of the blood facility.

    The corrected form is available here.

    What is a facility?

    A ward in a hospital (note this does not mean a ward in the same hospital as the HBB), hospice or care home etc which receives blood from a Hospital Blood Bank for transfusion purposes (but does not perform compatibility tests on site) is defined as a ‘Facility’.

    Am I still considered a facility if I don’t store blood and
    receive fully cross-matched units for named patients on day/time of transfusion only?

    Yes.
    Regulations 12A and 12B of the Blood Safety and Quality Regulations 2005 (as amended) (BSQRs) for blood facilities concern the requirements to retain certain data, for not less than 30 years, to ensure full traceability of blood and blood components and to report serious adverse reactions and events. These requirements are in place regardless of whether blood is stored. Where there is storage there are, of course, additional requirements in terms of monitoring, maintenance and calibration of any controlled temperature storage equipment.

    Do I need to fill in the Blood Facility Declaration form if I have a Service Level Agreement (SLA) in place with the Hospital Blood Bank that states that they will maintain traceability records and report serious adverse reactions and events to SABRE?

    Yes, all facilities must fill in a Blood Facility Declaration form and send it to the MHRA.
    Where a facility has made arrangements for a Hospital Blood Bank to maintain traceability and submit SABRE reports on their behalf this should be evidenced by a written agreement. The SLA may also cover monitoring, maintenance and calibration of fridges used for blood storage. SLAs do not need to be submitted to the MHRA. The blood facility is still subject to the requirements of the BSQRs in that they must provide the appropriate data for retention and supply the information necessary to allow SABRE reporting within the regulated timescale. The blood facility is also still responsible for maintaining the integrity of the blood components by the proper use of controlled temperature storage equipment including transport boxes. The facility should ensure that it operates in compliance with the BSQRs and has a quality system based on the principles of good practice. This is necessary to confirm that personnel, premises, documentation and quality management including non-conformances support their ability to meet compliance requirements.

    What is the purpose of the Blood Facility Declaration form?

    It demonstrates that you are aware of the requirements of the BSQRs and your responsibilities as a facility.
    Under regulation 15 (6) of the BSQRs, the person responsible for the management of a facility can be served notice to supply information concerning the compliance of the facility. The declaration form is a vehicle to request this information. The form has now been corrected to ensure that it clearly signals that key individuals at the facility have read and understood the BSQRs, have ensured that arrangements have been made for the provision of their responsibilities under regulations 12A and 12B and have a quality system in place that will facilitate compliance with the regulations.

    Who should sign the Blood Facility Declaration form?

    The declaration form should be signed by the person completing the form and the "person responsible for management of a facility", as defined by Regulation 1 of the BSQRs. Where the provision of services is outsourced to a third party (e.g. private company or other legal entity such as a pathology partnership), the Chief Executive of the outsourced service provider should also sign. The form does not need to be signed by the supplying Hospital Blood Bank.
    Please note the form must be signed and scanned not merely typed with the name of the person responsible for management of a facility.

    What happens if I have already signed the
    Blood Facility Declaration form?

    If this is the case there is no need to re-sign the corrected version of the form, please just submit the version you already have.
    Last edited by Graham-Carroll; 1st Apr 2019 at 04:49 PM.

  6. #6
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    Many thanks for the above

  7. #7
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    To clarify - we only need one declaration form from each facility. If your facility receives blood from more than one blood bank, a form for each is not necessary. The declaration covers the responsibilities of the facility in terms of requirements of the BSQRs. Specific arrangements between blood banks and facilities should be covered in agreements between the two parties.

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