JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

2009 July

The Blood Consultative Committee (BCC) is a forum where the regulator (MHRA) meets with industry representatives (NHSBT, hospital blood bank managers, SHOT, professional groups etc.). I am currently on this group representing the IBMS. The BCC meets twice a year to discuss information on any matters affecting regulation.

  1. SABRE update
    The annual SABRE report from MHRA to the EU commission was submitted on time, but then the commission changed what they wanted so the agency is putting in the extra info required (by September). Reporting through SABRE is up (by about 30%) which the agency considers to be a positive thing.

    MHRA plan to publish some further guidance on Serious Adverse Events which should help sites decide whether a particular incident is categorised as an SAE. This guidance will draw from a recent meeting of EU blood experts where it was decided that SAE did include any event where:
    a) inappropriate blood was issued but not used
    b) there was a loss of autologous donated units or highly matched allogeneic units
    c) there was a loss of a significant quantity of blood components
    d) there were implications across organisations and sites because of shared services and procedures
    e) impacted confidence in the transfusion system

    There still seems to be a number of sites who have not made a single SABRE report in three years. The details were passed to the inspectors who did consider this when deciding who to inspect in the next round.

  2. Serious adverse events in donors
    This is not a legislative requirement (at present), however there is a EU initiative to start collecting the data on a voluntary basis. The representatives of the four blood services at the meeting all agreed that their organisations would collaborate and supply relevant information for this project.

  3. Blood Compliance Report (BCR) Control Site review 2008/09
    Nine sites were selected as control sites, 6 compliant sites where the BCR indicated a robust and fully operational quality management system (QMS) in place and 3 conditionally compliant sites who had indicated some elements missing but had submitted a satisfactory action plan.
    4 of the nine sites were not compliant, while 5 were as compliant as indicated by the information in the BCR. The failures to be as compliant as expected were split into two categories, in one case there had been a deliberate attempt by the site to mislead when completing the compliance report, while for the other three it was felt that the requirements of the report had not been completed accurately because of a lack of understanding of the requirements of good practice.

    The changes to the new BCR this year were a response to the findings of this review as were the MHRA road shows put on earlier this year to improve understanding of good QMS practice.

  4. Hospital Blood Bank (HBB) Regulatory Review meeting
    In light of the control site review above a meeting was called between a number of hospital transfusion specialists to look at ways in which regulatory requirements could be better met and monitored. A number of actions (in italics) were proposed which fell into 4 broad categories:

    a) Guidance on Good Practice / BSQR
    There is still a highly variable knowledge base in the HBBs regarding Good Practice and how to implement within local systems. A number of sites still have significant resource limitations that prevent sites from having their own regulatory professionals.

    - contact EU commission on how development of Good Practice in Transfusion document is coming
    - consider need for further road shows, with preferential places and encouragement for those sites who were not able to attend last time
    - review approaches taken in other EU states
    - put out more specific guidance on the OIG website, including examples of good practice seen during inspections with inspectors encouraging sites that have robust systems to share with others.

    b) Commitment confidence
    Need to ensure both parties have confidence in the process so that HBBs are sure that their commitments put down when accepting that they are not fully compliant will be acceptable as risk mitigation factors and MHRA confident that these commitments will be actioned in a timely manner.
    Where action/inspection is to be taken by the MHRA on the basis of issues highlighted in the BCR they will provide clear reasons for the basis for taking the action.

    c) Engagement
    Recognition that there have been challenges in obtaining an appropriate level of engagement in some HBB staff but particularly with senior management and some clinical staff.
    - share information and explore options for communication from DoH to senior management
    - ensure inclusion of basic BSQR and Good QMS Practice in education programmes for key professionals
    - explore opportunities for engagement with clinicians
    - strengthen and clarify the implications of ‘conditional compliance status, particularly with senior management
    - include in the declarations section a confirmation that sites have highlighted to senior management the key issues where non compliances exist, with proposed remedial actions, plus confirmation that senior management have acknowledged these issues and will support the proposed actions.

    d) Sanctions
    Recognised that apart from the rather ‘nuclear’ option of cease and desist that there are few incentives to push compliance or commitments for reluctant sites.
    - clarify to CEOs and Lab managers that non compliance with commitments would significantly increase the likelihood of inspection
    - share information with other regulatory agencies
    - evaluate options for immediate sanctions e.g. improvement notices

  5. 2008/09 Inspections update:
    A summary of results from MHRA inspections from year 3 was given and this is provided in a separate report.

  6. Guidance on Blood Banks and Facilities
    The MHRA will be putting guidance on their website (in the near future) for those sites where transfusion occurs but they do not have any testing facilities. If such sites (known as ‘facilities’) perform any of the following three key tasks then they will be required to fill out a BCR next year. The guidance explains which sections of the BCR are relevant under which circumstances and there will be no charge for assessing these reports. If a service level agreement with a supplying HBB is in place which specifies that all these functions are the responsibility of the HBB then the facility will not need to complete a BCR.
    Key tasks:

    1. Control of monitoring, maintenance and calibration of any temperature controlled storage equipment on site
    2. Reporting of serious adverse events and reactions to SABRE
    3. Maintenance of traceability reports
  7. Consultation on guidance on electronic issue
    The MHRA will be placing on their website at the beginning of August a consultation document of draft guidance on electronic issue. The consultation period will last for three months after which responses will be analysed and discussed before a final guidance document appears. I would advise all transfusion staff read this document and take the opportunity to respond as they feel appropriate as inspectors will inevitably follow the final advice when issued.

  8. Pandemic flu
    A brief discussion on the plans being developed in response to the flu pandemic. The MHRA recognises the need for some flexibility regarding normal working practice during extraordinary times (such as major system crisis brought on by flu pandemic) however, changes to legislation take a long time to bring in (too long to be of use in the current pandemic wave) and the MHRA are actively looking at ways of accommodating requests for flexibility in this area, whilst retaining appropriate controls, in order to maintain the continuity of supply of components.. Any actions proposed by a flu plan were (whenever possible) risk assessed and subject to change control and validation as part of the planning. The agency would be prepared to offer advice to any site which was unsure whether a proposed action would be acceptable under BSQR.

  9. EU initiatives
    The EUBIS project continues with a proposed good practice guide for blood establishments to be presented in draft by end of year. There is no current proposal to extend this to hospital blood banks but funding is being applied for to try and extend the project to HBBs at a later date.

  10. Good Practice Guidance
    The Competent Authority (MHRA) is expecting to be in receipt, in the next 2 weeks, of the document on Good Practice Guidance. It is envisaged this will be related to the GMP guidance.

Report prepared by Chris Elliott
July 2009