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

2010 October

The Blood Consultative Committee (BCC) is a forum where the regulator (MHRA) meets with industry representatives (Blood Services, Hospital Transfusion Laboratories, SHOT, Professional groups etc.).

  1. SABRE 2009 update

    Reporting so far this year shows little significant deviation from previous year. The UK report on incidents was collated and verified with SHOT data for SARs but as SAEs have a different criteria for reporting these were not completely reconciled. There are 19 registered reporters who have not yet submitted any haemovigilance report to either MHRA or SHOT but these are all small independent organisations. The data was submitted to the EU on time. The MHRA noted that there had been an improvement this year on submission of the annual summaries by hospitals with significantly fewer sites needing to be reminded.

    Updated guidance is being prepared, currently with the lawyers, and this will be placed on their website once completed. hopefully in the next couple of months. The MHRA SABRE team will put on some road shows to support the implementation of guidance (good reporting practice will also be covered in these road shows).

    The MHRA haemovigilance team are available for advice on reporting systems and problems and are willing to provide presentations to regional groups.

    A Haemovigilance expert panel has been set up with representation from a number of professional bodies to assist the MHRA with the analysis of SABRE reports that need expert knowledge to assess the report.

  2. Requirement to complete a Blood Compliance Report (BCR) for those sites covered by a blood establishment license.

    The MHRA confirmed that those sites undertaking laboratory testing and/or hospital blood bank activities where the site is registered as a blood establishment would not need to complete a BCR next year. However, in situations where there are multiple sites within a single organisation with only one of the sites registered as a blood establishment a BCR would need to be completed by the sites not covered by the blood establishment license.

  3. 2009/10 Control site review

    Eight sites were subject to a control inspection (that is where the site had been awarded full or conditional compliance based on their BCR but the inspection was undertaken as part of the validation of the overall reporting process), a ninth site could not be inspected during the period due to MHRA operational issues (it was inspected in this recent cycle).

    Most of the sites were found to be as expected, although one site that had been awarded compliance was found to have non compliances that turned into a critical which resulted in that site (their decision) changing into a facility only site. During the discussion the existence of various types of letter arose. A type one letter is issued in cases where the inspectorate have made an assessment that while there are non compliances they expect the proposed site actions will be sufficient to remedy the issues.
    A type two letter is where the inspectorate have not referred the site to the Inspection Action Group but still have concerns and would re-inspect the site in the near future to be assured that non compliance was being rectified.

    Type three and four letters deal with situations where regulatory action is being instigated.

  4. 2009/10 Blood Compliance Report review and outcomes

    a) The new BCR v 5 (spreadsheet) was reviewed, the inspectorate found that on the whole its implementation had been successful. Only a few sites had problems opening the file and completing it. The spreadsheet had allowed the MHRA to complete the assessment within a much shorter period. It provided risk scores that helped identify potential candidates for inspection and by controlling responses it allowed a greater consistency in assigning risk scores.

    b) One organisation had rather ambitiously ‘cracked’ the spreadsheet password protected environment leaving the BCR formulae open to unauthorised alterations. The MHRA were concerned and have identified that organisation for inspection because they cannot rely on the responses given. In order to prevent a re-occurrence of this next year, no formulae will be embedded in the BCR and a data extraction tool will be used to place submitted data in an analysis sheet held by the MHRA.

    c) The next BCR will not be substantially different from the last one although questions relating to the control of electronic issue will be included.

    d) 359 Hospital Blood Bank BCRs were received, of which 72 sites were selected ‘for cause’ inspection and there were 172 conditional compliance letters issued. There will be 9 control inspections with these sites, typically being given 2-4 weeks notice.

    e) 58 Facility compliance reports were received, 27 conditional compliance letters were issued. Three facilities were selected ‘for cause’ inspections and those hospital blood banks supplying these facilities are also on the inspection list with the same inspector to perform both inspections so that an end to end assessment of the supply chain can be made.

    f) With regard to risk scores generated by the automatic BCR system a high score did not necessarily mean inspection. Sites with a high score who had recently been inspected would be given ‘regulatory relief’ to enable them to implement action plans. Sites within a single organisation would have only one site inspected. Low scores may still be inspected as other factors are taken into consideration such as:

    • SABRE reports
    • Additional information
    • Relocation of laboratory
    • Upgrade its LIMS or merger of LIMS between sites
    Late returns will also incur penalty scores.

     

  5. Inspections update:

    72 sites were selected for inspection during 2009/10 with a further 9 further sites selected as controls. Deficiency data is now being collated by inspectors for Critical and Major deficiencies raised and placed in a database. This data informs which types of deficiencies are most prevalent in any given period.

    The top ten causes for Hospital blood bank non compliance are (percentages are approximate):

    1. Investigation of anomalies (14%)
    2. CAPA (8.5%)
    3. Change Control (8.5%)
    4. Complaints and product recall (8%)
    5. Equipment validation (7%)
    6. Quality Management System (6%)
    7. SABRE reporting (4.5%)
    8. Traceability (4%)
    9. Document control (4%)
    10. Training (3.5%)


    A presentation on the top ten causes for non compliance can be accessed here. Caution should be used in interpreting some of the reasons for non compliance as they are meant as general indicative reasons rather than establishing MHRA position on any particular area.

  6. BSQR effect on clinical areas

    A report on how differences between various agencies (MHRA, NPSA and QIS) mean that competency checking for clinical staff is difficult to achieve for all organisations. MHRA position remains that organisations should determine the terms of training and competency checking but must be prepared to justify what they are doing and have the evidence to show that it minimises risk.

  7. Regulatory update

    a) The EU is still to publish draft good practice guidance, covering both tissue and blood establishments. Those areas appropriate to hospital labs will apply to them.

    b) The Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 came into force in April 2010 requiring healthcare organisations to register various activities and meet certain legal requirements to be enforced by the CQC. Two of the activities included are ‘Diagnostic and screening procedures’ and ‘Management of supply of blood and blood derived products etc’, this overlaps with the BSQR. The MHRA have just started talking to the CQC as to what this means for the regulation of hospital blood banks and blood establishments.