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

2008 July

Update from the MHRA Blood Consultative Committee - July 2008

Blood supplied from UK dependencies.

After consideration the MHRA have advised that it is not appropriate for components supplied with a patient from outside the UK e.g. Jersey, Isle of Man etc. to be placed into stock, although the blood may be transfused to the named patient in order to ensure continuity of care.

SABRE

  1. Of the 308 annual reports eight arrived after the closing date. Of these eight late arrivals four were determined to have no adequate excuse and this information has been passed to the inspectorate colleagues.
  2. It should be noted that the time span for the SABRE annual report and the figures required by the BCR cover different dates
  3. Local IT issues seem to be less
  4. There are incidences where addresses and emails of SABRE accounts are no longer active
  5. Emails appear in some instances to be ignored or not monitored
  6. The report to the EU commission has been sent and the data supplied has been reconciled with the SHOT data
  7. Guidance is being prepared by the EU working group on what should be reported but there are several; issues which remain without common agreement

Review of blood compliance reports

  • 390 reports
  • 194 sites referred for further assessment
  • 64 sites identified as “high risk” and will be inspected “for cause”. 20 of these are re-inspections of sites previously inspected in the last 2 years.
  • There will be 9 control inspections to verify the BCR
  • Change in format of the letters
  • Some sites will receive a letter which refers to “conditional compliance” and asks that the sites meets the necessary corrective actions in their action plan and this will be reviewed to ensure the actions are completed
  • Slots have been identified to allow for inspections to be undertaken as a result of SABRE reports if required

The following changes need to be notified:

  • Any change which may impact on the HBB compliance status must be notified to the GMP inspection division. These changes may be implemented without formal approval from MHRA, provided that the change does not in itself require an application for a Blood Establishment Authorisation.
  • Any changes which occur in a BE in relation to personnel or activities these changes should be sent to the licensing office as formal variation. The proposed changes should not be implemented until approval has been received.
  • Changes in the blood transfusion laboratory manager should be notified to the GMP inspection division

The following questions were raised:

  • What do the MHRA expect to achieve in collecting staffing numbers?
  • There should be credible evidence re “sufficient” staffing numbers but currently this is difficult to interpret. Information on staff numbers may be used to further aid investigation if other areas of the Quality System appear to be weak.
     
  • The issue of raising awareness in Trusts and the MHRA were asked if it would be possible to copy the CE into the letters sent to hospital blood bank managers in response to their BCR?
  • This would be difficult to undertake this year as the database does not include the name of the CE but they will include in the letter a request that the BBM ensure a copy is sent to the CE
     
  • Is there a requirement for annual competency assessments for staff collecting blood components from the fridge?
  • Assessments should be undertaken in a manner that are commensurate with the level of risk associated with the process but should not exceed two yearly.
     
  • IT Legacy systems. When changing provider how much data needs to be visible in the new system?
  • The previous transfusion history is a useful safety check and the inspectors would expect it to be available so the laboratory is able to respond immediately to historical data. With regards to clinical information e.g. requirement for irradiated components this is desirable but from a regulatory aspect it would be impossible to say essential. It should be noted that EU GMP Annex 11 (Computerised systems) clearly says new system should not detract from the current system.
     
  • Concern was expressed by the NHSBT Quality Manager in relation to some motorcycle carriers collecting blood components and their lack of understanding of GMP principles. The NHSBT will, if they have concerns over the courier, discuss this with the hospital concerned but if requested to continue they will hand over the components but lodge this as a SAE through SABRE.
     
  • Does the MHRA feel that the requirement for a Transfusion Practitioner is necessary?
  • It is not a Regulatory requirement for hospitals to have a TP, however the DH Better Blood Transfusion HSC 2007/001 does require hospitals to have a transfusion practitioner and highlights the importance of this role as a member of the Hospital Transfusion Team. It is noted that in organisations where there is a TP in post, the organisation of training and competency assessment for staff collecting blood is well developed..

Update on legislation

SI 2008/525 Fee amendments

SI 2008/941 Minor errors in BSQR e.g. record retention should read 15 years

Good Practice Update

In progress but currently not appearing to be a document that hospitals will find "easy to use"

Common deficiencies presented by Steve Grayson

Download the presentation.

Other issues

IT Legacy Systems