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

2007 April

Operational Impact Group − Update Report

The NHS Operational Impact Group met for what was its last face to face meeting. It has been agreed by the group and the DH that the terms of reference have been met. The OIG will continue as a virtual network and myself ( and members of the group can be contacted regarding clarification issues. The OIG toolkit will continue to be posted on the JPAC website and additional information will be provided as and when received.


Adverse Events sub-group

A sub committee has been set up under the auspices of the Blood Consultative Committee, chaired by the MHRA "Clinical Transfusion expert" Dr. Clare Taylor. Membership of this group comprises MHRA, SHOT, HPA, Blood Service Quality representative, Transfusion Practitioner, Transfusion Lab Manager, 4 UK Countries, the Blood Services and professional groups. This group will review any detailed operational issues relating to SABRE. It will also discuss any technical points related to the reporting of serious adverse reactions and events and will be the primary focus for discussions between the MHRA and SHOT.

MHRA Compliance Form 2007

The 2007 compliance form is available from the MHRA website. The form is to be completed and returned to the MHRA by the end of April 2007. These will then be reviewed by the Inspectorate division and those hospital blood banks deemed "non compliant" will be informed regarding an inspection. The compliance form can be completed and returned online or downloaded, completed and returned by snail mail.

Clarification Issues

Several issues have been raised with transfusion managers have raised questions they require some clarification on. These are listed below with clarification provided by the MHRA

  1. Training: It appears that concerns have been raised by some hospitals what is required under the regulations regarding training records. The following response was received and perceived as useful to share with everyone.

    Hospital blood bank requirements

    (1) The person responsible for the management of a hospital blood bank shall ensure that personnel directly involved in the testing, storage and distribution of human blood and blood components for the hospital blood bank are qualified to perform those tasks and are provided with timely, relevant and regularly updated training;

    In terms of how this can be achieved MHRA would ideally expect a training record to include the following information:

    - a brief CV
    - job description
    - records of induction training (less of an issue for staff in post for many years)
    - records of regular refresher GMP training (typically done annually)
    - records of staff awareness of specific regulations (a signed/dated attendance sheet would suffice with a  presentation/training material available for review if requested)
    - records of technical training specific to the role demonstrating competency (if appropriate to the role)
    - records of training in SOPs (although these can often be attached to the SOP rather than in the training file - where this is the case it can be helpful for a matrix to be held in the individual's training record showing which SOPs are relevant to the role and which he/she has been trained against)
    - copies of relevant professional qualifications/exams taken

    The legislation talks about staff being "qualified", however "competency" is frequently accepted to have a similar meaning in this context. It is generally regarded as being insufficient for staff performing technically complex activities to simply sign a procedure to confirm they know what they are doing. Competency based records should include evidence of the individual having demonstrated competence in complex (but not every) tasks e.g. if performing a manual blood grouping operation the records should provide evidence that the individual performed however many blood groupings under supervision before being signed off as being competent. Common sense should prevail - It would not necessarily be expected to see full competency records for staff who have been performing manual blood grouping for the past 25 years, although some means of continued assessment/professional development would be appropriate in such circumstances.

  2. User requirement specification for document control systems
    The question raised was where information could be found to help with writing the specifications, prior to purchase, for document control systems. The information received in answer to this question may be useful to others wishing to purchase this sort of system. Guidance on documentation control systems (general requirements) can be found in the Orange Guide and also in the Annex to Directive 2005/63.

    Documentation should be written, approved and distributed in a controlled manner which prevents the use of unauthorised documents. The system should not allow the uncontrolled amendment of approved documents. There should also be a system to enable the secure retention of superseded documents.

    Depending on the proposed functions of the documentation control system, its specifications will differ. However, the principles as listed in the Orange Guide and 2005/63 should be complied with.