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

2008 January

Update on the Blood Compliance Report January 2008

The following information was provided to the MHRA Blood Consultative Committee held in January 2008.

The Blood Compliance Report (BCR) version 3 has not yet been finalised but it is envisaged that this will be completed and on the NHRA website by mid February. Transfusion laboratories are reminded that this must be completed and returned to the MHRA by 30th April 2008. Failure to comply may lead to “for cause” inspection.

The changes to the BCR are based on the successes and challenges faced in reviewing the BCR v 2.

Successes

  • Allowed identification of “high risk” sites
  • All reports assessed within a 3 week time frame
  • Allowed sites to demonstrate robust corrective and preventative actions (CAPA)

Challenges

  • Assessment of the BCRv2 required huge resources (1100 hours)
  • Number of referrals for further consideration for inspection (191 to be reduced to 65)
  • Problems encountered in issuing letters through the automated system

The BCR v3 will include the following changes:

  • The format of questions will be changed to ensure that less free text responses are required
  • Inclusion of some IT specific questions as inspections have shown some areas of significant risk
  • An area for hospitals to identify planned work where an answer to a question may have indicated a non compliance
  • Allow for use of an automated risk assessment process (will not be in use for this years’ reports
  • Tick box to ascertain that laboratories have returned the annual SABRE report verification

The SABRE system/team

  • No significant access or user problems have been reported to the SABRE team
  • Introduction of folders and the search facility seems to have been well received
  • There will be further developments for the SHOT site
  • Dr Clare Taylor will no longer be the expert haemovigilance advisor to the MHRA but will continue in her position as Medical Co-ordinator for SHOT to work closely with the MHRA and will continue to chair the adverse events sub-group.
  • An expert panel to review incidents will be formed and nominations from professional groups will be sought
  • The SABRE team will be expanding with an additional full time post for a person with a clinical background
  • The fees for SABRE registration are likely to increase by approximately £30

SABRE Statistics

Reports - to date

England

Scotland

N. Ireland

Wales

Total

SAR

501

33

11

34

579

SAE

1125

97

63

137

1422

MHRA & SHOT

       

2001

SHOT Only

       

1158

 

Reports - 2007

England

Scotland

N. Ireland

Wales

Total

SAR

242

23

9

22

296

SAE

601

48

35

61

745

MHRA & SHOT

       

1041

SHOT Only

       

426

 

Further statistics are being produced and as these become available they will be made available on the OIG site.

Last year the annual summary reports were distributed for verification and to be returned to the MHRA by March 2007. It was November 2007 before the final reports were returned and this is not considered to be acceptable. This year the summary reports will be sent for verification to hospitals in mid January and these are to be completed and returned by end of March 2007

An EU working group has been established to review the many issues surrounding the variance across the EU in the reporting systems, to address the areas on “what is required to be reported” and to provide guidance to laboratories for both Saes and SARs.

Concern expressed that approximately 20% of registered reporters have not sent in any reports. Some of the non reporters are not low users and a review of these non reporters will be undertaken.

Please get in touch with Chris Robbie or Roy Saunders if you have any issues you would like to discuss with them.