§ Ms Blears
The serious hazards of transfusion (SHOT) reports provide a comprehensive picture of serious transfusion complications in the UK. The fifth annual SHOT report (published April 2002) showed an increase in participation to 92 per cent. of eligible hospitals. Participation in the scheme has been encouraged by guidance to the National Health Service, most recently in HSC 2002/009—("Better Blood Transfusion—Appropriate use of blood") http://www.doh.gov.uk/bbt2/009hsc2002). This asks Chief Executives of National Health Service trusts to ensure participation in the SHOT scheme by December 2002.
SHOT is currently collaborating with the new National Patient Safety Agency (NPSA) whose core function is to improve the safety of NHS patient care by promoting a culture of reporting and learning from adverse incidents and professional errors without fear of personal reprimand. The NPSA reporting system will be implemented across the NHS from 2003 and will cover of all types adverse incidents and "near misses" affecting NHS patients, including those associated with transfusions.810W
The draft European Commission Directive on standards of quality and safety of human blood and blood components requires Member States to report "any serious adverse events (accidents and errors) related to the collection, testing, processing, storage and distribution of blood and blood components which may have an influence on their quality and safety, as well as any serious adverse reactions observed during or after transfusion which may be attributed to the quality and the safety of blood and blood components".
§ Ms Blears
The Government's advisory committee on the microbiological safety of blood and tissue for transplantation is continuing to consider the relative efficacy and risks of the different types of fresh frozen plasma (FFP) available.
United Kingdom FFP is already a very safe product. To minimise the risk from viruses, it is made only from previously tested blood donors. Since the year 2000, an additional test for hepatitis C has been added. As a result the risk from a unit of FFP is estimated to be one in five million for HIV and lower than one in one million for hepatitis C. Over 300,000 units of FFP are issued annually and it is only given in life-threatening situations to prevent or stop haemorrhage associated with abnormal blood clotting.
The National Blood Service is conducting an option appraisal of means to minimise the risk of transfusion-related acute lung injury from FFP.
§ Ms Blears
The Government has received correspondence from Octapharma Ltd supporting the increased use of their product "Octaplas". Department officials have also met Octapharma and further discussions are planned.
"Octaplas" is licensed in the United Kingdom and can be purchased by National Health Service trusts. It is made by pooling plasma from donors but is treated with solvent detergent to reduce the increased risk of viruses caused by pooling. There would also appear to be a reduced risk of transfusion-related acute lung injury (TRALI) with this product. We understand that it is not yet made exclusively from United States plasma but soon will be.
United Kingdom sourced fresh frozen plasma (FFP) is also available from the National Blood Service and is more commonly used by the NHS than Octaplas. It is made from single donations from donors who have been previously tested for viruses to minimise the risk of infection. Like all blood for transfusion, FFP is also leucodepleted to reduce the theoretical risk from vCJD.
As an added precaution against the theoretical risk of vCJD, the Government announced on 15 August that FFP for young children and babies will be imported from the United States. This FFP will be treated with methylene blue to reduce the risk of viral transmission 811W still further for this most vulnerable group. This decision was made following advice from the advisory committee on microbiological safety of blood and tissues for transplantation (MSBT) who are continuing to review the safety of FFP.