The scope of the Transplant Accreditation Committee (TAC) is:

• To ensure that BSBMT members are fully conversant with the requirements for JACIE accreditation
• To ensure that enough laboratory, clinical and collection facility inspectors are trained
• To organise inspection/accreditation visits for applicants within the UK (in conjunction with the JACIE office in Barcelona)

BSBMT JACIE inspectors will review material submitted prior to accreditation visits and advise BSBMT centres as appropriate. Following inspection the inspectors provide detailed reports for the JACIE office in Barcelona. These are then reviewed by the JACIE Medical Director, Dr. Diana Samson, and a final report to the applicant centre is made. The final decision on accreditation rests with the JACIE Board. In order to achieve these objectives the TAC meets regularly, organises training courses and liaises with the JACIE office and BSBMT centres.

Members of the BSBMT TAC Committee

• Kathryn Aldous
• Jane Apperley
• Jenny Byrne
• Mark Cook
• Jackie Cornish
• Charles Craddock
• Rafael Duarte
• Ian Franklin
• Mark Lowdell
• Don Milligan
• Derwood Pamphilon
• Kim Orchard
• Sarah Raymond
• Nigel Russell
• Diana Samson
• Mike Scott
• Nina Som
• Jeremy Whelan

UK JACIE Inspectors

There are currently 31 inspectors trained to cover clinical transplantation (adult and paediatric), collection facilities and stem cell processing for laboratories.

How do I apply for inspection and accreditation?

Contact Eoin McGrath.

Detailed information is available via the EBMT website. Click on JACIE documentation. This page contains copies of the JACIE Standards – second edition (January 2005), the JACIE accreditation manual, initial registration form and guidelines pack for inspectors. This should supply all the information that you will need.

Current JACIE Accredited Centres

A regularly updated list of the UK centres who currently have JACIE Accreditation can be found at:

ttp://www.jacie.org/portal/en/public/accreditedFacilities

2007 Human Tissue Authority update

The relationship between BSBMT and HTA continues to be cordial and beneficial to both. In response to our suggestion that HTA accreditation inspections of HPC collection and processing facilities would benefit from the inclusion of professionals from the HPC transplant community the HTA established “accredited assessor” training days and now has a group of experienced professionals from the tissue banking and HPC fields who are available to assist the inspection process. A number of HPC transplant programmes have now been inspected by the HTA and a BSBMT member has accompanied each inspection. BSBMT representatives continue to work with the HTA providing advice on implementation of the directives, particularly with regard to the import/export requirements.

Regulatory status of Donor Leukocyte Infusions:

Many of you will be aware of the controversy surrounding the regulation of DLI in the UK towards the end of 2005 when it was proposed by the MHRA that such preparations should be regulated under the Blood Quality & Safety directive rather that the Tissues & Cells Directive. This would have required HPC collection and processing facilities obtaining parallel licenses from both MHRA and HTA and the standards to be met would be different. After intensive lobbying by BSBMT (including a question in the House of Lords) it was decided by the DH that DLI should be regulated by the HTA under the T & C Directive. JACIE and EBMT made additional representation to the EU and the appropriate authorities in each MS have now been informed to harmonise the regulation of DLI under the T & C Directives.

TAC continues to provide help and advice to programmes preparing for JACIE accreditation and is instrumental in assisting those facing HTA inspection. The Quality Managers’ group is the most active in this area providing a fabulous resource to anyone who joins the e-mailing list. This is an excellent example of selfless assistance between groups where documentation and advice is freely exchanged. A “JACIE Accreditation” pack is also available on request.