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BSBMT Transplant Accreditation Committee


New – JACIE Centre Preparation Training Courses June 2008. We are pleased to announce that we are now taking pre-registrations for the first JACIE Centre Preparation Training Course of 2008.

Date: 23rd & 24th June 2008
Title: JACIE Centre Preparation Training Course
Location: Athens, Greece (To be confirmed)
Fee: Approx. €900 (To be confirmed)

If you are interested please return the registration form (below) to Eoin James Mac Hale at jacie@ebmt.org or by fax to: +34 93 453 1263. There are a limited number of places available on this course. Therefore, interested candidates should respond by Monday, 15th February 2008

Pdf   Download Registration Form

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

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.

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.

2007 JACIE Update

7 clinical transplant programmes have been accredited in the UK to date. Additionally three standalone processing laboratories and one standalone HPC collection facility have achieved full JACIE accreditation.

Nottingham City Hospital
Yorkshire Blood & Marrow Transplant Centre, Leeds
SCI NBS Leeds
Heartlands Hospital, Birmingham
SCI NBS Birmingham
Bristol BMT Programme
SCI NBS Bristol
Sheffield Children’s Hospital
Royal Hallamshire Hospital, Sheffield
NBS Sheffield
John Radcliffe Hospital, Oxford

This year will see inspections of at least three new programmes and the first instance of non-UK inspectors taking part in an inspection of a UK transplant programme. The inspection team will be led by Sally Kinsey but the collection and processing inspectors will be colleagues from Germany. This has always been the intention of JACIE inspections and it is good to see us taking advantage of the excellent English language skills of so many of our European colleagues. The new JACIE / FACT standards (3rd Edition) have now been published and inspections are already taking place against these standards where the new standard is lower than previously. Full implementation of the 3rd edition will occur as of 19th August. This edition now completely harmonises JACIE and FACT terminology. Diana Samson has undertaken a very comprehensive comparison of the JACIE/FACT standards with the EU Tissues & Cells Directives and this “walk-through” is available on the JACIE website which is linked to this page.

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. This summer will see the first co-incident inspection by JACIE and HTA of a single centre. 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 has, this year, been 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 in preparation by Kathryn Aldous and Nina Som and it will be posted on the website in early autumn 2007.