Items 2-6 were agreed. The constitution to be revised to include representation from the following groups:

• BSBMT
• Scientists/Laboratory Directors
• JACIE
• UK BM Registries
• Quality
• Nursing
• Paediatrics
• Cancer Networks
• EBMT

AM talked to a presentaton on the roles and responsibilities of the HTA. The authority came into being on 1 April 2005 and is in its early days of operation. There are 17 authority members, 9 of whom are lay members, including one transplant surgeon (but no HSC representative).

Its responsibilities under the Human Tissue Act (HTAct) cover the removal, storage and use of human tissue. The HTA will be responsible for licensing of anatomical examination, post mortem examination and storage of tissue, donation and storage of anatomical specimens, public display and the approval of live transplantation from organ and tissue donors. All its corporate support functions have been outsourced to other and the Authority has yet to decide if it commissions inspection from another body or bodies.

The implementation of the HTA's Code of Practice on transplantation of solid organs and tissue are currently being discussed by a Transplantation Working Group (TWG) of which DP is a member. In addition to the TWG, an HTA working group is looking at issues relating to import and export of organs, tissues and cells. It was felt that additional representation from the BMT community on the TWG or a separate group to discuss HSC issues was desirable. During a lengthy and informative discussion it emerged that there were 3 areas where close collaboration and discussion between the HTA and BMT community was essential:

1. Revision of Code 2 to include a subsection on HSC donation.
2. The import and export of stem cells - an HTA responsibility under the HTAct and EU Directive on Tissues and Cells (EUDTC).
3. Inspection and licensing of HSC collection and processing facilities. The HTAct will be implemented after April 2006. The EUDTC will be implemented on 7th April 2006. The Technical Directives for the EUDTC will be implemented in April 2007.

It was agreed that further discussions are required between the HTA and key representatives of the HSC community.

With regard to implementation of the EUDTC the HTA is conducting 2 workshops in November/December 2005 to design the necessary process and documentation, pilot sites will be tested in January 2006, applications for licensing will be invited in February 2006 and licenses issues in March/April 2006. The licenses will be initially issued after completion of a self-assessment form. The forms will be straightforward for facilities with existing MHRA and/or JACIE accreditation.

There are currently 21 members, of whom around 10 attend regular, bimonthly meetings. Terms of reference are agreed. A QM training course will be held in April/May 2005. SOP templates, indexes and QM plans will soon be available on a website linked to the BSBMT website. View The Quality Forum report.

The programmes at Bristol, Birmingham Heartlands and Nottingham are accredited. Leeds and Oxford programmes have met the JACIE standard except for EFI accreditation which is pending. The NBS Collection Centre and processing facilities at Leeds have obtained stand alone accreditation. The NBS collection and processing facilities at Bristol and Birmingham are in the process of applying for stand alone accreditation. Inspections have recently been completed at Cambridge and Sheffield (Children's Hospital and NBS). Further inspections in 2006 will include Hammersmith Hospital, London, Queen Elizabeth Hospital, Birmingham, Warwick and Coventry.

This will be held on 15th February 2006 [view programme].

This was circulated with the agenda and is appended to these minutes. DS discussed the issues raised in this including the inspection process, new FACT standards to be available on their website for consultation in January 2006 and the EUDTC.

Currently up-to-date. The minutes of this meeting, DS's JACIE report and programme for the Symposium on 15th February 2006 will also be posted.

The Committee reviewed the UK and European survey data. No further action to be taken.

This was discussed under Quality Forum.

It will be essential for the TAC to know exactly how many clinical, collection (BM and PB) and processing facilities require accreditation and licensing. Under the EUDTC facilities for collection and processing will need to register and apply for a licence. This also applies to NHS and private collection facilities for BM including BM from BM Donor Registries.

Several instances have been documented where HSC are either imported or transported from one centre to another in the UK have suffered loss of stem cell viability or red cell damage leading to difficulties in processing. Clearer guidance and standards are required, including an adverse events reporting scheme. This should be discussed with WMDA.

All outstanding actions have been closed, except:

11(i). Whether DLI and other cells for immune therapy are included in the Tissue and Cells Directive - this is not explicitly stated. It is also conceiveable that they may be covered by the Directive 2002/98/EED - "Setting the standards of quality and safety for the collection, testing, processing, storing and distribution of human blood and blood components". It was agreed that clarity was required urgently from the Department of Health and EU.

One hour meeting with HTA to be arranged for 15th February 2006 after the Symposium.

The next full BSBMT TAC meeting is on Friday 19^th May 2006 from 10am - 1pm at The Novartis Foundation.