These were accepted.

All important actions were completed. It was agreed to update the list of members of the TAC on the Terms of Reference and also the frequency of meetings to twice yearly.

The group meets bimonthly. There are roughly 15 attendees at each meeting. The Minutes of meetings are posted on the BSBMT website. Topics discussed include JACIE standards, check lists and preparation for inspection. There has been positive feedback from meetings so far. The group is exploring the possibility of running a 1-2 day Quality Workshop soon.

An article written by KA and NS is to be submitted to the EBMT newsletter. It was agreed to put more SOPs on the BSBMT website. NS indicated that the Bristol Transplant Programme SOPs could be accessed via Avonweb NHSnet [NHSNet connection required], and login details should be obtained from her.

DS reported on 5 inspections that took place in 2004:-

One centre is accredited. One has met all the requirements but is awaiting EFI inspection. In the other 3 centres there are ongoing document revisions. All are expected to achieve Level 1 status in the near future.

So far there are applications from Cambridge, Sheffield Children's Hospital, National Blood Service and Hammersmith Hospitals.

A number of other centres have expressed an interest in application in 2005/06. It was agreed that it is important to understand the requirements and accreditation schedule of each centre so that inspections could be sensibly scheduled on a 3-year rolling cycle.

DP tabled a suggestion for a workshop to be held in Feb 2006. This was agreed and DP said that a detailed proposal would be circulated soon.

DS presented a detailed report which is attached to these Minutes. (Appendix 1).

This now contains up to date information and will be kept updated 3 monthly.

There is a requirement that all centres carrying out allogeneic BMT should have full EFI accreditation before they can achieve level 1 JACIE status. JACIE request that applications for EFI accreditation should have been submitted by the time of application/inspection for JACIE. For centres that have already been inspected without having applied for EFI, and are subsequently found to be fully compliant in all other respects, the position is that the centre cannot be accredited but the Board will write formally to state that the centre is fully compliant with the exception of EFI, and that JACIE accreditation will granted directly on receipt of EFI accreditation provided this is obtained within 12 months of the date of the JACIE Medical Director's final letter. A survey conducted by DP showed that most respondents did not anticipate problems. There were significant constraints in 2 centres.

It was agreed that a further survey targeted specifically to allo-transplant centres with follow-up to non-respondents should be conducted.

It was also felt appropriate to make further enquiries as to how other European centres would comply with the requirement for EFI.

It was agreed that in the mean time centres should not be discouraged from applying for JACIE accreditation - EFI accreditation would be discussed with them on an individual basis. DP would write formally to JACIE after the further survey had been done.

The funding requirements in 2005/2006 are for 2 x TAC meetings and support for the venues at which Quality Forum meetings are held. The expected funding requirement is less than £10k.

There are now a large number of documents that are relevant to BMT. These are:-

• EU Directive on Tissues and Cells 2004/23/84, and two Technical annexes
• JACIE Guidelines and Standards
• European Commission Consultation on the Regulation of Human Tissue Engineering and Tissue Engineering Products
• WHO Regulatory Requirements for Human Cells and Tissues for Transplantation
• Council of Europe Guide to Safety and Quality Assurance for Organs, Tissues and Cells Second Edition: 2004 version, Council of Europe Publishing ISBN 92 871 5517 8
• Council of Europe Research Group on Cellular Immune Therapies (draft) CDSP(2004)51

It was agreed that taking note of and implementing all the requirements of these documents presented a considerable challenge. During discussion it emerged that there was a lack of clarity on:

• Whether DLI and other cells for immune therapy are included in the Tissue and Cells Directive - this is not explicitly stated. It is also conceivable that they may be covered by the Directive 2002/98/EEC - "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.
• It is unclear who will inspect BMT collection and processing facilities after April 2006 when the EU Directive on Tissues and Cells becomes law. The Human Tissue Authority (HTA) will be the competent authority. It is unclear if the MHRA will continue to act as its inspectorate. There may be a role for JACIE. The TAC agreed that a proactive approach was required and that discussion with the DH and HTA were required. A letter would be drafted.

1. ML advised that Stem Cell Technologies offer free training and participation in their QA scheme for centres who purchase their reagents. It was agreed to disseminate the relevant information.
2. There will be further courses on Quality management (1st/2nd September) and inspector training (20th/21st September) in Athens. Places would likely be available on these courses. No specific funding is available at the moment from JACIE.
3. DP indicated that he is now sending out a 3 monthly update on JACIE/TAC activities to BSBMT members.

Next meeting will be on Friday 25^th November 2005, 10am at the Novartis Foundation.