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Present:

• Mark Cook (MC)
• Adrian McNeil (AM)
• Derwood Pamphilon (DP)
• Nina Som (NS)
• Mark Lowdell (MWL)
• Don Milligan (DM)
• Kim Orchard (KO)
• Colin Steward (CS)

Apologies:

• Kathryn Aldous (KA)
• Jane Apperley (JA)
• Jenny Byrne
• Jackie Cornish
• Diana Samson (DS)
• Mike Scott (MS)
• Mike Potter
• Jeremy Whelan

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1.	Reitrement of DP from the Chair of TAC   DP announced that he is has been appointed Chair of the newly created Accreditation Committee of JACIE and is to stand-down as chair of TAC. It was proposed at the BSBMT board meeting the previous week that MWL should be asked to replace him as chair of TAC and as the UK national representative on the JACIE board. This proposal was put to the TAC members present and it was agreed. DP suggested that the committee should have a secretary and proposed that Mike Scott should be approached. This was agreed	Action: MWL
2.	Minutes of TAC held 25.11.05   Approved	Action: None
3.	TAC terms of reference Section 3.2 needs to be redrafted as some words appear to have been lost in transposition. MWL proposed that the committee should include at least two standing members of which one should be the president of BSBMT and the second should be a representative of JACIE (e.g. DS as Medical Director). DP suggested that TAC members should ask suitable colleagues to deputise for them if they themselves were unable to attend a meeting. DM pointed out that he represents the Cancer Networks and no Cancer Registries.	Action: MWL
4.	The Human Tissue Authority (HTA)   DP explained how CS, John Goldman, Irene Roberts, Nigel Russell, Charlie Craddock and he had worked with the HTA to draw-up the HTA Code of Practice for allogeneic donation of HSC. AM explained that there has been a delay in the publishing of the CoP as it required negotiation with DoH lawyers who were unhappy about the provision for protection of donors incapable of provision of informed consent; particularly non-Gillick competent children. Despite much lobbying and significant in put from CS and Irene Roberts the final draft of the CoP approved by ministers and now laid before Parliament.   DP reported that DS, ML and he had been in discussion with the HTA regarding the possibility that JACIE (UK) act as the inspection body on behalf of the HTA for therapeutic tissue banks. AMcN that the successful bidder for the inspection contract is likely to be one which is capable of inspecting all therapeutic banks, not just those banking HSC. Furthermore, the inspectorate will have to inspect to HTA standards which have not yet be set. AMcN accepted that JACIE standards are very close to those laid down in the T&C directive.   AMcN stated that the HTA has issued 220 deemed licenses to therapeutic tissue banks so far and that full license offers are awaiting legal direction to accompany them stating that the holders commit to implementing td1 and TD2 by April 2007.
5.	Report from the Quality Forum (NS) Nina Som reported that the group is working well using e-mail and the face-to-face meetings will now be held every 6 months. Document exchange has proved very popular but some Trusts have firewalls which block large file transfers by e-mail; possibility that these files will be held on the BSBMT website for direct download.
6.	JACIE update   CS asked how the UK is progressing with accreditation. DP replied that the majority of UK centres are on track for the 2008 deadline for Cancer Network Accreditation. The latest JACIE standards are now on the JACIE website.
7.	Website   Currently up-to-date.
8.	SAE reporting   It is a requirement within the T&C directive that SAE are reported to the national authority – the HTA in the UK. MUD products are already covered by the WMDA reporting system. Jenny Bryne is to take this forward on behalf of BSBMT and will report back to TAC.	ACTION   Jenny Byrne
9.	AOB   ML thanked DP on behalf of the TAC for his excellent service as chairman.
10.	HSC Activity   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.	Action DP
11.	Date of Next Meeting   The next full BSBMT TAC meeting is on Friday 27th October 2006 from 10am – 1pm at The Novartis Foundation	Action ML

 

APPENDIX 1

 

 

Report from UK National Quality Forum November 2005

 

Membership/Meetings

 

There are currently 21 members of the National Quality Forum who receive copies of the minutes and are part of the email network. Of this number around 10 members attend the meetings every two months (since June 3 meetings have been held). The meetings are held at a different centre each time to make travelling times fairer. This is working well and the meetings will continue in this way in 2006.

 

Email networking is proving very effective allowing advice to be quickly obtained from a range of centres. This support is reducing the number of enquiries submitted to the JACIE office and allowing central queries to be made and reported back to the group.

 

Terms of reference

 

These have been agreed but are fluid as the group is still very new currently they are agreed as follows:

 

Aims of the forum

 

The initial aim of the group is to provide support for centres as they prepare for accreditation by:

 

á      Sharing experiences of best practice in meeting the standards.

á      More advanced centres sharing lessons learned to prevent all centres making the same mistakes.

á      To discuss each section of the standards in detail to compare understanding and prevent centres new to the process having to repeat exactly the same work as those further on.

á      Sharing documentation nationally to give centres new to the process a clear idea of what is required and to prevent each centre repeating the same work.

 

Long term goals

 

In the long term it is planned to further the forum in line with both the JACIE and UK governmental standards by:

 

á      Using the forum to discuss adverse incidents at a national level, to enable members to learn from failures and share good practice and new approaches.

á      To provide quality training for those new to JACIE and inspectee training to prepare centres for the accreditation visit.

á      Work towards a harmonised system for quality across all centres within the UK. This will include national SOPÕs and policies where appropriate, whilst supporting centres in providing individual patient care.

 

Quality Training

           

Quality training is being organised for April/May 2006 this will cost approximately £350 per delegate including accommodation and food, based on 26 delegates. This cost would increase if less than 26 delegates took part, however this is unlikely as many centres have expressed an interest. Each delegate will need to fund this via their centre or external sponsorship.

 

Document Exchange

 

It is planned to have copies of SOP templates and indexes and QM plans and attendance lists from all centres that are accredited/have these documents available, on the BSBMT website. So far 6 centres have submitted information for inclusion in this: Bristol, Manchester ChildrenÕs, Hammersmith, Addenbrookes, Birmingham Heartlands and Leeds. These will be submitted for inclusion on the website in the next month.

 

APPENDIX 2

British Society for Blood and Marrow Transplantation

 

Wednesday 15^th February 2006

Symposium on Accreditation and Regulatory Affairs

 

VENUE:                     Rutherford Suite

Institute Of Physics

                                    76, Portland Place

London

 

SPEAKERS:               Diana Samson, JACIE Medical Director

                                    Paul Ashford, Executive Director, ICCBBA

                                    Jenny Byrne, City Hospital, Nottingham

                                    Sandy Mather, Human Tissue Authority

                                    Mark Lowdell, Royal Free Hospital, London

                                    Derwood Pamphilon, National Blood Service, Bristol

 

TOPICS:        

¬     How JACIE works

¬     The role of BSBMT in accreditation

¬     The International Cellular Therapy Coding and Labelling Advisory Group

¬     Experience of JACIE in a large BMT centre

¬     The EU Directive on Clinical Trials

¬     The EU Directive on Tissues and Cells

¬     The Human Tissue Authority

 

This meeting will be of interest and relevant to BMT physicians and scientists, senior BMT and apheresis nurses and Quality Managers.

 

Registration Fee:         £30 to include lunch (cheques payable to the BSBMT)

 

For further details please contact:

Anne Baxter

Hartley Taylor Ltd

(on behalf of the BSBMT)

 

anne@hartleytaylor.co.uk tel: 07786 916915

 

 

 

Accreditaion Symposium

 

WEDNESDAY 15^th FEBRUARY 2006

              Institute of Physics

           76 Portland Place, London, W1B 1NT

 

REGISTRATION FORM

 

Please print details clearly
FULL NAME
TITLE
Institution
Department
Address
Post Code	Telephone No:
Email Address* (preferred method of communication!)

 

Registration £30

 

Please return this form as soon as possible to the address below to secure a place.

 

Make cheques payable to: BSBMT

 

Anne Baxter

Hartley Taylor

24 Mulberry Close

Clifton

Preston

PR3 4OY

 

Please contact Anne at anne@hartleytaylor.co.uk if you require any further information.

APPENDIX 3

 

 

Report from JACIE Board Nov 2005

1. Inspections

 

1.1.  Individual Inspections

32 centres now inspected, 9 in UK (6 clinical programmes plus 3 stand-alone NBS facilities). 19 centres/facilities are now accredited, plus 2 centres fully compliant except for EFI. Fewer new applications this year than initially expected, probably because centres now more realistic about amount of work needed to be ready.

30 centres have applied/ said will apply for next year.

 

1.2 Inspection Process

 

Improvements to process including

 

a)     amendments to on-line application form to allow entry of data for multiple clinical sites, and documents for both BM and/or PBPC , plus clarification of facilities served by collection and processing facilities

b)    clarification of process for stand- alone facilities serving a number of clinical programmes

c)     Improvements to post-inspection phase

 

a.     Introduction of a table of required documentation of corrections for completion by centre and inspectors

b.     Introduction of time limits for each stage of process with time allowed for corrections dependent on severity of deficiencies

 

2. Standards

 

2.1  New Edition of FACT Standards

 

JACIE is taking part in the current FACT process for updating and revising the standards (DS on the Clinical Sub-Committee, DP on the Collection Sub-committee and I Slaper-Cortenbach on the Processing Sub-Committee). The guidance is being updated at the same time. The draft 3^rd edition of the FACT standards and guidance will be finalised shortly for approval by FACT Board at ASH meeting and also be JACIE Board. Expected to be available for public consultation on FACT website in January. There is extensive rewording and improvements in all areas, with a more clearly written quality management section, but few important changes. Latter include

 

a)     proposed decrease in minimum activity for autologous transplants to 5 for a centre applying for autograft alone, and no minimum for a centre that is accredited for allogeneic SCT.

b)    Proposed increase in minimum activity for paeds/adults in a combined programme from 4 to 5. Previous proposal for increase to 10 was rejected after further discussion because of lack of good evidence for improved outcome with 10 as opposed to 5 per annum.

c)     Proposed increase in minimum activity for separate clinical sites from 4 to 5 per site

d)    Change in timing of infections disease markers. For HPC this will remain within 30 days prior to each collection but for Òlymphocyte-rich productsÓ e.g. DLI this will now be within 7 days prior to each collection. This is to comply with FDA and EU Directive requirements

e)     Addition of specific standards about TBI administration (as per those for HD chemotherapy)

f)     Introduction of a minimum activity for collection centres. Proposed min is 5 apheresis procedures and 1 BM collection in the year prior to application. It was difficult to arrive at an agreed minimum for BM and this may be an area for comment

g)    Collection centres must have a quarantine area for components where testing is not complete

 

2.2  JACIE Standards and the EU Directive

JACIE standards cover all the areas included in the Directive. JACIE has prepared a crosswalk comparing the FACT-JACIE standards with the Directive and showing in detail which standards deal with which Directive Requirement. The first Technical Directive has also been completed covering donor selection and procurement and a crosswalk comparing FACT-JACIE standards and also WMDA guidelines with the TD is in progress. TD2 has not yet been finalised but in due course a similar crosswalk will be prepared.

 

3. Regulatory Issues

 

3.1. The EU Directive Concerns

 

The directive raises 2 issues of concern for JACIE. One is the possibility that different EU states will interpret the requirements differently leading to a difference in regulations in different countries. The second is the requirement for member States only to import tissues/cells that have been procured in accordance with the requirements of the Directive. This could delay/ prevent the import of HPC from UD donors in non-EU states and is a matter of great concern to WMDA. A joint letter has been sent to the relevant person in the EU (Head of Publich Health) from JACIE, EBMT, ISCT, FACT and WMDA requesting a meeting to discuss these issues and proposing that the EU formally recommend the adoption of the FACT –JACIE standards as a means of compliance with the Directive.

 

3.1. The EU Directive – Implementation in Different Countries

 

In several countries it has already been agreed to use JACIE or link the national system with JACIE (Netherlands, Belgium, Spain, Germany). In Switzerland (non-EU) a new law on transplants specifically requires JACIE accreditation of SCT programmes/facilities.

 

3.2 WMDA, Registries etc.

 

A liaison committee is being set up involving FACT, JACIE and the WMDA to look at the regulatory issues relating to transfer of cells across international boundaries, and also the role of Donor Registries in fulfilling JACIE standards in relation to UD transplants (i.e. who is responsible for which of the standards).

 

3.3 International Labelling Committee

 

Continues to meet. Will deal with requirements of EU for coding of HPC etc.

D. Samson, 22 Nov. 05