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Present:

• Mark Cook (MC)
• Derwood Pamphilon (DP)
• Mark Lowdell (MWL)
• Kim Orchard (KO)
• Diana Samson (DS)
• Mike Scott (MS)
• Sarah Raymond (SR)

Apologies:

• Jane Apperley
• Jackie Cornish
• Nina Som
• Don Milligan
• Charlie Craddock

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1.	Minutes of TAC held 19.05.2006   Approved	Action: None
2.	Report from JACIE Board It was reported that The Oxford Centre which underwent JACIE inspection in 2004 were still operating under a temporary accreditation due to the lack of EFFI accreditation of their tissue typing laboratory used by the Centre. The JACIE Board wrote to the programme director asking for this to be sorted as soon as possible or the accreditation would be rescinded. The Centre has now switched itÕs tissue typing for unrelated donors to an EFFI accredited laboratory. Documentary evidence to support this has been requested.
3.	JACIE Item 2. All Centres performing transplantation in the UK are being asked by the National Representative to indicate when they might be a position to undertake an inspection. All programme directors will be emailed in the New Year to request this information.	Action: MWL
4.	It was noted that nurses can now train as experts and will be able to undertake review of documentation prior to inspection particularly related to nurse relevant SOPs. Nurses are not expected to attend the accreditation visits.
5.	HTA licence will be subject to meeting the new EU Tissue and Cells Directive related to compliance of procurement. It was noted that the UK were currently one of the leading member states in ensuring the delivery of compliance with EU Tissue and Cells Directive. Other countries such as Finland, Germany and France have no licensing authority as yet.
6.	The Directive is stating that the air quality must be grade A within a grade D background but that each member state can implement minimum standards as required. This clearly has a cost implication for many member states. Data have been collected regarding contamination of stem cell products with a view to publishing and presenting this data to the European Community. Action: Any data relevant to this can be sent to Mark Lowdell.   As a new accreditation committee being established as per the arrangements that FACT have in existence the Medical Director of JACIE (DS) and Derwood Pamphilon (DP) are representatives on this Committee. Countries include Belgium, France, UK, Switzerland and The Netherlands. Meetings are monthly by teleconference and decisions on accreditation are passed on to the JACIE Board for final ratification. DS reported that a group called USTITE are involved with implementation of the Directive. JACIE has an input into this with two committee members, 1 standards (DS), 2 Adverse Events (JA).
7.	DS informed the Committee that a new body has been conceived called the Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA). JACIE is one of the representative bodies on this organisation. The mission statement and membership are attached.
8.	DP reported that 90 JACIE applications have been received. Thirty eight centres have been inspected and 34 have received accreditation.
9.	It was noted that there will be a JACIE specific session in Lyon at the EBMT meeting in March. It was suggested that legal aspects of adverse incident reporting could be a topic of interest.
10.	Quality Forum   No representatives of the Quality forum were present. Therefore an update was deferred until the next meeting.
11.	Inspection Update on inspection and accreditation There are four centres awaiting inspection. It was noted that the Royal Marsden had recently withdrawn their application. It is anticipated that four centres will apply for accreditation in 2007.
12.	HTA   A JACIE inspector will be asked to accompany HTA inspectors on all accreditation visits. JACIE inspectors must have undergone HTA inspection training.   With respect to the HTA and the requirement to maintain records of volunteer unrelated donors it was felt that clarification needed to be obtained so that the institution knows exactly what information is required. Action: ML to write to Adrian McNeal of the HTA   The impact of the HTA act on transplantation practice with respect to obtaining consent from children and those individuals who were deemed not to be able to give informed consent was discussed. HTA have said that they are happy with the way that the system is working and that most incidents are dealt with within 24 hours. It was reported that the HTA had underestimated the number of imported and exported HPCs from and to the UK. It was suggested that the actual number is somewhere between 250 and 500 per annum. The import of tissues under the HTA was discussed and currently the importer should ensure that the level of consent is appropriate to the country of the donor origin and that this documentation should be obtained. It was noted that a document has been drafted for the EU (which the HTA have also received) looking specifically at donor evaluation and testing covered in addition to consent. The ACHTA are looking at minimum criteria required, what documentation a facility is required to submit and who will assess compliance.	Action: MWL
13.	DH thinking on RATE ML reported that the HTA and IFEA would merge in 2008 to form RATE. A working party to establish the remit and the power for this group included a BSBMT representative (ML). A conclusion is awaited from Triona Norman at the Department of Health.
14.	13.       Any other business DP raised the issue of the discard of stem cells that are not longer required and has revisited a document drafted some time ago. This will be circulated and sent to the HTA for approval.      DP also reported that a labelling committee are working towards standardisation of label or bags, vials and cord blood. They plan to publish their findings in Bone Marrow Transplantation and Cytotherapy. Issues which are being addressed include terminology and the use of ISBT 128 labels.	Action: DP
15.	Date of Next Meeting   The next full BSBMT TAC meeting is on Friday 29th June 2007 from 10am – 1pm at The Novartis Foundation	Action:

 

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