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Minutes Friday 14th January 2005 at The Novartis Foundation, London


Present:

Apologies:


1. Minutes of previous meeting

It was agreed to review and update the TOR.

Minute 10, para 2 reworded as follows: "CTL's, NK cells etc are listed in the glossary and although the text of FACT and JACIE standards then refer to haemopoietic stem cells, the standards and guidance refer to both haemopoietic and immunotherapeutic cells".

Minute 11.4, sentence 2. "it was noted that these may not in future always have to accord with FACT guidelines."

The minutes, with these amendments, were accepted as an accurate record.

Action DP
2. Training Courses

The issue of whether or not a course for future inspectees should be run was discussed. It was agreed that the quality forum would provide regular, interactive meetings that would give the appropriate level of support. These are aimed principally at quality managers but senior nursing attendance would also be encouraged. BSBMT would pay for the costs of the venue and a working lunch for these; delegates would be expected to cover travel and subsistence costs.

 
3. UK Inspectors

The spreadsheets with updated information on inspectors was reviewed. There are 2 which contain slightly disparate data; these will be merged.

It was agreed that all JACIE inspection visits should be carried out by trained inspectors who have passed the JACIE exam and received a certificate. Those whose documentation is not up to date will be asked to update it.

Action DP
4. Eligibility to inspect

FACT guidance allows nurses and scientific staff who do not hold PhD degrees to inspect in association with a team leader/clinical inspector who has an MD.

 
5. Inspections to date

Five centres (Bristol, Oxford, Leeds, Birmingham Heartlands and Nottingham) have been inspected. The duration of an inspection has been increased to 1.5 days. Collection and processing facilities serving more than one clinical programme should list all centres to whom they provide services in order to obtain stand alone accreditation. The application forms have been modified to facilitate this.

Most problems encountered so far are related to documentation and quality systems. In some cases more time was required for these to become more robust. Efforts are being made to enhance the consistency of the inspection process.

 
6. Inspections in 2005

A survey of UK BMT Centres and applications received indicate that 7-9 inspections in the following sites are likely. These are: Cambridge, Hammersmith Hospital, Leicester, Liverpool, Manchester and Sheffield Childrens Hospitals, Glasgow Royal Infirmary, Southampton and St. George's.

 
7. Website

The accreditation page was recently updated. The Quality Forum section will be added shortly.

It was agreed that the names of centres should be added when they achieve accreditation.

Action KA
8. Report from JACIE Board

This was given by DS.

  1. Paediatric BMT: JACIE has agreed in principle to the recommendations of the Paediatric Disease Working Party (PDWP) that a minimum of 10 BMT's are required each year and that this should not be a mixture of adult and paediatric cases to 'make up the numbers'. A PDWG survey had been suggested; the utility of this in the face of a clear recommendation from the PDWP was questioned by some members of the committee. A brief document was required to allow UK JACIE inspectors to accredit to current JACIE and proposed PDWP Standards.
  2. There was a desire for more nursing involvement in development of standards, review of documentation and training courses.
  3. JACIE is now accessible on line. It will include model documents, guidelines and FAQ's.
  4. JACIE has developed 2 surveys. The first is for centres to fill in after inspections and the second for them to complete after accreditation has been achieved. These aim to evaluate the impact of the process and assess how practice has been improved.
  5. Version 2 of the JACIE Standards and Manual are now available. They have been revised to be compatible with European terminology.
  6. DS is now the Medical Director of JACIE.
  7. There will be a joint meeting with WMDA at the EBMT this year
  8. Labelling: Paul Ashford is to convene a group at EBMT to discuss the construction of labels suitable for all European centres. This group would have JACIE representation (DP and Ineke Slaper-Cortenbach).
Action JC
9. Quality Forum

This is to be led by Kathy Aldous and Nina Som. SOP's and associated documents are about to appear on the website. The QF minutes would also appear there. DS offered to input a summary of problems commonly encountered in European inspections to date.

Action DS
10. Finance

The BSBMT spent £21K on JACIE activities in 2004. Roughly 50% of this spending will be needed in 2005 as a formal training course is not to take place. It was agreed to check whether non-UK delegates paid for their accommodation at the course held in London in September.

The TAC wished to thanks Amgen for supporting the course dinner in September.

Cost of inspections: the EBMT may subsidise these in 2005 - either all or part costs.

Action DP
11. Matters arising
  • DH Policy Collaborative: Andrew Hadley, JA and DS represent the BMT community on this group. DS' suggestion that JACIE was the appropriate body for inspection and accreditation in Europe was well received by the group. The next meeting is scheduled for 08.02.05. These documents are available herewith:
  • Transplant policy team - tissue banking policy development
    EU Tissues and Cells Directive. Essential Guidance.
  • CIT: this document has been appropriately amended following consultation. It will be circulated to KS, KA, RD and ML who asked to see it.
  • SLA: the document being produced by the ANT is nearing completion. RD agreed to send to DP so that if possible the BBMR could produce a similar draft. This would lead to some consistency in the practice of the UK BM donor registries.
Action RD
12. Any Other Business

None.

 
13. Date of Next Meeting

Next meeting will be on 15th June 2005, 12 noon at the Novartis Foundation.