JACIE Board Meeting

1
JACIE Board Meeting

• 20th March 2005, Prague

2
Update
3
National JACIE Representatives
2 new NRs

• Damianos Sotiropoulos, Thassalonika
• Osman Ilhan, Ankara

4
Overview of inspections
5
Inspections in 2004
6
Inspections in 2004

• September
• Ospedale San Giovanni, Bellinzona
• St. Anna, Vienna (Collection)
• CHU, Bordeaux
• October
• John Radcliffe Hospital, Oxford
• Univ. Children's Hospital, Zürich
• Nottingham City Hospital
• University Hospital,Zürich
• November
• Kantonsspital, Arrau
• Centre Hospitalier Universitaire, Lausanne
• Heartlands, Birmingham
• December
• Institut G.Roussy, Paris

• January
• Kantonsspital, Basel
• University Hospital, Bern
• Hôpital cantonal universitaire, Geneva
• March
• St. Anna, Vienna
• April
• Schlieren, Zürich
• Hôpital E.Herriot, Lyon
• May
• Nijmegen, The Netherlands
• June
• BRHC, Bristol
• St James', Leeds
• Kantonsspital, St.Gallen

7
Level of compliance at inspection (n20/24)
8
Current Status of Centres

• 2 accredited in October 2004 (Bern, Geneva)
• 3 currently recommended for accreditation
• 5 centres have submitted evidence of correcting
  deficiencies and awaiting review of this by
  inspectors
• 10 centres are in process of correcting
  deficiencies
• 4 centres inspected but initial reports not yet
  complete

9
Anticipated inspections in 2005

• Austria 1
• Belgium 2
• Czech Rep. 1
• Finland 2
• France 5
• Germany 18
• Israel 2

• Italy 5
• Netherlands 3
• Norway 1
• Spain 3
• Sweden 1
• UK 10
• Total54

Total of centres who indicated 2005 for
inspection but 25-30 probably more realistic
10
For further analysis of JACIE experience

• Oral Session 24 Regulatory issues / Stem cell
  donor
• Wednesday, March 23, 2005 1315 - 1330
• (Meeting Hall V)
• The JACIE accreditation programme experience
  after the first year of full implementation
• (D. Samson on behalf of JACIE)

11
Inspectors inspections

• 1 inspector has carried out 5 visits
• 6 inspectors have carried out 3 visits
• 12 inspectors have carried out 2 visits
• 25 inspectors have carried out 1 visit

12
Number of inspectors per visit

• 15 visits with 3 inspectors
• 5 visits with 4 (combined adult paed units)
• 3 visits with 2
• 1 visit with 1
• National representatives as observers in UK/Switz

13
International cooperation

• Non-national inspector
• Switzerland all inspections. Assistance from
  France, Austria and Italy
• Austria all inspections. Assistance from Germany
  and Switzerland
• France all inspections to date. Assistance from
  Switzerland and Belgium

14
JACIE Online

• Launched December 2004
• 12 centres online
• 4 new applications
• 8 old applications inputted by JACIE Office
• All applications from 2004 will be inputted
• 2 inspections managed via the system
• 2 inspection reports submitted

15
Developments

• Standards (adapted to European terminologyJan
  2005)
• Accreditation Manual
• Information Pack
• Common labelling workgroup
• Surveys of centres
• Model documents (QM plan, SOPs, etc.)
• In progress

16
Information Pack

• Contents
• Standards
• Information leaflet
• EU Directive
• Sent to non-JACIE network countries with Manual

17
Accreditation Manual version 2

• 2 copies sent to all EBMT centres
• Guidance and terminology amended
• Word version available for download and
  completion of checklist on computer

18
Adaptation to JACIE

• Definition of single metropolitan area
• Mid-level practitioners
• Relevant degree qualified by post-graduate
  training
• ABO/Rh group clarification
• Section C now in BM PBSC
• Nurses training

19
Special thanks

• Bernard Chapuis, CH,
• most experienced JACIE inspector
• retiring

20
Main Problem Areas

• QMP and Documentation
• QMP for clinical programme and BM collection
• sometimes for PBPC collection (if not EFS /NBS)
• SOPS references, forms etc
• Labels
• Solutions
• Improved guidance in new manual
• More educational materials through JACIE
• Advise centres not to apply till QMP mature
• Labelling working party

21
General issues arising from inspections

• Issues with Unrelated transplants
• Areas where standards may need amendment
• Conflicts with current practice in different
  countries, e.g.
• France national law forbids biohazard labelling
  
• France EFS has national QMP with revision of
  SOPs every 3 years
• Switzerland national laboratory accreditation
  scheme requires uncompleted proformas / labels
  to be attached to SOPs, JACIE requires examples
  of completed proformas / labels
• UK centres ready for inspection but many HLA
  labs not planning to apply for EFI in foreseeable
  future

22
The Inspection and Accreditation Process

• Preparation by Centre
• implements measures as described in the JACIE
  accreditation manual
• submits self-assessment checklist and other
  documentation
• Inspection
• On-site visit by trained inspectors
• Inspectors submit report for review by Medical
  Director (MD)
• MD writes additional report noting
• current level of compliance
• recommendations for changes
• Centre Response
• Centre makes agreed changes and submits evidence
  to confirm
• Documentation reviewed by inspectors and MD
• Accreditation
• JACIE Executive Cttee makes a recommendation to
  the JACIE Board
• If approved, accreditation awarded, valid for 3
  years

23
FACT/JACIE interaction
24
Modifications to Standards

• Members of JACIE Board currently working with
  FACT Sub-committees developing 3rd edition of
  standards and manual
• Part B Diana Samson
• Part C Derwood Pamphilon
• Part D Ineke Slaper-Cortenbach

Available to the membership
Membership review
Publisher
Crosswalk with cGTP and EU Directive New edition
standards and manual
Consistency and Legal review
Changes review
1
5/ 6 8
9 10
11 12
25
FACT Clinical Standards Sub-Committee

• Section B1 programme
• No change to minimum numbers of transplants
  required,
• except
• For a centre doing allo and auto, if 10 allos are
  done, there will be no minimum for autos
• New patients are defined as
• Auto then another auto 1 new auto patient
• Allo then another allo 1 new allo patient
• Auto then and allo 1 new auto patient AND 1
  new all patient

26
FACT Clinical Standards Sub-Committee
Paediatric numbers

• PDWP and JACIE Board position raised, for
  discussion
• Current FACT position
• Minimum numbers originally set based on available
  data from CIBMTR showing no centre effect above
  5-10 per annum (this was for all ages)
• COG has mandated that all centres be FACT
  accredited within next 2 years
• does not want to close smaller centres without
  good evidence
• COG is going to examine outcome data by centre
  size in its current trials
• FACT and COG are keen to get an international
  consensus on this issue

27
FACT Clinical Standards Sub-Committee

• Section B2 facilities
• No significant changes some improvements in
  wording
• Decided not to be more specific about air
  handing, nurse numbers
• add requirement for access to ITU and renal
  dialysis
• Section B3 Personnel
• To raise issue of staff in training

28
Surveys
29
National Representatives Survey

• 10 out of 15 replies
• Contact established with authorities in all
  responses
• JACIE recognised in law in AT CH
• No health authority support in France, strong
  support in ES CH
• No other accrediting body in HE AT
• JACIE cited in official publications UK, CH, AT
• No national society in Finland

30
Survey of CentresResults1 Motivation

• What was your motivation for applying for JACIE
  Accreditation?

31
Survey of CentresResults2 Personnel

• Was there a person responsible for day-to-day
  management of the process apart from the
  Programme Director?
• Was this person employed full-time or part-time?
• Was this person a trained expert in quality
  management?
• Was this person part of your team or was it an
  external person?

32
Survey of CentresResults3 Difficulties

• Which of the following areas presented the most
  difficulties in preparing for accreditation?
• What were the most difficult parts of your
  preparations?

33
Survey of CentresResults4 Difficulties (cont)

• What levels of difficulty did you experience in
  the following?

34
Survey of CentresResults5 Training

• Did you or any member of your team attend any
  JACIE-specific training?
• If yes, how much did this training help?

35
Survey of CentresResults6 Resources

• What extra resources
• were required specifically
• to implement JACIE?
• What financial support
• did your programme receive,
• if any?

36
Survey of CentresResults7 Satisfaction

• Were you satisfied with the manner in which your
  centre was inspected?
• Please rate the inspection team that visited your
  centre
• Do you consider that the inspection was fair and
  objective?
• How would you rate the quality of the inspection?

37
Survey of CentresResults8 Satisfaction

• How satisfied are you with the overall
  accreditation process?
• How satisfied are you with the support received
  from the JACIE Office?
• Is accreditation worth the effort?

38
Funding Application to EU
39
EU funding

• 2004 project concluded
• report
• 2005 application
• Assistance from National Societies

40
Training
41
Inspectors Area/Language
Not necessarily native speakers. Some
inspectors can inspect more than one area
42
Next Board meeting
43
Exec Board meeting

• Executive Committee meeting Friday 30th Sept
• Board meeting Friday 7th October
• Probable locations Schipol Airport, NL