JACIE Board meeting

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JACIE Board meeting

• Sunday, 28 March 2004
• 13.00 15.00
• Room E1, Palau de Congressos de Catalunya,
  Barcelona

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Agenda

• Constitution of JACIE Board A Gratwohl
• Role of JACIE Board A Urbano
• Update on EC JACIE project F Mc Donald
• Update on inspections E Mc Grath
• Status of JACIE F Mc
  Donald
• AOB

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1. Constitution of JACIE
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Constitution of JACIE Board

• Legal advice has been sought and it is
  recommended to establish JACIE as a separate
  legal entity
• The EBMT is currently going through structural
  changes and it is advised to postpone the legal
  constitution of JACIE until 2005

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Proposal for structure of new JACIE Board

• A Gratwohl and G Kvalheim step-down from their
  positions as Co-Chairman of JACIE
• The EBMT has appointed A Urbano as the new Chair
  of the EBMT Accreditation Subcommittee and
  designated candidate for President of JACIE
• ISCT Europe has appointed I Slaper as designated
  candidate for Vice President of JACIE

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Specialist representatives

• Paediatric Designated candidate by PDWP, J
  Cornish
• Nursing To be deisgnated by Nurses Group Board
• NETCORD To be discussed with
• P Wernet

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National JACIE Representatives
To be designated by National Societies

• D Pamphilon, UK
• A Gratwohl, CH
• M Michallett, F
• N Schmitz, DE
• H Greinix, A
• T Ruutu, FI
• B Bär, NL

• A Rambaldi, I
• M Boogaerts, BE
• C Solano, ES
• N Jacobsen, DK
• G Kvalheim, NO
• P Ljuhgman, SW

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Support roles to JACIE Office and Board

• Medical Consulant Diana Samson
• JACIE Executive Officer TBC
• Executive Board President, Vice President,
  Medical Consultant and Executive Officer

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2. Role of JACIE Board
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Role of JACIE Board

• Updating standards
• Appointment of working committees
• Important modifications to accreditation process
• Defining interaction, policy and lobbying
  strategies with regards to other organisations

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• Harmonisation of different accreditation
  processes
• Resolution of general conflicts
• Approval of budget and accounts
• Official approval of centres accreditation and
  issue of certification

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Updating of standards

• Coordination with FACT (meeting May)
• Standards points for discussion (D Samson)
• Clarification
• (procedure for accreditation of cord blood
  collection and processing)
• level of physicians - wording
• Modification
• board -certification of physicians
• instructions for administration of HSCT ? to be
  issued with products
• Additions
• assessment of recipient (diagnosis, fitness etc)
• safe administration of TBI

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Level of physicians - wording

• Section B3.3 Other Attending Physicians
• attending physician is the US term for a
  senior physician in the UK this would be
  consultant physician. There is some confusion in
  the current manual between training required for
  attending physicians and for all physicians
  
• Suggestion replace by Senior Transplant
  Physicians (consultant staff / faculty / ? other
  terms in use in Europe)
• Section B3.5 Mid-level Practitioners
• Suggestion replace by Mid-level Physicians
  (Registrars / Fellows / ? other terms in use in
  Europe)
• Section B3.6 Consulting Physicians
• this term can be confused with the consultant
  physicians of the transplant team. Suggestion
  replace by Consultant Staff in Other
  Specialities

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Interaction with other organisations

• FACT Meeting in Dublin with F Le Maistre
• WMDA EU Directive on standards for human tissues
  and cells
• NETCORD
• EU Participation in meetings of the European
  Commission and Council of Europe

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Meetings and conferences
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3. EU JACIE Project
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(No Transcript)
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Funding in 2004

• Project timeframe 1 January 2004 31 December
  2004
• Project budget 375,000 (50 co-financing
  European Commission EBMT (Main Beneficiary) and
  National Socities and ISCT (Associate
  Beneficiaries)

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Contributions to project
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Expectations from national representatives

• Completion of mandate
• Accurate budget estimate for 2004
• Timely production of accounts and receipts
• Liaison with national societies, national health
  authorities
• Communication with keystake holders above re
  JACIE project and EU requirements

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JACIE project activities in 2004

• Establishment of a European JACIE office
• Development of a JACIE online management system
• Production and dissemination of JACIE materials
• Delivery of QMS and inspector training courses
• Network building (extension of JACIE network
  increased interaction with health authorities
  centres)

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• 25 inspection visits
• Sharing of best practice
• Liaison with European Commision and harmonisation
  of standards
• Analysis and report writing

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Establishment of JACIE office

• E Mc Grath, JACIE Administrator
• Appointment of Dianan Samson as Medical
  consultant
• Development of JACIE online

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JACIE materials

• Production and dissemination of 2nd edition of
  JACIE manual
• Harmonisation of standards with EU Directive
• Production of educational packs for countries
  being bought into the JACIE network
• JACIE sessions at EBMT 2004 and ESH/EBMT Training
  Course, Budapest May 2004
• Model materials for training and sharing of best
  practice

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Training courses in 2004
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Network building

• Interaction with national societies
• Interaction with national and regional health
  authorities
• Lobbying on behalf of JACIE/ liaison with
  national accreditation bodies
• Extension of JACIE netowrk ( 8 applicant and 4
  additional member states brought into JACIE
  network)
• Liaison with other organisations

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Liaison, analysis and report writing

• Participation in development of European-wide
  standards
• Analysis of common difficulties in accreditation
  process
• Analysis of common deficiencies in implementation
  of standards
• Analysis of impact of implemenation of standards
• Report on harmonisation of standards in Europe
• Assessment of use of EBMT JACIE data to monitor
  impact of implementation of standards

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Communications

• Press releases in national press and scientific
  journals
• EBMT News and EBMT/JACIE web sites
• Monthly e-bulletins?
• Tracking and dissemination of data and information

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4. Update on JACIE inspections
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Scheduled inspections in 2004
provisional
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Schedule of inspections

• January
• Kantonsspital, Basel ?
• University Hospital, Bern ?
• Hôpital cantonal universitaire, Geneva ?
• March
• St. Anna, Vienna ?
• April
• Schlieren, Zürich
• Hôpital E.Herriot, Lyon
• St. Louis, Paris
• June
• BRHC, Bristol
• St James', Leeds
• Kantonsspital, St.Gallen
• CHU, Bordeaux
• St. Anna, Vienna (Collection)

• July
• Nottingham City Hospital
• August
• Hammersmith, London
• September
• Kantonsspital, Arrau
• Ospedale San Giovanni, Bellinzona
• Centre Hospitalier Universitaire, Lausanne
• Univ. Children's Hospital, Zürich
• University Hospital,Zürich
• Institut G.Roussy, Paris
• October
• AKH, Vienna
• John Radcliffe Hospital, Oxford
• November

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Completed inspections 1

• Basel, Switzerland 26 January 2004
• Inspection Team
• Bernard Chapuis
• Thomas Klingebiel
• Jörg Halter
• Adults ? Allo Auto
• Children ?
• Bone marrow collection ?
• PBSC collection ?
• Cord Blood Collection Facilities ?
• Cell Processing Laboratory ?

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Completed inspections 2

• Bern, Switzerland, 27 January 2004
• Inspection Team
• Urs Schanz
• Tayfun Güngör
• Rainer Blasczyk
• Sabine van den Bosch (Nurse inspector)
• Adults ? Auto only
• Children ?
• Bone marrow collection ?
• PBSC collection ?
• Cord Blood Collection Facilities ?
• Cell Processing Laboratory ?

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Completed inspections 3

• Geneva, Switzerland, 28 January 2004
• Inspection Team
• André Tichelli
• Hélène Esperou
• Anne Rosselet
• Adults ? Allo only
• Children ?
• Bone Marrow ?
• PBSC ?
• Cord Blood Collection Facilities ?
• Cell Processing Laboratory ?

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Completed inspections 4

• St. Anna, Vienna, Austria, 9 March 2004
• Inspection Team
• Thomas Klingebiel
• Tayfun Güngör
• Adults ?
• Children ?
• Bone Marrow ?
• PBSC ?
• Cord Blood Collection Facilities ?
• Cell Processing Laboratory ?

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Feedback from applicants

• a long day but we had a fruitful and fair
  inspection with two experts in SCT. They did an
  excellent job
• we had a thorough inspection and we are thankful
  to the auditors for their skill and seriousness.
  The atmosphere was excellent, there was no
  misunderstanding
• we are all happy that the audit is finished and
  that we got good feedback from the inspectors.
  The atmosphere of the audit was very
  constructive, open and clear. .. learned many
  things about quality....after the exit interview,
  we had a little party

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Feedback from inspectors

• ..a terrible lot of work and all the inspectors
  were terribly tired after the audit
• we had a good inspection and everything went
  smoothly. The only problem was the lack of a cord
  blood bank inspector, but we did what we could in
  that matter

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Format of consultants report

• Facility name
• Programme Director
• Date of inspection
  
• Accreditation applied for Clinical Collection
  Lab Autologous Allogeneic Adult Paediatric
• Inspectors
• Team Leader/Clinical Facility Inspector/Collection
  Facility Inspector/Processing Facility
  Inspector
• Report
• Recommendation
• General issues arising from this inspection

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Sample consultants report

• Deficiencies and/or variations
• A few minor deficiencies and variations were
  noted.
• Clinical Programme
• The inspectors commented that there was no formal
  documentation of the diagnosis and indication for
  allogeneic BMT
• Marrow Collection
• The SOP for bone marrow collection requires
  amendment to specify the action to be taken if
  expected limits are not reached. The SOP should
  be received and a copy sent to the Jacie Office
  (JO)
• There is currently no established procedure for
  reporting medical AEs in the operating theatre.
  An appropriate report form and provision for
  follow-up should be created and copies sent to
  JO.
• PBSC collection
• Components are currently labelled only with the
  recipient and donor name. An alphanumeric code
  should be used.
• Cell Processing
• The responsibilities of medical director are not
  clearly defined in an SOP. A SOP should be
  created and a copy sent to JO.
• RECOMMENDATION
• This centre currently meets the requirements for
  accreditation at Level 2. It will meet the
• standards for full accreditation at level 1 if
  the applicants are able to submit
• documentation verifying correction of the minor
  deficiencies and variations noted.

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Issuesconsultants notes on inspection reports

• At present, no confirmation by inspection team
  that they had actually reviewed certain key
  elements of the programme
• makes it difficult to assess the
  comprehensiveness of the inspection visit.
• Guideline for Inspectors should be revised to
  include a list of 10 items inspectors must do or
  see during their visit.
• Should also be included in Checklist document and
  Inspection Report so that inspector is obliged to
  confirm that they have reviewed the necessary
  document/equipment or spoken to the required
  person(s) and make a general comment
• SOPs reviewed
• Comment on content and/or completeness Excellent
  Good Satisfactory Poor
• Comments
• Examples of key items
• A Quality System is in place and has been
  reviewed
• The nursing part of the programme has been
  reviewed

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Issues -inspection schedule

• Centres should be realistic in setting dates to
  allow for document collection and conversion to
  electronic format
• Allows for a more realistic annual schedule of
  visits
• Documentation should be supplied in full at least
  4 weeks in advance of inspection where possible
• Gives time for consultant and inspectors to
  review files
• Documents in electronic format (PDF/Word/image
  files)
• Makes distribution much easier via internet and
  reduces costs
• Will be required method when JACIE online
  introduced

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Issues -inspection team

• Appointment of inspection teams
• JACIE Office proposes names to National Rep who
  confirms or makes other proposal. JACIE Office
  then approaches proposed inspectors
• Rep proposes names to JACIE Office who approaches
  proposed inspectors

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5. JACIE inspections 2005
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Outlook for 2005

• New submission to EU for funding to continue this
  launch phase of JACIE.
• Please consider how many centres in your country
  will be prepared for JACIE inspection in 2005 and
  let us know.

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Anticipated inspections in 2005

• Austria
• Belgium 2
• Denmark 1
• Finland 2
• France 5
• Germany

• Italy 5
• Netherlands
• Norway
• Spain 3
• Sweden
• UK

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6. JACIE Online
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JACIE Online

• Online system
• Part-funded by EU
• Counsultant contracted to manage project
• IT development by Barcelona company
• Local designer
• Input from JACIE Accreditation Office

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JACIE Online

• Design of online system to manage processes
• Initial / renewal applications
• Document submission
• Inspectors tasks
• Consultants tasks
• Board review of application
• Renewal
• General JACIE information

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JACIE Online

• Design of online system
• Currently finalising different users/roles
• Design of views
• Next phase will move onto database design and
  programming functionality
• Expected roll-out July 2004

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JACIE Online -National Representative view

• Summary view of current status for country
• Export to excel function for reports
• Application stages
• Initial applications
• Alert when new application submitted
• Centres at documention submission stage
• Inspections scheduled
• Inspections completed
• List of inspectors for respective country
• Name, contact details, language skills, JACIE
  training etc.
• Inspection record ( experience)
• Feedback/comment facility to contribute when
  Board is deciding on accreditation award

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JACIE Online Applicant view

• Initial application submission
• Document submission/upload
• Progress tracked through stages
• Summary view of application for export to Word
• View list of inspectors appointed to inspection
• Add hotel details or practical details
• Feedback/comment facility to correspond with
  JACIE Office/inspectors/consultant/Board
• Email alerts when input is required
• Renewal of accreditation
• Alert of impending renewal date

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Sample view of portlets design
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Sample view of online document checklist
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And now....
JACIE Online
wants you
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JACIE Online

• Volunteers required to test the system when the
  prototype is ready
• Expected in May-June
• Small amount of work required
• Contact Eoin at end of meeting or email
  jacie_at_ebmt.org

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Suggestions for JACIE logo
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7. Overview of JACIE at the national level
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Motivation for accreditation?

• Main incentive for accreditation
• Legislation of guidelines incorporating JACIE
• Interactions with national authorities
• Logistical, financial or other support from
  national authorities / national societies