JACIE Board meeting

1
JACIE Board meeting

• Friday, 7 October 2004 (12.00 17.00)
• Amsterdam

2
Role of JACIE Board (I)

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

3
Role of JACIE Board (II)

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

4
1.JACIE Project update
5
Overview of inspections
6
Inspections scheduled in 2004
7
Schedule of inspections 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 ?
• Institut G.Roussy, Paris
• November
• Kantonsspital, Arrau
• Centre Hospitalier Universitaire, Lausanne
• Heartlands, Birmingham

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

8
Impressions from the JACIE Office
9
Organisation

• Biggest headaches
• coordinating dates
• finding appropriate inspectors with expertise and
  language
• Biggest satisfaction
• hearing good feedback/report on an inspection

10
Feedback from centres

• The inspectors were professional and courteous.
  No-one felt humiliated or was made to feel
  uncomfortable. We were very pleased with that
  during what was a stressful time for all of us.
  Many congratulations for the organisation.
• a long day but we had a fruitful and fair
  inspection with two experts in SCT. They did an
  excellent job and the final discussion confirmed
  my impression that I am part of the best team one
  can imagine
• The atmosphere of the audit was very
  constructive, open and clear. I learned many
  things about quality. Directly after the exit
  interview, we had a party
• We had a thorough inspection and we are thankful
  to the auditors for their skill and seriousness.
  The athmosphere was excellent
• Well, the Inspectors came and went and we now
  await the news!!  Appeared to go favourably - we
  had what they wanted anyway!
• the day was very busy and intense and not that
  smooth
• It was really an intense day, but the days and
  nights (and weeks) before the inspection have
  been even worse. The inspection team was
  excellent and very competent

11
Feedback from inspectors

• In my opinion the exchange among inspectors from
  different countries will make the accreditation
  process more homogeneous
• For me it was an exiting day. I learned a lot of
  things, for my own centre and I met very nice
  people. This is the real European spirit
• The job was exhausting but it seems to me we did
  a good job. The customers looked satisfied at the
  end
• It was really not as difficult as I had thought,
  especially with 2 very decent colleagues
• It was a very interesting and stimulating
  experience to participate to the JACIE
  inspection. It was nice working with my
  inspector-colleagues
• It was a terrible lot of work and all the
  inspectors were terribly tired after the audit
• I think we had and interesting and peaceful day
  yesterday. So just to say that everything went on
  smoothly.

12
Overall sense

• Inspectors have enormous good will towards the
  project- hard work but worth it
• Learning experience for them
• As inspectors and as practitioners
• Applicants appreciate the efforts of JACIE Office
  and inspectors
• Part of bigger picture

13
Inspectors inspections

• 1 inspector has carried out 4 visits
• 3 inspectors have carried out 3 visits
• 11 inspectors have carried out 2 visits
• 17 inspectors have carried out 1 visit

14
Number of inspectors per visit

• 11 visits with 3 inspectors
• 4 visits with 4 inspectors (usually where visit
  is to a combined adult paed units)
• 2 visits with 2 inspectors
• 1 visit with 1 inspector
• National representatives attended visits as
  observers in the UK and Switzerland
• 1 nurse attended one inspection in Switzerland

15
International cooperation

• Inspections including non-national inspector
• Switzerland all inspections (including 1 where
  the entire inspection team was non-national).
  Assistance from France, Austria and Italy
• Austria all inspections. Assistance from Germany
  and Switzerland
• France all inspections to date. Assistance from
  Switzerland and Belgium

16
Special thanks

• André Tichelli, CH
• Bernard Chapuis, CH
• Derwood Pamphilon, UK
• Alois Gratwohl, CH
• Thomas Klingebiel, D
• Rainer Blasczyk, D
• Catherine Boccacio, F
• Volkmar Böhme, D

17
Consultants overview
18
First impressions

• A great deal of work for all concerned
• Very cooperative atmosphere
• Everyone learning
• Every inspection is different
• Every inspection so far has raised issues with
  wider implications
• Very interesting and enjoyable

19
General Review of Inspections

• Reports completed for 10 centres so far
• None level 1
• Majority level 2 minor deficiencies
• Most are problems with documentation, SOPs,
  labels
• Few other issues,e.g.need temperature monitor
  during transport
• Few level 3 significant deficiencies e.g.
• no monitoring of engraftment data by processing
  facility
• inadequate in-patient facilities at second
  clinical site

20
General Review of Inspections

• Inspectors Reports
• Most have required clarification of some points
• In view of old manual/ checklist some comments
  when checked against new standards were found to
  be no longer deviations
• some problems not resolved where inspectors have
  not had time to obtain relevant documentation
  during the visit

21
General Review of Inspections

• Consultants Initial Report
• Has incorporated inspectors comments with
  modification where needed after point clarified
  with inspectors
• Has made specific recommendations for each
  deficiency
• From July has included time frame for corrections
  to be made
• In future consultant will ask inspectors to amend
  their report after clarification of unclear
  points and then write an overview report which
  will go to the centre with the inspectors
  report.

22
General issues identified to date

• No formal documentation of diagnosis
• No standards for assessment of recipient nor
  recipient consent
• Labelling a recurrent problem
• Biohazard labels not used in France due to
  national regulations

23
General issues identified to date

• Position of collection and processing facilities
  that serve more than one clinical programme
• Unrelated transplants
• Receipt of cells from non-accredited facilities
• Use of national registry evaluation and consent
  forms for donation
• Provision of engraftment data to collection
  facilities

24
Developments to process

• Should see list for inspectors centres
• Time-scale for producing documents or actions
  post-inspection i.e. 3 6 months
• Additional half-day introduced in UK to give
  inspectors more time. This could be adopted
  generally.

25
Training
26
3. Training courses in 2004
27
Attended inspector training
Not all have returned the documents and
completed the exam -In progress
28
Inspectors

• 54 inspectors have completed the exam, returned
  their CV and a copy of their medical
  qualification/license since June 2003.
• Currently inviting pre-June 2003 trainees to
  complete the above process

29
Inspectors languages

• German 20-25
• French 15-20
• English 35-40 (plus non-natives with high
  level)

30
Number of inspectors by area
Some inspectors cover multiple areas. Pre-2003
trainees may not have registered their area
31
JACIE Online
32
5. JACIE Online

• Design and implementation of an online system to
  manage the accreditation process
• Initial / renewal applications
• Document submission
• Inspectors tasks
• Consultants tasks
• Board review of application
• Renewal
• General JACIE information
• Launch due end-October 2004

33
SAMPLE VIEW ONLY
Online document submission
34
SAMPLE VIEW ONLY
35
SAMPLE VIEW ONLY
36
Publications
37
Publications

• By JACIE
• EBMT News, July 2004 JACIE Project Update
  article on EU Directive 2004/23/EC
• FECS Newsletter, July 2004 Article Towards
  standards of quality and safety for human tissues
  and cells in Europe
• Abstract submitted for the 10th European Forum on
  Quality Improvement in Health Care (BMJ) The
  JACIE project A Quality Improvement and
  Accreditation Programme for Haematopoietic Stem
  Cell Transplantation Facilities in Europe
• Plans to publish Press Releases to inform general
  public about the project/ importance of Standards
  in this field Assistance in translation,
  relevant media contacts.

38
Publications

• About JACIE
• Implementation of the JACIE Standards for a
  haematopoietic progenitor cell transplantation
  programme a cost analysis. D Zahnd et al. In
  print
• Editorial by Jane in November issue of BMT
  Journal
• Requirements for a Clinical BMT Unit A Urbano.
  chapter 4. EBMT Handbook. 2004 revised ed.
• List of publications on EBMT web site

39
Documentation
40
Documents

• 2nd edition of JACIE Standards Standards
  reviewed by D Samson to adopt to European
  terminology practice
• 2nd edition of JACIE Manual FACT manual adapted
  to European terminology reviewed by JACIE Board
  inspectors two copies to be sent to each EBMT
  member centre
• Information Packs These are intended to present
  JACIE to health authorities/ other accreditation
  bodies centres in countries outside the JACIE
  network.
• Training packs and model materials Training
  materials developed scripts being written in
  process of compiling model materials. Valuable to
  orientate centres, but danger of prescribing how
  things should be done centres can be protective
  of documentation produced

41
Surveys
42
Survey of centres inspected

• As part of the project evaluation we will be
  assessing the following
• Analysis of common difficulties in the process of
  accreditation Self-evaluation survey completed
  by centres (post inspection)
• Analysis of common deficiencies in meeting
  Standards Evaluated by the Medical Consultant,
  based on inspection reports and documentation
  submitted by centres (ongoing)
• Analysis of impact of implementation of JACIE
  Survey of centres to identify changes introduced,
  improvements noted as a result of implementing
  the Standards errors detected by the Quality
  Assurance System in place (6 mth post
  inspection) Assessment by Medical Consultant of
  impact on harmonisation
• Final reports to be produced for EC seek
  publication in BMT

43
Reporting to the EU

• Final technical implementation reports
  financial statements before the 1 Mar 2005
• What is required from National Representatives?
• Financial report on spending of national society
  on JACIE project activities in 2004 Accompanied
  by copies of receipts (flights, taxis,
  etc.)ensure invoices from JACIE office are paid.
• Report on status of JACIE at the national level
  Short report from each country on the impact of
  the JACIE project at the national level. Status
  of JACIE at the start of the project and any
  changes identified as a result of the project
  (1000 word report to the EU)
• Survey of JNRs of the utility of JACIE online
  JACIE Office to produce bi-monthly progress
  reports from system assist national
  representatives in producing overview reports at
  national level. National Representatives will be
  surveyed on the value of these reports, as part
  of the acceptance testing of the system (1000
  word report to EU)

44
2. Financing
45
Funding sources

• EU Call for Proposal 2004 Funding application
  unsuccessful
• Leonardo da Vinci A possibility for training
  courses educational materials. May be
  successful if we focus it on Member States which
  have recently joined the EU.
• Other funding bodies Ideas?
• EBMT ISCT Limited funding available in this
  initial project launch phase, but independent
  funding will be needed in the long-term
• National Societies Some of the bigger societies
  have been willing to fund participation in
  training courses. Will they still commit this
  funding for 2005? Long-term perspective?
• Prospect of charging centres To be discussed

46
Budget requirements in 2005

• Budget under Call for Proposal 2004
• Total 275,000
• EC Contribution 138,000
• EBMT Contribution 75,000
• National Societies 62,000

47
Core project costs in 2005
48
Option of charging centres

• Minimum annual budget 200,000
• BUT No reserves, potential problems end of yr
  no new
• projects Inspector training not covered no
  expansion
• 25 centres
• _at_ 10,000 250,000
• _at_ 12,000 300,000
• Or 8,000 200,000 seek additional support
  from EBMT
  ISCT and national societies?

49
3. Update of Standards finalisation of 2nd
edition of Manual
50
Draft proposals for amendments to Standards 1.
Junior Medical Staff

• Reason
• Junior medical staff are not specifically
  mentioned at all in section 3. This has led to
  confusion over whether junior staff need to meet
  requirement for transplant physicians or
  mid-level practitioners.
• Proposed modification
• B 3.5 Title replace Mid-level Practitioners by
  Nurse Practitioners and Junior Physicians
• B 3.520 to read Nurse practitioners shall be
  trained and competent specifically in the
  transplant-related cognitive and procedural
  skills that they routinely practise. Nurse
  practitioners should participate regularly in
  educational activities related to the field of
  HSC transplantation.
• Add new points following B3.510 and 3.520
• B3.530 Junior physicians should be
  appropriately licensed to practise medicine in
  Europe.
• B 3.540 Junior physicians shall be trained and
  competent specifically in the transplant-related
  cognitive and procedural skills that they
  routinely practise. Junior physicians should
  participate regularly in educational activities
  related to the field of HSC transplantation.

51
Draft proposals for amendments to Standards 2.
Evaluation of the Recipient

• Reason
• Section B.5.1 states The programme shall have
  written policies for..donor and patient
  evaluation, selection and treatment... Donors
  are dealt with extensively in section 6.0 but
  there is no further mention of evaluation of the
  recipient.
• Proposed modifications
• B 6.000 Change title to Patient and Donor
  evaluation, selection and management
•  B 6.1 Change first sentence to There shall be
  patient and donor evaluation procedures in place
  to protect the safety of the haemopoietic cell
  donor and the recipient.
•  B 6.11 Change to There shall be written
  criteria for patient and donor evaluation and
  selection
• B 6.400 Change to Donor and Patient Consents
• Add new items as follows
• 6.43 Patient Consent
• B 6.43 Informed consent from the patient for
  undergoing the transplant procedure must be
  obtained and documented.
• B 6.431 The procedure shall be explained in terms
  the patient can understand and shall include
  information about the significant risks and
  benefits of the procedure.
• B 6.432 In the case of a minor patient, informed
  consent shall be obtained from the patients
  parents or legal guardian in accordance with
  applicable law and shall be documented.

52
Draft proposals for amendments to Standards 3.
Therapy Administration (addition of TBI)

• Reason
• Section 7.1 States There shall be a written
  policy to ensure that the preparative regimen is
  administered safely. However, B 7.11, 7.12 and
  7.13 refer only to the prescription and
  administration of chemotherapy and there is no
  mention of radiotherapy.
• Proposed modifications
• Amend B 7.100 to read There shall be a written
  policy to ensure that the preparative regimen,
  including radiotherapy, is administered safely.
• Add new points after B7.130, as follows
• B7.140 There shall be a written request for
  radiotherapy to the consultant (senior physician)
  in radiation oncology including details of any
  prior radiotherapy. (D)
• B7.150 Radiotherapy planning must be the
  responsibility of the consultant (senior
  physician) in radiation oncology. (D)
• B7.160 Prior to administration of each dose of
  radiotherapy two persons qualified to administer
  radiotherapy shall verify the treatment doses
  against the protocol and verify the identity of
  the patient to be treated.
• B7.170 A final report of treatment administered
  should be approved by the consultant (senior
  physician) in radiation and provided to the
  patients transplant physician (D)

53
Draft proposals for amendments to Standards 4.
ABO and Rh testing of Products or Samples at time
of collection (D4.260)

• Reason
• Standard D 4.260 requires that ABO and Rh type
  shall be performed on each product or on blood
  obtained from the donor at collection. If there
  are previous records, there shall be a comparison
  of ABO and Rh type with the last available
  record. Any discrepancies shall be resolved and
  documented prior to issue of the product
• It is widely felt that performing ABO and Rh
  group at the time of collection does not confirm
  whether or not the component came from the
  correct patient. Even if the groups are the same.
  It is more likely that a mistake is made
  labelling the blood sample than the harvested
  PBPC.
• Proposed modification
•  Delete this standard OR change from Deficiency
  to Variance

54
Paediatrics and JACIE

• In JACIE there are a set of standards that seeks
  to equally protect children and adults
• It is not envisaged that adult transplant teams
  care for paediatric patients

55
Paediatrics and JACIE

• B3.110 Centres performing paediatric transplants
  shall have a transplant team trained in the
  management of paediatric patients.
• B3.120 For programmes performing paediatric
  transplantation, there shall be at least one
  attending physician who is board
  certified/eligible in Paediatric
  Haematology/Oncology or Paediatric Immunology.
• B3.413 Programmes transplanting paediatric
  patients shall have physicians experienced in
  treating paediatric patients.

56
Paediatrics and JACIE

• B3.620 Programmes treating paediatric patients
  shall have consultants, as defined in B3.610,
  qualified to manage paediatric patients.
• B3.720 Programmes treating paediatric patients
  shall have nurses formally trained and
  experienced in the management of paediatric
  patients.

57
Paediatrics and JACIE

• These requirements were proposed by the PDWP and
  incorporated to JACIE and FACT.
• A paediatric patient must be cared for by trained
  paediatric professionals in order to be
  accredited.
• The requirement for accreditation is identical
  for paediatric and for adults 10 new patients
  per year.
• If one adult centre performs lt10 allos and wants
  to join with a paediatric unit (or vice versa) to
  achieve the number of 10, this does not present a
  problem.

58
Paediatrics and JACIE

• It must be demonstrated that these adult and
  paediatric units really work together e.g. Same
  SOPs, same training programs, frequent joint
  meetings, same quality program etc.
• Paediatric and adult units that are working
  together in this manner should receive our
  support rather than being forced to work
  separately.
• The adult unit must perform at least 4 allo
  transplants, and the paediatrics unit must
  perform at least 4 allo transplants

59
Paediatrics and JACIE

• European paediatric centres are satisfied with
  the current requirements.
• If the minimum number of transplants for a joint
  programme is raised from 4 to 10, this would
  result in many paediatric centres being
  disaccredited or ineligible for accreditation.
• Before changing the standards we need evidence
  that European paediatric units consider 10 allos
  as the minimun, without the possibility of
  applying together with an adult unit

60
Paediatrics and JACIE

• Jackie Cornish, Paediatric representative
• Contribution on behalf of the Paediatric Diseases
  Working Party

61
Feedback received on 2nd edition of Manual
issues arising

• Comments received from
• 2 National Representatives
• 4 Inspectors
• Executive Committee also conducted review and
  forwarded comments to FACT
• Diana Samson in regular contact with Phyllis
  Warkentin, FACT Medical Director

62
Feedback received on 2nd edition of Manual
issues arising

• Standard D7.100 Samples. Sample aliquots of the
  component cryopreserved and stored under the same
  conditions as the component should be available
  for testing as necessary.
• Whilst 'cryopreserved under the same conditions'
  is unequivocal 'stored under the same conditions'
  appears not to be John Davis, UK
• Under discussion with FACT
• Labelling issues requirements too restrictive
  Gunnar Kvalheim, Norway
• See item 6 Ineke Slaper
• Changes from North American to European
  terminology

63
Terminology

• FDA changed to National and / or EU regulations
  and directives.
• Metropolitan area in context of common
  transplant programme replaced by programme sites
  should be situated geographically close enough to
  allow close and regular interaction
• Guidance one hour travel max

64
Sign off distribution of Manual

• Awaiting final FACT edition
• Incorporate changes agreed by Board into
  Standards and Guidance
• Make available on web site and publicise
• Send hard-copies to each EBMT centre in November
• Seek feedback for ongoing revision

65
4. Role of the Medical Consultant
66
Role of JACIE Medical Consultant

• Inspection of individual centres (35 time)
• Answer queries
• Review inspectors report and clarify where
  necessary
• Write summary report with specific
  recommendations
• Identifying Issues of General Relevance (15)
• Identify from inspectors reports or other
  sources (standards, wording, process)
• Interact with FACT Medical Consultant as
  appropriate
• Propose changes /modifications
• Acting as Member of JACIE Executive Committee
  (25)
• Assist with general work of JACIE
• Reading /revising documentation

67
Additional roles

• Assisting JACIE process in Individual Countries
  (10)
• Attended meetings of BSBMT accreditation
  Committee
• Will attend Swiss JACIE day Nov 24
• Interacting on behalf of JACIE with Other
  Organisations (15)
• Represent JACIE on
• FACT standards committee
• Council of Europe group on Cells and Tissue
  Guidelines
• UK DoH Policy Group on implementing EU Directive
• Contribute to JACIE response to EU and CE
  documents

68
5. Nursing JACIE

• Mairead Ní Chonghaile
• Secretary
• EBMT Nurses Group

69
Aims

• To develop a proposed strategy for the
  involvement of nurses, nursing allied health
  professionals (AHPs) in the JACIE process
• To recognise the involvement of nurses AHPs
• To recognise the contribution of nurses AHPs
• To include nursing issues in the documentation
  (evidence, manual report)

70
Background 1

• Nurses Group (NG) board met developed a draft
  strategy
• Nursing section of report is open to
  interpretation of what is meant covered needs
  clarification
• Need to look at short long term goals/issues

71
Background 2

• Want to be involved in the process
• Raise the profile of nurses nursing
• Areas to be included
• Care
• Management
• Experience
• Training Education

72
Document Review Process

• Initially an informal process
• Add to the pool of knowledge
• Highlight issues to be looked at
• Suggest a pilot project in 2005 with centres
  undergoing accreditation where documentation is
  reviewed by a panel of nurses

73
Nursing Standards

• Need to look at current standards
• Clarify or amend the guidance to assist in the
  process
• Set out standards where none currently exist
• Future discussion with FACT about the inclusion
  of nurses on the standards committee

74
Training

• Educational session to be presented on the
  training courses where possible to be delivered
  by a nurse
• Places to be reserved on training courses
  suggested 2 on quality course and 1 on inspectors
  training.

75
6. Harmonisation at EU and national levels
76
EU directive 2004/23/EC
77
EU Directive 2004/23/EC Setting standards of
quality and safety for the donation, procurement,
testing, processing, preservation, storage and
distribution of human tissues and cells

• Date March 31, 2004
• Published in the Official Journal of the European
  Union on April 7, 2004. Two years for
  implementation in each Member State
• This Directive should apply to tissues and cells
  including hematopoietic peripheral blood,
  umbilical cord (blood) and bone marrow stem
  cells, reproductive cells (eggs, sperm), foetal
  tissues and cells, and adult and embryonic stem
  cells

78
EU Directive 2004/23/EC

• Exclusion
• blood and blood products (other than
  Hematopoietic progenitor cells) and human organs,
  as well as organs, tissues, or cells of animal
  origin (EU 2002/98/EC Blood and Blood
  Components, followed by Commission Directive
  2004/33/EC 30-3-2004).
• Tissues and cells used as an autologous graft
  (tissues removed and transplanted back within the
  same surgical procedure and without being
  subjected to any banking
• Not applicable for research (animal studies)
• Tissues and cells intended for industrially
  manufactured products including medical devices
  only as far as donation, procurement and testing
  are concerned (further steps are covered by
  Directive 2001/83/EC)

79
EU Directive 2004/23/EC

• Chapter I General provisions (article 1-4)
• Chapter II Obligations on Member State
  Authorities (article 5-11)
• Chapter III Donor Selection and Evaluation (
  article 12-15 )
• Chapter IV Provisions on the quality and safety
  of cells (article 16-24)
• Chapter V Exchange of information, reports and
  penalties (article 24 - 30)
• Chapter VI Final provisions on the quality and
  safety of cells (article 31-33)
• Annexes Technical requirements

80
EU Directive 2004/23/EC

• Establishment of a register of entities operating
  in the field
• Designation of the competent authority(ies) in
  Member States
• Implementation of a quality system for tissue
  establishments, including specification of
  activities relating to a quality system (SOPs,
  guidelines, training reference manuals,
  reporting forms, donor records, information on
  final destination of tissues or cells, etc.)
• Introduction of a system of accreditation of
  tissue establishments by Member States and a
  system for notification of adverse events and
  reactions
• Organisation of inspections and control measures
  within Member States
• Data protection and confidentiality.
• Assurance of traceability of tissues and cells
  through laboratory identification
• procedures, record maintenance and an appropriate
  labelling system
• Design of a single European coding system to
  provide information on the main characteristics
  and properties of tissues and cells

81
EU Directive 2004/23/EC Setting standards of
quality and safety for the donation, procurement,
testing, processing, preservation, storage and
distribution of human tissues and cells

• Annexes Commission Directive implementing EU
  Directive 2004/23/EC of the European Parliament
  and of the Council as regards certain technical
  requirements for
• the donation, procurement and testing of human
  tissues and cells
• Public consultation for the first set October 1,
  2004
• processing, preservation, storage and
  distribution of human tissues and cells
• Private consultation for the second set October
  20, 2004

82
Feedback on technical requirements for the
donation, procurement and testing of human
tissues

• JACIE welcomes the EU directive, in principle
  correct and in agreement with the JACIE
  standards.
• Drawbacks generic nature of the document,
  written largely from the viewpoint of cadaveric
  organ donation.
• Suggestion JACIE would be happy to assist in the
  re-writing of a separate section for
  haematopoietic progenitor cells. It would also be
  helpful to include a reference to the
  JACIE standards in these annexes as an example of
  the organisation of a tissue collection/processing
  establishment
• Terminology used to describe Haematopoietic
  Cells the terms bone marrow haematopoietic
  progenitor cells cord blood and peripheral
  blood cells are variably used at different
  places and this is confusing. It should also be
  recognised that haematopoietic products include
  cellular therapy products other than stem cells,
  such as donor lymphocytes.

83
Cellular immunotherapies
84
CoE RESEARCH GROUP ONCELLULAR IMMUNE THERAPIES

• Cellular immune therapies (CIT) involve the
  collection, manipulation and/or infusion of
  lymphocytes, natural killer (NK) cells,
  macrophages, dendritic cells and (modified)
  tumour cells. CIT show potential for the
  treatment of malignant, viral and autoimmune
  diseases and for inducing tolerance following
  organ transplantation.

85
CoE RESEARCH GROUP ON CELLULAR IMMUNE THERAPIES

• SP-CIT Appointed by the governments of Council of
  Europe States
• All articles of EU Directive 2004/23/EC are
  relevant
• Quality Assurance based on Good Manufacturing
  Practice or ISO 9000 series

86
CoE RESEARCH GROUP ON CELLULAR IMMUNE THERAPIES

• The SP-CIT recommends that CIT should be carried
  out by institutions which are officially licensed
  by national health administrations, or recognised
  by the competent authorities. The accreditation
  of facilities by international voluntary
  organisations (e.g. JACIE) should be encouraged.

87
European LRA Committee?
88
Legal and RegulatoryAffairs

• There is no official European LRA Committee
• ISCT has a LRA Committee (chair Linda Kelley),
  mostly focussed on Northern America
• JACIE is offering a accreditation system and
  thereby directly involved
• Involvement EBMT?
• Council of Europe has advisory committee
  structure
• Aim European group of experts (laboratory,
  clinicians) for official feedback on LRA in EU.
• Key questions do we need an European LRA and who
  to approach?

89
Common labelling procedure

• EU coding system for tissues and cells
• Jim Foreman has been chairing a group that has
  done an excellent job in producing an ISBT128
  label design for stem cells that meets UK
  requirements and is compliant with JACIE
  labelling guidance

90
What is ISBT128 ?

• ISBT128 is an information standard for
  transfusion and transplantation
• Developed and accepted by ISBT in 1994
• Endorsed by AABB, EBA, FDA, EPFA
• Managed by ICCBBA Inc.
• http//www.ibts.ie/docs/Traceability20in20a20Eu
  ropean20Context,20Mr20Paul20Ashford.PPT

91
What does ISBT128 offer?

• A donation numbering system that ensures globally
  unique identification
• International product codes and definitions
  (Blood Components, Tissues and Stem Cells)
• Standard data structures for other key
  information (blood group, expiry, antigen
  profiles etc.)

92
Donation Identification Number

• Comprises 4 elements
• Facility identification code
• Year indicator
• Sequential number
• Flag characters
• Manual entry check character

93
Product Codes

• Definitions built up from
• Component Class
• Modifiers
• Core Conditions
• Attributes
• Over 4,000 codes currently defined
• If the code you need is not there, it can easily
  be added
• Product barcode also holds information on splits

94
An example

• Component ClassRed Blood Cells
• Modifier None
• Core Conditions
• anticoagulent CPDA-1
• original volume 450 ml
• storage conditions refrigerated
• Attribute Irradiated
• E0206

95
Discussion items

• European LRA Committee.
• Proposal by Paul Ashford a small international
  working group with participation of JACIE/FACT to
  develop standard label templates

96
EU Doctors Directive
97
EU Doctors Directive

• European Parliament legislative resolution on the
  proposal for a European Parliament and Council
  directive on the recognition of professional
  qualifications (COM(2002) 119 - C5-0113/2002 -
  2002/0061(COD))
• Directive cited only 17 of 52 medical specialties
  cited within the current Directive. It excludes
  Hematology.
• The European Parliament moved to reinstate all 52
  specialties
• European Commission then supported original text
  of proposal and moved to retain only 17 of the 52
  previously cited medical specialties. This would
  exclude Hematology.
• The European Council suggested that medical
  disciplines recognized as independent specialty
  in 2/5 of European Union member States should be
  cited in Directive.
• MEPs directly interested in this issue met for
  first time at end of August 2004.
• The second Parliament reading of proposal for new
  Directive scheduled for October. Possible that
  final decision taken at that time.

98
EU Doctors Directive

• Implications for JACIE
• B3.000 Higher specialist training in
  adult/paediatric Haematology/Oncology or
  Immunology
• JACIE to make representation to EU
• EHA is leading campaign

99
7. National updates
100
Anticipated inspections in 2005

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

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

101
Overview at National level

• Overall feeling with respect to JACIE
• Issues arising from inspections, training
  courses, etc. (difficulties, doubts, positive
  factors)
• Status of JACIE (legal, insurance, funding,
  interactions with health authorities other
  accreditation bodies)
• Plans for 2005 (Nº of centres interested in
  inspections Nº/speciality of inspectors to
  train training of centres in QMP)

102
Information Packs

• Aims objectives
• To inform transplant centres, national societies
  health authorities in countries being brought
  into the JACIE network about the requirements of
  JACIE
• For use by all JACIE national representatives to
  advocate with health authorities on behalf of
  JACIE to liaise with other accreditation bodies
• General information pack for enquiries received
  by the JACIE Office

103
Information Packs

• Content
• Introductory booklet
• 2nd edition of Standards
• 2nd edition of Manual necessary or not?
• Copy of EU Directive
• Other items?

104
Information Packs

• Content outline of Introductory booklet
• The context
• The solution
• Why JACIE?
• Who or what is JACIE?
• Why should health authorities take notice?
• What does JACIE offer?
• Where is JACIE already working?
• Resources required.
• Snapshot of JACIE

105
8. Moving forward
106
Interactions with WMDA

• It is JACIEs objective to reach agreement with
  the WMDA that as of
• 2010, transplant programmes would require
  JACIE/FACT
• accreditation in order to receive cells from
  unrelated donors.
• Discussions on this issue with the WMDA are
  ongoing
• The next meeting will take place at ASH, San
  Diego with
• representatives from JACIE, FACT and WMDA

107
Joint session EBMT/ WMDA/ ISCT at EBMT 2005

• Jeremy Chapman (WMDA) Regulation of
  haematopoietic stem cell transplantation -
  globalization versus separatism (or something
  like that including his WHO activities)
• Alvaro Urbano-Ispizua (EBMT, JACIE)
  Accreditation of haematopoietic stem cell
  transplant facilities
• Dr. Erik Braakman (ISCT) Accreditation of stem
  cell collection and storage facilities
• Colette Raffoux (or someone else from the French
  registry) Accreditation of unrelated donor
  registries
• For the EU Mariza Papaluca in EMEA could be a
  possibility - open to suggestions

108
Outside Europe

• There is interest in JACIE Standards from centres
  in Latin America including Argentina and Mexico
• Possible extension of JACIE

109
9. AOB
110
AOB

• Next meeting
• Issues arising in relation to selection of
  inspectors and training courses (dates of
  courses selection of trainee inspectors exams
  certification of inspectors)
• Confidentiality of inspectors
• Letter to support centres in applying for funding
  for quality managers, etc.