JACIE Board meeting - PowerPoint PPT Presentation

1 / 110
About This Presentation

JACIE Board meeting


Harmonisation of different accreditation processes. Resolution of general conflicts ... Network building & harmonisation. Public reassurance. Breakdown of costs ... – PowerPoint PPT presentation

Number of Views:277
Avg rating:3.0/5.0
Slides: 111
Provided by: ebmt


Transcript and Presenter's Notes

Title: JACIE Board meeting

JACIE Board meeting
  • Friday, 7 October 2004 (12.00 17.00)
  • Amsterdam

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

Role of JACIE Board (II)
  • Harmonisation of different accreditation
  • Resolution of general conflicts
  • Approval of budget and accounts
  • Official approval of centres accreditation and
    issue of certification

1.JACIE Project update
Overview of inspections
Inspections scheduled in 2004
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 ?

Impressions from the JACIE Office
  • Biggest headaches
  • coordinating dates
  • finding appropriate inspectors with expertise and
  • Biggest satisfaction
  • hearing good feedback/report on an inspection

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
  • 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

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
  • 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
  • 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

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

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

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

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

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

Consultants overview
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

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,
  • Few other issues,e.g.need temperature monitor
    during transport
  • Few level 3 significant deficiencies e.g.
  • no monitoring of engraftment data by processing
  • inadequate in-patient facilities at second
    clinical site

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

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
  • 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

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

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

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

3. Training courses in 2004
Attended inspector training
Not all have returned the documents and
completed the exam -In progress
  • 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

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

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

Online document submission
  • 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.

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

  • 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
  • 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

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

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)

2. Financing
Funding sources
  • EU Call for Proposal 2004 Funding application
  • 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

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

Core project costs in 2005
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
  • 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?

3. Update of Standards finalisation of 2nd
edition of Manual
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
  • 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.

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
  • 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
  • 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.

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)

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
  • Proposed modification
  •  Delete this standard OR change from Deficiency
    to Variance

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

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.

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

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
  • 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

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
  • The adult unit must perform at least 4 allo
    transplants, and the paediatrics unit must
    perform at least 4 allo transplants

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

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

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

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

  • 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

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

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

Additional roles
  • Assisting JACIE process in Individual Countries
  • Attended meetings of BSBMT accreditation
  • 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
  • UK DoH Policy Group on implementing EU Directive
  • Contribute to JACIE response to EU and CE

5. Nursing JACIE
  • Mairead Ní Chonghaile
  • Secretary
  • EBMT Nurses Group

  • 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)

Background 1
  • Nurses Group (NG) board met developed a draft
  • Nursing section of report is open to
    interpretation of what is meant covered needs
  • Need to look at short long term goals/issues

Background 2
  • Want to be involved in the process
  • Raise the profile of nurses nursing
  • Areas to be included
  • Care
  • Management
  • Experience
  • Training Education

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

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

  • 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

6. Harmonisation at EU and national levels
EU directive 2004/23/EC
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

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)

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

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
  • 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

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,
  • processing, preservation, storage and
    distribution of human tissues and cells
  • Private consultation for the second set October
    20, 2004

Feedback on technical requirements for the
donation, procurement and testing of human
  • JACIE welcomes the EU directive, in principle
    correct and in agreement with the JACIE
  • 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
  • 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.

Cellular immunotherapies
  • 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.

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

  • 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.

European LRA Committee?
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
  • 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?

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

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

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.)

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

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

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

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

EU Doctors Directive
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 -
  • Directive cited only 17 of 52 medical specialties
    cited within the current Directive. It excludes
  • The European Parliament moved to reinstate all 52
  • 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.

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

7. National updates
Anticipated inspections in 2005
  • Austria
  • Belgium 2
  • Denmark 1
  • Finland 2
  • France 5
  • Germany
  • Italy 5
  • Netherlands
  • Norway
  • Spain 3
  • Sweden 1
  • UK 10

Overview at National level
  • Overall feeling with respect to JACIE
  • Issues arising from inspections, training
    courses, etc. (difficulties, doubts, positive
  • 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)

Information Packs
  • Aims objectives
  • To inform transplant centres, national societies
    health authorities in countries being brought
    into the JACIE network about the requirements of
  • 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

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

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

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

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
  • For the EU Mariza Papaluca in EMEA could be a
    possibility - open to suggestions

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

9. 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.
Write a Comment
User Comments (0)
About PowerShow.com