Title: JACIE Board meeting
1JACIE Board meeting
- Friday, 7 October 2004 (12.00 17.00)
- Amsterdam
2Role 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
3Role 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
41.JACIE Project update
5Overview of inspections
6Inspections scheduled in 2004
7Schedule 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 ?
8Impressions from the JACIE Office
9Organisation
- Biggest headaches
- coordinating dates
- finding appropriate inspectors with expertise and
language - Biggest satisfaction
- hearing good feedback/report on an inspection
10Feedback 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
11Feedback 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.
12Overall 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
13Inspectors 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
14Number 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
15International 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
16Special 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
17Consultants overview
18First 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
19General 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
20General 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
21General 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.
22General 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
23General 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
24Developments 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.
25Training
263. Training courses in 2004
27Attended inspector training
Not all have returned the documents and
completed the exam -In progress
28Inspectors
- 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
29Inspectors languages
- German 20-25
- French 15-20
- English 35-40 (plus non-natives with high
level)
30Number of inspectors by area
Some inspectors cover multiple areas. Pre-2003
trainees may not have registered their area
31JACIE Online
325. 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
33SAMPLE VIEW ONLY
Online document submission
34SAMPLE VIEW ONLY
35SAMPLE VIEW ONLY
36Publications
37Publications
- 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.
38Publications
- 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
39Documentation
40Documents
- 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
41Surveys
42Survey 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
43Reporting 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)
442. Financing
45Funding 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
46Budget requirements in 2005
- Budget under Call for Proposal 2004
- Total 275,000
- EC Contribution 138,000
- EBMT Contribution 75,000
- National Societies 62,000
47Core project costs in 2005
48Option 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?
493. Update of Standards finalisation of 2nd
edition of Manual
50Draft 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.
51Draft 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.
52Draft 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)
53Draft 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
54Paediatrics 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
55Paediatrics 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.
56Paediatrics 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.
57Paediatrics 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.
58Paediatrics 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
59Paediatrics 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
60Paediatrics 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
63Terminology
- 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
64Sign 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
654. Role of the Medical Consultant
66Role 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
67Additional 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
685. Nursing JACIE
- Mairead Ní Chonghaile
- Secretary
- EBMT Nurses Group
69Aims
- 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)
70Background 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
71Background 2
- Want to be involved in the process
- Raise the profile of nurses nursing
- Areas to be included
- Care
- Management
- Experience
- Training Education
72Document 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
73Nursing 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
74Training
- 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.
756. Harmonisation at EU and national levels
76EU directive 2004/23/EC
77EU 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
78EU 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)
79EU 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
80EU 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
81EU 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
82Feedback 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.
83Cellular immunotherapies
84CoE 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.
85CoE 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
86CoE 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.
87European LRA Committee?
88Legal 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?
89Common 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
90What 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
91What 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.)
92Donation Identification Number
- Comprises 4 elements
- Facility identification code
- Year indicator
- Sequential number
- Flag characters
- Manual entry check character
93Product 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
94An example
- Component ClassRed Blood Cells
- Modifier None
- Core Conditions
- anticoagulent CPDA-1
- original volume 450 ml
- storage conditions refrigerated
- Attribute Irradiated
- E0206
95Discussion items
- European LRA Committee.
- Proposal by Paul Ashford a small international
working group with participation of JACIE/FACT to
develop standard label templates
96EU Doctors Directive
97EU 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.
98EU 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
997. National updates
100Anticipated inspections in 2005
- Austria
- Belgium 2
- Denmark 1
- Finland 2
- France 5
- Germany
- Italy 5
- Netherlands
- Norway
- Spain 3
- Sweden 1
- UK 10
101Overview 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)
102Information 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
103Information Packs
- Content
- Introductory booklet
- 2nd edition of Standards
- 2nd edition of Manual necessary or not?
- Copy of EU Directive
- Other items?
104Information 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
1058. Moving forward
106Interactions 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
107Joint 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
108Outside Europe
- There is interest in JACIE Standards from centres
in Latin America including Argentina and Mexico - Possible extension of JACIE
1099. AOB
110AOB
- 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.