D Pamphilon JACIE ppt NIBSC 23 11 2004

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Published on October 17, 2007

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JACIE - Update on Progress:  JACIE - Update on Progress Derwood Pamphilon Stem Cells and Immunotherapy National Blood Service Slide2:  The Joint Accreditation Committee EBMT-ISCT Europe (JACIE) program of accreditation was established in 1999, with the aim of creating a standardised system of accreditation officially recognised across Europe. Slide3:  SCT PROGRAMME marrow stem cells apheresis unit Section C COLLECTION FACILITY - laboratories Section D PROCESSING FACILITY clinical SCT in and outpatients Section B CLINICAL FACILITY Slide4:  BOARD PRESIDENT Alvaro Urbano EBMT NATIONAL REPRESENTATIVE Vice-President I Slaper-Cortenbach ISCT JACIE OFFICE ORGANISATION OF JACIE GENERAL SCHEME FOR THE MANAGEMENT OF JACIE ACCREDITATION:  GENERAL SCHEME FOR THE MANAGEMENT OF JACIE ACCREDITATION Agreement that a centralised procedure is needed. The central office will manage: Initial registration. Processing and checking of documentation. Review of inspector reports and issue of certificates. Production and update of materials. Closely coordinated with the national representatives. Web-based system will facilitate the information and tracking. INSPECTORS:  INSPECTORS National representatives are responsible for the recruitment of inspectors and assignment of visits. Coordinated centrally: - Common training courses and examinations. - Qualifications and issue of certification. - Registration in the central database. Full access to this information will be available to national representatives via the online system. JACIE in the UK:  JACIE in the UK Administered in concert with the BSBMT Transplant Accreditation Committee (TAC) Medical, Scientific and Quality representatives, Nursing appointment tba Role: training, standards, inspection, budgetary Inspector Training:  Inspector Training Courses in Barcelona annually for inspectors; 2004 - 6 UK trainees Course in Jan 2004 for inspectees 10 UK delegates BSBMT course for inspectors Sept 2004 in London; 14 UK and 4 non-UK delegates MULTIPLE CHOICE EXAM:  MULTIPLE CHOICE EXAM A single clinical programme cannot include inpatient units in two different hospitals. True or False? A cell processing facility may serve more than one clinical programme. True or False? To meet JACIE Standards, transplant physicians must: a) be proficient in BM harvest – True or False? b) be proficient in HPC component infusion – True or False? c) be able to process/cryopreserve HPC – True or False? UK Inspectors Trained:  UK Inspectors Trained Clinical/collection - 24* Processing laboratories - 13 Total - 31 Inspectors are ‘qualified’ *includes 4 paediatric inspectors INSPECTION/ACCREDITATION PROCESS:  INSPECTION/ACCREDITATION PROCESS Complete Registration form from JACIE office Submit programme documentation SATISFACTORY YES Inspection scheduled 8 weeks minimum notice Report back to Centre NO Request further information Qualifications No. of procedure Checklist Section B, C, D checklists. Organisational chart and names. Physical map of facilities. EFI Certificate. Satisfactory INITIAL TIMETABLE:  INITIAL TIMETABLE 8.00 a.m. Initial interview. 8.30 a.m. Inspectors review documentation. 12.00 p.m. Lunch. 1.00 p.m. On site evaluations. 3.30 p.m. Closed session. 4.00 p.m. Exit interview (closed session??). Slide13:  INSPECTION OUTCOMES LEVEL DESCRIPTION 1 Full 3-year accreditation (FA) 2 FA subject to review of documents. 3 As 2, but Board must review. 4 Focused reinspection. 5 Full reinspection. 6 Non-accreditation must reapply. Slide14:  Inspections scheduled in 2004 UK Inspections in 2004:  UK Inspections in 2004 Bristol - 25th June; 4 inspectors Leeds - 28th June; 4 “ Oxford - 30th Sept/1st Oct; 3 insp Nottingham - 4-5th Oct; 3 insp Birmingham - Nov/Dec National rep attends as an observer Feedback from centres:  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” Feedback from inspectors:  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.” Inspectors & inspections:  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:  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:  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 General Review of Inspections:  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 General issues identified to date:  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:  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 Developments to process:  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. UK Inspections in 2005:  UK Inspections in 2005 10 are predicted based on BSBMT member survey Some will be ‘stand alone’ inspections for processing labs and clinical programmes JACIE Online:  JACIE Online Design and implementation of an online system to manage the accreditation process: Initial / renewal applications Document submission Inspectors’ tasks Consultant’s tasks Board review of application Renewal General JACIE information Launch due: end-October 2004 Slide27:  Online document submission Documents:  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 3. Update of Standards & finalisation of 2nd edition of Manual:  3. Update of Standards & finalisation of 2nd edition of Manual Draft proposals for amendments to Standards 1. Junior Medical Staff:  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.” Draft proposals for amendments to Standards 2. Evaluation of the Recipient:  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. Draft proposals for amendments to Standards 3. Therapy Administration (addition of TBI):  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) B7.170 A final report of treatment administered should be approved by the consultant (senior physician) in radiation and provided to the patient’s transplant physician (D) Terminology:  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 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 Common labelling procedure:  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 does ISBT128 offer?:  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.) Labelling Initiative:  Labelling Initiative Paul Ashford - establish a small international working group. Endorsed by FACT/JACIE JACIE reps - DHP, Ineke Slaper

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