How JACIE Works

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How JACIE Works
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Aims /Role of JACIE
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JACIE Structure
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The JACIE BOARD

• Executive Committee
• Chairman Alvaro Urbano-Ispizua (EBMT) (clinical)
• Vice Chairman Ineke Slaper-Cortenbach (ISCT)
  (laboratory)
• Medical Director Diana Samson (clinical)
• Co-opted Member Derwood Pamphilon (collection)
• Executive Officer Eoin McGrath
• Sector representatives
• Paediatrics Jackie Cornish
• Nursing Barry Quinn
• NETCORD Peter Wernet
• National Representatives
• 20 countries at present

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The JACIE Office

• Located in Barcelona at Hospital Clinic
• Shares office with EBMT Secretariat
• All processes and documentation now managed
  on-line
• www.jacie.org

Eoin McGrath
Sarah Craig
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Aims /Role of JACIE
1. Accreditation of Individual Centres
Standards Accreditation process Typical
deficiencies
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(No Transcript)
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FACT - JACIE Standards do not apply to HPC-C
collection/storage do apply to TC
Section headings from 3rd edition
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Standards - general points

• Importance of documentation
• Not just SOPs and policies
• Training records
• Written criteria for donor selection
• Documentation of donor suitability in recipients
  medical record
• Documented communications between facilities
• Service contracts with external facilities
• Written information to collection facility about
  donor
• Written request for collection / cells for
  infusion
• Importance of training and competency
• All staff must be trained for what they do
• Competency must be documented
• Importance of quality management
• SOPs, policies, validation, qualification,
• Monitoring performance outcome review, audit,
  adverse event reporting

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The Inspection and Accreditation Process 1.

• Preparation by Centre
• implements measures to meet standards
• as described in the JACIE accreditation manual
• Applies for accreditation under relevant areas
• clinical, BM collection, apheresis collection,
  processing
• notes if any facilities serve other
  organisations
• and if so, whether stand-alone accreditation
  is requested
• Submits documentation
• self-assessment inspection checklist (i.e. the
  questions in the JACIE manual with questions
  completed)
• other documentation including list of all
  SOPs, SOP for SOP, nursing summary etc at least
  6 weeks prior to inspection

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Inspection checklist
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The Inspection and Accreditation Process 2.

• Preparation by JACIE Office
• Application and documentation reviewed by office
  and MD
• Any particular points noted that inspectors need
  to look at
• Any facilities serving other programmes
• Any possible problem areas - e.g. 2-site
  clinical programme, combined adult/paed programe
• Inspectors appointed
• Usually I inspector per facility (clinical
  /collection/processing)
• Paediatric expertise if relevant
• Inspectors must all be JACIE-trained and have
  passed exam.
• Must speak /understand language of centre
• First inspection always with another inspector
  who has already inspected
• One inspector asked to act as Team Leader (must
  have done at least one inspection before)
• Cross- inspection between centres is avoided
• The Applicant may reject a proposed inspector

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The Inspection and Accreditation Process 3.

• Inspection
• Inspectors review submitted documentation prior
  to visit
• On-site visit lasting 1- 1.5 days, depending on
  size of programme
• Inspection involves observation, interview and
  review of documentation
• Inspectors complete their boxes in the inspection
  checklist, noting all non-compliances
• Exit meeting with Programme Director summarising
  main findings
• Submit report to JACIE office

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Documentation - Clinical programme

• Submitted before inspection
• Organigramme of programme
• CVs, registration, evidence of training,
  educational activity for all senior medical staff
• Nursing summary (staffing, training etc)
• Quality manual and SOP for SOP
• List of SOPs
• Patient and donor consent forms
• List of patients (Activity data)
• MED-A data for 10 consecutive patients

• Documentation to see on site
• Patient notes for check of MED A data
• Sample donor notes
• Selected SOPs
• Proformas for High Dose Therapy
• Training records
• Audit reports
• Adverse Event (AE) reports
• Minutes of meetings
• Quality review meetings
• Patient management meetings
• etc

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The Inspection and Accreditation Process 4.

• Reports
• Inspectors report
• Includes general comments and specific comments
  on individual standards
• M Director and JACIE officer write additional
  report
• Commenting where necessary on inspectors
  findings, e.g. interpreting standard
• Noting current level of compliance
• Making recommendations for changes listed in
  Correction Form
• Aim is to ensure consistency between centres /
  countries
• Both reports are reviewed by Executive Committee
• Sent to centre with copy to National
  Representative

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Sample Inspector report
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Sample Medical Directors report

• Deficiencies and/or variations
• General
• SOPs were often not associated with examples of
  completed forms or labels. The centre needs to
  ensure that completed forms or labels are
  appended to all SOPs, where relevant, and send
  copies of the revised SOPs to the JACIE Office
  (JO).
• Clinical programme
• Not all of the attending physicians are
  board-certified in haematology or another of the
  requested specialties. However those that are not
  certified in haematology etc. are certified in
  internal medicine and have appropriate training
  in clinical transplantation according to the
  standards. In the opinion of the medical
  director, this is satisfactory
• Not all the transplant physicians are proficient
  in bone marrow harvest. However the team had
  sufficient trained staff to carry out marrow
  harvests when requested. In fact the standards
  (section 3.4) state that the transplant
  physicians should be knowledgeable in bone marrow
  harvest, and do not specify they need to be
  proficient

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Level of compliance at inspection (n36/41)
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The Inspection and Accreditation Process 5.

• Centre Response
• Centre makes agreed changes and submits evidence
  to confirm
• Should be within specified time period (3-12
  months)
• Documentation reviewed by original inspectors
  and MD
• Final report written indicating centre is fully
  compliant
• Final report and docs reviewed by the Executive
  Committee
• Accreditation
• JACIE Executive Committee makes a recommendation
  to the JACIE Board
• Board have 2 weeks to repond
• If approved, accreditation awarded
• valid for 3 years subject to return of an
  Annual Report
• Accredited centres / facilities listed on
  JACIE website
• currently 21, 6 in UK

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Examples of Deficiencies

• Difference between a minor deficiency and a
  significant deficiency is a matter of judgement
• Minor deficiencies
• SOPs missing references
• pregnancy assessment not documented during donor
  evaluation
• Significant deficiencies
• Programme not functioning as a single programme
  (e.g. SOPs not uniform across different clinical
  sites)
• Inpatient isolation facilities inadequate (shared
  rooms for autografts)
• Engraftment data not monitored by processing
  facility
• No continuous temperature monitoring of freezers
• Temperature not monitored during transport of HPC
  from lab to clinical unit
• Inadequate quality management programme

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Typical Problem Areas 1.

• Quality Management (clinical / collection
  gtlaboratory)
• Inadequate document control
• Policies /SOPs not reviewed annually
• deviations from SOPs not documented
• audits not regularly performed
• adverse events not reviewed by Programme director
• (recommend at least 6 months running QMP prior
  to inspection)
• Patient / Donor issues
• No record of verification of patients diagnosis
• No formally documented criteria for defining
  suitable donor
• Not clear how the decision is made to use a donor
  not meeting the programmes selection criteria

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Typical Problem Areas 2.

• Processing Facility
• temperature not monitored during transport
• engraftment data not regularly monitored
• alarm system not adequate
• Labels not compliant in various ways
• no unique alphanumeric code
  (code must be unique to the collection
  not just the patient /donor)
• Correct components names not used
• Missing volume of anticoagulant
• Biohazard labels not used (due to local /national
  restrictions)

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General issues arising from inspections

• Conflicts with current practice in different
  countries, e.g.
• France national law forbids biohazard labelling
• Issues with Unrelated transplants, e.g.
• Clinical programmes often receive cells from
  non-accredited collection centres cannot easily
  enforce requirement to use an accredited
  collection facility
• Provision of engraftment data to collection
  facilities is not always in place
• Areas where standards needed amendment, e.g.
• No specific standards for safe administration of
  TBI
• Requirement to check ABO/Rh group on donation not
  logical

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Aims /Role of JACIE 2

• Information /
• Education
• Information
• QM courses
• Training courses
• for inspectors
• Sample documents

• JACIE website
• FAQs,
• Discussion forum
• List of common deficiencies
• etc.

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Aims /Role of JACIE 3

• Regulatory Issues
• Standards
• Regulations
• Harmonisation
• International
• cooperation

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Revisions to Standards (3rd Ed)

• Work ongoing since last May
• Need to take into account
• Suggestions for improvement
• new regulations (FDA, EUD)
• concurrent revision of FACT-Netcord standards
• FACT subcommittees (Clinical /Collection/Processin
  g) with JACIE representation, and Oversight
  Committee
• Public consultation FACT website
• Revision by committees in response to comments
• Final draft - this is where we are now
• Agreement by FACT and JACIE Boards
• THESE ARE NOW JOINT FACT-JACIE STANDARDS one
  document

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3rd Edition Main Changes - 1
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3rd Edition Main Changes - 2
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Regulatory/ accrediting bodies affecting SCT
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Import and Export of Cells A global issue

• 20 of HPC now cross international boundaries

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Implications of Directive 2004/23/EC for Import
and Export of Cells

• Member States are required to ensure that cells
  imported meet requirements of the Directive
• Potential problem with donors from non-EU
  countries
• Similar issues with FDA and import of cells to US
• Concerns that UD donation will be endangered
  /delayed
• FACT-JACIE / WMDA could provide a system for
  demonstrating compliance with requirements
• Also need a clear system to allow import of
  ineligible cells in case of urgent medical need
• Meeting with EU Head of Public Health 9th March
  to discuss these issues, including
  representatives of EBMT, ISCT, WMDA and JACIE

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Harmonisation and cooperation

• JACIE

• FACT

• EU

• WMDA

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Numbers of HSCT centres in Europe
Based on 2003 EBMT Activity Survey