JACIE Inspectors Meeting

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JACIE Inspectors Meeting

• Sunday, 19th March 2006
• Hamburg, Germany

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INFORMATION UPDATE

• Applications

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Inspections Jan 2004Mar 2006

• Austria 3
• Finland 2
• France 6
• Italy 1
• Netherlands 4
• Switzerland 10
• United Kingdom 10
• 36

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Accredited Centres
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Centres close to accreditation

• Clermont Ferrand, Francerecommended to Board
• Institut Gustave Roussy, Franceto be
  recommended to Board
• John Radcliffe Hospital, Oxfordawaiting EFI
  certification for HLA lab.

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Centres in post-audit phase

• Helsinki
• Turku
• Turin (paediatric)
• Leiden
• Erasmus MC
• Utrecht lab collection

• Zurich (paediatric)
• Zurich University Hospital
• Cambridge
• Hammersmith
• NBS Sheffield
• Sheffield Childrens

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Upcoming inspections 2006

• Sanquin Research HSC Lab, Amsterdam, The
  Netherlands
• Institut Català d'Oncologia, Badalona, Spain
• Queen Elizabeth Hospital, Birmingham, UK
• South Warwickshire General Hospitals NHS Trust,
  UK
• University Hospitals Coventry Warwickshire NHS
  Trust UK
• Centre Léon Bérard, Lyon, France
• Univ. Hospital, Katowice Poland

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Inspectors

• 103 certified inspectors in total
• 18 countries
• Experience
• 53 min. 1 inspection (1-28 2-17 3-8)
• 50 no experience
• Additional 53 pending (attended training but
  has not returned documents /exam /registration)
• Of these 4 have inspected due to shortage
• First qualified inspectors due for renewal June
  2006
• Requires recertification
• Inspector workshop desirable
• Inspector input into Inspection Guidelines

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Inspectors categories by country
Note Inspectors may be qualified in more than
one category
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Training Courses

• Quality Management Courses
• April 20th 21st Brussels, Belgium
• May 10th 11th Bristol, United Kingdom
• June 29th 30th Olomuec, Czech Rep.
• (prov.) September Athens, Greece
• Inspector Courses
• (prov.) May/June Rhodes, Greece
• September Frankfurt, Germany (1-day
  conversion course)

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Meetings

• Future seeking inclusion of JACIE/quality
  management in EBMT annual meeting programme
• Any other opportunities?
• National society meetings
• Congresses
• Nurses conferences
• Slides and assistance available from JACIE Office

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3rd version of Standards
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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 ed. Main Changes - 1
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3rd ed. Main Changes - 2
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Nurse input on audits

• Nurse expert looks at documentation before
  inspection
• Expert should have attended training course
• Lists specific items for inspector to examine
• Piloted for Hammersmith audit
• Barry Quinn reviewed nursing documentation
• Shortage of nurse experts
• Report to be incorporated into Inspection Report
  as an appendix

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Inspection costs
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PROPOSAL Inspection Accreditation Committee

• Inspection Accreditation Committee
• Similar to FACT
• Committee would replace Medical Director role for
  consideration of applications and reports
• 1 member or more from each area of Standards
• Work with JACIE Exec. Officer on reports and
  recommendations on applications and audits
• Spread accreditation experience among wider group
  of experts
• Require 1 telecon per month plus time to review
  documentation (est. 5 hours per month)

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European Union Standards and Training for the
Inspection of Tissues Establishments (EUSTITE)

• Project funded under the EU 2005 Work Plan
• Objectives
• State-of-the-Art document which clearly
  outlines the proposed EU approach to national
  inspection of tissue establishments.
• compatible with systems operating in other parts
  of world.
• will include system for verification of safety
  and quality standards for imported and exported
  tissues and cells.
• Supported by rationale
• agreed set of practical Guidelines for the
  Inspection of Tissue Establishments, based on
  best practice
• 40 tissue and cell bank inspectors from 15 Member
  States attending one of 6 model training courses.
  
• Inspector Training course and material optimised
  through feedback and improvement. Final version
  provided to Community as model for future
  training.
• System for classification and reporting of
  adverse events agreed and established on pilot
  basis and action plan for extension to all Member
  States. Links to developing surveillance systems
  in the field outside the EU.
• Programme of wide dissemination will ensure that
  all regulatory authorities in the EU are aware of
  project outputs and rationale and evidence that
  support them.
• JACIE will be invited to contribute

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Issues, problems, positives Discussion
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Questions

• Time aspect before, during, after
• Political sensitivities
• Sufficient expertise
• Responsibility of team leader
• Financial aspect
• Access to other centres
• Prestige?
• Training

• Contact/support
• Online system
• Expectations fulfilled?
• Perception of role?
• Positive aspects?

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ANY OTHER BUSINESS