Inspectors 06

JACIE Inspectors Meeting: 

JACIE Inspectors Meeting Sunday, 19th March 2006 Hamburg, Germany

INFORMATION & UPDATE: 

INFORMATION & UPDATE Applications

Inspections Jan 2004–Mar 2006: 

Austria: 3 Finland: 2 France: 6 Italy: 1 Netherlands: 4 Switzerland: 10 United Kingdom: 10 36 Inspections Jan 2004–Mar 2006

Slide4: 

Accredited Centres

Centres close to accreditation: 

Centres close to accreditation Clermont Ferrand, France –recommended to Board Institut Gustave Roussy, France –to be recommended to Board John Radcliffe Hospital, Oxford –awaiting EFI certification for HLA lab.

Centres in post-audit phase: 

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 Children’s

Upcoming inspections 2006: 

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

Inspectors: 

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

Inspectors categories by country: 

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

Training Courses: 

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)

Meetings: 

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

3rd version of Standards: 

3rd version of Standards

Revisions to Standards 3rd ed.: 

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/Processing) 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 ◄

3rd ed. Main Changes - 1: 

3rd ed. Main Changes - 1

3rd ed. Main Changes - 2: 

3rd ed. Main Changes - 2

Nurse input on audits: 

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

Inspection costs: 

Inspection costs

PROPOSAL: Inspection & Accreditation Committee: 

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)

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

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

Issues, problems, positives: Discussion: 

Issues, problems, positives: Discussion

Questions: 

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?

ANY OTHER BUSINESS: 

ANY OTHER BUSINESS