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Survey: incorporation of Quality Mangers to JACIE Inspection Teams.

posted 18 Sep 2014 02:00 by Eoin McGrath   [ updated 18 Sep 2014 02:00 ]

JACIE is evaluating a new role for Quality Managers as part of JACIE Inspection Teams. Currently, teams are typically made up of physicians and scientists drawn from the clinical, cell collection and cell processing areas. The proposal is to add an experienced Quality Manager to this team since a significant part of the Standards in each of these areas concentrate on quality management and are currently assessed by the respective inspectors alongside the other standards. This represents a significant workload for the inspector.

The hypothesis is that
  1. a Quality Manager is an expert in quality management in the same way as the other inspectors are experts in their respective fields and so will ensure a more thorough assessment of the QM system; and
  2. that the other inspectors will have more time to assess their main areas of competence (clinical, collection and processing) which will raise the overall quality of the inspection and reduce the time required on-site and reporting.
Your opinion is requested on this important proposal.
Please follow the link to participate in the survey https://es.surveymonkey.com/s/JACIE_QM_Inspectors

The deadline for participating is 10 October 2014. 

September newsletter

posted 16 Sep 2014 02:25 by Eoin McGrath   [ updated 16 Sep 2014 02:25 ]

The September newsletter is now published. Click here.

Changes to JACIE application fees for 2015

posted 31 Jul 2014 01:27 by Eoin McGrath   [ updated 31 Jul 2014 01:56 ]

With effect from 1 January 2015, new application fees along with a discount scheme will be introduced.

New Fees
The new fees are as follows:
  • Registration fee: €3,500 (applied to all applications including for re-accreditation and non-refundable)
  • Fee per site: €2,100 (First clinical / collection / processing site)
  • Fee per additional site: €1,000
More details on the new fees are available at www.jacie.org/fees-2015.

Non-EBMT members: Where a clinical centre is not a member of the EBMT, double fees apply. More information on EBMT membership is available here (www.ebmt.org).

Discount
Applications from centres whose staff members have participated in an inspection event(s) in the 4 years preceding submission of the new application will qualify for a discount of 10% per event up to a maximum of 20%.

The discount scheme is designed to compensate centres that actively support the accreditation programme by releasing staff members to participate in inspections. This willingness to share the effort has been and remains one of the fundamental factors for sustaining the success of the JACIE programme.

This is the first JACIE fee increase since 1 January 2009. Since then inspections have increased from 23 in 2009 to 57 in 2013 with the associated increase in inspectors’ travel and other costs including the per diem payment introduced in 2013.
It is hoped that the introduction of the new fees will allow JACIE to provide more support to the centres and the inspectors, provide more education and training as well as to improve processes for inspectors and centres.

The increase was approved by the EBMT Executive Committee on 17 July 2015.

JACIE is run on a not-for-profit basis in line with the EBMT mission and values. JACIE relies almost exclusively on accreditation fees in order to support standard-setting and accreditation activities. The principal costs come from maintaining the small Accreditation Office team in Barcelona and Inspectors' travel, accommodation and subsistence expenses. Other activities include supporting the standards review process, inspector training and systems support and development.

Key dates for 6th edition

posted 17 Jul 2014 07:28 by Eoin McGrath   [ updated 21 Jul 2014 06:11 ]

See the publication and implementation dates in 2015 for the 6th edition of the FACT-JACIE Standards. Centres that plan to apply for accreditation in 2014 or 2015 should pay particular attention to these dates.

Draft 6th ed. Standards now open to consultation

posted 30 Apr 2014 04:12 by Eoin McGrath   [ updated 30 Apr 2014 04:13 ]

The draft 6th edition is now open for public consultation. Click here for more details.

EBMT 2014 slides

posted 28 Apr 2014 01:59 by Eoin McGrath   [ updated 28 Apr 2014 02:01 ]

You can access in PDF many of the presentations given during the Quality Management Meeting, held as part of the 2014 EBMT Annual Meeting in Milan. The outstanding slides will be added as they are received from the speakers.

Link: www.jacie.org/news/ebmt2014slides

Prof. Christian Chabannon

posted 10 Apr 2014 05:11 by Eoin McGrath   [ updated 10 Apr 2014 05:20 ]

The 2014 EBMT Meeting in Milan was Prof. Chabannon's last EBMT Congress as a member of the JACIE Committee when he stepped down after many years of leadership and active participation. At the meeting with the National Representatives on 29 March 2014, Dr. Alessandro Rambaldi, Chair of the JACIE Committee, presented him with a gift of hiking poles (Prof. Chabannon is a frequent visitor to the Alpes and other mountains) and expressed the thanks of everyone involved with JACIE down the years.

Prof. Chabannon joined the then JACIE Executive Committee as Vice President in September 2008. He succeeded Prof. Jane Apperley as President in 2010 until 2012 and stayed on as Past-President during the transition of JACIE to becomming a full EBMT Committee.

Prof. Chabannon brought his sharp and pragmatic analysis to JACIE and was an invaluable source of expertise, particularly regarding advanced therapies involving stem cells. He was also an able voice for the cell processing community in terms of the Standards and the accreditation process. Durng his involvement with JACIE, two editions of the FACT-JACIE Standards were issued and JACIE also expanded greatly both in Europe and beyond. Aside from his regular participation in inspections, he also took part in the first inspection outside of the European Union when he was on the team that visited the King Fasial Hospital in Riyadh. He also contributed to the important papers by Prof. Alois Gratwohl showing a relationship between quality management and improved outcome.

Prof. Chabannon remains an active member of the EBMT and is the chair of the EBMT Cell Processing Committee. He also remains as the Co-Chair of the Processing Standards Sub-Committee for the 6th edition.

Quality managers - free EBMT membership

posted 3 Apr 2014 03:49 by Eoin McGrath   [ updated 3 Apr 2014 03:49 ]

Since 2013, EBMT membership of centres includes quality managers at no additional cost.
See here for more information.

New study published on impact of quality improvement on HSCT

posted 4 Feb 2014 02:02 by Eoin McGrath   [ updated 4 Feb 2014 02:03 ]

A new study led by Prof. Alois Gratwohl has been published in Haematologica. The pape
http://www.haematologica.it/content/early/2014/01/27/haematol.2013.096461.full.pdf+html
r entiled Use of the quality management system 'JACIE' and outcome after hematopoietic stem cell transplantation was published ahead of print on January 31, 2014.

The study concludes that working towards implementation of a quality management system triggers a dynamic process associated with a steeper reduction in mortality over the years and a significantly improved survival after allogeneic stem cell transplantation.

Access the paper here (open access).

AHCTA survey on Processing Personnel qualifications, training and competency

posted 7 Jan 2014 01:27 by Eoin McGrath   [ updated 7 Jan 2014 01:29 ]

The Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA) requests processing facilities to complete a survey to assist with developing recommendations for cell processing laboratory staff qualifications, training and competency. Please limit your responses to just those staff responsible for the processing of minimally manipulated products like hematopoietic progenitor cells (HPC) for stem cell transplantation and therapeutic cells (TC)- T cells.

Only a single response from each processing facility is required.

Deadline is 31 January 2014

Access the survey here.

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