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Publication: "The impact of improved JACIE standards on the care of related BM and PBSC donors."

posted 13 Nov 2014 01:18 by Eoin McGrath

Advance online publication 10 November 2014

Abstract
:
Discrepancies exist between the care of unrelated donors (UDs) and related donors (RDs), particularly regarding medical suitability criteria, consenting procedures and donor follow-up. Changes to the most recent JACIE standards have addressed these issues. We studied 208 RDs who underwent PBSC or BM donation in a single centre during 2004-2013 to determine the impact of regulatory changes on donor care, and assessed the safety and efficacy of stem cell donation in donors not meeting UD medical suitability criteria. We observed significant improvements in donor consenting procedures (P=0.003) and donor follow-up (P=0.007) after stipulations in these areas were introduced. We saw a higher incidence of serious adverse events (SAEs) in RDs not meeting UD suitability criteria (P=0.018), and a higher incidence of SAEs in donors ⩾60 years (P=0.020). Haematopoietic progenitor cell donation is less safe in RDs who do not meet UD criteria for medical suitability. Although changes to JACIE standards have improved practice, development of specific medical suitability for RDs and guidelines around 'grey areas' where risks to a donor are unclear or theoretical, will be important in improving RD safety and standardising practice.Bone Marrow Transplantation advance online publication, 10 November 2014; doi:10.1038/bmt.2014.260.

Go to: http://www.nature.com/bmt/journal/vaop/ncurrent/abs/bmt2014260a.html

Special Request for Public Comments: Evaluating One-Year Survival in FACT-JACIE Standards

posted 10 Nov 2014 03:07 by Eoin McGrath   [ updated 10 Nov 2014 03:07 ]

FACT and JACIE are finalizing the sixth edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Based on public comments and strategic initiatives, an additional standard is proposed:

“The Clinical Program should achieve one-year survival outcome within or above the expected range when compared to national or international outcome data. If expected one-year survival outcome is not met, the Clinical Program shall submit a corrective action plan.”

The FACT-JACIE Standards already require internal outcome analyses. With the introduction of published comparative national and international data, Clinical Programs have additional resources to evaluate their one-year survival rates and improve upon them when they fall below expected ranges. Note that this standard is written with “should,” signifying that it is a recommendation. If a Clinical Program does not meet expected outcomes, accreditation will not be withheld but the program will be required to submit a corrective action plan for achieving expected one-year survival.

The proposed Standard, general principles and limitations, proposed implementation process, and instructions for submitting comments are described in the official Request for Public Review and Comment: One-Year Survival for Allogeneic Transplant Requirements. We strongly encourage review of this document to gain a full understanding.

Access the online comment form at www.surveymonkey.com/s/clinicaloutcomes.

Results of survey on incorporation of Quality Mangers to JACIE Inspection Teams.

posted 18 Sep 2014 02:00 by Eoin McGrath   [ updated 13 Nov 2014 01:20 ]

14-11-2014 Summary of results now available here.

Survey closed 10-10-14


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.

This survey is now closed. The deadline for participating was 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.

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