See also Events for training courses and other events of interest.
The 6th edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration are now available effective. See here for more information.
The JACIE Inspector Training Course will take place on 2-3 July 2015 in Manchester, UK.
This course is designed to train JACIE inspectors. Anyone working in the transplant setting who is interested in JACIE but is not interested or is not qualified to become an inspector can also attend. Note that priority will be given to inspector candidates.
For more information, go to the event registration site at ebmt.stagehq.com/events/3198.
Advance online publication 10 November 2014
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
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.
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
This survey is now closed. The deadline for participating was 10 October 2014.
With effect from 1 January 2015, new application fees along with a discount scheme will be introduced.
The new fees are as follows:
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).
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.
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.