News

See also Events for training courses and other events of interest.

English-Spanish glossary of quality management terms

posted 5 Feb 2016, 02:42 by Eoin McGrath   [ updated 5 Feb 2016, 02:43 ]

The Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA) and Worldwide Network for Blood & Marrow Transplantation (WBMT) along with the Latin American Group for Bone Marrow Transplantation (LABMT) have facilitated the preparation of a simple glossary of quality management terminology to help create awareness and understanding of basic but important quality management terminology among Spanish-speaking transplant professionals. The glossary can be accessed at www.ahcta.org/documents.html.

JACIE Training Course, UK - 2-3 June 2016

posted 27 Jan 2016, 07:48 by Eoin McGrath

JACIE will hold a training course near Southampton, UK on 2-3 June 2016. Full details are available at https://ebmt.stagehq.com/events/3560.

Another training course for early October 2016 in Barcelona, Spain will be announced shortly.

JACIE introduces new fees and agreement document for applications.

posted 5 Jan 2016, 02:18 by Eoin McGrath   [ updated 20 Jan 2016, 03:36 ]

From 1 January 2016, centres submitting applications for accreditation will be required to sign an agreement with the EBMT which covers all aspects of the accreditation process. The agreement sets out the rights and obligations of both organisations during the process. This agreement replaced the previous terms and conditions document.
The document entitled 'F-009-01-Standard Agreement for JACIE Accreditation' can be accessed in the Document Centre in the 'Applicants' section.

New applications must also be completed using the updated application form, also available in the Document Centre.

Both documents are also linked below.

New fees will also be applied from 20 March 2016. See here for more information.

Dr. Riccardo Saccardi appointed as new JACIE Medical Director

posted 14 Dec 2015, 08:52 by Eoin McGrath

The EBMT is pleased to announce the appointment of Dr. Riccardo Saccardi as the new JACIE Medical Director. Dr. Saccardi will take over from Prof. John Snowden with effect from 1 January 2016. The appointment follows an open recruitment process launched in October which led to three candidates being shortlisted for interview. The high quality of all of the candidates made the decision very difficult and we are grateful to everyone who participated.

Dr. Saccardi has been involved in the field of Haematopoietic Stem Cell Transplantation since his specialization in Haematology and has worked in the clinical, laboratory and cord blood bank areas. His centre has successfully implemented both the ISO and FACT-JACIE Standards. 

In 2003, he participated in one of the first JACIE inspector training courses and since then has regularly participated in JACIE inspections, mostly in clinical facilities and often as team leader. He also regularly attends the annual courses organized by the Italian Transplant Agency (CNT) for training inspectors for the national accreditation program, based on the JACIE standards.

In addition to day-to-day haemato-oncology and HSCT practice, his main academic interest has been severe autoimmune diseases and he has led and contributed to various national and international networks, both in the clinic and in the lab including cooperative studies for the standardization of graft quality both in cord blood and peripheral blood stem cells. In this way, Dr Saccardi is not only well positioned to advise on routine aspects of HSCT, but also his expertise will help develop JACIE’s perspective of new cellular therapies.

He firmly believes that rules and regulations in all fields of clinical medicine must continuously evolve, updating clinical practice from experimental medicine and promoting standardization across countries. He considers that JACIE has been a very important tool to both increase the safety of procedures and promote the homogenization of clinical practice of HSCT in Europe and further afield. He also believes that the development and management of regulations must be carried out through close interaction between quality management specialists and clinical professionals involved in daily practice, keeping the standards as close as possible to the field of transplantation.

We look forward to supporting Dr. Saccardi in his new role and to bringing his experience and knowledge to bear on the continuous improvement of the Standards and the accreditation process for the benefit of patients, donors and transplant professionals.

Selected membership and participation
  • Member of EBMT (CIC 304)
  • Member of the Board of the Italian HSCT Society (GITMO)
  • Coordinator of the GITMO Cell Processing section
  • Member of Italian Health Authority Committee for the implementation of the Unique Identification Code System of Tissues and Cells for Human Application
  • Member of the Working Group (WG) promoted by the European Directorate for the Quality of Medicines and Healthcare (EDQM) preparing the 3rd edition of the Guide to the Quality and Safety of Tissues and Cells for Human Application.
  • Dr. Saccardi was a member of the EBMT Board for 8 years which gave him both an insight into the Society and an overview of HSCT across Europe. 
Dr. Saccardi is based at the Azienda Ospedaliero Universitaria Careggi Largo Brambilla n° 3 – 50134 Firenze, Italy

Changes in the JACIE Accreditation Process for 2016

posted 30 Nov 2015, 03:41 by Iris Bargallo   [ updated 30 Nov 2015, 03:47 ]

JACIE has reviewed the current Accreditation process with the objective to improve and optimize the process for all parts involved. Our goal is to make the process shorter for centres that are already well prepared for the accreditation and to identify the centres that need more time and support from the JACIE Office to prepare their application sufficiently in advance of any eventual inspection.

Therefore the following changes will be introduced with effect from 1 January 2016: 

  • Applicant centres will be required to formally accept a quotation for the fees. This will make clear the scope of the accreditation and related costs at the earliest possible point in the process in order to avoid misunderstandings and time-consuming corrections at a later date.
  • Applicants must sign an agreement with the EBMT (JACIE’s parent organisation) once the application for Accreditation is approved. This document outlines the responsibilities both of JACIE and of the centre. 
  • Applicant centres will be required to submit the Pre-audit documentation within 30 days from receipt of the service agreement signed by the centre’s representative. Where an applicant delays more than 30 days in submitting the pre-audit documentation, the accreditation process of the centre will be considered expired and the centre must restart the process

You will find the process in detail in the applicant's flowchart and in the JACIE Inspection guide, both documents can be downloaded from the Document Centre in this website.

If you have any queries, please do not hesitate to contact the JACIE Office.

EDQM Survey on Tissues and Cells Guide 2015

posted 25 Nov 2015, 06:44 by Eoin McGrath   [ updated 17 Dec 2015, 02:14 ]

The EDQM Guides are excellent and accessible sources for help on all aspects associated with tissues and cells including HSC. EBMT experts have contributed to the Guides in the past and to the 3rd edition which is currently in preparation.
The review committee have launched a survey to help them understand how it has been accessed and used in the past. You are now invited to participate in this review by completing the survey. The survey is expected to take between 5-10 minutes to complete.

New data indicate that country- and center-specific economic factors impact on survival after HSCT

posted 24 Nov 2015, 08:31 by Eoin McGrath   [ updated 25 Nov 2015, 02:21 ]

Abstract

Hematopoietic stem cell transplantation (HSCT) is a lifesaving expensive medical procedure. Hence, more transplants are performed in more affluent countries. The impact of economic factors on patient outcome is less defined. We analyzed retrospectively a defined cohort of 102,549 patients treated with an allogeneic (N = 37,542; 37%) or autologous (N = 65,007; 63%) HSCT. They were transplanted by one of 404 HSCT centers in 25 European countries between 1999 and 2006. We searched for associations between center-specific microeconomic or country-specific macroeconomic factors and outcome. Center patient-volume and center program-duration were significantly and systematically associated with improved survival after allogeneic HSCT (HR 0·87; 0·84–0·91 per 10 patients; p < 0·0001; HR 0·90;0·85–0·90 per 10 years; p < 0·001) and autologous HSCT (HR 0·91;0·87–0·96 per 10 patients; p < 0·001; HR 0·93;0·87–0·99 per 10 years; p = 0·02). The product of Health Care Expenditures by Gross National Income/capita was significantly associated in multivariate analysis with all endpoints (R2 = 18%; for relapse free survival) after allogeneic HSCT. Data indicate that country- and center-specific economic factors are associated with distinct, significant, systematic, and clinically relevant effects on survival after HSCT. They impact on center expertise in long-term disease and complication management. It is likely that these findings apply to other forms of complex treatments.

Gratwohl, A., Sureda, A., Baldomero, H., Gratwohl, M., Dreger, P., Kröger, N., … Brand, R. (2015).  Economics and Outcome After Hematopoietic Stem Cell Transplantation: A Retrospective Cohort Study. EBioMedicine. doi:10.1016/j.ebiom.2015.11.021

New publication shows better related donor care in accredited centres

posted 19 Nov 2015, 07:35 by Eoin McGrath   [ updated 19 Nov 2015, 07:43 ]

EBMT transplant centers with FACT-JACIE accreditation have significantly better compliance with related donor care standards

Anthias, C., O’Donnell, P. V., Kiefer, D. M., Yared, J., Norkin, M., Anderlini, P., … Shaw, B. E. (2015). EBMT transplant centers with FACT-JACIE accreditation have significantly better compliance with related donor care standards. Biology of Blood and Marrow Transplantation. doi:10.1016/j.bbmt.2015.11.009 http://www.bbmt.org/article/S1083-8791(15)00736-3/abstract

Results show that practice in accredited centers was much closer to recommended standards as compared to non-accredited centers. Specifically, a higher percentage of accredited centers use eligibility criteria to assess RDs (93% versus 78%; P=0.02) and a lower percentage have a single physician simultaneously responsible for a RD and their recipient (14% versus 35%; P=0.008). The authors go on to recommend measures to address these issues through enhancement of regulatory standards as well as national initiatives to standardize RD care.

See also an analysis of US practice in Anthias, C., Shaw, B. E., Kiefer, D. M., Liesveld, J. L., Yared, J., Kamble, R. T., … O’Donnell, P. V. (2015). Significant improvements in the practice patterns of adult related donor care in US transplant centers. Biology of Blood and Marrow Transplantation. doi:10.1016/j.bbmt.2015.11.008

This publication reinforces the findings from Anthias et al (2015). The impact of improved JACIE standards on the care of related BM and PBSC donors. Bone Marrow Transplantation, 50(2), 244–247. doi:10.1038/bmt.2014.260

Quality management inspectors - Call for candidates

posted 22 Oct 2015, 07:28 by Eoin McGrath   [ updated 22 Oct 2015, 07:33 ]

The FACT-JACIE Standards and accreditation programmes have successfully introduced concepts of quality management that has had significant impact on how transplant programmes organise themselves and interact with other services. The Gratwohl et al* studies (see below) showed the impact of this change on transplantation and outcome.
 

In support of these findings and to reinforce the importance of quality management, JACIE plans to introduce inspectors specifically to focus on the quality management standards in mid-2016 alongside the existing inspector profiles. These inspectors will be responsible for assessing compliance with the standards for quality management and policies and procedures across all services in transplant programmes.
 

Goals
  1. To distribute the inspection process across additional expert inspectors
  2. To achieve a more global view of quality management across the transplant programme (the so-called "helicopter view") rather than as individual sites or units ("silos")
  3. Reflect the role and expertise of quality managers
In order to be able to implement this important initiative, JACIE has opened a call for candidates to put themselves forward as Inspectors subject to the criteria described below.

Criteria

Candidates must meet the following requirements:
  • 3 years experience as Quality Manager in an accredited centre or in preparing a centre for accreditation
  • Letter from the Programme Director confirming this experience
  • Evidence  (documented) of continuous education and training in quality management. This can include internal and external training.
In addition, as for all JACIE Inspectors, candidates must complete training and a Standards-based exam.

Training

In recent years, JACIE Training Courses have been open not just to inspectors candidates but to anyone with the need to understand the accreditation process. This has seen many transplant quality leads or coordinators attend and learn about the standards and accreditation process. Anyone who has participated in these more recent courses (since 2013) and who meets the criteria set out above will be considered to have received the appropriate training. 
JACIE reserves the right to select and exclude candidates.

In addition, JACIE recognises that it may not be feasible to train sufficient inspectors in in-person courses in the short-term. For that reason, an online training course will be developed to cater for those candidates who meet the criteria above. More details will be announced in November 2015 regarding the online content. 


Courses held in 2016 will cater for this new inspector profile. Places on courses may be limited and JACIE reserves the right not to accept candidates for courses.


How to apply

Candidates should complete the Registration Form online at the following link: https://www.surveymonkey.com/r/QM_Inspector

On receipt of the application, the JACIE Office will contact the candidates to request the documentation indicated above. 
Candidates who meet the criteria will be divided into two groups:
  • Group 1: candidates who have attended JACIE course
  • Group 2: candidates who have not attended JACIE course and who will need to participate
Group 1 will be registered as inspectors straight away and opportunities for them to participate in inspections will be sought in 2016. 
Group 2 will be directed to the online training that will be in place in November 2016. Successful completion will result in their registration as inspectors.

This initiative requires significant support in order to succeed in terms of having sufficient inspectors to cover future demand. We look forward to your participation in this very important project. 

References
  • Gratwohl, A., Brand, R., McGrath, E., van Biezen, A., Sureda, A., Ljungman, P., … Apperley, J. (2014). Use of the quality management system “JACIE” and outcome after hematopoietic stem cell transplantation. Haematologica, 99(5), 908–15. doi:10.3324/haematol.2013.096461
  • Gratwohl, A., Brand, R., Niederwieser, D., Baldomero, H., Chabannon, C., Cornelissen, J., … Apperley, J. (2011). Introduction of a Quality Management System and Outcome After Hematopoietic Stem-Cell Transplantation. J. Clin. Oncol., 29(15), JCO.2010.30.4121–. doi:10.1200/JCO.2010.30.4121

New mechanism to establish equivalence to doctoral degrees for processing facility directors

posted 7 Oct 2015, 03:03 by Eoin McGrath   [ updated 7 Oct 2015, 03:04 ]

The FACT-JACIE Standards, 6th edition, describe the academic requirements for the position of Processing Facility Director (PFD):

D3.1.1 There shall be a Processing Facility Director with a medical degree, doctoral degree, or equivalent degree in a relevant science, qualified by a minimum of two (2) years training and experience for the scope of activities carried out in the Processing Facility.

A doctoral degree including a medical degree is considered as the ‘gold standard’ of scientific and medical achievement. However, the term doctoral degree is not applied in a uniform fashion in all countries. The Guidance to Standard D3.1.1, 6th edition FACT-JACIE Standards reads:

Some regions of the world may have degrees that are equivalent to the doctoral degree. If a Processing Facility Director has such a degree, significant and compelling information regarding the degree requirements must be submitted to demonstrate equivalency (p.325).

JACIE has developed a points system to be applied in those cases where the PFD does not hold a doctoral degree but has other qualifications combined with experience. This system is described in this document (also available below this text or on request to jacie@ebmt.org).

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