See also Events for training courses and other events of interest.
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.
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
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
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
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.References
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.
Candidates must meet the following requirements:
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 will be registered as inspectors straight away and opportunities for them to participate in inspections will be sought in 2016.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.
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.
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 email@example.com).
Quoted from EU Document released 1 October 2015:
1. Legal requirements
The Commission Directive (EU)2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells was published on 9 April 2015 (http://eurlex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015L0565&from=EN).
The Directive introduces the obligation for tissue establishments to affix a "Single European Code” or “SEC” on tissues and cells distributed for clinical application in the EU. The Directive also sets out the requirements for its application (including exceptions) and general obligations of the tissue establishments, competent authorities and the European Commission.
The following situations are excluded from the application of the SEC:
(a) reproductive cells from partner donation;
(b) tissues and cells distributed directly for immediate transplantation to the recipient, as referred to in Article 6(5) of Directive 2004/23/EC;
(c) tissues and cells imported into the Union in case of emergency authorised directly by the competent authority or authorities, as referred to in Article 9(3)b of Directive 2004/23/EC.
The slides from the JACIE-related sessions at the EBMT 2015 Annual Meeting can be accessed here.
With the publication of the 6th edition of the FACT-JACIE Standards on 1 March 2015, JACIE Inspectors are now asked to complete the Inspector Exam. As with previous editions, the exam is designed to test inspectors' knowledge of the new standards and to offer explanations for why certain answers are incorrect or correct. By these means, the exam is considered to be an educational tool that helps to maintain and develop inspectors' skills and knowledge.
Who has to complete this exam?
All inspectors have to complete the exam. Failure to do so could result in being removed from the JACIE register of inspectors.
For non-inspectors - there is an open exam available to everyone to test their knowledge. Go here for more details.
The exam is divided into 2 parts. Part 1 must be completed by all inspectors and is an exam based on the JACIE Inspection Process and Common Standards. There are30 multiple choice questions in Part 1.
Part 2 consists of up to three exam(s) depending on the experience of each inspector. There are 20 questions in each exam. Please complete the exam for the area in which you quality to inspect. For instance, if you qualify to inspect only in the clinical setting, you should only complete the clinical exam. If you qualify to inspect processing and collection, then you should complete these two exams.
All inspectors will complete at minimum 2 exams and a maximum of 4.
With the online exam, you will be able to save your answers and return to the exam later if you wish. You will be asked to enter your email address and to create a password so that you can exit the exam and start again at a later date.
The next step is to enter your name and email so that we can easily identify who has completed the exam and also to complete the certificate that will be generated on passing the tests.
You should keep your password simple and easy to remember for future use.
The exams are separate and for this reason you are asked for your details for each exam.
A pass mark of 75% is required for each exam you complete. Note that marks are deducted for incorrect answers.
We calculate that you will need between 40-90 minutes in total. You will need to have the relevant documents at hand as the exams are open book, that is, you are expected to use the Standards, Manual, Comparison table of editions and the Inspection Guide. These documents are available on the exam page.
The deadline is 30 May 2015.
In order to start, go to www.jacie.org/inspectors/exam1. After you complete Part 1, you will be brought to another web page where there are 3 links to the remaining exams.