See also Events for training courses and other events of interest.
The EMBMT kindly invited Eoin McGrath to present on JACIE at their Business Meeting on 15 November, 2013. The EMBMT has long been a supporter of JACIE accreditation and the FACT-JACIE Standards and this was an excellent opportunity for JACIE to meet programme directors and nurses from transplant programmes in the region.
The slides from this presentation can be downloaded from here
: Slides presented by Eoin McGrath at the APBMT session can now be downloaded
JACIE will be represented at the 18th congress of the Asia Pacific Blood & Marrow Transplantation Group
which kicks off on Friday 1 November. Mr. Eoin McGrath (JACIE) and Dr. Nadim Mahmid (FACT) will jointly present on the standards, the accreditation process and the experience of centres in Europe, North America and elsewhere. The session is open to anyone interested in how standards have been developed for the bone marrow and related sectors and the experience of centres.
The session entitled International Standards of Cellular Therapy
takes place on Sunday 3 November from 08:00-09:30 in Hall C. More information is available on the congress programme at http://www.apbmt2013.vn/Pages/ScientificProgramme.aspx
Eoin will also be at the EBMT/JACIE stand (no. 21) in the exhibition area and will be happy to meet with you.
There is an increasing number of publications dedicated to quality
management in healthcare and we regularly publicise articles that we
think could be interest to anyone working with JACIE accreditation.
However, many people are unaware of the existance of such publications
so we have added a short list here.
If you are aware of any others, we would be happy to add them to the list.
The Circular of Information (Circular) for the Use of Cellular Therapy Products is intended to be an extension of the cellular product label. It has been prepared and endorsed by AABB, American Association of Tissue Banks, American Red Cross, American Society for Blood and Marrow Transplantation, American Society for Apheresis, Americas Blood Centers, College of American Pathologists, Foundation for the Accreditation of Cellular Therapy, ICCBBA, International Society for Cellular Therapy, National Marrow Donor Program, Joint Accreditation Committee of ISCT and EBMT, and NETCORD.
The US Food and Drug Administration and Health Resource and Services Administration provided liaisons to this group.
As an extension of container labels, each processing/issuing facility has the option and is encouraged to provide more facility or product specific information in the space provided in the Circular. More>>>
Croatia joined the European Union on 1 July 2013. As part of the need to align national legislation with EU law, EU Directive 2004/23/EC and the supporting directives were transposed into Croatia law through the Act on the Application of Human Tissues and Cells. This Act is further supported by a series of ordinances. Since June 2013, Article 35(2)
of the Ordinance on the conditions in terms of premises, personnel, medical
and technical equipment and quality system for the performance of the
activities of collection, procurement, testing, processing, preservation, storage
and distribution of human tissues and cells
cites JACIE as a requirement for HPC banks.
This is good news as it shows that JACIE accreditation can be a solution for regulatory agencies as they meet their obligations under European and national regulations.
Croatia joins a number of other European states that cite JACIE among their authorisation or social insurance regulations. More information is available at Regulations & guidelines
We had 17 participants in the Inspector Training Course held here in Barcelona on 3-4 October. It would have been more except for 4 last minute cancellations for unavoidable reasons. It was a lively and mixed group with 8 countries represented including Croatia, Brasil, Jordan and Romania.
Thanks are owed to the participants for their excellent input, questions and interest and we look forward to them entering the ranks of JACIE Inspectors.
The next course is in Tel Aviv on 23-24 October being organised with the kind support of the Israeli Association for Bone Marrow Transplantation.
FACT and JACIE published version 5.3 of the International Standards for Cellular Therapy Product Collection, Processing, and Administration and its accompanying Cellular Therapy Accreditation Manual on August 21, 2013 to reflect FDA requirements for donor eligibility documentation.
Specifically, this version removes the requirements for donor eligibility documentation for autologous donors in Appendix III.
The updated Accreditation Manual also includes updated guidance on DMSO lot-to-lot qualification for Standard D4.13.2.
This version of the Standards becomes effective on September 20, 2013.
Teambox will be phased-out over the coming 6 months. This decision is due to insurmountable problems encountered by many users that we have not been able to resolve. While many users (centres and inspectors) were happy with the tool, the fact that so many had difficulties meant that we could not be sure that files and communications could be accessed by everyone, this being the fundamental added-value of Teambox for JACIE.
Teambox itself is a good tool and we will continue to use it internally but because it is based in the 'cloud', many hospitals block access to it. In addition, it is currently not possible to guarantee that files and documents are stored within the European Union raising concernes about data protection. More >>>
Preliminary surveys suggest that there are no uniform criteria concerning the identification of shipped cord blood units, nor does there appear to be a consensus regarding preparation of units for administration. All transplant centers worldwide are invited to participate in an inter-organizational survey of transplant center practices for testing cord blood units and preparing them for administration.More>>>
Have you treated patients in 2012
with "novel cellular therapies" (i.e., related to non-hematopoietic cell types and indications)?
If so please complete the simple survey form (Click on PDF
format) and send it to Helen Baldomero as soon as possible by e-mail: email@example.com
or by fax: + 41 61 265 2735 and help have an effective impact on the scientific, clinical and regulatory aspects of cellular therapy.Background to the survey
In 2008, 5 societies joined forces to establish a survey on "novel cellular therapies":
- the Tissue Engineering & Regenerative Medicine Society, European Chapter (TERMIS-EU),
- the International Society of Cellular Therapy, European Section (ISCT-Europe),
- the International Cartilage Repair Society, European Section (ICRS),
- the European group for Blood and Marrow Transplantation (EBMT) and
- the European League Against Rheumatism (EULAR).
The survey is designed to establish a comprehensive, quantitative map of which specific cell types, sorted by the cell processes and delivery mode, are being used to treat patients in Europe and to distribute this information rapidly. It also integrates the original EBMT "transplant activity survey", launched in 1990 to capture the number of patients transplanted with hematopoietic stem cells in Europe.Deadline
31 August 2013
The survey only includes the number of treated patients, without any reference to their clinical outcome, and leads to a yearly publication, which presents the data, summarizes the trends and lists in the appendix the names of the participating teams.
Go to www.termis.org/chapters_eu_novel.php
for more information.