Inspector Training Courses
Updated Quality Management Inspectors Criteria
Transplant Procedures Update for Physicians and Nurses operating in JACIE accredited transplant centers
New JACIE inspectors
Third Party Agreements
With 3 JACIE courses taking place in the last quarter of 2016, interest has been high. The first course of the period was the traditional early October course in Barcelona. The 20 participants came from 10 countries: Belgium, Germany, Greece, Hungary, Italy, Saudi Arabia, Spain, Switzerland, Turkey and the United Kingdom.
The next course was held in Nijmegen, The Netherlands at the end of October. The 25 participants were almost all from Dutch centres but were joined by two colleagues from Germany. Sincere thanks are due to the team at Radboud Hospital for their support in preparing the event.
The last event for 2016 will take place near Stockholm in Sweden and is practically full with participants from Norway, Finland, Denmark and of course Sweden. Full details of the event are available at https://ebmt.stagehq.com/events/3794
JACIE has updated the Quality Management (QM) inspectors criteria as follows:
3 years experience as Quality Manager in an accredited centre or in preparing a centre that meets the minimum transplant activity requirements set out in the Standards.
Evidence (documented) of continuous education and training in quality management and/or cellular therapy as indicated in the Standards. This can include internal and external training.
Letter from the Programme Director confirming this experience and continuous training. Please see attached a letter template.
JACIE is already including QM Inspectors in as many inspections as possible since October 2016. If you are interested in becoming a JACIE QM inspector, our recruitment is an on going process, thus new candidates are always welcome and all of our JACIE Inspector Training Courses cater for this inspector profile too. If you have any questions or would like more information, please feel free to contact us at firstname.lastname@example.org.
Raquel Espada Martín
JACIE Accreditations Coordinator
September 16 2016 in Bellinzona, Switzerland
The first edition of clinical unit ‘Transplant Procedures Update for Physicians and Nurses operating in JACIE accredited transplant centers’ with focus on competency maintenance has been held in IOSI hospital, Bellinzona, Switzerland on September 16th 2016.
The conference was freely accessible for in-site participation and have seen over 60 participants both physicians and nurses. Topics were carefully selected, from indications for HSC transplantation, care of immunocompromised patients, acute and chronic complications, evaluation of donor and selection of HSC sourse. Excellent speakers have contributed to keep the high interest of participant.
The conference was a source of the video recorded e-sessions, lectures and questionnaires, that will be available shortly online at the EBMT website, free of charge and will provide access to CME and a certificate of competencies that focused on physicians, nurses and technicians working in the hematopoietic stem cell transplantation field.
Upon correct answer of questionnaires on every topic, participants will obtain a Certificate of Competence that will be validated by EBMT and JACIE and will serve as a certificate for JACIE audits. In addition, the activities will be granted with CME certification by EBMT/EBAH.
The JACIE office is pleased to announce and welcome the new JACIE inspectors who are already included in the Register of inspectors.
- Julia Ruiz - Spain
- Alba Piras - Italy
- Songul Tepebasi - Turkey
- Hakan Ozdogu - Turkey
- Alexandrine Maes – Belgium
We would like to take this opportunity to thank the new and current JACIE volunteers for making the JACIE Accreditation Process possible and contributing to improving quality in HSCT programmes in Europe and beyond.
The JACIE Team
The JACIE Office has received various queries regarding the following standard and we would like to take this opportunity to share the JACIE interpretation of the standard.
B4.6- The Quality Management Plan shall include, or summarize and reference, policies and procedures for establishment and maintenance of written agreements with third parties whose services impact the clinical care of the recipient and/or donor.
If the Clinical Program interacts with third parties (e.g., for provision or testing of cellular therapy products) it must have policies and procedures for development, review, and approval of written agreements or contracts. These agreements should clearly define roles and responsibilities for critical tasks.
It is not the intent of this standard to generate third party agreements within the same hospital or institution nor does it apply to individuals. For example, a complete transplant program within a single institution is not required to have written agreements for the Collection and Processing Facilities within the institution. It is highly recommended that a Clinical Program with a complete transplant program have a contingency plan in place in the event the Collection or Processing Facility is unable to provide services as intended (e.g., significant personnel change or natural disaster). The contingency plan would likely require a written agreement with a third party.
JACIE Accreditations Coordinator