by
Joaquim Vives, PhD, Contributing Editor
Banc de Sang i Teixits
Barcelona, Spain
During 2023, the ISCT Telegraft published quarterly articles presenting different aspects and initiatives of the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE), Europe’s only official accreditation body in the field of haematopoietic stem cell transplantation (HSCT) and cellular therapy. The 4 articles, briefly summarised next, were signed off on by Tuula Rintala, the Director of Quality of Care and Advocacy at the European Society for Blood and Marrow Transplantation (EBMT).
Inspectors
JACIE inspectors are volunteers contributing their time and expertise to advance the transplant and cellular therapy community. Trained in specific areas such as Clinical, Collection, Processing, and Quality Management, inspectors commit to two inspections annually based on their availability. The inspector role provides valuable professional development, fostering a network within the community and allowing for learning and sharing of best practices during visits to transplant centers. The COVID-19 pause prompted a review of the inspector training format, resulting in a two-part approach: e-learning modules covering standards and processes followed by a practical face-to-face workshop focusing on inspection preparation, evidence finding, interview techniques, and post-inspection tasks. The new format aims to enhance understanding and confidence among inspectors.
Strategic Plan
The EBMT undertook the development of a new strategic plan for 2023-26, involving workshops with the EBMT Board, JACIE Committee, staff, and the wider EBMT community, serving as an opportunity for JACIE to reflect on past experiences and address future challenges. The strategic objectives for 2023-26 include fostering a culture of continuous improvement within the JACIE Community, adapting standards and accreditation processes to meet stakeholders' evolving needs, and developing a global community through partnerships, education, and training. The focus on continuous improvement involves operational leadership, benchmarking, and potentially exploring a more risk-based approach for centers undergoing multiple accreditation cycles. Additionally, JACIE aims to enhance relationships with internal and external partners, embedding itself further within the EBMT Governance structure. The third objective emphasizes the development of stakeholder relationships, with a focus on supporting volunteer inspectors and transplant centers undergoing the accreditation process. This involves updating training formats, reviewing incentives for inspectors, and developing resources to guide transplant center staff through the accreditation process. The new strategic plan was approved at the Annual Meeting in Paris in April 2023, and JACIE looks forward to collaborating with stakeholders over the next four years to achieve these ambitious yet relevant goals.
Standards Review
The FACT-JACIE Steering group convened in Paris on June 4th, 2023, to initiate the review process for the 9th edition of FACT-JACIE Standards, chaired by Dr. Nicole Prokopishyn. Coordinated by FACT, the review process involves collaboration with JACIE, which will contribute to the review of the 3rd edition of Standards for Immune Effector Cells (IECs). The development of a standalone IEC pathway by JACIE reflects evolving practices in the field. The FACT-JACIE Standards, rooted in evidence-based requirements, involve committees comprising clinicians, scientists, and quality experts, covering the entire patient and product pathway for hematopoietic stem cell transplantation and cellular therapies. A draft for public consultation planned for June 2024. The full implementation of the 9th edition is anticipated in August 2025. The Steering Committee will also assess potential impacts of the SoHO EU regulatory proposal and collaborate with initiatives like GoCART and the 80:20 initiative to streamline the accreditation process and reduce the audit burden in the IEC context.
E-Learning
On October 20th, 2023, JACIE launched a new e-learning program tailored for Transplant Centers engaged in or planning to apply for accreditation. Designed to benefit centers at various stages of the accreditation journey, the course is divided into four online modules covering pre-inspection, inspection, post-inspection, and post-accreditation phases. Accessible at any time, the program aims to enhance the confidence of center staff by addressing frequently asked questions. The modules utilize engaging formats, featuring presentations from experienced JACIE Quality Management Committee members and Accreditation Coordinators. The development process involved collaboration with the E-learning department, accreditation coordinators, and the Quality Management Committee, with materials reviewed by relevant groups for accuracy and usability. The course, accessible through the EBMT e-learning platform, is open to all transplant program staff, including directors, nurses, and quality managers. It serves as a valuable resource for explaining accreditation processes to hospital administrators, illustrating how standards support daily operations.
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