By:
Ángela Ruso
JACIE Accreditation Office
EBMT, European Society for Blood and Marrow Transplantation
Barcelona, Spain
What is JACIE?
Standards and Accreditation – JACIE
The Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) was established in 1998. It promotes high-quality patient care and laboratory performance in the collection, processing, and administration of cellular therapies through a profession-led, voluntary accreditation scheme.
JACIE works continuously with international partner organisations to develop and maintain standards for the provision of quality medical and laboratory practice in hematopoietic stem cell transplantation (HSCT). JACIE performs inspections and accredits those programmes that demonstrate compliance with these standards. JACIE also provides training for inspectors and centres on the accreditation process.
The 8th edition of the FACT-JACIE Standards was published in May 2021. Based on these standards, JACIE offers accreditation to transplant programmes in order to encourage health institutions and facilities to establish and maintain quality management systems impacting all aspects of their activities and to engage in continuous improvement.
JACIE's primary aim is to promote high quality patient care and laboratory performance in collection, processing, and transplantation centres through an internationally recognised system of accreditation.
JACIE is a committee of the EBMT, and as such is part of its fiscal and legal identity. Members are appointed by, and accountable to, the EBMT Board. The ISCT is represented through two members of the Committee.
What impact has accreditation had on centers and patient safety?
The impact of quality standards / accreditation on centers and patient safety has been published in the following articles:
- Snowden JA, McGrath E, Duarte RF, Saccardi R, Orchard K, Worel N, Kuball J, Chabannon C, Mohty M. JACIE accreditation for blood and marrow transplantation: past, present and future directions of an international model for healthcare quality improvement. Bone Marrow Transplant. 2017 Oct;52(10):1367-1371. doi: 10.1038/bmt.2017.54.
- Anthias C, O'Donnell PV, Kiefer DM, Yared J, Norkin M, Anderlini P, Savani BN, Diaz MA, Bitan M, Halter JP, Logan BR, Switzer GE, Pulsipher MA, Confer DL, Shaw BE. European Group for Blood and Marrow Transplantation Centers with FACT-JACIE Accreditation Have Significantly Better Compliance with Related Donor Care Standards. Biol Blood Marrow Transplant. 2016 Mar;22(3):514-9. doi: 10.1016/j.bbmt.2015.11.009.
- Pamphilon D, Apperley JF, Samson D, Slaper-Cortenbach I, McGrath E. JACIE accreditation in 2008: demonstrating excellence in stem cell transplantation. Hematol Oncol Stem Cell Ther. 2009;2(2):311-9. doi: 10.1016/s1658-3876(09)50019-2.
Immune Effector Cells
Administration of Immune Effector Cells (IECs) was first included within the scope of the FACT-JACIE Standards for Hematopoietic Cellular Therapy in edition 6.1 in 2017. These standards were further developed in edition 7 in 2018.
An IEC is defined as “A cell that has differentiated into a form capable of modulating or effecting a specific immune response.” This broad definition includes cellular therapies considered both high risk (e.g., CAR-T cell therapy) and low risk (e.g., mesenchymal stem cells). Donor lymphocyte infusions (DLI) are not considered IECs for the purposes of the FACT-JACIE standards.
In recent years, the focus has been on CAR-T cells, which are principally being applied in the HSCT setting.
JACIE Activity
Since 2000, 508 transplant programmes and facilities in 34 countries in Europe and beyond have applied to JACIE, and 790 inspections (first-time and reaccreditation) have been performed. 368 applicants have achieved accreditation at least once, with practically all centres repeating the process after the first accreditation cycle. There are over 300 registered inspectors, all volunteers drawn from the HSCT and cellular therapy field.
In terms of activity, 2021 continued to see a severe negative impact of the pandemic on activities, although this has been somewhat mitigated by the introduction of a remote inspection format and a so-called Short Process that avoids the need for inspectors to travel. 72 applications were received, 31 inspections of different formats were performed, and 28 accreditations were awarded.
Applications
Figure 1. Number of applications received per year.
Inspections
Figure 2. Number of inspections performed per year.
Accreditations
Figure 3. Number of accreditations awarded per year.
Sources:
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