Regional
Global standards, local impact: Why FACT-JACIE accreditation matters for emerging transplant programs
FACT-JACIE standards provides a comprehensive framework for hematopoietic cell transplantation (HCT) and cellular therapy programs, covering clinical practice, Collection, laboratory processing and quality systems. In atleast 40 countries over six continents, these standards offer developing nations a structured pathway to enhance safety, reduce practice variation, and strengthen clinical outcomes.
India performs around 12,000–14,000 HCT procedures annually across 115 centers (ISHBT, 2023). This rapid expansion highlights significant variability in processes, documentation, staffing, and regulatory oversight. FACT-JACIE accreditation could harmonize practices across this diverse landscape. Studies reported improved engraftment, reduced transplant-related mortality and enhanced safety among accredited centers (Gratwohl et al., 2014; Booth et al., 2020). Alignment with these global standards prepares programs for participation in International multicentric clinical trials and supports readiness for advanced cell and gene therapies, including CAR-T products.
The experience of Tata Medical Center-Kolkata, one of the first Indian institutions to implement a FACT-mandated Quality Management System (QMS), demonstrates that accreditation is achievable even within resource-constrained environments. A coordinated, multi-stakeholder effort (including Transplant physicians, transfusion and laboratory specialists, administrators, and quality professionals) has enabled the systematic integration of core QMS elements in clinical practice.
Tata Medical Center, Kolkata
To promote equity, accreditation bodies could consider fee waivers or subsidized models for low- and middle-income countries, enabling broader participation and reducing disparities. In India, the FACT-India Working Group has been instrumental in delivering online education and contextual interpretation of standards. Importantly, the recently published Ninth Edition HCT Standards and Third Edition Immune Effector Cell (IEC) Standards are freely accessible, allowing centers to use them as a roadmap for phased quality improvement even before seeking accreditation.
Centres may begin with a gap analysis against the standards and complete the self-assessment. Programs then strengthen their QMS through document control, competency programs, and internal audits. Once clinical, collection, and processing practices are aligned with the standards, they may submit the eligibility and compliance applications. The onsite inspection is typically completed within a year of the initial submission.
Ultimately, FACT-JACIE accreditation is more than a certificate, it is a catalyst for a sustained culture of quality. For developing countries, adopting these standards offers a practical and globally aligned pathway toward safer and more reliable transplant care.
References
1. Booth C, et al. Bone Marrow Transplant. 2020;55:168–175. 2. FACT-JACIE Standards, 9th Edition 3. ISHBT Annual Activity Report, 2023 4. Gratwohl A, et al. Lancet Haematology. 2014;1(3):e91–e98
