JACIE accreditation: Evaluation at the STSH cell therapy unit.

Hematopoietic stem cell transplantation (HSCT) is a standard treatment for many hematologic disorders. Its success depends on graft quality and donor safety, making the collection process critical. The adoption of international standards such as FACT-JACIE helps harmonize practices and enhance reliability. This study evaluated the compliance level of an ISO 9001-certified stem cell collection unit to identify discrepancies and propose areas for improvement. The analysis was based on Chapter C of the FACT-JACIE standard dedicated to collection, covering organizational, technical, and quality aspects. The self-assessment grid was adapted to the local context and supplemented by a rating system (2 = compliant, 1 = partially compliant, 0 = non-compliant). Enabling an overall score per section and the identification of improvement priorities. The analysis highlights a solid foundation, with many requirements already integrated thanks to ISO 9001 certification. However, certain gaps persist, mainly linked to the absence of a national regulatory framework aligned with international standards, the lack of formalization of certain procedures, the incomplete systematization of quality controls, and the need to strengthen traceability. These gaps, observed in a few chapters with lower compliance, do not compromise donor safety or graft quality, but are priorities for consolidating risk control and achieving better alignment with international standards. This study demonstrates that a structured diagnosis effectively assesses a collection unit's compliance with JACIE standards. It underlines a strong foundation while highlighting key areas for improvement to enhance donor protection, graft quality, and overall reliability of the transplantation process.