#2 Mar-Apr Cell Therapy JACIE Standards Organization

The quality manager at the center: an original study presented at EBMT 2025

During this year's EBMT 2025 Annual Meeting, held in an atmosphere of great participation and scientific ferment, a poster dedicated to a topic still little explored in the international scientific literature garnered particular interest: the evaluation of Quality Manager competencies in stem cell transplant centers, according to a structured methodology inspired by the FACT-JACIE standards.

The poster, presented within the "Quality Management" section, is proposed as the first step toward defining a shared, objective and measurable model for the self-assessment of the Quality Manager's role. The figure of the Quality Manager is central to quality management in transplant programs: not just a supervisor of procedures, but an active promoter of organizational culture, guarantor of regulatory compliance and facilitator of continuous improvement.

A project participated in by more than 60 industry professionals

What made the study particularly original was the methodological approach adopted: the construction of the self-assessment questionnaire took place through an iterative process, involving more than 60 Quality Managers from public, private and IRCCS facilities, distributed in different geographical areas of the world. A membership that testifies to the concrete interest in a tool that not only measures but also enhances the profession.

The model identified five core areas of expertise:

1. Technical/regulatory skills, including in-depth knowledge of FACT-JACIE standards.

2. Process and quality system management, with attention to integration with other clinical-organizational areas.

3. Audit and monitoring capabilities, in terms of effectiveness, nonconformities and corrective actions.

4. Document management and indicators, as operational and decision-making tools.

5. Cross-disciplinary, relational and training skills that are essential for coordinating multidisciplinary teams.

Each area was explored through a series of assessable statements on a scale, which enabled the generation of an individual radar chart, useful for visually representing each participant's competency profile.

The power of a visual and reflective approach

The use of the radar chart-a graphic form often adopted in management-allowed each Quality Manager to obtain, in an immediate and intuitive way, a picture of his or her own positioning with respect to the five areas. This stimulated constructive, nonjudgmental reflection on his or her role and training priorities.

One of the most appreciated elements, also reported during the poster presentation, was precisely the possibility of activating internal, multidisciplinary discussion: in fact, many participants shared their experience with colleagues at their center, using the questionnaire as a basis for constructive discussions on organizational improvement.

The importance of the JACIE framework

The reference to the FACT-JACIE standards is not coincidental. The most recent eighth edition of these standards places a strong emphasis on defining the responsibilities and competencies of professionals involved in transplant programs. The quality manager, according to JACIE, is not just an administrative figure, but a key element in patient safety, traceability of activities and the effectiveness of the quality management system.

The study presented showed how it is possible, through a simple and accessible tool, to transform standards into levers for professional growth, giving concrete form to requirements that otherwise risk remaining formal.

An open project: toward the creation of a dedicated portal

In light of the interest aroused, and the value collected through the active participation of professionals, an ambitious project is being conceived: the creation of an open and free portal for the self-assessment of Quality Manager competencies.

The goal is to provide all professionals in the field with a simple, accessible and useful digital tool that allows them to:

- Complete the questionnaire anonymously;

- Display the results via customized radar chart;

- Access targeted training content for each area of expertise;

- Participate in a community of practice, sharing experiences and operational strategies.

The portal will have no commercial purpose, but will be promoted by a network of experts and scientific entities that will ensure its methodological rigor and independence.

"Each area was explored through a series of assessable statements on a scale, which enabled the generation of an individual radar chart, useful for visually representing each participant's competency profile."

A call for participation

This project was born from an idea, but it wants to grow as a collective initiative. For this reason, an open consultation process will be launched in the coming weeks, aimed at gathering suggestions, membership and proposals from all those who would like to contribute to the development of the platform.

Participation in the EBMT 2025 congress was the starting point of a journey to bring lasting value to the Quality Manager community by promoting a culture of assessment, awareness and continuous improvement.

In a time when quality can no longer just be declared, but must be lived, measured and shared, this project represents a concrete opportunity to strengthen the role of the quality manager as a key figure in the healthcare of the future.

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