Visions for a JACIE Quality Management System 4.0

Area of Science:

• Hematology
• Transplantation Medicine
• Quality Management Systems

Background:

• Quality management has been integral to hematopoietic stem cell transplantation (HSCT) since its inception.
• The FACT/JACIE-based quality management system (QMS) has been in place for two decades, improving patient outcomes and facilitating cooperation.
• Current advancements in cellular therapies, targeted treatments, and regulatory demands for advanced therapeutic medicinal products are challenging the existing QMS framework.

Purpose of the Study:

• To propose an evolution of the current quality management system (QMS) for hematopoietic stem cell transplantation (HSCT) based on the Medicine 4.0 concept.
• To redefine quality metrics from "Best Quality Transplant" to "Optimal Treatment," encompassing the entire patient healthcare journey.
• To outline a future direction for HSCT quality management that integrates advanced technologies and broader outcome measures.

Main Methods:

• Conceptual framework development based on Medicine 4.0 principles.
• Review and critique of the current FACT/JACIE-based QMS.
• Proposal for integrating real-time data, artificial intelligence, and harmonized data collection.

Main Results:

• The current QMS is nearing its limits due to the expansion of complex therapies and regulatory requirements.
• A shift towards "Optimal Treatment" is proposed, focusing on overall survival, quality of life, and cost-effectiveness.
• Integration of real-time digitized data collection and analysis, supported by artificial intelligence, is identified as crucial for future decision-making.

Conclusions:

• The existing quality management system for HSCT requires significant updates to accommodate modern therapeutic advancements.
• The Medicine 4.0 concept offers a framework for a more holistic and data-driven approach to HSCT quality.
• Harmonization efforts at institutional, national, and European levels, accelerated by technological advancements, are essential for implementing the next stage of HSCT quality management.