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Visions for a JACIE Quality Management System 4.0.

John A Snowden1, Eoin McGrath2, Kim Orchard3

  • 1Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.

Bone Marrow Transplantation
|September 30, 2021
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Summary

Hematopoietic stem cell transplantation (HSCT) quality management is evolving beyond the current FACT/JACIE system. A new "Optimal Treatment" approach will integrate Medicine 4.0 concepts for improved patient outcomes.

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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.