By Anne Emmett, Quality Managers Committee Chair and QM Member of the Accreditation Committee, and Rachel Luke, Quality Managers Committee Member.
Introduction
The field of Clinical Haematopoietic Stem Cell Transplantation and Cellular Therapy is evolving rapidly, driven by the introduction of innovative therapies and new operational models. In this dynamic environment, the Quality Manager plays a pivotal role—not only in ensuring compliance but also in fostering a culture of continuous improvement that enhances patient safety, clinical outcomes, and operational efficiency.
Certification and Standards: The Backbone of Quality
Establishing a robust quality management structure and culture is essential to support and drive necessary change.
A solid BMT quality management system begins with certification and adherence to international standards, such as JACIE. The role of the Quality Manager, as we know, is critical to enabling the clinical programme to develop their quality programme in line with required standards.
Integrating Advanced Cellular Therapies (ACT)
Innovations such as cellular therapies, ie CAR-T, introduce new complexities, requiring a flexible and responsive quality management framework. By empowering the Quality Manager and adapting existing structures, centres can effectively manage the integration of advanced cellular therapies via a number of avenues, such as, the seamless implementation of SOPs for apheresis, cell handling, and infusion protocols.
Robust product traceability systems from manufacturing to bedside is critical to the process and requires cross-functional collaboration among clinical, laboratory, and pharmacy teams. Competency frameworks incorporating both commercial training and internal assessments will be required. Comprehensive adverse event reporting systems should be broadened to incorporate CAR-T related complications (e.g. CRS and ICANS).
Risk assessments, validation and change management procedures should be developed appropriately.
Digitalisation and Data Governance
The transition to electronic health records (EHRs) and digital platforms presents both opportunities and challenges. Quality Managers can leverage digital tools to ensure data accuracy and system validation through routine audits. Driven data-informed quality improvement initiatives through trend analysis is key as well as monitoring key performance indicators (KPIs) such as infection rates, length of stay, and readmissions. It is acknowledged that interoperability between EHRs, laboratory systems and databases etc however can be challenging within the clinical setting.
Collaboration and Effective Communications
Effective collaboration and communication are foundational to a successful quality programme. The Quality Manager must act as a bridge between multidisciplinary teams, ensuring that quality objectives are clearly understood and consistently applied across clinical, laboratory, and administrative functions. Open channels of communication foster transparency, encourage shared ownership of quality goals, and enable timely identification and resolution of issues. Regular team meetings, feedback and inclusive decision-making processes help cultivate a culture where quality is everyone's responsibility—not just the remit of the Quality Manager.
Conclusion
As the landscape of Clinical Haematopoietic Cell Transplantation and Cellular Therapy continues to evolve, the role of the Quality Manager becomes increasingly strategic and multifaceted. No longer confined to regulatory compliance, the Quality Manager is a catalyst for innovation, safety, and operational excellence. By embedding quality into every aspect of care—from certification and standards to the integration of advanced therapies and digital transformation—clinical programmes can ensure they remain agile, resilient, and patient-focused.
Investing in quality leadership and infrastructure is not just a regulatory necessity; it is a commitment to delivering the highest standards of care in a rapidly changing clinical environment.