The ISBT Quality Management Working Party promotes excellence, safety, and continuous improvement in transfusion medicine. It supports the development and implementation of evidence-based quality standards and best practices across the transfusion chain, from donor care to patient outcomes. Through collaboration, innovation, and data-driven approaches, the Working Party aims to enhance patient safety, improve efficiency, and strengthen confidence in transfusion services worldwide.
Chairperson and committee
Chairperson: Nigar Ertuğrul Őrüç (Türkiye)
Vice chair: Christian Seidl (Germany)
Board members:
Tomislav Vuk (Croatia)
Lesley Bust (South Africa)
Wade Atkins (USA)
Yan Qiu (China)
WP Subgroups - leaders
- Database (survey) on quality management standards and criteria, Christian Seidl
- Quality indicators for blood establishments (BE) and hospital blood banks (HBB), Tomislav Vuk
- Harmonization of definitions in quality management, Lesley Bust
- Training, education and e-learning, Christian Seidl, Lesley Bust, Nigar Ertuğrul Őrüç
Membership
The Working Party currently comprises 45 members representing 24 countries across six continents. During the reporting period, the group welcomed five new members, while eleven members left due to non-renewal of their ISBT membership. This diverse international representation reflects the Working Party’s commitment to advancing quality management practices in transfusion medicine worldwide.
Meetings
Hybrid Business Meeting
A hybrid business meeting was held during the ISBT Congress in Milan on 1 June 2025, with 21 members attending in person and 7 joining virtually. The meeting provided an opportunity to review the Working Party’s progress, discuss subgroup activities, and plan future initiatives. Key discussion points included:
- Annual Report: Overview of QM-WP activities during the reporting period.
- Subgroup updates:SG1: Plans to repeat the survey on quality management standards, with revisions and support from regional representatives. SG2: Acceptance of the manuscript Quality Indicators for Blood Establishments and Hospital Blood Banks for publication in Vox Sanguinis (May 2025). SG3: Progress on the manuscript addressing harmonisation of quality management definitions. SG4: Discussion on developing interactive quality management training in response to member requests.
- Collaborations and external contributions: Continued collaboration with the Global Blood Supply Working Party on the International Coalition for Safe Plasma Proteins (ICSPP). Planned collaboration with the Haemovigilance Working Party on training activities and harmonisation of definitions. Updates on contributions to the GAPP-PRO Joint Action / EURO GTP II Project and the ISBT Academy Educational Programme in Chandigarh, India. Invitation to contribute to the KEQAS 2026 Conference in Seoul, South Korea, through a presentation on Quality Indicators.
- Future activities: Planning of a workshop and scientific session on Quality Management and the New SoHO Regulation for the ISBT Congress 2026. Discussion of a webinar on the New SoHO Regulation, potential Transfusion Today topics, project funding needs, and strategies to recruit and engage members.
Online Board Meetings
Two online Board meetings were held on 17 October 2025 and 22 January 2026. These meetings focused on planning upcoming activities, reviewing subgroup progress, and strengthening collaborations. Key points included:
- ISBT Congress 2026: Planning of the QM-WP session and workshop in Kuala Lumpur.
- Training activities: Organisation of face-to-face quality management training in low- and middle-income countries (LMICs).
- Subgroup updates:SG1: Revision of the quality management standards survey aligned with current quality indicators. SG2: Proposal for a new project on classification of events. SG3: Expansion of the harmonisation of definitions project. SG4: Development of a webinar on the New SoHO Regulation and risk assessment.
- Collaborations and contributions:
- Ongoing work with the Global Blood Supply Working Party on ICSPP.
- Updates on GAPP-PRO / EURO GTP II Project involvement.
- Contributions to the ISBT Academy Programme in Chandigarh, India.
- Planning participation in KEQAS 2026 in Seoul, South Korea.
- Future projects:Webinar on the New SoHO Regulation (2026).
- Workshop planning for future ISBT congresses.
- Potential Transfusion Today publications.
- Discussion of funding requirements.
Additional Communications
Throughout the reporting period, several teleconferences and email exchanges were held among QM-WP Board members to support ongoing work. These focused on:
- Preparation and editing of manuscripts for Vox Sanguinis:Quality Indicators for Blood Establishments and Hospital Blood Banks. Definitions Used in Quality Management of Blood Establishments.
- Development of the interactive session The New SoHO Regulation – Challenges for Blood Establishments for ISBT Congress 2026 in Kuala Lumpur.
- Preparation of a detailed interactive training programme in response to requests from members in low- and middle-income countries under SG4 (Training and Education).
Collaboration with the Haemovigilance Working Party
Two online meetings between the Chairs of the Haemovigilance Working Party and the QM-WP were held on 15 October and 7 November 2025, supported by ongoing email discussions. The collaboration focused on:
- Development of joint scientific and educational activities.
- Planning of a collaborative workshop for the ISBT Congress 2026.
- Definition of workshop aims, format, and preparation of the ISBT submission.
Activities during the period
ISBT Academy Educational Programme (Chandigarh, India)
Co-chair of the Working Party, Christian Seidl, contributed as a keynote speaker in April 2025. He presented “Quality Systems: A pillar of safe and effective transfusion services”, highlighting the importance of robust quality systems in supporting safe transfusion practice.
Interactive Scientific Session – ISBT Congress (Milan, June 2025)
An interactive scientific session titled “Quality requirements for SoHO – the risk-based approach” was held during the ISBT Congress in Milan. The session included the following presentations:
- Proposal of new EU SoHO regulation and its potential impact on quality management systems of blood establishments (V. de Angelis)
- Requirements for effective haemovigilance systems (J. Reinhardt)
- Quality monitoring in support of risk-based quality systems (T. Vuk)
- WHO guidance on implementation of quality systems in blood establishments (L. Bust)
Young Professionals Breakfast – ISBT Congress (Milan, 2026)
Chair of the Working Party, Nigar Ertuğrul Örüç, participated as a mentor in the Young Professionals Breakfast at the ISBT Congress in Milan, supporting engagement and networking among early-career professionals.
WHO Review – Maldives National Blood Transfusion Standards Guide
At the request of WHO, selected chapters (1–5, 7, and 14) of the Maldives National Blood Transfusion Standards Guide were reviewed. The review covered organization and management, facility requirements, supplies and services, equipment, human resources, record and document control, and biosafety and waste management. Contributors included Nigar Ertuğrul Örüç, Lesley Bust, Wade Atkins, and Yan Qiu.
GAPP-PRO External Advisory Board Meeting
Christian Seidl and Nigar Ertuğrul Örüç represent the QM-WP on the External Advisory Board of the GAPP-PRO Joint Action. Christian Seidl attended the External Advisory Board meeting in Rome on 21 October 2025.
GAPP-PRO is a 40-month European Joint Action co-funded by the European Commission and led by Italy’s National Blood and Transplant Centres. It aims to harmonise and strengthen the evaluation and authorisation of Substances of Human Origin (SoHO) across Europe using a consistent, science- and risk-based approach.
The project involves stakeholders from 13 EU countries and one non-EU country, including regulatory authorities, research bodies, technical organisations, and healthcare professionals, and is supported by an External Advisory Board of scientific societies such as ISBT.
Key outputs include the EUROGTP II Risk Assessment Guide and the Interactive Assessment Tool (IAT), which are available here.
KEQAS Congress (Seoul, South Korea, February 2026)
At the International Congress of the Korean Association of External Quality Assessment Service (KEQAS 2026), the Chair of the Working Party, Nigar Ertuğrul Örüç, presented the Working Party Report on Quality Indicators for Blood Establishments and Hospital Blood Banks. The presentation received significant attention, and the related article in Vox Sanguinis reached over 1,000 views within five days.
AfSBT Congress (Windhoek, Namibia, March 2026)
Lesley Bust participated in the ISBT Academy Day Programme on Hospital Transfusion, chaired by ISBT President Prof. Pierre Tiberghien. She also delivered a presentation titled “Sustainable Quality Improvement (SusQI) for Blood Establishments” at the Africa Society for Blood Transfusion (AfSBT) Congress.
Working Party Publications
Challenges and Opportunities
Challenges: Countries operate under diverse regulatory frameworks and varying levels of resources, making harmonisation of practices between highly regulated systems (e.g., EU and US) and low- and middle-income settings challenging. Although guidelines are available, their implementation remains inconsistent across regions.
Opportunities: The QM-WP is well positioned to act as a bridge between regions and to support global harmonisation efforts. This can be further strengthened through collaboration with organisations such as the EuBIS Academy, WHO, and EDQM.
Summary
During 2025–2026, the QM-WP demonstrated strong international engagement in advancing quality management in transfusion medicine through education, scientific contribution, and strategic collaboration.
The group delivered key presentations at major international events, including ISBT Academy programmes and congresses in Chandigarh, Milan, Seoul, and Windhoek, addressing topics such as quality systems, risk-based approaches for SoHO, quality indicators, and sustainable quality improvement. QM-WP also supported professional development through mentorship activities at the ISBT Congress 2026.
In collaboration with WHO, QM-WP contributed to the review of the Maldives National Blood Transfusion Standards Guide, covering essential operational and quality system components.
At the strategic level, QM-WP participated in the External Advisory Board of the GAPP-PRO Joint Action, contributing to the development and dissemination of Updated EUROGTP II Risk Assessment Guide and Interactive Assesment Tool, which were subsequently published on the ISBT QM-WP platform.
Overall, QM-WP’s activities reflect its continued leadership in promoting quality, harmonisation, and capacity building in transfusion practices globally. The key impact and outcome has been to share knowledge and promote excellence, safety, and continuous quality improvement across all aspects of blood transfusion establishments. The working party thanks ISBT for their ongoing encouragement and support of our activities.
