Definitions used in quality management of blood establishments: A report of the ISBT Quality Management Working Party.

IF 1.6 4区医学 Q3 HEMATOLOGY

Vox Sanguinis Pub Date : 2025-09-07 DOI:10.1111/vox.70108

Lesley Bust, Christian Seidl, Tomislav Vuk, Yan Qiu, Nigar Ertuğrul Örüç

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引用次数: 0

Abstract

Background and objectives: The International Society of Blood Transfusion (ISBT) Quality Management Working Party (QM-WP) initiated a project to harmonize the definitions commonly used in quality management within blood establishments (BEs) around the world. A working group was established with the aim of providing simple, unambiguous definitions that can be applied in a standardized way.

Materials and methods: Common references available internationally were consulted in drafting a list of definitions relating to quality management. The criteria for selecting the most appropriate definition included clarity, simplicity, comprehensiveness and optimal applicability.

Results: The resulting list of definitions was published on the ISBT website in July 2023, with reference sources quoted for each definition. Individual references can be accessed via links appearing at the end of the document.

Conclusion: BEs are encouraged to utilize the document when developing internal quality system documents. The list is not prescriptive but is meant to serve as a recommendation. It is understood, however, that establishments in some countries are obliged to follow national legislation and terminology. It is the intention of the ISBT QM-WP to periodically review the list of definitions, performing updates when required.

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血液机构质量管理中使用的定义：ISBT质量管理工作组报告。

背景和目标：国际输血学会（ISBT）质量管理工作组（QM-WP）启动了一个项目，以协调世界各地血液机构（BEs）质量管理中常用的定义。成立了一个工作组，目的是提供可以以标准化方式应用的简单、明确的定义。材料和方法：在起草与质量管理有关的定义清单时，参考了国际上常用的参考资料。选择最适当定义的标准包括清晰性、简洁性、全面性和最佳适用性。结果：最终的定义列表于2023年7月在ISBT网站上公布，每个定义都引用了参考来源。个别引用可以通过出现在文档末尾的链接访问。结论：鼓励BEs在制定内部质量体系文件时使用该文件。这份清单不是规定性的，只是作为一种建议。但是，据了解，一些国家的机构必须遵守国家立法和术语。ISBT QM-WP的目的是定期审查定义列表，并在需要时进行更新。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Vox Sanguinis 医学-血液学

CiteScore

4.40

自引率

11.10%

发文量

156

审稿时长

6-12 weeks

期刊介绍： Vox Sanguinis reports on important, novel developments in transfusion medicine. Original papers, reviews and international fora are published on all aspects of blood transfusion and tissue transplantation, comprising five main sections: 1) Transfusion - Transmitted Disease and its Prevention: Identification and epidemiology of infectious agents transmissible by blood; Bacterial contamination of blood components; Donor recruitment and selection methods; Pathogen inactivation. 2) Blood Component Collection and Production: Blood collection methods and devices (including apheresis); Plasma fractionation techniques and plasma derivatives; Preparation of labile blood components; Inventory management; Hematopoietic progenitor cell collection and storage; Collection and storage of tissues; Quality management and good manufacturing practice; Automation and information technology. 3) Transfusion Medicine and New Therapies: Transfusion thresholds and audits; Haemovigilance; Clinical trials regarding appropriate haemotherapy; Non-infectious adverse affects of transfusion; Therapeutic apheresis; Support of transplant patients; Gene therapy and immunotherapy. 4) Immunohaematology and Immunogenetics: Autoimmunity in haematology; Alloimmunity of blood; Pre-transfusion testing; Immunodiagnostics; Immunobiology; Complement in immunohaematology; Blood typing reagents; Genetic markers of blood cells and serum proteins: polymorphisms and function; Genetic markers and disease; Parentage testing and forensic immunohaematology. 5) Cellular Therapy: Cell-based therapies; Stem cell sources; Stem cell processing and storage; Stem cell products; Stem cell plasticity; Regenerative medicine with cells; Cellular immunotherapy; Molecular therapy; Gene therapy.