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造血干细胞移植的标准化与认证——亚太地区视角

Standardization and Accreditation in Haemopoietic Stem Cell Transplantation - an Asia Pacific Perspective.

作者信息

Damodar Sharat, Ma David D, Ragg Scott J, Chang Annabella, Hwang William Yk, Ho Aloysius Yl, Srivastava Alok

机构信息

Dept of Haematology and BMT, Mazumdar shaw medical center, Narayana health city, India.

Department of Haematology and BM Transplant, St Vincent's Hospital Sydney, NSW, Australia.

出版信息

Blood Cell Ther. 2021 Oct 14;4(Spec Edition):S14-S19. doi: 10.31547/bct-2021-015.

DOI:10.31547/bct-2021-015
PMID:36713471
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9847258/
Abstract

Standardization and formal accreditation of practices related to hematopoietic stem cell transplantation (HSCT) and therapies using hematopoietic-derived cellular products aim to promote quality in clinical and laboratory practice and provide knowledge to all stakeholders of centers. This article refers to three aspects of these processes starting with the importance of accurate viable CD 34 enumeration in HSCT. A highly accurate method of enumeration and a robust EQAS program is required, especially during the current COVID-19 pandemic. The second section shares experiences with FACT-JACIE accreditation at the Singapore General Hospital demonstrating how accreditation is part of continuous improvement and not only a destination. This journey can be difficult in many HSCT centers of low- and middle-income countries (LMICs) because of the intensive and rigorous requirements of the internationally accredited models. Hence, in LMICs, a staged movement toward establishing such standards must be considered. This approach is presented in the third section of the article with data on the current situation in countries reporting to the APBMT registry.

摘要

造血干细胞移植(HSCT)及使用造血来源细胞产品的治疗相关操作的标准化和正式认证旨在提升临床和实验室实践的质量,并为各中心的所有利益相关者提供知识。本文从HSCT中准确的活CD 34计数的重要性开始,阐述了这些过程的三个方面。需要一种高度准确的计数方法和一个强大的外部质量评估计划,尤其是在当前的新冠疫情期间。第二部分分享了新加坡总医院FACT-JACIE认证的经验,展示了认证如何成为持续改进的一部分,而不仅仅是一个目标。由于国际认可模式的严格要求,在许多低收入和中等收入国家(LMICs)的HSCT中心,这一过程可能会很困难。因此,在LMICs中,必须考虑分阶段朝着建立此类标准迈进。本文第三部分介绍了这种方法,并提供了向亚太骨髓移植登记处报告的国家的现状数据。

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Blood Cell Ther. 2021 Oct 14;4(Spec Edition):S14-S19. doi: 10.31547/bct-2021-015.
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本文引用的文献

1
Variable CD34+ recovery of cryopreserved allogeneic HPC products: transplant implications during the COVID-19 pandemic.冷冻保存的异基因造血祖细胞产品的 CD34+ 恢复情况可变:COVID-19 大流行期间的移植影响。
Blood Adv. 2020 Sep 8;4(17):4147-4150. doi: 10.1182/bloodadvances.2020002431.
2
Multi-laboratory assay for harmonization of enumeration of viable CD34+ and CD45+ cells in frozen cord blood units.多实验室检测法用于协调冷冻脐血单位中 CD34+ 和 CD45+ 有核细胞的计数。
Cytotherapy. 2020 Jan;22(1):44-51. doi: 10.1016/j.jcyt.2019.10.009. Epub 2019 Dec 27.
3
Benchmarking of survival outcomes following haematopoietic stem cell transplantation: A review of existing processes and the introduction of an international system from the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE).造血干细胞移植后生存结果的基准评估:对现有流程的综述以及欧洲血液和骨髓移植学会(EBMT)与国际细胞治疗学会和 EBMT 联合认证委员会(JACIE)引入的国际系统介绍。
Bone Marrow Transplant. 2020 Apr;55(4):681-694. doi: 10.1038/s41409-019-0718-7. Epub 2019 Oct 21.
4
Worldwide Network for Blood and Marrow Transplantation (WBMT) recommendations for establishing a hematopoietic stem cell transplantation program in countries with limited resources (Part II): Clinical, technical and socio-economic considerations.全球血液和骨髓移植网络(WBMT)关于在资源有限国家建立造血干细胞移植项目的建议(第二部分):临床、技术和社会经济考量
Hematol Oncol Stem Cell Ther. 2020 Mar;13(1):7-16. doi: 10.1016/j.hemonc.2019.08.002. Epub 2019 Aug 20.
5
Providing both autologous and allogeneic hematopoietic stem cell transplants (HSCT) may have a stronger impact on the outcome of autologous HSCT in adult patients than activity levels or implementation of JACIE at Belgian transplant centres.为成人患者提供自体和同种异体造血干细胞移植(HSCT)可能比对比利时移植中心的活动水平或 JACIE 的实施对自体 HSCT 的结果有更强的影响。
Bone Marrow Transplant. 2019 Sep;54(9):1434-1442. doi: 10.1038/s41409-019-0458-8. Epub 2019 Jan 29.
6
JACIE accreditation for blood and marrow transplantation: past, present and future directions of an international model for healthcare quality improvement.JACIE 血液和骨髓移植认证:国际医疗质量改进模式的过去、现在和未来方向。
Bone Marrow Transplant. 2017 Oct;52(10):1367-1371. doi: 10.1038/bmt.2017.54. Epub 2017 Mar 27.
7
One million haemopoietic stem-cell transplants: a retrospective observational study.一百万例造血干细胞移植:一项回顾性观察研究。
Lancet Haematol. 2015 Mar;2(3):e91-100. doi: 10.1016/S2352-3026(15)00028-9. Epub 2015 Feb 27.
8
European Group for Blood and Marrow Transplantation Centers with FACT-JACIE Accreditation Have Significantly Better Compliance with Related Donor Care Standards.获得FACT-JACIE认证的欧洲血液和骨髓移植中心集团在相关供体护理标准方面的合规性显著更好。
Biol Blood Marrow Transplant. 2016 Mar;22(3):514-9. doi: 10.1016/j.bbmt.2015.11.009. Epub 2015 Nov 18.
9
The impact of center accreditation on hematopoietic cell transplantation (HCT).中心认证对造血细胞移植(HCT)的影响。
Bone Marrow Transplant. 2015 Jan;50(1):87-94. doi: 10.1038/bmt.2014.219. Epub 2014 Nov 10.
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Use of the quality management system "JACIE" and outcome after hematopoietic stem cell transplantation.质量管理体系“JACIE”的应用与造血干细胞移植后的结果
Haematologica. 2014 May;99(5):908-15. doi: 10.3324/haematol.2013.096461. Epub 2014 Jan 31.