国外捐献器官获取质量管理与控制进展

金律; 范晓礼; 叶啟发

doi:10.3969/j.issn.1674-7445.2023206

国外捐献器官获取质量管理与控制进展

doi: 10.3969/j.issn.1674-7445.2023206

金律^1,,
范晓礼^1, ,,
叶啟发^{1, 2}

1.
430071　武汉，武汉大学中南医院武汉大学肝胆疾病研究院武汉大学移植医学中心国家人体捐献器官获取质量控制中心移植医学技术湖北省重点实验室湖北省天然高分子生物肝临床医学研究中心湖北省天然高分子基医用材料构建工程技术研究中心
2.
中南大学湘雅三医院（叶啟发）；卫生部移植医学工程技术研究中心

基金项目: 国家自然科学基金（82370671）；武汉大学中南医院临床研发项目（lcyf202205）

详细信息

作者简介:

通讯作者:
范晓礼（ORCID 0000-0001-6153-5648），Email：fanxl_whu@hotmail.com

中图分类号: R617, R19
计量
- 文章访问数: 184
- HTML全文浏览量: 86
- PDF下载量: 36
- 被引次数: 0
出版历程
- 收稿日期: 2023-11-14
- 网络出版日期: 2024-01-05
- 刊出日期: 2024-03-15

Progress in quality management and control of donor organ procurement in foreign countries

Jin Lyu^1
,,
Fan Xiaoli^{1
, ,},
Ye Qifa^{1, 2}

1.
Zhongnan Hospital of Wuhan University, Hepatobiliary Disease Research Institute of Wuhan University, Transplantation Medical Center of Wuhan University, National Quality Control Center for Donor Organ Procurement, Hubei Provincial Key Laboratory of Transplantation Medical Technology, Hubei Provincial Natural Polymer Biological Liver Clinical Medical Research Center, Hubei Provincial Natural High Molecular Weight Medical Material Construction Engineering Technology Research Center, Wuhan 430071, China

More Information

Corresponding author: Fan Xiaoli, Email:fanxl_whu@hotmail.com

摘要

摘要: 器官移植是二十世纪以来有效挽救终末期器官衰竭患者生命的一项突破性技术，显著改善了患者生存质量。器官捐献作为器官移植的重要来源，提升捐献器官获取质量是促进捐献器官转化、改善器官移植预后的关键。美国、西班牙等国家在捐献器官获取质量管理与控制方面提出了系列政策和标准，并取得了积极成果。本文通过探讨医疗质量管理与控制有关概念、国际捐献器官获取质量管理先进策略及模式，研究器官获取组织、捐献者、捐献器官质控举措，以期为形成具有“中国特色”的捐献器官获取质量管理与控制体系、推进捐献器官获取高速度高质量发展提供参考。
- 器官捐献 /
- 器官获取 /
- 器官获取组织（OPO） /
- 质量管理 /
- 管理模式 /
- 质量控制 /
- 器官移植 /
- 捐献者
Abstract: Since the 20th century, organ transplantation has become a breakthrough technology to effectively save the lives of patients with end-stage organ failure, which has significantly enhanced the quality of life of patients. Organ donation is an important source of organ transplantation. Improving the quality of donor organ procurement is the key to promote the translation of donor organs and improve the prognosis of organ transplantation recipients. The United States, Spain and other countries have put forward a series of policies and standards in the quality management and control of donor organ procurement and achieved positive results. In this article, related concepts of medical quality management and control, advanced strategies and models of international donor organ procurement quality management, and quality control measures of Organ Procurement Organization, donors and donor organs were reviewed, aiming to provide reference for establishing a quality management and control system of donor organs with "Chinese characteristics" and advancing high-speed and high-quality development of donor organ procurement.
- Organ donation /
- Organ procurement /
- Organ Procurement Organization (OPO) /
- Quality management /
- Management mode /
- Quality control /
- Organ transplantation /
- Donor

HTML全文

FIG. 2988. FIG. 2988.

FIG. 2988.. FIG. 2988.

下载: 全尺寸图片幻灯片

图 1 美国2000年至2022年器官捐献情况

注：DBD为脑死亡器官捐献，DCD为心脏死亡器官捐献。

Figure 1. The situation of organ donation in the United States from 2000 to 2022（数据来源：GODT）

下载: 全尺寸图片幻灯片

图 2 美国捐献器官获取管理架构

Figure 2. Architecture of organ donation acquisition management in the United States

下载: 全尺寸图片幻灯片

图 3 西班牙2000年至2022年器官捐献情况

注：DBD为脑死亡器官捐献，DCD为心脏死亡器官捐献。

Figure 3. The situation of organ donation in Spain from 2000 to 2022（数据来源：GODT）

下载: 全尺寸图片幻灯片

参考文献(38)

[1]	王炳龙, 程永忠. 《医疗质量与安全管理》[M]. 北京: 中国协和医科大学出版社, 2022: 6-7
[2]	范奕雯, 封晓如, 赵婕, 等. 美国人体器官获取组织管理体系解析[J]. 中国医院院长, 2022, 18(20): 22-25. FAN YW, FENG XR, ZHAO J, et al. Analysis of the human Organ Procurement Organization management system in the United States[J]. China Hosp CEO, 2022, 18(20): 22-25.
[3]	MONE T, DANOVITCH G. US Organ Procurement Organization donation principles, laws, and practices[J]. Am J Kidney Dis, 2020, 76(5): 735-738. DOI: 10.1053/j.ajkd.2020.05.022.
[4]	Centers for Medicare & Medicaid Services (CMS), HHS. Medicare and Medicaid programs; conditions for coverage for Organ Procurement Organizations (OPOs). final rule[J]. Fed Regist, 2006, 71(104): 30981-31054.
[5]	Medicare and Medicaid Programs: Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization[EB/OL]. [2023-08-22]. https://www.federalregister.gov/documents/2020/12/02/2020-26329/medicare-and-medicaid-programs-organ-procurement-organizations-conditions-for-coverage-revisions-to.
[6]	Organ Procurement Organization (OPO) conditions for coverage final rule: revisions to outcome measures for OPOs CMS-3380-F[EB/OL]. [2023-08-22]. https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos.
[7]	The OPTN policy development process[EB/OL]. [2023-08-22]. https://optn.transplant.hrsa.gov/policies-bylaws/policy-development/.
[8]	张玮晔. 西班牙器官捐献组织架构与法律管窥[J/CD]. 实用器官移植电子杂志, 2015, 3(2): 82-87. DOI: 10.3969/j.issn.2095-5332.2015.02.005. ZHANG WY. Organizational structure and legal perspective of organ donation in Spain[J/CD]. Pract J Organ Transplant (Electr Vers), 2015, 3(2): 82-87. DOI: 10.3969/j.issn.2095-5332.2015.02.005.
[9]	MATESANZ R, DOMÍNGUEZ-GIL B, COLL E, et al. How Spain reached 40 deceased organ donors per million population[J]. Am J Transplant, 2017, 17(6): 1447-1454. DOI: 10.1111/ajt.14104.
[10]	Organización Nacional de Trasplantes (ONT) [EB/OL]. [2023-08-22].https://www.ont.es/la-organizacion-nacional-de-trasplante/quienes-somos/.
[11]	Law 14/1986 of 25 April, General Health[EB/OL]. [2023-08-22]. https://www.global-regulation.com/translation/spain/1477584/law-14-1986-of-25-april%252c-general-health.html.
[12]	Royal Decree 2070/1999 Of 30 December, Which Regulates The Activities Of Collection And Clinical Use Of Human Organs And The Territorial Coordination In The Field Of Donation And Transplantation Of Organs And Tissues[EB/OL]. [2023-08-22]. https://www.global-regulation.com/translation/spain/1453933/royal-decree-2070---1999-of-30-december%252c-which-regulates-the-activities-of-collection-and-clinical-use-of-human-organs-and-the-territorial-coordinat.html.
[13]	MATESANZ R, DOMÍNGUEZ-GIL B, COLL E, et al. Spanish experience as a leading country: what kind of measures were taken?[J]. Transpl Int, 2011, 24(4): 333-343. DOI: 10.1111/j.1432-2277.2010.01204.x.
[14]	STREIT S, JOHNSTON-WEBBER C, MAH J, et al. Ten lessons from the Spanish model of organ donation and transplantation[J]. Transpl Int, 2023, 36: 11009. DOI: 10.3389/ti.2023.11009.
[15]	Organs, tissues and cells - Background & Mission[EB/OL]. [2023-08-22]. https://www.edqm.eu/en/background-mission-organs-tissues-cells.
[16]	Guide to the quality and safety of organs for transplantation[M]. Amsterdam: European Directorate for the Quality of Medicines & Healthcare, 2022.
[17]	CORSI CAC, ASSUNÇÃO-LUIZ AV, CINTRA ÁS, et al. Models of quality management systems applied in specialized services for the donation and transplantation of human organs and tissues[J]. Transplant Proc, 2023, 55(6): 1337-1345. DOI: 10.1016/j.transproceed.2023.01.026.
[18]	CORSI CAC, SHOJI M, SCARPELINI KCG, et al. Implementation and certification of ISO 9001: 2015 seal in human tissue bank HCFMRP-USP[J]. Cell Tissue Bank, 2020, 21(4): 563-571. DOI: 10.1007/s10561-020-09852-1.
[19]	Quality Management[EB/OL]. [2023-08-22]. https://www.edqm.eu/en/edqm/about/quality-management.
[20]	KLEIN V. High security standards in organ donation and transplantation ISO 9001-certificate for organ procurement organisation in Germany[J]. Transpl Int, 2000, 13(3): 232-233. DOI: 10.1007/s001470050693.
[21]	GÓMEZ MP, OBAIDLI AA, PROCACCIO F, et al. ISO quality certification for a hospital-based organ procurement unit: the United Arab Emirates (UAE) experience[J]. Transplantation, 2020, 104(S3): S22. DOI: 10.1097/01.tp.0000699568.75617.20.
[22]	The Joint Commission[EB/OL]. [2023-09-18]. https://www.jointcommission.org/.
[23]	LANG LH. JCAHO to develop certification program for organ transplant centers[J]. Gastroenterology, 2005, 129(5): 1370. DOI: 10.1053/j.gastro.2005.09.029.
[24]	ED accreditation update: JCAHO revises standard on organ procurement. [EB/OL]. [2023-08-24]. https://www.reliasmedia.com/articles/121853-ed-accreditation-update-jcaho-revises-standard-on-organ-procurement.
[25]	The-Joint-Commission-Standards: Hospital Accreditation Program[EB/OL]. [2023-08-24]. https://www.dnaz.org/wp-content/uploads/2015/07/The-Joint-Commission-Standards.pdf.
[26]	MANYALICH M, GUASCH X, GOMEZ MP, et al. Organ Donation European Quality System: ODEQUS project methodology[J]. Transplant Proc, 2013, 45(10): 3462-3465. DOI: 10.1016/j.transproceed.2013.09.009.
[27]	Project ODEQUS (Organ Donation European Quality System). [EB/OL]. [2023-08-24]. http://www.odequs.eu/pdf/ODEQUS_Quality_Criteria-Indicators.pdf.
[28]	PARK J, PARK H, MIN J, et al. Effects of policy on promotion of organ donation and donation improvement program on donation[J]. Korean J Transplant, 2022, 36(Suppl 1): S132-S132. DOI: 10.4285/ATW2022.F-2516.
[29]	RAMSI MA, AL MAEENI SM, AL SEREIDI HM, et al. United Arab Emirates' future perspective: converting potential organ donors into actual organ donors in an academic setting[J]. Exp Clin Transplant, 2020, 18(2): 177-181. DOI: 10.6002/ect.2019.0251.
[30]	赵婕, 霍枫, 赵洪涛, 等. 系统性多科室协作器官捐献国际经验对我国的启示[J]. 器官移植, 2022, 13(6): 683-689. DOI: 10.3969/j.issn.1674-7445.2022.06.001. ZHAO J, HUO F, ZHAO HT, et al. Enlightenment of international experience of organ donation related systematic multi-department collaboration to China[J]. Organ Transplant, 2022, 13(6): 683-689. DOI: 10.3969/j.issn.1674-7445.2022.06.001.
[31]	KOTLOFF RM, BLOSSER S, FULDA GJ, et al. Management of the potential organ donor in the ICU: Society of Critical Care Medicine/American College of Chest Physicians/Association of Organ Procurement Organizations Consensus Statement[J]. Crit Care Med, 2015, 43(6): 1291-1325. DOI: 10.1097/CCM.0000000000000958.
[32]	CHO WH. Organ donation in Korea in 2018 and an introduction of the Korea national organ donation system[J]. Korean J Transplant, 2019, 33(4): 83-97. DOI: 10.4285/jkstn.2019.33.4.83.
[33]	范晓礼, 叶啟发, RUGER PLOEG. 英国国家器官获取系统科学建设及质量控制[J]. 武汉大学学报(医学版), 2016, 37(4): 526-528. DOI: 10.14188/j.1671-8852.2016.04.003. FAN XL, YE QF, RUGER PLOEG. The scientific establishment and quality control of United Kingdom National Organ Retrieval Service[J]. Med J Wuhan Univ, 2016, 37(4): 526-528. DOI: 10.14188/j.1671-8852.2016.04.003.
[34]	黄伟, 叶啟发, 范晓礼, 等. 中国人体器官获取组织发展与建设历程[J]. 武汉大学学报(医学版), 2021, 42(2): 173-178. DOI: 10.14188/j.1671-8852.2021.8001. HUANG W, YE QF, FAN XL, et al. Development and history of organ procurement organization in China[J]. Med J Wuhan Univ, 2021, 42(2): 173-178. DOI: 10.14188/j.1671-8852.2021.8001.
[35]	江文诗, 马联胜, 殳儆, 等. 多学科融合促进器官捐献学科体系建设及专业化发展[J]. 器官移植, 2022, 13(6): 711-721. DOI: 10.3969/j.issn.1674-7445.2022.06.004. JIANG WS, MA LS, SHU J, et al. Multi-disciplinary integration promotes the disciplinary system construction and professional development of organ donation[J]. Organ Transplant, 2022, 13(6): 711-721. DOI: 10.3969/j.issn.1674-7445.2022.06.004.
[36]	薛武军. 中国器官移植发展的必由之路——器官移植学科体系化、器官捐献专业化、OPO建设学科化[J]. 中华器官移植杂志, 2023, 44(4): 193-196. DOI: 10.3969/j.issn.2095-5332.2023.02.002. XUE WJ. The only way for the development of organ transplantation in China— systematization of organ transplantation disciplines, specialization of organ donation and disciplinarization of OPO construction[J]. Chin J Organ Transplant, 2023, 44(4): 193-196. DOI: 10.3969/j.issn.2095-5332.2023.02.002.
[37]	AHN C, LEE S, KIM YH, et al. Improving self-sufficiency in organ transplantation in Korea[J]. Korean J Transplant, 2021, 35(3): 137-142. DOI: 10.4285/kjt.21.0022.
[38]	赵慧佳, 叶啟发. 器官共享联合网络在器官捐献与移植中的作用[J]. 中华肝胆外科杂志, 2018, 24(10): 713-716. DOI: 10.3760/cma.j.issn.1007-8118.2018.10.015. ZHAO HJ, YE QF. The impacts of United Network for Organ Sharing(UNOS) in the ogran donation and tranplantation[J]. Chin J Hepatobiliary Surg, 2018, 24(10): 713-716. DOI: 10.3760/cma.j.issn.1007-8118.2018.10.015.