Interpretation of Guide to the Quality and Safety of Organs for Transplantation (6th edition): biosafety early warning
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摘要: 随着器官捐献和移植事业的蓬勃发展,完善管理体系,确保移植器官的质量和安全也越来越重要。欧盟的《移植器官质量与安全指南(第6版)》在生物安全性预警方面提出了严重不良反应和严重不良事件的定义,以及管理和报告的流程,鼓励器官移植相关医务人员尽早发现不良反应和不良事件,并进行调查、评估和反馈。同时对移植风险警戒和监控进行了系统地阐述,值得临床学习和实践。Abstract: With the rapid development of organ donation and transplantation, it becomes increasingly important to improve the management system and ensure the quality and safety of organs for transplantation. Guide to the Quality and Safety of Organs for Transplantation (6th Edition) by European Committee provides the definitions of severe adverse reactions and severe adverse events in the perspective of biosafety early warning, delivers management and reporting processes, and encourages medical staff involved in organ transplantation to identify the adverse reactions and adverse events as soon as possible, and to carry out investigation, assessment and feedback. At the same time, it also systematically illustrates the warning and monitoring of organ transplantation risk, which is worthy of application in clinical study and practice.
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表 1 不良反应严重性程度量表
Table 1. Severity scale of adverse reaction
严重程度 注释 非严重 无需住院治疗或无长期不良后果的轻微损伤 严重 引起住院或住院时间延长,和(或)持续或严重的残疾
(1)为防止永久性损伤行手术治疗或其他医疗干预
(2)传播严重疾病或病程延长危及生命 活体捐献者或器官受者需重大干预如血管活性药物、机械通气、进入重症监护,避免死亡或传播危及生命的疾病 死亡 活体捐献者或受者死亡 表 2 描述归因性调查的可能结果的量表
Table 2. The scale describing the possible outcomes of attribution survey
分级 组织和细胞预警归因调查结果① 传染病和恶性肿瘤传播的标准② 不可评估 归因性评估数据不足 归因性评估数据不足 排除 排除合理性怀疑,将不良反应归因于其他原因的确凿证据有明确的证据将不良反应归因于其他原因,而不是捐献过程或移植器官 疑似传播并满足以下条件中的至少1个:(1)明确证据表明其他原因; (2)进行适当的诊断检测未能在同一捐献者的任何移植受者中记录相同病原体的感染; (3)实验室证据表明受者在移植前感染了相同的病原体或已患有肿瘤 可能 将不良反应归因于移植过程或移植器官或其他原因的证据不明确 疑似传播:(1)单个受者体内发现病原体或肿瘤的实验室证据; (2)数据表明有传播,但不足以证实 很有可能 证据明显支持将不良反应归因于供器官 满足以下两个条件:(1)疑似传播; (2)受者体内病原体或肿瘤的实验室证据
满足以下两个条件中的至少1个:(1)其他受者体内有相同病原体或肿瘤的实验室证据; (2)捐献者体内有相同病原体或肿瘤的实验室证据; (3)如有移植前实验室证据,这些证据必须表明移植前相关受者病原体是阴性的确定 对不良反应归因于移植过程或移植器官,证据是无可置疑的 满足以下所有条件:(1)疑似传播; (2)受者体内发现病原体或肿瘤的试验室证据; (3)其他受者体内有相同病原体或肿瘤的实验室证据(如有其它受者); (4)捐献者体内有相同病原体或肿瘤的实验室证据; (5)如有移植前实验室证据,这些证据必须表明移植前相关受者病原体是阴性的 注:①改编自EUSTITE-SoHO V & S[8]。
②改编自美国疾病传播咨询委员会发布的血液预警量表[24]。 -
[1] BRETT KE, RITCHIE LJ, ERTEL E, et al. Quality metrics in solid organ transplantation: a systematic review[J]. Transplantation, 2018, 102(7):e308-e330. DOI: 10.1097/TP.0000000000002149. [2] SALMELA K. Quality and safety of organ transplantation[J]. Ann Transplant, 2004, 9(1):51-52. [3] GREEN M, COVINGTON S, TARANTO S, et al. Donor-derived transmission events in 2013: a report of the Organ Procurement Transplant Network Ad Hoc Disease Transmission Advisory Committee[J]. Transplantation, 2015, 99(2):282-287. DOI: 10.1097/TP.0000000000000584. [4] MARAZUELA R, GARRIDO G, MATESANZ R. European Union and Spanish regulations on quality and safety of tissues and cells: overview and biovigilance[J]. Transplant Proc, 2009, 41(6):2044-2046. DOI: 10.1016/j.transproceed.2009.06.033. [5] European Committee (Partial Agreement) on Organ Transplantation (CD-P-TO) EDQM.移植器官质量与安全指南(原书第6版)[M].张雷, 译.北京: 科学出版社, 2019. [6] Directive 2010/45/EU of the European parliament and of the council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation [EB/OL]. (2016-01-30). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:207:0014:0029:EN:PDF. [7] ISON MG, HAGER J, BLUMBERG E, et al. Donor-derived disease transmission events in the United States: data reviewed by the OPTN/UNOS Disease Transmission Advisory Committee[J]. Am J Transplant, 2009, 9(8): 1929-1935. DOI: 10.1111/j.1600-6143.2009.02700.x. [8] GARZONI C, ISON MG. Uniform definitions for donor-derived infectious disease transmissions in solid organ transplantation[J]. Transplantation, 2011, 92(12):1297-1300. DOI: 10.1097/TP.0b013e318236cd02. [9] MILLER R, COVINGTON S, TARANTO S, et al. Communication gaps associated with donor-derived infections[J]. Am J Transplant, 2015, 15(1):259-264. DOI: 10.1111/ajt.12978. [10] GKIOKA V, TSIRIGOTIS P, SARRIS M, et al. Biovigilance for the quality and safety of medical products of human origin[J]. J Clin Med Res, 2018, 10(12):857-867. DOI: 10.14740/jocmr3549w. [11] SNYDER JJ, SALKOWSKI N, KIM SJ, et al. Developing statistical models to assess Transplant Outcomes Using National Registries: the process in the United States[J]. Transplantation, 2016, 100(2): 288-294. DOI: 10.1097/TP.0000000000000891. [12] KAYE S, BADDON A, JONES M, et al. A UK scheme for reporting serious adverse events and reactions associated with ocular tissue transplantation[J]. Cell Tissue Bank, 2010, 11(1):39-46. DOI: 10.1007/s10561-009-9139-y. [13] Notify Library[EB/OL]. (2016-01-30). http://www.notifylibrary.org. [14] GALLAGHER TH, WATERMAN AD, EBERS AG, et al. Patients' and physicians' attitudes regarding the disclosure of medical errors[J]. JAMA, 2003, 289(8):1001-1007. doi: 10.1001/jama.289.8.1001 [15] ISON MG, NALESNIK MA. An update on donor-derived disease transmission in organ transplantation[J]. Am J Transplant, 2011, 11(6):1123-1130. DOI: 10.1111/j.1600-6143.2011.03493.x. [16] ISON MG, HOLL JL, LADNER D. Preventable errors in organ transplantation: an emerging patient safety issue?[J]. Am J Transplant, 2012, 12(9):2307-2312. DOI: 10.1111/j.1600-6143.2012.04139.x. [17] MATHUR AK, STEMPER-BARTKUS C, ENGHOLDT K, et al. Identifying patterns of adverse events of solid organ transplantation through departmental case reviews[J]. Mayo Clin Proc Innov Qual Outcomes, 2019, 3(3):335-343. DOI: 10.1016/j.mayocpiqo.2019.04.007. [18] ECHENIQUE IA, ISON MG. Update on donor-derived infections in liver transplantation[J]. Liver Transpl, 2013, 19(6):575-585. DOI: 10.1002/lt.23640. [19] VAN ASSCHE K, STERCKX S, LENNERLING A, et al. The relevance of directive 2010/53/EU for living organ donation practice: an ELPAT view[J]. Transplantation, 2015, 99(10):2215-2222. DOI: 10.1097/TP.0000000000000670. [20] LUMBRERAS C, SANZ F, GONZÁLEZ A, et al. Clinical significance of donor-unrecognized bacteremia in the outcome of solid-organ transplant recipients[J]. Clin Infect Dis, 2001, 33(5):722-726. doi: 10.1086/322599 [21] MARTINIÈRE K, LUCAS S, ZORZI P. Events and adverse reactions in biovigilance: descriptive analysis of French national data following a four-year practical experience[J]. Transfus Clin Biol, 2008, 15(4):179-189. DOI: 10.1016/j.tracli.2008.04.008. [22] CZERWIŃSKI J, ANTOSZKIEWICZ K, GRYGIEL K, et al. National Transplants Registry in Poland: early and long-term results of organ transplantations in the years 1998 to 2014[J]. Transplant Proc, 2016, 48(5):1407-1410. DOI: 10.1016/j.transproceed.2016.01.086. [23] CAMERON AM, SULLIVAN BE. Regulatory oversight in transplantation: there and back again[J]. JAMA Surg, 2013, 148(11):997-998. DOI: 10.1001/jamasurg.2013.2762. [24] SoHO V & S Guidance for competent authorities: communication and investigation of serious adverse events and reactions associated with human tissues and cells[EB/OL]. (2016-01-30). http://www.notifylibrary.org/sites/default/files/SOHO%20V%26S%20Communication%20and%20Investigation%20Guidance.pdf. [25] LEN O, GARZONI C, LUMBRERAS C, et al. Recommendations for screening of donor and recipient prior to solid organ transplantation and to minimize transmission of donor-derived infections[J]. Clin Microbiol Infect, 2014, 20(Suppl 7):10-18. DOI: 10.1111/1469-0691.12557. [26] STRONG DM. Tissue banking, biovigilance and the notify library[J]. Cell Tissue Bank, 2018, 19(2):187-195. DOI: 10.1007/s10561-017-9639-0. [27] FEHILY D. Sharing vigilance experience and knowledge globally - a preliminary overview of the Notify Library[J]. Cells Tissues Organs, 2013, 16:117-125. [28] STEWART DE, TLUSTY SM, TAYLOR KH, et al. Trends and patterns in reporting of patient safety situations in transplantation[J]. Am J Transplant, 2015, 15(12):3123-3133. DOI: 10.1111/ajt.13528.