目标:ESHREART中心认证(ARTCC)计划开始三年后,系统的当前状态是什么,
结论:截至2021年12月1日,25个欧洲ART中心参与了认证的各个阶段,检查员最常见的建议是需要有文件的培训,核实所有工作人员的能力,验证实验室和临床性能指标,实施质量管理体系,避免过度使用ICSI和附加组件。
背景:欧盟(EU)立法已将ART活动纳入欧盟组织和细胞指令(EUTCD)中。经过欧盟国家当局的检查,关于文档的许多细节,实验室环境,处理生殖细胞和组织,可追溯性,编码和患者测试已经变得标准化。然而,EUTCD并不涵盖所有特定于ART的方面。出于这个原因,ARTCC的成立专注于特殊领域,包括相关员工资格,培训,持续的专业发展,工作量,设备适用性,使用的(非)循证实验室和临床方法,根据ESHRE指南的治疗方法,建议以及实验室和临床关键性能指标。
UNASSIGNED:本文回顾了在最初的3年运营期间,ART中心的ESHRE认证的最新技术,以获得良好的临床和实验室实践,包括参与不同认证阶段的ART中心的数量以及检查员最常见的建议。
方法:2016年,ARTCC工作组开始建立新的ESHREARTCC计划。从那以后,工作组组织了4个预备课程,并任命了37名检查员(19名临床医生,17名胚胎学家和一名辅助医学)。开发了一种工具来验证符合ESHRE建议的良好实验室和临床实践。自2018年9月以来,ARTCC已开放申请。在步骤1中,申请人输入有关ART中心的基本信息,员工和ART活动进入应用平台。审查和批准后,申请人有机会进入步骤2,并提供详细的在线清单,实验室,临床服务和临床结果。两名检查员(一名临床医生和一名胚胎学家)独立评估提交的清单。进行评估的条件是来自四个检查表中的每一个的正平均得分(至少66%)。在步骤3中,组织现场访问(或由于2019年冠状病毒病(COVID-19)大流行而虚拟访问),检查员准备一份最终报告,并提出适当的建议。如果不满足进入下一阶段所需的标准,则可以随时拒绝该申请。ARTCC计划目前适用于ESHRE内部规则中列出的欧洲国家,可在ESHRE网站上查阅。证书有效期为3年,之后可以提交续期申请。
结果:在3年期间(至2021年12月1日),来自25个国家的63个ART中心开始通过在线平台申请。到目前为止,38份申请没有取得进展,原因是最初的申请没有在一年内完成,或者申请来自非欧洲国家。在剩下的25份申请中,对8个中心进行了检查,对7个中心进行了认证。视察员向评估中心提出的最常见建议是需要有文件记录的培训,能力验证,所有工作人员的技能和持续专业发展,验证实验室和临床性能指标,实施质量管理体系。检查人员确定了一些偏离良好做法的医疗辅助生殖反复出现的领域:过度使用ICSI,非整倍体的植入前遗传测试,冻结所有和其他附加组件。他们经常报告,由于未纳入开始的周期或频繁使用冷冻-所有周期,无法客观评估临床结果。
结论:自认证计划的早期阶段以来,没有对应用程序平台和清单进行重大修改。然而,在这么短的时间内,临床实践发生了相当多的变化,特别是关于更频繁地使用“冻结所有”策略。因此,在临床结局评估中出现了一些问题.此外,由于COVID-19大流行,现场访问被虚拟访问的实施所取代。虽然这使认证计划得以继续,在传统的现场访问期间注意到的某些关键细节可能被忽视了。
结论:定期监测ARTCC检查员的观察结果并分析其报告无疑有助于在评估过程中协调检查员的标准,并确定临床和实验室实践中的慢性缺陷。ESHRE可以通过指南和建议解决不符合项问题。以及通过与欧盟机构和主管当局的讨论。
背景:ARTCC计划由ESHRE开发和资助,支付与会议相关的费用。作为本文作者的指导委员会成员没有收到完成本研究的付款。视察员的工作得到酬劳。作者没有利益冲突要声明。
OBJECTIVE: Three years after the start of the ESHRE ART Centre Certification (ARTCC) programme, what is the current state of the system, in terms of the interest expressed in it and experiences during the assessment of ART services?
CONCLUSIONS: As of 1 December 2021, 25 European ART centres have been involved in the various stages of certification and the most common recommendations from inspectors were the need for documented training, verification of competencies for all staff members, verification of laboratory and clinical performance indicators, implementation of a quality management system and avoidance of overusing ICSI and add-ons.
BACKGROUND: European Union (EU) legislation has included ART activities in the EU Tissue and Cells Directives (EUTCDs). Following inspections by national EUTCD authorities, many details regarding documentation, laboratory environment, handling of reproductive cells and tissues, traceability, coding and patient testing have become standardized. However, the EUTCDs do not cover all ART-specific aspects. For this reason, the ARTCC was established to focus on peculiar areas, including relevant staff qualifications, training, continuing professional development, workload, equipment suitability, (non)-evidence-based laboratory and clinical methods used, treatment approaches according to ESHRE guidelines, recommendations and laboratory and clinical key performance indicators.
UNASSIGNED: The article reviews the state-of-the-art of the ESHRE certification of ART centres for good clinical and laboratory practice over an initial 3-year period of operation, including the number of ART centres involved in the different stages of certification and the most common recommendations by inspectors.
METHODS: In 2016, the ARTCC working group began to establish a new ESHRE ARTCC programme. Since then, the working group has organized 4 preparatory courses and appointed 37 inspectors (19 clinicians, 17 embryologists and one paramedical). A tool to verify compliance with ESHRE recommendations for good laboratory and clinical practice was developed. The ARTCC has been open for applications since September 2018. In Step 1, the applicant enters basic information about the ART centre, staff and ART activities into the application platform. After review and approval, the applicant is given the opportunity to enter Step 2 and provide detailed online checklists on general, laboratory, clinical services and clinical outcomes. Two inspectors (one clinician and one embryologist) independently evaluate the submitted checklists. The condition to proceed to evaluation is a positive mean score (at least 66%) from each of the four checklists. In Step 3, a live site visit (or virtual owing to the coronavirus disease 2019 (COVID-19) pandemic) is organized and the inspectors prepare a final report with appropriate recommendations. The application may be rejected at any time if the criteria required to advance to the next stage are not met. The ARTCC programme is currently available for European countries listed in ESHRE internal rules, available on the ESHRE website. The certificate is valid for 3 years, after which an application for renewal can be submitted.
RESULTS: Over a 3-year period (until 1 December 2021), 63 ART centres from 25 countries started applying through an online platform. So far, 38 applications did not progress owing to lack of completion of the initial application within a 1-year period or because applications came from non-European countries. Of the remaining 25 applications, 8 centres have been inspected and 7 centres have been certified. The most common recommendations given by inspectors to assessed centres were the need for documented training, verification of competencies, skills and continuing professional development for all staff members, verification of laboratory and clinical performance indicators and implementation of a quality management system. The inspectors identified some recurring areas of medically assisted reproduction that deviate from good practice: the overuse of ICSI, preimplantation genetic testing for aneuploidies, freeze-all and other add-ons. They often reported that the clinical outcomes could not be objectively assessed because of non-inclusion of the started cycles or the frequent use of freeze-all cycles.
CONCLUSIONS: No major modifications have been made to the application platform and checklists since the early stages of the certification programme. However, in this short time, quite a few changes in clinical practice have occurred, especially concerning the more frequent use of the \'freeze-all\' strategy. As a result, problems arose in the evaluation of clinical outcomes. In addition, because of the COVID-19 pandemic, site visits were substituted by the implementation of virtual visits. While this enabled the certification programme to continue, it is possible that certain critical details that would have been noticed during a traditional site visit may have been overlooked.
CONCLUSIONS: Regular monitoring of the observations of ARTCC inspectors and analysis of their reports is certainly useful to harmonize inspectors\' criteria in the assessment process and to identify chronic deficiencies in clinical and laboratory practice. Non-conformities can be addressed by ESHRE through guidelines and recommendations, as well as through discussion with EU institutions and competent authorities.
BACKGROUND: The ARTCC programme was developed and funded by ESHRE, covering expenses associated with the meetings. The Steering Committee members who are the authors of this article did not receive payments for the completion of this study. The inspectors were remunerated for their work with an honorarium. The authors have no conflicts of interest to declare.