Blood Collection Unit, AVIS Provinciale Piacenza, Piacenza, Italy
Immunohaematology and Transfusion Medicine Unit, Azienda USL di Piacenza, Piacenza, Italy.
BMJ Open Qual. 2021 Nov;10(4). doi: 10.1136/bmjoq-2021-001408.
Institutional accreditation in Italy represents the license given by a region to a public or private facility to provide services in the name and on behalf of the National Health Service. This study aims to evaluate the improvement of the Emilia-Romagna Regional Blood System and to highlight its unresolved issues, analysing non-conformities observed during accreditation and maintenance inspections between 2013 and 2018.
All the Emilia-Romagna Regional Blood facilities were invited to participate in this study voluntarily and anonymously. Participants had to access a web application that we developed specifically. For each of the three inspections evaluated in this study, they had to enter data about the state of their organisation branches and non-conformities observed by regional inspectors. All data entered were finally exported from the web application database and analysed with spreadsheets. Statistical analysis was performed using Wilcoxon signed-rank test with continuity correction.
17 structures took part in the study, with a total of 174 organisation branches. The number of branches changed over the years because of new openings and closures due to reorganisations or non-conformities that were too difficult to correct. Inspectors observed 2381 non-conformities (291 structural, 611 technological and 1479 organisational). As a result of accreditation inspections and consequent improvement actions, non-conformities were reduced by 88%. The most frequent non-conformities concerned the management software and the transportation of blood and blood components.
An improvement in the Emilia-Romagna Regional Blood System over time is evident: institutional accreditation certainly pushed it to change and overcome its problems to comply with specific requirements. The remaining non-conformities after the three inspections were mostly organisational and management software was the most critical issue. Despite these non-conformities, all currently active structures are accredited and guarantee high standards of quality and safety of products and services.
意大利的机构认证代表一个地区授予公立或私立机构以国家卫生服务的名义和代表提供服务的许可证。本研究旨在评估艾米利亚-罗马涅地区血液系统的改进，并突出其未解决的问题，分析 2013 年至 2018 年认证和维护检查期间观察到的不符合项。
所有艾米利亚-罗马涅地区的血液机构都被邀请自愿匿名参加这项研究。参与者必须访问我们专门开发的网络应用程序。对于本研究评估的三次检查中的每一次，他们都必须输入关于其组织分支机构的状态和地区检查员观察到的不符合项的数据。所有输入的数据最终都从网络应用程序数据库中导出并使用电子表格进行分析。统计分析采用 Wilcoxon 符号秩检验（带连续性校正）。
17 家机构参加了这项研究，共有 174 个组织分支机构。分支机构的数量随着时间的推移而变化，原因是新的开设和关闭，因为重组或难以纠正的不符合项。检查员观察到 2381 项不符合项（291 项结构，611 项技术和 1479 项组织）。由于认证检查和随后的改进措施，不符合项减少了 88%。最常见的不符合项涉及管理软件以及血液和血液成分的运输。
随着时间的推移，艾米利亚-罗马涅地区血液系统的改进是显而易见的：机构认证肯定推动了它的改变，并克服了遵守特定要求的问题。三次检查后剩余的不符合项主要是组织和管理软件方面的问题。尽管存在这些不符合项，但所有目前活跃的机构都获得了认证，并保证了产品和服务的高标准质量和安全性。
