PT - JOURNAL ARTICLE AU - Cortellazzi, Pilade AU - Carini, Davide AU - Bolzoni, Luana AU - Cattadori, Evelina AU - Randi, Vanda TI - Emilia-Romagna Regional Blood System accreditation as an example of improvement through application of specific requirements: a retrospective analysis AID - 10.1136/bmjoq-2021-001408 DP - 2021 Nov 01 TA - BMJ Open Quality PG - e001408 VI - 10 IP - 4 4099 - http://bmjopenquality.bmj.com/content/10/4/e001408.short 4100 - http://bmjopenquality.bmj.com/content/10/4/e001408.full SO - BMJ Open Qual2021 Nov 01; 10 AB - Background 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.Methods 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.Results 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.Conclusion 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.Data are available upon reasonable request.