Emilia-Romagna Regional Blood System accreditation as an example of improvement through application of specific requirements: a retrospective analysis

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.