Evaluation of the effectiveness of the combined use of Patient Safety Indicator 13 and Clinical Audit for the analysis of post-operative sepsis events. A pilot project.

Healthcare-associated infections (HAIs) continue to pose a significant challenge for the global scientific community, as they are the most common adverse events associated with healthcare practices. The impact of these infections extends beyond the patients themselves, affecting their families, healthcare workers, and the entire healthcare system. Factors such as the use of invasive medical devices, antibiotic resistance, the advanced age of patients, and their vulnerability all contribute to the prevalence of these infections. Literature indicates that more than half of HAIs can be prevented by adopting preventive and control measures. From a medico-legal perspective, for healthcare companies to be exempt from liability if a patient claims compensation for HAI, recent jurisprudential developments impose the obligation to establish procedures and protocols to prevent these infections and to demonstrate their implementation in specific cases, making defence extremely difficult. In this context, this study aims to comprehensively analyse the issue from clinical, medico-legal, and risk-management perspectives, with a particular focus on the most feared complication of HAIs: sepsis. This condition is a frequently encountered adverse event, particularly in the surgical setting. In this scenario, and in response to the provisions of Law 24/2017, which promotes activities aimed at mitigating risks associated with healthcare practices, the latter part of this work is dedicated to presenting and discussing the findings of a retrospective study conducted on patients who developed sepsis following surgical procedures. The study seeks to evaluate the effectiveness of utilizing two clinical risk management tools: Patient Safety Indicator 13, for identifying post-surgical sepsis using administrative data from Hospital Discharge Records, and the Clinical Audit, for assessing the quality of care according to best evidence-based practices. At the end of the study, critical issues and potential improvements will be identified in ...