Surveillance and Reporting of Hospital-Associated Infections—A Document Analysis of Romanian Healthcare Legislation Evolution over 20 Years

Abstract

Background/Objectives: The objective of this study is to evaluate the evolution of Romanian legislation related to HAIs. The evolution of healthcare-associated infections (HAIs)’s definitions and surveillance frameworks in Romania reflects progressive advancement in diagnostic criteria, reporting, and prevention. Recent changes emphasize the need for accurate and centralized electronic reporting, inclusion of medico-social and palliative care institutions, and modernized hospital infrastructure standards. However, workforce deficits, insufficient infrastructure, and punitive sanctions remain barriers to effective implementation. Methods: This study analyzed publicly available Romanian legislative texts and their evolution, comparing definitions, diagnostic criteria, and surveillance structures. Key informant insights supplemented findings to contextualize legislative impacts. Legislative acts were reviewed sequentially to identify updates in regulatory frameworks and barriers to effective HAI management. Results: The legislative evolution demonstrates a shift from basic diagnostic criteria to a comprehensive surveillance framework aligned with European standards. However, challenges persist, including workforce capacity deficits, under-reporting due to fear of sanctions, and infrastructure inadequacies. The prevalence of HAIs remains largely under-reported (4.1%), with studies revealing rates well below the European average (7.1%). Manual and isolated reporting systems further hinder real-time surveillance and accuracy. Legislative advancements in Romania reflect progress in HAI management but highlight systemic barriers that impede effective implementation. Conclusions: Collaborative efforts across individual, organizational, and system levels are required to address workforce training, reduce under-reporting, and invest in infrastructure and electronic reporting systems. Promoting a blame-free organizational culture, combined with training, is essential to encourage behavior of accurate reporting and improve HAI prevention strategies.