Background: Regulatory interventions are widely recommended to improve the quality of health services, but there are few studies on the possible models and their effects. The aim of this study is to describe the implementation process and analyse the results of a nationwide regulatory intervention for the implementation of patient safety practices.Methods: Four nationwide annual cross-sectional assessments were conducted in Brazilian hospitals with Intensive Care Unit beds. The participants involved all facilities operating during 2016-2019 (average N=1,989). The regulatory intervention theory aimed to increase adherence to safe evidence-based practices through national annual assessment involving a set of 21 validated structure and process indicators related to patient safety practices. At moment 1(Risk assessment), data were collected to classify hospitals according to the risk. In the sequence, the Sanitary Surveillance Centers (VISAS) carried out the analysis of the information sent by the hospitals. VISAS classified services into three groups according to compliance with the composite adherence indicator: High (67-100%); Medium (34-66%); and Low Compliance (0-33%). Moment 2 (Risk management) used responsive actions according to the hospital’s classification. Results: The intervention resulted in six annual cyclic stages and, between 2016-2019, 782 (40.1%), 980 (49.0%), 1,093 (54.3%) and 1,255 (61.8%) hospitals participated, respectively. 17 of the 20 indicators with at least two measurements had a significant improvement after national interventions (p<0.05). The overall percentage of compliance increased from 70.7 to 84.1 (p<0.001) and the percentage of hospitals with high compliance increased from 59.1 to 83.0 (p<0.001).Conclusion: The regulatory intervention used was a good tool to strengthen the information system and government actions to promote patient safety. The set of low-cost interventions seems to be useful to prioritise hospitals at higher risk and to induce responsive measures to implement patient safety practices in the evaluated context, promoting the efficiency of the regulatory process.
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