Objective:

The aim of this study was to observe and describe the changes in the structures for patient safety (PS) and PS culture (PSC) at the level of health facilities, following the implementation of the National Patient Safety Program (NPSP).

Methods:

An observational, longitudinal, and descriptive study including follow-up of changes in structure and activities for PS and assessments of PSC before and 15 months after the NPSP enforcement. Three Brazilian hospitals with different management logistics participated in the study (federal public, state public, and private). PSC was measured using the AHRQ’s instrument, adapted and validated for the Brazilian context (Hospital Survey on Patient Safety Culture [HSOPSC]). Changes in structure and activities to improve PS were mapped against the NPSP objectives. Changes in PSC were assessed by the hospital and discussed considering a change theory based on the literature.

Results:

Structural changes occurred in all hospitals but at a different pace and extension. A PS unit, adoption of some PS protocols, and training on PS occurred in the three hospitals. PSC significantly improved in all facilities. Public hospitals had the worst baseline PSC but showed greater improvements. The state hospital presented few structural changes and soon had the lowest ratings of PSC.

Conclusions:

This study demonstrates that external regulatory initiatives can trigger, even if unevenly, actions promoting PS and relevant internal structural changes, which in turn seem to increase awareness and improvement in PSC.

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