Banca de DEFESA: DANIELA PINA MARQUES TOMAZINI

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : DANIELA PINA MARQUES TOMAZINI
DATE: 20/02/2026
TIME: 11:30
LOCAL: Online
TITLE:

Responsive regulation for patient safety in dialysis services: a national evaluation of a multifaceted regulatory intervention

KEY WORDS:

Patient Safety; Quality Improvement; Renal Dialysis; Health Surveillance; Government Regulation; Responsive Regulation

 

PAGES: 122
BIG AREA: Ciências da Saúde
AREA: Saúde Coletiva
SUMMARY:

Introduction: Adverse events in dialysis services are frequent and potentially severe due to the complexity of care and the vulnerability of individuals undergoing renal replacement therapy. In 2024, these services reported 11,566 incidents to the Brazilian Health Regulatory Agency (ANVISA), highlighting a critical patient safety scenario. Findings from the National Assessment of Patient Safety Practices indicate low adherence to safe practices and an incipient safety culture. In response to this context, ANVISA implemented a multifaceted regulatory intervention grounded in Responsive Regulation, the effects of which had not yet been evaluated.

Objective:To evaluate the effects of a multifaceted regulatory intervention, based on Responsive Regulation, on barriers to the implementation of patient safety practices in dialysis services in Brazil.

Method: A quasi-experimental before-and-after study conducted in two stages—diagnostic and interventional—aligned with the quality improvement cycle proposed by Saturno (2015). In the diagnostic stage, barriers perceived by dialysis services were identified using synthesis techniques and tools from quality improvement and implementation science, considering external, internal, and individual contexts. These barriers informed the design of the regulatory intervention, structured by ANVISA according to eight regulatory impact mechanisms. The evaluation compared two rounds of data collection using the same national instrument to analyze changes in the identified barriers.

Results: The reassessment revealed relevant improvements in barriers related to team knowledge and preparedness. Progress was observed in institutional support for the implementation of patient safety practices. An improvement in the understanding of regulatory requirements by the evaluated services was also identified. Overall, the six barriers that showed the greatest reduction were: “Limited knowledge of the medical team on the topic”; “Insufficient encouragement and support”; “Untrained managers”; “Communication failure”; “Excessive number of rules and protocols”; and “Management is unaware of needs”. These findings suggest that the regulatory intervention may have contributed to strengthening organizational capacities and to the adoption of patient safety practices in dialysis services.

Conclusion: The multifaceted regulatory intervention, guided by the principles of Responsive Regulation, demonstrated potential to enhance sanitary governance and promote advances in the safety of care in dialysis services, a sector characterized by high complexity and risk. The results reinforce the importance of responsive regulatory models as a strategy to support the implementation of safe practices within the scope of health surveillance and the Brazilian Unified Health System.

COMMITTEE MEMBERS:
Presidente - 1868020 - ZENEWTON ANDRÉ DA SILVA GAMA
Interna - ***.321.701-** - VIVIANE PEIXOTO DOS SANTOS PENNAFORT - UECE
Externo à Instituição - PAULO JORGE DOS SANTOS SOUSA