NATIONAL STUDY ON PATIENT SAFETY IN DIALYSIS SERVICES: EVALUATION OF A MULTIFACETED INTERVENTION BASED ON RESPONSIVE REGULATION
Patient Safety, Renal Dialysis, Quality Improvement, Sanitary Surveillance, Government Regulation
ntroduction: The occurrence of adverse events in dialysis services is common and potentially severe, given the complexity of hemodialysis care. The National Assessment of Safety Practices in Dialysis Services, conducted by the Brazilian Health Regulatory Agency (Anvisa) in 2022 and 2023, revealed that more than half of dialysis services demonstrated low compliance with patient safety practices, highlighting that the safety culture remains incipient in these settings.
Objective: To analyze the effect of a multifaceted intervention based on responsive regulation on compliance with patient safety practice indicators in dialysis services in Brazil.
Methodology: This study follows the steps of the quality improvement cycle proposed by Saturno (2015) and is structured in two phases: a diagnostic phase, based on a sequential exploratory mixed-methods approach (qualitative followed by quantitative), and an intervention phase, conducted as a quasi-experimental before-and-after study without a control group to assess the effects of the implemented actions.
During the diagnostic phase, a semi-structured open-ended questionnaire was sent to the Patient Safety Centers of dialysis services across Brazil to identify the causes of low compliance with patient safety indicators. The responses were analyzed and categorized according to the categories of the Consolidated Framework for Implementation Research - CFIR (Damschroder, 2022). Next, a Likert scale questionnaire was sent to the same target audience to prioritize the main identified barriers.
Following the diagnostic phase, a series of regulatory actions were designed participatively to address the identified causes. Certain indicators from the National Assessment were prioritized as the focus of these interventions, including the regularity of incident reporting related to healthcare, the protocol for preventing system coagulation during hemodialysis, the technology management plan (covering hemodialysis and peritoneal dialysis equipment), and the safety checklist applied to hemodialysis.
The interventions are currently in progress, and the study aims to measure their effects—both in terms of perceived causes and compliance with safety indicators in healthcare services—by October 2025.
Preliminary Results: The most significant barriers to compliance with patient safety indicators included: the absence of a foundational document or guidelines on safety protocols in dialysis services (external context), the lack of a dedicated professional for the Patient Safety Center (internal context), and limited knowledge on the topic among medical staff (individuals). These findings underscore the need for strategic interventions through a multifaceted approach to overcome obstacles and promote patient safety in dialysis services.
So far, the following actions have been carried out: raising awareness and holding health managers accountable at the federal and state levels (Ministry of Health and state health secretaries), engaging state coordinators of Patient Safety Centers in health surveillance agencies, dialysis societies and associations, and dialysis services to emphasize the importance of promoting patient safety in these settings. Additionally, educational initiatives have been implemented for service professionals, including a National Webinar on patient safety in dialysis services and the dissemination of specific guidance on how to report adverse events in these services.
By the end of this project, it is expected that dialysis services in Brazil will show improvements in compliance with patient safety practice indicators from the National Assessment of Patient Safety Practices in Dialysis Services.