Project-based approach to managing changes in implementing a regional digital model of quality management of medical care.

<jats:p>The implementation of regional digital models for managing the quality of medical care is a large-scale organizational transformation that covers all levels of the healthcare system. The success of this transformation critically depends on the correct application of project management principles, which integrate defect management, quality management systems (QMS), laboratory control, and digital technologies. However, there is a lack of methodological approaches in the scientific literature for managing changes during the implementation of such models at the inter-organizational regional level. Purpose of study is to substantiate and describe a project-based approach to change management in the implementation of a regional digital model for managing the quality of medical care, which integrates project management standards, a continuous improvement cycle, systematic risk management, and a communication strategy. Materials and methods. The methods of system and structural-functional analysis, organizational design, and modeling were used. The methodological basis was formed by the standards of GOST R ISO 21500–2023 and GOST R ISO 21502–2024, as well as the experience of testing the model at the G. G. Kuvatov Republican Clinical Hospital and other medical organizations in the Republic of Bashkortostan. Results. The implementation of the model is proposed to be considered as a program of three interrelated projects: creation of a system basis (ISO 9001, ISO 7101), strengthening of internal quality and safety control mechanisms of medical activity (VKkiBMD) with the introduction of a unified defect classifier, digitalization (information portal, integration with MIS/LIS, automation of defect accounting). The application of the PDSA cycle at the strategic, tactical, and operational levels is substantiated. A roadmap for implementation has been developed in five stages with clear criteria for readiness for transition. The groups of organizational risks (human resources, methodological, technical, resource, regulatory, and regional) and measures to minimize them have been systematized. A communication strategy has been proposed that is differentiated by target audiences and based on the principles of transparency, bi-directionality, and a non-punitive environment. Mechanisms for managing organizational changes and evaluating their effectiveness have been developed based on the digital maturity model. Findings. The proposed project approach creates a methodological and practical basis for the implementation of a regional digital model, ensuring process control, reducing risks, and ensuring the sustainability of results. The presented methodology can be replicated in other constituent entities of the Russian Federation.</jats:p>