Barriers to Lean & Safety Management Implementation in Primary Care Settings: Insights from an Unsuccessful Case.

BACKGROUND

Primary care is widely recognized as a cornerstone of universal health coverage, providing high-quality care in community-based settings. Structured managerial approaches such as Lean & Safety Management (L&SM) can support quality improvement in healthcare by reducing waste and risk and enhancing patient safety and satisfaction. However, evidence on the sustainable implementation of L&SM-defined as the ability to complete implementation and maintain improvements over time-remains limited in primary care. This study aims to identify key challenges affecting the sustainability of L&SM implementation in community healthcare centers.

METHODS

An unsuccessful L&SM implementation was analyzed through an in-depth case study of an Integrated Family Medicine Centre in Italy. The project, based on the DMAIC framework, was discontinued after the Define phase. A structured three-step methodology was adopted: 1) selection of a failed implementation case using predefined suitability criteria; 2) identification of implementation barriers through a systematic assessment of Critical Success Factors for sustainable Lean and Safety implementation adapted from the literature; and 3) validation of findings and exploration of corrective actions through a stakeholders focus group.

RESULTS

The analysis identified multiple barriers that contributed to implementation failure. These barriers were synthesized into three interrelated themes: organizational readiness, stakeholder ownership and engagement, and governance fragmentation. Together, these factors limited coordination, reduced commitment to improvement activities, and hindered the sustainability of the implementation process.

CONCLUSION

Sustainable L&SM implementation in primary care requires organizational readiness, committed leadership, stakeholder engagement, adequate training, and robust data infrastructure. Addressing these factors may improve the successful adoption and long-term sustainability of quality improvement initiatives in community-based settings.