Analysis of the factors that contributed to the passage of Rory's regulations using the 3I + E framework: Implications for future sepsis policy

Sepsis is the dysregulated host response to an infection, accounting for an estimated 48.9 million cases and 11 million sepsis-related deaths worldwide. In 2013, New York State passed “Rory's Regulations”, requiring all hospitals to develop protocols for early identification and treatment of sepsis. The purpose of this analysis is to (a) identify and describe the ideas, interests, and institutions that led to the New York State Sepsis Regulations; and (b) the implications for future sepsis policy. Methods This study was a retrospective document analysis using qualitative description. To guide this policy analysis, the “3-I + E” framework was utilized. This framework includes consideration of institutions, interests, ideas, and external factors and is the most appropriate methodology to identify the factors that contribute to the development of a policy. To identify relevant sources of information, we conducted (a) a literature search of academic databases; (b) a review of publicly available policy documents and government websites; and (c) a review of news media. Results The implementation of Rory's regulations legally mandated the use of protocols that require timely fluid resuscitation, antibiotic administration, and frequent assessment of hemodynamic response to therapy. At the time, there was evidence to support the efficacy of early detection and treatment of sepsis; however, less was known about the impact of government-mandated regulations (1,2). Although the interplay of institutions, interests, and ideas contributed to the decision to enact Rory's regulations, the passing of Rory Staunton facilitated the passage and limited the negative effects of institutions, interests, and ideas that may otherwise have prevented the passage of Rory's regulations. This analysis highlights potential barriers including (a) failure to justify the need for a policy response, and (b) lack of coordination with existing policies or programs, which could influence decisions against proceeding with sepsis regulations. Given the impact of COVID-19, which can lead to sepsis, and the 2017 WHO resolution that identified sepsis as a global priority, understanding what other countries have done to address sepsis, and the lessons learned is important to identify future policy directions. Conclusion We identified and described the institutions, interests, ideas, and external events that aided the passage of Rory's regulations, using the 3I+ E framework. This analysis provides a useful framework for other jurisdictions considering similar policies to identify potential facilitators and barriers and, importantly, to identify next steps to bring sepsis policy to the forefront.