Bundle compliance increased, mortality decreased under New York sepsis regulations

Under “Rory's Regulations,” use of the three-hour bundle for severe sepsis and septic shock increased from 53.4% to 64.7%, while six-hour bundle compliance increased from 23.9% to 30.8%.


Mortality from sepsis decreased after New York State required hospitals to implement protocols to identify and treat sepsis and report outcomes, a recent study found.

The cohort analysis looked at cases submitted to the New York State Department of Health by all 185 hospitals in the state under “Rory's Regulations,” which were named after a patient who died of septic shock and required hospitals to develop and implement sepsis protocols and report patient-level data on sepsis treatment and outcomes. The study included the first 27 months after the regulations took effect—April 1, 2014, to June 30, 2016—and used a total of 91,357 of the 113,380 submitted cases (those who met the study's inclusion criteria). Results were published online by the American Journal of Respiratory and Critical Care Medicine on Sept. 7.

Overall, 81.3% of the studied patients had sepsis protocols initiated in their care. Among those patients, full implementation of the recommended three-hour bundle for severe sepsis and septic shock increased from 53.4% to 64.7% (P<0.001). Among patients eligible for the six-hour bundle (n=35,307), bundle compliance increased from 23.9% to 30.8% (P<0.001). For all patients who had a sepsis protocol initiated, risk-adjusted mortality decreased over the course of the study, from 28.8% to 24.4% (P<0.001). Hospitals with higher compliance with either bundle had lower length of stay and risk- and reliability-adjusted mortality among their sepsis patients.

Study authors concluded that the statewide initiative increased compliance with sepsis performance measures, although they noted that it is difficult for research on quality improvement projects to prove causation. “While we cannot prove that the improvement in risk-adjusted mortality among sepsis patients was a direct result of the regulations, there is reason to believe that this may be the case,” they wrote. Such reasons include increases in adherence to both the bundles and their individual elements, the authors said.

Despite these increases, the study found that a third of patients still were not receiving blood cultures, antibiotics, and serum lactate measurement within the recommended time, which shows that additional work is needed to standardize care, the authors said.

The sepsis regulations were not associated with any financial incentives but did receive substantial public attention, including commentary from the governor, the study noted. “Public calls to professionalism and the attention of state leaders may be powerful drivers of quality improvement in sepsis care, perhaps complementing public reporting and financial incentive approaches, and a model that could potentially serve as a blueprint to implement similar strategies in other states,” the authors said.