Mandatory Hospital Sepsis Protocols Save Thousands of Lives

New York hospitals must report sepsis-related data to the state Department of Health.

The establishment of mandatory sepsis protocols at all hospitals in New York State is estimated to have saved more than 16,000 lives between 2015 and 2019, according to the New York State Department of Health.

Sepsis develops in response to infection, and it can lead to tissue damage, organ failure, and death. Sepsis is the leading cause of in-hospital death in the United States. More than 1.7 million Americans are diagnosed with sepsis annually.

The mandatory sepsis protocols in New York were implemented in 2013 following the death of a 12-year-old boy from Queens, Rory Staunton, who succumbed to undiagnosed and untreated sepsis in a New York City hospital in 2012. The regulations requiring the sepsis protocols are known as Rory's Regulations.

Other states should follow New York's lead, says Jeffrey Hammond, deputy director of communications at the New York State Department of Health. "States should identify subject matter experts, hospitals, and physicians who can work collaboratively with the state to provide input and feedback on the program. Sepsis protocols should be evidence-based, including training of professional staff to implement the protocols and a mechanism for data collection and analysis."

The mandatory sepsis protocols are intended to improve rapid identification and treatment of sepsis. Rory's Regulations have five primary requirements for hospitals to adopt sepsis protocols.

• There must be a process for screening and early recognition of patients with sepsis, severe sepsis, and septic shock.
   
• There must be a process to identify and document patients for treatment with protocols for severe sepsis and septic shock.
   
• There must be treatment guidelines, including early administration of antibiotics.
   
• There must be training for healthcare providers to quickly recognize and treat sepsis in adults and children.
   
• There must be reporting of sepsis-related data to the New York State Department of Health. The data is used to develop and evaluate risk-adjusted mortality rates.

The number of lives saved by Rory's Regulations was estimated by comparing the observed severe sepsis in-hospital deaths between Jan. 1, 2015, and Dec. 31, 2019, to the expected number of deaths among severe sepsis cases during the same timeframe, Hammond says.

"The expected number of in-hospital deaths was calculated by projecting the unadjusted severe sepsis in-hospital mortality rate observed in 2014 to all subsequent years' cases and the number of observed deaths was then subtracted from this figure to determine the estimate of lives saved. The analysis of adults and children shows an estimated 16,011 New York State lives saved from 2015 to the end of 2019, which is the most current year of validated data available," he says.

The mandatory sepsis protocols must be evidence-based, Hammond says. "Each hospital develops their own protocols based on accepted standards of care and then updates their protocols based on clinical evidence."

Implementing the protocols is an ongoing process, he says. "Hospitals should have internal review processes that use data to monitor their achievements, identify areas for improvement, and modify their protocols and procedures as needed to ensure performance targets are met."