MedicalResearch.com Interview with: Chanu Rhee, MD, MPH Harvard Medical School and Harvard Pilgrim Health Institute Boston, MA MedicalResearch.com: What is the background for this study? Response: Sepsis is a leading cause of death, disability, and healthcare costs.  This has triggered regulators and hospitals to invest heavily in improving sepsis recognition and care.  Most notably, the Centers for Medicare & Medicaid Services (CMS) implemented the Severe Sepsis/Septic Shock Early Management Bundle (SEP-1) by the in October 2015.  SEP-1 requires hospitals to report compliance with a 3 and 6 hour sepsis care bundle, which includes initial and repeat lactate measurements, blood culture orders, broad-spectrum antibiotic, specific quantities of fluid boluses for hypotension, vasopressors for persistent hypotension, and documentation of a repeat volume and perfusion assessment for patients with septic shock. While SEP-1 has helped raise awareness of sepsis and catalyzed sepsis quality improvement initiatives around the country, concerns have been raised about its potential unintended consequences -- particularly around increasing unnecessary broad spectrum antibiotic use -- and the strength of evidence supporting the measure.  In this study, we used detailed clinical data from a diverse cohort of hospitals to assess whether SEP-1 implementation was associated with changes in key processes of care and mortality in patients with suspected sepsis.  (more…)