• Ian J Barbash, Billie S Davis, Jonathan G Yabes, Chris W Seymour, Derek C Angus, and Jeremy M Kahn.
• University of Pittsburgh School of Medicine and UPMC Health System, Pittsburgh, Pennsylvania (I.J.B., C.W.S.).
• Ann. Intern. Med. 2021 Jul 1; 174 (7): 927-935.

BackgroundMedicare requires that hospitals report on their adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1).ObjectiveTo evaluate the effect of SEP-1 on treatment patterns and patient outcomes.DesignLongitudinal study of hospitals using repeated cross-sectional cohorts of patients.Setting11 hospitals within an integrated health system.Patients54 225 encounters between January 2013 and December 2017 for adults with sepsis who were hospitalized through the emergency department.InterventionOnset of the SEP-1 reporting requirement in October 2015.MeasurementsChanges in SEP-1-targeted processes, including antibiotic administration, lactate measurement, and fluid administration at 3 hours from sepsis onset; repeated lactate and vasopressor administration for hypotension within 6 hours of sepsis onset; and sepsis outcomes, including risk-adjusted intensive care unit (ICU) admission, in-hospital mortality, and home discharge among survivors.ResultsTwo years after its implementation, SEP-1 was associated with variable changes in process measures, with the greatest effect being an increase in lactate measurement within 3 hours of sepsis onset (absolute increase, 23.7 percentage points [95% CI, 20.7 to 26.7 percentage points]; P < 0.001). There were small increases in antibiotic administration (absolute increase, 4.7 percentage points [CI, 1.9 to 7.6 percentage points]; P = 0.001) and fluid administration of 30 mL/kg of body weight within 3 hours of sepsis onset (absolute increase, 3.4 percentage points [CI, 1.5 to 5.2 percentage points]; P < 0.001). There was no change in vasopressor administration. There was a small increase in ICU admissions (absolute increase, 2.0 percentage points [CI, 0 to 4.0 percentage points]; P = 0.055) and no changes in mortality (absolute change, 0.1 percentage points [CI, -0.9 to 1.1 percentage points]; P = 0.87) or discharge to home.LimitationData are from a single health system.ConclusionImplementation of the SEP-1 mandatory reporting program was associated with variable changes in process measures, without improvements in clinical outcomes. Revising the measure may optimize its future effect.Primary Funding SourceAgency for Healthcare Research and Quality.

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