A Critical Review of the Government Mandated Cardiovascular Resuscitation Interventions for Sepsis (SEP-1)

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The National Quality Forum (NQF) endorsed and CMS has instituted a performance measure to be applied to patients presenting with sepsis termed the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1). The primary purpose of this performance measure is to decrease hospital mortality and costs of care related to sepsis, severe sepsis and septic shock. The performance measure includes five interventions (both treatments and measures) related to the hemodynamic management of patients with sepsis: In adults with severe sepsis, initial lactate level measurement must be performed within 3 hours of presentation, and repeat lactate level measurement must be performed within 6 hours of presentation, if initial lactate level is elevated. In adults with septic shock, resuscitation with 30ml/kg crystalloid fluids must be performed within 3 hours of presentation. Within 6 hours of presentation of septic shock, adults must receive vasopressors if hypotension persists after fluid administration. Also, if hypotension persists after fluid administration or if the initial lactate level is > 4 mmol/L, then a volume status and tissue perfusion assessment must be performed. According to the CMS performance measure, assessment of volume status and tissue perfusion requires either a focused physical exam (vital signs, cardiopulmonary exam, capillary refill evaluation, peripheral pulse assessment and skin examination all must be performed), or any two of the following: measure CVP, measure ScvO2, bedside cardiovascular ultrasound, or passive leg raise or fluid challenge. At present CMS requires that providers report on their institutions use of the interventions in this performance measure. Subsequently, however, CMS will require that providers complete all interventions. This performance measure is complex and requires substantial hospital resources to achieve compliance. We will perform a systematic review and meta-analysis that will focus on the evidence supporting the use of each of these hemodynamic interventions in decreasing mortality from sepsis, as well as the length of hospital stay, organ failure and cost of care.