What are the criteria for the Centers for Medicare and Medicaid Services (CMS) sepsis bundle?

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Last updated: May 6, 2025View editorial policy

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From the Guidelines

The CMS sepsis bundle requires immediate intervention, including measuring lactate levels, obtaining blood cultures, administering broad-spectrum antibiotics, and providing fluid resuscitation with a target of at least 30 mL/kg of IV crystalloid fluid within the first 3 hours, as well as maintaining a mean arterial pressure of 65 mmHg in patients with septic shock requiring vasopressors 1. The key components of the bundle include:

  • Measuring lactate levels within 3 hours of presentation, with repeat measurement within 6 hours if the initial level is elevated
  • Obtaining blood cultures before administering antibiotics
  • Administering broad-spectrum antibiotics within 3 hours of presentation for sepsis and within 1 hour for septic shock
  • Providing an initial fluid bolus of 30 mL/kg crystalloid within 3 hours for hypotension or lactate ≥4 mmol/L, as recommended by the Surviving Sepsis Campaign 1
  • Maintaining a mean arterial pressure of 65 mmHg in patients with septic shock requiring vasopressors, with norepinephrine as the first-line vasopressor The goal of the CMS sepsis bundle is to rapidly identify and treat sepsis, reducing mortality by addressing the underlying infection, supporting hemodynamics, and improving tissue perfusion, with timely implementation being critical to reduce mortality risk 1. The bundle's focus on early recognition and treatment is supported by the Surviving Sepsis Campaign's guidelines, which emphasize the importance of immediate treatment and resuscitation in patients with sepsis and septic shock 1.

From the Research

CMS Sepsis Bundle Criteria

The Centers for Medicare and Medicaid Services (CMS) sepsis bundle criteria are based on the early recognition and management of sepsis. The criteria include:

  • Suspected or proven infection
  • Organ failure, which can be identified by:
    • Two or more Systemic Inflammatory Response Syndrome (SIRS) criteria 2
    • Elevated lactate levels (>2 mmol/L) 3
  • Signs that meet two or more SIRS criteria, which include:
    • Body temperature greater than 38°C or less than 36°C
    • Heart rate greater than 90 beats per minute
    • Respiratory rate greater than 20 breaths per minute or PaCO2 less than 32 mmHg
    • White blood cell count greater than 12,000 cells/mm^3 or less than 4,000 cells/mm^3
  • Initiation of early broad-spectrum antibiotics and fluid resuscitation 4

SIRS Criteria

The SIRS criteria are used to identify patients with severe sepsis. However, studies have shown that the use of two or more SIRS criteria to define severe sepsis may not be sufficient, as it excludes some patients with infection, organ failure, and substantial mortality 2. The use of lactate levels as a criterion for severe sepsis has been shown to be more effective in identifying high-risk patients 3.

Pathophysiology of Sepsis

Sepsis is a clinical syndrome that results from the dysregulated inflammatory response to infection, leading to organ dysfunction 4. The pathophysiology of sepsis involves a complex interplay of pro-inflammatory and anti-inflammatory responses, which can lead to multiorgan failure and death 5. Understanding the signaling pathways involved in sepsis and SIRS is crucial for the development of effective therapeutic interventions 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Sepsis: Current Definition, Pathophysiology, Diagnosis, and Management.

Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition, 2017

Research

The inflammatory response in sepsis.

Trends in immunology, 2013

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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