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, also known as SEP-1, includes specific criteria for early identification and management of sepsis, requiring blood cultures before antibiotics, lactate measurement, broad-spectrum antibiotics within 3 hours of presentation, and 30 mL/kg crystalloid fluid bolus for hypotension or lactate ≥4 mmol/L within 3 hours, as recommended by the Surviving Sepsis Campaign guidelines 1.

Key Components of the CMS Sepsis Bundle

  • Blood cultures before antibiotics
  • Lactate measurement
  • Broad-spectrum antibiotics within 3 hours of presentation
  • 30 mL/kg crystalloid fluid bolus for hypotension or lactate ≥4 mmol/L within 3 hours

Management of Septic Shock

  • For patients with persistent hypotension after fluid resuscitation or initial lactate ≥4 mmol/L, the bundle requires repeat lactate measurement within 6 hours and vasopressors for persistent hypotension to maintain MAP ≥65 mmHg, as recommended by the guidelines 1.
  • Norepinephrine is the first-line vasopressor, typically starting at 0.05-0.1 mcg/kg/min and titrating as needed.

Importance of Early Implementation

  • Early implementation of these measures has been shown to reduce mortality in sepsis patients by addressing the pathophysiologic cascade of infection, inflammation, and organ dysfunction before irreversible damage occurs, as supported by the guidelines 1.

Documentation and Reassessment

  • Documentation of reassessment of volume status and tissue perfusion is also required within 6 hours for patients with septic shock, emphasizing the importance of ongoing evaluation and adjustment of treatment, as recommended by the guidelines 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
  • Signs that meet two or more criteria for the systemic inflammatory response syndrome (SIRS) 2 Some of the SIRS criteria include:
  • Body temperature greater than 38°C or less than 36°C
  • Heart rate greater than 90 beats per minute
  • Tachypnea, as manifested by a respiratory rate greater than 20 breaths per minute or hyperventilation, as indicated by a PaCO2 less than 32 mmHg
  • White blood cell count greater than 12,000 cells/mm^3 or less than 4,000 cells/mm^3, or the presence of more than 10% immature neutrophils (bands) 3

Diagnosis and Management

The diagnosis and management of sepsis involve the use of appropriate antimicrobial agents, optimization of intravascular volume, and vasopressors to counteract vasoplegic shock 4. The implementation of these treatments, combined with novel therapeutic approaches, aims to decrease the impact of sepsis.

Performance of SIRS-Based Screening Algorithms

The performance of SIRS-based screening algorithms in identifying severe sepsis has been investigated in several studies. One study found that the sensitivity and specificity of these algorithms ranged from 20.2% to 82.3% and 57.8% to 94.8%, respectively 5. Another study found that algorithms with lactate levels thresholds of >2 mmol/L performed better than those with thresholds of >4 mmol/L 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Sepsis and the systemic inflammatory response syndrome.

Journal of the Royal College of Surgeons of Edinburgh, 2000

Research

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

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

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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