What does Centers for Medicare and Medicaid Services (CMS) consider a fall out regarding sepsis?

CMS Sepsis Core Measure Fall Outs

CMS considers a fall out in sepsis care to be any failure to comply with the SEP-1 core measure bundle requirements, which includes missed timeframes for interventions, incomplete documentation, or failure to provide required treatments within specified windows.

Understanding SEP-1 Core Measure Requirements

The Centers for Medicare and Medicaid Services (CMS) implemented the Severe Sepsis/Septic Shock Core Measure Bundle (SEP-1) as a value-based purchasing program that links sepsis care to financial incentives 1. Common fall outs occur when healthcare providers fail to meet the following requirements:

Initial Sepsis Identification and Management (3-Hour Bundle)

• Blood cultures: Must be drawn prior to antibiotic administration
• Lactate measurement: Initial lactate must be obtained within 3 hours of sepsis identification
• Antibiotic administration: Broad-spectrum antibiotics must be administered within 3 hours of sepsis identification
• Fluid resuscitation: 30 mL/kg crystalloid fluid bolus must be initiated within 3 hours for patients with hypotension or lactate ≥4 mmol/L

Follow-up Care (6-Hour Bundle)

• Repeat lactate measurement: Required within 6 hours if initial lactate was elevated
• Vasopressor administration: Required for persistent hypotension despite fluid resuscitation
• Documentation of reassessment: Must include volume status and tissue perfusion assessment

Common Reasons for SEP-1 Fall Outs

1. Documentation deficiencies:

   • Incomplete or missing documentation of time zero (when sepsis was first identified)
   • Failure to document reasons for clinical exceptions
   • Missing documentation of fluid status reassessment

2. Timing failures:

   • Delays in obtaining blood cultures
   • Administering antibiotics after the 3-hour window
   • Delayed fluid resuscitation
   • Failure to repeat lactate measurement within required timeframe

3. Bundle component omissions:

   • Not performing all required interventions
   • Failure to escalate care appropriately for patients with persistent hypotension

Important Considerations for Preventing Fall Outs

The definition of sepsis itself has evolved over time, with the Sepsis-3 definitions now defining sepsis as "life-threatening organ dysfunction caused by a dysregulated host response to infection" 2. However, CMS still uses older criteria based on SIRS (Systemic Inflammatory Response Syndrome) parameters for SEP-1 compliance 3.

This discrepancy between current clinical definitions and regulatory requirements creates challenges for clinicians, as noted in the Western Journal of Emergency Medicine, which states that "CMS-assigned definitions for severe sepsis and septic shock are premature and inconsistent with evidence-based definitions" 3.

Strategies to Improve SEP-1 Compliance

1. Implement standardized protocols:

   • Use electronic health record alerts for early sepsis identification
   • Create order sets that include all bundle components
   • Develop clear documentation templates

2. Establish clear time zero identification:

   • Train staff to recognize and document the exact time when sepsis criteria are first met
   • Use qSOFA scoring (altered mental status, systolic BP ≤100 mmHg, respiratory rate ≥22) as a rapid assessment tool 4

3. Ensure timely interventions:

   • Create systems to prioritize blood culture collection before antibiotics
   • Develop pharmacy protocols for rapid antibiotic delivery
   • Implement fluid resuscitation protocols with appropriate monitoring

4. Improve documentation:

   • Document clinical reasoning for any deviations from the bundle
   • Create standardized reassessment documentation tools
   • Ensure complete documentation of all interventions with accurate timestamps

Pitfalls to Avoid

• Focusing solely on compliance rather than clinical judgment: While meeting SEP-1 requirements is important for reimbursement, patient care decisions should still be guided by clinical judgment and the most current evidence-based practices 5.

• Overlooking exceptions: CMS allows for documented exceptions to certain bundle elements when clinically contraindicated, but these must be thoroughly documented.

• Failing to identify sepsis early: Delayed recognition leads to delayed interventions and increased likelihood of fall outs.

By understanding these requirements and implementing systems to ensure compliance, healthcare facilities can avoid SEP-1 fall outs while providing evidence-based care for patients with sepsis.