What is SEP-1: Essential Insights for Improving Sepsis Care Outcomes

What is SEP-1? A Guide to CMS SEP-1 Compliance & Challenges

Dealing with SEP-1 compliance is a significant challenge facing the healthcare industry. Some clinicians believe it’s a critical tool to improve sepsis care, while others view it as government overreach into clinical decision-making. Regardless of your view on SEP-1, the reality is: it’s here, non-compliance is penalized, and it will either help your hospital succeed—or strain your resources.

The good news? In many hospitals with low SEP-1 performance, the issue isn’t clinicians skipping required steps. More often, it’s documentation gaps that prevent proper credit. This guide explains what is SEP-1, the common barriers hospitals and labs face, and how to navigate them effectively.

What is SEP-1

For those unfamiliar with it, SEP-1 is a CMS quality measure introduced in 2015 to improve the management of sepsis and septic shock. The protocol outlines specific steps emergency physicians must take within the first 3 and 6 hours of identifying a sepsis patient.

This early intervention bundle aims to accelerate sepsis care and improve patient outcomes. Despite its critics, SEP-1 has been supported by organizations like the Sepsis Alliance and backed by data showing better sepsis outcomes. Starting in 2024, CMS began rewarding or penalizing hospitals based on SEP-1 compliance—cementing it as a top priority for hospital medicine professionals.

Key SEP-1 Requirements

To comply with SEP-1, providers must complete specific tasks within 3 and 6 hours after a patient meets severe sepsis criteria. These steps form what’s known as the SEP-1 bundle.

3-Hour Bundle:

• Measure lactate levels
• Draw blood cultures
• Administer broad spectrum antibiotics
• Infuse crystalloids if the patient is hypotensive or lactate ≥4

6-Hour Bundle:

• Maintain MAP >65mmHg
• Re-assess volume status and document if lactate remains high or hypotension persists
• Re-measure lactate if initially elevated

These requirements are part of a broader septic shock management bundle designed to rapidly stabilize sepsis patients and reduce mortality rates.

What are the Challenges of SEP-1 Compliance for Labs and Hospitals?

Although SEP-1 encourages timely sepsis care, it brings several complications. For starters, there’s limited incentive to avoid overtreatment. This often results in unnecessary cultures, increased lab workloads, and higher contamination risk. Overuse of broad spectrum antibiotics can contribute to resistance and strain on infectious diseases teams.

In busy EDs, the momentum behind a sepsis diagnosis can also delay detection of other life-threatening conditions that mimic it, like cardiogenic shock. Many providers feel forced to follow SEP-1 pathways—even when it doesn’t align with their clinical judgment.

A major frustration is how SEP-1 is measured: Hospitals are scored by the number of eligible sepsis patients who receive all bundle elements, divided by the total eligible population. That includes patients diagnosed with severe sepsis or septic shock.

Importantly, inclusion in the SEP-1 denominator requires a clearly documented time of sepsis onset—by clinical criteria or documentation. Timely, justified clinical notes can override automatic criteria. For example, if a physician promptly documents that a patient does not have sepsis, they are free to follow an alternative treatment path without penalty.

This underscores the need for better tools that allow healthcare professionals to confidently rule out sepsis and septic shock without compromising compliance.

How IntelliSep Can Help Hospitals and Labs Improve SEP-1 Compliance

The IntelliSep test helps tackle this exact problem. It offers rapid stratification of sepsis patients into low (Band 1), (Band 2), or high (Band 3) risk categories—empowering emergency physicians with immediate diagnostic clarity.
Results of a multi-centered pooled analysis of IntelliSep showed that over 50% of tested patients fell into Band 1—with a 97.5% likelihood they did not have sepsis. Meanwhile, Band 3 patients had a >55% probability of having severe sepsis or septic shock.

For SEP-1 compliance, this is game-changing. As an aid to sepsis detection, a Band 1 result gives clinicians confidence to document “no sepsis,” offering them clinical flexibility and helping to mitigate against SEP-1 penalties, a considerable relief for overworked EDs juggling dozens of possible diagnoses.

A post-implementation review of IntelliSep data showed dramatic improvements:

• 36% reduction in sepsis mortality rates
• 15% drop in 30-day readmissions among sepsis patients

This suggests that IntelliSep not only supports compliance—it helps improve overall patient outcomes.

While SEP-1 presents real hurdles, the ultimate intent of SEP-1 is centered on improved patient outcomes and tools like IntelliSep can make compliance simpler and more effective. They allow physicians to rule in or rule out sepsis and septic shock swiftly, follow clinical intuition, and still stay aligned with SEP-1 metrics.

To learn more about Cytovale and the IntelliSep test, contact the Cytovale team.