Awaiting a Decision About the Fate of SEP-1
April 13, 2022
Apr 29, 2022 UPDATE: The NQF Appeals Board has voted to dismiss the submitted appeal of SEP-1. Read more about that decision here.
In 2002, when Erin Flatley developed the infection that would later progress into sepsis and take her life, her local hospital did not follow the process known as SEP-1. That’s because it didn’t exist yet.
“SEP-1” is the shorthand name for The Severe Sepsis and Septic Shock Early Management Bundle. This bundle lays out a process for hospital clinicians to follow when managing patients with severe sepsis or septic shock. The National Quality Forum (NQF), an organization that works to ensure patient protections and overall healthcare quality, first endorsed SEP-1 back in 2008 and has re-endorsed it in regular review processes every three years since. But recently, some groups have been calling for SEP-1’s endorsement to be revoked, even submitting a request for an appeal of its most recent re-endorsement. NQF will meet on April 29th, 2022, to determine SEP-1’s fate.
Looking Backward: The Need for SEP-1
Carl Flatley, DDS, MSD, Erin’s father and the founder of Sepsis Alliance, had been practicing oral surgery for years but had never heard of sepsis before Erin’s diagnosis. He wasn’t alone. Twenty years ago, sepsis was largely considered a specialized topic, not something that should be at the forefront of all hospital clinicians’ minds. It was quite common for people like Dr. Flatley to be unaware of sepsis, and far too common for doctors like Erin’s to fail to look for its telltale signs.
This lack of attention created patient safety disasters. Clinicians did not have support in recognizing this fast-moving condition, which meant that extremely sick patients were diagnosed with sepsis too late. These delays cost lives and limbs: studies show that every hour sepsis treatment is delayed is associated with a 4-9% increased chance of progression to septic shock. If sepsis was recognized in a patient, there was no common terminology or universal treatment process in place for clinicians to follow, so care was inconsistent and unreliable. These problems were worse in facilities that were over-crowded or under-resourced.
Emanuel Rivers, MD, MPH, of Henry Ford Hospital and Sean Townsend, MD, of California Pacific Medical Center set out to address these problems by creating SEP-1. They based their bundle on the Surviving Sepsis Campaign recommendations, which were first developed in 2001 by a highly knowledgeable group of clinicians from across North America and Europe. The SEP-1 process includes rapid assessment for patients with suspected sepsis (vital signs and blood work), the quick administration of broad-spectrum antibiotics, and the careful introduction of fluids. The existence of the bundle meant there was, for the first time, a standardized approach to delivering evidence-based sepsis care, which could be replicated for every single patient. This marked a moment of lifesaving change for patients across the nation.  
SEP-1 Today: Calls for Appeal
Studies confirm that SEP-1’s endorsement and incorporation into day-to-day hospital operations has saved, and continues to save, many lives. Between 2015 and 2017, compliance with SEP-1 was associated with lower 30-day sepsis mortality in 3,241 facilities across the United States.
Unfortunately, despite these clear benefits to patients, not everyone is supportive of SEP-1. SEP-1’s opponents make a few different arguments—each of which Sepsis Alliance rebuts.
The Argument: Opponents argue that SEP-1’s quick treatment with antimicrobials contributes to the growing problem of antimicrobial resistance (AMR). AMR occurs when specific strains of bacteria, viruses, fungi, or parasites learn to defeat medicines designed to treat them. SEP-1’s opponents argue that when clinicians are encouraged to administer drugs very quickly, they don’t have time to correctly identify which drugs, if any, are needed, therefore contributing to overuse and resistance.
Our Response: SEP-1 only dictates when a first dose of antimicrobials should be given. By the time a second dose might be appropriate, clinicians usually have had time to get a more complete picture of the patient and can adjust the course of treatment as necessary. This discourages antimicrobial overuse and resistance while still encouraging clinicians to give drugs quickly to patients who may desperately need them.
The Argument: Opponents argue that early antimicrobials save more patients with septic shock than patients with sepsis—and that, therefore, early treatment is not necessary for everyone.
Our Response: A larger fraction of septic shock patients can be saved by early antibiotics, but that is simply because patients are more likely to die once they have progressed to septic shock. Studies show that early antibiotics for patients with infection or sepsis can prevent those patients from progressing to septic shock and can save lives.
The Argument: Opponents argue that the process is tricky to implement in hospitals because it has many steps and requires extra personnel to track those steps.
Our Response: Many who argue that SEP-1 is tricky to implement may be responding to difficulty diagnosing sepsis. The SEP-1 treatment steps need to be achieved within a short window of time once sepsis is recognized, and sepsis diagnosis can be complex. With training, however, diagnosing sepsis becomes easier and the timing of treatments improves. Processes like SEP-1 also become easier to implement over time as they become a routine part of hospital operations. Studies show that as hospitals assign personnel and develop procedures, these processes become increasingly able to “serve as a focus for improvement strategies.”
The Argument: Opponents argue that not all sepsis patients need the amount (30mL/kg) of intravenous fluid recommended by SEP-1.
Our Response: We know that not all patients with sepsis need this amount of IV fluid for resuscitation, and there are acceptable ways to determine which patients need that volume of fluid and which do not. SEP-1 merely requires that providers document their clinical reasoning if they choose to administer less than the recommended amount; it does not require that every patient receives that quantity of IV fluid. Having a standard operating procedure—including what to do when there is a reason not to follow a recommendation—ensures the best care for the most people.
The Argument: Opponents argue that SEP-1 encourages diagnosing sepsis in patients who are not severely ill, and that the reduction in mortality shown in studies is simply due to treating less sick patients earlier.
Our Response: SEP-1 does encourage diagnosing sepsis in patients who are less ill. As people who could some day be patients with sepsis, we find it hard to see what is wrong with encouraging intervention before things get worse. That philosophy applies to any disease, but it is very poignant when applied to sepsis, the leading cost of care and cause of death in U.S. hospitals.
Dr. Flatley acknowledged the difference SEP-1 could have made for his family, had it been around in 2002. “Twenty years ago, when Erin got sick, sepsis was not yet top-of-mind for clinical leaders,” he recalled. The Surviving Sepsis Campaign was then only in its infancy, and experts around the world were still grappling with standardizing terminology, screening, and treatment. “What SEP-1 has done for the clinical world is bring sepsis into the spotlight. It has helped to ensure that clinicians are looking out for sepsis in every case, and it has given us an evidence-based process to adhere to for every single patient.” If SEP-1 had existed in Erin’s hospital, she might be with us today.
What’s Next for SEP-1?
Until April 29th, we will not know the long-term fate of SEP-1. In the meantime, we can campaign for NQF to do the right thing and uphold its endorsement decision. Opponents of SEP-1 will be campaigning, too—so the more Sepsis Alliance advocates who vocalize their support, the stronger our position will be! Click to sign our community petition.
Do you have a personal experience with SEP-1 (either as a caregiver or as a patient) that demonstrates its effectiveness? We’d love to hear your story. Send a note outlining your experience to afeinman@sepsis.org.
Want to follow along with SEP-1 updates? Sign up for Sepsis Alliance’s advocacy newsletter here.
