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WASHINGTON -- A longstanding controversy over a quality measure for managing sepsis is bubbling up once again.

The quality measure, known as the , or SEP-1, was endorsed in 2013 by the National Quality Foundation (NQF), and first implemented by the Centers for Medicare & Medicaid Services (CMS) in October 2015.

The measure has several unusual features, Bruce Quinn, MD, PhD, a health policy consultant in Los Angeles, said in a phone call. First, "it is by far the most complex measure CMS has ... The rules are dozens and dozens of pages long, it has to be processed manually for every relevant patient at every hospital in the U.S." In addition, "the measure steward is not CMS or the American Medical Association or an infectious disease association -- the measure steward is Henry Ford Hospital [in Detroit]."

Although the measure is long, it has seven basic elements, according to Sean Townsend, MD, vice president of quality and safety at California Pacific Medical Center in San Francisco, and one of the measure's co-developers:

• Measure the patient's initial lactate level
• Take a blood culture before administering a broad-spectrum antibiotic
• Administer a broad-spectrum antibiotic within 3 hours
• Administer 30 mL/kg of crystalloid fluid to patients with low blood pressure or elevated lactate
• Repeat the lactate test if it was elevated initially
• Administer a vasopressor for patients who remain hypotensive
• Reassess the patient after a certain period

Subject to Clinician Judgment

Like anything else, the measure is subject to the physician's clinical judgment, Townsend told 麻豆传媒 in a phone interview. "We always recommend that clinicians retain their judgment," he said. "If they think that somehow or another this bundle should not be applied to patients, they shouldn't do it. Take care of the patient; don't try to take care of a measure." However, he added, "if the doctor truly thinks it's sepsis, it's hard to imagine it's controversial to say, 'That person should get an antibiotic because we think they're infected."

The measure has engendered a fair amount of controversy, explained Michael Klompas, MD, and Chanu Rhee, MD, both of Harvard Medical School in Boston, in a 2021 Annals of Internal Medicine .

"Some believe it has brought welcome attention to sepsis and catalyzed hospitals to implement protocols that save lives," they wrote. "Others are concerned that the measure's rigid treatment requirements and aggressive timelines encourage excessive fluids and antibiotics, curtail clinicians' latitude to calibrate their management to their certainty of infection and patients' severity of illness, and unduly anchor providers' diagnostic focus on sepsis to the exclusion of other serious conditions."

The editorial came in response to an Annals that found that the sepsis measure, when implemented at one healthcare system, was associated with "a 50% increase in lactate checks (70% observed vs. 47% expected if pre–SEP-1 trends had continued), a 10% increase in broad-spectrum antibiotic administration (50% vs. 45%), and a 30% increase in infusions of 30 mL/kg of intravenous fluid (13% vs. 10%) within 3 hours of culture orders," wrote Klompas and Rhee.

However, "despite these significant changes in processes, there were no significant changes in hospital mortality or the percentage of patients discharged to home," they wrote. Klompas and Rhee also were part of -- this one of patients in more than 100 hospitals -- showing similar findings.

Appeal by Infectious Disease and Emergency Medicine Groups

The editorial's authors suggest several possible reasons why adherence to the measure did not improve outcomes. First, "the specific components of SEP-1 are controversial. Its primary effect in this study was on lactate testing, but elevated lactate levels are not specific for infection, and checking lactate in and of itself does not change a patient's prognosis."

And second, "sepsis preferentially affects patients with severe comorbidities whose deaths are difficult to prevent once they become septic, even with optimal hospital-based care." In addition, they said, misdiagnosis may play a role: "Diagnosing infection and knowing whether organ dysfunction is due to infection or some other cause can be difficult. About a third of patients treated for serious infections in the emergency department or intensive care unit turn out to have noninfectious conditions."

In 2021, the NQF re-endorsed the measure for a third time. Several infectious disease and emergency medicine groups, including the Infectious Diseases Society of America (IDSA), the American College of Emergency Physicians (ACEP), and the Society of Hospital Medicine, with NQF in January, expressing concerns about the way the re-endorsement process was handled.

"The measure stewards and CMS repeatedly interrupted the proceedings and forcefully redirected the conversation, posing a conflict of interest," the groups wrote. "Our understanding is that measure stewards and CMS guests attend as information resources but are not empowered to interrupt or to stop panelists from pursuing various lines of query. We fear that these repeated interruptions and obstructions prevented the sharing of relevant data and perspectives that could have been relevant to the panel's final vote."

They also noted that "two leading panelists with significant content expertise on SEP-1 were recused from the discussion and vote. We believe their deep understanding and experience working on SEP-1 and evaluating its impact in real-word settings should have been seen as assets to NQF's deliberations, rather than barriers."

The concerns about the process revolved around whether both sides were adequately heard, Rhee said in a phone interview. "There are good reasons to support a national sepsis measure and there are data that on its face appear to support the bundle ... but at the same time, there are many nuances to the data and I think people didn't necessarily have a chance to really explore that level of detail during the re-endorsement process."

Townsend agreed that the re-approval meetings "were probably not as well organized as they could have been, from a parliamentary perspective; there were questions about when people could speak and when they couldn't." On the other hand, he noted in an email, "the measure won approval three times" during NQF votes, and the arguments in the appeal have already been addressed and voted down. In addition, he said, the show that the appellants were given time to explain their concerns but they weren't prepared to do so. And comments on the appeal show an equal number of organizations supporting and opposing the measure.

He also argued that the study from Barbash's group was flawed because the mortality rate for patients with sepsis who are not in septic shock is thought to be around 20%, but the paper found a 4%-5% mortality rate in all groups, including that one. "I don't know what patients they studied, but those weren't septic patients," he said. Townsend pointed to a 2022 conducted, which found that compliance with the bundle was associated with a reduction in 30-day mortality (21.81% vs 27.48%, respectively), for an absolute risk reduction of 5.67%.

Too Broadly Targeted?

In a related issue, another criticism of the guidelines is that they are too broadly targeted. The studies done on this issue seem to agree "that timely treatment appears to be more important for septic shock compared to patients who are infected with sepsis but are not in shock," Rhee said. "And it makes sense that every hour delay in care probably matters more for the sickest patients ... My colleagues and I have therefore recommended narrowing the scope of the measure to focus on patients who have suspected septic shock, because the evidence better supports the measure in that population."

Townsend calls that idea "wrong-headed." "The data to support the notion that patients in shock respond to antibiotics better than patients that have sepsis that are not in shock does not exist," he said. The physicians from IDSA who support that idea "overclaim those findings, and they prefer that because they would like to limit the amount of antibiotics given. However, the patients who are not in the shock, who have sepsis, the mortality rate is still above 20%" and those patients will die if not treated early.

Compliance with the guidelines has been low, which is another problem, said 麻豆传媒 editor-in-chief Jeremy Faust, MD, of Harvard Medical School in Boston, who is also critical of the measure.

CMS, for its part, said in an email that the agency "is aware of the proceedings of the appeal and the concerns for measure NQF #0500 (SEP-1). Any plans to modify the measure is the responsibility of the developer."

Also asked to comment on the issue, an ACEP spokesman said the organization "appreciates the significant and ongoing efforts to bring attention to sepsis treatment. Emergency physicians welcome the chance to refine clinical approaches to this condition and look forward to working with NQF, Surviving Sepsis and others to continue to improve these measures, enhance the way physicians and other health professionals approach sepsis care, and save lives."

are due to NQF by 6 p.m. ET on March 16. The NQF's Appeals Board will consider the letter and comments, and could decide to uphold the re-endorsement, overturn it, or dismiss the appeal if it doesn't meet the appeal criteria.

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