Noncompliance with Sepsis Measures Used to Prove Care Was Negligent
When plaintiff attorneys pursue a missed sepsis malpractice claim, experts will scour the ED medical record looking for evidence indicating the provider failed to meet the standard of care. “There are multitude of challenges that exist in the ED with regards to compliance,” says Kyle Weant, PharmD, BCPS, BCCCP, FCCP, an emergency medicine clinical pharmacy specialist at University of South Carolina.
One issue is the existence of two different organizations — CMS and the Surviving Sepsis Campaign (SSC) — with different sepsis standards for EDs. “There is a lack of alignment between the two. That creates substantial confusion,” Weant observes.
For example, CMS requires hospitals to report compliance with a sepsis treatment bundle (the SEP-1 measure), which continues to use the term “severe sepsis.” However, that term was eliminated from the SSC guidelines. “For both the SEP-1 measure and the SSC guidelines, time itself is a huge challenge, both in terms of how it is measured and how it is applied,” Weant explains. “For example, both put an unreasonable emphasis on immediate antibiotic administration in all patients with sepsis, regardless of severity.”
The data supporting immediate administration of antibiotics in patients with septic shock is controversial.1 “But it is far more justifiable than the immediate administration of antibiotics in all patients with possible sepsis, regardless of severity,” Weant argues.
This has resulted in the unintended consequence of many patients who receive antibiotics for possible sepsis turning out to be uninfected.2 “This has individual and societal antimicrobial implications regarding resistance patterns. It also has profound implications on ED workflow,” Weant says.
Resources are directed to all the presumed sepsis patients instead of other ED patients. “This is an often-underappreciated and unmeasured aspect of overly rigid recommendations and requirements,” Weant notes.
A similar situation exists with the SEP-1 recommendation for repeated measures of lactate in all patients with an initially elevated lactate, regardless of severity. “This is not an evidence-based practice, and does not take into account the strain on limited ED resources and workflow in the absence of a defined benefit,” Weant says.
There are abundant data indicating the earlier sepsis is diagnosed and treated, the better the clinical outcomes.3 “This creates an enormous challenge for emergency departments,” says Mark L. Graber, MD, FACP, founder and president emeritus of the Society to Improve Diagnosis in Medicine.
It is especially difficult to identify "early" sepsis in ED patients. “Where and how do you draw the line between someone with a localized infection, and their transition to ‘sepsis’?” Graber asks.
Many other conditions can mimic early sepsis. “It is a bad idea to just treat everyone with a fever with broad-spectrum antibiotics,” says Graber, project partner of the Leapfrog Group’s Recognizing Excellence in Diagnosis initiative. (Learn more about Recognizing Excellence in Diagnosis here.)
Many of these patients will not derive any benefit from the antibiotics because they really have a viral infection or a non-infectious inflammatory condition. “A small fraction will suffer side effects, allergic responses, or will develop colonization with antibiotic-resistant organisms that will be treatment-resistant if they do blossom into an infection down the road,” Graber says.
Definitions and criteria have evolved substantially over the past decade. For instance, the “Sepsis-1” criteria have matured into what is now known as the “Sepsis-3” criteria. Many different “bundles” have been created to assist in identifying patients who will go on to develop full-blown sepsis and benefit from early antibiotics. “Unfortunately, not all of the studies of these bundles have positive results; some find that only certain populations of patients benefit, but not others,” Graber says.
Amer Aldeen, MD, FACEP, chief medical officer of US Acute Care Solutions (USACS), says, “sepsis is one of the highest priority conditions we manage in the ED.”
Aldeen recognizes two major challenges regarding sepsis and EDs. One is distinguishing bacterial sepsis from severe COVID-19. “While COVID-19 has a characteristic pattern of hypoxia and acute respiratory distress syndrome, bacterial sepsis can certainly coexist with COVID,” Aldeen explains.
The treatment of hypoxic COVID-19 patients often involves corticosteroids, but corticosteroids may be deleterious in bacterial sepsis cases. Thus, potential malpractice allegations include failure to diagnose bacterial sepsis when COVID-19 is clouding the picture.
The other major challenge is the ability to identify subtle cases, especially in older populations. “Geriatric patients with sepsis often do not mount a significant fever or white blood cell response, making the diagnosis more difficult,” Aldeen notes.
Potential allegations in that kind of case include failure to diagnose bacterial sepsis because systemic inflammatory response syndrome criteria were not present, but the patient still had sepsis. “Surges in patient volume have made it challenging for staff to perform all of the clinical actions needed to meet sepsis metrics,” Aldeen says.
Physician experts at USACS have implemented clinical management tools that address sepsis and COVID-19. “The tools are clinical decision instruments that supplement clinical gestalt to avoid errors and narrow variability of care,” Aldeen says.
Aldeen says an important metric for EDs is discharges of infected patients with tachycardia. “We know from the literature that tachycardia is a high-risk discharge characteristic,” Aldeen says. “We focus on education to assess and document clinical status on discharge for patients who are tachycardic.”
Those patients are at high risk for sepsis, and discharging them without appropriate evaluation represents a clear threat to patient safety. “Sepsis can be a complex diagnosis that coexists with many others,” Aldeen says. “We have a very low threshold for addressing sepsis, especially given its high associated morbidity and mortality.”
Graber points to some recent positive developments for ED sepsis care, including laboratory tests helpful in diagnosing sepsis cases that have improved substantially. Also, there are new biomarkers of sepsis that are promising, and new molecular tests allow a lab to identify bloodborne infections in hours (instead of the days formerly required for blood cultures to grow). “Another piece of good news: Sepsis awareness has also increased dramatically, which can only help,” Graber says.
- Im Y, Kang D, Ko RE, et al. Time-to-antibiotics and clinical outcomes in patients with sepsis and septic shock: A prospective nationwide multicenter cohort study. Crit Care 2022;26:19.
- Rhee C, Chiotos K, Cosgrove SE, et al. Infectious Diseases Society of America position paper: Recommended revisions to the national severe sepsis and septic shock early management bundle (SEP-1) sepsis quality measure. Clin Infect Dis 2021;72:541-552.
- Gauer R, Forbes D, Boyer N. Sepsis: Diagnosis and management. Am Fam Physician 2020;101:409-418.
Along with growing general awareness, there are several positive developments in ED sepsis care, including laboratory tests helpful in diagnosing sepsis cases that have improved substantially. Also, there are new biomarkers of sepsis that are promising, and new molecular tests allow a lab to identify blood-borne infections in hours instead of the days formerly required for blood cultures to grow.
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