Starting in October, hospitals under a new federal quality reporting measure will have to meet prescriptive checklists under certain windows of time for responding to and treating adult patients with either severe sepsis or septic shock. This complicated new measure, “Severe Sepsis/Septic Shock Early Management Bundle (SEP-1),” is proving controversial because of how it defines septic shock in particular, and because of the criteria it uses to exclude patients from both conditions.

On Oct. 1, hospitals will begin submitting data on the new measure, which updates an existing measure (NQF #0500) on severe sepsis and shock management. SEP-1 will be one of the Centers for Medicare and Medicaid Services’ (CMS) new publicly reported core measures.

SEP-1 requires lactate measurements, samples for blood cultures and administration of broad-spectrum antibiotics within 3 hours. Lactate values are a key determinant of additional interventions required within 6 hours. For example, SEP-1 calls for administering 30 mL/kg of crystalloid when lactate is ≥4 mmol/L or for hypotension.

At the same time, SEP-1 stipulates that central venous line intervention is no longer a requirement for monitoring sepsis patients.

SEP-1 defines severe sepsis in adult patients as “a suspected source of clinical infection, 2 or more manifestations of systemic infection (SIRS criteria), and the presence of sepsis-induced organ dysfunction,” whereas septic shock “requires the presence of severe sepsis and…sepsis-induced hypoperfusion persisting despite adequate fluid resuscitation, or lactate >4 mmol/L.”

Emergency physicians have mixed opinions about SEP-1, its definitions, and how it will be implemented.

One wrote that CMS appears to have “re-dubbed severe sepsis to be something very different than we are used to or have read in any of the major sepsis studies…I am still fairly desperate to know the evidence for this new definition, but I haven’t found it yet. Pretty unacceptable to hold every hospital in the US accountable to an arbitrary definition that has not been tested in large-scale trials.”

Another emphasized that SEP-1 will require close coordination between various hospital departments: “given the teamwork needed and the auditing to be completed and reported out, if your hospital doesn't have an existing multidisciplinary sepsis committee, now's the time to start one.”