Early Management Bundle, Severe Sepsis/Septic Shock

SEP-1: Complex measure of a complex process

Alexandre Andrianov, M.D.

 "This measure focuses on adults 18 years and older with a diagnosis of severe sepsis or septic shock. Consistent with Surviving Sepsis Campaign guidelines, it assesses measurement of lactate, obtaining blood cultures, administering broad spectrum antibiotics, fluid resuscitation, vasopressor administration, reassessment of volume status and tissue perfusion, and repeat lactate measurement. As reflected in the data elements and their definitions, the first three interventions should occur within 3 hours of presentation of severe sepsis, while the remaining interventions are expected to occur within 6 hours of presentation of septic shock" (Specification Manual for National Hospital Inpatient Quality Measures). 

Despite very clear rationale stated in the CMS instructions for the collection of data there remains a substantial amount of confusion among providers. Most of providers agree that sepsis remains widely underdiagnosed and that early intervention can and will result in improved outcomes. Despite this wide recognition of the problem there appears to be some ambiguity in regards to specific cut of values and definitions that are underpinning the bundle. First of all it is worth to mention that the initial concerns of the medical community regarding the suggested aggressive use of invasive monitoring techniques that was not supported by clinical evidence in the further studies had been successfully removed and replaced by another module ("Sepsis Reassessment") that became a part of "all or nothing" 6 hour bundle. Another major point of confusion for healthcare providers in the use of relatively low cutoff value for the initial lactic acid measurement (2.0). CMS has defined patients who have evidence of infection (documented or objectively present) in addition to two or more SIRS criteria and who have lactate greater than 2.0 as having "Severe Sepsis". We as clinicians are well aware that any number of reasons can lead to increase in lactate (CHF, renal failure, liver failure etc) that are not sepsis related. Nevertheless for the purposes of CMS reporting all these patients will be included in the denominator.

Another big point of confusion is the exact definition of Septic Shock. As far as CMS is concerned, any patient with lactate 4 or above meets the definition of septic shock and should be treated accordingly. These types of patients must receive blood cultures, broad antibiotics and 30 cc/kg crystalloid bolus in the first 3 hours of presentation (three hour bundle) in addition to lactate measurement (initial within three hours and another one within 6 hours of presentation). Another way a patient can meet the criteria for septic shock that is more familiar to most of us clinicians is failure to respond to initial adequate volume resuscitation (even though it is not spelled out but we assume it is 30 cc/kg of crystalloid within 3 hours of presentation). In other words the application of the quality measure itself serves as its own definition. I will try to illustrate this on a clinical example:

Mr. John Doe, a 75 y/o caucasian male who has history of CAD, CABG x4, HTN, T2DM, CRF stage 3 presented to the ED of a community hospital with a chief complaint of leg edema, pain and redness for last 3 days, getting progressively worse. In ED he was found to have BP of 89/55 mm Hg, pulse 110, RR 15, T=102 F. Very appropriately the ER team suspected infectious process and with two points present he has bona fide SIRS. He is given initial volume resuscitation 1000 cc NS, blood cultures are obtained and initial dose of Zosyn administered. His blood pressure improves to 120/70. Initial labs confirm SIRS with WBC 16K, lactate is 4.5 mmol/l. Even though the patient has responded nicely to 1000 cc of 0.9% NaCl he is now classified as septic shock by the CMS definition and initial volume resuscitation is not consistent with the quality measure. At this time in order to meet the 3 hour bundle a clinician has to order additional fluid challenge calculated as 30 cc/kg. This has to be completed within 3 hours of presentation in order to meet the measure. As we can see from this example ordering initial bolus as 30 cc/kg would have made meeting the quality measure much easier. 

As we can see from the example a clinician has to always be aware of the exact definition that the patient meets (sepsis vs severe sepsis vs septic shock). Please recognize that 30 cc/kg initial crystalloid resuscitation is only applicable to the septic shock three hour bundle for reporting purpose. CMS does not want us to administer ton of  fluids to patient with strep throat. On the other hand it is easy to see how a particular case may fall out of compliance based on lactate level equal or greater than 4 mmol/l. 

Another source of confusion results from mixing up the sepsis treatment guidelines as published by different professional societies (for instance Society of Critical Care Medicine) with the SEP-1 CMS quality measure. Sepsis treatment guidelines are much more complex and describe a comprehensive approach to these type of patients. Every institution has to adapt or develop a sepsis treatment protocol that in not only in accordance with professional guidelines but also makes it easy to meet the SEP-1 compliance. 

The flow chart presented below is not intended to be used as a standard protocol for treating septic patient. It is simply a tool designed to improve physician understanding of this complex reporting measure and some of the definitions that are involved. 

 
Sepsis pathway.jpg