Important Update: SEP-1 Adapts to Volume Concerns

CMS has responded to concerns associated with this issue.

As usual, Dr. Ronald Hirsch is making more work for me! He saw an article on sepsis and knew I, and you, my audience, would be interested, so he brought it to my attention (Litell JM, Guirgis F, et. al., Most emergency department patients meeting sepsis criteria are not diagnosed with sepsis at discharge, Acad Emerg Med, April 2021, Vol. 28, Issue 7, p. 745-752.

The background for this is that SEP-1, the Centers for Medicare & Medicaid Services (CMS) core bundle measures for sepsis, has a data element called Crystalloid Fluid Administration. It mandates that a certain volume of crystalloid fluids (e.g., normal saline, lactated Ringer’s solution) be given within a specified time frame. Through the end of 2021, the volume is specified as 30 mL/kg. The average 75-kg patient demands more than two liters of fluid. There is no dispensation for receiving fluids as colloids although pre-arrival fluids can be counted.

Many providers, Ron and I included, worry that this large volume could be detrimental in certain kinds of patients such as the elderly, patients with heart failure, and patients with renal failure. To avoid falling out of core measures, the concern is that a practitioner can push a patient into an exacerbation of heart failure or fluid overload. The prime directive in medicine is: Primum non nocere – do no harm. This leaves the prudent clinician in a quandary. Should you give fluids to treat possible sepsis and meet your core measures but possibly harm the patient in doing so? Just because CMS arbitrarily mandates 30 cc/kg?

As noted above, the article was published in the Academic Emergency Medicine journal in April by Litell et. al. and is titled, “Most emergency department patients meeting sepsis criteria are not diagnosed with sepsis at discharge.” The objective was to determine what proportion of patients triggering sepsis urgent treatment protocols on presentation ultimately were diagnosed definitively with sepsis. Some of these patients were deemed to be potentially at risk from harm from fluid resuscitation.

Their results showed, overall, 60-75 percent of ED patients meeting Sepsis-3 criteria did not receive a sepsis diagnosis at discharge. However, 19-36 percent of patients had “at least one plausible risk factor for harm from large-volume fluid resuscitation.”

I am supportive of screening in the ED and diagnosing uncertain sepsis early on. I posit it is better to preliminarily consider it and rule it out over the course of time than miss the diagnosis and have a patient die because you didn’t consider it. Casting a wide net will result in a high number of “false positives” on final analysis.

It also should be noted that even though those patients had a theoretical risk factor, the study did not investigate whether there was actual harm incurred. Let’s presume that sometimes the risk does translate into morbidity, potentially even mortality. It would be desirable to minimize the risk.

Many providers and institutions seem to be unaware that this is not a mutually exclusive situation. There is a current loophole which I pose as a potential solution. The patient or their authorized advocate is permitted to refuse IV fluid administration, thereby invoking a SEP-1 exclusion, the administrative contraindication to care. But how would they know to do this? I, as the provider, would do shared decision making with them informing them that there may be a risk due to their precarious heart or kidney failure and letting them know they had the option to decline the fluids. I would then dutifully document it.

However, the Centers for Medicare & Medicaid Services (CMS) has responded to providers’ concerns, and the Specifications Manual for National Hospital Inpatient Quality Measures for the first and second quarters of 2022 has been modified. They have added the clause “or a lesser volume with a reason for the lesser volume specifically documented by the physician/APN/PA” to the Crystalloid Fluid Administration requirement. After Jan. 1, 2022, if the clinician feels that 30 mL/kg would be excessive, they only need to document the volume they are giving and the reason why they are not giving the recommended amount.

Additionally, I discovered that Surviving Sepsis Campaign (SSC-the originators of Sepsis-2 way back when) has updated their recommendations for best practice sepsis protocol. Details are found in Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021, Critical Care Medicine, November 2021, Vol. 49, Issue 11, p. e1063-e1143. The specifics of the guidelines changes are beyond the scope of this article, but it is necessary for facilities/systems to carefully read them.

Institutions will need to alter their order sets to reflect the change in SEP-1 and per the SSC guidelines. Providers should be educated on how to recognize and diagnose sepsis, how to optimally treat it, and how to document it.

They should suspect sepsis early if there is organ dysfunction but do no harm if there are reasons to avoid large fluid volumes.

Your patient’s life may depend on it.

Programming Note: Listen to Dr. Erica Remer on Talk Ten Tuesdays, 10 Eastern when she co-hosts the broadcast with Chuck Buck.


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