The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)¹ published in February 2016 in the Journal of the American Medical Association represents a radical departure from the prior sepsis definitions in 1991² (identified as Sepsis-1) and 2001³ (identified as Sepsis-2) and subsequent Surviving Sepsis Campaign (SSC) guidelines through 2015⁴ ⁵.
Noting “inadequate specificity and sensitivity of the systemic inflammatory response syndrome (SIRS) criteria”, the new definitions discard the concept of sepsis as SIRS due to infection which has been the diagnostic standard for the last 25 years.
The Sepsis-3 consensus concludes that the new definitions “should replace previous definitions” (without specifically stating that they “do” replace them) and that the process “remains a work in progress.” How will other professional societies, the medical community in general, payers and regulatory agencies respond to this radical change? Is it definitive or subject to comment and change? Could or should clinicians using their clinical judgment and the CDI team have the discretion to continue using Sepsis-2 criteria while awaiting the healthcare community’s reaction to this new definition? All of this will play out in the real world setting of everyday medical practice, and only time will tell.
The New Sepsis Criteria: Sepsis-3 defines sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection [suspected or confirmed].”
Sequential [Sepsis-related] Organ Failure Assessment Score (SOFA) is used to define organ dysfunction as an increase in the total SOFA score of 2 points or more. The SOFA requirement is met by a minimum of 1 point increase in at least 2 organ systems or by a 2 point increase (or more) in a single organ system. With SOFA, the function of six organ systems is graded on a scale of 0 to 4 depending on the degree of dysfunction using objective measurements. Zero represents normal function. For each organ system, the baseline SOFA score is assumed to be 0 in patients who don’t have preexisting organ dysfunction.
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|Organ system||Objective measurement||Points|
|Respiration||PaO2/FIO21||> 400||< 400||< 300||< 200 with resp support||< 100 with resp support|
|Coagulation||Platelet count||> 150,000||< 150,000||< 100,000||< 50,000||< 20,000|
|Liver||Bilirubin (mg/dL)||< 1.2||1.2-1.9||2.0-5.9||6.0-11.9||>12.0|
|Cardiovascular2||MAP (mmHg) or
|MAP > 70||MAP < 70||DPA < 5||DPA 5.1-15||DPA >15|
|CNS||Glasgow Coma Scale Score||15||13-14||10-12||6-9||3-6|
|Renal||Creatinine (mg/dL) or urine output||
1.2 – 1.9
1 P/F Ratio. 2 MAP = mean arterial pressure; DPA = dopamine in mcg/kg/min for > 1 hour; includes vasopressors other than dopamine.
A 76 year old woman who has no prior history of kidney disease, dementia or other mental impairment is admitted for UTI, AKI with creatinine of 1.4 and altered mental status. A Glasgow Coma Scale score is done totaling 13. It is presumed that her renal and CNS baseline states are normal (SOFA scores = 0). She therefore has sepsis due to UTI since she now has a SOFA score of 1 in the renal and CNS categories for a total SOFA score of 2 points.
Quick SOFA (qSOFA) is a bedside clinical approach used to identify patients who are likely to have a prolonged ICU stay or die in the hospital, but it does not substitute for SOFA for defining organ dysfunction. It is defined as the presence of two or more of three clinical criteria: (1) altered mentation (GCS < 15), (2) respiratory rate > 22, and (3) systolic blood pressure < 100 mmHg.
Update: In a special article published in October 2021, the Surviving Sepsis Campaign strongly recommends against using qSOFA as a screening tool compared with SIRS criteria, which have been shown to be a more accurate predictor of likely sepsis.
The new definition of septic shock is quite strict: “persisting hypotension requiring vasopressors to maintain MAP [mean arterial pressure] > 65 mmHg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation.” The requirement for both vasopressor-sustained MAP and an elevated lactate level seems extreme and inconsistent with other concepts and definitions of shock states.
Sepsis-3 states that “the term severe sepsis was redundant” indicating that sepsis without organ dysfunction does not exist. It appears that all cases of sepsis could now be considered severe sepsis having organ dysfunction; there would no longer be any cases of sepsis without organ dysfunction.
Unfortunately the Sepsis-3 definitions are inconsistent with the ICD-10-CM Official Guidelines for Coding and Reporting (OCG) which do distinguish between sepsis without organ dysfunction and sepsis with organ dysfunction.
Sepsis-3 also makes erroneous recommendations for the “primary” codes to be used pursuant to the new definitions in the United States, identifying code R65.20 for “sepsis” and R65.21 for “septic shock”. Here we use ICD-10-CM, a modified version of the international ICD-10, and these codes are not “primary” sepsis codes at all. ICD-10-CM and the OCG require a primary code for sepsis (e.g., A41.9, unspecified organism or B37.7, candida sepsis) be sequenced first followed by code R65.20 for severe sepsis (sepsis with organ dysfunction) without septic shock if present, or R65.21 when septic shock is identified.
Based on Sepsis-3, it appears that acute organ dysfunction is intrinsically associated with sepsis because organ dysfunction is a necessary prerequisite for the diagnosis of sepsis. According to Sepsis-3, sepsis cannot be a valid diagnosis without organ dysfunction caused by an infection. If organ failure (dysfunction) as defined by SOFA is documented in the record as well as sepsis, it therefore must be “associated with” sepsis.
How does this new sepsis definition impact the Surviving Sepsis Campaign (SSC) guidelines and quality reporting of sepsis? The 2012 SSC guidelines reaffirm and utilize the 2001 Sepsis-2 definitions. On March 1, 2016, SSC released its response to Sepsis-3⁶ stating that “screening for early identification and treatment of patients with sepsis (formerly called severe sepsis) should continue essentially as has been previously recommended by SSC.” Commenting on severe sepsis it says: “sepsis (formerly called severe sepsis) should still be identified by the same organ dysfunction criteria”, but adds that SOFA criteria and the qSOFA screen can also be used to identify patients with severe sepsis for initiation of treatment.
The CMS Hospital Inpatient Quality Reporting (Hospital IQR) program gives hospitals a financial incentive to report the quality of their services. Hospitals that do not successfully report IQR measures are financially penalized. One of these is a sepsis measure that utilizes the National Quality Forum (NQF) Severe Sepsis and Septic Shock management bundle (NQF #0500). It defines sepsis as 2 or more of 4 SIRS criteria (temperature, heart rate, respiratory rate and WBC) from the Sepsis-2 definition. Severe sepsis is defined as SIRS (sepsis) and the presence of sepsis-induced organ dysfunction defined by the 2012 SSC guidelines based on Sepsis-2.
Following the new Sepsis-3 definitions alone will leave the expectations and practices for national coding and reporting requirements unmet. The national healthcare database will become inconsistent disrupting research, quality reporting and national healthcare trends and planning. Even sepsis screening, early identification and treatment that are the hallmarks of SSC may be impaired.
Of course ICD-10-CM and the OCG can be modified on October 1 each year, and this may very well happen, and we may eventually see corresponding changes from SSC, NQF and the IQR program. It appears likely that following both the old Sepsis-2 and new Sepsis-3 definition may be necessary to accommodate these critical conflicts for now. Until such time when clear and consistent guidance is available, providers and institutions must make serious decisions about diagnosis, documentation, sepsis management guidelines, quality reporting and coding.
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