Sepsis 3 Consensus definitions---the impact on quality (part one)

How do you know what you don’t know? That’s the conundrum of the new Sepsis 3 definitions and the impact on measurement of quality outcomes.   As I am quite passionate about this and because there are multiple implications, I will address the subject in two parts.  First, a lesson in statistics. 

I had to take a statistics class in college and scraped by with a basic understanding of why statistics matter and how to fully delve into the data for reliability and validity of measured metrics or results.  The Centers for Disease Control (CDC) requires hospitals to report statistics on certain infectious diseases and additionally obtains statistics on morbidity and mortality from data bases such as MedPar.  The CDC then reports those statistics to the World Health Organization (WHO).  WHO then looks at trends, successes and failures on a global level and reports them.  The problem is in the data of course.  We in the United States have used our own criteria and definitions for many diseases and conditions---sepsis is no exception.  How can there be an adequate global comparison of incidence, morbidity and mortality when different sets of criteria are utilized around the world?

In an effort to provide standardized definitions, and more importantly, treatment protocols, the Third International Sepsis Consensus was called in February 2016 and resulted in standard definitions of sepsis and septic shock. I am sure most of you are aware that many quality and health information management professionals have problems with the definitions, including the following: 

• Per the Sepsis 3 criteria, a patient isn’t considered septic until there is associated organ failure or shock
• Codes for sepsis and septic shock were provided as a reference in the published paper which, per Coding Guidelines, would not be assigned as principal diagnosis
• These definitions do not align with existing definitions utilized in current quality metrics

I will leave the discussion to those more expert than myself as to whether or not the definitions published by the Third International Sepsis Consensus are clinically correct.  However, I would like to note the following:

• Our current quality metrics are derived using definitions established prior to the Sepsis Consensus meeting
• When tracking longitudinal outcomes, it becomes increasingly difficult to trend (or interpret trends) when you change the definition mid-stream. In other words, how can your organization know how well it’s doing at reducing total incidence of sepsis when the rates may be fluctuating---not based on actual patient volumes and outcomes, but based on definitions?
• How will an organization be able to identify success in meeting treatment protocol requirements for septic patients when the number of "patients" being treated swings widely based on whatever criteria is deemed best?

If I were Queen for a Day, I would make the following suggestions/changes:

• Place a moratorium on penalties and/or reporting until a period of time so that the retrospective data collection would only incorporate one set of criteria
• Establish a U.S. set of standard definitions to be used by all parties to provide real, meaningful data on performance and incidence

Next time we will talk about the specific metrics affected by the Sepsis 3 Consensus definitions.

Cheryl Manchenton is a senior inpatient consultant and project manager for 3M Health Information Systems.