Understanding the New SEP-1 Sepsis Rollout

Dear Director: I heard that there is a new core measure related to sepsis that will “go live” on October 1st. My hospital VP of quality wants to set up a series of meetings over the next few months to plan for the measure. I feel like we already provide good sepsis care. Do I really need to attend all these meetings?

Unlike some other core measures, where CMS makes a decision to track and publicly report in a rapid fashion, this measure has been in the works for several years. Even so, since the Rivers article came out in 2001, controversy over the sepsis bundle and in particular the central venous line (CVL) intervention, has lingered – and recent evidence has prompted rethinking this bundle yet again.

In 2007, my wife had sepsis secondary to pneumonia and was in the ICU. I remember thinking there was no need for a CVL. After she was safely discharged and recovered, I discussed her need for a CVL with an academic intensivist who didn’t share the same views as me on the risk versus benefit of a CVL in my wife’s case. Thankfully, she did fine without the line. Although the sepsis measure was supposed to go live this past January 1st, over the years, the discussion regarding the mandatory use of central lines continued, postponing CMS’s decision to go live with this measure. Additional studies were published (ProCESS and ARISE) which provided evidence that CVL placement was not an essential component of the sepsis “bundle.” Based on these studies, the National Quality Forum recommended the draft measure be revised. CMS accepted this recommendation and the measure will now go live on October 1st without the central line requirement. The new measure is called the Severe Sepsis/Septic Shock Early Management Bundle (SEP-1).

How this measure is different
Compared to previous ED core measures, SEP-1 is more complicated, requires more teamwork, and has the potential to more significantly impact patient outcomes.

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This is not like the ED core measures of the past, such as the percentage of patients that receive ASA in MI, or receive blood cultures prior to pneumonia treatment. Shortly after I started as a chairman, nearly all hospitals exceeded a 99% success rate with these measures and they were retired. SEP-1 is by far the most complicated one I’ve had to be involved with. To give you some idea, the CMS “specifications manual” that describes the parameters of the measure is 63 pages long. The chances are your hospital quality team is still developing a solid understanding of the measure. Here are some of the highlights.

The definition of severe sepsis provided by SEP-1 is fairly standard. You need to have a suspected source of infection, 2 SIRS criteria, and evidence of end-organ dysfunction. The definition of septic shock is a bit more tricky. The measure defines this as an initial lactate greater than or equal to 4 OR evidence of hypotension documented in the first hour following the completion of a 30 cc/kg IVF bolus.

Another key concept introduced by the measure is that of “time of presentation.” Unlike most other timed ED core measures in which the clock starts upon patient arrival to the ED, for this measure, the clock starts when the patient meets criteria for either severe sepsis or septic shock. Because the patient might meet both of these criteria during their ED stay, there are potentially “two clocks” running for this measure.

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The measure spells out what is required for both severe sepsis and septic shock. For severe sepsis, you have 3 hours from time of presentation to draw a lactate, send blood cultures, and start broad-spectrum antibiotics. Within 6 hours, the lactate needs to be repeated if it was initially 2 or greater. For septic shock, you have three hours to start a 30 cc/kg IVF bolus and 6 hours to start vasopressors and to perform a “volume status and tissue perfusion assessment.” This can be performed using a central line but also can be performed using ultrasound or even a focused physical exam.

Exclusion criteria for this measure are also described in fine detail. The patient is excluded if “comfort care” is ordered for the patient within 3 hours of time of presentation of severe sepsis and 6 hours of septic shock. The patient is also excluded if he/she expires within 3 hours of severe sepsis or 6 hours of septic shock. Transfers from outside hospitals and emergency departments are excluded. Lastly, patients are excluded if they refuse any component of the recommended care. Of course, all of these potential exclusions need to be appropriately documented.

Emergency physicians are definitely team players. We show this by sitting on STEMI and Stroke Committees where multiple disciplines work together to coordinate care and to improve outcomes. That same mentality will be needed again because SEP-1 will not only require cooperation with our hospitalist and intensivist colleagues, but will also require infectious disease input for antibiotic guidance, nursing cooperation for handoffs between the ED, floor, and ICU, and also teamwork from the lab and even IT as alerts and EMR phrases are standardized. At my current hospital, over the last couple of years, the ED has taken responsibility for the first 3 hour bundle and the ICU team has taken responsibility for the 6 hour bundle. I have pretty much been able to only look at the ED data—fluid resuscitation, blood cultures and lactic acid obtained, and antibiotic administration. However, going forward, there will be no partial credit for completing some of the measure. Given the 6 hour requirements, we’ll all need to have more effective handoffs regarding what’s been done and what’s next to be done to complete the measure. This will require (likely written) clarification of who is responsible for the next portion of the bundle. This measure is also a bit unique in that in includes patients who develop sepsis anywhere in the hospital, not just the ED. Like in the ED, the clock will start for inpatients when criteria for either severe sepsis or septic shock are met, although it will likely be more challenging to complete the 3 and 6 hour bundles in these patients. Bottom line, 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.

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Unlike some of the other measures that the ED is part of, SEP-1 has the potential to make a real impact on mortality, morbidity, and hospital length-of-stay. At my community ED, we have about 10 STEMI’s a month, but we admit around 30 septic patients a month. I went into emergency medicine to save lives but most of the glory goes to the specialists who manage the patient in the hospital. We identify the STEMI and while I used to be the one to administer the thrombolytics, now the patient leaves the ED in minutes and goes to the cath lab. While we may intubate the respiratory failure patient, it’s really the intensivist who the patient comes back to thank for returning them to health. But if you believe most of the data on sepsis and early goal directed therapy (EGDT), these patients represent a huge opportunity for us to make a life-saving difference during the first few hours of care that the patient receives. And while these patients may not come back to thank us, at least we’ll know we’re making a critical difference in the outcomes. While you’ve likely been working on some aspects of sepsis care over the last several years, chances are that your hospital’s sepsis can be still improve.

Key ED Interventions Shown to Improve Sepsis Care
There are some hospitals that have demonstrated best practices for improving sepsis care. The first is an ED screening tool, typically done as part of the triage process. If a patient meets certain criteria, the next step is a notification system. Who gets notified is debatable but at the very least it should likely be the charge nurse and a physician. Some hospitals are having hospital wide alerts go out that notify phlebotomy, the ICU, and administration. Once the patient is identified, the doc should be ordering from an order set. This is the best way to insure that the critical orders are performed, including the 30 cc/kg IV fluid bolus, the lactic acid and blood cultures, and the appropriate antibiotic (if necessary). If you don’t already have a best practice antibiotic guide for your hospital that you jointly developed with your infectious disease physicians, now’s the time to get everyone on the same page. Just like we have Q/A forms that track the steps of the STEMI or stroke patient, it’s likely that we’ll have a checklist to track all of the necessary steps in managing the sepsis patient.

Takeaway Points
You will definitely need to keep those dates on your calendar. In fact, you’ll probably need to schedule more meetings for in between to make sure that the docs and the nurses are on the same page and also on the same page as the ICU team. Your Sepsis Committee should be meeting on a regular basis to get into the weeds of the measure and to make sure everyone is on the same page as your quality team. Some of the documentation can be built into your EMR so get working on it now so you’re ready by October. Since we all want our hospital leadership team to appreciate and value the work that we do, this is a high profile measure that presents a great opportunity to show your leadership within the hospital. Finally, be reassured that work on this measure can make a real impact on patient care.

The Economics of Sepsis
SEP-1 has the potential to save lives, but it also decreases hospital length of stay, improving the bottom line. Here are some important numbers to understand in the economics of Sepsis:

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• $20.3 Billion: Sepsis was the most expensive condition treated in U.S. hospitals in 2011, at an aggregate cost of $20.3 billion.
• 1.1 million: Number of sepsis hospitalizations in 2011.
• 4x: Costs for sepsis hospital stays more than quadrupled since 1997, with an 11.5 percent annual increase
• Medicare: By payer, sepsis was the most costly condition billed to Medicare, the second-most costly billed to Medicaid and the uninsured, and the fourth-most costly billed to private insurance.
• 25.7 million: The value of the sepsis-specific treatment space across the US, France, Germany, Italy, Spain, and the UK in 2016, according to GlobalData.