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Adapting to the CMS Sepsis Bundle

News  |  By Sandra Gittlen  
   April 07, 2016

Although many healthcare leaders applaud the attention CMS is bringing to this deadly condition, some are finding the highly prescriptive measures too constricting.

This article first appeared in the April 2016 issue of HealthLeaders magazine.

In the wake of the October 2015 release of the Centers for Medicare & Medicaid Services' sepsis management bundle, health systems are reviewing their sepsis identification and treatment approaches. And although many healthcare leaders applaud the attention CMS is bringing to this deadly condition, some are finding the highly prescriptive measures too constricting.

"The CMS bundle takes a little bit of the art of medicine out of the hands of the physician," says Nirav G. Shah, MD, FCCP, and director of the pulmonary and critical care fellowship program at the University of Maryland Medical Center, the flagship academic medical center of the 12-hospital University of Maryland Medical System.

Shah has closely studied sepsis and shared his expertise by discussing this topic as part of his grand rounds at his hospital and surrounding hospitals in Baltimore.

He supports the intent of the CMS bundle, though, which is to create a sense of urgency to address the condition.

Sepsis, according to the Centers for Disease Control and Prevention, is the body's overwhelming and life-threatening response to an infection, which can lead to tissue damage, organ failure, and death. There are more than 1 million cases of sepsis each year, and it kills more than 258,000 Americans annually. Sepsis is the primary cause of death from infection and is one of the leading causes of death in intensive care units.

CMS' sepsis management bundle concentrates heavily on treatment and reporting for the first three and six hours—time frames known to be critical in controlling the outcome. Researchers have found that each hour of delay in administering antibiotics results in an average decrease in survival of 7.6%.

Closely aligned with bundles from the Surviving Sepsis Campaign and the National Quality Forum, the CMS bundle requires detailed reporting on diagnosis, fluids, antibiotics, monitoring, outcomes, and more.

Craig Coopersmith, MD, FACS, FCCM, and associate director for the Emory Critical Care Center at Emory University School of Medicine, calls the agency's prescriptive bundle "absolutely fantastic" because it promotes "earlier recognition and earlier treatment."

If healthcare systems follow the bundle, "they will save thousands of lives," he says, adding that mortality isn't the only issue with sepsis; speed in diagnosis and treatment is also essential to avoid long-term cognitive issues, lengthy hospital stays, and readmissions.

"The medical profession is actually recognizing that sepsis exists and that it is a medical emergency on par with heart attacks, strokes, and gunshot wounds," says Coopersmith, who sees a tremendous number of patients with sepsis who come into the intensive care unit from the emergency department and the patient floors at Emory University Hospital, a part of the Emory Healthcare Network, the Atlanta-based network that includes six hospitals, 200 provider locations, and 1,800 physicians.

A member of the steering committee of the Surviving Sepsis Campaign and immediate past president of the Society of Critical Care Medicine, Coopersmith says what Emory faces in terms of sepsis is "representative of every medical center around the world."

But as some healthcare leaders, including the University of Maryland Medical Center's Shah, dig deeper into the CMS bundle, they are finding the measures to be too prescriptive and somewhat at odds with their existing sepsis protocols.

For instance, ahead of the CMS bundle, many at the University of Maryland Medical Center used PlasmaLyte as its preferred fluid to administer to sepsis patients. The CMS bundle, however, prescribes normal saline or Lactated Ringer's solution.

"If we don't use those specific solutions, then we don't meet the CMS checklist and it will impact reporting," Shah says. Not following the bundle to the letter also could affect reimbursement if that follows the reporting measures.

Shah says that while using the CMS core measures doesn't impact care, the stringent nature "leaves a bad taste" with physicians.

He says he worries that the trigger for the CMS bundle—systemic inflammatory response syndrome (SIRS)—is not always sepsis and, therefore, broad-spectrum antibiotics might not be the appropriate response. There has to be room, he says, for physicians to make the sepsis diagnosis.

To help support the monitoring and reporting aspects of the sepsis bundle and to evoke early goal-directed therapy, the University of Maryland Medical Center implemented a critical care consult service that operates from 7 a.m. to 5 p.m. If a patient is thought to be septic, the medical staff can page the consult service and an attending physician, fellow, and other skilled clinicians will assess the situation.

"They determine the patient's acute needs, such as whether they require a line for fluids, antibiotics, or vasopressors, and they can start the order set with the pharmacy," Shah says. The consult service also can coordinate with the intensive care unit to ensure proper transition of care, if necessary.

"Sepsis is certainly difficult to diagnose, but we are doing a better job of getting patients plugged into treatment as fast as possible," Shah says.

The power of automation

At South Nassau Communities Hospital, a 455-bed acute care facility in Oceanside, New York, the patient population is older and, therefore, at higher risk for sepsis, according to Ruth Ragusa, RN, senior vice president for quality and care management.

She has found the biggest challenge with sepsis is identification. "When anyone comes in with a fever, elevated heart rate, and other SIRS criteria, there could be many different reasons," she says.

The hospital has programmed algorithms into the electronic medical record system that help alert physicians to certain sepsis cues. "Rather than having to rely on their memory, the EMR offers prompts to alert physicians when they should consider the diagnosis to be sepsis," she says.

Once the diagnosis is made, then the EMR system helps set the CMS bundle protocol in motion, prompting medical teams on each element of the bundle, down to how much, how often, and the type of fluid to administer. The EMR also can automatically bring up the order sets necessary for the bundle.

Sepsis has been on South Nassau Communities Hospital's radar for the past five or six years, but it wasn't until recently that protocols moved from paper to the EMR. When the CMS bundle came out, Ragusa says the hospital was already in substantial compliance with its protocols.

Also, the hospital already was tracking sepsis and reporting on it because of the 2013 New York state law passed in the wake of the 2012 sepsis death of 12-year-old Rory Staunton.

"Everyone is tracking sepsis and reporting on the same measures and steps in the protocol. Each quarter, the state health department sends a report not only on how we're doing but how we're doing against other hospitals in the state," she says.

To hasten care to sepsis patients, the hospital recently adopted several new measures, including embedding phlebotomists in the ED at all times to shorten the turnaround time on necessary blood cultures.

The sooner medical teams get lab results, the sooner patients can move from broad-spectrum to targeted antibiotics, providing good stewardship of these medications. Medical teams also now put two lines into a septic patient instead of one to expedite the delivery of fluids and antibiotics.

Ragusa says hospital staff continues to train on sepsis signs and symptoms to ensure everyone is on the same page and providing timely treatment.

Getting resourceful

At Beaumont Health System's Beaumont Hospital–Royal Oak campus, a tertiary care center with 1,070 beds in Royal Oak, Michigan, having the CMS core measures integrated into the EMR system will assist in fulfilling bundle requirements. However, Paul Bozyk, MD, assistant director of the medical ICU, says physicians still must carefully assess each patient to ensure the core measures match the necessary level of care.

"The CMS core measures are very prescriptive in what they want to see documented," he says. "But many of the things they want documented are binary without a need to explain that's an appropriate next step."

Like Shah, Bozyk says the CMS bundle "leaves little to no room for clinical decision-making."

For instance, if an elderly patient with severe systolic dysfunction were to present as septic, CMS would expect the provider to administer a full fluid treatment. On such a patient, though, the prescribed 30ccs per kilogram may be harmful. Bozyk says his institution's physicians are aware that missing elements on the bundle means the hospital doesn't get credit for treatment and could impact the publicly reported measurement.

"The best physicians may take a hit on CMS measures," he says, emphasizing that the health system must back them up. Physicians must be empowered by the health system to overrule EMR protocol alerts and determine if patients are sick for other reasons, such as complications due to COPD or end-stage renal failure, Bozyk says.

"We can't always assume that SIRS presentation is sepsis," he says. Conversely, it should be clear that just because the core measures have been fulfilled, it doesn't mean the source of infection has been addressed, he says.

Bozyk also is concerned about the ability of health systems to follow the six-hour bundle outside of the critical care units. "Sepsis protocols can be tricky on a medical floor. If you can get fluids, antibiotics, and lactic acid measurements, then you've checked the boxes on the three-hour bundle. But they might not have the resources to handle the six-hour bundle, which requires more intensive care," he says.

At Beaumont, if a noncritical care patient is thought to be septic, nurses can contact a rapid response team to quickly assess patient status and determine if he or she needs to be moved to the medical ICU for close monitoring.

A smaller hospital, he says, might not have layered resources like a rapid response team and, therefore, could wind up with poor scores on reported core measures.

"The resources the bundle requires are significant," he says. Core measures should be based on guidelines without controversy and stick to areas of consensus. "The intention is correct, but the methodology is flawed."

University of Maryland Medical Center's Shah says he has contacted CMS about some of the specifics in the bundle and the organization has agreed to review his concerns, but not until later this year.


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