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47 Executive Briefing Sponsored by: Improving the Quality, Outcomes and Economics for Sepsis Management S epsis — one of the most deadly and costly conditions at hospitals — remains a widespread problem, but hospitals and health systems across the nation are improving sepsis management through earlier detection and more rapid treatment. Sepsis is the body's extreme response to an infection characterized by systemic inflammatory response. It is a life- threatening condition that affects more than 1 million U.S. patients each year. The incidence of sepsis is high because almost any infection can lead to sepsis, and anyone can get an infection. Sepsis was present in 6 percent of hospitalizations from 2009 to 2014, according to a study published in JAMA in 2017. Although common, the fast-moving illness is extremely difficult to diagnose. Infections in the respiratory, genitourinary and gastrointestinal systems, as well as the skin and soft tissue, are often linked with sepsis, and the clinical presentation of sepsis varies depending on the site of the infection. It can cause a variety of symptoms, including high heart rate, clammy or sweaty skin, confusion, shortness of breath, and fever or shivering. Without timely treatment, sepsis can cause tissue damage, organ failure and death. About 250,000 Americans die from sepsis each year, and it is the leading cause of death in hospitals annually. According to the JAMA study, roughly 15 percent of in-hospital deaths are attributable to sepsis. Sepsis is a major threat to patients' health, but it can also take a toll on a hospital or health system's finances. Sepsis accounts for $23.6 billion in combined costs each year for hospitals across the nation, making it the most expensive condition treated in hospitals, according to a 2016 report from the Healthcare Cost and Utilization Project and the Agency for Healthcare Research and Quality. Challenges in the management of sepsis To understand how to improve sepsis management, it is important to first understand how sepsis is traditionally diagnosed and treated. Most sepsis cases are due to bacterial infections, but some are due to fungal infections. There are more than 100 drugs available to treat sepsis, but effective treatment requires first knowing if the patient has a bacterial or fungal infection and then pinpointing the species of bacteria or fungus. For the last 90 years, a blood culture was the only means available to detect the presence of bacteria or fungi in the blood. It can take several days to receive results from a blood culture, as the bacteria or fungi must grow to sufficient numbers before they can be detected or identified. "The reason why blood culture has been the only way to identify species [of bacteria or fungi] is that when patients are sick they typically have somewhere between one and 25 cells of the pathogen per milliliter of blood in their blood stream, and there has been no diagnostic that can detect at that low concentration," said John McDonough, president and CEO of T2 Biosystems, an emerging leader in the field of in vitro diagnostics. While hospitals wait for blood culture results, physicians examine a patient's symptoms to make an educated guess as to what drugs to give the patient. "They'll give a drug to a patient, and 12 to 24 hours later if the patient is not responding they switch, and then they sometimes switch again," said Mr. McDonough. Clinicians play this guessing game because they know every minute counts when treating serious blood infections. In patients with sepsis, each hour of delayed targeted treatment increases the risk of mortality by 8 percent. However, treating patients with the wrong drugs can lead to a new problem: antimicrobial resistance. When microorganisms, such as bacteria or fungi, develop antimicrobial resistance, medicines become ineffective, increasing the risk of spreading infections to others. Blood cultures can also fail to detect infections because they are dependent upon cell growth, which only occurs 50 to 60 percent of the time, according to Mr. McDonough. How hospitals and health systems can improve sepsis management To avoid relying on guesswork in the identification and treatment of sepsis, hospitals and health systems across the nation are using the T2Candida Panel, an FDA-cleared test for the detection of Candida, one of the deadliest sepsis-causing pathogens. T2Candida is the only FDA-cleared product that can identify sepsis-causing pathogens directly from blood without the need for blood culture. T2Candida can detect these pathogens at concentration levels as low as one cell of the pathogen per milliliter of blood, and test results are available in three to five hours. Because the test is not dependent on growing cells through a culturing process, it can detect infections completely missed by a blood culture. This allows provider organizations to begin targeted treatment sooner.