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Risk assessment Risk management is crucial to promoting safer healthcare and proactively identifying, prioritizing, and mitigating patient safety risk. Many national organizations recognize that conducting a baseline alarm assessment to understand current needs and conditions contributing to alarm fatigue is an important step in alarm management. For example, the AAMI Foundation recommends engaging a multidisciplinary team to prepare an alarm inventory risk analysis and gap analysis that identifies patient safety vulnerabilities that could be amenable to change. 35 An additional element is to identify the most important alarm signals to manage based on: input from the medical staff and clinical departments; risk to patients if the alarm signal is not attended to or if it malfunctions; whether specific alarm signals are needed or unnecessarily contribute to alarm noise and alarm fatigue; potential for patient harm based on internal incident history; and published best practicesand guidelines. Conducting an alarm risk assessment can include evaluating medical devices and computer systems, including the default alarm settings; assessing patient satisfaction (e.g., sleep interruption from nuisance alarms); and assessing the physical environment to determine whether clinically significant alarm signals are audible to staff. In addition, healthcare settings may use data from event reporting systems to identify actual or near-miss harm reported by staff as a method of risk assessment. Conclusions about alarm fatigue The two PSPs reviewed in this section aim to address alarm fatigue by implementing hospital- or unit- wide initiatives to target nonactionable, nuisance alarms and decrease overall alarm burden. The review of evidence shows that implementing elements of safety culture can lead to a decrease in the total number of alarms, number of false alarms, and overall alarm noise level; however, since these initiatives often involve multiple components, it is difficult to know which intervention(s) have the greatest impact. The evidence also shows moderately strong support for conducting risk assessments to understand the current state of alarm management and identify which alarms are the greatest contributors to alarm fatigue. The results of these risk assessments should be used to inform the implementation of processes for safe alarm management and priorities for adoption of alarm technology. Investing in training and education for care providers on new technology as well as ensuring buy-in at all levels and engaging multidisciplinary teams are key to effectively implementing these strategies to reduce alarm fatigue. Sepsis recognition Sepsis has been a leading cause of hospitalization and death in U.S. healthcare settings for many years, and accounts for more hospital admissions and spending than any other condition.

As a result, preventing, diagnosing, and treating sepsis effectively has been a focus of patient safety and public health in recent years. This section discusses two patient safety practices that aim to identify signs of sepsis and septic shock as quickly as possible so that treatment can be started: manual screening tools and electronic patient monitoring systems (PMSs). Screening tools are manually administered paper or electronic forms that guide clinicians through a set of criteria as they are assessing a patient. The screening process is administered either at a care transition (e.g., presentation at the emergency department [ED] or to emergency medical services [EMS]) or at regular intervals (e.g., the start of every nursing shift). Current evidence indicates that performance (sensitivity/ specificity) of the tools varies, especially in the prehospital setting. Evidence for process measure improvement (i.e., time to initiation of treatment) was of moderate strength in both the hospital and prehospital setting. Evidence for outcome measure improvement was sparse but showed a trend toward improvement. More high-quality studies are needed in diverse settings to test the effects of sepsis screening tools. Automated systems continuously monitor patient status, such as vital signs, and alert a clinician if criteria for possible sepsis are met. These systems are becoming more widespread, especially in hospitals, which have sophisticated technology infrastructures. While the studies were inconsistent, there appears to be evidence of moderate strength in the current literature for improvement in both process and outcome measures for PMSs. More high-quality studies are needed to confirm these findings, and to identify implementation best practices and lessons learned. Background Sepsis is a syndrome of life-threatening organ dysfunction due to a person’s systemic dysregulated response to infection. Sepsis can be caused by many types of infection (bacterial, fungal, and viral) and can affect any age group, from neonatal to geriatric. It is a common reason for hospital admission and readmission, with an estimated incidence of 6 percent of all hospital admissions, or more than 1 million admissions in the United States every year. 36 Sepsis also has one of the highest mortality rates of any hospital condition, estimated at 15–30 percent. Tracking incidence and mortality over time is challenging due to shifting definitions and an increasing awareness of sepsis. Some studies show an increase in incidence and a decrease in mortality in recent years, but some show no significant change in either. Among subgroups, older adults and nursing home residents are much more likely to develop and die from sepsis compared with younger adults and non-nursing home residents. In 2013, $24 billion was spent treating sepsis, more than any other condition treated in U.S. hospitals. 37 The symptoms of sepsis (e.g., high temperature, high blood pressure) are shared by many other conditions, making sepsis difficult to

diagnose, especially in the early stages. In addition, sepsis can start suddenly and quickly lead to organ dysfunction and death. In response to this, international organizations such as the Society for Critical Care Medicine have focused on addressing the two problems that sepsis presents: delay in recognition and diagnosis of sepsis, and delay in start of treatment, which combined contribute to the high mortality rate for sepsis. The need for early recognition and rapid treatment have led to guidelines about how to treat septic patients, with aggressive interventions and timeframes. The most commonly adopted of these is the Surviving Sepsis Campaign (SSC) bundle, which has gone through many iterations, and includes starting broad-spectrum antibiotics and intravenous (IV) fluids, and obtaining blood culture and lactate measurements within a 1- to 6-hour timeframe. 38 Many government agencies across the world have proposed measuring and evaluating hospital compliance to strongly encourage its use. Most notably, since October 2015, the Centers for Medicare & Medicaid Services requires U.S. hospitals to report their performance on a composite process-of-care measure for severe sepsis and septic shock, and ties reimbursement to the measure results. There is occasionally tension between the goals of antibiotic stewardship and sepsis guidelines, with the former focused on reducing inappropriate use of broad-spectrum antibiotics, and the latter requiring rapid and barrier-free initiation of broad-spectrum antibiotics. Clinicians sometimes perceive antibiotic stewardship goals as being purely restrictive, thereby creating tension in decisions about antibiotics; however, good antibiotic stewardship encompasses appropriate administration of antibiotics, including when there is clinical suspicion for severe sepsis or septic shock. In addition, many clinicians have apprehension about the IV fluid level due to the risk of fluid overload. The need to diagnose sepsis unambiguously and quickly has led to development of various diagnostic criteria. The signs and thresholds used in these criteria vary but always include at least one vital sign with abnormal thresholds (heart rate [HR], respiratory rate [RR], blood pressure [BP], temperature, etc.), and sometimes include clinical assessments (mental status, suspicion of infection) and laboratory results (lactate, creatinine). The most commonly used criteria are the qSOFA (quick Sequential Organ Failure Assessment), the NEWS (National Early Warning Score), and the increasingly abandoned SIRS (systemic inflammatory response syndrome) criteria. Sepsis screening tools Identifying signs of sepsis as early as possible is critical to averting organ failure and risk of death. However, sepsis does not have a simple diagnostic test or specific symptoms that unambiguously indicate onset. International organizations have developed diagnostic criteria and have recommended screening patients at risk of sepsis using these criteria.

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