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The Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) measure has appropriately established sepsis as a national priority. However, the Infectious Diseases Society of America (IDSA and five additional endorsing societies) is concerned about SEP-1's potential to drive antibiotic overuse because it does not account for the high rate of sepsis overdiagnosis and encourages aggressive antibiotics for all patients with possible sepsis, regardless of the certainty of diagnosis or severity of illness. IDSA is also concerned that SEP-1's complex "time zero" definition is not evidence-based and is prone to inter-observer variation. In this position paper, IDSA outlines several recommendations aimed at reducing the risk of unintended consequences of SEP-1 while maintaining focus on its evidence-based elements. IDSA's core recommendation is to limit SEP-1 to septic shock, for which the evidence supporting the benefit of immediate antibiotics is greatest. Prompt empiric antibiotics are often appropriate for suspected sepsis without shock, but IDSA believes there is too much heterogeneity and difficulty defining this population, uncertainty about the presence of infection, and insufficient data on the necessity of immediate antibiotics to support a mandatory treatment standard for all patients in this category. IDSA believes guidance on managing possible sepsis without shock is more appropriate for guidelines that can delineate the strengths and limitations of supporting evidence and allow clinicians discretion in applying specific recommendations to individual patients. Removing sepsis without shock from SEP-1 will mitigate the risk of unnecessary antibiotic prescribing for noninfectious syndromes, simplify data abstraction, increase measure reliability, and focus attention on the population most likely to benefit from immediate empiric broad-spectrum antibiotics. [ABSTRACT FROM AUTHOR]

Background Ceftazidime-avibactam has in vitro activity against some carbapenem-resistant gram-negative infections (GNIs), and therefore may be a useful alternative to more toxic antibiotics such as colistin. Understanding ceftazidime-avibactam uptake and usage patterns would inform hospital formularies, stewardship, and antibiotic development. Methods A retrospective cohort study assessed inpatient encounters in the Vizient database. Ceftazidime-avibactam and colistin administrations were categorized into presumed empiric (3 consecutive days of therapy or less with qualifying exclusions) versus targeted therapy (≥4 consecutive days of therapy) for presumed carbapenem-resistant GNIs. Quarterly percentage change (QPC) using modified Poisson regression and relative change in frequency of targeted ceftazidime-avibactam to colistin encounters was calculated. Factors associated with preferentially receiving targeted ceftazidime-avibactam versus colistin were identified using generalized estimating equations. Results Between 2015 quarter (q) 1 and 2017q4, ceftazidime-avibactam was administered 21 215 times across 1901 encounters. Inpatient prescriptions for ceftazidime-avibactam increased from 0.44/10 000 hospitalizations in 2015q1 to 7.7/10 000 in 2017q4 (QPC, +11%; 95% CI, 10–13%; P <.01), while conversely colistin prescriptions decreased quarterly by 5% (95% CI, 4–6%; P <.01). Ceftazidime-avibactam therapy was categorized as empiric 25% of the time, targeted 65% of the time, and indeterminate 10% of the time. Patients with chronic kidney disease were twice as likely to receive targeted ceftazidime-avibactam versus colistin (RR, 2.02; 95% CI, 1.82–2.25), whereas those on dialysis were less likely to receive ceftazidime-avibactam than colistin (RR, 0.71; 95% CI,.61–.83). Conclusions Since approval in 2015, ceftazidime-avibactam use has grown for presumed carbapenem-resistant GNIs, while colistin has correspondingly declined. Renal function drove the choice between ceftazidime-avibactam and colistin as targeted therapy. [ABSTRACT FROM AUTHOR]

Keywords: care improvement; mandates; quality of care; sepsis EN care improvement mandates quality of care sepsis 890 893 4 05/23/20 20200601 NES 200601 There is no debate that sepsis is a major public health problem that merits the vigorous attention of the medical and public health community. Retrospective analyses of almost 50,000 patients treated for sepsis in New York State and 35,000 patients treated for sepsis in Northern California, for example, reported strong associations between time-to-antibiotics and in-hospital mortality ([2], [3]). In addition, an important part of sepsis quality improvement programs is improving sepsis recognition, diagnosis, and documentation in addition to optimizing care. Patients ultimately deemed to have something other than sepsis are often excluded from sepsis-bundle analyses because most analyses are limited to patients with confirmed sepsis ([2]). [Extracted from the article]

Objectives: Prior studies have reported that hospital-onset sepsis is associated with higher mortality rates than community-onset sepsis. Most studies, however, have used inconsistent case-finding methods and applied limited risk-adjustment for potential confounders. We used consistent sepsis criteria and detailed electronic clinical data to elucidate the epidemiology and mortality associated with hospital-onset sepsis.Design: Retrospective cohort study.Setting: 136 U.S. hospitals in the Cerner HealthFacts dataset.Patients: Adults hospitalized in 2009-2015.Interventions: None.Measurements and Main Results: We identified sepsis using Centers for Disease Control and Prevention Adult Sepsis Event criteria and estimated the risk of in-hospital death for hospital-onset sepsis versus community-onset sepsis using logistic regression models. In patients admitted without community-onset sepsis, we estimated risk of death associated with hospital-onset sepsis using Cox regression models with sepsis as a time-varying covariate. Models were adjusted for baseline characteristics and severity of illness. Among 2.2 million hospitalizations, there were 95,154 sepsis cases: 83,620 (87.9%) community-onset sepsis and 11,534 (12.1%) hospital-onset sepsis (0.5% of hospitalized cohort). Compared to community-onset sepsis, hospital-onset sepsis patients were younger (median 66 vs 68 yr) but had more comorbidities (median Elixhauser score 14 vs 11), higher Sequential Organ Failure Assessment scores (median 4 vs 3), higher ICU admission rates (61% vs 44%), longer hospital length of stay (median 19 vs 8 d), and higher in-hospital mortality (33% vs 17%) (p < 0.001 for all comparisons). On multivariate analysis, hospital-onset sepsis was associated with higher mortality versus community-onset sepsis (odds ratio, 2.1; 95% CI, 2.0-2.2) and patients admitted without sepsis (hazard ratio, 3.0; 95% CI, 2.9-3.2).Conclusions: Hospital-onset sepsis complicated one in 200 hospitalizations and accounted for one in eight sepsis cases, with one in three patients dying in-hospital. Hospital-onset sepsis preferentially afflicted ill patients but even after risk-adjustment, they were twice as likely to die as community-onset sepsis patients; in patients admitted without sepsis, hospital-onset sepsis tripled the risk of death. Hospital-onset sepsis is an important target for surveillance, prevention, and quality improvement initiatives. [ABSTRACT FROM AUTHOR]

Objectives: Administrative claims data are commonly used for sepsis surveillance, research, and quality improvement. However, variations in diagnosis, documentation, and coding practices for sepsis and organ dysfunction may confound efforts to estimate sepsis rates, compare outcomes, and perform risk adjustment. We evaluated hospital variation in the sensitivity of claims data relative to clinical data from electronic health records and its impact on outcome comparisons.Design, Setting, and Patients: Retrospective cohort study of 4.3 million adult encounters at 193 U.S. hospitals in 2013-2014.Interventions: None.Measurements and Main Results: Sepsis was defined using electronic health record-derived clinical indicators of presumed infection (blood culture draws and antibiotic administrations) and concurrent organ dysfunction (vasopressors, mechanical ventilation, doubling in creatinine, doubling in bilirubin to ≥ 2.0 mg/dL, decrease in platelets to < 100 cells/µL, or lactate ≥ 2.0 mmol/L). We compared claims for sepsis prevalence and mortality rates between both methods. All estimates were reliability adjusted to account for random variation using hierarchical logistic regression modeling. The sensitivity of hospitals' claims data was low and variable: median 30% (range, 5-54%) for sepsis, 66% (range, 26-84%) for acute kidney injury, 39% (range, 16-60%) for thrombocytopenia, 36% (range, 29-44%) for hepatic injury, and 66% (range, 29-84%) for shock. Correlation between claims and clinical data was moderate for sepsis prevalence (Pearson coefficient, 0.64) and mortality (0.61). Among hospitals in the lowest sepsis mortality quartile by claims, 46% shifted to higher mortality quartiles using clinical data. Using implicit sepsis criteria based on infection and organ dysfunction codes also yielded major differences versus clinical data.Conclusions: Variation in the accuracy of claims data for identifying sepsis and organ dysfunction limits their use for comparing hospitals' sepsis rates and outcomes. Using objective clinical data may facilitate more meaningful hospital comparisons. [ABSTRACT FROM AUTHOR]

Background Resistance to all first-line antibiotics necessitates the use of less effective or more toxic "reserve" agents. Gram-negative bloodstream infections (GNBSIs) harboring such difficult-to-treat resistance (DTR) may have higher mortality than phenotypes that allow for ≥1 active first-line antibiotic. Methods The Premier Database was analyzed for inpatients with select GNBSIs. DTR was defined as intermediate/resistant in vitro to all ß-lactam categories, including carbapenems and fluoroquinolones. Prevalence and aminoglycoside resistance of DTR episodes were compared with carbapenem-resistant, extended-spectrum cephalosporin-resistant, and fluoroquinolone-resistant episodes using CDC definitions. Predictors of DTR were identified. The adjusted relative risk (aRR) of mortality was examined for DTR, CDC-defined phenotypes susceptible to ≥1 first-line agent, and graded loss of active categories. Results Between 2009–2013, 471 (1%) of 45011 GNBSI episodes at 92 (53.2%) of 173 hospitals exhibited DTR, ranging from 0.04% for Escherichia coli to 18.4% for Acinetobacter baumannii. Among patients with DTR, 79% received parenteral aminoglycosides, tigecycline, or colistin/polymyxin-B; resistance to all aminoglycosides occurred in 33%. Predictors of DTR included urban healthcare and higher baseline illness. Crude mortality for GNBSIs with DTR was 43%; aRR was higher for DTR than for carbapenem-resistant (1.2; 95% confidence interval, 1.0–1.4; P =.02), extended-spectrum cephalosporin-resistant (1.2; 1.1–1.4; P =.001), or fluoroquinolone-resistant (1.2; 1.0–1.4; P =.008) infections. The mortality aRR increased 20% per graded loss of active first-line categories, from 3–5 to 1–2 to 0. Conclusion Nonsusceptibility to first-line antibiotics is associated with decreased survival in GNBSIs. DTR is a simple bedside prognostic measure of treatment-limiting coresistance. [ABSTRACT FROM AUTHOR]

The study includes a full range of sepsis codes, including the codes for septicemia and the sepsis-specific codes for sepsis, severe sepsis, and septic shock introduced in 2002. Finally, 6-month sepsis-associated mortality rates declined over the study period but remained extraordinarily high: approximately 60% for patients with codes for septic shock, 36.4% for severe sepsis, and 30.9% for unspecified sepsis. Notably, the same study documented substantial undercoding for sepsis and an increase in the proportion of sepsis cases that were assigned sepsis codes, rising from 24.9% in 2009 to 30.5% in 2014, thus confirming that sepsis documentation and coding are incomplete but improving. Costs for sepsis hospitalizations decreased, whereas costs for nonsepsis hospitalizations increased. [Extracted from the article]

Background: Reports that septic shock incidence is rising and mortality rates declining may be confounded by improving recognition of sepsis and changing coding practices. We compared trends in septic shock incidence and mortality in academic hospitals using clinical vs claims data.Methods: We identified all patients with concurrent blood cultures, antibiotics, and vasopressors for ≥ two consecutive days, and all patients with International Classification of Diseases, 9th edition (ICD-9) codes for septic shock, at 27 academic hospitals from 2005 to 2014. We compared annual incidence and mortality trends. We reviewed 967 records from three hospitals to estimate the accuracy of each method.Results: Of 6.5 million adult hospitalizations, 99,312 (1.5%) were flagged by clinical criteria, 82,350 (1.3%) by ICD-9 codes, and 44,651 (0.7%) by both. Sensitivity for clinical criteria was higher than claims (74.8% vs 48.3%; P < .01), whereas positive predictive value was comparable (83% vs 89%; P = .23). Septic shock incidence, based on clinical criteria, rose from 12.8 to 18.6 cases per 1,000 hospitalizations (average, 4.9% increase/y; 95% CI, 4.0%-5.9%), while mortality declined from 54.9% to 50.7% (average, 0.6% decline/y; 95% CI, 0.4%-0.8%). In contrast, septic shock incidence, based on ICD-9 codes, increased from 6.7 to 19.3 per 1,000 hospitalizations (19.8% increase/y; 95% CI, 16.6%-20.9%), while mortality decreased from 48.3% to 39.3% (1.2% decline/y; 95% CI, 0.9%-1.6%).Conclusions: A clinical surveillance definition based on concurrent vasopressors, blood cultures, and antibiotics accurately identifies septic shock hospitalizations and suggests that the incidence of patients receiving treatment for septic shock has risen and mortality rates have fallen, but less dramatically than estimated on the basis of ICD-9 codes. [ABSTRACT FROM AUTHOR]

This before-after study examines the association between value-based incentive programs that link financial rewards and penalties to hospital performance on quality indicators and catheter-associated urinary tract infection outcomes in intensive care units (ICUs). [ABSTRACT FROM AUTHOR]

The recent rise in unfilled training positions among infectious diseases (ID) fellowship programs nationwide indicates that ID is declining as a career choice among internal medicine residency graduates. Supplementing ID training with training in critical care medicine (CCM) might be a way to regenerate interest in the specialty. Hands-on patient care and higher salaries are obvious attractions. High infection prevalence and antibiotic resistance in intensive care units, expanding immunosuppressed host populations, and public health crises such as the recent Ebola outbreak underscore the potential synergy of CCM-ID training. Most intensivists receive training in pulmonary medicine and only 1% of current board-certified intensivists are trained in ID. While still small, this cohort of CCM-ID certified physicians has continued to rise over the last 2 decades. ID and CCM program leadership nationwide must recognize these trends and the merits of the CCM-ID combination to facilitate creation of formal dual-training opportunities. [ABSTRACT FROM AUTHOR]

Barbash and colleagues examined SEP-1 implementation and processes of care and risk-adjusted outcomes. The editorialists discuss explanations for why this study identified no association between SEP-1 and better patient outcomes. [ABSTRACT FROM AUTHOR]

The article focuses on regulatory mandates imposed by the U.S. Centers for Disease Control and Prevention (CDC) for the management of sepsis. Topics discussed include the rate of sepsis incidence in the country from 2000 to 2011, a metric for adherence to sepsis protocols, trends in nationwide hospital-discharge diagnoses, and protocols that force the behavior risk of physicians in promoting inappropriate broad-spectrum antibiotic prescription and overuse of invasive catheter.

The author discusses aspects of mandatory norms adopted by Centers for Medicare & Medicaid Services (CMS) for medical reporting of "SEP-1" sepsis management bundle to improve sepsis recognition and medical care. Topic discussed include Broad-spectrum antibiotics, electronic medical record system and Clostridium difficile attributable to unnecessary antibiotics.

Background: Sepsis is the focus of national quality improvement programs and a recent public reporting measure from the Centers for Medicare and Medicaid Services. However, diagnosing sepsis requires interpreting nonspecific signs and can therefore be subjective. We sought to quantify interobserver variability in diagnosing sepsis.Methods: We distributed five case vignettes of patients with suspected or confirmed infection and organ dysfunction to a sample of practicing intensivists. Respondents classified cases as systemic inflammatory response syndrome, sepsis, severe sepsis, septic shock, or none of the above. Interobserver variability was calculated using Fleiss' κ for the five-level classification, and for answers dichotomized as severe sepsis/septic shock versus not-severe sepsis/septic shock and any sepsis category (sepsis, severe sepsis, or septic shock) versus not-sepsis.Results: Ninety-four physicians completed the survey. Most respondents (88%) identified as critical care specialists; other specialties included pulmonology (39%), anesthesia (19%), surgery (9%), and emergency medicine (9%). Respondents had been in practice for a median of 8 years, and 90% practiced at academic hospitals. Almost all respondents (83%) felt strongly or somewhat confident in their ability to apply the traditional consensus sepsis definitions. However, overall interrater agreement in sepsis diagnoses was poor (Fleiss' κ 0.29). When responses were dichotomized into severe sepsis/septic shock versus not-severe sepsis/septic shock or any sepsis category versus not-sepsis, agreement was still poor (Fleiss' κ 0.23 and 0.18, respectively). Seventeen percent of respondents classified one of the five cases as severe sepsis/septic shock, 27.7% rated two cases, 33.0% respondents rated three cases, 19.2% rated four cases, and 3.2% rated all five cases as severe sepsis/septic shock. Among respondents who felt strongly confident in their ability to use sepsis definitions (n = 45), agreement was no better (Fleiss' κ 0.28 for the five-category classification, and Fleiss' κ 0.21 for the dichotomized severe sepsis/septic shock classification). Cases were felt to be extremely or very realistic in 74% of responses; only 3% were deemed unrealistic.Conclusions: Diagnosing sepsis is extremely subjective and variable. Objective criteria and standardized methodology are needed to enhance consistency and comparability in sepsis research, surveillance, benchmarking, and reporting. [ABSTRACT FROM AUTHOR]

The author reflects on the article published within the issue on the national burden of sepsis in the U.S. emergency departments. It mentions delay in antibiotic administration relative to initial Emergency Medical Services (EMS) contact is associated with increased mortality and need of sepsis recognition and rapid antibiotic administration. It also mentions availability of electronic health record and conduct sepsis surveillance.

Background: The prevalence and effects of inappropriate empirical antibiotic therapy for bloodstream infections are unclear. We aimed to establish the population-level burden, predictors, and mortality risk of in-vitro susceptibility-discordant empirical antibiotic therapy among patients with bloodstream infections.Methods: Our retrospective cohort analysis of electronic health record data from 131 hospitals in the USA included patients with suspected-and subsequently confirmed-bloodstream infections who were treated empirically with systemic antibiotics between Jan 1, 2005, and Dec 31, 2014. We included all patients with monomicrobial bacteraemia caused by common bloodstream pathogens who received at least one systemic antibiotic either on the day blood cultures were drawn or the day after, and for whom susceptibility data were available. We calculated the prevalence of discordant empirical antibiotic therapy-which was defined as receiving antibiotics on the day blood culture samples were drawn to which the cultured isolate was not susceptible in vitro-overall and by hospital type by using regression tree analysis. We used generalised estimating equations to identify predictors of receiving discordant empirical antibiotic therapy, and used logistic regression to calculate adjusted odds ratios for the relationship between in-hospital mortality and discordant empirical antibiotic therapy.Findings: 21 608 patients with bloodstream infections received empirical antibiotic therapy on the day of first blood culture collection. Of these patients, 4165 (19%) received discordant empirical antibiotic therapy. Discordant empirical antibiotic therapy was independently associated with increased risk of mortality (adjusted odds ratio 1·46 [95% CI, 1·28-1·66]; p<0·0001), a relationship that was unaffected by the presence or absence of resistance or sepsis or septic shock. Infection with antibiotic-resistant species strongly predicted receiving discordant empirical therapy (adjusted odds ratio 9·09 [95% CI 7·68-10·76]; p<0·0001). Most incidences of discordant empirical antibiotic therapy and associated deaths occurred among patients with bloodstream infections caused by Staphylococcus aureus or Enterobacterales.Interpretation: Approximately one in five patients with bloodstream infections in US hospitals received discordant empirical antibiotic therapy, receipt of which was closely associated with infection with antibiotic-resistant pathogens. Receiving discordant empirical antibiotic therapy was associated with increased odds of mortality overall, even in patients without sepsis. Early identification of bloodstream pathogens and resistance will probably improve population-level outcomes.Funding: US National Institutes of Health, US Centers for Disease Control and Prevention, and US Agency for Healthcare Research and Quality. [ABSTRACT FROM AUTHOR]

Objectives: Observational studies suggest obesity is associated with sepsis survival, but these studies are small, fail to adjust for key confounders, measure body mass index at inconsistent time points, and/or use administrative data to define sepsis. To estimate the relationship between body mass index and sepsis mortality using detailed clinical data for case detection and risk adjustment.Design: Retrospective cohort analysis of a large clinical data repository.Setting: One-hundred thirty-nine hospitals in the United States.Patients: Adult inpatients with sepsis meeting Sepsis-3 criteria.Exposure: Body mass index in six categories: underweight (body mass index < 18.5 kg/m), normal weight (body mass index = 18.5-24.9 kg/m), overweight (body mass index = 25.0-29.9 kg/m), obese class I (body mass index = 30.0-34.9 kg/m), obese class II (body mass index = 35.0-39.9 kg/m), and obese class III (body mass index ≥ 40 kg/m).Measurements: Multivariate logistic regression with generalized estimating equations to estimate the effect of body mass index category on short-term mortality (in-hospital death or discharge to hospice) adjusting for patient, infection, and hospital-level factors. Sensitivity analyses were conducted in subgroups of age, gender, Elixhauser comorbidity index, Sequential Organ Failure Assessment quartiles, bacteremic sepsis, and ICU admission.Main Results: From 2009 to 2015, we identified 55,038 adults with sepsis and assessable body mass index measurements: 6% underweight, 33% normal weight, 28% overweight, and 33% obese. Crude mortality was inversely proportional to body mass index category: underweight (31%), normal weight (24%), overweight (19%), obese class I (16%), obese class II (16%), and obese class III (14%). Compared with normal weight, the adjusted odds ratio (95% CI) of mortality was 1.62 (1.50-1.74) for underweight, 0.73 (0.70-0.77) for overweight, 0.61 (0.57-0.66) for obese class I, 0.61 (0.55-0.67) for obese class II, and 0.65 (0.59-0.71) for obese class III. Results were consistent in sensitivity analyses.Conclusions: In adults with clinically defined sepsis, we demonstrate lower short-term mortality in patients with higher body mass indices compared with those with normal body mass indices (both unadjusted and adjusted analyses) and higher short-term mortality in those with low body mass indices. Understanding how obesity improves survival in sepsis would inform prognostic and therapeutic strategies. [ABSTRACT FROM AUTHOR]

Importance: Little is known about the degree to which suspected sepsis drives broad-spectrum antibiotic use in hospitals, what proportion of antibiotic courses are unnecessarily broad in retrospect, and whether these patterns are changing over time., Objective: To describe trends in empiric broad-spectrum antibiotic use for suspected community-onset sepsis., Design, Setting, and Participants: This cross-sectional study used clinical data from adults admitted to 241 US hospitals in the PINC AI Healthcare Database. Eligible participants were aged 18 years or more and were admitted between 2017 and 2021 with suspected community-onset sepsis, defined by a blood culture draw, lactate measurement, and intravenous antibiotic administration on admission., Exposures: Empiric anti-methicillin-resistant Staphylococcus aureus (MRSA) and/or antipseudomonal β-lactam agent use., Main Outcomes and Measures: Annual rates of empiric anti-MRSA and/or antipseudomonal β-lactam agent use and the proportion that were likely unnecessary in retrospect based on the absence of β-lactam resistant gram-positive or ceftriaxone-resistant gram-negative pathogens from clinical cultures obtained through hospital day 4. Annual trends were calculated using mixed-effects logistic regression models, adjusting for patient and hospital characteristics., Results: Among 6 272 538 hospitalizations (median [IQR] age, 66 [53-78] years; 443 465 male [49.6%]; 106 095 Black [11.9%], 65 763 Hispanic [7.4%], 653 907 White [73.1%]), 894 724 (14.3%) had suspected community-onset sepsis, of whom 582 585 (65.1%) received either empiric anti-MRSA (379 987 [42.5%]) or antipseudomonal β-lactam therapy (513 811 [57.4%]); 311 213 (34.8%) received both. Patients with suspected community-onset sepsis accounted for 1 573 673 of 3 141 300 (50.1%) of total inpatient anti-MRSA antibiotic days and 2 569 518 of 5 211 745 (49.3%) of total antipseudomonal β-lactam days. Between 2017 and 2021, the proportion of patients with suspected sepsis administered anti-MRSA or antipseudomonal therapy increased from 63.0% (82 731 of 131 275 patients) to 66.7% (101 003 of 151 435 patients) (adjusted OR [aOR] per year, 1.03; 95% CI, 1.03-1.04). However, resistant organisms were isolated in only 65 434 cases (7.3%) (30 617 gram-positive [3.4%], 38 844 gram-negative [4.3%]) and the proportion of patients who had any resistant organism decreased from 9.6% to 7.3% (aOR per year, 0.87; 95% CI, 0.87-0.88). Most patients with suspected sepsis treated with empiric anti-MRSA and/or antipseudomonal therapy had no resistant organisms (527 356 of 582 585 patients [90.5%]); this proportion increased from 88.0% in 2017 to 91.6% in 2021 (aOR per year, 1.12; 95% CI, 1.11-1.13)., Conclusions and Relevance: In this cross-sectional study of adults admitted to 241 US hospitals, empiric broad-spectrum antibiotic use for suspected community-onset sepsis accounted for half of all anti-MRSA or antipseudomonal therapy; the use of these types of antibiotics increased between 2017 and 2021 despite resistant organisms being isolated in less than 10% of patients treated with broad-spectrum agents.

The Centers for Medicare & Medicaid Services (CMS) introduced the Severe Sepsis/Septic Shock Management Bundle (SEP-1) as a pay-for-reporting measure in 2015 and is now planning to make it a pay-for-performance measure by incorporating it into the Hospital Value-Based Purchasing Program. This joint IDSA/ACEP/PIDS/SHEA/SHM/SIPD position paper highlights concerns with this change. Multiple studies indicate that SEP-1 implementation was associated with increased broad-spectrum antibiotic use, lactate measurements, and aggressive fluid resuscitation for patients with suspected sepsis but not with decreased mortality rates. Increased focus on SEP-1 risks further diverting attention and resources from more effective measures and comprehensive sepsis care. We recommend retiring SEP-1 rather than using it in a payment model and shifting instead to new sepsis metrics that focus on patient outcomes. CMS is developing a community-onset sepsis 30-day mortality electronic clinical quality measure (eCQM) that is an important step in this direction. The eCQM preliminarily identifies sepsis using systemic inflammatory response syndrome (SIRS) criteria, antibiotic administrations or diagnosis codes for infection or sepsis, and clinical indicators of acute organ dysfunction. We support the eCQM but recommend removing SIRS criteria and diagnosis codes to streamline implementation, decrease variability between hospitals, maintain vigilance for patients with sepsis but without SIRS, and avoid promoting antibiotic use in uninfected patients with SIRS. We further advocate for CMS to harmonize the eCQM with the Centers for Disease Control and Prevention's (CDC) Adult Sepsis Event surveillance metric to promote unity in federal measures, decrease reporting burden for hospitals, and facilitate shared prevention initiatives. These steps will result in a more robust measure that will encourage hospitals to pay more attention to the full breadth of sepsis care, stimulate new innovations in diagnosis and treatment, and ultimately bring us closer to our shared goal of improving outcomes for patients., Competing Interests: Potential conflicts of interest. K. C. discloses grants or contracts from the CDC and AHRQ to my institution and serves as the IDSA and PIDS representative to the SCCM Pediatric Sepsis Definitions Taskforce. D. C. C. reports payment for expert testimony. S. E. C. reports grants or contracts from Patient-Centered Outcomes Research Institute (PCORI), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Agency for Healthcare Research and Quality (AHRQ); consulting fees from Duke Clinical Research Institute; participation on a Data Safety Monitoring Board or Advisory Board for Debiopharm; roles as a Board Member for National Foundation for Infectious Diseases and for Global Antibiotic Research & Development Partnership North America (GARDP-NA). R. G. reports support for attending meetings and/or travel for his government relations work from Society of Hospital Medicine; participation as an advisor on a Data Safety Monitoring Board or Advisory Board for Honor Technologies, Clinical Language Engineering Workbench (CLEW), Sitka; volunteer position as Sr. Advisor for Government Affairs SHM; stock from Sitka, Honor Technologies, CLEW. E. L. H. reports consulting fees paid to author for peer review of drug monographs from Wolters Kluwer (Lexi-Comp); honoraria for continuing education presentations from Clinical Care Options. A. C. K. reports grants or contracts as Investigator for the National Institutes of Health Adaptive COVID-19 Treatment Trial. M. K. reports grants to institution from CDC and AHRQ; royalties to author from UpToDate; Honorarium for lecture on sepsis metrics, paid to author, from Burns & Trauma Journal. H. M. reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Infectious Disease Board Review and International AIDS Society USA; patents planned, issued or pending for Immunofluorescent antibody for pneumocystis; leadership or fiduciary role with Society of Critical Care Medicine, Critical Care Medicine (Senior Editor) and is an IDSA representative to Surviving Sepsis Guideline; and other financial or non-financial interests in Infectious Disease Board Review LLC. C. R. reports grants to institution from CDC and AHRQ; royalties to author from UpToDate; payment to author for consulting related to sepsis diagnostics from Cytovale; leadership or fiduciary role with IDSA as Associate Editor for Clinical Infectious Diseases. D. A. S. reports grants or contracts as investigator for the National Institutes of Health Adaptive COVID-19 Treatment Trial. A. T. reports consulting fees from Vapotherm (no payments made related to this manuscript; Vapotherm is a medical device that can be used to treat sepsis); a role as President-elect for the American College of Emergency Physicians (no direct payment related to this manuscript). D. M. Y. reports grants or contracts to institution from National Heart, Lung, and Blood Institute (NHLBI); royalties or licenses from UpToDate (pneumonia chapter) and Lippincott Inc (EM text editor); payment or honoraria as journal editor for American College of Emergency Physicians; payment for expert testimony from University of Pennsylvania and Pennsylvania State University. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

As the third edition of the Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals is released with the latest recommendations for the prevention and management of healthcare-associated infections (HAIs), a new approach to reporting HAIs is just beginning to unfold. This next generation of HAI reporting will be fully electronic and based largely on existing data in electronic health record (EHR) systems and other electronic data sources. It will be a significant change in how hospitals report HAIs and how the Centers for Disease Control and Prevention (CDC) and other agencies receive this information. This paper outlines what that future electronic reporting system will look like and how it will impact HAI reporting.

Among 287 US hospitals reporting data between 2015 and 2018, annual pediatric surgical site infection (SSI) rates ranged from 0% for gallbladder to 10.4% for colon surgeries. Colon, spinal fusion, and small-bowel SSI rates did not decrease with greater surgical volumes in contrast to appendix and ventricular-shunt SSI rates.

Background: Nontuberculous mycobacteria are water-avid pathogens that are associated with nosocomial infections., Objective: To describe the analysis and mitigation of a cluster of Mycobacterium abscessus infections in cardiac surgery patients., Design: Descriptive study., Setting: Brigham and Women's Hospital, Boston, Massachusetts., Participants: Four cardiac surgery patients., Intervention: Commonalities among cases were sought, potential sources were cultured, patient and environmental specimens were sequenced, and possible sources were abated., Measurements: Description of the cluster, investigation, and mitigation., Results: Whole-genome sequencing confirmed homology among clinical isolates. Patients were admitted during different periods to different rooms but on the same floor. There were no common operating rooms, ventilators, heater-cooler devices, or dialysis machines. Environmental cultures were notable for heavy mycobacterial growth in ice and water machines on the cluster unit but little or no growth in ice and water machines in the hospital's other 2 inpatient towers or in shower and sink faucet water in any of the hospital's 3 inpatient towers. Whole-genome sequencing confirmed the presence of a genetically identical element in ice and water machine and patient specimens. Investigation of the plumbing system revealed a commercial water purifier with charcoal filters and an ultraviolet irradiation unit leading to the ice and water machines in the cluster tower but not the hospital's other inpatient towers. Chlorine was present at normal levels in municipal source water but was undetectable downstream from the purification unit. There were no further cases after high-risk patients were switched to sterile and distilled water, ice and water machine maintenance was intensified, and the commercial purification system was decommissioned., Limitation: Transmission pathways were not clearly characterized., Conclusion: Well-intentioned efforts to modify water management systems may inadvertently increase infection risk for vulnerable patients., Primary Funding Source: National Institutes of Health.

Purpose of Review: Sepsis guidelines and quality measures set aggressive deadlines for administering antibiotics to patients with possible sepsis or septic shock. However, the diagnosis of sepsis is often uncertain, particularly upon initial presentation, and pressure to treat more rapidly may harm some patients by exposing them to unnecessary or inappropriate broad-spectrum antibiotics., Recent Findings: Observational studies that report that each hour until antibiotics increases mortality often fail to adequately adjust for comorbidities and severity of illness, fail to account for antibiotics given to uninfected patients, and inappropriately blend the effects of long delays with short delays. Accounting for these factors weakens or eliminates the association between time-to-antibiotics and mortality, especially for patients without shock. These findings are underscored by analyses of the Centers for Medicaid and Medicare Services SEP-1 measure: it has increased sepsis diagnoses and broad-spectrum antibiotic use but has not improved outcomes., Summary: Clinicians are advised to tailor the urgency of antibiotics to their certainty of infection and patients' severity of illness. Immediate antibiotics are warranted for patients with possible septic shock or high likelihood of infection. Antibiotics can safely be withheld to allow for more investigation, however, in most patients with less severe illnesses if the diagnosis of infection is uncertain., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Importance: In October 2015, the Centers for Medicare & Medicaid Services began requiring US hospitals to report adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1)., Objective: To evaluate the association of SEP-1 implementation with sepsis treatment patterns and outcomes in diverse hospitals., Design, Setting, and Participants: This retrospective cohort study with interrupted time-series analysis and logistic regression models was conducted among adults admitted to 114 hospitals from October 2013 to December 2017 with suspected sepsis (blood culture orders, ≥2 systemic inflammatory response syndrome criteria, and acute organ dysfunction) within 24 hours of hospital arrival. Data analysis was conducted from September 2020 to September 2021., Exposures: SEP-1 implementation in the fourth quarter (Q4) of 2015., Main Outcomes and Measures: The primary outcome was quarterly rates of risk-adjusted short-term mortality (in-hospital death or discharge to hospice). Secondary outcomes included lactate testing and administration of anti-methicillin-resistant Staphylococcus aureus (MRSA) or antipseudomonal β-lactam antibiotics within 24 hours of hospital arrival. Generalized estimating equations with robust sandwich variances were used to fit logistic regression models to assess for changes in level or trends in these outcomes, adjusting for baseline characteristics and severity of illness., Results: The cohort included 117 510 patients (median [IQR] age, 67 years [55-78] years; 60 530 [51.5%] men and 56 980 [48.5%] women) with suspected sepsis. Lactate testing rates increased from 55.1% (95% CI, 53.9%-56.2%) in Q4 of 2013 to 76.7% (95% CI, 75.4%-78.0%) in Q4 of 2017, with a significant level change following SEP-1 implementation (odds ratio [OR], 1.34; 95% CI, 1.04-1.74). There were increases in use of anti-MRSA antibiotics (19.8% [95% CI, 18.9%-20.7%] in Q4 of 2013 to 26.3% [95% CI, 24.9%-27.7%] in Q4 of 2017) and antipseudomonal antibiotics (27.7% [95% CI, 26.7%-28.8%] in Q4 of 2013 to 40.5% [95% CI, 38.9%-42.0%] in Q4 of 2017), but these trends preceded SEP-1 and did not change with SEP-1 implementation. Unadjusted short-term mortality rates were similar in the pre-SEP-1 period (Q4 of 2013 through Q3 of 2015) vs the post-SEP-1 period (Q1 of 2016 through Q4 of 2017) (20.3% [95% CI, 20.0%-20.6%] vs 20.4% [95% CI, 20.1%-20.7%]), and SEP-1 implementation was not associated with changes in level (OR, 0.94; 95% CI, 0.68-1.29) or trend (OR, 1.00; 95% CI, 0.97-1.04) for risk-adjusted short-term mortality rates., Conclusions and Relevance: In this cohort study, SEP-1 implementation was associated with an immediate increase in lactate testing rates, no change in already-increasing rates of broad-spectrum antibiotic use, and no change in short-term mortality rates for patients with suspected sepsis. Other approaches to decrease sepsis mortality may be warranted.

Policies to prevent respiratory virus transmission in health care settings have traditionally divided organisms into Droplet versus Airborne categories. Droplet organisms (for example, influenza) are said to be transmitted via large respiratory secretions that rapidly fall to the ground within 1 to 2 meters and are adequately blocked by surgical masks. Airborne pathogens (for example, measles), by contrast, are transmitted by aerosols that are small enough and light enough to carry beyond 2 meters and to penetrate the gaps between masks and faces; health care workers are advised to wear N95 respirators and to place these patients in negative-pressure rooms. Respirators and negative-pressure rooms are also recommended when caring for patients with influenza or SARS-CoV-2 who are undergoing "aerosol-generating procedures," such as intubation. An increasing body of evidence, however, questions this framework. People routinely emit respiratory particles in a range of sizes, but most are aerosols, and most procedures do not generate meaningfully more aerosols than ordinary breathing, and far fewer than coughing, exercise, or labored breathing. Most transmission nonetheless occurs at close range because virus-laden aerosols are most concentrated at the source; they then diffuse and dilute with distance, making long-distance transmission rare in well-ventilated spaces. The primary risk factors for nosocomial transmission are community incidence rates, viral load, symptoms, proximity, duration of exposure, and poor ventilation. Failure to appreciate these factors may lead to underappreciation of some risks (for example, overestimation of the protection provided by medical masks, insufficient attention to ventilation) or misallocation of limited resources (for example, reserving N95 respirators and negative-pressure rooms only for aerosol-generating procedures or requiring negative-pressure rooms for all patients with SARS-CoV-2 infection regardless of stage of illness). Enhanced understanding of the factors governing respiratory pathogen transmission may inform the development of more effective policies to prevent nosocomial transmission of respiratory pathogens.

Objectives: Widespread use and misuse of prescription and illicit opioids have exposed millions to health risks including serious infectious complications. Little is known, however, about the association between opioid use and sepsis., Design: Retrospective cohort study., Setting: About 373 U.S. hospitals., Patients: Adults hospitalized between January 2009 and September 2015., Interventions: None., Measurements and Main Results: Sepsis was identified by clinical indicators of concurrent infection and organ dysfunction. Opioid-related hospitalizations were identified by the International Classification of Diseases, 9th Revision, Clinical Modification codes and/or inpatient orders for buprenorphine. Clinical characteristics and outcomes were compared by sepsis and opioid-related hospitalization status. The association between opioid-related hospitalization and all-cause, in-hospital mortality in patients with sepsis was assessed using mixed-effects logistic models to adjust for baseline characteristics and severity of illness.The cohort included 6,715,286 hospitalizations; 375,479 (5.6%) had sepsis, 130,399 (1.9%) had opioid-related hospitalizations, and 8,764 (0.1%) had both. Compared with sepsis patients without opioid-related hospitalizations (n = 366,715), sepsis patients with opioid-related hospitalizations (n = 8,764) were younger (mean 52.3 vs 66.9 yr) and healthier (mean Elixhauser score 5.4 vs 10.5), had more bloodstream infections from Gram-positive and fungal pathogens (68.9% vs 47.0% and 10.6% vs 6.4%, respectively), and had lower in-hospital mortality rates (10.6% vs 16.2%; adjusted odds ratio, 0.73; 95% CI, 0.60-0.79; p < 0.001 for all comparisons). Of 1,803 patients with opioid-related hospitalizations who died in-hospital, 928 (51.5%) had sepsis. Opioid-related hospitalizations accounted for 1.5% of all sepsis-associated deaths, including 5.7% of sepsis deaths among patients less than 50 years old. From 2009 to 2015, the proportion of sepsis hospitalizations that were opioid-related increased by 77% (95% CI, 40.7-123.5%)., Conclusions: Sepsis is an important cause of morbidity and mortality in patients with opioid-related hospitalizations, and opioid-related hospitalizations contribute disproportionately to sepsis-associated deaths among younger patients. In addition to ongoing efforts to combat the opioid crisis, public health agencies should focus on raising awareness about sepsis among patients who use opioids and their providers., Competing Interests: Drs. Alrawashdeh’s, Klompas’s, Larochelle’s, and Rhee’s institutions received funding from the Centers for Disease Control and Prevention (CDC; U54CK000484). Drs. Alrawashdeh’s, Klompas, and Rhee’s institutions received funding from the Agency for Healthcare Research and Quality (AHRQ; K08HS025008). Drs. Alrawashdeh’s and Larochelle’s institutions received funding from the National Institutes of Health (NIH). Drs. Alrawashdeh, Kimmel, and Kadri received support for article research from the NIH. Dr. Klompas’ institution received funding from the Massachusetts Department of Public Health. Drs. Klompas and Rhee received funding from UpToDate. Dr. Kimmel received funding from Abt Associates on a Department of Public Health–funded project. Dr. Larochelle’s institution received funding from the National Institute on Drug Abuse and the Robert Wood Johnson Foundation; he received funding from the University of Baltimore, the Office of National Drug Control Policy, and OptumLabs. Drs. Gokhale, Hoots, Hatfield, Reddy, and Fiore received support for article research from the government. Drs. Reddy and Rhee received support for article research from the CDC. Dr. Rhee received support for article research from the AHRQ. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2021 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Many US states published crisis standards of care (CSC) guidelines for allocating scarce critical care resources during the COVID-19 pandemic. However, the performance of these guidelines in maximizing their population benefit has not been well tested. In 2,272 adults with COVID-19 requiring mechanical ventilation drawn from the Study of the Treatment and Outcomes in Critically Ill Patients with COVID-19 (STOP-COVID) multicenter cohort, we test the following three approaches to CSC algorithms: Sequential Organ Failure Assessment (SOFA) scores grouped into ranges, SOFA score ranges plus comorbidities, and a hypothetical approach using raw SOFA scores not grouped into ranges. We find that area under receiver operating characteristic (AUROC) curves for all three algorithms demonstrate only modest discrimination for 28-day mortality. Adding comorbidity scoring modestly improves algorithm performance over SOFA scores alone. The algorithm incorporating comorbidities has modestly worse predictive performance for Black compared to white patients. CSC algorithms should be empirically examined to refine approaches to the allocation of scarce resources during pandemics and to avoid potential exacerbation of racial inequities., Competing Interests: The authors have no conflicts of interest relevant to this work. For unrelated work, the authors have the following disclosures: S.P.K. served as a consultant for Resolve to Save Lives and has previously led a partnership on multiple chronic conditions at the Icahn School of Medicine at Mount Sinai with Teva Pharmaceuticals. W.B.F. serves as a consultant for Alosa Health and Aetion. He also received an honorarium for a presentation to Blue Cross Blue Shield of Massachusetts. E.Y.K. is a co-investigator in NCT04389671 (Windtree Therapeutics) testing lucinactant (surfactant-like treatment) in COVID-19 patients and received unrelated research funding from Bayer AG, N.I.H., the American Heart Association, the American Lung Association, and the American Thoracic Society., (© 2021 The Author(s).)

Background: US hospitals are required by the Centers for Medicare and Medicaid Services to publicly report central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), Clostridioidesdiffficile, methicillin-resistant Staphylococcus aureus bacteremia, and selected surgical site infections for benchmarking and pay-for-performance programs. It is unclear, however, to what extent these conditions capture the full breadth of serious healthcare-associated infections (HAIs). The Centers for Disease Control and Prevention's (CDC's) hospital-onset Adult Sepsis Event (HO-ASE) definition could facilitate more comprehensive and efficient surveillance for serious HAIs, but the overlap between HO-ASE and currently reportable HAIs is unknown., Methods: We retrospectively assessed the overlap between HO-ASEs and reportable HAIs among adults hospitalized between June 2015-June 2018 in 3 hospitals. Medical record reviews were conducted for 110 randomly selected HO-ASE cases to determine clinical correlates., Results: Among 282 441 hospitalized patients, 2301 (0.8%) met HO-ASE criteria and 1260 (0.4%) had reportable HAIs. In-hospital mortality rates were higher with HO-ASEs than reportable HAIs (28.6% vs 12.9%). Mortality rates for HO-ASE missed by reportable HAIs were substantially higher than mortality rates for reportable HAIs missed by HO-ASE (28.1% vs 6.3%). Reportable HAIs were only present in 334/2301 (14.5%) HO-ASEs, most commonly CLABSIs (6.0% of HO-ASEs), C. difficile (5.0%), and CAUTIs (3.0%). On medical record review, most HO-ASEs were caused by pneumonia (39.1%, of which only 34.9% were ventilator-associated), bloodstream infections (17.4%, of which only 10.5% were central line-associated), non-C. difficile intra-abdominal infections (14.5%), urinary infections (7.3%, of which 87.5% were catheter-associated), and skin/soft tissue infections (6.4%)., Conclusions: CDC's HO-ASE definition detects many serious nosocomial infections missed by currently reportable HAIs. HO-ASE surveillance could increase the efficiency and clinical significance of surveillance while identifying new targets for prevention., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: Several U.S. hospitals had surges in COVID-19 caseload, but their effect on COVID-19 survival rates remains unclear, especially independent of temporal changes in survival., Objective: To determine the association between hospitals' severity-weighted COVID-19 caseload and COVID-19 mortality risk and identify effect modifiers of this relationship., Design: Retrospective cohort study. (ClinicalTrials.gov: NCT04688372)., Setting: 558 U.S. hospitals in the Premier Healthcare Database., Participants: Adult COVID-19-coded inpatients admitted from March to August 2020 with discharge dispositions by October 2020., Measurements: Each hospital-month was stratified by percentile rank on a surge index (a severity-weighted measure of COVID-19 caseload relative to pre-COVID-19 bed capacity). The effect of surge index on risk-adjusted odds ratio (aOR) of in-hospital mortality or discharge to hospice was calculated using hierarchical modeling; interaction by surge attributes was assessed., Results: Of 144 116 inpatients with COVID-19 at 558 U.S. hospitals, 78 144 (54.2%) were admitted to hospitals in the top surge index decile. Overall, 25 344 (17.6%) died; crude COVID-19 mortality decreased over time across all surge index strata. However, compared with nonsurging (<50th surge index percentile) hospital-months, aORs in the 50th to 75th, 75th to 90th, 90th to 95th, 95th to 99th, and greater than 99th percentiles were 1.11 (95% CI, 1.01 to 1.23), 1.24 (CI, 1.12 to 1.38), 1.42 (CI, 1.27 to 1.60), 1.59 (CI, 1.41 to 1.80), and 2.00 (CI, 1.69 to 2.38), respectively. The surge index was associated with mortality across ward, intensive care unit, and intubated patients. The surge-mortality relationship was stronger in June to August than in March to May (slope difference, 0.10 [CI, 0.033 to 0.16]) despite greater corticosteroid use and more judicious intubation during later and higher-surging months. Nearly 1 in 4 COVID-19 deaths (5868 [CI, 3584 to 8171]; 23.2%) was potentially attributable to hospitals strained by surging caseload., Limitation: Residual confounding., Conclusion: Despite improvements in COVID-19 survival between March and August 2020, surges in hospital COVID-19 caseload remained detrimental to survival and potentially eroded benefits gained from emerging treatments. Bolstering preventive measures and supporting surging hospitals will save many lives., Primary Funding Source: Intramural Research Program of the National Institutes of Health Clinical Center, the National Institute of Allergy and Infectious Diseases, and the National Cancer Institute.

Importance: Central catheter-associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs) increase morbidity, mortality, and health care costs in pediatric patients., Objective: To examine changes over time in CLABSI and CAUTI rates between 2013 and 2018 in neonatal intensive care units (NICUs) and pediatric intensive care units (PICUs) using prospective surveillance data from community hospitals, children's hospitals, and pediatric units within general hospitals., Design, Setting, and Participants: This time series study included 176 US hospitals reporting pediatric health care-associated infection surveillance data to the National Healthcare Safety Network from January 1, 2013, to June 30, 2018. Patients aged 18 years or younger admitted to PICUs or level III NICUs were included in the analysis., Main Outcomes and Measures: The primary outcomes were device-associated rates of CLABSI in NICUs and PICUs and CAUTI in PICUs (infections per 1000 device-days). Secondary outcomes included population-based rates (infections per 10 000 patient-days) and device utilization (device-days per patient-days). Regression models were fit using generalized estimating equations to assess yearly changes in CLABSI and CAUTI rates, adjusted for birth weight (≤1500 vs >1500 g) in neonatal models., Results: Of the 176 hospitals, 132 hospitals with NICUs and 114 hospitals with PICUs contributed data. Of these, NICUs reported 6 064 172 patient-days and 1 363 700 central line-days and PICUs reported 1 999 979 patient-days, 925 956 central catheter-days, and 327 599 indwelling urinary catheter-days. In NICUs, there were no significant changes in yearly trends in device-associated (incidence rate ratio [IRR] per year, 0.99; 95% CI, 0.95-1.03) and population-based (IRR, 0.96; 95% CI, 0.92-1.00) CLABSI rates or central catheter utilization (odds ratio [OR], 0.97; 95% CI, 0.95-1.00). Results were similar in PICUs, with device-associated (IRR, 1.03; 95% CI, 0.99-1.07) and population-based (IRR, 1.03; 95% CI, 0.99-1.07) CLABSI rates and central catheter utilization (OR, 0.99; 95% CI, 0.97-1.01) remaining stable. While device-associated CAUTI rates in PICUs also remained unchanged over time (IRR, 0.97; 95% CI, 0.91-1.03), population-based CAUTI rates significantly decreased by 8% per year (IRR, 0.92; 95% CI, 0.86-0.98) and indwelling urinary catheter utilization significantly decreased by 6% per year (OR, 0.94; 95% CI, 0.91-0.96)., Conclusions and Relevance: Recent trends in CLABSI rates noted in this study among critically ill neonates and children in a large cohort of US hospitals indicate that past gains have held, without evidence of further improvements, suggesting novel approaches for CLABSI prevention are needed. Modest improvements in population-based CAUTI rates likely reflect more judicious use of urinary catheters.

Importance: In the US, federal value-based incentive programs are more likely to penalize safety-net institutions than non-safety-net institutions. Whether these programs differentially change the rates of targeted health care-associated infections in safety-net vs non-safety-net hospitals is unknown., Objective: To assess the association of Hospital-Acquired Condition Reduction Program (HACRP) and Hospital Value-Based Purchasing (HVBP) implementation with changes in rates of targeted health care-associated infections and disparities in rates among safety-net and non-safety-net hospitals., Design, Setting, and Participants: This interrupted time series included all US acute care hospitals enrolled in the Preventing Avoidable Infectious Complications by Adjusting Payment study that participated in mandatory reporting to the National Healthcare Safety Network from January 1, 2013, through June 30, 2018. Hospital characteristics were obtained from the 2015 American Hospital Association annual survey. Penalty statuses for 2015 to 2018 were obtained from Hospital Compare. Data were analyzed between July 9, 2018, and October 1, 2019., Exposures: HACRP and HVBP implementation in fiscal year 2015 or 2016., Main Outcomes and Measures: The primary outcomes were rates of 4 health care-associated infections: central line-associated bloodstream infection (CLABSI), catheter-associated urinary tract infection (CAUTI), surgical site infection (SSI) after colon surgical procedures, and SSI after abdominal hysterectomy procedures. Regression models were fit using generalized estimating equations to assess the association of HACRP and HVBP implementation with health care-associated infection rates and disparities in infection rates., Results: Of the 618 acute care hospitals included in this study, 473 (76.5%) were non-safety net and 145 (23.5%) were considered safety net. In these hospitals, HACRP and HVBP implementation was not associated with improvements in level or trend for any health care-associated infection examined (eg, CAUTI in safety-net hospitals: incidence rate ratio [IRR] for level change, 0.98 [95% CI, 0.79-1.23; P = .89]; IRR for change in slope, 1.00 [95% CI, 0.97-1.03; P = .80]). Before program implementation, infection rates were statistically significantly higher for safety-net than for non-safety-net hospitals for CLABSI (IRR, 1.23; 95% CI, 1.07-1.42; P = .004), CAUTI (IRR, 1.38; 95% CI, 1.16-1.64; P < .001), and SSI after colon surgical procedure (odds ratio [OR], 1.26; 95% CI, 1.06-1.50; P = .009). The disparity persisted over time when comparing the last year of the study with the first year (CLABSI: ratio of ratios [ROR], 0.93 [95% CI, 0.77-1.13; P = .48]; CAUTI: ROR, 0.90 [95% CI, 0.73-1.10; P = .31]; SSI after colon surgical procedures: ROR, 0.96 [95% CI, 0.78-1.20; P = .75]). Rates of SSI after abdominal hysterectomy procedure were similar in safety-net and non-safety-net hospitals before implementation (OR, 1.13; 95% CI, 0.91-1.40; P = .27) but higher after implementation (OR, 1.43; 95% CI, 1.11-1.83; P = .006), although this change was not significant (ROR, 1.20; 95% CI, 0.91-1.59; P = .20)., Conclusions and Relevance: This study found that HACRP and HVBP implementation was not associated with any improvements in targeted health care-associated infections among safety-net or non-safety-net hospitals or with changes in disparities in infection rates. Given the persistent health care-associated infection rate disparities, these programs appear to function as a disproportionate penalty system for safety-net hospitals that offer no measurable benefits for patients.

Importance: Broad-spectrum antibiotics are recommended for all patients with suspected sepsis to minimize the risk of undertreatment. However, little is known regarding the net prevalence of antibiotic-resistant pathogens across all patients with community-onset sepsis or the outcomes associated with unnecessarily broad empiric treatment., Objective: To elucidate the epidemiology of antibiotic-resistant pathogens and the outcomes associated with both undertreatment and overtreatment in patients with culture-positive community-onset sepsis., Design, Setting, and Participants: This cohort study included 17 430 adults admitted to 104 US hospitals between January 2009 and December 2015 with sepsis and positive clinical cultures within 2 days of admission. Data analysis took place from January 2018 to December 2019., Exposures: Inadequate empiric antibiotic therapy (ie, ≥1 pathogen nonsusceptible to all antibiotics administered on the first or second day of treatment) and unnecessarily broad empiric therapy (ie, active against methicillin-resistant Staphylococcus aureus [MRSA]; vancomycin-resistant Enterococcus [VRE]; ceftriaxone-resistant gram-negative [CTX-RO] organisms, including Pseudomonas aeruginosa; or extended-spectrum β-lactamase [ESBL] gram-negative organisms when none of these were isolated)., Main Outcomes and Measures: Prevalence and empiric treatment rates for antibiotic-resistant organisms and associations of inadequate and unnecessarily broad empiric therapy with in-hospital mortality were assessed, adjusting for baseline characteristics and severity of illness., Results: Of 17 430 patients with culture-positive community-onset sepsis (median [interquartile range] age, 69 [57-81] years; 9737 [55.9%] women), 2865 (16.4%) died in the hospital. The most common culture-positive sites were urine (9077 [52.1%]), blood (6968 [40.0%]), and the respiratory tract (2912 [16.7%]). The most common pathogens were Escherichia coli (5873 [33.7%]), S aureus (3706 [21.3%]), and Streptococcus species (2361 [13.5%]). Among 15 183 cases in which all antibiotic-pathogen susceptibility combinations could be calculated, most (12 398 [81.6%]) received adequate empiric antibiotics. Empiric therapy targeted resistant organisms in 11 683 of 17 430 cases (67.0%; primarily vancomycin and anti-Pseudomonal β-lactams), but resistant organisms were uncommon (MRSA, 2045 [11.7%]; CTX-RO, 2278 [13.1%]; VRE, 360 [2.1%]; ESBLs, 133 [0.8%]). The net prevalence for at least 1 resistant gram-positive organism (ie, MRSA or VRE) was 13.6% (2376 patients), and for at least 1 resistant gram-negative organism (ie, CTX-RO, ESBL, or CRE), it was 13.2% (2297 patients). Both inadequate and unnecessarily broad empiric antibiotics were associated with higher mortality after detailed risk adjustment (inadequate empiric antibiotics: odds ratio, 1.19; 95% CI, 1.03-1.37; P = .02; unnecessarily broad empiric antibiotics: odds ratio, 1.22; 95% CI, 1.06-1.40; P = .007)., Conclusions and Relevance: In this study, most patients with community-onset sepsis did not have resistant pathogens, yet broad-spectrum antibiotics were frequently administered. Both inadequate and unnecessarily broad empiric antibiotics were associated with higher mortality. These findings underscore the need for better tests to rapidly identify patients with resistant pathogens and for more judicious use of broad-spectrum antibiotics for empiric sepsis treatment.

Pediatric sepsis is a major public health concern, and robust surveillance tools are needed to characterize its incidence, outcomes, and trends. The increasing use of electronic health records (EHRs) in the United States creates an opportunity to conduct reliable, pragmatic, and generalizable population-level surveillance using routinely collected clinical data rather than administrative claims or resource-intensive chart review. In 2015, the US Centers for Disease Control and Prevention recruited sepsis investigators and representatives of key professional societies to develop an approach to adult sepsis surveillance using clinical data recorded in EHRs. This led to the creation of the adult sepsis event definition, which was used to estimate the national burden of sepsis in adults and has been adapted into a tool kit to facilitate widespread implementation by hospitals. In July 2018, the Centers for Disease Control and Prevention convened a new multidisciplinary pediatric working group to tailor an EHR-based national sepsis surveillance approach to infants and children. Here, we describe the challenges specific to pediatric sepsis surveillance, including evolving clinical definitions of sepsis, accommodation of age-dependent physiologic differences, identifying appropriate EHR markers of infection and organ dysfunction among infants and children, and the need to account for children with medical complexity and the growing regionalization of pediatric care. We propose a preliminary pediatric sepsis event surveillance definition and outline next steps for refining and validating these criteria so that they may be used to estimate the national burden of pediatric sepsis and support site-specific surveillance to complement ongoing initiatives to improve sepsis prevention, recognition, and treatment., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2019 by the American Academy of Pediatrics.)

Catheter-associated urinary tract infections in 592 hospitals immediately declined after federal value-based incentive program implementation, but this was fully attributable to a concurrent surveillance case definition revision. Post revision, more hospitals had favorable standardized infection ratios, likely leading to artificial inflation of their performance scores unrelated to changes in patient safety.

Competing Interests: Competing interests: None declared.

Objectives: Sepsis-3 defines organ dysfunction as an increase in the Sequential Organ Failure Assessment score by greater than or equal to 2 points. However, some Sequential Organ Failure Assessment score components are not routinely recorded in all hospitals' electronic health record systems, limiting its utility for wide-scale sepsis surveillance. The Centers for Disease Control and Prevention recently released the Adult Sepsis Event surveillance definition that includes simplified organ dysfunction criteria optimized for electronic health records (eSOFA). We compared eSOFA versus Sequential Organ Failure Assessment with regard to sepsis prevalence, overlap, and outcomes., Design: Retrospective cohort study., Setting: One hundred eleven U.S. hospitals in the Cerner HealthFacts dataset., Patients: Adults hospitalized in 2013-2015., Interventions: None., Measurements and Main Results: We identified clinical indicators of presumed infection (blood cultures and antibiotics) concurrent with either: 1) an increase in Sequential Organ Failure Assessment score by 2 or more points (Sepsis-3) or 2) 1 or more eSOFA criteria: vasopressor initiation, mechanical ventilation initiation, lactate greater than or equal to 2.0 mmol/L, doubling in creatinine, doubling in bilirubin to greater than or equal to 2.0 mg/dL, or greater than or equal to 50% decrease in platelet count to less than 100 cells/μL (Centers for Disease Control and Prevention Adult Sepsis Event). We compared area under the receiver operating characteristic curves for discriminating in-hospital mortality, adjusting for baseline characteristics. Of 942,360 patients in the cohort, 57,242 (6.1%) had sepsis by Sequential Organ Failure Assessment versus 41,618 (4.4%) by eSOFA. Agreement between sepsis by Sequential Organ Failure Assessment and eSOFA was good (Cronbach's alpha 0.81). Baseline characteristics and infectious diagnoses were similar, but mortality was higher with eSOFA (17.1%) versus Sequential Organ Failure Assessment (14.4%; p < 0.001) as was discrimination for mortality (area under the receiver operating characteristic curve, 0.774 vs 0.759; p < 0.001). Comparisons were consistent across subgroups of age, infectious diagnoses, and comorbidities., Conclusions: The Adult Sepsis Event's eSOFA organ dysfunction criteria identify a smaller, more severely ill sepsis cohort compared with the Sequential Organ Failure Assessment score, but with good overlap and similar clinical characteristics. Adult Sepsis Events may facilitate wide-scale automated sepsis surveillance that tracks closely with the more complex Sepsis-3 criteria.

Importance: Sepsis is present in many hospitalizations that culminate in death. The contribution of sepsis to these deaths, and the extent to which they are preventable, is unknown., Objective: To estimate the prevalence, underlying causes, and preventability of sepsis-associated mortality in acute care hospitals., Design, Setting, and Participants: Cohort study in which a retrospective medical record review was conducted of 568 randomly selected adults admitted to 6 US academic and community hospitals from January 1, 2014, to December 31, 2015, who died in the hospital or were discharged to hospice and not readmitted. Medical records were reviewed from January 1, 2017, to March 31, 2018., Main Outcomes and Measures: Clinicians reviewed cases for sepsis during hospitalization using Sepsis-3 criteria, hospice-qualifying criteria on admission, immediate and underlying causes of death, and suboptimal sepsis-related care such as inappropriate or delayed antibiotics, inadequate source control, or other medical errors. The preventability of each sepsis-associated death was rated on a 6-point Likert scale., Results: The study cohort included 568 patients (289 [50.9%] men; mean [SD] age, 70.5 [16.1] years) who died in the hospital or were discharged to hospice. Sepsis was present in 300 hospitalizations (52.8%; 95% CI, 48.6%-57.0%) and was the immediate cause of death in 198 cases (34.9%; 95% CI, 30.9%-38.9%). The next most common immediate causes of death were progressive cancer (92 [16.2%]) and heart failure (39 [6.9%]). The most common underlying causes of death in patients with sepsis were solid cancer (63 of 300 [21.0%]), chronic heart disease (46 of 300 [15.3%]), hematologic cancer (31 of 300 [10.3%]), dementia (29 of 300 [9.7%]), and chronic lung disease (27 of 300 [9.0%]). Hospice-qualifying conditions were present on admission in 121 of 300 sepsis-associated deaths (40.3%; 95% CI 34.7%-46.1%), most commonly end-stage cancer. Suboptimal care, most commonly delays in antibiotics, was identified in 68 of 300 sepsis-associated deaths (22.7%). However, only 11 sepsis-associated deaths (3.7%) were judged definitely or moderately likely preventable; another 25 sepsis-associated deaths (8.3%) were considered possibly preventable., Conclusions and Relevance: In this cohort from 6 US hospitals, sepsis was the most common immediate cause of death. However, most underlying causes of death were related to severe chronic comorbidities and most sepsis-associated deaths were unlikely to be preventable through better hospital-based care. Further innovations in the prevention and care of underlying conditions may be necessary before a major reduction in sepsis-associated deaths can be achieved.

National policies target healthcare-associated infections using medical claims and National Healthcare Safety Network surveillance data. We found low concordance between the 2 data sources in rates and rankings for surgical site infection following colon surgery in 155 hospitals, underscoring the limitations in evaluating hospital quality by claims data.

Objectives: Presenting symptoms in patients with sepsis may influence rapidity of diagnosis, time-to-antibiotics, and outcome. We tested the hypothesis that vague presenting symptoms are associated with delayed antibiotics and increased mortality. We further characterized individual presenting symptoms and their association with mortality., Design: Retrospective cohort study., Setting: Emergency department of large, urban, academic U.S. hospital., Patients: All adult patients with septic shock treated in the emergency department between April 2014 and March 2016., Interventions: None., Measurements and Main Results: Of 654 septic shock cases, 245 (37%) presented with vague symptoms. Time-to-antibiotics from first hypotension or elevated lactate was significantly longer for those with vague symptoms versus those with explicit symptoms of infection (1.6 vs 0.8 hr; p < 0.01), and in-hospital mortality was also substantially higher (34% vs 16%; p < 0.01). Patients with vague symptoms were older and sicker as evidenced by triage hypotension, Sequential Organ Failure Assessment score, initial serum lactate, and need for intubation. In multivariate analysis, vague symptoms were independently associated with mortality (adjusted odds ratio, 2.12; 95% CI, 1.32-3.40; p < 0.01), whereas time-to-antibiotics was not associated with mortality (adjusted odds ratio, 1.01; 95% CI, 0.94-1.08; p = 0.78). Of individual symptoms, only the absence of fever, chills, or rigors (odds ratio, 2.70; 95% CI, 1.63-4.47; p < 0.01) and presence of shortness of breath (odds ratio, 1.97; 95% CI, 1.23-3.15; p < 0.01) were independently associated with mortality., Conclusions: More than one third of patients with septic shock presented to the emergency department with vague symptoms that were not specific to infection. These patients had delayed antibiotic administration and higher risk of mortality even after controlling for demographics, illness acuity, and time-to-antibiotics in multivariate analysis. These findings suggest that the nature of presenting symptoms is an important component of sepsis clinical phenotyping and may be an important confounder in sepsis epidemiologic studies.

Objectives: Many septic patients receive care that fails the Centers for Medicare and Medicaid Services' SEP-1 measure, but it is unclear whether this reflects meaningful lapses in care, differences in clinical characteristics, or excessive rigidity of the "all-or-nothing" measure. We compared outcomes in cases that passed versus failed SEP-1 during the first 2 years after the measure was implemented., Design: Retrospective cohort study., Setting: Seven U.S. hospitals., Patients: Adult patients included in SEP-1 reporting between October 2015 and September 2017., Interventions: None., Measurements and Main Results: Of 851 sepsis cases in the cohort, 281 (33%) passed SEP-1 and 570 (67%) failed. SEP-1 failures had higher rates of septic shock (20% vs 9%; p < 0.001), hospital-onset sepsis (11% vs 4%; p = 0.001), and vague presenting symptoms (46% vs 30%; p < 0.001). The most common reasons for failure were omission of 3- and 6-hour lactate measurements (228/570 failures, 40%). Only 86 of 570 failures (15.1%) had greater than 3-hour delays until broad-spectrum antibiotics. Cases that failed SEP-1 had higher in-hospital mortality rates (18.4% vs 11.0%; odds ratio, 1.82; 95% CI, 1.19-2.80; p = 0.006), but this association was no longer significant after adjusting for differences in clinical characteristics and severity of illness (adjusted odds ratio, 1.36; 95% CI, 0.85-2.18; p = 0.205). Delays of greater than 3 hours until antibiotics were significantly associated with death (adjusted odds ratio, 1.94; 95% CI, 1.04-3.62; p = 0.038), whereas failing SEP-1 for any other reason was not (adjusted odds ratio, 1.10; 95% CI, 0.70-1.72; p = 0.674)., Conclusions: Crude mortality rates were higher in sepsis cases that failed versus passed SEP-1, but there was no difference after adjusting for clinical characteristics and severity of illness. Delays in antibiotic administration were associated with higher mortality but only accounted for a small fraction of SEP-1 failures. SEP-1 may not clearly differentiate between high- and low-quality care, and detailed risk adjustment is necessary to properly interpret associations between SEP-1 compliance and mortality.

We compared sepsis "time zero" and Centers for Medicare and Medicaid Services (CMS) SEP-1 pass rates among 3 abstractors in 3 hospitals. Abstractors agreed on time zero in 29 of 80 (36%) cases. Perceived pass rates ranged from 9 of 80 cases (11%) to 19 of 80 cases (23%). Variability in time zero and perceived pass rates limits the utility of SEP-1 for measuring quality.

OBJECTIVEIn 2012, the Centers for Medicare and Medicaid Services expanded a 2008 program that eliminated additional Medicare payment for mediastinitis following coronary artery bypass graft (CABG) to include Medicaid. We aimed to evaluate the impact of this Medicaid program on mediastinitis rates reported by the National Healthcare Safety Network (NHSN) compared with the rates of a condition not targeted by the program, deep-space surgical site infection (SSI) after knee replacement.DESIGNInterrupted time series with comparison group.METHODSWe included surveillance data from nonfederal acute-care hospitals participating in the NHSN and reporting CABG or knee replacement outcomes from January 2009 through June 2017. We examined the Medicaid program's impact on NHSN-reported infection rates, adjusting for secular trends. The data analysis used generalized estimating equations with robust sandwich variance estimators.RESULTSDuring the study period, 196 study hospitals reported 273,984 CABGs to the NHSN, resulting in 970 mediastinitis cases (0.35%), and 294 hospitals reported 555,395 knee replacements, with 1,751 resultant deep-space SSIs (0.32%). There was no significant change in incidence of either condition during the study. Mediastinitis models showed no effect of the 2012 Medicaid program on either secular trend during the postprogram versus preprogram periods (P=.70) or an immediate program effect (P=.83). Results were similar in sensitivity analyses when adjusting for hospital characteristics, restricting to hospitals with consistent NHSN reporting or incorporating a program implementation roll-in period. Knee replacement models also showed no program effect.CONCLUSIONSThe 2012 Medicaid program to eliminate additional payments for mediastinitis following CABG had no impact on reported mediastinitis rates.Infect Control Hosp Epidemiol 2018;39:694-700.

Objectives: Serum lactate monitoring is central to risk stratification and management of sepsis and is now part of a potential quality measure. We examined 11-year trends in lactate testing and predictors of failure to measure lactates in patients with severe sepsis., Design: Retrospective cohort study., Setting: Two U.S. academic hospitals., Patients: Adult patients admitted from 2003 to 2013., Interventions: Annual rates of lactate measurement were assessed in patients who had blood cultures ordered and patients with severe sepsis, as defined by concomitant International Classification of Diseases, Ninth Revision codes for infection and organ dysfunction. The approximate time of suspected sepsis was determined by the first blood culture order with concurrent antibiotic initiation. Multivariate analysis was performed to identify predictors of failure to measure lactates in severe sepsis cases in 2013., Measurements and Main Results: Among hospitalizations with blood culture orders, rates of lactate measurement increased from 11% in 2003 to 48% in 2013 (p < 0.001 for linear trend). Rates of repeat lactate measurement within 6 hours after lactate levels greater than or equal to 4.0 mmol/L increased from 23% to 69% (p < 0.001). Patients were progressively less likely to be on vasopressors at the time of first lactate measurement (49% in 2003 vs 21% in 2013; p < 0.001). Despite these trends, lactates were measured at the time of suspected sepsis in only 65% of patients with severe sepsis in 2013. On multivariate analysis, hospital-onset sepsis and hospitalization on a nonmedical service were significant predictors of failure to measure lactates (adjusted odds ratio, 7.56; 95% CI, 6.31-9.06 and adjusted odds ratio, 2.08; 95% CI, 1.76-2.24, respectively)., Conclusions: Lactate testing has increased dramatically over time and is being extended to patients without overt shock. However, rates of serial lactate testing are still suboptimal, and lactates are not being measured in many patients with severe sepsis. Hospital-onset sepsis and nonmedical units may be high-yield targets for quality improvement initiatives.