The Society for Healthcare Epidemiology of America, the Association of Professionals in Infection Control and Epidemiology, the Infectious Diseases Society of America, and the Pediatric Infectious Diseases Society represent the core expertise regarding healthcare infection prevention and infectious diseases and have written multisociety statement for healthcare facility leaders, regulatory agencies, payors, and patients to strengthen requirements and expectations around facility infection prevention and control (IPC) programs. Based on a systematic literature search and formal consensus process, the authors advocate raising the expectations for facility IPC programs, moving to effective programs that are:

• Foundational and influential parts of the facility’s operational structure

• Resourced with the correct expertise and leadership

• Prioritized to address all potential infectious harms

This document discusses the IPC program’s leadership—a dyad model that includes both physician and infection preventionist leaders—its reporting structure, expertise, and competencies of its members, and the roles and accountability of partnering groups within the healthcare facility. The document outlines a process for identifying minimum IPC program medical director support. It applies to all types of healthcare settings except post-acute long-term care and focuses on resources for the IPC program. Long-term acute care hospital (LTACH) staffing and antimicrobial stewardship programs will be discussed in subsequent documents.

Interval estimates of the Pearson, Kendall tau-a and Spearman correlations are reviewed and an improved standard error for the Spearman correlation is proposed. The sample size required to yield a confidence interval having the desired width is examined. A two-stage approximation to the sample size requirement is shown to give accurate results.

OBJECTIVES/GOALS: The aim of this study was to design and implement the Pharos application to map the cellular network support structure around Lake Victoria in Western Kenya. Additionally, the Pharos app was used to collect images of disease-relevant vector and plant life surrounding the study sites to train a computer vision algorithm to map disease-relevant areas. METHODS/STUDY POPULATION: Pharos was provided to a 4-person team of healthcare workers. The app was pre-loaded on both iOS and Android devices to be used during the course of normal field activity. Pharos ambiently collects network data and the team was asked to capture images of landmarks relevant to their work in schistosomiasis control. The field team traveled to 4 counties of differing schistosomiasis risk surrounding Kisumu, Kenya in autumn 2022 and will return to these areas in early spring 2023. Cell signal indicators (upload and download speed) were collected and asynchronously uploaded to a database for further analysis. Additionally, all landmark images (cell network towers, landmarks (e.g. schools, churches, public centers), plant life, vectors, and water bodies) were recorded and tagged with GPS coordinates and time stamps. RESULTS/ANTICIPATED RESULTS: Iterative development powered by small, informal, user-centered focus group discussions with the field team led to several key adaptations to the Pharos software. On the first deployment, 1,297 unique upload and download events were recorded across 3 Kenyan cell providers and 1 American provider. 1,197 data points were collected in Kenya using both Android and iOS devices using several versions of the Pharos application. 154 unique landmarks were photographed, but a distinct difference in landmark recording was observed between devices, prompting a transition to iOS-only data collection. Of the landmarks recorded, the majority (120, 77.9%) were landmarks or cell network towers, while 22.1% were water bodies, plant life, or schistosomiasis vectors. DISCUSSION/SIGNIFICANCE: For the first time, high-detail maps of cellular signal and critical schistosomiasis-related landmarks were generated. Future work on this project is focused on training computer vision algorithms using the captured images of environmental and ecological factors to isolate possible areas of human disease transmission.

The coronavirus disease 2019 (COVID-19) pandemic highlighted the lack of agreement regarding the definition of aerosol-generating procedures and potential risk to healthcare personnel. We convened a group of Massachusetts healthcare epidemiologists to develop consensus through expert opinion in an area where broader guidance was lacking at the time.

Testing of asymptomatic patients for severe acute respiratory coronavirus virus 2 (SARS-CoV-2) (ie, “asymptomatic screening) to attempt to reduce the risk of nosocomial transmission has been extensive and resource intensive, and such testing is of unclear benefit when added to other layers of infection prevention mitigation controls. In addition, the logistic challenges and costs related to screening program implementation, data noting the lack of substantial aerosol generation with elective controlled intubation, extubation, and other procedures, and the adverse patient and facility consequences of asymptomatic screening call into question the utility of this infection prevention intervention. Consequently, the Society for Healthcare Epidemiology of America (SHEA) recommends against routine universal use of asymptomatic screening for SARS-CoV-2 in healthcare facilities. Specifically, preprocedure asymptomatic screening is unlikely to provide incremental benefit in preventing SARS-CoV-2 transmission in the procedural and perioperative environment when other infection prevention strategies are in place, and it should not be considered a requirement for all patients. Admission screening may be beneficial during times of increased virus transmission in some settings where other layers of controls are limited (eg, behavioral health, congregate care, or shared patient rooms), but widespread routine use of admission asymptomatic screening is not recommended over strengthening other infection prevention controls. In this commentary, we outline the challenges surrounding the use of asymptomatic screening, including logistics and costs of implementing a screening program, and adverse patient and facility consequences. We review data pertaining to the lack of substantial aerosol generation during elective controlled intubation, extubation, and other procedures, and we provide guidance for when asymptomatic screening for SARS-CoV-2 may be considered in a limited scope.

The Hierarchical Taxonomy of Psychopathology (HiTOP) has emerged out of the quantitative approach to psychiatric nosology. This approach identifies psychopathology constructs based on patterns of co-variation among signs and symptoms. The initial HiTOP model, which was published in 2017, is based on a large literature that spans decades of research. HiTOP is a living model that undergoes revision as new data become available. Here we discuss advantages and practical considerations of using this system in psychiatric practice and research. We especially highlight limitations of HiTOP and ongoing efforts to address them. We describe differences and similarities between HiTOP and existing diagnostic systems. Next, we review the types of evidence that informed development of HiTOP, including populations in which it has been studied and data on its validity. The paper also describes how HiTOP can facilitate research on genetic and environmental causes of psychopathology as well as the search for neurobiologic mechanisms and novel treatments. Furthermore, we consider implications for public health programs and prevention of mental disorders. We also review data on clinical utility and illustrate clinical application of HiTOP. Importantly, the model is based on measures and practices that are already used widely in clinical settings. HiTOP offers a way to organize and formalize these techniques. This model already can contribute to progress in psychiatry and complement traditional nosologies. Moreover, HiTOP seeks to facilitate research on linkages between phenotypes and biological processes, which may enable construction of a system that encompasses both biomarkers and precise clinical description.

Background: Admission laboratory screening for asymptomatic COVID-19 has been utilized to mitigate healthcare-associated SARS-CoV-2 transmission. A better understanding of the impact of such testing across a variety of patient populations is needed. Methods: Beginning April 2020, every patient admitted within an academic healthcare system underwent SARS-CoV-2 PCR testing upon admission. Between April 20, 2020 through June 14, 2021, results were analyzed in asymptomatic patients across 4 inpatient facilities: a tertiary-care adult hospital, a free-standing pediatric hospital, a community-based hospital, and a behavioral health hospital. Positivity rates and the number needed to test (NNT) to identify 1 asymptomatic infected patient were calculated overall, by hospital type, by patient vaccination status, and by CDC-defined levels of community transmission. Weekly community incidence rates of COVID-19 for the system’s metropolitan service area (8 central Tennessee counties) were obtained from Tennessee Department of Health records. Weekly COVID-19 incidence rates per 100,000 people were calculated using US Census Bureau data. Using a national survey of hospital epidemiologists, a clinically meaningful NNT was identified (ie, 1 positive patient per 100 patients tested). A crude admission testing cost (covering testing supplies, reagents, and lab personnel costs) was obtained from operational data ($50 per test) to assess testing utility. Results: In total, 51,187 tests were collected during the study period with a positivity rate of 1.8%. No periods of low transmission were observed (Table 1). During high transmission periods, the NNT met the clinically relevant threshold in all populations. In addition, the NNT approached or met the 1:100 threshold for most locations during periods of less transmission, suggesting continued benefit even as infection rates decline. In all transmission periods, the NNT for non–fully vaccinated patients met the clinically meaningful threshold, in contrast to testing of fully vaccinated patients (Table 2). Discussion: Implementing an asymptomatic patient admission testing program can provide clinically relevant value based on the NNT, even during lower periods of transmission and in different patient populations. Limiting admission testing to non–fully vaccinated patients during periods of lower transmission may be a strategy to address cost and resource concerns around this practice. Further investigations into the impact of booster vaccination and newer SARS-CoV-2 variants on admission testing programs are also necessary. Although the impact of such testing on healthcare-associated COVID-19 among patients and healthcare workers could not be clearly determined, these data provide important information as facilities weigh the costs and benefits of such testing.

Funding: None

Disclosures: None

OBJECTIVES/GOALS: In triple negative breast cancer (TNBC), obesity is associated with poor outcomes. Adipose stem cells (ASCs) from obese patients (obASCs) secrete higher levels of adipokines compared to ASCs from lean individuals. Leptin, one of these adipokines, has been implicated in many cancers. This study seeks to examine the role of leptin signaling in TNBC. METHODS/STUDY POPULATION: Previous work in conjunction with a collaborating lab has shown that leptin signaling promotes metastasis and increased expression of epithelial-mesenchymal transition (EMT) markers in triple negative breast cancer cell lines. This project expands upon this work through using both patient-derived cell lines and and patient-derived xenografts (PDX), and examines the role of leptin signaling both in vitro and in vivo. To determine the effects of obesity upon a PDX model of TNBC, a high fat diet was used to induce obesity in vivo. A pharmacological inhibitor of the leptin receptor was used to test the requirement for leptin signaling both in vivo and in vitro. RESULTS/ANTICIPATED RESULTS: Exposure to conditioned media harvested from obASCs increased the percentage of TNBC cells that expressed cancer stem cell markers, whereas exposure to an inhibitor of the leptin receptor decreased the percentage of cells with cancer stem cell markers. PDX tumors implanted into mice with diet-induced obesity had an increased volume compared to tumors implanted into lean controls. Further analysis will be conducted on metastasis, circulating tumor cells, and survival in both lean and obese mice. DISCUSSION/SIGNIFICANCE: Understanding the complex signaling events in the obese tumor microenvironment is essential, as these molecular differences may contribute to different outcomes for obese and lean individuals with triple negative breast cancer. Therefore, study of the crosstalk between obASCs and TNBC cells is critical.

Background: Handshake antibiotic stewardship is an effective but resource-intensive strategy for reducing antimicrobial utilization. At larger hospitals, widespread implementation of direct handshake rounds may be constrained by available resources. To optimize resource utilization and mirror handshake antimicrobial stewardship, we designed an indirect feedback model utilizing existing team pharmacy infrastructure. Methods: The antibiotic stewardship program (ASP) utilized the plan-do-study-act (PDSA) improvement methodology to implement an antibiotic stewardship intervention centered on antimicrobial utilization feedback and patient-level recommendations to optimize antimicrobial utilization. The intervention included team-based antimicrobial utilization dashboard development, biweekly antimicrobial utilization data feedback of total antimicrobial utilization and select drug-specific antimicrobial utilization, and twice weekly individualized review by ASP staff of all patients admitted to the 5 hospitalist teams on antimicrobials with recommendations (discontinuation, optimization, etc) relayed electronically to team-based pharmacists. Pharmacists were to communicate recommendations as an indirect surrogate for handshake antibiotic stewardship. As reviewer duties expanded to include a rotation of multiple reviewers, a standard operating procedure was created. A closed-loop communication model was developed to ensure pharmacist feedback receipt and to allow intervention acceptance tracking. During implementation optimization, a team pharmacist-champion was identified and addressed communication lapses. An outcome measure of days of therapy per 1,000 patient days present (DOT/1,000 PD) and balance measure of in-hospital mortality were chosen. Implementation began April 5, 2019, and data were collected through October 31, 2019. Preintervention comparison data spanned December 2017 to April 2019. Results: Overall, 1,119 cases were reviewed by the ASP, of whom 255 (22.8%) received feedback. In total, 236 of 362 recommendations (65.2%) were implemented (Fig. 1). Antimicrobial discontinuation was the most frequent (147 of 362, 40.6%), and most consistently implemented (111 of 147, 75.3%), recommendation. The DOT/1,000 PD before the intervention compared to the same metric after intervention remained unchanged (741.1 vs 725.4; P = .60) as did crude in-hospital mortality (1.8% vs 1.7%; P = .76). Several contributing factors were identified: communication lapses (eg, emails not received by 2 pharmacists), intervention timing (mismatch of recommendation and rounding window), and individual culture (some pharmacists with reduced buy-in selectively relayed recommendations). Conclusion: Although resource efficient, this model of indirect handshake did not significantly impact total antimicrobial utilization. Through serial PDSA cycles, implementation barriers were identified that can be addressed to improve the feedback process. Communication, expectation management, and interpersonal relationship development emerged as critical issues contributing to poor recommendation adherence. Future PDSA cycles will focus on streamlining processes to improve communication among stakeholders.

Funding: None

Disclosures: None

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.