An Implementation Strategy to Develop Sustainable Surveillance Activities Through Adoption of a Target Operating Model.

The increasing threat of emerging and re-emerging pathogens calls for a shared vision toward developing and maintaining global surveillance mechanisms to enable rapid characterization of pathogens, a foundational requirement for effective outbreak response. Efforts establishing new surveillance programs in low- and middle-income countries (LMICs) have repeatedly led to siloed systems that prove unsustainable or ineffective due to narrowly focused approaches, competing priorities, or lack of resourcing. Barriers inherent to LMICs, such as resource limitations, workforce strain, unreliable supply chains, and lack of enduring champions exacerbate implementation and sustainability challenges. In order to improve adoption and endurance of new surveillance programs, more effective design and implementation of programs is needed to adequately reflect stakeholder needs and simultaneously support population-level disease monitoring and clinical decision-making across a range of chronic and acute health issues. At the heart of this cross-sectorial integration between clinical care and public health initiatives are emerging technologies and data modalities, including sequencing data. In this prospective, we propose an implementation strategy for genomics-based surveillance initiatives in LMICs founded on the use of a target operating model. Adoption of a target operating model for the design and implementation of genomic surveillance programs will ensure programs are agile, relevant, and unified across diverse stakeholder communities, thereby increasing their overall impact and sustainability.

Implementation of SARS-CoV-2 Monoclonal Antibody Infusion Sites at Three Medical Centers in the United States: Strengths and Challenges Assessment to Inform COVID-19 Pandemic and Future Public Health Emergency Use.

Monoclonal antibody therapeutics to treat coronavirus disease (COVID-19) have been authorized by the US Food and Drug Administration under Emergency Use Authorization (EUA). Many barriers exist when deploying a novel therapeutic during an ongoing pandemic, and it is critical to assess the needs of incorporating monoclonal antibody infusions into pandemic response activities. We examined the monoclonal antibody infusion site process during the COVID-19 pandemic and conducted a descriptive analysis using data from 3 sites at medical centers in the United States supported by the National Disaster Medical System. Monoclonal antibody implementation success factors included engagement with local medical providers, therapy batch preparation, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges included confirming patient severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positivity, strained staff, scheduling, and pharmacy coordination. Infusion sites are effective when integrated into pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources.

Staffing and Capacity Planning for SARS-CoV-2 Monoclonal Antibody Infusion Facilities: A Performance Estimation Calculator Based on Discrete-Event Simulations.

Background: The COVID-19 pandemic has significantly stressed healthcare systems. The addition of monoclonal antibody (mAb) infusions, which prevent severe disease and reduce hospitalizations, to the repertoire of COVID-19 countermeasures offers the opportunity to reduce system stress but requires strategic planning and use of novel approaches. Our objective was to develop a web-based decision-support tool to help existing and future mAb infusion facilities make better and more informed staffing and capacity decisions. Materials and Methods: Using real-world observations from three medical centers operating with federal field team support, we developed a discrete-event simulation model and performed simulation experiments to assess performance of mAb infusion sites under different conditions. Results: 162,000 scenarios were evaluated by simulations. Our analyses revealed that it was more effective to add check-in staff than to add additional nurses for middle-to-large size sites with ≥2 infusion nurses; that scheduled appointments performed better than walk-ins when patient load was not high; and that reducing infusion time was particularly impactful when load on resources was only slightly above manageable levels. Discussion: Physical capacity, check-in staff, and infusion time were as important as nurses for mAb sites. Health systems can effectively operate an infusion center under different conditions to provide mAb therapeutics even with relatively low investments in physical resources and staff. Conclusion: Simulations of mAb infusion sites were used to create a capacity planning tool to optimize resource utility and allocation in constrained pandemic conditions, and more efficiently treat COVID-19 patients at existing and future mAb infusion sites.

Real-world Effect of Monoclonal Antibody Treatment in COVID-19 Patients in a Diverse Population in the United States.

BACKGROUND: Monoclonal antibodies (mAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are a promising treatment for limiting the progression of coronavirus disease 2019 (COVID-19) and decreasing strain on hospitals. Their use, however, remains limited, particularly in disadvantaged populations. METHODS: Electronic health records were reviewed from SARS-CoV-2 patients at a single medical center in the United States that initiated mAb infusions in January 2021 with the support of the US Department of Health and Human Services' National Disaster Medical System. Patients who received mAbs were compared with untreated patients from the time period before mAb availability who met eligibility criteria for mAb treatment. We used logistic regression to measure the effect of mAb treatment on the risk of hospitalization or emergency department (ED) visit within 30 days of laboratory-confirmed COVID-19. RESULTS: Of 598 COVID-19 patients, 270 (45%) received bamlanivimab and 328 (55%) were untreated. Two hundred thirty-one patients (39%) were Hispanic. Among treated patients, 5/270 (1.9%) presented to the ED or required hospitalization within 30 days of a positive SARS-CoV-2 test, compared with 39/328 (12%) untreated patients (P < .001). After adjusting for age, gender, and comorbidities, the risk of ED visit or hospitalization was 82% lower in mAb-treated patients compared with untreated patients (95% CI, 56%-94%). CONCLUSIONS: In this diverse, real-world COVID-19 patient population, mAb treatment significantly decreased the risk of subsequent ED visit or hospitalization. Broader treatment with mAbs, including in disadvantaged patient populations, can decrease the burden on hospitals and should be facilitated in all populations in the United States to ensure health equity.