Attachment 1 - EIP 2024 Activities.docx

NOFO: CK24-2401

Emerging Infections Program

ATTACHMENT 1 – 2024 EIP ACTIVITY DESCRIPTIONS

Table of Contents:

Description and Goals

ATTACHMENT 1, SECTION A

Infrastructure and Data Modernization

Background The Emerging Infections Program (EIP) network assists in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases. Activities of the EIPs include infrastructure and data modernization as well as: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) rapid and flexible response to public health emergencies and newly emerging issues for infectious diseases. The EIP network is able to address important public health questions collaboratively, using population-based data to inform public health policy recommendations and treatment guidelines for the prevention of disease.

The EIP network conducts active, population-based surveillance and special studies for respiratory viral diseases [influenza, respiratory syncytial virus (RSV), COVID-19], invasive bacterial diseases including antibiotic-resistant infections, foodborne pathogens, healthcare-associated infections, and other infectious diseases. EIP has flexible response capabilities and unique strengths as a multi-site network, for example, the platform for laboratory-confirmed influenza hospitalization surveillance started in 2003 and RSV-associated hospitalizations surveillance started in 2016; COVID-NET was added to the EIP network to provide important data on hospitalization rates associated with COVID-19 beginning in March 2020 allowing the EIP network to respond efficiently and effectively to the COVID-19 pandemic.

As the EIP network has transitioned and grown, there is a need to enhance cross-cutting infrastructure, bioinformatics, and data modernization activities and resources to support EIP recipients. These activities include scientific, programmatic, business/administrative capacities and the modernization of EIP systems, processes, and approaches. Also, enhanced data to understand systemic health and social inequities to advance public health practices and policies that advance health equity, is a new focus for data exchange and across all activities. The specific strategies and activities that applicants are required to apply for are indicated below, along with data modernization projects that applicants are strongly encouraged to apply for.

Other National Public Health Priorities and Strategies This EIP activity aligns with CDC’s Data Modernization Initiative (DMI) and health information system investments made through Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) and other cooperative agreements. For specific information on CDC’s DMI, refer to: https://www.cdc.gov/surveillance/index.html.

Purpose The purpose of this Infrastructure/Data Modernization activity is to provide support to EIP recipients to establish and maintain their cross-cutting scientific, programmatic, business/administrative, and data modernization capacities. Recipient requests are intended to include staff, activities, and related costs that are essential to assuring general EIP infrastructure and are not supported by the applicant’s Indirect Cost Rate Agreement or other cooperative agreement activities.

Outcomes

· Enhanced cross-cutting scientific, programmatic, and business management for conducting EIP programmatic activities

· Effective population-based data to reflect national representativeness for informing public health policy and practices

· Flexibility and efficiency for responding to emerging infections and public health emergencies

· Established partnerships and collaborations to enhance the EIP network activities and outcomes

· Enhanced training and workforce development for the EIP workforce

· Enhanced bioinformatics, pathogen genomics, and other relevant advanced molecular detection (AMD) technologies

· Adherence to human subjects and institutional review board (IRB), Office of Management and Budget Paperwork Reduction Act (OMB-PRA), and Dual Use Research of Concern (DURC) policies and procedures

· Modernized and improved EIP information systems for collection, entry, and electronic exchange of data, including demographic and social data, on infectious diseases and other emerging health threats to inform public health policy and practices

· Enhanced data visualization capacity and sharing to inform local, state, and national audiences

Strategies and Activities

1. Scientific, Programmatic, and Business/Administrative Oversight and Coordination. Ensure effective scientific, programmatic, and business/administrative leadership, management, coordination, execution, and continuity of EIP activities overall. Organize staffing and related support structure to effectively manage cross-cutting functions and to adequately support recipient’s portfolio of programmatic and cross-cutting activities. This also includes scientific and programmatic coordination and management of cross-cutting areas such as bioinformatics and data modernization.

2. Populations/Catchment Areas. Due to the goals of national representativeness and feasibility to conduct active population-based surveillance and assess health disparities, some proposed catchment areas may be too small to meaningfully contribute to the EIP network, or, alternatively, be too large to feasibly conduct these very intensive surveillance activities. Total population of catchment areas must be between 1,000,000–11,000,000 people. Of note, this minimum of 1,000,000 people applies to the overall catchment area and not each individual EIP activity (e.g., FluSurv-NET, COVID-NET, RSV-NET, ABCs, etc.). To help achieve health equity aims, applicants should consider establishing or expanding surveillance catchment areas to be representative of the diversity of their jurisdiction and enable accurate estimation of the burden and impact of EIP pathogens. Diversity of populations in the catchment area can be defined by multiple factors, such as geography, rurality/urbanicity, age distribution, race/ethnicity, socioeconomic status, and under-represented populations at increased risk of infectious diseases or at increased risk of poor outcomes of infectious diseases. To achieve outcomes, applicants should consider conducting or expanding surveillance in, or collaborating on special projects with, healthcare facilities that serve particular communities/populations (e.g., facilities in or serving rural communities or specific racial/ethnic populations). Applicants should describe plans and apply for the resources needed to establish or enhance expertise in health equity and social and behavioral science for related data collection and analysis. The population base may vary by activity and may change over time as needs evolve.

3. Flexibility and Efficiency. Organize resources in a manner that allows for flexibility to respond to new public health issues as they arise and for optimal efficiency across multiple projects conducted in one or more facilities within an EIP site. For a flexible response, each EIP will be expected to participate in a workgroup convened on short notice to review newly emerging infectious disease issues. Should the workgroup determine that EIPs will help guide the response, each EIP site is expected to contribute to rapid study design and initiate and complete the relevant study. In this application, describe how applicant will ensure (1) the surge capacity to participate in workgroups convened on short notice to review newly emerging infectious disease issues and (2) the surge capacity including rapid staffing approaches needed to help guide the response to that issue in the short-term, including by contributing to the rapid study design and initiating and completing new studies in a timely manner.

4. Collaborations and Partnerships. Collaboration with a variety of appropriate partners is strongly encouraged but partners must include at least one academic institution, unless the applicant is an academic institution. The academic partner chosen by the applicant does not need to be within their jurisdiction, it could be any academic institution within the U.S. Also, the academic partner can be engaged in select specific activities within the application. Develop and operate the EIP site to function effectively as a member of the national network. Participate actively in EIP working groups to help establish network priorities, coordinate projects, monitor progress, and, when appropriate, ensure standardized implementation of activities across sites. Establish and maintain working relationships with local partners, including but not limited to, academic centers, health departments, infection control practitioners, hospitals, healthcare providers, public and private laboratories, research organizations, tribal organizations (if partnering with Native American/Alaskan Native populations), and other Federal and state government agencies.

5. Training and Workforce Development. Incorporate training such as infectious disease fellowships for clinicians, laboratorians, and researchers, as well as other training opportunities for public health students and local public health professionals. Opportunities can include, but are not limited to, fellowships, educational conferences or seminars, thesis advising or mentoring, and work study or research assistant positions. Also, data science training and workforce development may be proposed.

6. Data Management, Access, and Sharing. Collect, manage, analyze, and interpret data from EIP projects; publish and disseminate important public health information resulting from EIP projects in collaboration with CDC and other EIP sites as appropriate. Ensure and maintain ability and capacity to conduct medical record reviews, surveys, laboratory audits, and analysis of hospital admissions and discharge data. Work with CDC programs and the network to ensure quality assurance.

Work with CDC programs and the network to ensure compliance with CDC’s Policy on Public Health Research and Non-research Data Management and Access. The goal of the policy is to ensure public access to federally funded public health data. This specifically requires development of Data Management Plans (DMPs) for each EIP activity that includes collection of public health data. CDC recognizes there may be certain legal limitations on the recipients for sharing certain data they may collect, and those legal limitations should be identified in their DMP. DMPs should be developed jointly by CDC and EIP recipients within the first six months after award and updated as appropriate throughout the life cycle of the data. DMPs should include:

· Descriptions of the data to be collected or generated;

· The standards to be used for the collected or generated data;

· Mechanisms for, or limitations to, providing access to the data, including a description for the provisions for the protection of privacy, confidentiality, security, and intellectual property, or other rights;

· Statement of the use of data standards that ensure all documentation that describes the method of collection, what the data represent, potential limitations for use, and

· Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified

7. Application of bioinformatics into EIP activities. Integration of pathogen genomics and other relevant advanced molecular detection (AMD) technologies into EIP’s programmatic activities, including applied research, surveillance, and response, to improve the control of pathogens of public health importance. In collaboration with CDC and other EIP sites, proposed EIP bioinformatics projects will address collaborative network activities targeting epidemiologically well-characterized strains or specimens. Sites are encouraged to readily implement bioinformatics methods and techniques to help transform and modernize the impact possible through EIP. Proposed activities may be complementary or in support of pathogen genomics and other AMD-related projects in other EIP activities. Applicants may propose some or all of the following:

1. Utilizing results of whole genome sequencing, metagenomics, or other AMD approaches for the integration of epi data with lab/sequencing/bioinformatics data collected through collaborative EIP network activities in order to:

0. Understand pathogen transmission;

0. Understand evolution of pathogens during outbreaks;

0. Infer resistance to antibiotics; and/or

0. Study susceptibility to infection

1. Developing bioinformatics expertise that contributes to the design and analysis of data from projects that include pathogen genomics for EIP.

8. Program Evaluation. Ensure capacity for general EIP program evaluation and performance measurement. The evaluation and performance measurement for individual EIP activities may be developed in collaboration with CDC and/or independently. Some EIP activities have established performance metrics that must be used – refer to activity-specific guidance in Attachment 1.

9. Human Subjects. Ensure appropriate local review of EIP activities and provide local IRB status and/or determination of all research projects undertaken. For activities involving research on human subjects, each institution that participates in human subjects research is required to review each protocol annually and submit current copies of IRB approval letters in the annual non-competitive continuation applications and to PGO as determinations are made during the year. For specific EIP studies that involve human subjects, obtain institutional review board approval prior to the commencement of study activities and ensure subjects are recruited according to study protocols.

10. Office of Management and Budget Paperwork Reduction Act (OMB-PRA). Work with CDC scientists to obtain OMB-PRA approvals, as needed.

11. Dual Use Research of Concern (DURC). Comply with the responsibilities for the PI as described in the United States Government Policy for Institutional Oversight of Life Science (DURC). See http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf).

12. Data Modernization. Modernization of EIP systems, processes, and approaches is critical to reducing burden and fragmentation, improving efficiency, data quality, and the ability to manage, use and share data. EIP efforts help answer priority questions and provide new insights that suggest new or adjusted paths for public health. Continuing to build on existing EIP informatics priorities, the EIP aligns with CDC’s broader Data Modernization Initiative (DMI) and health information system investments through Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) and other cooperative agreements. Proposed activities should build upon the appropriate existing investments and infrastructure supported by existing data modernization and health information system funding.

This guidance provides goals for modernizing how EIP obtains and exchanges information, while also considering how EIP can serve as a model for health departments and data modernization activities.

Data and infrastructure modernization to support the EIP network for public health practice and applied research will consist of EIP site activities, described below, as well as CDC implementing modernized infrastructure across EIP programs for ingestion, processing, analytics, and visualization (e.g., Enterprise Data Exchange (DEX), EZ Data Exchange, Data Lake & Services, Data Collation and Integration for Public Health Event Response (DCIPHER), Enterprise Data Analytics and Visualization (EDAV)). As services become available and activities continue to develop, EIP sites will be expected to continue to align with and engage in these modernization efforts.

Please respond to each activity as indicated below. Candidate sites should describe their capacity, engagement with CDC, other EIP sites, or other local institutions, and how they will leverage parallel data modernization and health information systems investments, including ELC funding, as appropriate.

General EIP Data and IT Modernization – All EIP Sites are required to work towards achieving the following goals:

1. Modernize EIP information systems including data collection, data entry and electronic data exchange within the EIP site. Activities should prioritize interoperability and use of data standards and automated methods, particularly those that replace previously manual activities.

a. Allow for efficient incorporation of annual updates and enhancements required by EIP programs.

b. As supported by CDC for specific EIP activities, transition data collection from EIP program standalone databases (i.e., Microsoft Access) to the state integrated surveillance information system(s). Details should be provided for implementation, including legacy data and timeline.

c. For data maintained outside of the surveillance system, adhere to data standards, and develop interoperability or shared infrastructure between systems.

2. Leverage existing electronic laboratory reporting (ELR) and electronic case reporting (eCR) infrastructure and processes to reduce duplication and manual effort for EIP active surveillance. Activities could include automating the population of lab data in EIP case report forms from ELR, auditing reporting facilities to maintain high data quality, prioritizing the integration of EIP pathogens from ELR, automating the population of case data in EIP case report forms from eCR.

3. Work towards a more flexible, efficient, and automated approach to exchanging data between electronic health records (EHRs) and public health, with a goal of automating data extraction for use in EIP surveillance or special studies as a model for how this can be achieved across public health. Approaches may include, but are not limited to direct querying, Fast Healthcare Interoperability Resources (FHIR) or other standards-based mechanisms (Clinical Document Architecture (CDA), identified Admission, Discharge, Transfer messages (ADTs)). Proposals should detail intended approach along with engagement with specific facilities, health systems, EHR vendors, health information exchanges, etc. Sites should work within the EIP site (e.g., vendors, health systems) and with CDC and other sites on implementation of these activities.

4. Enhance capacity for analytics, visualization, and reporting (AVR) for EIP activities. Examples include, but are not limited to:

a. Modernize and automate EIP data cleaning, reporting, or visualization processes.

b. Implement AVR tools for internal and external data sharing.

c. Geocode EIP cases by residence using novel strategies.

d. Engage in the use of shared AVR services from CDC, as they are available.

5. Modernize data exchange with CDC. EIP site activities will occur in addition to ongoing CDC activities to modernize EIP Data Flows through DEX and EZ Data Exchange, which consists of Data Lake & Services, DCIPHER, and REDCap. Case Surveillance efforts should be consistent with ongoing agency efforts around Case Surveillance Modernization including activities to:

i. Maintain current transmission until replaced by new, approved transmission.

ii. Participate in a CDC collaborative national process to establish standardized data for case-based surveillance

6. Participate in the EIP IT Support and Monitoring and coordination efforts. This includes scheduling requested calls in a timely manner, having all requested participants on calls, and completing REDCap monitoring updates prior to quarterly calls.

Special Projects – In addition to the required activities above, EIP sites should propose modernization activities that will enhance existing and future EIP work.

1. Implement modernized and automated methods of data extraction, linking, or collection from a variety of data sources in defined settings for EIP. Activities should focus on interoperability between systems across clinical facilities, labs, public health, and other entities. Respondents should propose at least 2 data modernization special projects for the 5-year funding cycle, and should include proposed approach, implementation plan, and partners. EIP sites should consider working with CDC on collaborative projects, where possible. Examples include, but are not limited to:

a. Systems should be enhanced to consume and integrate data from the state Immunization Information System (IIS) for EIP use where applicable.

b. Automate data extracts or exchange required with the state’s vital statistics system for the extraction of birth, death, or other data for EIP case report forms and/or special projects.

c. Implement privacy preserving record linkage (PPRL) or other novel data linking mechanisms to allow for linking across EIP data.

d. Work with novel data sources across one or many EIP program areas to enhance understanding of cross-cutting themes, such as social vulnerabilities or access to care. See the novel data sources and linkages section below for more information.

e. Modernize EIP data use and sharing workflows, including functionalities to easily audit and manage users and data products.

Exploration of novel data sources and linkages using multi-agency, multi-sector, or multidisciplinary approaches is strongly encouraged, as these may yield innovative insights to EIP and potentially transformative approaches to drivers of health inequities. For example, incorporation of wastewater epidemiology for community monitoring of COVID-19 and the early detection of viral variants has proven valuable and effective, though this approach only reaches communities with municipal wastewater systems and excludes communities relying on private septic tanks, thus innovative solutions are needed for further implementing wastewater epidemiology. Exploring novel data linkages outside of the normal infectious disease causal pathways, such as data sources describing social, cultural, and economic inequities, may illuminate new challenges or opportunities to improve health for all people in all communities. Novel data sources may include, but are not limited to, data describing a wide range of population and community health outcomes (e.g. length of life, quality of life), health factors (e.g. health behaviors, access to care, quality of care), social, cultural, and economic factors (e.g. food security, housing, education, occupation, employment, income, family and social support, community safety), or physical and built environment factors (e.g. weather, climate, pollution, transportation).

Evaluation and Performance Measurement

· Performance measures will be finalized in the first 90 days of the award

ATTACHMENT 1, SECTION B

Surveillance and Reporting 1

Background Since 1995, the EIP network has been engaged in surveillance and applied research activities related to infectious disease emergencies. Most notably, those situations included SARS, novel H1N1, and more recently the COVID-19 pandemic. During the early stages of the COVID-19 pandemic, these Surveillance and Reporting 1 and 2 activities were utilized to rapidly add COVID-NET to the EIP network to provide important data on hospitalization rates associated with COVID-19. Ultimately, due to the unpredictable nature of these infectious disease emergencies, CDC EIP needs the ability to support EIP sites with the resources to respond to these infectious disease emergencies.

Other National Public Health Priorities and Strategies N/A

Purpose This potential funding would provide additional epidemiologic, laboratory, and/or health information systems surge capacity necessary for enhanced public health surveillance or applied research activities due to factors such as an increase in response efforts for emerging or re-emerging infectious disease(s), outbreak scenarios, or other public health threats. Activities in this section will only be funded should applicable surveillance and/or applied research conditions warrant.

Outcomes Conduct robust surveillance and/or applied research activities that will ensure timely and efficient control of infectious diseases, updated knowledge and guidelines, and intervention recommendations as applicable. EIP sites will also work with CDC as outcomes are developed for this activity.

Strategies and Activities

1) Conduct and enhance surveillance and/or applied research activities in response to new or emerging infectious disease investigation(s) or priorities.

2) Enhance the ability of the laboratory and/or information systems to rapidly respond to the surveillance and/or applied research activity.

3) Collaborate with CDC and other EIP sites to update knowledge, guidelines, and intervention recommendations as applicable.

4) Report activities, performance measures, and outcomes (as they become available) to CDC.

Collaborate with CDC as evaluation and performance measures are defined for this activity.

ATTACHMENT 1, SECTION C

Surveillance and Reporting 2

Since 1995, the EIP network has been engaged in surveillance and applied research activities related to infectious disease emergencies. Most notably, those situations included SARS, novel H1N1, and more recently the COVID-19 pandemic. During the early stages of the COVID-19 pandemic, these Surveillance and Reporting 1 and 2 activities were utilized to rapidly add COVID-NET to the EIP network to provide important data on hospitalization rates associated with COVID-19. Ultimately, due to the unpredictable nature of these infectious disease emergencies, CDC EIP needs the ability to support EIP sites with the resources to respond to these infectious disease emergencies.

Other National Public Health Priorities and Strategies N/A

Purpose This potential funding would provide additional epidemiologic, laboratory, and/or health information systems surge capacity necessary for enhanced public health surveillance or applied research activities due to factors such as an increase in response efforts for emerging or re-emerging infectious disease(s), outbreak scenarios, or other public health threats. Activities in this section will only be funded should applicable surveillance and/or applied research conditions warrant.

Outcomes Conduct robust surveillance and/or applied research activities that will ensure timely and efficient control of infectious diseases, updated knowledge and guidelines, and intervention recommendations as applicable. EIP sites will also work with CDC as outcomes are developed for this activity.

Strategies and Activities

1) Conduct and enhance surveillance and/or applied research activities in response to new or emerging infectious disease investigation(s) or priorities.

2) Enhance the ability of the laboratory and/or information systems to rapidly respond to the surveillance and/or applied research activity.

3) Collaborate with CDC and other EIP sites to update knowledge, guidelines, and intervention recommendations as applicable.

4) Report activities, performance measures, and outcomes (as they become available) to CDC.

Collaborate with CDC as evaluation and performance measures are defined for this activity.

Respiratory Virus Hospitalization Surveillance Network (RESP-NET):

Description and Goals

Respiratory viruses, including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2, are major causes of severe illness resulting in significant numbers of hospitalizations and deaths each year. Surveillance programs are crucial for monitoring the timing, burden and severity of disease, characterizing circulating virus strains, and describing changes in the epidemiology or risk factors associated with infection, as well as describing trends in treatment and interventions. Surveillance data may also be used to monitor the impact of vaccines, to alert the public about the intensity and magnitude of an epidemic, and to evaluate the effectiveness of intervention programs. Surveillance programs are essential for guiding response efforts and assisting with resource prioritization.

Surveillance for laboratory-confirmed influenza hospitalizations (FluSurv-NET) was added to the EIP platform in 2003. This platform was then adapted to conduct surveillance for RSV-associated hospitalizations (RSV-NET) starting in 2016 and COVID-19-associated hospitalization surveillance (COVID-NET) starting in March 2020. This combined three-platform system is referred to as the Respiratory Virus Hospitalizations Surveillance Network (RESP-NET). RESP-NET conducts active, population-based surveillance for laboratory-confirmed influenza-, COVID-19-, and RSV-associated hospitalizations among children and adults in pre-defined geographic areas. Surveillance is conducted throughout the year and may vary between platforms and from year to year depending on observed patterns of circulation. At minimum, all three platforms perform active surveillance between October 1 and April 30 of each year. Recent years have seen all three platforms perform surveillance past April 30 due to observed pathogen-specific trends.

The precise composition of the geographic areas might differ slightly between the three platforms, but funded RESP-NET sites are generally expected to have overall similar surveillance catchment areas for both comparability across platforms as well as potential cost savings through reductions in duplicated efforts. Successful RESP-NET applicants will:

· Identify a surveillance catchment area (i.e., counties from which population estimates can be obtained for rate calculations), including number of residents (i.e., population) and all hospitals in that surveillance area that could potentially admit patients with influenza, COVID, and RSV. The surveillance catchment areas should, ideally:

· Make up a reasonable proportion of the state’s population (e.g., most FluSurv-NET sites have between 9 and 61% of their state population included in surveillance).

· Demographic makeup of catchment is ideally similar to that of the whole state.

· All hospitals within the surveillance catchment area that might admit catchment area residents with acute respiratory illnesses should be included and willing to participate in surveillance.

· Not include counties in which a large proportion of the residents seek care outside of the county of residence (e.g., a county that borders 2 states and many residents go over state borders to seek care out of catchment).

· Be able to clearly identify all hospitals in which residents of the catchment areas are hospitalized so that population estimates can be obtained for rate calculations on an annual basis.

· Estimate the proportion of catchment population hospitalizations that occur outside of the catchment area.

· Utilize hospital laboratories, admission/discharge information, infection control practitioner logs/databases, and review of reportable conditions databases to identify all laboratory-confirmed influenza-, RSV-, and COVID-19-associated hospitalizations in a timely manner as determined in conjunction with CDC.

· Conduct periodic audits of clinical, reference, commercial, and public health laboratories within the surveillance catchment area to verify completeness of COVID-19, influenza, and RSV case ascertainment-using methods defined in discussion with CDC.

· Complete standardized case report forms for deidentified cases using data obtained from laboratory records and medical chart review. Because burden by pathogen and across the surveillance season may vary, sampling strategies might be implemented by CDC in order to reduce data abstraction burden on sites. Sampling strategies might vary from month to month and across the three platforms.

· Enter case data into a standardized data collection database or send de-identified data extracts that match the format of the standardized database. CDC recommends REDCap software for this purpose.

· Submit data electronically to CDC (in an agreed upon secure format) by the specified deadline and upon CDC request.

· CDC encourages sites to directly enter data into site-specific electronic databases (e.g., REDCap) rather than first abstracting onto paper to enhance efficiency.

· Provide timely responses to reports and requests for information to assist in preliminary & final analyses, reports, and data close-outs.

· Perform other platform-specific activities as outlined in the subsequent sections for FluSurv-NET, COVID-NET, and RSV-NET.

· Link influenza-, RSV- and COVID-19-associated hospitalized cases for cross-platform analyses (e.g., vaccine effectiveness, prevalence and outcomes of co-infections).

Because of the level of integration within the three RESP-NET platforms, some activities are performed for the benefit of all three platforms in a combined effort. The four core activities conducted across all three RESP-NET platforms include:

1. Conduct an annual laboratory survey to describe diagnostic tests used for influenza, COVID-19, and RSV at all laboratories that serve catchment area hospitals.

2. Geocode all cases on an annual basis using standard CDC geocoding protocol and provide case-level data on census tract.

3. Monitor testing practices for influenza, COVID-19, and RSV among all, or a majority of hospitals that fall within the catchment area by participation in the disease burden project every year. (New sites that have not previously participated in EIP may develop methods/capacity to collect burden data over several years.)

4. Ascertain influenza-, COVID-19-, and RSV-associated deaths that occurred during hospitalization within the first 60 days of hospital discharge by matching the dataset of hospitalized patients captured through regular surveillance with records from the National Center for Health Statistics Electronic Death Registration System to identify death-cases missed by surveillance and/or deaths occurring after hospital discharge. (New sites that have not previously participated in EIP may develop methods/capacity to collect mortality data over several years.)

Sites should consider the budget implications of these shared activities and be mindful about how costs are distributed across the three platforms. Similarly, requests for funding for other costs that are shared across the three RESP-NET platforms, such as building fees, equipment, or travel allotments for surveillance officer and/or principal investigator meetings should also be distributed as appropriate across proposed budget lines.

ATTACHMENT 1 – SECTION D

Influenza Hospitalization Surveillance Network (FluSurv-NET)

Background Influenza viruses circulate worldwide each year, causing substantial illness and severe complications including hospitalization and death. In addition, novel strains of influenza virus emerge from time to time, leading to global influenza pandemics. Influenza surveillance programs are crucial for monitoring the timing, burden and severity of seasonal influenza, characterizing circulating virus strains, and describing changes in the epidemiology or risk factors associated with influenza virus infection. Surveillance data may also be used to plan for annual influenza virus strain selection, to alert the public about the intensity and magnitude of an epidemic, to assess disease severity in high-risk populations, and to evaluate the effectiveness of intervention programs. In the event of an influenza pandemic, surveillance programs are essential for guiding response efforts and assisting with resource prioritization.

The Emerging Infections Program (EIP) was established in 1995 to provide a national resource for infectious disease surveillance and response, conduct applied epidemiologic and laboratory research, identify measures to prevent and control emerging infectious diseases, and strengthen national public health infrastructure. In response to reports of elevated rates of pediatric influenza hospitalization and deaths during the 2003−04 influenza season, the EIP principal investigators initiated laboratory-confirmed influenza hospitalization surveillance among persons aged ≤17 years. During the 2005−06 influenza season, in response to the threat of avian influenza and as part of pandemic planning, EIP sites expanded surveillance activities to include adults hospitalized with laboratory-confirmed influenza so that all ages hospitalized with influenza were represented. During the 2009 pandemic, additional states were added as part of the Influenza Population-Based Hospitalization Surveillance Project (IHSP) to enhance existing surveillance through a cooperative agreement with the Council of State and Territorial Epidemiologists (CSTE). Together the EIP and IHSP sites constitute the Influenza Hospitalization Surveillance Network (FluSurv-NET) which conducts population-based surveillance for children and adults hospitalized with influenza.

Influenza hospitalization surveillance uses hospital laboratory data, admissions information, infection control practitioner databases/logs, or review of reportable conditions databases to identify cases. Cases are residents of pre-identified catchment areas with laboratory-confirmed influenza infection who are hospitalized during an influenza season. Laboratory testing for influenza is ordered at the discretion of clinicians providing patient care or based on facility testing practices. Therefore, efforts to understand clinician testing practices are necessary for some FluSurv-NET analyses. Laboratory confirmation is defined by a positive result from viral culture, direct or indirect fluorescent antibody staining, rapid antigen testing, real-time reverse transcriptase polymerase chain reaction (RT-PCR) or other molecular assays. Medical chart reviews of cases are conducted to collect clinical and epidemiologic information including patient demographics, underlying medical conditions, influenza vaccination, antiviral treatment, clinical outcomes during hospitalization, and hospital discharge diagnoses. Influenza vaccination status is obtained through a hierarchical review of sources including medical chart, vaccination registries, provider records, and lastly by interview of patient or proxy.

During each influenza season, core data collected through FluSurv-NET (including surveillance site, hospital admission date, patient age, sex, type of influenza test performed, and influenza test result) are reported weekly to the CDC influenza division with a median lag time of 7 days between date of a positive influenza test result and reporting to CDC. FluSurv-NET primarily produces rates of laboratory-confirmed hospitalizations by age, sex, race/ethnicity, and site in the United States, calculated using population denominators from the most recent census data available for each surveillance county catchment area. These unadjusted rates are made available to the public weekly through a web-based application called Fluview (Laboratory-Confirmed Influenza Hospitalizations (cdc.gov)) and can be utilized to provide near real-time information about the current influenza season and compare rates across seasons, age groups, sex, and race/ethnicity.

FluSurv-NET data also provides a platform for timely assessments of seasonal influenza severity and national disease burden estimates. Disease burden estimates depend on modeling that accounts for age-specific influenza testing practices and underreporting of cases. Disease burden estimates (Disease Burden of Flu | CDC), in addition to annual vaccine effectiveness and coverage estimates, are critical for annual estimates of vaccine averted hospitalizations (Estimated Influenza Illnesses, Medical Visits, and Hospitalizations Averted by Vaccination | CDC). FluSurv-NET data has also been used for special studies to evaluate influenza antiviral use (which is recommended for all patients hospitalized with influenza) and vaccine effectiveness. FluSurv-NET data have also been used to explore the relationship between socioeconomic and other disparities and influenza-associated hospitalization. FluSurv-NET has and will continue to serve as a platform to address various epidemiologic questions of public health relevance as they arise. A key feature of FluSurv-NET is its flexibility to respond to public health emergencies. During the 2009 influenza A H1N1 pandemic, FluSurv-NET data was critical for rapid monitoring of the pandemic. During the COVID-19 pandemic, the FluSurv-NET infrastructure was used to establish COVID-NET.

The ongoing COVID-19 pandemic has highlighted the need for data modernization of the public health infrastructure in order to provide data for public health action. A priority for this upcoming period will be to explore methods to collect and disseminate data more efficiently through data extraction.

Other National Public Health Priorities and Strategies FluSurv-NET data has been used to formulate national policy recommendations developed by the Advisory Committee on Immunization Practices (ACIP) and to determine the real-world impact of antiviral treatment and vaccination through antiviral and vaccine effectiveness studies. CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2030" (Browse Objectives - Healthy People 2030 | health.gov) and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This EIP Influenza activity is in alignment with the “Healthy People 2030” priority focus area, Vaccination and HHS Strategic Plan Goals and Objectives: Goal 2 – Protect the Health of Americans Where They Live, Learn, Work and Play: Strategic Goal 2: Protect the Health of Americans Where They Live, Learn, Work, and Play | HHS.gov. FluSurv-NET also serves as an emergency response resource in the event of an influenza pandemic.

Purpose Implement population-based surveillance to provide near real-time weekly rates of laboratory-confirmed influenza-associated hospitalizations by age, sex, and race/ethnicity and data on disparities during each influenza season. Data will be collected to 1) describe demographic and clinical characteristics and clinical course and outcomes of patients hospitalized with influenza, 2) allow annual estimation of disease burden and burden averted through vaccination, and 3) assess uptake and effectiveness of vaccination and antiviral treatment. Data will be used to determine the timing and severity of influenza seasons and to guide future influenza prevention and control strategies. Special studies will be conducted to better understand laboratory practices and evaluate prevention strategies in disproportionately affected and historically marginalized populations.

Outcomes Provide new knowledge Surveillance for influenza-associated hospitalizations along with special studies are intended to enhance our understanding of the burden and severity of influenza, to assess risk factors and outcomes associated with influenza, and to evaluate prevention strategies. This knowledge will be used to inform national policy and help guide future prevention and control efforts as well as pandemic planning.

Develop staff expertise Site personnel will develop expertise in the epidemiology of influenza as well as clinical disease course and management. Site personnel will also develop and over time, hone skills to conduct case finding, medical record abstraction and extraction using varied electronic and paper medical record systems, and data entry and management, such that influenza hospitalization rates and other measures will be produced using complete and accurate data.

Control outbreaks of infectious diseases The surveillance infrastructure will assist health departments and CDC in detection and control of outbreaks of influenza. Sites will have the ability to quickly modify data collection tools and site databases and maintain flexibility to rapidly respond to changes in core surveillance in response to a novel influenza A virus epidemic of pandemic potential.

Develop/modify treatment guidelines FluSurv-NET data will be used to help develop and evaluate prevention and treatment guidelines produced by the ACIP, including influenza vaccine recommendations, influenza virus testing and antiviral treatment guidance.

Develop/modify intervention recommendations FluSurv-NET data will be used to estimate weekly in-season disease burden estimates throughout each influenza season, and well and the annual influenza disease burden and the vaccine averted burden and to evaluate the impact of guidance on empiric antiviral treatment in high-risk patients with acute respiratory illness. FluSurv-NET data will also be used to evaluate the impact of influenza testing on both antiviral and antibiotic use in patients with acute respiratory illness with and without influenza.

Strategies and Activities Two activity tiers will be offered to sites for FY24. Sites are required to choose to participate in either Tier 1 or Tier 2 activities. Sites will be required to complete all activities outlined in their selected tier.

Tier 1 Required Activities

1. Conduct active, population-based surveillance for laboratory-confirmed influenza-associated hospitalizations among children and adults during the influenza season (typically beginning on October 1 and ending on April 30 of the following year).

a. Define a surveillance catchment area.

i. The lowest unit of the catchment area should be county.

b. Clearly identify all hospitals in which residents of the catchment areas are hospitalized so that population estimates can be obtained for rate calculations on an annual basis.

i. Estimate the proportion of catchment population hospitalizations that occur outside of the surveillance catchment area.

c. Utilize hospital databases, laboratory databases, admission/discharge logs, infection control practitioner logs/databases, health information exchanges, data warehouses and/or reportable conditions databases to identify influenza cases among residents of the surveillance catchment area.

d. Conduct periodic (at least annual) audits using methods determined in conjunction with CDC to verify completeness of influenza case ascertainment within the FluSurv-NET surveillance area.

2. Enter minimum case data into a standardized data collection database or send de-identified data extracts that match the format required by CDC on a weekly basis during the surveillance period

a. Minimum case-level data to be transmitted to CDC on a weekly basis (ideally within 7 days of case identification) include: surveillance site, county of residence (if possible), patient age or date of birth, sex, race/ethnicity (if possible), hospital admission date, positive influenza testing data (test type, test result, test date).

b. Submit data electronically to CDC (in an agreed upon secure format) by the specified deadline and upon CDC request.

i. CDC encourages sites to directly enter CRF data into site-specific databases rather than first entering data onto paper CRF forms to enhance efficiency.

c. Provide timely responses to reports and requests for information to assist in preliminary & final analyses, reports, and data close-outs.

3. Determine influenza A subtype on at least 20% of FluSurv-NET specimens each year. Determine influenza B lineage on specimens as feasible.

a. Methods for obtaining subtype information or for obtaining specimens to send to public health laboratories for subtype/lineage determination should be submitted to CDC in writing at the beginning of each influenza season and updated if any changes are made.

i. Sampling specimens only from select hospitals that are able to systematically provide specimens to PHLs for subtyping/lineage determination is acceptable.

ii. Convenience samples are discouraged; however, if only convenience samples are available, this should be clearly indicated.

b. Sites should ensure that subtyped specimens are well-represented across the 5 main FluSurv-NET age groups and months of hospital admission throughout the entire season.

c. Some sites may find that to ensure adequate representation of subtype data across age groups and months of hospital admission, they may need to obtain subtyping data on >20% of surveillance specimens in a year. CDC will work with sites to determine how best to ensure representative subtyping data.

d. Sites should strive to ensure that subtype information is linked to patient clinical records.

4. Conduct a laboratory survey among all laboratories that serve FluSurv-NET hospitals to determine diagnostic tests used at participating laboratories every year (these surveys may be coordinated with other surveillance programs).

5. Perform geocoding and linkage to US Census data using standardized methods for all FluSurv-NET cases.

6. Monitor influenza testing practices among all, or a majority of hospitals that fall within the catchment area by participation in the influenza disease burden project every year.

a. New sites that have not previously participated in EIP may develop methods/capacity to collect burden data over several years.

7. Ascertain influenza-associated deaths that occurred during hospitalization or within the first…