FY 2024 Annual Performance Plan and Report - Strategic Goal 4: Objective 4.3

Fiscal Year 2024
Released March, 2023

Topics on this page: Objective 4.3: Strengthen surveillance, epidemiology, and laboratory capacity to understand and equitably address diseases and conditions | Objective 4.3 Table of Related Performance Measures

Objective 4.3: Strengthen surveillance, epidemiology, and laboratory capacity to understand and equitably address diseases and conditions

HHS supports strategies to strengthen surveillance, epidemiology, and laboratory capacity to understand and equitably address diseases and health conditions. HHS is focused on expanding capacity to improve laboratory safety and quality, monitor conditions, understanding the needs of various sub-groups of people, and establishing the pipeline for future professionals. HHS is working to modernize surveillance systems for timeliness, accuracy, and analytic reporting while engaging and learning from partners and stakeholders to inform improvements and innovation.

The Office of the Secretary leads this objective. The following divisions are responsible for implementing programs under this strategic objective: CDC, FDA, IHS, OASH, NIH, OGA, and SAMHSA. In consultation with OMB, HHS has determined that performance toward this objective is a focus area for improvement. Although HHS continues to find success in this objective, the scope and risk of the ongoing pandemic highlights the continued importance of additional progress. The narrative below provides a brief summary of progress made and achievements or challenges, as well as plans to improve or maintain performance .

Objective 4.3 Table of Related Performance Measures

CDC estimates the burden of foodborne disease in the U.S. to be approximately 48 million cases per year (one out of every six Americans), 128,000 hospitalizations, and 3,000 deaths per year. Foodborne disease is mostly preventable, but controlling and preventing outbreaks requires that HHS understands the foods and settings that cause illness. Fast and effective outbreak investigations are needed to identify and remove contaminated food from the market to prevent additional illnesses and improve the safety of the nation’s food supply.

In 2019, the standard method for outbreak detection in PulseNet changed to whole-genome sequencing (WGS) of bacteria in food that cause human illness. Tracking the progress of this new method is important because the degree to which it is adopted affects the sensitivity of outbreak detection, and multiple trends could affect PulseNet’s ability to detect outbreaks in a positive or negative direction. Data indicates in FY 2021, 98% of isolates of priority PulseNet pathogens (Salmonella, Shiga toxin-producing E. coli, and Listeria monocytogenes) were sequenced and uploaded to the PulseNet National Database (Measure 3.D). These data exceeded the FY 2021 target, in part, because COVID-19 impacted the overall volume of isolates received by state laboratories. Lower isolate volume, combined with changes in state public health laboratories’ workflows, has allowed labs to improve efficiencies to sequence most of their PulseNet organisms.

With the change in PulseNet to use WGS to detect foodborne outbreaks, CDC expects to see an increase in suspected clusters of foodborne disease, which, in turn, will need to be interviewed in order to determine if they are part of an outbreak. CDC invests in improving interview capacity in state and local health departments in order to also improve the availability of data for multistate foodborne outbreak investigations. Tracking state epidemiologic interview capacity is also important to help identify and address challenges in the availability of epidemiologic data critical for multistate foodborne outbreak investigations.

As a significant health concern in the U.S., malaria, and other parasitic diseases have a tremendous impact on global morbidity and mortality, due to increased international travel, importations, and domestically acquired infections. CDC’s parasitic disease labs serve as global and national resources for ensuring efficient and high-quality analyses, which are essential to timely and accurate diagnosis and treatment.

In FY 2021, CDC labs tested 3,682 specimens from U.S. residents and overseas government staff for parasitic diseases and analyzed and reported results for 96% of submitted specimens in a timely manner (within the expected turnaround times posted in the CDC test directory for each test), exceeding the target. A target of 90% for this measure helps ensure accountability for consistent, timely reporting. Meeting or exceeding 90% each year represents ideal performance and the flexibility to respond to unforeseen challenges, such as those associated with the COVID pandemic. While the COVID pandemic did not directly impact CDC’s ability to meet this performance target, it did initially affect CDC’s laboratory operations. This includes having fewer people working in labs together at the same time and social distancing. FY 2021 results reflect 11 months of diagnostic testing (October 1, 2020—August 31, 2021). In September 2021, CDC’s Parasitic Diseases Laboratory paused all diagnostic testing operations for parasitic diseases to implement laboratory system improvements. CDC is utilizing a phased, prioritized approach for bringing tests back online. CDC webpages are routinely updated to reflect the list of tests that have resumed to date .

The Sentinel Initiative is FDA’s medical product surveillance program. The Initiative is comprised of multiple components including: the Sentinel System, and its Active Risk Identification and Analysis (ARIA) program; FDA Catalyst; and the Biologics Effectiveness and Safety System. The goal of the Sentinel Initiative is to provide high quality real-world evidence to support regulatory decision-making about the performance of medical products, and this performance measure provides an estimate for the program’s impact on FDA’s public health mission. This performance measure captures the quantity of analyses conducted in the Sentinel System by FDA investigators to monitor the safety of drugs and therapeutic biologics. The number of analyses is a function of multiple factors beyond FDA’s control, such as the nature and number of medical product safety issues, which can vary year-to-year. FDA will continue reporting the total number of analyses conducted by the Sentinel Initiative to show the scientific productivity of the system and describe its impact on public health. Prior to 2018, the Sentinel performance measure captured the number of people for whom FDA was able to evaluate product safety, based on benchmarks outlined in the Food and Drug Administration Amendments Act of 2007. FDA consistently exceeded these benchmarks, and in 2018 FDA changed the performance measure to reflect Sentinel’s role as a vital source of safety information that informs regulatory decision-making and expands FDA’s knowledge of how medical products perform once they are widely used in medical practice. In 2019, Congress required that FDA build on Sentinel’s core successes by establishing a new Real-World Evidence Medical Data Enterprise with access to at least 10 million electronic medical records. In 2020 the performance measure was updated to capture not only Sentinel’s ARIA system, which is comprised of pre-defined, parameterized, reusable routine querying tools and the electronic data in the Sentinel Common Data Model, but also activities from these other components of the Sentinel Initiative, including those conducted in response to the COVID-19 pandemic.

The Indian Health Service (IHS) provides core funding support to twelve Tribal Epidemiology Centers (TECs) across Indian Country. The TECs provide critical support to the tribal communities they serve by using epidemiological data to support local Tribal disease surveillance and control programs, producing a variety of reports annually or bi-annually that describe activities and progress towards public health goals, and providing support to Tribes who self-govern their health programs. This measure reports the number of completed trainings and technical support to Tribes and Tribal organizations and demonstrates the sustained efforts of the TECs to engage, support, train, and collaborate with the Tribes in their service area. In fiscal year (FY) 2016, the TEC program launched the training and technical assistance measure to coincide with the 5-year funding and cooperative agreement cycle and, as a way to strengthen and simplify performance tracking of TEC efforts to engage, support, train, and collaborate with Tribes in their service area. The TECs’ direct support to Tribes translates emerging public health strategies, resources, and information to reduce the burden on the overall Indian health system through prevention. In FY 2022, TECs completed 1,197 TEC-sponsored trainings, largely driven by the Tribal demand for technical assistance with the COVID-19 pandemic. This represents a shift in focus from in-person trainings to more tailored technical support.

The measure target is informed by input from TEC partners. Actual performance among the TECs varies but overall performance has exceeded the target consistently. Because training and technical assistance events are driven largely by Tribal requests, which can vary greatly year-to-year in their frequency and complexity, the target was unchanged to support consistency throughout the 5-year funding and cooperative agreement period during FY 2016 – FY 2020. The 2021 Notice of Funding Opportunity announcing the current TEC funding cycle from FY 2021 – FY 2025 instituted a more robust and comprehensive evaluation plan, supported in part by this measure, which IHS proposes to increase in FY 2024 to better reflect the increased core resources and robust Tribal demands on the program. This plan provides TECs with the flexibility to meet the training and technical assistance needs of their Tribal partners while also responding to the broader evaluation goals of the IHS. The IHS is committed to supporting TEC performance through partnership and direct technical assistance, performance metric tracking and feedback, as well as by providing resources sufficient to meet the training and technical assistance needs of supported Tribes through available appropriations.