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.

Objectives represent the changes, outcomes and impact the HHS Strategic Plan is trying to achieve.  This objective is informed by data and evidence, including the information below.

• Electronic Laboratory Reporting (ELR) replaces paper-based reporting, which accelerates reporting to public health labs; reduces the reporting burden on clinicians, hospitals, and commercial laboratories; and decreases errors and duplicate reporting.  For FY 2019, electronic laboratory reports accounted for nearly 90 percent of reports received, which met the target and was an improvement over FY 2018.  (Source: FY 2022 Annual Performance Plan and Report - Goal 4 Objective 1)
• Within hours of the COVID-19 emergency declaration, CDC's National Notifiable Disease Surveillance System (NNDSS) issued a COVID-19 event code, which states used to notify CDC of cases.  The data helped CDC and Emergency Operations better understand and support the national response.  With the influx of data modernization funding and the best practices adopted to date, CDC anticipates more states participating in the system and for states to share health data related to STIs, vaccine preventable diseases, and foodborne diseases.  (Source: FY 2022 Annual Performance Plan and Report - Goal 4 Objective 1)
• The incidence of most infections transmitted commonly through food has not declined for many years.  Incidence of infections caused by Listeria, Salmonella, and Shigella remained unchanged, and those caused by all other pathogens reported to FoodNet increased during 2019.  (Source: Preliminary Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food—Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2016–2019)
• As part of the CDC's Surveillance Strategy Report, the percentage of mortality records collected electronically from states within 10 days increased from 29 percent in 2014 to 63 percent in 2018.  As this number continues to rise, the CDC will have knowledge of the causes of death at faster rates, giving officials more time to respond appropriately.  (Source: Surveillance Strategy Report – Modernizing Mortality Reporting)
• The Sentinel Initiative has been a vital source of information especially on the safety and utilization of medical products once they become widely used in practice.  In response to COVID-19, FDA used Sentinel in novel ways, ranging from developing near real-time drug monitoring, describing the course of illness among patients with COVID-19, and evaluating the utilization and safety of therapies under real-world conditions.  (Source: FDA's Sentinel Initiative)

Contributing OpDivs and StaffDivs

CDC, FDA, IHS, OASH, NIH, OGA, and SAMHSA work to achieve this objective.

HHS OpDivs and StaffDivs engage and work with a broad range of partners and stakeholders to implement the strategies and achieve this Objective.  They include: the GenomeTrakr Network, National Residue Program, Partnership for Food Protection (PFP), Veterinary Laboratory Investigation and Response Network (Vet-LIRN), and Whole Genome Sequencing alignment (part of LG STEC Action Plan).

Strategies

Expand capacity to improve laboratory safety and quality, detect and prevent public health threats, monitor health conditions, understand the unique needs of various sub-groups of persons, and establish the pipeline for future professionals

• Advance the development, access, and use of standards, guidelines, and regulations to improve the quality of laboratory testing and public health data collection.
• Leverage existing surveillance efforts to better understand the unique and common needs of various sub-groups of persons by race, ethnicity, national origin (including primary language), sex, sexual orientation, gender identity, pregnancy, education status, income, and other population characteristics.
• Improve capacity for advanced laboratory, epidemiologic, and environmental methods across federal and state agencies to enhance the detection of potential violations throughout the full lifecycle of HHS-regulated products to ensure only safe and effective products reach the public.
• Identify and assess adverse events related to the use of regulated human and animal medical products, including the development and more effective use of large nationally representative database systems, electronic health records, common data models, and natural language processing.
• Build expertise in cutting edge laboratory, surveillance, and epidemiology techniques to address public health threats and disease conditions, including harmful chemical exposures and diseases, foodborne pathogens, antimicrobial resistance pathogens and other emerging pathogens, healthcare-associated infections, chronic diseases that disproportionately affect specific populations (e.g., sickle cell disease), individuals with disabilities, maternal health, and behavioral health.
• Train and sustain a diverse pipeline of surveillance, epidemiology, laboratory professionals to address current and emerging needs and strengthen connections with clinical workforce development stakeholders.

Modernize surveillance systems for timeliness, accuracy, and analytic reporting

• Accelerate the development and implementation of technological solutions, tools, and approaches to optimize information, knowledge, and data management, standardization, and quality, while ensuring the protection of personally identifiable information and other privacy concerns and minimizing threats to information security.
• Develop and introduce data standards for geographic information within the notifiable diseases reporting system to scales that are meaningful for assessment of socio-ecologic factors.
• Promote completeness and accuracy of race and ethnicity variables and other population characteristics—including age, disability status, geographic area, socioeconomic status, national origin (including primary language), and sex, sexual orientation, gender identity, and pregnancy—in laboratory data and data submitted for surveillance purposes in order to better explain the burden of disease and health conditions in diverse populations.
• Partner across HHS agencies to utilize nationally collected data to create customized surveillance reports to address the incidence of infectious disease in underserved populations.
• Provide actionable information for public health officials, policy makers, and regulators to establish and evaluate exposure and disease interventions within disproportionately affected communities or populations.

Engage and learn from partners and stakeholders to inform improvements and innovation

• Strengthen state, federal, territorial, international, and public health partnership data and information sharing to improve surveillance and laboratory capacity to identify and better control threats to public health.
• Collaborate with domestic and international partners to develop innovative surveillance, epidemiological, and laboratory approaches that improve situational awareness and communication before, during, and after emergencies and disasters, including food and medical emergencies.
• Identify and address barriers to participation of underserved populations in epidemiologic studies and enhance use of community-based participatory research to ensure studies are meaningful and beneficial to participants.

Performance Goals

The HHS Annual Performance Plan provides information on the Department’s measures of progress towards achieving the goals and objectives described in the HHS Strategic Plan for FY 2022–2026.  Below are the related performance measures for this Objective.

• Percentage of isolates of priority PulseNet pathogens (Salmonella, Shiga toxin-producing E. coli, and Listeria monocytogenes) sequenced and uploaded to the PulseNet National Database
• The percentage of laboratory test results reported within the expected turn-around time (two weeks) upon receipt by CDC labs
• Number of medical product analyses conducted through FDA's Sentinel Initiative
• Number of Tribal Epidemiology Center-sponsored trainings and technical assistance provided to build tribal public health capacity

Learn More About HHS Work in this Objective

• Biologics Effectiveness and Safety (BEST) Program: This program is a part of the FDA Sentinel Initiative and provides access to Electronic Health Records for over 50 million persons and access to over 100 million claims to conduct robust, rapid safety and effectiveness studies of blood, advanced therapeutics, and vaccines.
• Comprehensive Animal Food Compliance Program: FDA has developed a new approach to modernize animal food safety inspections that incorporates new regulations and traditional regulations into a single comprehensive inspection.  This comprehensive inspection approach will help ensure a holistic, risk-based, and prevention-oriented approach to inspections and will better utilize resources of both FDA and state inspection partners, who FDA works with routinely to ensure greater inspectional oversight of the animal food industry.
• Center for Surveillance, Epidemiology, and Laboratory Services (CSELS) Strategic Plan: The CSELS Strategic Priorities and core functions are centered around our mission to strengthen and modernize the public health infrastructure of the United States through science and collaboration.  The four core functions are: public health workforce, scientific communication, laboratory systems, and data, surveillance, and analytics.
• CFSAN Adverse Event Reporting System (CAERS): CAERS is a database that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics.  The database is designed to support CFSAN's safety surveillance program.
• FDA Adverse Event Reporting System (FAERS): FAERS supports the FDA's post-marketing safety surveillance program for all marketed drug and therapeutic biologic products.  It contains adverse event reports FDA has received from manufacturers as required by regulation along with reports received directly from consumers and healthcare professionals.
• GenomeTrakr Network: The GenomeTrakr network is the first distributed network of laboratories to utilize whole genome sequencing for pathogen identification.  It consists of public health and university laboratories that collect and share genomic and geographic data from foodborne pathogens.  The data, which are housed in public databases at the National Center for Biotechnology Information (NCBI), can be accessed by researchers and public health officials for real time comparison and analysis that promises to speed foodborne illness outbreak investigations and reduce foodborne illnesses and deaths.
• Medical Device Reporting (MDR): MDR is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
• National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan 2021–2025: The National Antimicrobial Resistance Monitoring System (NARMS) was established in 1996 as a collaboration of the CDC, FDA, U.S. Department of Agriculture (USDA), and state and local health departments.  NARMS currently tracks resistance in enteric bacteria from humans, retail meats, and food-producing animals at the time of slaughter.
• National Syndromic Surveillance Program: CDC’S National Syndromic Surveillance Program (NSSP) hosted a virtual Syndromic Surveillance Symposium that provided an opportunity to make significant advances in establishing a public use shared data set for national emergencies.
• Research and Development Survey (RANDS): RANDS is an ongoing series of surveys conducted by the Division of Research and Methodology at the National Center for Health Statistics.  These surveys use recruited, probability-sampled, commercial survey panels, and are designed to explore the feasibility of using these panels to collect information on national health outcomes and to augment NCHS’ question evaluation and research program with quantitative methodologies for measuring error.  NCHS launched a COVID-specific data collection in July 2020 using the Research and Development Survey (RANDS) to evaluate COVID related survey questions.
• Safety Reporting Portal for Tobacco Products: Consumers, manufacturers, clinical investigators, and health professionals can submit reports about tobacco products that are damaged, defective, contaminated, or smell or taste wrong.  FDA wants to know if you have experienced undesired health or quality problems that you believe may have been caused by use of a particular tobacco product.  FDA also wants to know about undesired health or quality problems that may have been caused by being exposed to a tobacco product, even if you were not the user.
• Sentinel: Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices.
• Surveillance, Epidemiology, and End Results (SEER) Program: The SEER Program provides information on cancer statistics in an effort to reduce the cancer burden among the U.S. population.  SEER is supported by the Surveillance Research Program (SRP) in NCI's Division of Cancer Control and Population Sciences (DCCPS).
• Vaccine Adverse Events (VAERS): VAERS is a national vaccine safety surveillance program co-sponsored by the FDA and CDC.  The purpose of VAERS is to detect possible signals of adverse events associated with vaccines.  VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of U.S. licensed vaccines.