FY 2022 Annual Performance Plan and Report - Goal 4 Objective 1

Fiscal Year 2022
Released June, 2021

Topics on this page: Goal 4. Objective 1 | Objective 4.1 Table of Related Performance Measures

Goal 4. Objective 1: Improve surveillance, epidemiology, and laboratory services

The Department is dedicated to conducting and funding scientific research that leads to evidence-based, high-quality care and responsive interventions to mitigate health crises.  Data and information from surveillance, epidemiology, and laboratory services can aid in the prevention and early intervention of foodborne illnesses, such as listeria and norovirus, and infectious disease outbreaks, such as COVID-19, Zika and Ebola.  To achieve this objective, the Department facilitates information exchange to identify risks quickly and efficiently, strengthens the quality and safety of our nation's laboratories, and strengthens the alignment of surveillance, epidemiology, and laboratory services.

In the previous administration, the Office of the Secretary led this objective.  The following divisions are responsible for implementing programs under this strategic objective: ASPR, CDC, CMS, FDA, NIH, OCR, OGA, and SAMHSA.  HHS has determined that performance toward this objective is progressing.  The narrative below provides a brief summary of progress made and achievements or challenges, as well as plans to improve or maintain performance.

Objective 4.1 Table of Related Performance Measures

Maintain the percentage of laboratory reports on reportable conditions that are received through electronic means nationally (Lead Agency - CDC; Measure ID - 3.5.2)

Advancing national implementation of Electronic Laboratory Reporting (ELR) is a priority in CDC's efforts to protect the public's health.  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.  As of FY 2019, electronic laboratory reports accounted for nearly 90 percent of laboratory reports for reportable conditions received, which met the target and was an improvement over FY 2018.  These results continue the upward trend begun FY 2012.

Since there are diminishing returns after reaching an ELR volume higher than 90 percent, the program considers moving from 62 percent in 2013 to 90 percent a success.  In FY 2021 and FY 2022, CDC will continue to monitor the implementation of ELR as part of its efforts to protect the public health.

Increase the percentage of notifiable disease messages transmitted in HL7 format to improve the quality and streamline the transmission of established surveillance data (Lead Agency – CDC; Measure ID - 8.B.1.4)⁴¹

During FY 2020, the investments CDC made in technology and infrastructure positioned CDC to efficiently receive data related to the COVID-19 outbreak.  Within hours of the COVID-19 emergency declaration, CDC's National Notifiable Disease Surveillance System (NNDSS), which helps public health monitor, control, and prevent diseases, issued a COVID-19 event code, which states used to notify CDC of cases.  CDC also updated the system used to receive this information so the COVID-19 data could be available to CDC programs.  The data received as a result of this work positioned CDC's disease experts and Emergency Operations Center to better understand and support the national response.

As of December 2020, data indicate the high volume of COVID-19 messages transmitted to CDC helped significantly improve the results for Measure 8.B.1.4 to 49%, enabling CDC to exceed the goal for FY 2020.  During the last quarter of FY 2020, NNDSS processed an average of 2,086,701 case notification messages in a standardized electronic format (HL7), 17 times as many as were processed in January of 2020 (123,960), due mainly to the volume of reporting associated with the COVID-19 response.  The prioritization of COVID-19 response activities has temporarily delayed implementation of Message Mapping Guides (MMG) – a way to transmit data on diseases, for the other disease conditions.  At the onset of the response, 46 of the 57 jurisdictions reporting data were at various stages of bringing reporting for diseases in this standardized electronic format (HL7 MMGs) online.  Forty-five jurisdictions are using CDC's NNDSS to send their COVID-19 case notifications to CDC.  Of these, 28 jurisdictions are sending them in the standardized electronic format (HL7).  In addition to the increase in the percentage of notifiable disease messages transmitted in the standardized format resulting from the COVID-19 response, data transmissions continue to improve and remain much more stable indicating that CDC has achieved a more routine and reliable mode to transmit this disease information.

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 begin transmitting health data related to sexually transmitted diseases, vaccine preventable diseases, and foodborne diseases once we return to normal operations.  Efforts in 2021 will focus on continued progress on and completion of the modernization process.  As CDC moves beyond 2021, NNDSS will transition from modernization to an operations mode that seeks continuous innovation and enhancement while laying the foundation for next generation case-based surveillance.

Number of medical product analyses conducted through the FDA's Sentinel Initiative (Lead Agency – FDA; Measure ID – 292203)

The Sentinel Initiative comprises 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 Sentinel Initiative has continued to evolve rapidly in the last two years.  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.  The year 2021 marks six years of the Sentinel System serving as a fully-functional and integrated part of FDA's regulatory process.  Sentinel has proven to be a vital source of safety information that informs regulatory decision-making and expands our knowledge of how medical products perform once they are widely used in medical practice.  In 2020, FDA began to leverage Sentinel in novel ways as part of a multi-layered response to the COVID-19 pandemic.  These activities range from developing the capability for near real-time drug monitoring to inform the potential for drug shortages, describing the course of illness among patients with COVID-19, and evaluating the impact of therapies being used in COVID-19 patients under real-world conditions.

⁴¹ The initially reported FY 2018 result of seven percent reflected only a segment of these data.  The FY 2018 result has been revised to reflect final data.

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