FY 2020 Annual Performance Plan and Report - Goal 4 Objective 1

Fiscal Year 2020
Released March, 2019

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 Zika and Ebola.  To achieve this objective, the Department is working to facilitate information exchange to identify risks quickly and efficiently, strengthen the quality and safety of our nation’s laboratories, and strengthen the alignment of surveillance, epidemiology, and laboratory services.

The Office of the Secretary leads this objective.  The following divisions are responsible for implementing programs under this strategic objective: ASPR, CDC, CMS, FDA, NIH, OCR, OGA, and SAMHSA.

Objective 4.1 Table of Related Performance Measures

Increase 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 2018, electronic laboratory reports accounted for nearly 80 percent of laboratory reports for reportable conditions received, which exceeds FY 2016 results and continues the upward trend since 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 2019 and 2020, 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)

During FY 2018, CDC advanced the modernization of infectious disease surveillance by producing technology upgrades to the Message Validation, Processing and Provisioning System, which receives production data from the states using the new Health Level Seven (HL7) based messages.  This system reduced development time to implement a new condition from months to weeks and ensures that CDC programs can access their data within an hour of receipt at CDC.  When new HL7 messages have been implemented for all diseases, the new strategy will allow the retirement of older, less efficient legacy systems, and will increase the number of HL7 messages received at CDC.  Data transmissions continue to improve and remain stable, which indicates that CDC has achieved a more routine and reliable mode.  The FY 2019 and FY 2020 focus will be on completion of the modernization process and transitioning to efficient long-term operations with continuous improvement and enhancement.

Increase the number of people for whom FDA is able to evaluate product safety through Mini-Sentinel/Sentinel system (Lead Agency – FDA; Measure ID – 292202)

FDA’s Sentinel Initiative provides significant public health benefits by developing new approaches and methods to actively monitor the safety of marketed medical products to complement existing FDA surveillance capabilities.  Through the Sentinel System, FDA evaluates drug safety issues that may require regulatory action.  FDA held the 10^th Annual Sentinel Initiative Public Workshop in February 2018 to bring together stakeholder communities to discuss a variety of topics on active medical product surveillance and emerging Sentinel projects.  To date, the Sentinel Initiative has contributed to multiple safety communications and labeling changes to better inform patients and providers about safe use of drugs and vaccines.  The Sentinel System ensures FDA will continue to have the tools necessary to conduct active safety surveillance work.  In FY 2019 and 2020, FDA will continue to monitor the number of people for whom it is able to evaluate product safety using the Mini-Sentinel/Sentinel system.

Number of medical product analyses conducted through the FDA’s Sentinel Active Risk Identification and Analysis (ARIA) system (Lead Agency – FDA; Measure ID – 292203)

FDA has developed a new Sentinel performance measure that focuses on using the system to generate high quality evidence about the use of medical products and their risks and benefits.  The new measure leverages Sentinel’s Active Risk Identification and Analysis system, which is comprised of pre-defined, parameterized, and reusable routine querying tools.  This enables FDA to conduct safety analyses more efficiently using a trusted distributed database that undergoes continuous quality checks and refreshes.  FDA has used the results of these analyses to present at FDA Advisory Committee meetings, highlight potential ways to intervene in the opioid crisis, inform responses to Citizen Petitions, and influence numerous regulatory decisions.

FDA has framed the new goal as the number of analyses conducted using the ARIA system.  Since this is a new goal and the analyses conducted each year can vary greatly in the number, timing, complexity, and character of the safety issues, FDA has set the initial targets at 50 and 55 analyses for FY 2019 and 2020 respectively.  FDA will reassess these targets periodically.  These targets reflect the trend toward more complex analyses that employ more sophisticated analytical methods, which yield more meaningful inputs to public health and regulatory decision making.