FY 2021 Annual Performance Plan and Report - Goal 4 Objective 1

Fiscal Year 2021
Released March, 2020

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. In consultation with OMB, HHS has determined that performance toward this objective is making noteworthy 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 4.1 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)

  FY 2014 FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 FY 2020 FY 2021
Target 65% 70% 75% 80% 82% 90% 90% 90%
Result 69% 69% 75% 80% 86% 90% 12/31/20 12/31/21
Status Target Exceeded Target Not Met Target Met Target Met Target Exceeded Target Met Pending Pending

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 2020 and FY 2021, 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)46

  FY 2014 FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 FY 2020 FY 2021
Target N/A Baseline 10% 40% 40% 40% 40% 40%
Result 1% 1% 3% 5% 5% 7.24% 2/1/21 2/1/22
Status Actual Actual Target Not Met but Improved Target Not Met but Improved Target Not Met but Improved Target Not Met but Improved Pending Pending

During FY 2019, 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 reduces 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 CDC completes implementation of new HL7 messages 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. In 2019, 7.24 percent of notifiable disease messages received at CDC were in the HL7 format, which is an increase over the FY 2018 result. Data transmissions continue to improve and remain stable, which indicates that CDC has achieved a more routine and reliable mode. The FY 2020 and FY 2021 focus will be on completion of the modernization process and transitioning to efficient long-term operations with continuous improvement and enhancement.

The National Notifiable Diseases Surveillance System (NNDSS) Modernization Initiative involved updating infrastructure, data standards, and state and programmatic capabilities to provide more complete, accurate, and timely data for public health awareness and action. CDC prioritized upgrading and developing technology and data standards to streamline the receipt and processing of information from states.HCDC worked with state partners to develop capacity to utilize the modernized system.

CDC is now focused on full implementation of the improved technology and standardized formats. CDC anticipates meeting the current target of 40 percent of all messages being transmitted in the HL7 format no later than end of FY 2022.

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

  FY 2014 FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 FY 2020 FY 2021
Target N/A N/A N/A N/A N/A 50 55 60
Result N/A N/A N/A N/A 74 68 01/31/21 01/31/22
Status N/A N/A N/A N/A Actual Target Exceeded Pending Pending

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. This system is comprised of pre-defined, parameterized, and reusable routine querying tools, which are combined with the multi-site electronic data in the Sentinel Common Data Model. 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. 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 set the initial target at 50 analyses for FY 2019. FDA will reassess these targets periodically. These targets reflect the trend toward more complex analyses that employ more sophisticated analytical methods and yield more meaningful inputs to public health and regulatory decision making.

46 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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