Transfusion-Transmissible Infections Monitoring System (TTIMS)   2

Background
The U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is seeking to enhance public health by establishing a Transfusion-Transmissible Infection Monitoring System (TTIMS). This initiative aims to monitor the incidence and prevalence of transfusion-transmissible infections among U.S. blood donors, particularly focusing on HIV, Hepatitis C, Hepatitis B, and Syphilis.

The TTIMS was initiated in response to recommendations from the Department of Health and Human Services following extensive epidemiologic research conducted by the National Heart Lung, and Blood Institute (NHLBI). Since its inception in 2015, TTIMS has monitored approximately 60% of the U.S. blood supply, collecting data from over 56 million blood donations.

Work Details
The contractor will be responsible for a range of tasks including:
1. Establishing and maintaining an allogeneic blood donation test result and demographic database representing over 60% of U.S. mainland allogeneic volunteer blood collections.
2. Monitoring and characterizing relevant transfusion-transmissible infections (RTTIs) among U.S. blood donors.
3. Evaluating temporal, demographic, and geographic trends in incidence and prevalence rates for RTTIs.
4. Compiling bio-specimens linked with donation datasets from TTI-positive donors.
5. Conducting validated 'recency' testing for HIV antibody positive donations to improve classification of HIV incidence.
6. Providing logistical support for TTIMS project meetings and ensuring timely transfer of confidential data among participating organizations.
7. Reporting complete lookback data for HIV and HCV regarding recipients transfused with prior donations from currently positive donors.
8. Preparing technical progress reports summarizing activities undertaken during reporting periods.

Period of Performance
Base Year: 09/25/2025 – 09/24/2026; Option Year 1: 09/25/2026 – 09/24/2027; Option Year 2: 09/25/2027 – 09/24/2028; Option Year 3: 09/25/2028 – 09/24/2029.

Place of Performance
Work will be performed at the contractor’s location but will support the FDA’s Center for Biologics Evaluation and Research (CBER) located at US FDA/CBER, 10903 New Hampshire Ave., Silver Spring MD 20993.