Transfusion-Transmissible Infections Monitoring System

National Heart, Lung, And Blood Institute

Investigators

Abstract

During its July 2, 2013 meeting, the DHHS Blood, Organ, and Tissue Senior Executive Council (BOTSEC), which includes representation from DHHS/OASH, CDC, NIH, CMS, HRSA, FDA, ASPE, ASPR, and AHRQ, unanimously voted to enhance monitoring of transfusion transmissible infections (TTls) in the US. At that time, no single comprehensive blood donor or recipient surveillance system existed in the United States to monitor transfusion-transmissible infections (TTls) such as HIV, Hepatitis B (HBV), and hepatitis C (HCV). Subsequently, the external Federal Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) met in December 2013 and concurred with the BOTSEC and recommended that DHHS establish "an ongoing, integrated, coordinated, and nationally representative U.S. transfusion transmissible infections monitoring system." The TTIMS program was consequently established in 2015 by the FDA in collaboration with NHLBI and HHS/OASH. TTIMS is an integrated, comprehensive blood donor and donation monitoring system for transfusion-transmitted infections (TTls) including HIV which currently monitors~ 60% of the US blood supply. The TTIMS project includes characterization of TTI marker risks in at least half of the US blood supply and monitoring of temporal, geographic, and demographic trends; and provides a framework for evaluating the effect of a new intervention (such as implementation of a new deferral policy) on TTI risks and blood donor risk factors. This program fills a significant gap in current public health blood donor surveillance efforts by monitoring the safety of the Nation's blood supply and can serve as a resource for additional investigations.