Subaward 12145OB181 — ONEBLOOD, INC under VITALANT

ONEBLOOD’S SCOPE OF WORK ON THIS PROJECT INCLUDES PROVISION OF DE-IDENTIFIED DONOR DEMOGRAPHIC AND HIV, HCV, HBV AND SYPHILIS INFECTIOUS DISEASE TESTING DATA TO THE AMERICAN RED CROSS WHICH WILL CONTINUE TO SERVE AS THE DATABASE COORDINATING CENTER FOR THE NEW TTIMS PROGRAM. PROVISION OF DONOR/DONATION DATA AND ADDITIONAL TESTING WILL BE CONDUCTED ON DE-IDENTIFIED SAMPLES MEETING THE EXPECTATIONS FOR PUBLIC HEALTH SURVEILLANCE. ONEBLOOD WILL NOT SORT OUT DONOR/DONATION DATA BASED ON WHETHER DONORS HAVE SIGNED A NEW COMMON RULE CONSENT. PROVISION OF ADDITIONAL DONOR DEFERRAL DATA IS EXPECTED TO BE IN SCOPE FOR THE PROGRAM TO ADDRESS CHANGES BECAUSE OF THE IMPLEMENTATION OF INDIVIDUAL DONOR ASSESSMENT AND ADDITIONAL RESOURCES MAY BE PROVIDED AS NEEDED FOR THIS ADDITIONAL REQUIREMENT. ONEBLOOD ALSO AGREES TO PERFORM QUALITY CONTROL (QC) ON ALL DATA ENTERED INTO THE STUDY DATABASE, RESPOND TO REQUESTS FROM TTIMS DATA COORDINATION GROUPS REGARDING DATA QUALITY ASSURANCE AND QC, REPORT SUMMARY LOOKBACK DATA FOR HIV AND HCV (NUMBER OF RECIPIENTS WHO RECEIVED COMPONENTS FROM PRIOR DONATIONS FROM DONORS WHO TESTED POSITIVE FOR HIV AND HCV AND IF AVAILABLE, NUMBER OF RECIPIENTS WHO WERE FOUND TO HAVE TESTED POSITIVE FOR HIV AND HCV IN LOOKBACK INVESTIGATIONS), AND ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS. FURTHER, AS IN PREVIOUS TTIMS PROGRAMS, ONEBLOOD WILL PROVIDE PLASMA UNITS AND SAMPLES (CODED BIOSPECIMENS) FOR THE TTIMS REPOSITORY AND THE ADDITIONAL TESTING THAT IS CONDUCTED AT VRI TO FURTHER CHARACTERIZE THE INFECTIONS IN TTIMSQUALIFYING INFECTIONS.