Paperless Quality Donor System with Decision Making

DESCRIPTION (provided by applicant): The long-term objectives of this project are to improve the safety and availability of the US blood supply. The principal aim of this SBIR Competing Continuation Phase II Proposal for a Paperless Quality Donor System with Decision Making is to complete the development of its Quality Donor System(tm) (QDS) and to secure ongoing 510(k) clearances for it from the US Food & Drug Administration (FDA), Center for Biologies Evaluation and Research (CBER) for implementation and evaluation of the total system in blood centers and hospital blood banks. The research is based on continuing development of the Quality Donor System and deploying it in regional blood centers and hospital blood banks. System use by donors and staff and user satisfaction will be measured and analyzed to assess success. Blood safety is enhanced by eliminating FDA-reportable errors and by increasing blood donor honesty in disclosing risky behaviors. Blood availability is enhanced by increasing donor satisfaction, resulting in higher return rates for new blood donors and increasing employer sponsorship of blood drives.