Paperless Quality Donor System with Decision Making

描述（由申请人提供）： 该项目的长期目标是提高美国血液供应的安全性和可用性。该SBIR竞争延续第二阶段提案的主要目的是完成其质量捐赠者系统（TM）（QDS）的开发，并确保美国食品药品监督管理局（FDA）正在进行的510（k）许可，生物制品评估和研究中心（CBER），负责血液中心和医院血库整个系统的实施和评估。 该研究基于优质献血者系统的持续发展，并将其部署在区域血液中心和医院血库。将衡量和分析捐助者和工作人员对系统的使用情况以及用户的满意程度，以评估成功与否。通过消除FDA可报告的错误和提高献血者在披露危险行为方面的诚实性，提高了血液安全性。通过提高献血者满意度来提高血液供应，从而提高新献血者的回报率，并增加雇主对献血活动的赞助。

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.