Paperless Quality Donor System with Decision Making

描述(由申请人提供)： 该项目的长期目标是改善美国血液供应的安全性和可用性。这项针对无纸化优质供体系统的SBIR竞争延续第二阶段提案的主要目的是完成其优质供体系统(Tm)(QDS)的开发，并确保其持续获得美国食品和药物管理局(FDA)、生物学评估和研究中心(CBER)的510(K)许可，以便在血液中心和医院血库实施和评估整个系统。 这项研究是基于对优质献血系统的持续开发，并将其部署在地区血液中心和医院血库。将对捐助者和工作人员的系统使用情况以及用户满意度进行衡量和分析，以评估成功。通过消除FDA可报告的错误并通过增加献血者披露危险行为的诚实程度，血液安全得到了增强。通过提高献血者的满意度，提高新献血者的返回率，增加雇主对献血活动的赞助，提高了血液供应。

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.