RFID Application in the Blood Product Supply Chain

描述（由申请人提供）：该项目首次全面研究、开发和引入无线射频识别（RFID）技术的创新应用，用于在整个输血药品供应链中对血液和血液制品进行自动识别、跟踪和状态监测，从采集点到血液制品的制造和分销，再到医疗保健提供者将产品交付给患者。目标是创建一个安全、准确和无故障的系统，用于从收集到输血的自动识别和数据采集，这将减少医疗差错，并提高以患者为中心的护理的安全性、质量和成本效益。STTR第一阶段建议的具体目标是：1。研究技术可行性和潜在的流程改进（在生产率、质量、安全性和成本方面），通过整个输血药品供应链，从收集到输血点，使用RFID积极识别、监测和跟踪血液制品。2. 开发一个功能原型RFID系统，作为技术可行性和过程有效性的概念验证演示。该原型将用质量体系方法补充良好的生产和输血规范以及现有的信息系统，并符合输血药物供应链的政策环境。这项STTR第一阶段的工作将包括在现实环境中进行的科学严谨的研究和开发活动，以解决关键的技术和面向过程的问题，例如：a.如何最好地应用RFID来改善输血药品供应链流程？b.将RFID数据集成到现有血库和输血服务软件和信息系统中，对中间件软件有什么要求？c.在输血药品供应链中使用RFID相关的技术挑战（例如，标签可读性问题）是什么，以及克服这些挑战的方法是什么？在第一阶段的研发工作之后，在第二阶段，我们将通过将RFID系统集成到实际供应链（由一个或多个血库和医院组成）的日常操作中来进行试点实施，以展示和评估系统的可行性和效益。在第三阶段，这些努力将导致该系统在军事和民用卫生保健组织的双重用途应用的商业化和部署，在这些组织中，无故障血液制品的分发对公共卫生至关重要。国家的血液制品供应链是我们公共卫生基础设施的重要支柱。美国国家科学院医学研究所和其他主要组织进行的研究强调了医疗事故的高发生率，每年导致44,000至98,000名美国人死亡。该计划旨在通过研究、开发和转让射频识别技术的创新应用，提高我国血液供应的安全性、质量、生产力和响应能力，以便在输血药品供应链（包括采集、制造、分销和输血）中准确无误地识别、监测和跟踪血液和血液制品。因此，该项目解决了美国卫生与公众服务部和国立卫生研究院的国家优先事项之一，并将有助于尽量减少输血医疗错误造成的死亡率。

DESCRIPTION (provided by applicant): This project represents the first-ever comprehensive investigation to research, develop and introduce innovative application of radio frequency identification (RFID) technology for automatic identification, tracking and condition-monitoring of blood and blood products across the entire transfusion medicine supply chain, from the point of collection, through blood products manufacturing and distribution, to the delivery of a product by a healthcare provider to a patient. The goal is to create a secure, accurate and failsafe system for automatic identification and data capture, from collection to transfusion, which will reduce medical errors and enhance the safety, quality and cost-effectiveness of patient-centered care. The specific aims of this STTR Phase I proposal are to: 1. Research the technical feasibility and potential process improvements (in terms of productivity, quality, safety, and cost) of using RFID to positively identify, monitor, and track blood products through the entire transfusion medicine supply chain, from collection to point of transfusion. 2. Develop a functioning prototype RFID system to serve as a proof-of-concept demonstration of technical feasibility and process efficacy in real-world scenarios. The prototype will complement good manufacturing and transfusion practices and existing information systems with a quality systems approach and conform to the policy environment of the transfusion medicine supply chain. This STTR Phase I effort will be comprised of scientifically rigorous research and development activities conducted in real-world settings to address key technical and process-oriented questions such as: a. How can RFID be best applied to improve transfusion medicine supply chain processes? b. What are the requirements for middleware software to integrate RFID data into existing blood banking and transfusion services software and information systems? c. What are the technical challenges (e.g., tag readability issues) associated with use of RFID in the transfusion medicine supply chain, and what are ways to overcome them? Subsequent to this Phase I R&D effort, in Phase II we will do a pilot implementation by integrating the RFID system within the everyday operations of an actual supply chain (comprised of one or more blood banks and hospitals) to demonstrate and assess system feasibility and benefits. These efforts will lead to the commercialization and deployment, in Phase III, of dual-use applications of this system in military and civilian health care organizations where failsafe blood products distribution is critical to public health. (RELEVANCE) The nation's blood products supply chain is a critical pillar of our public health infrastructure. Studies conducted by the National Academy of Science's Institute of Medicine and other leading organizations have highlighted the high incidence of medical errors that result in between 44,000 and 98,000 American deaths each year. The proposed project aims at enhancing the safety, quality, productivity and responsiveness of our nation's blood supply through research, development and transfer of innovative application of radio frequency identification technology for accurate and failsafe identification, condition monitoring and tracking of blood and blood products through the transfusion medicine supply chain (including collection, manufacturing, distribution and transfusion). Thus, this project addresses one of the national priorities of the US Department of Health and Human Services and the National Institutes of Health, and will help in minimizing mortalities due to transfusion medical errors.