چارچوب نظام مند برای شناسایی فرکانس رادیویی (RFID) کاهش خطر در زنجیره تامین انتقال خون از کمک مالی به توزیع
Abstract: The RFID Consortium is developing what will be the first FDA-approved use of radio frequency identification (RFID) technology to identify, track, manage, and monitor blood throughout the entire blood transfusion supply chain. The iTrace(TM) is an innovative technological system designed to optimize the procedures currently employed when tracing blood from the donor to the recipient. With all novel technologies it is essential to consider not only the advantages, but also the potential harms that may come about from using the system. The deployment of the iTrace(TM) consists of two phases: 1) Phase One - application of the iTrace(TM) from the donor to blood center distribution, and 2) Phase Two - application of the iTrace(TM) from blood center distribution to transfusion. This dissertation seeks to identify the possible hazards that may occur when utilizing the iTrace(TM) during Phase One, and to assess the mitigation and correction processes to combat these hazards. A thorough examination of verification and validation tests, as well as of the system design, requirements, and standard operating procedures was performed to qualify and quantify each hazard into specific categories of severity and likelihood. A traceability matrix was also established to link each hazard with its associated tests and/or features. Furthermore, a series of analyses were conducted to determine whether the benefits of implementing the iTrace(TM) outweighed the risks and whether the mitigation and correction strategies of the hazards were effective. Ultimately, this dissertation serves as a usable, generalizable framework for the management of RFID-related hazards in the blood transfusion supply chain from donor to blood center distribution.
Keywords: Biological sciences, Health and environmental sciences, Health informatics, Blood transfusion supply chain, Hazard mitigation, Health care devices, Radio frequency identification, Risk mitigation