SBIR-STTR Award

Rfid Application in the Blood Product Supply Chain
Award last edited on: 3/28/19

Sponsored Program
STTR
Awarding Agency
NIH : NHLBI
Total Award Amount
$1,499,754
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Rodeina Davis

Company Information

SysLogic Inc

375 Bishops Way Suite 105
Brookfield, WI 53005
   (262) 780-0380
   tchang@syslogicinc.com
   www.syslogicinc.com

Research Institution

University of Wisconsin

Phase I

Contract Number: 1R41HL086272-01A1
Start Date: 9/24/09    Completed: 6/30/11
Phase I year
2007
Phase I Amount
$100,000
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.

Thesaurus Terms:
biomedical automation, blood bank /supply contamination, computer system design /evaluation, monitoring device, radiowave radiation, technology /technique development automated data processing, blood transfusion, computer assisted patient care, computer program /software, health care cost /financing, information system, patient safety /medical error, sample collection

Phase II

Contract Number: 2R42HL086272-02
Start Date: 9/24/09    Completed: 6/30/11
Phase II year
2009
(last award dollars: 2010)
Phase II Amount
$1,399,754

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 status-monitoring of blood and blood products across the entire transfusion medicine supply chain, from the point of collection to the delivery of a product by a healthcare provider to a patient. The goal is to create a failsafe system for automatic identification and data capture that will reduce medical errors and enhance the patient safety, quality, and cost-effectiveness of patient-centered transfusion medicine care. The specific aims of this STTR Phase 2 proposal are to: 1. Develop a comprehensive RFID-enabled blood product tracking (BPT) solution for the transfusion medicine supply chain including blood centers and hospitals. The BPT application software will be a market-ready product and will be positioned for FDA 510(k) clearance. The BPT system will augment existing blood center and transfusion services functionality and will not replace or interfere with any required barcode or key labeling information. Further, it will comply and work in conjunction with the internationally accepted ISBT 128 labeling and data messaging standard. 2. Conduct a proof-of-concept exercise followed by an integrated operational pilot implementation at one blood center and one hospital. The purpose is to demonstrate, verify and validate the technical feasibility and potential benefits of using RFID in transfusion medicine. 3. Perform technical and clinical tests, following scientifically rigorous protocols developed in collaboration with and approval of the FDA, to conclusively confirm the safety, reliability and performance of using 13.56 MHz RFID technology with blood products. The STTR Phase 2 will provide insight into three fundamental research questions that are central to the industry acceptance of the proposed RFID-enabled BPT solution, and the success of this project. 1. Can the proposed RFID-enabled BPT solution, from donation to transfusion, be applied safely and effectively to the core processes in the transfusion medicine supply chain? 2. What is the extent of improvement on operational productivity, patient safety, quality, supply chain responsiveness and cost-effectiveness that can be achieved in a real-world setting? 3. What is a roadmap for successfully implementing and deploying the RFID-enabled BPT solution within a blood center and a hospital? What are the success factors and potential barriers for introduction, integration, adoption and use of the system within an organization and across the supply chain? These efforts will lead to the commercialization and deployment of the RFID-enabled BPT solution in military and civilian health care organizations where failsafe distribution of blood products is critical to public health.

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 pilot of an innovative application of radio frequency identification technology for accurate and failsafe identification, tracking, and status monitoring of blood and blood products through the entire 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, as well as helping increase cost-effectiveness of patient care with enhanced efficiency and productivity in the blood supply chain.

Thesaurus Terms:
Address; Adoption; American; Armed Forces Personnel; Back; Blood; Blood Banks; Caring; Cessation Of Life; Clinical; Collaborations; Collection; Computer Programs; Computer Software; Data; Death; Department Of Health And Human Services; Department Of Health And Human Services (U.S.); Development And Research; Dorsum; Drugs, Nonproprietary; Environment; Exercise; Exercise, Physical; Frequencies (Time Pattern); Frequency; Generic Drugs; Goals; Hhs; Hosp; Health Care Providers; Health Personnel; Healthcare Providers; Healthcare Worker; Hospitals; Incidence; Industry; Infrastructure; Institute Of Medicine; Institute Of Medicine (U.S.); Investigation; Label; Lead; Love; Marketing; Medical Errors; Medical Mistakes; Medicine; Military; Military Personnel; Monitor; Mortality; Mortality Vital Statistics; Nas/Iom; Nih; National Academy Of Sciences; National Academy Of Sciences (U.S.); National Institutes Of Health; National Institutes Of Health (U.S.); Outcome; Patient Care; Patient Care Delivery; Patients; Pb Element; Performance; Phase; Position; Positioning Attribute; Process; Productivity; Protocol; Protocols Documentation; Public Health; R & D; R&D; Radio; Research; Research Infrastructure; Reticuloendothelial System, Blood; Sttr; Safety; Science Of Medicine; Services; Small Business Technology Transfer Research; Software; Solutions; Staging; System; System, Loinc Axis 4; Trnsf; Technology; Testing; Transfusion; United States Department Of Health And Human Services; United States Dept. Of Health And Human Services; United States National Academy Of Sciences; United States National Institutes Of Health; Use Effectiveness; Vascular Blood Supply; Work; Blood Product; Blood Supply; Commercialization; Computer Program/Software; Cost Effectiveness; Fundamental Research; Generic; Hazard; Health Care Organization; Health Care Personnel; Health Care Service Organization; Health Care Worker; Health Provider; Healthcare Personnel; Heavy Metal Pb; Heavy Metal Lead; Improved; Innovate; Innovation; Innovative; Insight; Medical Complication; Medical Personnel; Patient Centered; Patient Oriented; Patient Safety; Public Health Medicine (Field); Public Health Relevance; Research And Development; Success; Technological Innovation; Treatment Provider; Vascular Supply