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Nov 20, 2012

Consortium Pilot Finds RFID Improves Efficiency of Blood Supply Chain
Source: Claire Swedberg

The Transfusion Medicine RFID Consortium reports that it has submitted the results of a radio frequency identification pilot to the U.S. Food and Drug Administration (FDA), as part of a request for 510(k) clearance of the blood-tracking solution. The consortium's membership includes RFID technology provider S3Edge Inc., numerous universities and clinics, the BloodCenter of Wisconsin, and other centers that supply blood products. The group had carried out the pilot over the course of several months at some of the BloodCenter of Wisconsin's blood-donation sites and headquarters facility (where blood products are manufactured), as well as at the University of Iowa Hospitals and Clinics (UIHC), where blood was administered to patients. Information systems consultant SysLogic Inc. provided project management for the deployment.

The consortium found that the use of RFID during the pilot resulted in a 33 percent reduction in reconciliation issues or misplaced products at the blood-donation points, as well as an 87 percent decrease in reconciliation issues or misplaced products when blood arrived at BloodCenter of Wisconsin's headquarters. In addition, efficiency during final inventory check-in at the BloodCenter of Wisconsin increased by 63 percent. At the hospital, product visibility was improved and the correct blood product was delivered to patient bedsides without a single error, for a total of 144 transfusions. Carter BloodCare and Mississippi Blood Services provided input regarding the system's design, thereby ensuring that a solution would be created to meet the needs of all blood centers, not just the BloodCenter of Wisconsin. Similarly, Baptist Health Systems, located in Mississippi, and UIHC provided input regarding a hospital's requirements. 

The pilot employed 13.56 MHz passive high-frequency (HF) RFID tags, complying with the ISO 15693 standard, on blood bags, as well as on the containers in which those bags were shipped. Mobile and desktop readers were used at the BloodCenter of Wisconsin's blood-donation units in Milwaukee. 

The group applied adhesive paper labels with embedded Avery Dennison AD-730x and Smartrac MiniTrack RFID tags to more than 75,000 blood bags. The RFID technology was tested in parallel with the existing bar-code-based tracking method.

The RFID Consortium plans to commercialize the technology once it receives 510(k) clearance from the FDA. According to the FDA's Web site, "a 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements." 

The consortium was formed in 2007 to study the integration of RFID into the blood product supply chain (see BloodCenter of Wisconsin to Study RFID's Effect on Blood). After completing studies into RFID's impact on blood products in 2008 and 2010, the group received FDA approval to proceed to a live pilot in November 2011, and to apply and encode HF tags on packets of red cells, platelets and plasma. The National Institutes of Health (NIH) provided a grant to conduct a study under SysLogic's management. 

S3Edge began developing the solution in February 2010, and the group then kicked off the pilot at the BloodCenter of Wisconsin in March 2012, and at the University of Iowa in May. The consortium's goal was to test whether an RFID-based system could enable participants to increase efficiency and generate gains from improved visibility into the movements of blood products when they are acquired, shipped to and received by a blood center for component manufacturing, and then shipped to a hospital or clinic. The second portion of the pilot tested the technology at a hospital, where the tagged blood products were tracked while being moved into storage, as well as while being administered to patients. 

The study's hypothesis, says Lynne Briggs, the BloodCenter of Wisconsin's VP and CIO, was that RFID would reduce the incidence of product loss and expiration, and that it would improve efficiency by providing greater product visibility and process automation. The group found that the RFID system did, indeed, achieve these expected benefits, and that it could provide an additional layer of visibility. By following the International Society of Blood Transfusion (ISBT) 128 bar-code-based system currently used worldwide for blood supply chain tracking, and by applying that system to RFID technology, the team ensured that the RFID-enabled solution they developed could be used anywhere. 

S3Edge designed the solution to be integrated with Mediware's LifeTrak software employed by the BloodCenter of Wisconsin, explains Anush Kumar, S3Edge's CTO and VP of business development. LifeTrak is a type of blood establishment computer software (BECS) that, according to the FDA, the blood transfusion industry utilizes to prevent disease in humans, "by identifying unsuitable donors and preventing the release of infectious or otherwise harmful blood and blood components for transfusion or for further manufacturing use." 

The technology was first piloted at several donor sites, and at the BloodCenter of Wisconsin, for a period of three months, beginning in March of this year. In May, the solution was then tested for one month at the UIHC. "Since then," Briggs reports, "we've done a tremendous amount of assessing the measurements/data collected." 

The group applied RFID tags to blood bags at three donor sites, and to the containers in which those tagged blood bags were placed and then shipped to the BloodCenter of Wisconsin. In addition, they affixed tags to blood bags at a mobile location that transports the blood-drive services to outlying communities and organizations. 

Staff members at the donor centers and mobile units were equipped with a Unitech PA600 handheld computer with a built-inRFID reader and bar-code scanner. The workers first entered data regarding the blood being drawn, and then scanned the bar-coded serial number printed on the RFID labels and input the Donation Identification Number (DIN). They used the handheld device to read each tag's ID number, which was linked to the bar-code number and the DIN, and that data was then stored on the S3Edge software. 

Once the filled containers of blood bags arrived at the BloodCenter of Wisconsin, the boxes were moved through aTagsys 50x50 HF RFID Tunnel reader, says Kumar, indicating which items had been received. Typically, the blood products are "manufactured," meaning the blood is put through specific processes in order to separate out various components, such as platelets and red blood cells. The resulting products can then be placed inside the bags with RFID tags, or into additional bags with tags married to the originating bag's RFID number.

A clinic or hospital typically places an order for specific blood products, and the BloodCenter of Wisconsin's staff members then locate those items in storage and pack them into a container. At this point, during the pilot, employees used a second Tagsys tunnel reader to interrogate the ID of every bag packed in the container. The S3Edge software then compared the read data with the list of products intended for that specific order, to ensure that the correct items were being packed. 

For the portion of the pilot involving the University of Iowa, UIHC's staff had to apply RFID labels to products as they were received. That, Briggs explains, was because the university is not a recipient of blood products from the BloodCenter of Wisconsin, but instead receives its blood products from the DeGowin Blood Center. "Unfortunately," she states, "the timing of the pilot did not allow for BloodCenter of Wisconsin's existing customers to participate." Those customers received tagged products, but did not read those tags.

Once the university hospital tagged the bags it received from the DeGowin Blood Center, its staff utilized a Tagsys PAD antenna mounted on top of a counter-height refrigerator with a table display to read the tagged bags. Workers interrogated the tag on each bag of blood before moving that product, and then selected a prompt either for "check-in" (to store the blood after receiving it from the DeGowin blood center) or "checkout" (indicating it was intended to be administered to a patient). 

The Unitech handheld reader was used at the bedside. In this case, UIHC's staff scanned the bar code printed on the patient's wristband, and then read the blood bag's RFID tag. The handheld transmitted the data via a connection to the S3Edge software running on a back-end server, which compared that information, and indicated on the handheld display whether the transfusion could proceed. 

"One of our goals was academic," Briggs explains. "We wanted to see if RFID technology would work in live transfusion medicine operations, and prove out various hypotheses from our original NIH study phases." Based on the study of the pilot, she says, she found that there were tremendous efficiency gains, primarily at the BloodCenter of Wisconsin's headquarters, where the technology and system allowed for rapid and accurate reconciliation of product counts and locations. Because the BloodCenter's employees saw which specific items were being shipped from the donor sites, Briggs adds, they were better able to prepare for the particular products en route to the facility. The system also helped eliminate errors that could occur at the time of receiving or shipping, when products are sometimes miscounted. 

"This is a mission-critical solution," Kumar states. Although Briggs notes that the BECS will always serve as the main system to manage inventory traceability, as well as information and decisions regarding blood products, the RFID technology adds a layer of visibility that can be integrated as part of the operational flow, "while still allowing the main system to do its work." RFID, he says, "augmented those systems to better protect the blood products," by providing greater visibility into the supply chain.

Once the FDA provides 501(k) clearance-which the group expects to take 90 to 180 days to complete-S3Edge will then be able to actively market and sell the blood center's RFID solution. The company anticipates selling two packaged solutions: the Blood Center Solution (for blood centers and donor locations) and the Hospital Transfusion Services Solution (for hospitals). Both systems can operate independently, the firm reports, or data can be shared between supply chain partners using both offerings.

Although the system was initially designed to be integrated with Mediware software, Kumar says, it could operate with other blood center BECS technology as well. 


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The S3Edge's RTVS based WiP (work in process) solution delivered on the promise of real visibility, real time in record time to enable GKB (Carl Zeiss Vision JV partner) to continue to raise the bar in the level of service .The WIP solution was delivered at ZEISS Brand Lab at Goa (a Carl Zeiss "Star One" accredited lab). In addition to enabling fewer delayed orders, and a multi-fold increase in customer satisfaction with a RFID based solution on the manufacturing floor, S3 is also closely working with us on designing innovative solution for our retail stores in India to further increase our customer value.

Manish Soni
General Manager
GKB Hi-Tech Lenses Pvt. Ltd.

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"The expertise and credibility of the S3Edge team made it an easy choice for us to engage with them to build out our device provider capabilities for the BizTalk RFID platform. In addition, their ability to deliver ‘80% done, 20% customizable’ software solutions via their rich RTVS solution framework is a much needed piece of the puzzle in enabling our integrators to deliver high-value, complex solutions in a repeatable cookie-cutter manner, with lesser custom code"

Sal Scafidi
Strategic Business Manager
Omron RFID Division
United Technologies

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The RFID system provided equivalent capabilities to those of IPR in terms of detecting and resolving process errors. It additionally provided the blood bank staff real-time visibility for blood products in transit from the hospital blood bank to the point-of-care and in remote storage in our emergency department.

Dr. Thomas J. Raife,
MD, Clinical Professor & Medical Director,
UIHC DeGowin Blood Center

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S3Edge's packaged asset tracking software has enabled us to go from assessing technical feasibility to building out a set of applications that address the operational needs of blood centers and hospitals in a relatively short period of time. Their technical abilities and experience in deploying enterprise-ready applications has helped the consortium deliver on the promise of a packaged mission critical solution to improve the safety and efficiency of our nation's blood supply

Tina Chang
CEO, SysLogic Inc.

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We are extremely pleased to team up with S3Edge to put this exciting system development into the hands of our clients. Our unified, best-of-breed approach, which brings together Access Solutions’ deep domain expertise in the FME industry and S3Edge’s Spotlight technology for RFID-based asset tracking, as well as their systems integration bench strength and expertise, will deliver unparalleled levels of efficiencies across the enterprise

Kelvin Mann,
President  & CEO, Access Solutions

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S3Edge continues to raise the bar in the area of software innovation to address customer needs. The support for Android-based devices for our transfusion medicine RFID applications will give healthcare professionals in our field an easy, well-understand interface to quickly adopt a new set of auto-ID applications aimed at cutting costs and eliminating errors in the blood supply chain. This new-paradigm is going to be the game-changer in the adoption of RFID based applications in Healthcare.

Clive Hohberger
RFID Systems Architect,
Blood Center of Wisconsin

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"S3Edge's commitment to quality, flexibility, and RFID domain expertise in deploying enterprise-ready software in an operationally challenging environment using a variety of devices, is second to none. Their approach to deploying a scalable Real-Time Visibility & Control System has allowed us to take a complex, emerging technology and convert it into a competitive advantage for our business and customers"

James Chan
General Manager

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Our strategic partnership with S3Edge allows Microsoft BizTalk RFID users to exploit the Speedway® reader’s advanced capabilities and performance. I highly recommend S3Edge as a partner to work with in building end-to-end solutions on the Microsoft RFID platform.

Daniel Bowman
Sr. Marketing Manager, Impinj, Inc

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S3Edge has helped Motorola take our partnership with Microsoft BizTalk RFID to the next level.

Matt Eschbach
Global Strategic Alliance Manager
Motorola Enterprise Mobility Business

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S3 Edge’s unique capabilities and deep understanding of Microsoft’s Mobile RFID platform was crucial in deploying a turnkey solution at RiteCare pharmacy for warehouse visibility – their ability to go from design to fully operational in 60-90 days at the customer site is a testament of their abilities to show demonstrable ROI and lower the barrier to rapid solution deployment.

Judy Huang
Product Manager RFID
Unitech Electronics Co., LTD

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"We selected S3Edge after evaluating solution providers based on their experience, and ability to deliver a mission-critical, large-scale enterprise application focused on the operator and the flow of work in our existing processes. Thanks to this approach and S3Edge's focus on delivering to commitments, the project benefits were realized within three months of launch with little to no re-engineering required. The system has been running live in a high velocity, dynamic manufacturing environment for over a year with no issues"

Balaji Suresh
Materials Manager, and project sponsor
United Technologies

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"S3Edge is a key partner in developing packaged solutions that fully utilize the capabilities of the Microsoft BizTalk RFID platforms to address real-world customer need. Their Spotlight product is a good example of how partners are innovating to deliver complete end-to-end solutions for customers on the Microsoft Application Platform, across the globe"

Sudhir Hasbe

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S3 Edge is our most preferred RFID technical partner

Kian NG
SOA, Process Platform & RFID Solutions Sales - ASIA Lead
Microsoft Asia Pacific

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We are extremely pleased to team up with S3Edge to design, and develop this innovative application for the transfusion medicine industry. Our collaborative, best-of-breed approach, which brings together the domain expertise in Transfusion Medicine practices and S3Edge's software strength, will deliver unparalleled levels of efficiencies for blood centers and hospitals across their supply chain operations

Rodeina Davis
Vice-President & CIO, BloodCenter of Wisconsin

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S3 Edge's RTVS capabilities enabled RiteCare Pharmacy to envision, design and implement game-changing business processes. The S3 Edge RTVS software built on Microsoft BizTalk platform has enabled us to cut down our cycle times to ship by 50%, eliminate errors due to mis-ships, and double our throughput times. This innovative real-time visibility platform for warehouse ensures RiteCare can now scale rapidly in the future to fulfill our promise of a quality pharmacy in every neighborhood with wide variety of medicines.

Seshu Guddanti
Managing Director of RiteCare

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Thanks to the outstanding work of the entire consortium team, we have successfully piloted the new system to track blood products as they move from fixed and mobile donation sites, through the blood center and to distribution. After 24 weeks of running the system in a pilot mode here at the BloodCenter of Wisconsin, we have seen process efficiency and traceability gains, as well as marked improvements in reconciliation

Lynne Briggs
Vice President and
Chief Information Officer,
Blood Center of Wisconsin, Milwaukee

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  Spotlight based RFID Software provides an automated method of identifying the movement of assets across various locations by deploying a packaged inventory-tracking solution across various devices, that can then be customized for specific business-process workflows.