For Blood / Biologics

Tracking Blood Electronically
by Jerry D. Holcombe

Blood centers have been using reliable and easy-to-scan barcodes to positively identify and track blood products for decades. Radio Frequency Identification (RFID) technology has been widely used in other industries with myriad applications for years. Marrying the two technologies for transfusion medicine can make it possible to "read" containers of blood simultaneously, reduce costs, streamline operations, and ultimately prevent mismatched blood at the point of transfusion. The addition of RFID in blood banking has the potential to reduce the incidence of life-threatening transfusion error.

Rodeina Davis, Vice President and CIO for BloodCenter of Wisconsin in Milwaukee, is leading an effort that will set the stage to introduce radio frequency identification (RFID) throughout the complete blood supply chain from donation to patient transfusion.

When the RFID project was first conceived in Milwaukee, there had been a number of RFID studies in hospitals (United States) and blood centers (Europe). None of the studies, however, appeared to show promise of bringing use of the technology into the complete supply chain for transfusion medicine. Ms. Davis and the study team saw its objective: to determine whether the use of RFID technology in transfusion medicine has the potential to advance both patient safety and operational efficiency and effectiveness. To realize the benefits of RFID use, the study team began a broad effort to work closely with standards organizations that were also looking at RFID from an international perspective.

The basics of RFID technology involve a reader that electronically asks an RFID tag to give up its information. When polled, the RFID tag "wakes up" and transmits the requested data. Significantly more data can be stored on the RFID tag than can be contained in a barcode, and each data element can be protected against being overwritten or can only be written at specific points in a process. It is possible to read whole containers of blood bags simultaneously in this manner, or to find a single blood bag among hundreds or thousands of others. And just before transfusion, critical data elements on the RFID tag can be automatically compared with what the patient requires to ensure a positive match.

Since introduction of the technology would require a significant investment in hardware and infrastructure, it was important that industries peripheral to transfusion medicine also be considered. RFID adoption for transfusion medicine would need to fit well with RFID use in pharma. And, it appeared that an RFID investment was improbable unless its application encompassed the entire blood supply chain from blood donation to the point of patient transfusion.

Ms. Davis initiated contact with Dr. Raj Veeramani who leads an eBusiness consortium in RFID at the School of Engineering at University of Wisconsin's Madison campus. That school also operates an RFID laboratory, and the university had expressed interest in becoming involved in the health care industry. With early planning underway, Ms. Davis began to talk with other blood centers regarding the endeavor.

BloodCenter of Wisconsin and a large contingent of blood operations experts from Carter BloodCare in Dallas/Ft. Worth and Mississippi Blood Services in Jackson assessed application of the technology for blood operations for two years. They worked with the University of Wisconsin's RFID Lab to study and refine operational processes that included RFID data capture, and developed an ROI model that revealed a positive return on investment in 3.9 years for a blood center with approximately 225,000 annual collections. The study team has begun its assessment on the transfusion services (hospital) side of the supply chain and is formulating plans to prototype use of the technology in both blood centers and transfusion services.

The team conducted clinical testing to see whether radio frequency (RF) energy had any adverse effects on blood products. That testing was completed last September with no adverse results, and the FDA has now agreed that a prototype study can safely proceed.

This study has been closely aligned with standards organizations such as EPCglobal, ICCBBA, and an ISBT working group on RFID to ensure global usability. The resulting system will work in tandem with ISBT bar coding and will offer quality and efficiency gains in our industry.

A major part of the study has already involved a close look at existing processes at blood centers and hospital transfusion services, identification of pain points, consideration of pain points that could be remediated by the use of RFID technology, and development of RFID-enabled processes. With this information in hand, the team was able to both calculate projected return on investment and develop use case scenarios for prototyping.

A full RFID solution that integrates seamlessly with existing systems … including hardware, software and peripheral devices … should be available to blood centers and hospitals within two to three years following the pilot phase.

Ms. Davis will spotlight her efforts in an AABB teleconference on June 18 with a presentation entitled "Tracking Blood Electronically: The Future Is Here." Her presentation will address the feasibility and impact of RFID in blood banking, describe the roles of various regulatory and standards organizations in providing guidance and participation for the implementation of RFID, and will identify stakeholders and their roles in deploying RFID technology including bag manufacturers, blood centers and hospitals. Ms. Davis will also explain how data is to be transferred to an RFID tag, how it will be protected, and efficiencies to be gained when RFID is layered to augment existing bar code technology.

Jerry D. Holcombe, project administrator for the RFID project team, has worked closely with Ms. Davis and all study partners from inception of this project.

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FDA Link:
Information Sheet:Radio frequency Identification Feasibility Studies and Pilot Programs for Drugs
http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html

Additional Article:
All Eyes on FDA for Drug E-Pedigree:
http://www.rfidjournal.com/article/articleview/4013/

RFID Pilot Project Aims to Improve Blood Banks:
http://wistechnology.com/articles/3571/