Barcode technology has been very good for the blood bank community. When it was introduced in transfusion medicine in the mid-1970s, it offered new opportunities to streamline process flows and avoid data entry errors. The latest barcode standard adopted by the international blood bank community is called “ISBT 128” and is owned by the International Council for Commonality in Blood Banking Automation (ICCBBA), a non-governmental organization recognized by the World Health Organization, and responsible for the maintenance and promulgation of the standard.
So what’s next? In 2006, the ISBT created a Task Force on Radio Frequency Identification (RFID) to study the potential of that technology in blood transfusion. The team highlighted two inherent advantages of RFID over barcodes:
- Barcodes must be seen by a human operator to be read; RFID tags, however, can be scanned without a line-of-sight. With the right combination of tags and readers, it’s possible to read an entire carton of uniquely-identified blood containers without even opening the box. That would be impossible with barcodes alone.
- Characteristics of a blood unit can change from day to day. RFID chips used to identify blood are “Read/Write,” which means data about a unit can be updated based on further processing such as irradiation or supernatant reduction. RFID chips can indicate, in real-time, the exact nature of the blood product; relabeling would still be required, of course, prior to distribution.
The first comprehensive U.S. effort to study RFID in blood banking was launched by the BloodCenter of Wisconsin in 2009 when it received a grant from the National Institutes of Health. Forming a consortium of multiple blood centers and hospitals, this group, along with the University of Wisconsin-Madison RFID lab, studied the usability, survivability, and safety of RFID in the blood supply chain. After the ISBT agreed to standardize on HF (High Frequency) RFID technology, and it was shown to the U.S. Food and Drug Administration (FDA) to have no deleterious effects on blood products, the team developed two of the first comprehensive systems for the blood supply chain. Real-world trials of RFID technology at both blood center and hospital facilities followed, and in 2013 the first FDA 510K was issued for this group’s groundbreaking blood center RFID system.
Takeaways: advantages of RFID
There were several “lessons learned” as a result of this effort:
- Standard off-the-shelf HF RFID tags function when applied to liquid and frozen blood products.
- These off-the-shelf tags can survive the rigors of blood component manufacturing, including centrifugation and irradiation.
- It was possible within a blood center to significantly reduce the time to count, reconcile, and track blood products, including fully reconciling containers coming in from collection, moving from labeling to inventory, or leaving for a hospital. Locating blood products—particularly frozen plasma—was much easier and better ensured that products requiring quarantine could be quickly found and isolated. The significantly improved accuracy of reconciliation from collections greatly reduced the need for back office quality/regulatory time in investigating “lost product” situations, etc.
- Within a hospital, the visibility of blood products within an institution was much greater, and advanced features of bedside match could improve patient safety.
- Positive Return on Investment (ROI) based on reduction of lost products, process efficiencies, and safety/quality gains existed, if tags could be produced for less than 30 cents each, with 25 cents as a target.
- The data gathered about the movement and use of blood products within the blood center and hospitals became a rich source of information to aid in assessing blood demand, utilization, and waste, as well as areas for improvement/efficiency in process flows. This data could be used to aid in recruitment planning, and closer to real-time. RFID would avoid the need to tap large back-end hospital systems to allow a blood center to help better manage inventory.
- For RFID to aid in the entire supply chain, a global standard would have to be promulgated that dictates the tag type, layout, and data structures. (The first standard, entitled Guidelines for the use of RFID Technology in Transfusion Medicine, was published in the journal Vox Sanguinis in 2010; the tags involved in the Blood Center of Wisconsin study complied with that standard.)
In addition to these takeaways, consensus within the blood bank community has been reached on a couple of important points:
- RFID tags will not replace barcodes. They will, instead, be implemented as a complementary identification technology, augmenting the barcodes; the barcodes become an important new source of redundancy, further improving the reliability of the information in the supply chain. The tags will not substitute for, replace, or contradict any required barcode or key labeling information;
- ISBT 128-defined data structures, the key to the success of the entire standard, will be used within any RFID-based system. So any change to RFID is primarily a change to the medium used to communicate those data structures—from labels that are scanned with a bar code reader to smart integrated chips that communicate wirelessly in two directions using radio frequency for data transmission.
Some commercial developments have occurred in the past few years to encourage the implementation of RFID. One European company based in Spain provides a three-module (donation, production, transfusion) vein-to-vein solution; each module can be deployed independently and coupled upon request. In one region, about 200,000 RFID-labeled blood components have been processed, stored, and subsequently distributed to hospitals, while in another region, 5,000 transfusions of RFID-labeled blood have occurred with measurable
improvements in safety.
There are also efforts underway to address another barrier to RFID implementation—cost. As patient blood management efforts and an aging donor population combine to reduce blood collection volumes, and while collection facilities are consolidating to survive, will the expected benefits of RFID technology be sufficient to warrant substantial investment? This has been a significant obstacle to the growth of RFID so far, and at least one company is seeking to overcome it with an entirely different business model. Rather than pay upfront for the RFID infrastructure, users pay per use. There is a fixed fee for every RFID-identified blood unit collected. Over a period of time, the cost of the equipment (readers, “smart refrigerators,” software, etc.) is paid for via the per-unit fee.
The business case for RFID is getting stronger (see sidebar) and regulatory concerns have largely been assuaged, assuming that other countries follow the FDA’s lead. The need for unique yet dynamic identification, coupled with the often labor-intensive nature of blood processing, seem to point to a growing usage of RFID technology in transfusion medicine. Growth in the technology’s usage on blood products will likely not be exponential. But is becoming clear that there are compelling reasons for blood bankers to take another look at a technology ideally suited to complement barcodes and offer even greater efficiency and safety to the collection, processing, distribution, and use of one of the world’s most precious resources.
The economics of RFID in blood banking
The business case for utilizing RFID in blood banking is becoming stronger because of three factors: (1) technology costs; (2) business model; and (3) benefits of dynamic data.
Technology costs. Costs of RFID technology components—including readers, RFID labels, software, and system integration—fall as service providers identify common needs and modify product offerings accordingly. The costs of RFID inlays have fallen significantly in the past few years, as other markets have expanded their usage.
Business model. An RFID business case with implementation costs borne by the blood centers with benefits accruing to others downstream will be marginal for the blood center: the hospital benefits cannot be included in the ROI for the blood center. This situation can be addressed by raising the price of the product from the blood center to the hospital; the hospital is able to justify the increase in cost through recognition of the associated benefits. RFID solution providers in transfusion medicine can ensure that product development efforts address the needs of each participant in the value chain.
Dynamic data. Dynamic data refers to the information that can be added to the chip and stored in the user memory—information that is variable, accompanying the unique user identification data that is equivalent to the data stored today in a barcode.
The information stored in the user memory can include quality indicators, time and date stamps, and even sensed information such as temperature history. One of the most exciting developments in RFID in recent years has been companion wireless sensors that provide monitored data that can be inexpensively stored on the chip. In parts of the world where the yield in the blood supply can be enhanced by improving temperature control in the supply chain, it is possible to use RFID to store the temperature history for the blood product directly in the user memory.
Other creative applications for dynamic data management will emerge as the technology is developed further and deployed in commercial transfusion medicine applications, increasing value and resulting in more compelling returns on the RFID investment.