- Email: [email protected]
Applying radio-frequency identification (RFID) technology in transfusion medicine
Biologicals 40 (2012) 209e213
Contents lists available at SciVerse ScienceDirect
Biologicals journal homepage: www.elsevier.com/locate/biologicals
Applying radio-frequency identification (RFID) technology in transfusion medicine Clive Hohberger a, *, Rodeina Davis a, Lynne Briggs a, Alfonso Gutierrez b, Dhamaraj Veeramani b a b
BloodCenter of Wisconsin, Milwaukee, WI, USA University of Wisconsin -Madison, WI, USA
a r t i c l e i n f o
a b s t r a c t
Article history: Received 10 October 2011 Accepted 18 October 2011
ISO/IEC 18000-3 mode 1 standard 13.56 MHz RFID tags have been accepted by the International Society for Blood Transfusion (ISBT) and the United States Food and Drug Administration (FDA) as data carriers to integrate with and augment ISBT 128 barcode data carried on blood products. The use of 13.56 MHz RFID carrying ISBT 128 data structures allows the global deployment and use of RFID, supporting both international transfer of blood and international disaster relief. The deployment in process at the BloodCenter of Wisconsin and testing at the University of Iowa Health Center is the first FDA-permitted implementation of RFID throughout in all phases of blood banking, donation through transfusion. RFID technology and equipment selection will be discussed along with FDA-required RF safety testing; integration with the blood enterprise computing system and required RFID tag performance. Tag design and survivability is an issue due to blood bag centrifugation and irradiation. Deployment issues will be discussed. Use of RFID results in significant return on investment over the use of barcodes in the blood center operations through labor savings and error reduction. Ó 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
Keywords: RFID 13.56 MHz Blood Transfusion safety ISBT 128
1. Introduction In the development of the ISBT 128 global standard for labeling of blood products [1] during the early 1990s, it was anticipated that data carriers in addition to barcode would eventually be used on blood products. Therefore, the barcode symbology utilized (ISO/IEC 15417:2000 Code 128) and the data structures were designed around the use of ISO 646 (7-bit ASCII) characters which are data carrier independent. Development of RFID technology largely occurred in the decade after the ratification of the ISBT 128 barcode standard in 1994. In low-cost passive RFID systems the tag is powered by the energy from the reader’s RF field. Passive RFID technology is superior to traditional barcode-based automatic identification and data capture in numerous ways: It does not require line-of-sight Allows reading of multiple tags in the same reader field
* Corresponding author. RFID System Architect, BloodCenter of Wisconsin, 638 N. 18th Street, Milwaukee, WI 53233, USA. Tel.: þ1 414 937 6406, þ1 847 910 8794(Mob). E-mail address: [email protected] (C. Hohberger).
Is able to store more data on the chip, and Allows for updating that stored data The potential advantages of RFID technology and its potential benefits of improving safety, quality, productivity and responsiveness in the delivery of care to patients have not gone unnoticed by the blood banking and transfusion medicine community [2e7]. An RFID task force within the ISBT Working Party on Information Technology was formed to consider how RFID tags might be utilized in blood collection, processing, distribution and transfusion. Because of considerations of blood RF safety and the need for a truly global RFID standard to support international transshipment and disaster relief efforts, RFID utilizing the only truly global standard frequency of 13.56 MHz was selected for use by this multinational task force. A several year effort resulted in the publication in April 2010 of the ISBT Guidelines for the use of RFID Technology in Transfusion Medicine, Version 1.0 [8]. Use of ISO/IEC 18000-3 mode 1 13.56 MHz RFID tags has been accepted by the ISBT and more recently by the United States FDA as supplemental data carriers on blood products. The Transfusion Medicine RFID Consortium (http:// transfusionmedicinerfid.org/), which includes 3 blood centers, 2 hospitals, the University of Wisconsin at Madison RFID Lab, and several technology partners is actively engaged in the first-ever
1045-1056/$36.00 Ó 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.biologicals.2011.10.008
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C. Hohberger et al. / Biologicals 40 (2012) 209e213
comprehensive investigation to research, develop and introduce RFID for automatic identification, tracking and status-monitoring of blood products across all entities in the supply chain e from the point of collection, through manufacturing and distribution, to transfusion by a healthcare provider to a patient. This paper describes the development, testing and deployment in process at the BloodCenter of Wisconsin and under test at the University of Iowa Health Center of the first FDA-permitted implementation of RFID-tagged blood products from donation through transfusion. 2. Guiding principles A fundamental assumption underlying ISBT 128 is that the blood product label should carry all the key data about the product, as database access may not be available at a disaster or battlefield site where transfusion occurs. RFID tags enable additional information about the product to be stored on the label: Reading at the transfusion site then can be as simple as a Near Field Communication (NFC) cell phone application. A guiding principle is that the RFID tag will not substitute for, replace, or contradict any required ISBT 128 barcode labeling information. Thus the RFID tag augments existing ISBT 128 barcodebased blood center operations and hospital transfusion systems, rather than replacing them: The RFID tag augments ISBT 128 barcodes AND the barcodes back up RFID tag The RFID based system solution will NOT perform critical functions already performed by a barcode-based Blood Enterprise Computing System (BECS), which remains the system of record RFID is only used as a supplemental tracking application to the BECS Only data carrier-independent ISBT 128 compliant data structures which use 7-bit ISO 646 (ASCII) characters are used in the byte-oriented tag memory. Additional ISBT 128 data structures will be designed for RFID-supported features not supported in ISBT 128 barcodes.
Tag user memory is allocated in 4-byte physical memory blocks which are individually addressable and lockable. Here certain blocks are reserved for the blood center to carry ISBT 128 DIN, ABO/ Rh, ISBT Product Code, Expiration Date and Time as well as bag code and lot number data structures; other blocks are reserved for transfusion service use in patient assignment and verification. Since the tag layout is not critical as each ISBT 128-compliant field is fixed length and start with a unique data identifier, the data was arranged in tag memory to permit contiguous block reads and writes whenever feasible. In addition, a CCITT CRC-16 data checksum is stored on the tag covering all key tag data fields. This permits detection of tag data integrity and/or memory corruption. If data integrity tests ever fail, the tag will be “killed” and only barcode data on the bag will be used. Passive RFID helps deal with “Pain Points” in the blood center: Reconciling data with physical reality by building RFID unit and container relationships enabling better tracking and faster container reconciliation, Physically locating products using RFID to record or update a database of the “last seen” location of all products encountered during searches, to enable finding products faster, Track time out of temperature-controlled locations and provide an alerts if the time between “last seen” reads of the passive tag in an uncontrolled temperature locations is too long. (Note: Active or passive temperature sensor tags would be preferable, but cost considerably more) Rapid donation check in and shipment verification at the blood center by using RFID’s ability to read multiple units in closed containers to significantly reduce labor.
3. Blood center implementation Fig. 1 shows the RFID enabled processes at the donation sites. Collection bag sets are RFID tagged using a 14 31mmRFID tag placed under the standard ISBT 128 DIN label. In a 3-bag collection
Fig. 1. RFID Enabled Processes at the Donation Site.
C. Hohberger et al. / Biologicals 40 (2012) 209e213
set, just the RBC product bag is tagged; the plasma bag and other manufactured products will be tagged at final labeling. All bags in an apheresis collection are tagged at the donation site as RFID enables accounting for missing or unused bags from that set. Wi-Fi connected Unitech PA600 Mobile Clinical Assistant personal data terminals (which have both barcode and HF RFID readers) are used at the donation sites to read the DIN barcode and perform tag initialization. All tag data is uploaded to a mobile RFID application database for transfer to the blood center for use in RFID-enabled donation check in. Donation shipping containers are also tagged. A packing list is created on each container tag. Load lists of each container are created and forwarded to the blood center as an advanced shipping notice where connectivity exists, or placed on a USB memory drive accompanying the shipment. Fig. 2 shows the RFID enabled processes within the blood center. A major application is donation check in and reconciliation of closed shipping containers in 50 50 cm aperture LAN-connected TAGSYS Medio L-400 4 channel tunnel readers using the RFID tags on the container and the collection sets. At BloodCenter of Wisconsin (225,000 donations/year) a potential labor saving of over 2000 h per year is foreseen as compared to barcode-based check in of each individual donation. RFID is not used in component manufacturing until final labeling; manufacturing is driven entirely by the barcode-based BECS. At final product labeling, all products going into inventory are tagged. Imported products are also tagged. RFID is used to automate inventory check in, find and move product, verify shipment accuracy, and process returned units from hospitals. TAGSYS 50 50 cm tunnel readers are also used in shipment verification and TAGSYS 30 30 cm tunnel readers are used in moving frozen plasma inventory from quarantined to release inventory. LAN-connected TAGSYS Medio L-400 readers with separate pad antennas are used at the final labeling stations. Wi-Fi connected Unitech PA600 Mobile Clinical Assistant personal data terminals are used for finding things in inventory. Both at the blood center and in the hospital the RFID devices are interfaced to a custom middleware application developed by S3edge, Inc. of Portland, OR, USA (http://www.s3edge.com) on the
211
Microsoft BizTalk RFID 2010 server platform as shown in Fig. 3. An SQL server maintains the RFID tag, location and status database. A web-services base interface provides a simple and near universal connector to any BECS (BloodCenter of Wisconsin uses Mediware LifeTrakÒ) for exchange of data. Status of the Blood Center of Wisconsin implementation at the beginning of September 2011 is: Completed FDA-required RF safety testing on blood products, Selected 13.56 MHz ISO/IEC 18000-3 mode 1 tags and all readers, Conducted successful performance and survivability tests with selected tags and equipment. Tags on blood bags were tested to survive: o Centrifugation (2 cycles maximum at 4750 g for 10 min each) o Blast freezing of plasma (30 C) and dry ice contact o Cs137 Gamma irradiation (2 25 Gy) S3edge is currently developing RFID middleware based on Microsoft BizTalk RFID which interfaces with an enhanced MediWare LifeTrakÒ BECS used at BloodCenter of Wisconsin. Pilot installation and testing at BloodCenter of Wisconsin begins in 1Q12; full deployment is expected in 3Q12.
4. RF safety testing Before RFID tagged blood products could be transfused, the FDArequired protocol testing to prove that no damage to the safety or efficacy of the blood product resulted from RF exposure from the RFID reader. The “Limit Test Protocol” was jointly developed by FDA’s CBER & CDRH and the RFID Consortium and is based on the concept of exposing a small group of blood components to higher reader RF magnetic field strengths and much longer times (5 A/m for 23 h) than would be seen over their product life in practice (typically 1 A/meter and <20 min intermittent total exposure). No test chamber existed which could expose a complete blood bag to these conditions. A custom one was designed and built for the University of Wisconsin RFID Lab by Hohberger and Tsirline [9].
Fig. 2. Blood Center RFID-Enabled Processes.
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C. Hohberger et al. / Biologicals 40 (2012) 209e213
Fig. 3. RFID Middleware Interface to the BECS.
In 2007, three pairs of young (6e10 days) RBCs and 3 pairs of whole blood derived platelets were tested and reported by Davis et al. [10]. Samples were taken at the beginning of the test and at 7 h and 24 h and assayed for morphological and biochemical changes as compared to similar samples from an unexposed control unit. Temperature rise due to Joule heating was to be measured throughout and did not exceed the test limits [10]. In 2010, additional tests on plasma and aged RBCs (39e41 days) were performed. Aged RBC test results were consistent with prior tests of young RBCs [11]. Plasma temperature rise due to Joule heating was acceptable [12] and the impact of RF exposure on Prothrombin Time (PT), activated Partial Thromboplastin (aPTT), Antithrombin III, Factor V, Factor VIII, Factor XI, Protein C, Protein S, and von Willebrand factor Ristocetin-cofactor (VWF:RCo) activities were all within acceptable limits [11]. These results were submitted to the FDA and in 2010 led to first US approval to deploy HF RFID in blood donation through transfusion. 5. Transfusion site implementation While there is substantial financial return on Investment in the blood center, improved transfusion safety is a goal largely achieved
at the transfusion site. Fig. 4 shows the RFID enabled processes in both the hospital blood bank, and at the point of patient care. Since the blood products are already RFID tagged, the hospital blood bank can utilize all the same check in, inventory management, and returns capabilities available in the blood center. It can also use RFID to release or return blood from satellite storage locations such as the operating room or emergency room. RFID-augmented three-way matching of the patient ID, transfusion order and the unit to be transfused can be performed at the point of patient care. This increases transfusion safety by reducing or eliminating clerical or transfusion errors, as well as automating issue and release of blood and the recording of chain of custody. Using a Unitech PA600 Mobile Clinical Assistant, the patient ID in either the barcode or an RFID tag in the patient’s wristband is scanned. An enquiry is made to the hospital IT system to determine if a valid transfusion order exists for that patient. If so, the assigned unit for transfusion has the patient identification recorded on the tag. Prior to starting the transfusion the handheld reader reads that information from bag tag and compares it to the patient wristband data, to complete the 3 way match. During transfusion, the PA600 reader may used to automatically or manually enter patient vital signs into the on-line patient record
Fig. 4. RFID Enabled Processes in the Hospital Blood Bank and at the Point of Patient Care.
C. Hohberger et al. / Biologicals 40 (2012) 209e213
system. At the completion of the transfusion, the nurse again scans the patient wrist band and enters the transfusion results into the PA600. Then the nurse scans the blood bag to complete the transfusion e the transfusion status is updated to “Complete” on the patient record. The nurse now scans the blood product bag and deletes all patient-related information from the RFID tag on the bag. If a transfusion does not happen for any reason, but the unit is still viable, the PA600 reader may be used to deassign that unit from the patient by clearing the patient ID and data of birth fields on the tag when returning it to the hospital blood bank. The blood center solution has been the primary focus of the research to date, which was principally supported by a grant from the National Institiutes of Health. Preliminary RFID-enabled process development for the hospital blood bank and point of care was performed in collaboration with the University of Iowa Health Center. A limited first round of hospital testing is taking place there in early 2012.
References [1] ISBT 128 standard technical specification, v4.0.1. Online: www.iccbba.org; February 2011. [2] Lusky K. Adding RFID layer to blood safety loop. CAP Today:45e52. Online: www.cap.org/apps/docs/cap_today/; July 2005.
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[3] Dzik S. Radio frequency identification for prevention of bedside errors. Transfusion 2007;47(suppl.):125Se9S. [4] Dzik S. Case study: RFID in action e the Massachusetts General hospital START project. IDTechEx Ltd. Online: www.idtechex.com/smarthealthcareusa/3.asp; 2004. [5] Sandler G, Langeberg A, Carty K, Dohnalek LJ. Barcode and radio-frequency technologies can increase safety and efficiency of blood transfusions. Lab Med 2006;37:436e9. [6] Knels R. Radio frequency identification (RFID): an experience in transfusion medicine. ISBT Sci Ser 2006;1:238e41. [7] Sandler GS, Langeberg A, DeBandi L, Gibble J, Wilson C, Feldman CL. Radiofrequency identification technology can standardize and document blood collections and transfusions. Transfusion 2007;47:763e70. [8] Knels Ralf, Davis R, Ashford P, Bidet F, Boecker W, Briggs L, et al. Guidelines for the use of RFID technology in transfusion medicine, Version 1.0. Vox Sanguinis 2010;98(Suppl. 2). [9] Hohberger Clive, Tsirline B. Design of a 13.56 MHz Segmented Helmholtz Coil for RF exposure testing of Biologics to Simulated RFID readers. Int J Radio Frequency Identification Technol Appl 2009;2:65e92. [10] Davis Rodeina, Gottschall J, Gutierrez A, Hohberger C, Veeramani D, Holcombe J. Absence of acute adverse in-vitro effects on AS-1 RBCs and whole blood-derived platelets following prolonged exposure to 13.56 MHz radio energy. Transfusion 2010;50:1596e603. [11] Gottschall Jerome G, Gutierrez A, Davis R. Limit Test results: Cellular and Protein impact of RF energy on aged Red cells and Thawed plasma. Unpublished results: Submission to the FDA dated July, 2010 from BloodCenter of Wisconsin. [12] Gottschall Jerome G, Hohberger C, Gutierrez A, Davis R. Limit Test results: temperature Impact of HF (13.56 MHz) Radiation on aged Red Cells and Thawed plasma. Unpublished results: Submission to the FDA dated August, 2010 from BloodCenter of Wisconsin.
Contents lists available at SciVerse ScienceDirect
Biologicals journal homepage: www.elsevier.com/locate/biologicals
Applying radio-frequency identification (RFID) technology in transfusion medicine Clive Hohberger a, *, Rodeina Davis a, Lynne Briggs a, Alfonso Gutierrez b, Dhamaraj Veeramani b a b
BloodCenter of Wisconsin, Milwaukee, WI, USA University of Wisconsin -Madison, WI, USA
a r t i c l e i n f o
a b s t r a c t
Article history: Received 10 October 2011 Accepted 18 October 2011
ISO/IEC 18000-3 mode 1 standard 13.56 MHz RFID tags have been accepted by the International Society for Blood Transfusion (ISBT) and the United States Food and Drug Administration (FDA) as data carriers to integrate with and augment ISBT 128 barcode data carried on blood products. The use of 13.56 MHz RFID carrying ISBT 128 data structures allows the global deployment and use of RFID, supporting both international transfer of blood and international disaster relief. The deployment in process at the BloodCenter of Wisconsin and testing at the University of Iowa Health Center is the first FDA-permitted implementation of RFID throughout in all phases of blood banking, donation through transfusion. RFID technology and equipment selection will be discussed along with FDA-required RF safety testing; integration with the blood enterprise computing system and required RFID tag performance. Tag design and survivability is an issue due to blood bag centrifugation and irradiation. Deployment issues will be discussed. Use of RFID results in significant return on investment over the use of barcodes in the blood center operations through labor savings and error reduction. Ó 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
Keywords: RFID 13.56 MHz Blood Transfusion safety ISBT 128
1. Introduction In the development of the ISBT 128 global standard for labeling of blood products [1] during the early 1990s, it was anticipated that data carriers in addition to barcode would eventually be used on blood products. Therefore, the barcode symbology utilized (ISO/IEC 15417:2000 Code 128) and the data structures were designed around the use of ISO 646 (7-bit ASCII) characters which are data carrier independent. Development of RFID technology largely occurred in the decade after the ratification of the ISBT 128 barcode standard in 1994. In low-cost passive RFID systems the tag is powered by the energy from the reader’s RF field. Passive RFID technology is superior to traditional barcode-based automatic identification and data capture in numerous ways: It does not require line-of-sight Allows reading of multiple tags in the same reader field
* Corresponding author. RFID System Architect, BloodCenter of Wisconsin, 638 N. 18th Street, Milwaukee, WI 53233, USA. Tel.: þ1 414 937 6406, þ1 847 910 8794(Mob). E-mail address: [email protected] (C. Hohberger).
Is able to store more data on the chip, and Allows for updating that stored data The potential advantages of RFID technology and its potential benefits of improving safety, quality, productivity and responsiveness in the delivery of care to patients have not gone unnoticed by the blood banking and transfusion medicine community [2e7]. An RFID task force within the ISBT Working Party on Information Technology was formed to consider how RFID tags might be utilized in blood collection, processing, distribution and transfusion. Because of considerations of blood RF safety and the need for a truly global RFID standard to support international transshipment and disaster relief efforts, RFID utilizing the only truly global standard frequency of 13.56 MHz was selected for use by this multinational task force. A several year effort resulted in the publication in April 2010 of the ISBT Guidelines for the use of RFID Technology in Transfusion Medicine, Version 1.0 [8]. Use of ISO/IEC 18000-3 mode 1 13.56 MHz RFID tags has been accepted by the ISBT and more recently by the United States FDA as supplemental data carriers on blood products. The Transfusion Medicine RFID Consortium (http:// transfusionmedicinerfid.org/), which includes 3 blood centers, 2 hospitals, the University of Wisconsin at Madison RFID Lab, and several technology partners is actively engaged in the first-ever
1045-1056/$36.00 Ó 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.biologicals.2011.10.008
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C. Hohberger et al. / Biologicals 40 (2012) 209e213
comprehensive investigation to research, develop and introduce RFID for automatic identification, tracking and status-monitoring of blood products across all entities in the supply chain e from the point of collection, through manufacturing and distribution, to transfusion by a healthcare provider to a patient. This paper describes the development, testing and deployment in process at the BloodCenter of Wisconsin and under test at the University of Iowa Health Center of the first FDA-permitted implementation of RFID-tagged blood products from donation through transfusion. 2. Guiding principles A fundamental assumption underlying ISBT 128 is that the blood product label should carry all the key data about the product, as database access may not be available at a disaster or battlefield site where transfusion occurs. RFID tags enable additional information about the product to be stored on the label: Reading at the transfusion site then can be as simple as a Near Field Communication (NFC) cell phone application. A guiding principle is that the RFID tag will not substitute for, replace, or contradict any required ISBT 128 barcode labeling information. Thus the RFID tag augments existing ISBT 128 barcodebased blood center operations and hospital transfusion systems, rather than replacing them: The RFID tag augments ISBT 128 barcodes AND the barcodes back up RFID tag The RFID based system solution will NOT perform critical functions already performed by a barcode-based Blood Enterprise Computing System (BECS), which remains the system of record RFID is only used as a supplemental tracking application to the BECS Only data carrier-independent ISBT 128 compliant data structures which use 7-bit ISO 646 (ASCII) characters are used in the byte-oriented tag memory. Additional ISBT 128 data structures will be designed for RFID-supported features not supported in ISBT 128 barcodes.
Tag user memory is allocated in 4-byte physical memory blocks which are individually addressable and lockable. Here certain blocks are reserved for the blood center to carry ISBT 128 DIN, ABO/ Rh, ISBT Product Code, Expiration Date and Time as well as bag code and lot number data structures; other blocks are reserved for transfusion service use in patient assignment and verification. Since the tag layout is not critical as each ISBT 128-compliant field is fixed length and start with a unique data identifier, the data was arranged in tag memory to permit contiguous block reads and writes whenever feasible. In addition, a CCITT CRC-16 data checksum is stored on the tag covering all key tag data fields. This permits detection of tag data integrity and/or memory corruption. If data integrity tests ever fail, the tag will be “killed” and only barcode data on the bag will be used. Passive RFID helps deal with “Pain Points” in the blood center: Reconciling data with physical reality by building RFID unit and container relationships enabling better tracking and faster container reconciliation, Physically locating products using RFID to record or update a database of the “last seen” location of all products encountered during searches, to enable finding products faster, Track time out of temperature-controlled locations and provide an alerts if the time between “last seen” reads of the passive tag in an uncontrolled temperature locations is too long. (Note: Active or passive temperature sensor tags would be preferable, but cost considerably more) Rapid donation check in and shipment verification at the blood center by using RFID’s ability to read multiple units in closed containers to significantly reduce labor.
3. Blood center implementation Fig. 1 shows the RFID enabled processes at the donation sites. Collection bag sets are RFID tagged using a 14 31mmRFID tag placed under the standard ISBT 128 DIN label. In a 3-bag collection
Fig. 1. RFID Enabled Processes at the Donation Site.
C. Hohberger et al. / Biologicals 40 (2012) 209e213
set, just the RBC product bag is tagged; the plasma bag and other manufactured products will be tagged at final labeling. All bags in an apheresis collection are tagged at the donation site as RFID enables accounting for missing or unused bags from that set. Wi-Fi connected Unitech PA600 Mobile Clinical Assistant personal data terminals (which have both barcode and HF RFID readers) are used at the donation sites to read the DIN barcode and perform tag initialization. All tag data is uploaded to a mobile RFID application database for transfer to the blood center for use in RFID-enabled donation check in. Donation shipping containers are also tagged. A packing list is created on each container tag. Load lists of each container are created and forwarded to the blood center as an advanced shipping notice where connectivity exists, or placed on a USB memory drive accompanying the shipment. Fig. 2 shows the RFID enabled processes within the blood center. A major application is donation check in and reconciliation of closed shipping containers in 50 50 cm aperture LAN-connected TAGSYS Medio L-400 4 channel tunnel readers using the RFID tags on the container and the collection sets. At BloodCenter of Wisconsin (225,000 donations/year) a potential labor saving of over 2000 h per year is foreseen as compared to barcode-based check in of each individual donation. RFID is not used in component manufacturing until final labeling; manufacturing is driven entirely by the barcode-based BECS. At final product labeling, all products going into inventory are tagged. Imported products are also tagged. RFID is used to automate inventory check in, find and move product, verify shipment accuracy, and process returned units from hospitals. TAGSYS 50 50 cm tunnel readers are also used in shipment verification and TAGSYS 30 30 cm tunnel readers are used in moving frozen plasma inventory from quarantined to release inventory. LAN-connected TAGSYS Medio L-400 readers with separate pad antennas are used at the final labeling stations. Wi-Fi connected Unitech PA600 Mobile Clinical Assistant personal data terminals are used for finding things in inventory. Both at the blood center and in the hospital the RFID devices are interfaced to a custom middleware application developed by S3edge, Inc. of Portland, OR, USA (http://www.s3edge.com) on the
211
Microsoft BizTalk RFID 2010 server platform as shown in Fig. 3. An SQL server maintains the RFID tag, location and status database. A web-services base interface provides a simple and near universal connector to any BECS (BloodCenter of Wisconsin uses Mediware LifeTrakÒ) for exchange of data. Status of the Blood Center of Wisconsin implementation at the beginning of September 2011 is: Completed FDA-required RF safety testing on blood products, Selected 13.56 MHz ISO/IEC 18000-3 mode 1 tags and all readers, Conducted successful performance and survivability tests with selected tags and equipment. Tags on blood bags were tested to survive: o Centrifugation (2 cycles maximum at 4750 g for 10 min each) o Blast freezing of plasma (30 C) and dry ice contact o Cs137 Gamma irradiation (2 25 Gy) S3edge is currently developing RFID middleware based on Microsoft BizTalk RFID which interfaces with an enhanced MediWare LifeTrakÒ BECS used at BloodCenter of Wisconsin. Pilot installation and testing at BloodCenter of Wisconsin begins in 1Q12; full deployment is expected in 3Q12.
4. RF safety testing Before RFID tagged blood products could be transfused, the FDArequired protocol testing to prove that no damage to the safety or efficacy of the blood product resulted from RF exposure from the RFID reader. The “Limit Test Protocol” was jointly developed by FDA’s CBER & CDRH and the RFID Consortium and is based on the concept of exposing a small group of blood components to higher reader RF magnetic field strengths and much longer times (5 A/m for 23 h) than would be seen over their product life in practice (typically 1 A/meter and <20 min intermittent total exposure). No test chamber existed which could expose a complete blood bag to these conditions. A custom one was designed and built for the University of Wisconsin RFID Lab by Hohberger and Tsirline [9].
Fig. 2. Blood Center RFID-Enabled Processes.
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C. Hohberger et al. / Biologicals 40 (2012) 209e213
Fig. 3. RFID Middleware Interface to the BECS.
In 2007, three pairs of young (6e10 days) RBCs and 3 pairs of whole blood derived platelets were tested and reported by Davis et al. [10]. Samples were taken at the beginning of the test and at 7 h and 24 h and assayed for morphological and biochemical changes as compared to similar samples from an unexposed control unit. Temperature rise due to Joule heating was to be measured throughout and did not exceed the test limits [10]. In 2010, additional tests on plasma and aged RBCs (39e41 days) were performed. Aged RBC test results were consistent with prior tests of young RBCs [11]. Plasma temperature rise due to Joule heating was acceptable [12] and the impact of RF exposure on Prothrombin Time (PT), activated Partial Thromboplastin (aPTT), Antithrombin III, Factor V, Factor VIII, Factor XI, Protein C, Protein S, and von Willebrand factor Ristocetin-cofactor (VWF:RCo) activities were all within acceptable limits [11]. These results were submitted to the FDA and in 2010 led to first US approval to deploy HF RFID in blood donation through transfusion. 5. Transfusion site implementation While there is substantial financial return on Investment in the blood center, improved transfusion safety is a goal largely achieved
at the transfusion site. Fig. 4 shows the RFID enabled processes in both the hospital blood bank, and at the point of patient care. Since the blood products are already RFID tagged, the hospital blood bank can utilize all the same check in, inventory management, and returns capabilities available in the blood center. It can also use RFID to release or return blood from satellite storage locations such as the operating room or emergency room. RFID-augmented three-way matching of the patient ID, transfusion order and the unit to be transfused can be performed at the point of patient care. This increases transfusion safety by reducing or eliminating clerical or transfusion errors, as well as automating issue and release of blood and the recording of chain of custody. Using a Unitech PA600 Mobile Clinical Assistant, the patient ID in either the barcode or an RFID tag in the patient’s wristband is scanned. An enquiry is made to the hospital IT system to determine if a valid transfusion order exists for that patient. If so, the assigned unit for transfusion has the patient identification recorded on the tag. Prior to starting the transfusion the handheld reader reads that information from bag tag and compares it to the patient wristband data, to complete the 3 way match. During transfusion, the PA600 reader may used to automatically or manually enter patient vital signs into the on-line patient record
Fig. 4. RFID Enabled Processes in the Hospital Blood Bank and at the Point of Patient Care.
C. Hohberger et al. / Biologicals 40 (2012) 209e213
system. At the completion of the transfusion, the nurse again scans the patient wrist band and enters the transfusion results into the PA600. Then the nurse scans the blood bag to complete the transfusion e the transfusion status is updated to “Complete” on the patient record. The nurse now scans the blood product bag and deletes all patient-related information from the RFID tag on the bag. If a transfusion does not happen for any reason, but the unit is still viable, the PA600 reader may be used to deassign that unit from the patient by clearing the patient ID and data of birth fields on the tag when returning it to the hospital blood bank. The blood center solution has been the primary focus of the research to date, which was principally supported by a grant from the National Institiutes of Health. Preliminary RFID-enabled process development for the hospital blood bank and point of care was performed in collaboration with the University of Iowa Health Center. A limited first round of hospital testing is taking place there in early 2012.
References [1] ISBT 128 standard technical specification, v4.0.1. Online: www.iccbba.org; February 2011. [2] Lusky K. Adding RFID layer to blood safety loop. CAP Today:45e52. Online: www.cap.org/apps/docs/cap_today/; July 2005.
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