Guidelines for the Use of RFID Technology in Transfusion Medicine

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10 Guidelinedoes not supply RFID tags as part of the donation set. Insome organizations, it may not be possible to providepatient identity on the tag because of data security legislation.As each ISBT 128 data structure is uniquely identifiable[1], it may not be necessary to define an overall fixedtag memory structure but it would probably be more efficient,with respect to IT systems, if a standard structurewere in place.Tag ManufacturersRFID tag manufacturers encode the UID, which is designedto be unique globally, on the chip. Part of this code is anAFI and for transfusion medicine the code ‘‘BBH’’ wasrequested from the ISO committee. The UID code is unique;therefore, it may be the only data item on the tag that isbeing read during routine processing.Blood Bag ManufacturersISBT128 provides data structures pertaining to manufacturersof blood bags, namely the ‘Container Manufacturer andCatalogue Number’, the ‘Container Lot Number’, and the‘Expiry Date’. The minimum data elements needed are theCatalogue Number and Lot Number [1].It may be possible to go further than these standards. Forexample, the current lot number relates to a batch of manyunits therefore, in the event of a recall, the number of packsimplicated can be high. However, if the UID is used in themanufacturing process, considerable benefits should begained for all parties as it may be possible to limit the scopeof a recall.Bag manufacturer data should be locked on the tag aspart of the pack manufacturing operation. It should not bepossible to amend this data once written; it should belocked irrevocably.Blood CentersISBT 128 defines data structures for use by blood centers[1]. It will be necessary to align the data structures with thedata blocks on the tag. Twelve data blocks are reserved foruse by blood centers. Mandatory data includes donationnumber, product ID and expiration date ⁄ time, and ABO ⁄ Rh.Donation number should be encoded and locked at the earliestopportunity. This may be as soon as the donation iscollected and donation number label sets are applied to thebag set. Alternatively, this data may be encoded when thedonor ⁄ donation link is made on an IT system. Other collectiondata could be encoded and locked at the same time.The data blocks reserved for product code and expirationdate ⁄ time are rewritable to allow for remanufacturing inthe same bag, such as irradiation. ABO ⁄ Rh is written onceand locked.Blood center data on the RFID tag will normally belocked as part of the shipping process. However,flexibility will be likely to be needed to allow productinformation locking at any time. For example, a bloodcenter could issue a unit of red cells subsequently irradiatedby a hospital. In this case, it would be necessary toallow the hospital to update the product information and,potentially, the expiration date. Alternatively, productdata could be locked by the blood center. The lockingunder such scenarios is likely to require flexibility at anational level.Because of the limited tag capacity available, it may benecessary to use a Special Testing data structure related tothe product being issued. One of the limitations of currentlinear barcode symbols is that it is difficult to fit specialtesting data within the available space. The higher memorycapacity in RFID tags will provide an alternative solutionfor a long-standing label space problem.HospitalsHospitals and transfusion services can add data to the tagregarding the intended recipient. Hemovigilance studiesshow that many serious adverse incidents are because oferrors that occur at the patient interface. This is an areawhere RFID can make a significant difference.It must be recognized that application of patient data tothe RFID-tag will be subject to national patient privacy anddata security legislation and may not be permissible.Where hospitals can add this information, it will be necessaryto determine what sort of information is required bythe hospitals for positive patient identification. For the purposesof this guideline, it has been assumed that 96 byteswould be sufficient.Examples of tag structureThe following three examples show how product-specificISBT128 data structures could be presented on a tag whileensuring that the data is aligned with the four-bytelocking blocks (Figs 5–7). Within each colored block, thesymbols use the same form as within the ISBT 128 specification[1].4.6 DisposalThe destruction of passive RFID tags can follow standardbiohazard destruction protocols used for blood bags (medicalwaste incinerators).If active RFID tags are used on containers, recyclingshould be addressed to conform with existing recommendationsfor battery recycling.RFID tags do not fall within the scope of the EU directive2002 ⁄ 96 ⁄ EC on Waste Electrical and Electronic Equipment(WEEE) if the tag is not attached to other electronic equipmentwhich falls within the scope of the WEEE directive[19].Ó 2010 The Author(s)Journal compilation Ó 2010 International Society of Blood Transfusion, Vox Sanguinis (2010) 98 (Suppl. 2), 1–24
Guideline 11Fig. 5 Red Cell Unit. Data Structure 012 is relevant to red cell or whole blood products.Platelet Unit1 2 3 4 5 6 7 8 9 101112131415161718192021222324= ) b q q w w w w w w w & ) x x x x x x x x x x Pack Manufacturers Information/Extended Audit data? ? ? ? ? ? ? ? = α p p p p y y n n n n n n f f Pack Manufacturers Extended Info/Donation No= % g g r e = < a o o o o t d s & > c y y j Blood Groups/Product Code and Expiration Date/Timej j h h m m & ( z z z z z & { A A A A B B Expiration/Special Testing : General/Platelet HLA and Platelet-Specific AntigensB B C C C C C C C C D DPlatelet HLA and Platelet-Specific Antigens& * c y y j j j h h m m = ? ? ? Collection Date and Time/Fit for issue/transfusion marker& # a a | | x x x x x x x x x x x x x x x x x x Patient Identification Number? ? z z z z z z z z z z z z z z z z z z z z z z Patient Name and Genderz z z z z z z z z z z z = # a a y y y y m m d d Patient Date of BirthData structure 014 is relevant to platelet products.Fig. 6 Platelet Unit. Data structure 014 is relevant to platelet products.Cellular Therapy Product1 2 3 4 5 6 7 8 9 101112131415161718192021222324= ) b q q w w w w w w w & ) x x x x x x x x x x Pack Manufacturers Information/Extended Audit data? ? ? ? ? ? ? ? = α p p p p y y n n n n n n f f Pack Manufacturers Extended Info/Donation No= % g g r e = < a o o o o t d s & > c y y j Blood Groups/Product Code and Expiration Date/Timej j h h m m & ( z z z z z = [ E E E E F F Expiration/Special Testing : General/Special Testing: Genomically-Determined HLA-F F G G G G H H H H L M = " I I I I J J J J M M Special Testing: Genomically-Determined HLA-A and -B AllelesM M M M M M M M & * c y y j j j h h m m = ? ? ? Special Testing: Genomically-Determined HLA-A and -B Alleles/Collection Date and& # a a | | x x x x x x x x x x x x x x x x x x Patient Identification Number? ? z z z z z z z z z z z z z z z z z z z z z z Patient Name and Genderz z z z z z z z z z z z = # a a y y y y m m d d Patient Date of BirthData structure 015 is relevant to cellular therapy products.Fig. 7 Cellular Therapy Product. Data structure 015 is relevant to cellular therapy products.5. Technical Architecture OverviewThe RFID-enabled technology for transfusion medicine canbe categorized in five high-level layers (domains):• Business processes• RFID devices• RFID middleware• Enterprise platform• Enterprise Application IntegrationThese layers and an overall system representation areshown in Fig. 8.The Business Process DomainIn the real world physical items move and processes areexecuted by both machines and people. This therefore createsthe demand for information systems to support andoptimize processes. Data that is generated and capturedrequires information systems to turn it into useful transactionalinformation for the execution of those processes; it isaggregated for analysis of trends and process optimization.In order to fully support this domain, additional customsoftware components (i.e. database schema, user interface,integration between process applications) are needed.RFID Device DomainThe RFID Device Domain refers to the technical infrastructureof tags, readers and printers. It also includes hand-heldRFID-enabled equipment and desktop ⁄ laptop computerswith user interfaces. It is usually located on the ‘edges’ ofthe technical solution interacting with real world items inthe Business Process domain.Tags are affixed to physical items in the business processdomain. In the transfusion medicine context, these areblood product items and containers. It is conceivable thatÓ 2010 The Author(s)Journal compilation Ó 2010 International Society of Blood Transfusion, Vox Sanguinis (2010) 98 (Suppl. 2), 1–24
Page 1 and 2: Vox SanguinisInternational Journal
Page 3 and 4: Sanquin, Hulleman Rik, The Netherla
Page 5 and 6: GUIDELINEVox Sanguinis (2010) 98 (S
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Page 27 and 28: Guideline 23Association (EAN). EPC

Guidelines for the Use of RFID Technology in Transfusion Medicine

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