Guidelines for the Use of RFID Technology in Transfusion Medicine

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8 Guidelinethe blood sample and later the transfusion process [3,8–11,13–15].The utilization of sample tubes with embedded or labeledRFID tags in lab management is at present difficult to costjustify.Currently sample tubes with an embedded RFID tagare primarily being used for long-term storage of geneticmaterial to support tracing of the samples.3.3.5 Facility and Device ManagementStandard RFID solutions are available for access controland time management. Similar to industrial track and tracesolutions, RFID tags, sometimes with integrated temperaturemonitoring, can be used for the logistics of bloodcontainer transport [7]. Further applications are being evaluatedfor using RFID tags to identify medical equipmentand devices [17]. In the USA, there have been extensiveinvestigations to address theft protection and misplacementof medical equipment through a special type of RFID technologycalled Real Time Location Systems (RTLS), whichallows for automatic identification, as well as locationtracking. The high cost of replacing stolen equipment isdriving the search for a more effective solution, similar tothe Electronic Article Surveillance theft protection principleemployed in some retail stores.Another application is the control and administration ofmaintenance and the proper cleaning ⁄ sterilization of medicaldevices. The relevant maintenance work can be notedon the label or the UID can be registered in correspondingcontrol systems when the work is carried out. There willthen be a record that the device was at the maintenancefacility and ⁄ or that the qualified employee serviced thedevice [16].Part II: Deployment Information4. Technical Recommendations(RFID standards see 10.3.2)The ISBT WPIT Task Force on RFID recommends the useof passive HF (13.56 MHz) technology in transfusion medicinewhen applied to blood bags and storage containers.The reasons include:• Existence of ISO 18000-3, which is a proven, maturestandard and technology;• Regulations around the world provide for standardizedaccess to HF;• Characteristics of HF support global deployment inblood banks and hospitals;• Lower cost tags and lowest cost reader hardware of thefrequency options;• No published evidence of adverse effects on blood productsand transfusion safety;• Limited HF radio energy field minimizes the risk of electromagneticinterference with medical devices;• HF item tags are likely to be widely used in hospitalpharmacies.4.1 StandardizationThe use of passive HF (13.56 MHz) RFID technology is supportedwith global standards including the ISO 18000-3 tagstandard and the ISO 15961 and ISO 15962 data encodingrules. These standards are in line with the GS1 EPC Globalproposed HF Gen 2 item tag standard for use in pharmaceuticalmanufacturing, too [18]. ISO 18000-3 is the recommendedtag standard in blood banking.It is essential to use standardized data structures; thedata structures defined in the ISBT 128 Standard TechnicalSpecification are strongly recommended for transfusionmedicine [1].4.2 Tag CapacityTransfusion medicine requires several different tags: bloodbag tags, container tags, location tags, tags for personalidentification, tube tags, etc. The following design considerationsfocus on the blood bag tag.Two approaches can be adopted for the use of RFID onblood bags. The first is a ‘license plate’ approach where theunique tag identification code (UID) of the tag is associatedwith the unique donation number ⁄ product code in the hostcomputer system and is used for tracking and informationgathering within that system.The second approach is to use the tag as a data carrier togather information held on the label in barcoded and eyereadableforms. The following criteria should apply:• Minimum tag capacity is 2 kilobits (2kBit), ISO 18000-3compliant.• System redundancy: A tag should contain sufficientdata regarding the product to allow stand-alone identificationand processing even when back-end systemsare not available. It should contain, at a minimum,the same data elements recorded in the ISBT 128 label[1].• System interoperability:o A tag should communicate with readers using theISO 18000-3 standard communications protocols.o Tags should provide data elements specific to thevarious stakeholders in the transfusion medicine supplychain, e.g. bag manufacturer, blood center andtransfusion service. If a required data element doesnot exist within ISBT 128, users are encouraged tocontact ICCBBA to determine if the data element canbe developed [1].Ó 2010 The Author(s)Journal compilation Ó 2010 International Society of Blood Transfusion, Vox Sanguinis (2010) 98 (Suppl. 2), 1–24
Guideline 94.3 Tag Functionality and SecurityThe RFID tag will carry critical blood product labelinginformation. It is therefore essential to ensure the securityand integrity of this information through suitable designof the tag as well as the software application that willbe handling the data. Key security features are listed asfollows:• Tags will have their own Application Function Identifier(AFI) as designated by ISO 7816. This AFI indicates thatthe tag contains data structures assigned by ICCBBA foruse by the blood in collection, processing, distributionand transfusion.• The required tag data structures will be identical to thoseused for ISBT 128 barcode data [1].• Key data elements on the tag will be written and lockedin pre-defined memory blocks, thus preventing updatesto these key data elements (e.g. Donation Number;ABO ⁄ Rh) once they are written.• Commands to deactivate ⁄ destroy damaged tags and tore-associate a new tag with a blood product will bedesigned into the tag, readers, and application software.• Tags may optionally carry internal process controlinformation used in the blood center or transfusion siteprocessing. Data shall be recorded in such a manner thatthere will be no possibility of confusion with requiredISBT 128 data structures [1].The application design will provide the necessary dataintegrity and security checks between the Blood EstablishmentComputer System (BECS)-generated barcode and theRFID tag at critical control points along the supply chain.4.4 Method of Tag AttachmentRFID tags can be attached in different ways. RFID tags canbe incorporated into the base label by the bag manufactureror they can be affixed on the base label by the blood center,preferably as part of the donation identification number(DIN) label. In both cases, the tags should be affixed to theupper part of the base label to optimize readability withoutcovering any of the manufacturer’s data.It is imperative that the RFID tag is embedded into thebag or ‘sandwiched’ into the DIN, rather than being appliedloosely to the blood bag itself. If the RFID tag is applied bythe manufacturer of the blood bags, the adhesive should bethe same as is used for the base label. The adhesive inlayused in transfusion is safe for the blood components andwill not interfere with the chip. This technique will protectthe RFID tag throughout the preparation processes and willpreclude removal of the tag. If the RFID tag is appliedby the manufacturer, it should withstand sterilizationprocesses (vapor sterilization at more than 120°C, Betasterilization or Ethylene Oxide).The location of the RFID tag is also very important inorder to avoid damage to the antenna. When the RFID tagis placed under or is integrated in the base label of anempty bag, the operator should take care not to fold theantenna during the centrifugation step.The method of adhesion should be resistant to centrifugation(up to 5000 g for 22 minutes), preparation processes(separation, filtration, blast and contact freezing) and storage(+22 ± 2°C for platelets, +4 ± 2°C for red blood cells,down to )40°C for plasma).4.5 Data StructureIt has been assumed that the RFID tag will provide datathroughout the lifecycle of the blood bag. The lifecycle foreach tag could commence at bag manufacture, continuethrough donation (but not always - e.g. split packs whichmay be the start point for a new tag), through componentproduction, issue to hospital, and finally transfusion topatient (or discard). In this lifecycle of the RFID tag, multiplecomputer systems at various points in the supply chainare likely to be used to read, write and process the RFID tagdata.The RFID tag can act as an electronic data interchange(EDI) carrier between IT systems, although adequate databackup is required to ensure that critical traceability data isnot lost if the tag is damaged or discarded. It will be necessaryto set out the data structures and method of use so thatdata can be added to the tag during the lifecycle in a securemanner - in the same way currently used for labels andbarcodes at different stages in the process.This guideline assumes use of data elements provided byICCBBA in the ISBT 128 data structure [1]. There is flexibilitybuilt into the data structure to allow for the use ofnon-standardized data elements outside the ISBT 128 datastructure, although without standard definitions such datacould not be globally interpreted. Provision should bemaintained for four stakeholders to encode data on the tag:• RFID Tag Manufacturer• Blood Bag Manufacturer• Blood Center• Hospital Transfusion ServiceEach stakeholder will safeguard the integrity, security,and confidentiality of the data it writes to the tag. Thesystem should be sufficiently flexible to accommodate ahospital that collects its own blood. Positioning of dataelements may change to optimize the read ⁄ write cycle ofthe tag.The structure must be able to comply with different scenarios.In some countries or regions, the stakeholders(Blood Center and Hospital Transfusion Service) may bethe same organization. In some cases, the tag may beapplied by the blood service where a bag manufacturerÓ 2010 The Author(s)Journal compilation Ó 2010 International Society of Blood Transfusion, Vox Sanguinis (2010) 98 (Suppl. 2), 1–24
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