ISBT Science Series (2015) 10 (Suppl. 1), 101–107
INVITED REVIEW
1D–A07–02
© 2015 International Society of Blood Transfusion
Using information technology to eliminate wrong blood transfusions R. W. Chu & A. Y. W. Cheng Department of Clinical Pathology, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong
Advances in the last three decades have dramatically improved blood safety, and wrong blood transfusion (mistransfusion) has now became the most important serious hazards of blood transfusion. The application of information technology in minimizing mistransfusion has further enhanced transfusion safety through the reduction of human steps that are prone to errors. Electronic bedside identification system using hand-held computer and portable printer will minimize the risk of mistransfusion caused by blood sampling error for compatibility testing and patient identification error before blood administration. Fully automated blood bank immunohaematology testing systems together with laboratory information system (LIS) would minimize blood bank errors. Remote electronic blood release system can be considered an extension of the blood bank LIS to the point of care in ensuring the safe release of computer cross-match-compatible blood. Computer physician order entry (CPOE) would guide physicians in making appropriate requests, and connectivity with clinical data repository and blood bank LIS would provide clinical decision support and thus help to prevent human errors. Key words: information technology, transfusion error, transfusion safety
Introduction Transfusion safety is more than just blood safety [1]. The term transfusion safety, which includes blood safety, refers to the overall perspective of delivering proper transfusion care. Errors can occur at any point of the transfusion process, starting from physician’s transfusion decision to the blood administration procedure [2, 3]. Numerous improvements have been made to blood safety in the last three decades such that blood safety has improved dramatically. In contrast, improvement in transfusion process safety has been rather slow. Therefore, it is now time to focus our attention on reducing transfusion process errors in order to enhance transfusion safety at the hospital level [4]. Mistransfusions are the most important serious hazards of blood transfusion globally, and their risks are much higher than the risk of acquiring infectious diseases by Correspondence: Raymond Chu, Department of Clinical Pathology, Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan, Hong Kong. E-mail:
[email protected]
transfusion [5–7]. Mistransfusion rates in different reports vary greatly [8–12] and may be explained by differences in methodology and transfusion systems being adopted, making the figures not strictly comparable. Linden et al. [13] published their 10-year experience on transfusion errors in New York State and reported that the red cell mistransfusion rate was 1:14 000 after adjusted for estimated underreporting and undetected ABO-compatible erroneous transfusions. This figure is likely to be representative considering that the study duration was 10 years, and there were 9, 000, 000 transfusions given during the study period. The true incidence of transfusion errors is estimated to be many folds higher than that of the actual mistransfusion events as highlighted by reports on near-miss events in blood transfusion [14, 15]. It is stated in the latest Serious Hazards of Transfusion (SHOT) report (2012) that for every ‘wrong blood in tube’ error that results in a wrong blood incident, there are about 100 near-miss sample mistakes [16]. Giving the wrong blood units to patients can lead to haemolysis due to serological incompatibilities in ABO or other blood groups, which may cause serious morbidity and even mortality. Also, it can cause Rh(D) sensitization
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if Rh(D) positive blood is given to Rh(D) negative patients, which could potentially lead to haemolytic disease of newborn if the blood recipient is a young female. If the wrong blood component is given, for example FFP given instead of the intended platelets, the therapeutic effect could not be achieved and the patient is exposed to the unnecessary risks of the mistransfused blood component. Even if serological compatible blood is given, errors can occur that could result in the blood unit given lacking the intended desired specification, for example, non-irradiated blood given to patients requiring irradiated blood products, which would impose unnecessary risks to patients. In a broad sense, wrong blood transfusion can also mean giving blood to patients with no good clinical indication. Besides exposing patients to the unnecessary risks of blood transfusion, it might have medico-legal implications if the patient unfortunately suffers from serious adverse transfusion reactions and it is discovered subsequently that the transfusion was given unnecessarily.
How can information technology help in minimizing bedside errors in blood transfusions? Human errors can occur at the bedside or in the blood bank, leading to mistransfusions. Bedside errors include errors in blood sampling for compatibility testing or at blood administration. The latest SHOT report (2012) showed that the greatest risk to recipients of blood transfusion was human error leading to incorrect blood component transfused (ICBT) [16]. It showed that out of the 76 incidents of incorrect blood component transfused (IBCT), 45 incidents (59%) originated from clinical areas and 6 incidents (8%) were caused by wrong blood in tube (WBIT). Linden et al. reported that 56% of the transfusion-associated errors in New York State originated from clinical areas, and 13% were caused by phlebotomy errors [13]. WBIT refers to a sample labelled with the identification details of a different patient. There are two possibilities for WBIT – blood is taken from the wrong patient and is labelled with the intended recipient’s details, or that blood is taken from the intended patient, but labelled with another patient’s details. WBIT is particularly dangerous as the historical ABO group of that patient may not be available for counter checking if the patient has no prior blood transfusion record in that hospital and may result in ABO-incompatible blood transfusion. An international survey (Dzik 2003) reported that WBIT occurs at a frequency of 1 in every 1986 samples, which is very alarming [17]. Various interventions have been attempted to reduce WBIT [18], and the use of electronic transfusion system is one of the proven effective methods [19].
Human errors in blood transfusion are mainly due to slips and lapses, which occur when attention is diverted due to distraction, fatigue or inattention such that one fails to monitor the actions being performed. Other factors include operator not following standard operating procedure (SOP) due to inadequate training, skipping or modifying steps for their own convenience; labelling of sample tube away from the patient, especially when patients are not handled one by one; using wrongly prelabelled sample tube; using nonstringent criteria for patient identification, etc. Various measures have been implemented to address human errors in blood transfusion but none of them is entirely satisfactory. The recent guideline published by the British Committee for Standards in Haematology (BCSH 2012) requires a second blood sample to confirm the ABO group for first time patient prior to blood transfusion unless a secure electronic patient identification system is in place [20]. Such practice could reduce WBIT [21, 22] but would increase the workload for blood bank and clinical staff in handling blood sampling and testing. Counter checking by another staff before blood administration is common practice but still cannot prevent mistransfusions from happening. In fact, whether or not checking conducted by two persons is more error-free than one person conducting the checking is controversial [23]. It is apparent that safeguards based purely on human checking are inadequate as human errors are rather inevitable. Machine-readable identification technology is ideally suited for matching alpha-numeric identifiers and is very helpful in preventing slip and lapse errors [24]. Systems based on barcoding technology have been used successfully in preventing bedside errors in transfusion as they can address the various human errors that may occur during the transfusion processes [25–35]. The system would usually consist of patient wristband with barcoded patient identifying information, a mobile printer connected wirelessly to a hand-held computer with barcode reading function with or without connectivity to the hospital information system. The hand-held computer can be programmed to guide and mandate the operator in performing the checking, document procedures and alert identification errors when they arise via the display screen with sound alerts. Patient identification checking right at the patient’s bedside can be ensured by limiting the unique machine-readable patient identification information to be available only from the patient’s wristband and nowhere else [30, 31]. Labels generated from the bedside mobile printer after patient identity verification will bear the patient’s identification information in barcode as well as eye-readable formats for labelling the sample tube for compatibility
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testing. As the label for the sample tube is generated at the bedside by the portable printer after matching with barcode on patient’s wristband for immediate blood taking, the possibility of mislabelling and WBIT can be minimized. The label for labelling the sample tube can also bear other information such as the date and time of the checking, the identity of the blood taker, etc. in visual form as well as in barcode format. The barcode on the sample can be read by the barcode reader in blood bank directly into their LIS, thus avoiding transcription errors. For blood administration, the label generated after identification check can be used as documentation of the blood transfusion and the label can bear information such as the blood unit serial number, blood group of the transfused unit, date and time of the checking, identity of the staff who has performed the blood administration step, etc. The display on the hand-held computer can be programmed to prompt and compel operators in completing the key steps in blood sampling or blood administration. This helps to reduce the likelihood of operator being distracted and ensure that the correct protocol is being followed. In fact, studies [29, 32–34] have showed great improvement on the compliance of operators to protocols after implementation of electronic system for blood transfusion. Such system would reduce the number of manual procedures in the transfusion process and thereby reduce human errors. The use of electronic bedside identification system can replace the second checker in the blood administration step (and blood sampling step for pretransfusion testing as some hospitals requires a second checker even for blood sampling), which would lessen the strain on clinical staff in addition to minimizing the chance of human error. However, it should be emphasized that over-reliance on technology for identity verification should be avoided, and it should be used for counter checking only. Error can still occur with the use of bedside identification technologies [36]. The software design should address the possibility of operator taking short-cuts to circumvent the system, for example, patient identity checking by scanning patient’s wristband barcode circumvented by scanning patient identifying barcode twice on barcode available in patient’s clinical record which is away from the patient [28].
Identification technologies for blood transfusion At present, barcoding system is commonly used but system employing RFID is slowly catching up. 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. RFID has advantages over barcode in that RFID reading does not require line of sight, reading is not affected by dirt or water and therefore is more userfriendly than barcode reading. Furthermore, RFID chips can hold more data than barcode, have read-write function and multiple tags can be read simultaneously with special tunnel reader [37]. The main obstacle to using RFID technology is the much higher cost of the tag (transponder) and hardware compared with barcode technology. Passive RFID technology is better suited for patient wristband and blood bags, much less costly than active tags and therefore are more commonly adopted [38]. Reports on systems based on radiofrequency identification (RFID) technology for use in transfusion medicine involved tracking of blood products in blood centres [38, 39] as well as their application in the hospital transfusion settings [40, 41]. Two-dimensional (2D) barcodes have advantages over linear (1D) barcodes and are rapidly being adopted [29]. 2D barcodes are more compact, can be read in any direction, have greater tolerance with respect to print quality and have error correction capability such that it can be read even when a large area is damaged. Moreover, 2D barcodes hold more data than 1D barcodes and can encode multiple fields into a single 2D barcode such that a single scan can populate several fields. 1D barcodes are read by laser scanner while 2D barcodes are read by imager barcode scanner, which are more expensive. A paper has reported on the use of fingerprint sensor in addition to barcode for use as identification system for bedside transfusion [42]. However, identification system based on biometric data is uncommonly used in the healthcare setting.
How can information technology help in minimizing human errors in blood bank? The 2012 SHOT report [16] showed that 41% of the 76 ICBT incidents originated from hospital transfusion laboratory. Linden et al. [13] reported that blood bank error alone occurred in 29% of their transfusion-associated errors. In developed countries, many clinical laboratory procedures have been automated but hospital blood banks have been the lone exception until recent years. Manual methods are prone to process variability, have poor reproducibility and results are interpreted subjectively. Manual record keeping and result traceability are also poor [43]. Automation of immunohaematology procedures seems to be the only solution in addressing these problems in hospital blood banks.
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Nowadays, fully automated blood bank immunohaematology testing systems are available in the market that require minimal human interventions. By putting LIS-registered barcoded sample tubes into the system, the system can automatically perform blood grouping and antibody screening and the results will be directly uploaded onto the blood bank LIS. This can prevent human errors on labelling of tube/plate, pipetting, result reading, interpretation, transcription, etc., from happening. A study by South et al. provided quantitative evidence on how automation could transform pretransfusion testing processes by dramatically reducing error potentials and thus would improve the safety of blood transfusion [44]. The latest BCSH guideline (2012) for pretransfusion compatibility procedures recommended that fully automated systems should be used wherever possible to reduce the risks of interpretation and transcription errors [20]. In the blood issuing step, a compatibility label would be generated from the LIS and put onto the blood units for the intended recipient. The label would bear the identifying information of the intended recipient in visual form as well as in barcode format. By scanning the barcode on the compatibility label, the blood unit serial number barcode and the product code barcode on the blood unit, the LIS can confirm that the blood unit bears the correct compatibility label for the patient and that the blood component type is the one being requested. Also, the LIS on blood issuing would ensure that the blood unit is fit for transfusing to that patient, that is, the blood groups of the blood unit are compatible with the recipient, the blood unit has not passed the expiry date, and all other requirements as requested for that patient are met, for example requirement for irradiated products. The LIS could also check if the patient has prior transfusion record in the hospital and WBIT could be picked up through this historical check. Some LIS can be interlinked with other hospitals’ LIS or have access to a regional or state/province wide blood bank information system, for example systems in Pittsburgh, Province of Quebec, New Zealand, Hong Kong, etc. The possibility of picking up WBIT would be further enhanced through checking the transfusion record of the same patient in other hospitals [45].
Remote electronic blood release Cox et al. first described the remote electronic blood release system [46]. Similar reports followed describing self-service, on-demand release of computer cross-matchcompatible red cells at remote location through connecting the system to the blood bank LIS [47–50]. Also called ‘virtual blood bank’, such system can extend the issuing of computer cross-match-compatible blood to the point
of care and has been proven to be safe. Remote blood inventory and bedside transfusion management system in the form of an intelligent blood vending machine are commercially available [51, 52].
Computer Physician/Provider Order Entry (CPOE) CPOE can provide features that can prevent errors and facilitate clinical practice consistent with guidelines by providing clinical decision support functions [53, 54]. If the CPOE is interfaced with the clinical data repository (also called clinical patient management system or hospital health record), clinical decision support can be provided during the order entry process and the system can display relevant clinical information during order request, for example, most recent platelet level when platelets are requested. Physicians or their delegates are guided in the selection of blood/blood components and their specific requirements, for example irradiated, CMV negative products, etc. For systems with clinical decision support functions, users can be alerted on certain selections based on predefined rules, for example, the use of irradiated blood would be prompted if the patient is on purine analogue drugs. The completed requests are then sent electronically to the blood bank LIS directly (so called ‘order communication’), which would prevent transcription error in blood bank as there is no need for manual entry during registration. For systems without order communication, some CPOE systems can print out a blood bank request form with a single 2D barcode that encodes patient identifying information and test requirements. The scanning of the 2D barcode in the blood bank could directly capture all the required information into the blood bank LIS, thus avoiding the possibility of transcription errors. It is highly desirable to have a system with order communication capability as the order transmitted to the LIS can create an LIS order at the time of CPOE test ordering. Handheld bedside devices with label printers are available that can download orders from LIS and subsequently LIS specimen label can be generated at the point of care by scanning patient’s barcoded wristband. Such system could reduce risk of mislabelled specimens and the use of incorrect container types. As the bedside label produced correspond to the LIS order, in-laboratory relabelling is not necessary, thus eliminating the risk of relabelling with a new laboratory number in the blood bank [55]. Bates et al. showed that CPOE can reduce serious medication incidents by 55% and all errors by 84% [56]. Blood transfusion can be seen as a form of intravenous medication, and so the findings may be applicable. However, a poorly designed CPOE system may facilitate more errors
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[57]. Therefore, the system should be carefully designed with input from front line practicing physicians.
Discussion The implementation of an end-to-end electronic transfusion management system has been shown to provide improvement in transfusion practice [33, 34] and can be used for the monitoring of hospital transfusion practice [58]. The implementation of such system involves major changes, and it is expected that there will be plenty of obstacles in the implementation. Murphy et al. have reported their experience in implementation of an electronic transfusion management system and have elaborated on how they have overcome the various obstacles in their implementation process [19]. The first obstacle is in getting support from hospital senior management in funding the project. This is easier nowadays when compared to 15–20 years ago when electronic bedside identification systems were more expensive, less user-friendly and there were few publications that could demonstrate their effectiveness in risk reduction, and cost and manpower saving capabilities in many areas. The second obstacle is getting support from stakeholders in designing and implementing this major change program. A team composed of key stakeholders as well as persons with the skills and knowledge to support the program would be formed to steer the whole project. The first thing the team should do is to understand and define the problem before the implementation, which would motivate staff to accept and participate in this change program, and solutions could only be devised when the problems are clearly defined. Afterwards, the team should set the objectives of the program and the processes that need to be changed in order to address the problem or risk areas. The next stage would be the software design, which requires a lot of communication between the implementation team and the software supplier. Before full implementation, a pilot run on a small scale would provide information for modifying and enhancing the system to make it more robust and user-friendly. The pilot run would also provide information on the benefits of the system, which would be communicated to users to gain their acceptance in implementing the system and to the senior management to get their support in scaling up the program. The training of all staff involved before full implementation is a big task but is essential for the successful implementation of the system.
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