Recommendations for the electronic pre-transfusion check at the bedside

Introduction

The current risk of acquiring viral transmission through blood components is very small¹. Thus, serious non-infectious hazards of transfusion have emerged as the most common complications². The risk of non-infectious complications, including risks related to hospital-based steps in transfusion care, is at least 100 times greater than the risk of acquiring human immunodeficiency virus or hepatitis C virus infection through blood components³. One of the most frequent causes of transfusion-associated morbidity or mortality is mistransfusion, when the wrong blood is transfused to the wrong patient. Mistransfusion is the final outcome of one or more procedural errors or technical failures in the transfusion process, starting with the decision to transfuse a patient and ending with the actual administration of blood components³. In particular, ABO-incompatible transfusions attributable to incorrect identification of the patient or the blood unit are among the most serious transfusion hazards^3–5. The Japan Society of Transfusion Medicine and Cell Therapy (JSTMCT) conducted nationwide surveys in Japan regarding ABO-incompatible blood transfusions (1^st survey: January 1995–December 1999; 2^nd survey: January 2000–December 2004). They found that the main cause of ABO-incompatible transfusion was identification error between the patient and blood unit⁶. These two surveys reported 9 and 8 “preventable” fatalities, respectively. Mislabelled and wrongly collected patient samples (wrong blood in tube [WBIT]) can also initiate a chain of events leading to mistransfusion³. Thus, correct patient identification at the time of sample collection and administration of blood components is critical.

The Serious Hazards of Transfusion (SHOT) scheme in England showed that approximately 70% of incorrect blood component transfused (IBCT) errors take place in clinical areas, with the most frequent error being failure of the final patient identification checking procedure at the bedside; the frequency of IBCT events was calculated as 7 per 100,000 components⁷. However, the true incidence of mistransfusion seems to be even higher due to a failure to recognise many of the errors, and because complete data on transfusion episodes are not available. Thus, the pre-transfusion checking procedure at the bedside is the most critical step to prevent mistransfusion, and represents the final opportunity to prevent blood component misuse. However, a large observational audit revealed a failure to perform the final bedside checking procedure⁸, in which the practice compliance of healthcare workers for identification and vital sign monitoring of patients receiving blood transfusions were substandard in many hospitals.

Machine-readable identification technology, especially a bar code-based electronic identification system (EIS), is ideally suited for pre-transfusion checking procedures and has been reported to significantly improve transfusion practice^9–15. The British Committee for Standards in Haematology (BCSH) Guidelines for the Use of Information Technology (IT) in blood transfusion laboratories were recently up-dated¹⁶, providing mainly guidance on the operational use of laboratory information management systems (LIMS). Thus, to our knowledge, there are no available recommendations addressing the issues regarding the pre-transfusion check procedures at the bedside employing an EIS. The JSTMCT Task Force proposed the original draft of recommendations for the electronic pre-transfusion check procedures at the bedside and raised public awareness regarding the draft of recommendations on the home page of the JSTMCT¹⁷. The draft of the current recommendations developed by the Task Force adopted the opinions were submitted without major changes to the description. The objective of this study was to establish recommendations for the electronic pre-transfusion checking procedures at the bedside, appropriate for clinical situations, where a bar code-based EIS is used.

Purpose of the recommendations

This document sets out recommendations specifically addressing the issues regarding the electronic pre-transfusion checking procedures at the bedside using an EIS. The main body of recommendations includes: 1) pre-transfusion checking procedures at the bedside; 2) requirements for electronic pre-transfusion checking procedures at the bedside; 3) pre-transfusion checking procedures at the bedside for a conscious patient; 4) pre-transfusion checking procedures at the bedside for an unconscious patient or child; 5) pre-issuing checking procedures at the transfusion service; and 6) monitoring of the bedside use of issued blood components.

Transfusion policy

Although blood components are administered to patients in most large-scale community and university hospitals in Japan, some hospitals have no transfusion services and do not employ laboratory technologists licensed by the JSTMCT. It is recommended that hospitals where blood transfusions are frequently performed have a transfusion service or appropriate system with a professional medical doctor(s) responsible for managing the overall safety of blood transfusions. Such hospitals should have a multidisciplinary hospital transfusion committee to oversee the provision of safe and appropriate transfusion support. The hospital transfusion committee may be made up of doctors and nurses from clinical departments where blood administrations are frequently required, pharmacists, laboratory technologists, as well as hospital representatives.

Finally, transfusion practices should be performed in accordance with the transfusion policy, approved by the hospital transfusion committee, and should comply with the Guidelines and Information for Using Blood Products and Blood Transfusion Therapy (Japan Guidelines), issued by the Ministry of Health, Labour and Welfare in Japan (September 2005, partially updated in March 2012)¹⁸, and also consider the number of people requiring electronic pre-transfusion checking procedures at the bedside.

Pre-transfusion checking procedures at the bedside

Current recommendations

Regarding the pre-transfusion checking procedures at the bedside Japan Guidelines recommend that: 1) blood components should be preserved under appropriate conditions; 2) the transfusionist (doctor or nurse) should check the appearance of blood components before initiating blood administration; 3) organisation and initiation of blood administration should be performed individually for each patient; 4) in order to prevent mistransfusion attributable to clerical errors, the transfusionist should check the information regarding both the patient and blood unit, i.e. the patient’s name, blood group, product lot number, date of collection, results of compatibility testing, and whether or not blood components have been gamma irradiated; 5) a standard 2-person visual and verbal double-check should be performed regarding the above issues before initiating blood administration at the bedside; and 6) the transfusionist should check the patient’s vital signs, including body temperature, blood pressure, pulse, and, if possible, oxygen saturation by pulse oximetry (SpO₂) before initiating blood administration. Finally, Japan Guidelines recommend the use of an EIS to ensure the safety and effectiveness of the pre-transfusion check at the bedside.

Number of people requiring pre-transfusion checking procedures

When an EIS is used in a hospital, the pre-transfusion checking procedures at the bedside may involve one or two healthcare professionals. Potential errors can be minimised if one individual carries out the pre-transfusion checking procedure using an EIS. However, if the electronic pre-transfusion check at the bedside fails because of human error¹⁹, a 1-person pre-transfusion check without the new technology may present a higher risk of mistransfusion than a standard 2-person double-check, although the number of people required to check the identity of the patient and blood unit at the bedside is a subject of debate²⁰. If an electronic pre-transfusion check is combined into a standard 2-person double-check it may help reduce confusion among healthcare professionals if the system malfunctions. Japan Guidelines recommend a standard 2-person visual and verbal double-check for pre-transfusion checking procedures at the bedside, as described above. In addition, the recent BCSH Guidelines stated that “the use of a bedside blood tracking system does not replace the role of the well trained and competency assessed clinician who administers blood components”¹⁶.

Current recommendations do not positively recommend a 1-person pre-transfusion check at the bedside, even if an EIS is used. Thus, the current recommendations state that the electronic pre-transfusion checking procedures at the bedside should be carried out by a 2-person team, one of whom should be the transfusionist and the other should be someone who carries out a second check (second checker); this need not necessarily be a healthcare professional but could be the patient her/himself. When the patient is conscious, the transfusionist (nurse or doctor), together with the patient, conducts the pre-transfusion checking procedures at the bedside using an EIS. When the patient is unconscious or a child, two nurses (or a doctor/nurse pair) can also conduct the pre-transfusion checking procedures. In this case, another healthcare professional, such as the staff member of the transfusion service who delivered the issued blood component into the clinical area, instead of the patient, may be available as the second checker.

Principle of the pre-transfusion checking procedures at the bedside using an EIS

The current recommendations state that: 1) the pre-transfusion checking procedures at the bedside should include, first, a standard 2-person visual and verbal double-check, followed by an electronic pre-transfusion check using a hand-held device “just” prior to the initiation of blood administration; 2) the electronic pre-transfusion checking procedures at the bedside should be carried out by a 2-person team, of whom one should be the transfusionist and the other should be the second checker; and 3) the second checker may change according to patient condition, and does not have to be a nurse or doctor.

Requirements for the electronic pre-transfusion check at the bedside

a) EIS

A bar code-based EIS: several vendors offer a bar code-based EIS, which may be a stand-alone configuration or a built-in product in an electronic medical chart. In Japan, a bar code-based EIS is based on the employment of the linear bar code (NW7), because it has been added to labels attached to all allogeneic blood components supplied from branches of the Japanese Red Cross Blood Centre. The bar code on allogeneic blood components identifies the blood group, product type, unit of blood, product number depending on the donor, and date of collection. In the case of autologous blood components, in-house bar codes identifying the product type and product number should be used. An EIS should be used on all inpatient wards, and in operating rooms and outpatient units. Inpatient wards with an infrequent need for blood transfusions, i.e. psychiatric and dermatology wards, may be excluded from using an EIS.

A hand-held device: a hand-held device is fitted with a laser bar code scanner and linked to an EIS with wireless or wired technology with a docking device, depending on its vendor. It is capable of reading bar codes during pre-transfusion checking procedures at the bedside, receiving transfusion data including the patient’s surname, first name, identification number, and blood group via a network and sending data regarding the bedside verification procedure (e.g. name of transfusionist, time of verification) to the host computer at the transfusion service. According to the general specifications of an EIS, if the bar codes of the wristband and blood are identical, the screen of the hand-held device displays “OK”. Non-matching data result in a warning on the screen (“NG”) with an alarm sound. The same process is used for the pre-issuing checking procedures at the transfusion service. A match/non-match is identified by the software installed in the hand-held device.

Link to a hospital information system: a bar code-based EIS should be linked to the hospital information system, as well as to the transfusion management system (or LIMS) via a network in order to be fully effective¹² The host computer at the transfusion service is linked to the hospital information system via a network and can: 1) store data for transfusion (patient’s details, details of blood component, results of pre-transfusion testing); 2) search for the stored data; 3) send the transfusion data to hand-held devices at the bedside; 4) receive the data on the pre-transfusion check at the bedside from hand-held devices; and 5) monitor the bedside use of the issued blood component.

Using an EIS: use of an EIS is recommended on all inpatient wards, except for those that do not frequently require blood transfusions, and in operating rooms and outpatient units. Among blood components, autologous blood components should be used on the basis of EIS readings, as well as allogeneic blood components²¹. Finally, paediatric patients should receive blood transfusions based on an EIS, because of special requirements regarding the administration of blood components, including small-volume transfusions and dispensing blood in plastic syringes, where the management is more likely to be inappropriate compared to that of blood bags²².

b) Wristbands

All patients, who are admitted to the hospital or who are scheduled to receive blood transfusions should be given wristbands with a bar code and eye-readable identification, including their surname, first name, gender, date of birth, patient identification number, and blood group ABO/RhD. When the wristband is attached to the patient, two nurses should carefully perform a visual and verbal double-check. If the wristband needs to be cut for venous access, or in the case of surgical intervention, the wristband should then be reattached. Therefore, multiple wristband printers may be needed, as described below.

c) Wristband printer

A wristband printer is specially designed to print the patient’s details, as described above. One should be installed at the check-in counter for admission, in operating theatres, and on some inpatient wards where cutting and re-attachment of wristbands are frequently required, i.e. obstetrics wards with a delivery room, and at the transfusion service.

d) Compatibility label and compatibility report form

The compatibility label attached to the blood unit should be printed with bar codes providing data of the pre-transfusion compatibility testing. The compatibility report form, which can be duplicated, should be printed with the same bar code as the compatibility label. A copy should be sent to the transfusion service irrespective of whether or not the description includes adverse events. Both bar codes providing data on the compatibility testing are used during the electronic pre-transfusion checking procedures at the bedside, as well as at the transfusion service.

e) Identification badge for staff members

Identification badges for staff members involved in the electronic pre-transfusion checking procedures at the bedside and the transfusion service should be printed with individual bar codes.

Pre-transfusion checking procedures at the bedside for a conscious patient

This may be the most common situation in most hospitals. The entire process of the electronic pre-transfusion checking procedures for a conscious patient should be conducted by one nurse (or doctor) and the patient together, and should be carried out at the bedside using an EIS. The patient is expected to act as the second checker. Given this, another healthcare professional, such as the staff member of the transfusion service who delivered the issued blood component into the clinical area, should also be available.

The transfusionist:

• - asks the patient to state his/her full name and date of birth;

• - together with the patient, checks the information and reviews both the blood unit and compatibility report form;

• - sequentially scans the bar codes of his/her own identification badge, the patient’s wristband, and the blood unit using the hand-held device;

• - together with the patient, verifies the data displayed on the hand-held device and assesses whether or not the bar codes on the wristband and blood unit match;

• - if the hand-held device displays “OK”, blood administration is initiated “immediately”.

Pre-transfusion checking procedure at the bedside for an unconscious patient or child

This case may be a common situation in intensive care units (ICUs), emergency rooms, and on inpatient wards for children. The entire process of the electronic pre-transfusion checking procedures for an unconscious patient or child should be conducted by two nurses (or a doctor/nurse pair) and carried out at the bedside using an EIS. If two nurses conduct these, one should act as the transfusionist and the other as the second checker. In the case of a doctor/nurse pair, a nurse may act as the transfusionist and a doctor as the second checker. The second checker may also be another healthcare professional, such as the staff member of the transfusion service who delivered the issued blood component into the clinical area.

The transfusionist:

• - together with the second checker, checks the patient’s full name and date of birth and reviews the patient’s wristband;

• - together with the second checker, checks the information and reviews both the blood unit and compatibility report form;

• - sequentially scans the bar codes of his/her own identification badge, the patient’s wristband, and the blood unit using the hand-held device;

• - together with the second checker, verifies the data displayed on the hand-held device and assesses whether or not the bar codes on the wristband and blood unit match;

• - if the hand-held device displays “OK”, blood administration is initiated “immediately”.

Pre-issuing checking procedure at the transfusion service

The SHOT scheme reported that approximately 30% of errors pertaining to IBCT events occur in the hospital transfusion laboratory⁷. These may involve the selection of the wrong sample for testing, transposition of labels, technical or transcription errors in manual pre-transfusion testing, or knowledge-based errors, such as the selection of components of an inappropriate specification. This may lead to a need for the electronic pre-issuing check at the transfusion service. The electronic pre-issuing checking procedures should be performed to ensure that the transfusion service staff member has attached the right compatibility label to the right blood unit after completing compatibility testing. Although this process is optional and does not play an essential role in the electronic pre-transfusion check at the bedside, it may prevent mislabelling and selection of the wrong blood unit. All blood components should be delivered from the transfusion service after completing the electronic pre-issuing check procedure.

The staff member of the transfusion service:

• - attaches the compatibility label printed with the bar codes providing data on the pre-transfusion testing to the blood unit after completing compatibility testing;

• - uses a hand-held device to sequentially scan the bar codes of his/her own identification badge, the “original” label of the blood unit, and the newly attached label of the blood unit (both sides of the blood unit should be scanned);

• - uses a hand-held device to scan the bar codes of the “original” label of the blood unit and the compatibility report form, on which the same bar code as the compatibility label is printed;

• - together with another staff member of the transfusion service, verifies the data displayed on the hand-held device, and assesses whether or not the bar codes on both sides of the blood unit match, and whether or not the bar codes on the blood unit and the compatibility report form match;

• - if the hand-held device displays “OK”, the blood unit is issued.

Monitoring of the issued blood components at the bedside

The BCSH has recommended that transfusion of blood and blood components should begin as soon as possible after their delivery to the ward or operating theatre²³. The risk of mistransfusion may increase when the issued blood unit remains unused for an extended period of time at the nursing unit or at the bedside. Therefore, it may be important to pay special attention to how the issued blood unit is used at the bedside in order to improve transfusion safety. When an EIS is used in most clinical areas in a hospital, it can facilitate use of a hand-held device as an electronic pre-transfusion check at the bedside to up-date the information contained in the host computer at the transfusion service, thereby allowing bedside use of the issued blood unit to be monitored. Communication between the transfusion service and the bedside via a network allows compliance with the electronic pre-transfusion checking procedures at the bedside to be monitored¹². Time after issuing (TAI) is defined as the time from issuing the blood unit at the transfusion service to initiating blood administration at the bedside. TAI can be calculated by a staff member of the transfusion service checking the time the blood unit is issued and also the time the electronic pre-transfusion checking procedure is performed by viewing the monitor of the host computer in the transfusion service. Although this calculation requires the electronic pre-transfusion checking procedures to be carried out “just” prior to the initiation of blood administration, TAI on inpatient wards has been reported to be shortened after initiating TAI monitoring and the immediate notification to use the issued blood unit by the transfusion service by phone¹². Although this secondary function is not an essential feature of an EIS, it may help improve transfusion safety in the hospital.

How prevalent is use of an EIS in Japan?

The Association of Transfusion Division of University Hospitals (ATDUH) issued questionnaires to a small group of the transfusion service of university hospitals in Japan (n=91). The members of the ATDUH are teaching hospitals and representatives of regions distributed widely across in Japan, and also those of the JSTMCT. All transfusion service members in university hospitals were registered. The questions referred to transfusion practices and use of IT systems, including a transfusion management system and a bar code-based EIS: system vendor, who applied for the system, date of initiation of the system, and compliance with the electronic pre-transfusion checking procedures at the bedside. Of the questionnaires sent to 91 transfusion services, 90 (99%) were returned fully completed. Eighty-one (90%) transfusion services answered that the pre-transfusion checking procedures had been carried out using a bar code-based EIS. At present, the overall prevalence rate of an EIS for pre-transfusion checking procedures at the bedside in Japanese university hospitals is 90%. Further studies, including a nationwide survey, are needed to explore the prevalence of EIS use in Japan.

Conclusions

The current recommendations may be appropriate for clinical situations, where a bar code-based EIS for the pre-transfusion checking procedures at the bedside is used. Although bar code technology is a widely used, reliable, and inexpensive machine-readable identification system, bar code-related patient misidentifications have been reported when a linear bar code is used²⁴. More advanced systems, such as radiofrequency identification (RFID), will be introduced in the near future. RFID may have advantages over bar code-based technology, i.e. more user-friendly, allowing more information to be recorded, allowing blood components to be traced. Technology-based solutions designed to prevent mistransfusion have recently been developed, and the effectiveness of the different systems in detecting errors has been reported²⁵. To reduce human error and the risk of mistransfusion, we have to address the issue at a hospital level, using a system-based approach.