Transfusion of blood and its components occasionally results in serious hemolytic reactions due to the transfusion of wrong blood type, which is considered a human clerical error. This type of error may occur at the initial stages of blood collection, labeling, grouping, and transportation, or more importantly, this error may possibly be observed when a healthcare personnel fails to perform final bedside identity check between the patient and blood component unit before transfusion. The World Health Organization has established several policies and guidelines for a safe blood transfusion [1].

Pretransfusion final identity check, which ensures the transfusion of the right unit for the right patient, is best achieved by using various electronic transfusion management systems [2–5]. However, in healthcare facilities that cannot afford these expensive instruments, identity check is performed by the healthcare personnel initiating the transfusion (transfusionist) by visually matching patient’s details available at bedside with the compatibility label attached to the blood component unit and transfusion prescription [1,6]. This is a subjective and self-confirmatory method performed based on the transfusionist’s subjective clinical assessment. Occasionally, clerical errors due to stress, increased workload, or mere negligence during this process, resulting in fatal and legal consequences, can be observed. Hence, the transfusionist may experience a significant level of anxiety. Therefore, the use of a cost-effective objective method would be beneficial. Hence, a novel ‘Sandesh Positive-Negative (SPON) protocol’ for checking the patient’s identity with the blood components before transfusion was developed and evaluated.

This study aimed to compare the SPON protocol with the standard protocol for the final identity check of blood components at bedside to ensure the transfusion of the right blood unit for the right patient. The primary study hypothesis was to compare the two protocols with respect to the transfusionists’ anxiety and satisfaction levels. The secondary hypothesis was to observe the chances of avoidable clerical errors/near-miss events of mismatched transfusion. Hence, a novel negative label was created that would match with the characters of a positive label only if it belonged to the same patient.

A total of 85.3% (64/75) of the subjects were anxious about the process of blood transfusion with reference to the existing standard protocol used to check patient’s identity (Table 1) due to fear of complications of mistransfusion. Moreover, in their professional career, 72.0% (54/75) of the transfusionists had near-miss events at least once, 14.7% (11) twice, and 13.3% (10) three or several times. Furthermore, the identity check of approximately 64.0% did not undergo cross-examination by a second personnel (double checking). Hence, approximately 69.3% (52/75) themselves performed the identity check twice or several times. Moreover, although only 9.3% (7/75) were dissatisfied about the existing protocol, approximately 70.7% (53) felt the need for a new/better or an additional protocol. After the implementation of the SPON protocol, only 38.7% (29/75) experienced any degree of anxiety (P = 0.001 in consultants, P = 0.001 in trainees, P = 0.012 in nurses). However, in total subjects, there are no differences with respect to the distribution of anxiety levels. The proportion of subjects being highly satisfied increasing from 8.0% to 38.7% (P = 0.011), and none of them were dissatisfied (Table 1). Additionally, 48.0% felt minimal but manageable extra work in performing the protocol. Moreover, 84.0% (63/75) considered the new protocol worthy, and 89.3% (67/75) recommended for its implementation on a regular basis (Table 2). None of the subjects had experienced difficulty in performing the protocol, and clerical error was not observed during the study.

Transfusion of blood and its components is a complex multistep process involving several diverse healthcare professionals, namely, doctors, laboratory technologists, and nurses apart from donors and recipients. Accordingly, errors can occur during any of these steps starting from the initial stages of blood collection until transfusion, causing fatal complications. Contributory causes for these errors are mostly due to the widely recognized ‘human factors’ such as increased workload, slips and lapses, fatigue, lack of attention, and taking shortcuts and omission of essential steps [7]. Patients are at a higher risk of a wrong blood transfusion than any other transfusion-related complications [8,9]. This type of error is frequently observed at the patient’s bedside just prior to the transfusion due to inappropriate identity check [10–13]. Similarly, in hospital areas requiring many blood components (e.g., large-sized wards, intensive care units [ICUs], and where several operating rooms are situated in one complex), the number of components arriving is significantly higher compared to hospital areas not requiring blood components. Often, they may have been ordered and expected simultaneously at close intervals for two or more patients positioned nearby. Hence, there are chances that the healthcare personnel transporting them may accidently deliver it to the wrong operating room/ward, probably leading to mistransfusion.

These potentially serious errors can nearly be eliminated by removing the manual steps/human factors and introducing certain tools, for example, patient identification bracelets with barcodes and barcode readers, radio-frequency identification devices, automated analyzers in laboratories, or mechanical and electronic locks that provide safe end-to-end electronic control across the whole transfusion process [3,4,5,10]. However, in healthcare facilities that cannot afford these expensive instruments, the standard method of identity check is performed by the transfusionist by visually matching the patient’s details with the compatibility report and compatibility label (attached on the blood component) [1]. This process is completely subjective as it is solely based on the transfusionist’s assessment; as a result, the transfusionist may perform the identity check more than once. Moreover, considering that the procedure is purely subjective, clerical errors are significantly possible due to various factors described earlier. Occasionally, the compatibility label is only matched with the compatibility report and is not matched with the patient’s identity details on the wristband or at bedside. Considering that both the compatibility label and report are generated by the same laboratory computer, the two will always match even if wrong blood component is being transfused. All these factors result in a significant level of anxiety and dissatisfaction in the transfusionist. Hence, to address the need for an objective method that is not only practical and simple but also inexpensive, the SPON protocol was developed and evaluated.

Most of the transfusionists were anxious about the process of transfusion with the existing standard protocol (Table 1). The major reason for this anxiety was the fear of mistransfusion due to judgmental errors. The most common anticipated serious consequences of these errors were the fear of losing the patient’s life (44.0%) and legal consequences (30.7%). Awareness regarding legal complications was more common in consultants than in postgraduate students and nurses. Due to the significant level of anxiety regarding clerical errors, approximately 69.3% of the subjects admitted having performed the identity check twice or several times. Moreover, although cross-examination of the identity checked by a second personnel (double check) was recommended and considered as part of the standard procedure, the identity check of approximately 64.0% (48/75) of the transfusionists did not undergo cross-examination. The common reason for this was the lack of healthcare personnel available at the time of cross-examination. Furthermore, evidence regarding the safety of performing bedside check by one or two healthcare staff does not exist [6]. Hence, 70.7% (53/75) felt the need for a new/better or an additional protocol for identity check.

The P-N label works based on the lock and key principle where only a unique key would fit into the respective keyhole of its corresponding lock to unlock it. In the SPON protocol, the P-N label is a proof of compatibility as the negative label will match with its corresponding positive label only if it belongs to the same patient. Although most of the steps in the SPON protocol are objective, the final step requires visual confirmation and judgment. Even then, it is significantly easier to determine any disparity between the positive and combined P-N label as they both lie adjacent to each other (Fig. 2). It is easier to compare thetwo items precisely when placed nearby rather than farther away. After the implementation of the protocol, the proportions of the transfusionists who rated the anxiety as mild, moderate, or severe decreased considerably from 85.3% to only 38.7%. Moreover, none of the subjects were dissatisfied with an overall increase in satisfaction levels.

Adding an extra phase to an existing protocol seemed to increase the transfusionists’ workload as 48% felt that the new protocol added extra, but minimal and manageable, work. Nevertheless, 84% felt that the extra effort was absolutely worthwhile (Table 2). They believed that the benefits of this minimal extra effort outweigh far greater than the consequences of a mistransfusion with respect to mortality and legal concerns. The SPON protocol was proven to be simple and easily comprehensible since none of the subjects had experienced difficulty in performing the protocol.

Clerical errors were not observed during the study probably because the overall incidence of clerical errors has drastically decreased over the years due to the comprehensive reporting of incidents and implementation of standard policies and the subjects were extra vigilant due to their conscious enrolment in the study. However, approximately 28% (21) reported to have experienced near-miss events in their profession more than once, causing a significant level of anxiety. ‘Near-miss’ events comprise a third of all SHOT reports, which was comparable to our study [7,14]. These were mainly observed in the ICU/general ward where blood components were erroneously placed near a different patient or in a common area. It was also noted that although those events were promptly avoided with the existing standard protocol itself, the subjects felt that a new protocol would have reduced the anxiety they experienced during those events. Hence, although the SPON protocol may be comparable to the standard protocol in terms of avoiding clerical errors, it is absolutely superior in terms of reducing anxiety and improving satisfaction levels. Therefore, most of the subjects recommended the protocol for implementation on a standard basis.

Traditional double checking performed by two medical personnel is also considered a subjective way that is dependent on the assessment of the second personnel; hence, when double checking is performed, objective confirmation is not provided. Hence, the SPON protocol performed by one transfusionist may provide an objective confirmation over traditional double checking. However, an adverse effect as a result of the omission of the standard double checking can be possibly observed, leading to errors and ethical concerns. Hence, the SPON protocol would yield superior results if used as an additional rather than a replacement method to the existing standard method, which also formed the basis for designing this study.

However, the study had the following limitations. First, the study could not be conducted as a randomized cross-over study to avoid the significant period effect and carryover effect. Second, this study comprised a small sample size; hence, clerical errors were not clearly evaluated considering that the estimation of errors required a large sample size (in this study, the incidence of clerical errors was significantly low even with the existing standard protocol). Furthermore, the implementation of any new method on a large scale involves ethical issues, specifically if it involves errors leading to significant morbidity. Third, clerical errors were not observed in the present study sample, which is possibly due to the conscious enrolment of subjects for the new protocol; hence, the subjects were extra vigilant.

The SPON protocol is more confirmatory than the existing protocol due to its dual subjective and objective nature indicating the right blood for the right patient. Importantly, evidence regarding the appropriate performance of identity check exists as the final label strip is attached to the patient’s hospital record file. This is considered beneficial in addressing possible medicolegal concerns or litigations in the future as erroneous transfusion amounts to medical negligence, resulting in punishment and warranting huge monetary compensation. Moreover, the cost of this additional protocol per patient was estimated to be merely 0.4 Indian National rupee/0.0058 US dollar/0.0044 Pound Sterling [15]. Since it does not require any additional infrastructure and manpower, it can be easily implemented and possibly be incorporated as a standard operating protocol for safe transfusion by regulatory authorities specifically in Third World countries. It can also be a major database used in the hemovigilance systems of any country [9].

Therefore, the ‘SPON protocol’ is a simple and cost-effective objective method when performing final bedside identity check of blood components for an improved transfusion practice.