|Year : 2017 | Volume
| Issue : 2 | Page : 118-123
Monitoring errors in a blood bank immunohematology laboratory: Implementing strategies for safe blood transfusion
Sudipta Sekhar Das, Ritam Chakrabarty, RU Zaman
Department of Transfusion Medicine, Apollo Gleneagles Hospitals, Kolkata, West Bengal, India
|Date of Web Publication||11-Sep-2017|
Sudipta Sekhar Das
Department of Transfusion Medicine, Apollo Gleneagles Hospitals, Kolkata, West Bengal
Source of Support: None, Conflict of Interest: None
Background: Errors occurring at patient bedside during specimen collection are the most common causes of adverse outcomes. We planned this prospective study to estimate the incidence and nature of transfusion errors, identify the source, site of occurrence, and assess the underlying problems in the system with the aim to prevent the potentially fatal human error. Materials and Methods: The study was performed over a period of 5 years at a hospital based blood transfusion service where all errors and discrepancies both in the recipient and donor samples were reported into an 'incident and error reporting register' and then analyzed. Results: While a total of 72,381 patient samples were received for pretransfusion testing, 43,762 samples were from blood donors for ABO and Rh grouping. A total of 79782 blood components were issued to patients during the study. Out of 229 errors in the blood transfusion chain, 164 (0.22% of total requisitions and 0.21% of total component issued) were reported in patient pretransfusion samples, and 65 errors (0.15%) were reported in donor samples. Majority of the errors were clerical in nature and related to human errors. Of the 164 errors in pretransfusion testing samples, 107 (65.2) were observed in night shift. The overall error frequency per 1000 requisitions was 2.26. Conclusion: Near miss event reporting can prevent potential transfusion associated mortality and morbidity caused by simple human ignorance. A good error reporting not only helps in accurate collection and analysis of data but also makes recommendations that improve transfusion safety.
Keywords: Errors, near miss event, pretransfusion testing, transfusion chain, transfusion safety
|How to cite this article:|
Das SS, Chakrabarty R, Zaman R U. Monitoring errors in a blood bank immunohematology laboratory: Implementing strategies for safe blood transfusion. Glob J Transfus Med 2017;2:118-23
|How to cite this URL:|
Das SS, Chakrabarty R, Zaman R U. Monitoring errors in a blood bank immunohematology laboratory: Implementing strategies for safe blood transfusion. Glob J Transfus Med [serial online] 2017 [cited 2019 Jan 16];2:118-23. Available from: http://www.gjtmonline.com/text.asp?2017/2/2/118/214283
| Introduction|| |
Blood transfusion-associated mortality due to human errors has been adequately documented by previous authors., In subsequent years, various reports regarding human errors have been published from different areas of medical disciplines.,,, These reports highlighted the issue of human errors and the need to consider patient safety as a top priority, including transfusion safety. Transfusion errors are mistakes that occur in the production and clinical supply processes of blood and blood components to the patients. The persistence of human errors despite extensive efforts to eradicate them suggests inherent irreducible quality. Although errors in blood transfusion are significant, most of these are underreported. Recent reports on serious hazards of transfusion (SHOT) estimated a frequency of incorrect blood component transfusion as high as 70% of total transfusion errors. Most of these errors were clerical, attributed to acute hemolytic transfusion reactions but were preventable. In most instances, such errors are identified as “near miss events” and do not lead to serious consequences. However, near miss events if undetected may result in a wrong blood group, or issue, collection or administration of an incorrect, and inappropriate or unsuitable component. Although no catastrophic outcome occurs, such incidences demonstrate an inefficient blood supply chain. Prospective studies on monitoring of errors in blood banking are not many. Here, we planned a prospective study to estimate the incidence and nature of transfusion errors to identify the source and site of occurrence and assess the underlying problems in the system with the aim to prevent the potentially fatal human errors.
| Materials and Methods|| |
The prospective study was performed over a period of 5 years at a hospital-based blood transfusion service. Here, we enumerated all transfusion errors encountered at any point in the process flow of our blood bank laboratory [Figure 1]. Any deviation of act or procedure from the departmental or institutional standard operating procedures (SOP) has been considered as an 'error' in the study. All transfusion-associated incidents whether or not an incident resulted in an adverse outcome were documented in the incident and error reporting registers. A report form was completed each time an error occurred with detailed information of each event, the point of breach in the process, circumstances under which the error occurred, type of error, the timing of error and name and designation of the person notifying the error. It was the responsibility of the blood bank medical officer in-charge to confirm the information, complete the documentation, and take necessary corrective actions. As per the mandatory policy, a complete requisition form for transfusion with properly labeled recipient's sample was required for pretransfusion testing. When a sample was received in the laboratory, an initial check was done by the technologist who confirmed that the information on the label and on the requisition form was identical. For positive sample identification, information mandated on the sample label included patient's full name, age/gender, identification number (ID No), ward, bed number, phlebotomist's full name with the date and time of collection. Once properly identified, both requisition and samples were handed over to designated technician for testing. Blood request or sample lacking the mandated information or having doubtful or mismatch information were not accepted. Pretransfusion testing on recipient's sample was performed as per the departmental SOP. This included ABO grouping (forward and reverse) and Rhesus typing including weak D testing by conventional tube technique and antibody screening and crossmatching using the established Column Agglutination Technology. When an error was recognized at any stage by any of the personnel within the blood bank laboratory, an incident and error reporting form was filled describing every detail of the happening. For the purpose of such analysis, all events encountered were categorized into two broad categories-extrinsic and intrinsic. Extrinsic incidents were true human errors while intrinsic errors were because of inherent factors in cell or serum. Extrinsic errors were further subcategorized according to the severity of incidents as major and minor errors. Major error was defined as a human error which was not identified before issue of blood component from the laboratory area, and minor error was defined as a human error that was identified before issue of blood component from the laboratory area. Evaluation of errors was also performed according to the timing of the day (shifts) and the type of requisition (routine, urgent, or immediate). As per the departmental policy, the working hours in laboratory area have been divided into three eight hourly shifts– morning, evening, and night shifts and all types of requisitions are accepted during these shifts. For routine, urgent, and immediate requests, the allotted time required to fulfill the demand is considered 2 h, 30 min, and 10 min, respectively, from the time the requisition and sample have been received in the blood bank.
| Results|| |
During the study period, we received 72,381 blood samples of patients for pretransfusion testing and 43,762 blood samples of donors for ABO and Rhesus grouping. A total of 79,782 blood components were issued during this period. [Figure 1] describes the complete process flow in a blood bank cross-match laboratory. We observed a total of 253 errors of which 24 samples had inherent problem with either cell or serum. These immunohematological problems were related to discrepancy in forward or reverse grouping in patients suffering from, blood cancers, autoimmune diseases, or samples of new born or patients who have undergone recent ABO incompatible stem cell or bone marrow transplantations. These problems were not errors in true sense and therefore not considered further [Figure 2]. A total of 164 human errors were reported on patient's samples that depicted an incidence of 0.22% of the total requisitions and 0.21% of total components issued [Table 1]. Sixty-five errors were reported in donor's samples with an error rate of 0.15% of the total samples received [Table 2]. Out of 164 errors in pretransfusion samples, 133 (81.1%) were minor, and 31 were major events. Out of 31 major events, 27 (87.1%) were clerical errors that included 15 major transcription errors on blood issue register and 12 serious errors in the form of wrong patient names and identifications either on sample vials and blood requisitions at bedside or compatibility report and label in blood bank. Major technical errors were 4 and included wrong patient blood in the sample vial, incorrect cross-match, and blood component issue. Of the 133 minor events, 18 were clerical errors mostly including sample vial-related errors or blood requisition errors. Minor technical errors were 15 and primarily included errors in compatibility test or/and misinterpretation of the result.
|Table 1: Types and sources of errors in pre-transfusion testing samples (N=164)|
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Considering errors in donor samples [Table 2], all were minor events of which 42 (64.6%) were clerical errors mostly including transcription errors and 23 (35.4%) technical errors of which 11 events were related to the failure of washing red cell during performing blood grouping. As shown in [Table 1], there were 2 events of incorrect component issue not resulting in wrong blood transfusion. There were 11 errors in blood component ordering where 3 cases were transfused cryoprecipitate-poor plasma instead of cryoprecipitate and vice versa. For the other 7 patients correction of order was made before transfusions.
Out of total 72,381 requisitions for blood and blood components, 12,379 (17.1%) were received in the morning shift, and 45,732 (63.2%) and 14270 (19.7%) received in evening and night shifts, respectively. Depicting the types of requisitions, 59,343 (82%) were routine, 8622 (11.9%) urgent and 4416 (6.1%) were immediate. The distribution of human errors on patient's pretransfusion sample per 1000 requisitions received is described in [Table 1]. The overall error frequency per 1000 requisitions was 2.26. Considering 164 errors in pretransfusion testing samples 107 (65.2) were observed in night shift, 33 (20.1%) in evening shift, and 24 (14.6%) in the morning shift. Therefore, the error frequency per 1000 requisitions was observed highest in the night shift (7.5/1000) followed by morning (1.9/1000) and evening (0.72/1000) shifts. Of the 65 errors associated with donor samples, 43 (66.2%) were observed in the night shift. All 19 technical errors related to donor samples were due to deviation from the departmental standard, operating procedures (SOP) of which 14 (73.7%) happened at night shift.
| Discussion|| |
“Near miss” events are preventable and they reflect the lacunae occurring both in the production of blood components and their transfusion to patients. Of the total requisitions received, 0.23% of errors were observed in the present study. In the developed countries, though the infectious risk has reduced remarkably, the noninfectious risk such as misadministration of blood components still prevail and is estimated to be 1 in 12,000 units while the risk of fatal acute hemolytic transfusion reaction due to error ranges between 1 in 600,000-1 in 800,000., In France, in 1994, a hemovigilance network for reporting of adverse transfusion events and their causes started as a mandatory nationwide scheme while in 1996, the United Kingdom launched SHOT, a voluntary confidential hemovigilance system. By the year 2001, many countries implemented hemovigilance system. The hemovigilance program of India is comparatively a new government initiative which is voluntary today with an objective to make it mandatory in the future. Out of the total 229 extrinsic errors, majority (191, 83.4%) was clerical, and the patient bedside was the major site of deviations that constituted 66% of all clerical errors. These errors were in varied form and described in [Table 1]. As per the American Association of Blood Banks standards each sample drawn for pretransfusion testing is labeled at the bedside and that there is a mechanism to identify the phlebotomist. The root cause analyzed for labeling errors revealed failure to label at the bedside or labeling two or three samples at the same time. Our results are in coherence with the findings of Sharma et al. where approximately 87% of all errors were at bedside. In the United States, FDA reported human error as the major cause of 355 transfusion-associated mortalities between 1976 and 1985, and patient bedside as the major site for these errors. Bedside transfusion errors leading to serious morbidity has also been highlighted by the SANGUIS study group and Mercuriali et al., In the current study, 22.6% human errors occurred in the blood bank during pretransfusion testing or issue of blood or blood components. Considering errors in pretransfusion testing samples as well as blood donor samples, the frequency of clerical errors outnumbered the technical errors (81.7% vs. 18.3%). When analyzed, most errors occurred as a result of shortcuts, failure to follow defined and approved protocols, attention deficit, and failure to recognize the importance of each procedure. Sidhu et al. concluded that errors in sample labeling, inappropriate request, and errors in sample receiving were the most frequent high-risk errors in pretransfusion testing.
The current study revealed 11 incidences of wrong blood component ordering and 3 patients receiving incorrect blood components. Lack of adequate knowledge was the most common cause of such error. Fortunately, there was no any mortality because all inappropriate transfusions were in the form of incorrect component transfusion and not relating to ABO mismatch. Evaluating the errors that occurred outside the blood bank majority (65.2%) occurred during the night shift. A look back revealed higher number (7693 of 13,038, 59%) of urgent or immediate types of requisitions at night, in addition to reduced number of nursing staff at night shift. Relatively, fewer errors were reported during the morning and evening shifts. Of the 7693 urgent and immediate requisitions at night, 4932 (64.1%) were from 3 specific specialties, namely, emergency and trauma, critical care medicine and medical oncology. Owing to inadequate staff, we anticipate underreporting and nondocumentation of errors at night. Our intention was not only to detect errors in the entire transfusion chain but also to identify the critical areas breached so as to implement necessary corrective measures in the error-prone areas. We found that the majority of errors were related to bedside sample labeling. Similar were the findings of previous authors who observed deficiency in performance during bedside sampling., Attention should be on the entire process of transfusion service rather the blood safety with implementation of error avoidance measures at each critical step with greater attention on the receiving end of the transfusion chain. It is important to examine human errors along with the understanding of the underlying issues that can contribute to an error. Besides education and training, maintaining confidentiality on fault reporting is one of the best ways to encourage event reporting. As commented by Callum et al., education of the medical and nursing staff is necessary but in itself, insufficient to reduce the frequency, and severity of events.
Our data regarding human errors is no different from any other transfusion services and gives an insight of the basic human nature of finding shortcuts, especially in overburdened conditions. Based on our experience, we recommend the following things for consideration: (a) Strict adherence to working SOP, (b) mandatory reporting of any and all events immediately with complete documentation, (c) encouragement for reporting of medical events and transfusion reactions by promoting “no blame” working environment, (d) mechanism for mandatory verification of information on blood compatibility documents with the requisition form before the issue of blood component, (e) regular competency assessment program for all personnel involved in the entire process of transfusion, (f) implementation of quality assessment and quality improvement program in transfusion practice to enhance transfusion safety, (g) appointment of dedicated transfusion nurse in each ward who has special training in transfusion services, and (h) development of new systems for positive patient and blood unit identification at bedside as well as in blood bank. To prevent errors at our institution, the strategies that have been implemented include (a) periodical staff training, retraining, and competency evaluation, (b) describing the importance of SOPs and blood transfusion process flow in the institution monthly induction program for doctors and nursing including the newcomers, (c) maintenance of error register and its daily review by blood bank medical officers, (d) appointment and training of transfusion nurses at each hospital floors including operations theater complex and emergency department, and (e) induction of automation in blood bank cross-match laboratory for compatibility testing. Thus, error reporting not only helps in accurate collection and analysis of data but also makes recommendations that improve transfusion safety.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]