We describe a completely preventable wrong patient blood transfusion in which a patient was administered another patient’s blood, collected as autologous-salvaged blood (ASB) during cardiac surgery. We review the root cause investigation (RCA) and highlight the systems issues that emerged and the corrective actions implemented in our hospital to prevent similar adverse incidents.
Transfusion Safety
The history of blood supply is one of early, sobering frequency of disease transmission but also remarkable improvement in systems safety in terms of correct blood transitions that is free of infectious agents. Blood product safety has been an improving area of focus for many countries over recent decades6. Several methods have been employed to reduce the risk of blood transfusions and improve blood product administration safety7. The entire blood harvesting and transfusion process has been redesigned from before blood donation collection through post-procedure follow-up of blood product recipients. There have been improvements made in the collection, storage, management, distribution, utilization, and monitoring of transfusions.
Transfusion System Infrastructure
The clinical laboratory is one of the most highly regulated services in the hospital, and the transfusion service is one of the most highly regulated services within the clinical laboratory. The pathway of blood delivery is inherently complex because multiple patient care areas are involved. The goal of the blood delivery pathway is to deliver the right product to the correct patient8. The pathway can be summarized by three simple steps:
1) Identify the patient with two unique identifiers (ID).
2) Connect the patient identifiers to all prepared lab samples, tests, and blood products.
3) Deliver the right blood product to the right patient at the right time, confirming patient ID again.
These three simple steps comprise numerous processes, each with its risk of failure. The highest rates of failure are associated with processes outside of the clinical laboratory.
Risk of ABO-Incompatible Transfusions and Hemolytic Reactions
The risk of fatality due to an ABO-mismatched red blood cell transfusion could therefore be estimated at 1 to 4 per 10,000,000 for each red blood cell unit transfused9. But fatal reactions represent the ‘tip of the iceberg’ as most ABO-incompatible near miss transfusions involve small volumes due to early clinical signs/symptoms and often patients survive10.
The risks of a lethal hemolytic transfusion reaction were estimated at 1 per 550,000 units transfused for the time period 1976–1985 in the US11. Not all hemolytic reactions are ABO-related and not all wrong transfusion events result in adverse clinical outcomes. Others have estimated that 1 in every 19,000 units of red blood cells is transfused to the wrong patient each year, 1 in 76,000 transfusions results in an acute hemolytic reaction, and 1 in 1.8 million units of transfused red blood cell units results in death due to acute hemolytic reaction12.
When estimating risk, the best information available indicates that most transfusions to the wrong patient occur as a result of potentially avoidable system failures13. The most frequent error leading to transfusion of ABO-incompatible blood occurs during patient identification/verification at the bedside; as a result, although the blood is labeled appropriately, it is transfused to someone other than the correct recipient.
Root Cause Analysis of this Case
A linkage diagram (Fig. 1) and root cause analysis of events (Table 1) were developed to link a problem statement to conditions and actions.
Table 1
Root cause analysis of events and its application to understanding this case.
Root cause
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Application to the case
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Communication problems
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The blood salvaged during operation of patient Y was not shared within the Cardiovascular Surgery department, Thoracic surgery department and among the nurses. Most of them were unaware that patient Y's blood was being stored postoperatively. Errors occurred in perception and cognition.
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Patient Y's blood was not discarded on 1 POD as policies dictate, nor was its presence shared among the nurses or even within the Cardiovascular Surgery department.
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Inadequate information flow
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Instructions for blood salvaging were not clearly communicated through either verbally or in writing. Nurses did not communicate with other nurses or physicans about their concerns regarding Patient Y's condition and questions regarding blood salvage protocols.
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Human factors problems
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Since collected blood devices was not equipped with a dedicated label, the patient's name was written directly on the red transfusion bag with black magic marker. In addition to this, Nurse D could not recognize that the blood was from the wrong patient because the intensive care unit in the evening was dimly lit and the visibility was poor. Nurse D, who was requested by Nurse C, the nurse in charge of Patient X, to retrieve the blood in the cold storage, was in a hurry because the patient's condition was unstable.
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Patient-related issues
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The patient was transferred to the ICU after a lengthy surgery, and his blood pressure was unstable.
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Organizational transfer of knowledge
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Nurse D did not know that the Intensive Care Unit had two cold fridges for storing blood.
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Staffing patterns/worl flow
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The reason for this is that the intensive care unit was always busy, and the duties of the lead nurse were shared among several staff members. The division of duties was the reason why labels were not applied, blood was not checked per hospital policies, and entries were not made in the logbook, nor was their absence noticed. However, in the patient were stable, and providers could have taken more time to check the blood for correct identify and follow hospital policy.
Multiple healthcare provider teams were involved in the care of the patients, also contributing to communication challenges.
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Technical failures
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Both the physicians and nurses on site assumed that the only blood collected was that of patient X. They did not know that patient Y's blood was stored. Therefore, they connected the blood to IV line, and administered it to the patient without doing the necessary checks.
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Inadequate policies and procedures
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The Surgery department did not issue an order to discard the blood on the following day. This was due to the lack of a written procedure and the unfamiliarity of the Thoracic surgeons.
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Intraoperative salvaged blood should have been placed in a dedicated basket with a note attached with the patient's name and ID, and placed in cold storage. However, this was not attached.
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The blood in the cold storage was supposed to be checked twice a day by the lead nurse and recorded in the management log. However, there was no record of these activities.
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It is against hospital policy to salvage blood products in cold storage where the temperature is controlled by the Blood Transfusion Service.
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The Blood Transfusion Service was unaware that intraoperative blood collections were kept away from patients and stored in cold storage. Therefore, the operating room and ICU were unable to question the blood collection procedure of the operating room and intensive care unit.
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The transfusion department could not question the blood salvage procedures in the operating room and intensive care unit because they were unaware that intraoperative salvaged blood was kept away from the patient and stored in cold storage.
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The central operating department and intensive care units were in a position to correct such misuse, but they did not have written procedures for handling intraoperative blood collection and did not exercise proper governance.
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The basket containing Patient Y's blood did not have a note attached with the name and ID, the pack did not have a dedicated label.
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Table legend:
Patient X: Patient underwent cardiac surgery. Blood type was O, Rhesus (Rh) D-positive.
Patient Y: Patient underwent lung surgery. Blood type was A, Rhesus (Rh) D-negative.
POD: Postoperative day
ICU: Intensive Care Unit
ID: Identification
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These charts identified a number of factors that predisposed the system to errors and revealed multiple contributing factors, including communication problems, human factors problems, inadequate policies and procedures, cultural problems, etc14. The downstream effects of the errors lead to the wrong blood reaching the patient’s bedside and serious patient outcome.
Initially, the cause of this accident appears to have been a simple case of rule violation, as the blood was administered by a nurse without checking the name against the blood bag label15. However, identifying this as the cause and taking measures to prevent recurrence, such as double-checking the patient details, may not improve the system16–18 and could leave the possibility of recurrence in the future. Therefore, the investigation committee searched for system errors at a deeper level.
Nurse B's action in "administering the wrong infusion" was considered a possible cause of human error, which was investigated using an RCA (see below). Human error is defined as the failure of planned actions to achieve their desired ends without the intervention of some unforeseeable events, and it is not the cause of the accident; it is the factor that causes the human to make the error that is the cause of the accident19. Human behavior is the result of a combination of human and environmental factors, known as the Lewin’s Eq. 20 or the SHELL model21. This could also be considered via the accident analysis. Figure 1 shows an extract from the RCA. Two factors, human and environmental factors, are involved in Nurse C's behavior. The unique actions of Nurse C are shown on the bottom, and the environmental factors are shown on the top.
First, we consider the human factors22. We explored the reasons why Nurse C believed that the blood bag in her hand belonged to Patient X. The probable background factors were that the: 1) fact that autologous salvaged blood from multiple patients were stored in a single refrigerator in the ICU and that this information was not shared among the staff; 2) patient’s ID and name were handwritten on the bag after collection, not labeled; and 3) barcode matching system was not applied to the salvaged blood as it was not managed by the Blood Transfusion Service.
Next, the environmental factors were discussed. The cause of Patient Y's blood being passed into the hands of Nurse C as Patient X's blood was discussed. The probable background factors for how Patient Y's blood was in the hands of Nurse C were as follows: 1) the blood collected from multiple patients was stored in multiple refrigerators in the ICU; 2) the patient’s name and other information were not written on the basket as required when storing the blood bag in the refrigerator; and 3) the thoracic surgeon who salvaged the blood from Patient Y was not familiar with blood salvage protocols and did not make a decision within 24 hours to use or discard the blood. Due to these factors, Nurse C administered the blood, believing that the blook in her hand belonged to Patient X, when in fact it belonged to Patient Y. The investigation committee determined that the "intraoperative salvaged blood, without starting to administer before leaving theatre, and bringing the bag to the ICU," was the root cause of this event.
Corrective and Preventative Action Plan
The investigation committee believed that measures addressing violations of the confirmation process by the staff, background factors such as lack of information sharing, and compliance failures in storage and destruction of bags, while critical, would not have completely prevented this from recurring. Therefore, measures to prevent a recurrence were focused on the upstream root causes, which included how intraoperative salvaged blood was managed. Transfuse salvaged blood is generally recommended to be given in the operating room but it is not prohibited to given it outside the operating room. However, to prevent mix-ups, it is necessary to start the administration in the operating room. The draft guidelines for the Implementation of Transfusion of Autologous Salvaged Blood (2020) by the Japanese Society for Autologous Blood Transfusion indicates that “in principle,” administration should be started in the operating room23. At our hospital, we decided to go one step further and require starting all ASB administration in the operating room without exception. Additionally, regulations have been established regarding the recording of blood salvage, labeling of bags, and instructions for administration and disposal, which have been casual and not clearly stated. These regulations will be managed by the Blood Transfusion Service of the hospital.
In conclusion, we investigated a serious adverse incident in which intraoperatively salvaged blood was transfused to another patient with a different blood type. This unfortunate event occurred because the protocol for the management of intraoperatively salvaged blood was not clearly defined, and the procedure was different from that of standard transfusion products. There were some unexpected events, such as the presence of the salvaged blood from other patients at the same time, as well as inadequate and ambiguous information sharing among the parties involved. We developed a system improvement strategy in which intraoperative blood collection would be administered before the patient leaves the operating room in order to completely prevent a recurrence, instead of simply requiring front-line staff to check or double-check the blood compatibility.