**4. The operational aspects of EBT**

Implementation of a software-driven bar code tracking system in place of the conventional "nurse to nurse" double check system for the administration of blood products has been identified as a key strategy for improving transfusion safety [9]. The bar code on blood components identifies blood group, blood type, unit of blood, product number, and the date of collection [9, 10]. Several companies offer a bar code electronic identification system (EIS) which may be portable or built into the electronic medical system [11]. A portable handheld scan and print electronic device can be used to verify and document patient identity. Such a device is utilized at our institution [11]. The common components of the pre-transfusion check list to be scanned include the patient name, medical record number, and blood group [11]. If the bar codes between the patient wristband and blood products match, then the handheld device indicates as such [11]. The bar code EIS is linked to a network host computer that can store, search, and send transfusion data [11]. Multiple studies have indicated that the electronic bar code system is effective in reducing human error related to transfusion procedures as it acts as another barrier for error in the transfusion process [10]. In a time-sensitive event such as a massive transfusion protocol, safety checks including barcoding EIS may be omitted. This may reintroduce transfusion-related human error, such as incorrect blood product adminis-

**Figure 1.** Serious hazards of transfusion (SHOT) best practice flowchart.

Current research is exploring the use of smartphone or tablet devices in transfusion medicine with the aim of achieving enhanced integrity of the transfusion process [10]. In addition, systems utilizing radiofrequency identification (RFID) are being analyzed as a new way of integrating technology into blood transfusion best practice. However, high costs for an institution can be a barrier [10, 11]. RFID is a more user-friendly technology and can be applied to improve visual and bar code electronic identification systems [11, 16]. Radiofrequency transponder microchips have been utilized on patient wristbands, blood sample tube labels, and

tration to the recipient.

130 Vignettes in Patient Safety - Volume 3

The operational aspects of EBT present many challenges that can be overcome by planning and employing best practices. These challenges include describing how to recognize, initiate, and alert others to an EBT. A hospital system must also decide on what kind of blood products to store and how to prioritize select products when they are in high demand. In addition, determining where to store blood products and deciding how to transport them to the bedside require careful planning, especially when faced with multiple concurrent patients requiring EBTs. Personnel should also be trained on how to resuscitate patients while waiting for the arrival of blood products.

The first step in any EBT starts with the attending provider recognizing the need to transfuse. Common indications for EBT include an elevated Assessment of Blood Consumption (ABC) score, the presence of visible rapid blood loss such as that seen in postpartum hemorrhage, or the observation of even moderate blood loss in the setting of comorbidities such as low cardiopulmonary reserve. This list is not exhaustive. The ABC score is calculated by assigning a score of one to each parameter present: penetrating injury, positive focused assessment sonography for trauma (FAST), systolic blood pressure of 90 mm Hg or less, and an elevated heart rate of at least 120 beats per minute (**Table 1**). An ABC score of 2 or higher is 75% sensitive and 86% specific for predicting the need for massive transfusion (MT) [19].

After recognizing the need for transfusion, the second step in an EBT is to alert the blood bank. Our institution offers two levels of response to an EBT: emergency blood release (EBR) and an elevated response level of "code crimson" (CC). Either is initiated by a medical provider dialing a simple hotline—"5555" at our institution—that is answered immediately by the emergency operator. Notification of an EBR arrives in the blood bank via an alphanumeric


**Table 1.** Assessment of blood consumption score.

pager alert. By contrast, a CC is initiated by an overhead announcement broadcast throughout the hospital, alerting support personnel from anesthesia, surgery, trauma, intensive care, and emergency medicine to move toward assisting resuscitation of the patient. Either level of response can be initiated by pre-hospital professionals such as paramedics, transporting a hemorrhaging trauma patient.

If the seal of a poorly maintained container is compromised, the leak can enter into the system tubing. Cleanup of a contaminated PTS system is a non-trivial task. Another limitation of PTS containers is that they arrive only in the vicinity of the patient and still require a runner for final transport to the bedside. A final concern with a PTS is that once a container enters the tubing system, the acceleration and speed of the system exerts at least some hemolytic effect [23].

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In concurrent emergency transport of blood products for two or more patients, separate pneumatic tube containers or separate runners must be used to carry blood products for each patient. Runners should be instructed to avoid exchanges along their route to the patient. The requirement of a unique runner for each patient can be challenging to meet during off-peak

During the interval between recognition for the need of EBT and the arrival of blood products, medical personnel should work to prepare the patient for transfusion. The airway needs to be assessed and protected. Vital signs should be measured. If possible, an attempt should be made to correct the underlying etiology of the hemorrhage. Tourniquets should be applied to the bleeding wounds of trauma patients, packing should be used to tamponade bleeding surgical patients, and uterotonic agents should be administered in cases of postpartum hemorrhage. A blood sample should be collected to facilitate a type and cross-match, though providers should expect at least a 45-min wait time for the screen to be completed. Large bore needles should be inserted to establish intravenous access. A baseline set of hemoglobin, platelets, electrolytes including calcium, a calculated anion gap, creatinine, lactate, prothrombin time, partial thromboplastin time, and fibrinogen level should be drawn [21]. The patient should be warmed to help stop the development of a coagulopathy. Depending on the clinical situation, volume resuscitation using intravenous fluid boluses may be judiciously used. The infusion of a crystalloid may dilute the remaining platelets and coagulation

The next step in an EBT lies in the administration of emergency blood products from the responding blood bank. Two different patient identifiers, such as hospital identification number and patient name, should be used by medical personnel to confirm the patient identiy [24].

While many different transfusion protocols exist, warmed erythrocytes, fresh-frozen plasma, and platelets are commonly transfused at a 1:1:1 ratio. Some centers have added 6–10 units of cryoprecipitate to their MBT practice to aid repletion of low fibrinogen levels [25]. However, there is a lack of high-quality randomized trials to show improved outcomes with the use of cryoprecipitate to raise fibrinogen levels [26]. The FDA's approval of the human fibrinogen concentrate drug RiaSTAP (CSL Behring, King of Prussia, PA) has been investigated in the off-label setting of MTP [27]. A second similar drug—Fibryna (Octapharma, Lachen, Switzerland)—was approved by the FDA in 2017. Further clinical trials are needed to establish whether human fibrinogen concentrates improve outcomes in severe hemorrhage featur-

Irrespective of the products transfused, the rate of infusion is a prime concern. Rapid infusers such as the RI-2 (Belmont Instruments, Billerica, MA) inductively warm and infuse blood at selectable rates of up to 1000 mL/min. This speed can surpass the loss in a postpartum hemorrhage patient, in whom at term blood perfuses the placental site at a rate of 500–700 mL per minute [25].

times when staffing levels are reduced.

factors as well as cause hypothermia.

ing hypofibrinogenemia.

Selecting which blood products to offer is an important decision made well before an alert is initiated. While regional blood bank centers can effectively offer continuous availability and supply of blood products to local hospitals—even at times of disaster [20]—there may be occasions when the hospital runs low on specific products, such as platelets or Rhesus negative blood. With only a small minority of the US population exhibiting an O negative blood group, the finite supply of O negative blood may dwindle in the face of ongoing massive transfusion. Switching to O positive blood reserves a minimal supply of emergency O negative blood for obstetric patients or other women of reproductive age who may need blood before depleted stocks can be replenished. This forethought helps prevent alloimmunization-associated problems in future pregnancies [21]. Aside from O negative blood, another scarce blood product is platelets. Though they can be used for up to 5 days after collection, the effective life of a pack of platelets is just 1–2 days by the time the collection is processed, tested, packaged, and transported from the regional blood bank to the hospital. Hospital blood banks can now take advantage of the Platelet PGD test (Verax Biomedical, Marlborough, MA) approved by the FDA in 2015 to extend the life of platelets by an additional 2 days, dramatically reducing the waste and expense of these products.

Once an EBT is initiated, the next consideration at some institutions is to determine which blood bank will respond. Close proximity to blood products is desirable, though not universally feasible. Many hospitals in America feature several hundred beds [22] that are spread across medical, surgical, obstetric, operative, intensive care, emergency, and trauma areas. A large campus with many buildings may have satellite blood stores. Attempts to minimize time and distance to blood products via the setup of decentralized blood refrigeration units add cost, complexity, and forgoes the expertise offered by specialized blood banking personnel during the early stages of an emergency transfusion.

After the appropriate blood bank has been alerted, the transport of emergency blood products to the patient requires a transport protocol. At our institution's centralized blood bank, an EBR utilizes a pneumatic tubing system (PTS) to move a maximum of two units of ice-packed erythrocytes, whereas a CC uses a human transporter—a "runner"—with a cooler. The cooler contains six units of iced erythrocytes, four units of thawed fresh-frozen plasma, and a single unit of platelets. Subsequent coolers are prepared regularly until the CC is terminated. The number of runners and their speed is the limiting factor in bringing blood to the patient, not the rate of cooler preparation. A PTS is faster than a runner [23], moving at up to 25 feet per second, often taking a route that is more direct than what is achievable by hallways and stairwells. PTS performance can be further enhanced with priority signaling or the use of dedicated tubing channels to patient areas that frequently require EBT, such as the emergency department.

Though advantageous in some ways, the PTS also has disadvantages. The dimensions and weight capacity of PTS containers can be limiting, with six containers needed to carry the cargo of a single cooler. Though rare, leaking blood product packaging can seep into the container. If the seal of a poorly maintained container is compromised, the leak can enter into the system tubing. Cleanup of a contaminated PTS system is a non-trivial task. Another limitation of PTS containers is that they arrive only in the vicinity of the patient and still require a runner for final transport to the bedside. A final concern with a PTS is that once a container enters the tubing system, the acceleration and speed of the system exerts at least some hemolytic effect [23].

pager alert. By contrast, a CC is initiated by an overhead announcement broadcast throughout the hospital, alerting support personnel from anesthesia, surgery, trauma, intensive care, and emergency medicine to move toward assisting resuscitation of the patient. Either level of response can be initiated by pre-hospital professionals such as paramedics, transporting a

Selecting which blood products to offer is an important decision made well before an alert is initiated. While regional blood bank centers can effectively offer continuous availability and supply of blood products to local hospitals—even at times of disaster [20]—there may be occasions when the hospital runs low on specific products, such as platelets or Rhesus negative blood. With only a small minority of the US population exhibiting an O negative blood group, the finite supply of O negative blood may dwindle in the face of ongoing massive transfusion. Switching to O positive blood reserves a minimal supply of emergency O negative blood for obstetric patients or other women of reproductive age who may need blood before depleted stocks can be replenished. This forethought helps prevent alloimmunization-associated problems in future pregnancies [21]. Aside from O negative blood, another scarce blood product is platelets. Though they can be used for up to 5 days after collection, the effective life of a pack of platelets is just 1–2 days by the time the collection is processed, tested, packaged, and transported from the regional blood bank to the hospital. Hospital blood banks can now take advantage of the Platelet PGD test (Verax Biomedical, Marlborough, MA) approved by the FDA in 2015 to extend the life of platelets by an

additional 2 days, dramatically reducing the waste and expense of these products.

nel during the early stages of an emergency transfusion.

department.

Once an EBT is initiated, the next consideration at some institutions is to determine which blood bank will respond. Close proximity to blood products is desirable, though not universally feasible. Many hospitals in America feature several hundred beds [22] that are spread across medical, surgical, obstetric, operative, intensive care, emergency, and trauma areas. A large campus with many buildings may have satellite blood stores. Attempts to minimize time and distance to blood products via the setup of decentralized blood refrigeration units add cost, complexity, and forgoes the expertise offered by specialized blood banking person-

After the appropriate blood bank has been alerted, the transport of emergency blood products to the patient requires a transport protocol. At our institution's centralized blood bank, an EBR utilizes a pneumatic tubing system (PTS) to move a maximum of two units of ice-packed erythrocytes, whereas a CC uses a human transporter—a "runner"—with a cooler. The cooler contains six units of iced erythrocytes, four units of thawed fresh-frozen plasma, and a single unit of platelets. Subsequent coolers are prepared regularly until the CC is terminated. The number of runners and their speed is the limiting factor in bringing blood to the patient, not the rate of cooler preparation. A PTS is faster than a runner [23], moving at up to 25 feet per second, often taking a route that is more direct than what is achievable by hallways and stairwells. PTS performance can be further enhanced with priority signaling or the use of dedicated tubing channels to patient areas that frequently require EBT, such as the emergency

Though advantageous in some ways, the PTS also has disadvantages. The dimensions and weight capacity of PTS containers can be limiting, with six containers needed to carry the cargo of a single cooler. Though rare, leaking blood product packaging can seep into the container.

hemorrhaging trauma patient.

132 Vignettes in Patient Safety - Volume 3

In concurrent emergency transport of blood products for two or more patients, separate pneumatic tube containers or separate runners must be used to carry blood products for each patient. Runners should be instructed to avoid exchanges along their route to the patient. The requirement of a unique runner for each patient can be challenging to meet during off-peak times when staffing levels are reduced.

During the interval between recognition for the need of EBT and the arrival of blood products, medical personnel should work to prepare the patient for transfusion. The airway needs to be assessed and protected. Vital signs should be measured. If possible, an attempt should be made to correct the underlying etiology of the hemorrhage. Tourniquets should be applied to the bleeding wounds of trauma patients, packing should be used to tamponade bleeding surgical patients, and uterotonic agents should be administered in cases of postpartum hemorrhage. A blood sample should be collected to facilitate a type and cross-match, though providers should expect at least a 45-min wait time for the screen to be completed. Large bore needles should be inserted to establish intravenous access. A baseline set of hemoglobin, platelets, electrolytes including calcium, a calculated anion gap, creatinine, lactate, prothrombin time, partial thromboplastin time, and fibrinogen level should be drawn [21]. The patient should be warmed to help stop the development of a coagulopathy. Depending on the clinical situation, volume resuscitation using intravenous fluid boluses may be judiciously used. The infusion of a crystalloid may dilute the remaining platelets and coagulation factors as well as cause hypothermia.

The next step in an EBT lies in the administration of emergency blood products from the responding blood bank. Two different patient identifiers, such as hospital identification number and patient name, should be used by medical personnel to confirm the patient identiy [24].

While many different transfusion protocols exist, warmed erythrocytes, fresh-frozen plasma, and platelets are commonly transfused at a 1:1:1 ratio. Some centers have added 6–10 units of cryoprecipitate to their MBT practice to aid repletion of low fibrinogen levels [25]. However, there is a lack of high-quality randomized trials to show improved outcomes with the use of cryoprecipitate to raise fibrinogen levels [26]. The FDA's approval of the human fibrinogen concentrate drug RiaSTAP (CSL Behring, King of Prussia, PA) has been investigated in the off-label setting of MTP [27]. A second similar drug—Fibryna (Octapharma, Lachen, Switzerland)—was approved by the FDA in 2017. Further clinical trials are needed to establish whether human fibrinogen concentrates improve outcomes in severe hemorrhage featuring hypofibrinogenemia.

Irrespective of the products transfused, the rate of infusion is a prime concern. Rapid infusers such as the RI-2 (Belmont Instruments, Billerica, MA) inductively warm and infuse blood at selectable rates of up to 1000 mL/min. This speed can surpass the loss in a postpartum hemorrhage patient, in whom at term blood perfuses the placental site at a rate of 500–700 mL per minute [25].

In addition to the use of fibrinogen-rich medications or cryoprecipitate, anti-fibrinolytics also play a role in EBT. Tranexamic acid can safely reduce the risk of death in both trauma and obstetric-related hemorrhage [28, 29]. The drug must be administered within 3 h of bleeding onset. It is associated with a minimal adverse event rate [28].

outcomes can be continuously improved [34]. Such methods are highlighted in the *Joint Commission Sentinel Alert* publication that recommends the adoption of protocols to address,

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There are many advantages to developing high-fidelity simulations. They include establishing a safe environment for patients and trainees, the opportunity for multidisciplinary team training, and the rehearsal of specific behavioral skills. In addition, simulations allow the difficulty levels of scenarios to escalate, providing multiple exposures to complex clinical scenarios. Simulators also allow the testing and learning of new technologies without exposing the patients to learning-associated risk [36]. High-fidelity simulators also allow individuals to train on demand rather than waiting for an uncommon or very specific situation to occur. Simulations allow for pause, discussion, feedback, and reflection in response to certain circumstances, as well as the

Though uncommon, transfusion-associated adverse events can occur in the emergency setting. In response, programs have been established that track these events. The goals of these programs are to ultimately improve patient safety by minimizing the morbidity and mortality of transfusion procedures. The programs also serve to identify emerging complications, including errors and near misses, as well as pathogens associated with blood transfusion. One such surveillance protocol is the National Healthcare Safety Network Biovigilance Component Hemovigilance (NHSN HV) module [38]. This module can be used by any US health-care facility where blood components and products are transfused. Participation requires a comprehensive surveillance of patients and blood components throughout the transfusion process, from product receipt until patient administration. In addition, the reporting of all adverse transfusion reactions and associated incidents that occur for patients transfused at the studied facility is required. By participating in the module, health-care facilities can use data entered into the National Healthcare Safety Network to monitor adverse reactions and events. This allows for better identification of areas requiring intervention and to modify pre-

for example, morbidity and mortality associated with maternal hemorrhage [35].

opportunity to identify and correct recurrent mistakes in an expedited manner [37].

vention strategies that reflect the specific needs of a particular health-care facility.

equipment, policies, and training that can be used to manage and mitigate such risks.

Like other tertiary-care centers, our hospital system has implemented an MTP designated as "code crimson" to facilitate the rapid availability of blood products when persistent hemodynamic instability occurs in a patient, among other indications. In line with our institution's initiative for continuous quality improvement, departmental risk assessments and safety management plans have been enacted. This program requires managers of departments with unique risks to assess their department's risk profile and submit a summary of safety guidelines to the safety and security manager of their campus. This call for ongoing quality improvement allows for brainstorming sessions with physicians and staff to identify risk and to determine the methods,

**8. St. Luke's University Health Network: blood transfusion** 

**7. Error tracking systems**

**information**

Different solutions exist for bleeding while anticoagulated on warfarin. The prothrombin complex concentrate drug Kcentra (CSL Behring, King of Prussia, PA) can reverse coagulation factor deficiency induced by a vitamin K antagonist faster than fresh-frozen plasma [30].

Determining when to stop transfusing can also be challenging. An i-Stat device (Abbott Point of Care Inc., Princeton, NJ, USA) should be avoided if possible [31]. Evaluating the response to transfusion can be achieved via a serum hemoglobin value 15 min after transfusion. Other reassuring laboratory values include a platelet count greater than 50,000/μL, an international normalized ratio (INR) of less than 1.5, or a fibrinogen level greater than 100 mg/dL. Ultimately, the normalization of the patient's hemodynamic status in conjunction with visible signs of hemostasis should signal the medical provider to terminate the code crimson. Alternatively, the recognition of the futility of resuscitation should also be viewed as a terminal end point. Upon termination of the blood transfusion, unused blood products should be returned to the blood bank for refrigeration and storage. The blood products transported by runners or the PTS are continuously monitored thermally to ensure the integrity of returned, unused products.
