|Home | About | Journals | Submit | Contact Us | Français|
The U.S. blood supply is safer today than at any time in history, thanks to advances in donor screening, improved viral marker tests, automated data systems, and changes in transfusion practices.1 Although the risks associated with blood transfusion continue to decrease, errors are still being made. In Virginia, for example, a patient who switched beds with her roommate to be near the window died after the hospital gave her a blood transfusion with her roommate’s blood type. At a Pittsburgh-area veteran’s hospital, a Navy veteran died after receiving a plasma transfusion of the wrong blood type. The FDA said that his blood sample was apparently switched accidentally with another patient’s without a confirmation test.
Fortunately, not all faulty transfusions result in death. Blood transfusions cause tens of thousands of noninfectious adverse reactions in hospitalized patients annually, stated Dr. Matthew Kuehnert, MD, FACP, Director of the Office of Blood, Organ, and Other Tissue Safety at the Centers for Disease Control and Prevention (CDC).
According to the FDA, the leading causes of transfusion-related fatalities from 2005 to 2009 were transfusion-related acute lung injury (TRALI), totaling 48%; hemolytic transfusion reactions, non-ABO (blood type), 16%; microbial infections, 10%; hemolytic transfusion reactions (ABO), 12%; transfusion-associated circulatory overload, 11%; and anaphylaxis, 3%.1
Sometimes transfusion reactions are difficult to prevent because of the way in which biologic products interact with humans, said Barbee Whitaker, PhD, Director of Data and Special Programs for AABB (the American Association of Blood Banks) in Bethesda, Maryland. She explained:
While hospitals do have very careful practices for typing a patient’s blood and cross-matching the patient with the unit, there can be an unknown antibody that the patient may have that causes an adverse event. Or if patients have received several transfusions in their lifetime and [have] developed multiple antibodies—these situations can be quite complex. These are not the fault of the hospital; it just shows how complex matching can be before a transfusion can occur. But let me be clear: ABO errors are always preventable.
The actual percentage of adverse events occurring within the estimated 5.3 million patients receiving transfusions annually in the U.S. is unknown because hospitals have not organized an effort to count them, as European countries have been doing for many years.2
“The U.S. is the only developed country that does not have an established method to track and monitor adverse events associated with blood transfusion on a national level,” said Dr. Whitaker.
That all changed this past February with the Hemovigilance Module, a joint project between the CDC, the AABB, and any hospital that wants to volunteer to follow the protocol and submit data on adverse events to the CDC. Launched within the National Healthcare Safety Network (NHSN), the CDC will review the national data in collaboration with AABB and other partners to identify ways to improve the safety of blood transfusions. The NHSN is an Internet-based surveillance system that already allows health care–associated infection data to be tracked and analyzed and enables the CDC and health care facilities to maximize prevention efforts.
This module represents the first release of the Biovigilance Component of the CDC’s NHSN and is now being used to monitor adverse events and quality-control incidents related to blood transfusions. Future modules will be used to collect data to improve outcomes in organ, tissue, and cellular therapies, said Dr. Kuehnert.
“Until February 2010, transfusion-related events and incidents were monitored by facilities on their own,” he stated. “This new module may enable CDC to identify the rate of adverse transfusion reactions related to ABO incompatibility.”
The CDC provides the module at no cost to hospitals and health care facilities, and it provides participating facilities with training and ongoing user support, also at no cost. To date, 20 to 25 hospitals are participating, including nine that launched the pilot project last year, said Dr. Whitaker.
University Hospitals Case Western Reserve is one of the original nine volunteer hospitals in the U.S. Biovigilance Network (BVN). As part of its efforts, Dr. Katharine Downes, who provides medical leadership and guidance for the participation and involvement of University Hospitals Case Medical Center, in the U.S. Biovigilance Project, explained that she and her team report all transfusion reactions into the U.S. BVN, including TRALI (a potentially life-threatening complication and adverse reaction following the transfusion of blood products).
The first TRALI fatality was reported to the Center for Biologics Evaluation and Research (CBER) in 1992. Since then, CBER has received more than 45 reports of TRALI fatalities. By the year 2000, this represented 13% of all transfusion fatalities. TRALI is thought to be the third leading cause of transfusion-related deaths. Most of the deaths were associated with fresh-frozen plasma transfusions; fewer fatalities were caused by packed red blood cell transfusions and platelet transfusions. In most cases, follow-up donor antibody screens implicated donors who were multiparous females testing positive for anti-HLA or antigranulocyte antibodies. Nonfatal TRALI events are also on the increase.3
“The Biovigilance Network is a way to get a snapshot of the transfusions adverse event issues in the U.S., determine gaps in practice, and help define a standard set of practices to improve patient care,” said Dr. Downes.
Health care facilities that join the Hemovigilance Module will now have a yardstick by which to measure their current safety initiatives and see how their performance stacks up compared with similar facilities nationwide.
“There is a lot of good information sharing about adverse events,” said Dr. Whitaker. “And this can be done in a nonpunitive environment.”
Dr. Kuehnert commented, “The ultimate objective is to create an organized effort that defines adverse events, counts them, and finds ways to prevent them.”
Counting and preventing errors has not been easy. The FDA estimates that 414 blood transfusion errors occur annually; in one study, nearly 80% of these were related to bedside or labeling errors.4 A bar-coding system for blood administration can reduce errors by as much as 90%. Point-of-care bedside bar-coding applications are being integrated with blood product administration activities to combine patient identification, medication, and product verification, according to a patient-safety white paper released last year.5
This is the type of research being conducted at Georgetown University in Washington, D.C. The school is considered a pioneer in researching bar coding and radiofrequency identification (RFID) for reducing errors related to blood transfusions, with its work dating back to the early 1970s. Georgetown University Hospital has evaluated the potential of radiofrequency (RF) transponder chips to help standardize and document key steps in collecting blood and performing transfusions.
According to S. Gerald Sandler, MD, Professor of Medicine and Pathology and Director of Transfusion Medicine at the university, passive RF transponder microchips were placed on patients’ wristbands, blood sample tube labels, and blood component containers to prompt hospital nurses through the key identification steps in sample collection and transfusion. Nurses scanned the chips with hand-held portable personal data terminals and uploaded the data to software programs that alerted operators to missteps. The software program did not move forward unless each function was performed according to programmed specifications.
Although RF has proved to be a viable way of confirming blood unit matching at the bedside before transfusion, Dr. Sandler is quick to point out that technology is not a replacement for caregivers knowing their patients.
“The event described earlier in this report about the patient switching beds and ultimately receiving her roommate’s blood would not have happened if the caregiver visually knew her patients,” he commented.
A white paper5 highlights how Hamilton Medical Center in Dalton, Georgia, has also deployed a patient-safety strategy that uses bar-code technology to prevent identification errors associated with phlebotomy services. The staff was handling more than 1,000 specimens daily. By labeling specimen containers at the bedside, the staff at the 282-bed hospital hoped to eliminate the potential for errors as well as inefficiencies with manually printing, sorting, and organizing labels in the laboratory. Phlebotomists now collect samples and generate labels intended for each patient at the bedside by using a mobile thermal printer and a personal digital assistant (PDA) device.
The hospital reported that the CareFusion system has saved staff members an average of 45 minutes per day, because they no longer have to return to the laboratory for additional labels; new tests are simply updated through the PDA. Turnaround times have improved and the number of repeated blood samplings has decreased, helping to lower the overall cost of care. By printing labels one at a time at the point of care, Hamilton has virtually eliminated the possibility of applying the wrong label to the wrong specimen.
The hospital has also expanded its use of bar coding to the blood bank to ensure that the correct patient receives the correct blood product. Laboratory Manager Nichole Shoemaker explained:
When the nurse picks up the blood unit from the blood bank, the unit is scanned. When the unit is brought to the patient, the patient’s armband is scanned to make sure [that] the patient and the unit are a match. If they aren’t, the system will catch the error and alert the nurse. If they are a match, the transfusion takes place, and the system can identify when the process started and ended and exactly which units were used.
Since the implementation of bar coding in 2003, there have been no misidentification errors, she added.
Making sure that the right patient receives the right product is definitely the goal at All Children’s Hospital, based in St. Petersburg, Florida. The hospital has adopted the BloodSafe Tx hand-held software application, which enables the staff to verify patient identification and to validate blood and transfusion specifications at the patient’s bedside. The system is fully integrated with blood bank software to enable clients to share data about the patient, the transfusion, and blood use with the electronic medical record (EMR) or other core hospital systems. The hand-held applications also run on the same device as the hospital’s other mobile nursing applications, which can reduce the number of tools each nurse needs to manage.
Pat Hughes, the hospital’s acting Chief Nursing Officer and Director of Accreditation and Licensure, stated:
Using this tool provides us a tremendous advantage in blood safety. This makes us more efficient, speeds up our identification, and ensures [that] we get the right blood to the right patient. It will also enable us to efficiently capture information at the bedside that can be shared with other information systems or the EMR.6
The deployment of the product is part of the hospital’s strategic plan to apply technology to improve process-oriented procedures in patient care. For example, remote-release refrigerators store blood securely in high-use areas of the hospital. The refrigerators interface with the transfusion software to match and dispense the right blood for each patient electronically.
Dee McMichael, Blood Bank Supervisor, states:
It’s critical that we monitor blood and transfusions at every step of the process. [These] refrigerators have been very effective in improving the productivity of our lab staff as well as improving the safe accessibility of blood. The addition of [the software] takes the safety controls one step further …. This includes real-time notifications in the blood bank whenever there is a transfusion reaction so we can immediately step into action.
The Blood and Tissue Bank of Balearic Islands (Foundació Bank de Sang i Teixits de les Illes Balears [FBSTIB]) on the island of Mallorca, Spain, is using an ultra-high-performance (UHP) RFID-based, hemo-derivative blood bag tracking application to improve efficiency, reduce errors, enhance visibility, and bolster security within its supply chain. High-density containers with more than 80 blood bags each are virtually read instantaneously, even on liquids in high-moisture, frozen environments. The organization provides more than 42,000 units of lifesaving blood to all public and private hospitals on the islands each year.7
According to Joseph Muncunill, MD, and FBSTIB’s Chief Executive Officer:
Maintaining inventory control, security, and plasma quality accuracy has always been a challenge for blood banks. Bar codes are currently still being used, but often the bar code label is crumpled or covered in a thick layer of ice during quarantine, making the plasma bag unreadable. When we have upwards of 40,000 plasma bags in our inventory chamber and a medical emergency requires us to find the correct plasma bag as quickly as possible, the quality and speed of our data capture system is of the utmost importance. We required a method to both reduce time consumption and labor intensity in order to track down the correct plasma or very unique hematite bags in inventory. The UHP inlay onto each bag has greatly simplified both our inventory control process, security, and quality management systems.
The system is slated to go live in September 2010 if integration is completed as planned.
Whether it’s technology or a national accounting system, the ultimate goal is to develop a transfusion process that is secure and safe for patients.
Dr. Whitaker said, “I don’t know how efficient technology will be because we don’t have any baseline yet. We’re just at the cusp of using these new technologies to reduce errors and adverse reactions. It’s like having new glasses. We will see the system in a whole new way.”
Dr. Sandler commented, “With regard to RFID, we must be cautious about recognizing that they cannot completely replace caregivers and that RFID should be used as a double-check method only. Add to this the work that the Biovigilance Project is doing, and we are taking that extra step forward in ensuring public health safety.”