your lab focus CE Update [blood banking/transfusion medicine | management/administration and training | immunology]

Errors in Transfusion Medicine

David A. Sauer, MD,1 Clark E. McDonald, MD, FASCP,2 and Lynn Boshkov, MD, PhD1 From the 1Department of Pathology, Oregon Health Science University, and 2Department of Pathology and Laboratory Medicine, Portland Veterans Administration Medical Center, Portland, OR On completion of this article, the reader should be able to identify the major causes of transfusion error and describe corrective actions designed to reduce the risks of erroneous transfusion. Blood banking/transfusion medicine exam 0104 questions and the corresponding answer form are located after the Your Lab Focus section, p 213.
Causes of transfusion error and points in the process where they occur Methods to reduce the risk of transfusion errors

the goal of having redundant checkpoints is to catch these errors before transfusion. Investigations Into the Problem In a review of 355 transfusion-related deaths reported to the US Food and Drug Administration (FDA) between 1976 and 1985, Sazama1 concluded that wherever errors could be made in the transfusion process, errors occurred. After excluding 99 deaths that were unrelated to transfusion or that involved transfusion-related hepatitis or AIDS, Sazama noted that of the remaining 256 reported deaths, most (51%) resulted from acute hemolytic transfusion reactions (AHTR). These instances followed transfusion of ABO-incompatible products; most commonly patients with blood group O received group A RBCs. Other cases involved acute pulmonary injury (15%), bacterial contamination (10%), delayed hemolysis (10%), damaged product (3%), and graft-vs-host disease (0.4%). Sazama1 found that one third of all transfusion-related deaths and two thirds of all incompatible RBC transfusions were the result of preventable errors. She estimated that between 1976 and 1985, 100 million units of RBCs were transfused to 30 million patients with a total death rate of 0.5 to 1.0 per 100,000 patients (average number of RBC units received, 3.5). Other authors2 have estimated that the incidence of ABO-incompatible transfusions is 1 per 33,000, while the fatality rate is 1 per 600,000 RBC transfusions. These calculations in-

Human error is a nearly constant component of human involvement in any complicated task. In clinical and laboratory medicine, considerable time and expense is invested in instituting policies and procedures, including detailed and often redundant patient and specimen identification and test result verification, for the specific purpose of minimizing human error. Despite such intensive measures, human errors continue to occur at a seemingly irreducibly small rate in medical practices, sometimes with catastrophic results. Transfusion medicine is unique among clinical laboratory services in that the end result is the delivery of a biologic product that may be both life saving and capable of causing death. The production and delivery of this product may involve many people in several different areas of the hospital. In tertiary care hospitals, as many as 10 different laboratory and medical professionals are involved in the complex process of blood transfusion. Many steps are involved, including physician orders, patient identification for specimen collection by nursing or phlebotomy staff, blood bank workup, product selection and issue, patient identification for transfusion, and ultimately the administration of the blood products to the patient by nursing or physician staff. Errors can and do occur at any point along the way;

dicate the magnitude of morbidity and mortality associated with transfusion errors and belie the public concern and enormous quality assurance efforts made by blood suppliers to prevent the much less frequent instances of transfusiontransmitted infectious disease. In a report of 104 transfusion errors occurring during the transfusion of 1,784,600 units of RBCs in New York State between January 1, 1990, and October
Transfusion Error Sources
Outside blood bank Failure to correctly identify patient

T1
43% 1% 58%

Phlebotomist error (eg, venipuncture on 11% wrong patient) Order sent with incorrect patient name, 3% no identification at bedside Emergency transfusion Subtotal Blood bank and other hospital service Blood issued for another patient, and error not noted at bedside Incorrect order, and error not noted in blood bank Subtotal Involving blood bank only Incorrect blood group issued Incorrect typing, technical error Incorrect typing, clerical error Incorrect specimen used for testing Subtotal Total 11% 7% 6% 1% 25% 100% 15% 2% 17%

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 your lab focus Case of Rh Incompatibility

A 74-year-old man, blood type O negative and antibody screen negative, was admitted with an acute gastrointestinal hemorrhage and a hematocrit value of 13% (0.13). The blood bank crossmatched 6 units of O-positive packed RBCs, of which 3 units were released (by 2 different technologists). These 3 units were checked, signed off, and uneventfully transfused by 2 different pairs of nurses on the ward during the evening and overnight shifts. The following morning, a routine blood bank inventory revealed the 3 remaining O-positive units on the O-negative shelf and an investigation was initiated. The investigation revealed that both blood bank technologists had independently issued Rh-incompatible blood and that the blood bank computer software alarm system that alerts in the event of such errors had been previously inactivated. Two pairs of nurses on different shifts had checked in, signed off on, and transfused the Rh-incompatible units. The incident was reviewed with the involved blood bank and nursing staff and the following corrective actions were taken: (1) the blood bank computer software was updated and the alarm system reactivated; (2) checklists were generated for the transfusion service and nursing staff; and (3) new in-service training schedules for the blood bank and nursing staff were instituted.
Recommendations to Reduce the Risk of Transfusion Errors

1. Hospitals should mandate the verification of patient identity, specifically including current identification of the patient compared with concurrent identification of product and intended recipient. Frequent in-service instruction to ensure compliance should be provided. 2. Protocol should mandate close monitoring of the patient during the first 10 to 20 minutes of transfusion. Transfusion staff should receive in-service training on the signs and symptoms of transfusion reactions, how to initiate early intervention, and submitting specimens and materials necessary for completing a transfusion workup.

T2

3. Training and frequent education should be provided to phlebotomy staff responsible for drawing blood bank specimens. Hand labeling of specimens at the patients bedside should be mandatory. 4. Blood products should be released only after the receipt of a written request with patients name and medical record number. 5. Special attention should be given to problems of transfusion in: (1) the operating room where a common blood product refrigerator is used for multiple simultaneous surgeries; (2) the emergency department where multiple unidentified patients may present simultaneously; (3) the intensive care unit where transfusion staff may become so familiar with patients that identification verification lapses; (4) outpatient transfusion services. 6. The simultaneous issuing of products for different patients on the same ward should be minimized. 7. Written guidelines should be provided addressing technical details of transfusion, including filters, transfusion rates, appearance of normal products, use of blood warmers, and intravenous fluids that may be administered with blood products.
Adapted from Sazama1 and Linden et al.2

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31, 1991, Linden et al2 noted that errors occurred at all steps of the transfusion process. Importantly, most transfusion errors occurred at the patient bedside and were attributed to either phlebotomy error (11%) or failure of nursing or physician staff to properly identify the patient and/or unit prior to transfusion (43%). Such errors included failure of phlebotomy personnel to properly identify the intended recipient, incorrect label placement on the phlebotomy specimen, or administration of a properly identified and released unit of blood to the wrong patient owing to inadequate preadminis-

tration verification. Blood banks alone were responsible for 25% of the transfusion errors, while the blood bank and other hospital services shared involvement in the remaining 17%. Within the blood bank, errors included issuing the wrong blood group (11%); incorrect blood typing, technical error (7%); incorrect blood typing, clerical error (6%); and wrong patient specimen used for typing (1%) [T1]. In her review, Sazama1 noted that managerial system errors involving proper written procedures and personnel training account for a greater proportion of transfusion errors than do clerical errors involving failure to properly observe and record information. Sazama emphasized that ordinary safeguards and standard operating procedures, such as verification of proper patient and product identification, were overlooked or ignored in more than one half of fatalities secondary to transfusion of an incompatible blood product. She noted that implementation of and strict adherence to explicit written procedures for hospital-wide transfusion practice may reduce such errors. The procedures

would be accompanied by regular inservice training addressing the distribution, handling, use, and administration of blood products as well as monitoring of adherence. She concluded that until every transfusion center has written procedures by which each transfusionist views blood with as much caution as any deadly drug, these mistakes will continue.1 Tourault and Mummert,3 expanding on Sazamas work, reviewed 150 transfusion-related fatalities reported to the FDA from 1990 to 1992. They determined that approximately one third of the fatalities could have been prevented by adherence to standard operating procedures, while noting that transfusion of ABO-incompatible RBCs continues to be the primary cause of preventable death in the transfusion setting. Tourault and Mummert concluded that these deaths may have been prevented had facilities: (1) accurately identified the patient; (2) recognized and responded to signs of transfusion reaction; (3) verified that the equipment used in blood transfusion (eg, blood warmer) functioned correctly;

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 your lab focus

(4) trained employees to follow the standard operating procedures manual. Linden and Kaplan4 emphasized that rapid identification of transfusion errors (especially AHTR) as well as properly identifying the cause of such errors and implementation of corrective actions are critical steps in the reduction of transfusion-associated fatalities. They cited previous work2 and recommended a number of strategies that may decrease the risk of AHTR. A modified version of these recommendations, including suggestions put forth by Sazama,1 is provided in [T2]. Conclusion Erroneous transfusion of ABO-incompatible blood is the most prevalent transfusion error and almost always reflects a preventable breakdown in transfusion protocol and standard operating procedure. These errors can have disastrous outcomes, accounting for significant iatrogenic morbidity and mortality. While most transfusion errors occur at the patients bedside and thus are remote from the blood bank and the immediate oversight of the transfusion service director, the hospital-wide implementation and enforcement of transfusion policies can

help minimize the risk and occurrence of transfusion errors.

1. Sazama K. Reports of 355 transfusionassociated deaths: 1976 through 1985. Transfusion. 1990;30:583-590. 2. Linden JV, Paul B, Dressler KP. A report of 104 transfusion errors in New York State. Transfusion. 1992;32:601-606. 3. Tourault MA, Mummert TB. Review of transfusion related fatalities: many preventable. Hosp Technol Scanner. 1993;11:1-3. 4. Linden JV, Kaplan HS. Transfusion errors: causes and effects. Transfus Med Rev. 1994;8:169-183.