Double standard for double ABO grouping?

H.S. was a 59-year-old female admitted to a university hospital October 1, 1974, for a total hip replacement. Otherwise, she was in good health. Presurgical testing on a single specimen labeled with her name and medical record number revealed her to be blood group A. No historical ABO group result was available. During surgery she initially received 2 units of group A red blood cells (RBCs). Subsequent to this transfusion episode, considerable bleeding was observed in the surgical field, accompanied by hypotension. The bleeding was attributed to surgery, and the hypotension was attributed to the bleeding. Two additional units of group A RBCs were transfused. Shortly thereafter, H.S. developed profound hypotension and fulminant disseminated intravascular coagulation. Obvious hemoglobinuria was observed. A specimen was obtained and again the ABO group was determined to be A. (In fact, the transfused cells were being grouped, and her anti-A had been sufficiently absorbed onto these cells to no longer be detectable.) Additional RBCs were ordered for transfusion, and two more group A units were transfused. At this point, the on-call pathologist suggested ABO grouping a preoperative specimen held in the chemistry laboratory, obtained at a different time from the one that had been originally sent to the blood bank. The RBCs in this specimen were group O. H.S. rapidly developed renal failure. After several dialysis procedures, she made an apparently complete clinical recovery and was discharged. Subsequent investigation revealed that H.S. had been sleeping when the phlebotomist arrived to obtain the presurgical specimen for the blood bank and had asked the other patient in the room whether she was H.S., to which this latter individual responded affirmatively. From this moment forward, all presurgical blood bank procedures were followed correctly, and H.S. was destined to receive ABO-incompatible RBCs. In the intervening 35 years since the foregoing true event occurred, this scenario has been repeated in one form or another a great many times throughout the world. Not all patients are as fortunate as H.S. to escape death or major, permanent organ morbidity from transfusion errors. Indeed, data from the US Food and Drug Administration document that ABO mishaps remain one of the leading causes of transfusion-related death year after year. During this time, enormous effort has been devoted to defining and preventing the microbial risks of blood transfusion. For example, from the early 1980s to the present in the United States, the risk of transmitting the human immunodeficiency virus by blood component transfusion has been reduced approximately 10,000-fold.1, 2 In contrast to this striking success, there is no evidence that the risks of mistransfusion have appreciably decreased overall. This problem has been well documented to be international in scope.3-5 While accrediting organizations located in the United States have taken steps to reduce the likelihood of mistransfusion, few institutions have adopted measures such as electronic identification systems that link the patient, the patient specimen, and the blood component to virtually assure that mistransfusion does not occur or have implemented mechanical barrier systems designed for the same purpose.6 The problem of mistransfusion has not gone unnoticed. The National Quality Forum has included “death/disability associated with incompatible blood” as a “never event,” and the Centers for Medicare and Medicaid Services has proposed restricting payment for such occurrences.7 The College of American Pathologists has included a Phase II checklist requirement (TRM 40670) that a recipient's ABO group be verified by repeat ABO testing of the sample, a different sample, or a historical search of the laboratory's records when a computer cross-match is performed.8 TRM 30575 (Phase I requirement) requires the facility to have a plan to implement a system to reduce the risk of mistransfusion for nonemergent RBC transfusions.8 AABB Standards for Blood Banks and Transfusion Services also requires (Standard 5.15.2.2) two determinations of the recipient's ABO group, one on a current sample and the second one by retesting the same sample, by testing a second current sample, or by comparison with previous records when a computer crossmatch is used.9 In distinction to these requirements, which are restricted to the use of a computer crossmatch, AABB Standard 5.12 requires the ABO group of each whole blood and RBC component be confirmed by a second test performed by the transfusion service before transfusion.9 Interestingly, the United Network for Organ Sharing has promulgated an absolute requirement (UNOS Policy 3.1.4) for two determinations on two separate samples, taken at different times, of a prospective solid organ allograft recipient's ABO group.10, 11 Thus, while no licensing or accrediting agency requires two separate ABO results on prospective recipients before blood transfusion, other than when a computer crossmatch is used, AABB Standards do require that two determinations be made on donor RBC components. Is this double standard reasonable? What is done in practice? One of us (PDM) conducted a University HealthSystem Consortium (UHC) e-mail survey of ABO grouping practices in April 2009. It must be emphasized that the respondents are a self-selected group of UHC hospitals and that no information was obtained on whether a computer crossmatch was used. Of 42 responses received, 26 institutions require two ABO group determinations when no historic group is available; these may be performed on a single specimen. Fifteen of the 42 respondents require two ABO tests on two different samples when no historic record is available. One responding institution requires one ABO test on one tube with no repeat testing. Some respondents limit the repeat testing to non–group O patients, whereas others include group O patients in the repeat testing, thus further ensuring the likelihood of plasma compatibility. In this issue of TRANSFUSION, Goodnough and coworkers12 present in detail the implementation of a two-specimen requirement for the verification of a patient's ABO group and Rh type in the absence of an historic record. This procedural change was not instigated as the result of a particular adverse event or “near-miss” occurrence, but rather was based on what the authors concluded was an appropriate response to error rates in patient identification and specimen labeling identified by their quality program. This practice change was implemented in a carefully planned stepwise approach, including educational interventions and the development of customized algorithms, over a 12-month period. Of note, the authors recommend the first ABO/Rh determination for patients likely to require transfusion should be completed early in care so that, when transfusion is required, a “historic” result is already available. As long as this practice is confined to patients with a high likelihood of transfusion, the policy is not likely to be wasteful of resources. The authors disclose that error rates remained approximately the same after implementation of the new procedures and that their initiative was designed to neutralize rather than correct errors. In the first few months after implementation, two ABO-incompatible transfusions were averted. While they did not experience a burdensome increase in the provision of group O, Rh-negative blood after implementation, or in patient service complaints, they did document an increase in turnaround times for stat testing and acknowledge the need for additional employees and automated instruments as a result of this initiative. On balance, they feel that the change was manageable and worthwhile and that it may continue to be necessary even with the implementation of electronic identification systems, owing to human error even with system improvements. A critical view of this work would emphasize the costs associated with the implementation of this protocol in that it required a considerable investment in full-time equivalents and equipment at a time of universal budgetary restraint. As noted, it also lengthened stat turnaround times and did not significantly improve sample collection performance. Others have addressed this issue. Kaplan13 has described a near-miss event reporting system to afford early detection of weaknesses leading to possible mistransfusion. Figueroa and colleagues14 and Cserti and colleagues15 have both described longstanding policies that require transfusion of group O RBCs if an ABO determination has not been completed on at least two separate samples. They concluded that such a policy is both feasible and capable of preventing mistransfusions at their tertiary-care hospitals. For those institutions undertaking a policy that in some fashion requires two specimens for ABO grouping, Goodnough and coworkers provide a thorough and clear plan for implementation. But is this policy right for everyone? And if all hospitals were to take this path, couldn't this put substantial strain on the supply of group O RBCs, for which there is already a disproportionate demand? How should a hospital decide whether or not to implement a two-sample collection procedure? There can be no doubt that more attention needs to be given to proper specimen collection and patient identification for pretransfusion samples. Proper patient identification has remained the single top priority of the Joint Commission on Accreditation of Hospitals for several years. We believe that the time for a national performance standard for the critical process of pretransfusion sample collection is long overdue. Standard-setting organizations, such as AABB and the College of American Pathologists, would be well advised to establish a minimum standard for the proportion of patient samples that are correctly collected and labeled. Proper sample collection is fundamental to accurate diagnosis throughout laboratory medicine, and pretransfusion testing offers a valuable readout on overall hospital performance in patient identification. This is important because previous work by Lumadue and colleagues16 documented that an incorrectly labeled sample carries a 40-fold higher chance of being miscollected. Two recent innovations offer a new opportunity to establish national performance standards for pretransfusion testing. A recent publication used routine principles of statistical process control to monitor the frequency of wrong blood in tube (WBIT) specimens.3 The authors suggested that the aggregate regional frequency of WBIT specimens could be obtained by combining results of WBIT monitoring conducted in individual hospitals operating under the same general blood bank standards. By combining results from sentinel hospitals, a sufficient sample size can be monitored to obtain a realistic estimate of national performance. This combined average performance could be used to establish a current minimal performance standard and, with ongoing monitoring, could be adjusted as new technology is introduced to improve patient identification. The promulgation of a national standard for the performance of pretransfusion sample collection would have far more direct bearing on patient safety than many of the technical standards that populate current blood bank laboratory practice. A pretransfusion performance standard would give hospitals a signal regarding whether or not to implement a two-specimen ABO policy such as the one described by Goodnough and colleagues.12 For example, if a facility practicing a one-sample policy finds that their current performance exceeds the national standard, then there would be little need to change practice. However, if a hospital using a one-sample policy found that its pretransfusion performance was below the standard, then a thorough review of the sample collection process and a change to the sample collection procedure should be undertaken until follow-up monitoring documented that a return to compliance had been achieved. Changes to the process could include, but would not be limited to, the use of a two-sample testing format. A second innovation was recently introduced in Quebec where the blood bank computers that store patient ABO blood group results have been linked. Thus, a patient whose blood group was previously determined at Hospital “A” and who now presents to Hospital “B” will have his first-time sample from Hospital “B” automatically compared to previous results at Hospital “A.” After implementation of this regional database, there was a significant decrease in the frequency of hemolytic events due to both ABO and non-ABO causes. Additionally, MacIvor and colleagues17 showed that access to a centralized patient database encompassing 16 hospitals detected 38% more ABO grouping errors and prevented six mistransfusions during an 18-month period. These would not have been prevented by using information at single institutions. In addition to the establishment of a national standard based on actual performance data obtained from sentinel hospitals and to the implementation of linked computer systems, other changes can improve the safety of blood transfusion for patients. These include new technologies that make it easier to label samples at the bedside with data taken directly from the wristband18 as well as structural changes to the health care system that make it unnecessary for patients without health care coverage to use the health care identity of insured individuals. While the implementation of extra sample collection and testing within the laboratory may be the correct solution for some facilities, we believe that ultimately the greatest single step to improve transfusion safety will be for practitioners in transfusion medicine to feel direct ownership and responsibility for the performance of processes related to blood transfusion that occur at the bedside. Until we fully embrace the responsibility for vein to vein patient safety, taking leadership of these efforts away from nursing services and the clinical staff, we will have overlooked our greatest opportunity for success. The authors thank Mrs Frances Parsons for excellent administrative support in the preparation of the manuscript. Dr Mintz serves as Chair of the Scientific Advisory Board for Immucor Corporation. Dr Dzik has no potential conflicts of interest to declare.

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