Vol. 15 •Issue 7 • Page 22
Legal Aspects of Transfusion Medicine
Determining if an error was made and assigning responsibility is only part of the solution.
More people die of medical errors in the United States than from motor vehicle accidents, HIV or breast cancer.1 Medical errors kill an estimated 100,000 people per year and are the eighth most frequent cause of death in this country. Because of heightened awareness of hospital errors and the critical nature of transfusion testing, mistakes by transfusion services often result in formal inquiries, with serious disciplinary and legal consequences. Blood bankers must understand how legal and administrative bodies approach human error and how responsibility for injuries is assigned.
Table 1 shows the frequency of common adverse events associated with transfusion.2 Fortunately, most of the listed reactions have a benign clinical course. Most also are attributable to technical limitations of testing. The fact that an adverse event has occurred is not proof that an error was made.
Table 2 shows a breakdown of morbidity and mortality associated with transfusion.3 Infusion of an incorrect blood component is the most frequent cause of transfusion-associated morbidity and mortality and is virtually always associated with human error.
Linden reported on why incompatible blood gets transfused,4 noting that 58 percent of errors occurred outside the blood bank, 25 percent occurred inside, and 17 percent of cases had errors both in and outside the laboratory. Failure to properly identify the patient, issuing blood of the wrong group, failure to match the product to the recipient and clerical mistakes were the most common errors.
Investigative Elements
Five elements should be reviewed when legal bodies investigate medical errors:
1. severity of outcome,
2. the presence of human error,
3. negligence,
4. recklessness and
5. intentional rule breaking.
Investigators always consider severity of outcome important, and often this feature is given undue weight. Marx defines the four other features that legal bodies consider when evaluating medical errors.5 These are presented in Table 3.
The following examples illustrate how these concepts apply.
Scenario 1. A blood banker is temporarily distracted on her way to remove two directed donor units from the refrigerator. When she resumes her duties, she removes two allogeneic units instead. While dispensing the units, another technologist gets a computer warning that directed donor units are on hold. Surgery is delayed while the directed donor units are prepared.
Analysis. Human error occurred because the technologist set up allogeneic blood instead of directed donor blood. She was negligent because a reasonably cautious professional would have performed differently. She is not guilty of reckless conduct because she did not intentionally put the patient at risk. No rules were broken and impact on the patient was minimal.
Scenario 2. An ED nurse checks a patient’s requisition and armband before drawing blood. She knows that hospital procedures require labeling specimens at the bedside, but she takes the tubes and labels to the ward clerk and asks her to finish the labeling.
While this is going on, another nurse comes by the desk with another unlabeled tube and the clerk mistakenly affixes the first patient’s label to the other patient’s specimen. The mislabeled sample is used to crossmatch red cells, and the patient has a moderately severe hemolytic transfusion reaction when transfused.
Analysis. Mislabeling the tube was a human error. There was negligence because professionals are expected to get labeling right. Intentional rule violation was present. It is arguable whether the RN is guilty of reckless conduct. Labeling tubes in the manner she did was dangerous; however, the mislabeling was inadvertent and the RN did not perceive a significant and unjustifiable risk. The error resulted in a severe complication.
Scenario 3. A technologist has to antigen type 2 units for a patient, and because it is late in the shift and he doesn’t want to quality control a new lot of reagents, he uses a lot that has expired. Later in the week, the patient has a workup for possible delayed hemolytic transfusion reaction. The technologist retrieves his original paperwork and alters it to show that he used in-date reagents.
Later, a co-worker discovers the alteration and reports it to her supervisor. Repeat antigen typing of the segments from the involved units shows that the original antigen typing results were correct. Delayed hemolytic transfusion reaction workup was negative and the patient suffered no adverse consequences.
Analysis. No human error was involved. The technologist was negligent because he failed to perform his duties as expected. He is guilty of reckless conduct because he intentionally placed the patient at increased risk. Finally, there was intentional rule breaking in the falsification of records and ignoring of laboratory directives.
Dealing With Transfusion Error Incidents
How should these incidents be dealt with? Scenario 1 is an example of a “dumb mistake,” one that could happen to anyone. The manager should look for underlying system problems that contributed to the error (e.g., too many distractions). The case should be discussed with the laboratorian, but disciplinary action is not necessary. Punishing simple mistakes is not considered an effective management strategy unless the individual has a history of repeated errors of similar type.
Scenario 2 is an example of rule breaking, resulting in a serious injury. The observation that a second unlabeled tube arrived simultaneously at the clerk’s desk suggests that labeling tubes away from the bedside is a common practice. Many institutions develop cultures where bending rules is commonplace, and singling out one individual for punishment is unlikely to fix the underlying problem.
Because an act of negligence directly led to patient injury, both the RN and the hospital are at risk for being sued. Defending the RN would be problematic because of the rule-breaking. The hospital is also at risk due to its failure to enforce safe practices.
Scenario 3 is an example of reckless behavior. The individual is unlikely to be involved with the courts because no injury resulted from his actions. It can be argued that, of the three examples given, this individual is the most in need of discipline. His cover-up of illicit activity aggravates the situation and amounts to an admission of guilt. Falsification of records is a common mistake when individuals sense trouble. Disciplinary action is appropriate.
Assigning Blame Not ‘Be All and End All’
The focus of legal and disciplinary systems on assigning blame often works at cross-purposes with efforts to reduce errors and improve quality. Fear of punishment has the unwanted effect of preventing error reporting and seriously impairs quality improvement efforts. A “blame-free workplace” with uninhibited error reporting is the cornerstone of effective quality improvement programs, but often remains an unattained ideal. Unfortunately, we live in litigious times and fear of punishment is not always irrational.
References
1. American Hospital Association. Hospital Statistics. 1999, Chicago.
2. Linden JV. Errors in transfusion medicine. Scope of the problem. Arch Path Lab Med 1999;123( 7):563-565.
3. Williamson LM. Serious hazards of transfusion (SHOT) initiative: Analysis of the first two annual reports. BMJ 1999;319:16-19
4. Linden JV. Transfusion errors in New York State: An analysis of 10 years’ experience. Transfusion 2000;40:1207-13.
5. Marx D. Patient safety and the “just culture”: A primer for health care executives. Medical Event Reporting System–Transfusion Medicine (MERS-TM), 2001. Accessed March 6, 2003 at www.mers-tm.net/support/Marx_Primer.pdf.
Tables
Find the tables referred to in this article beginning the Wednesday after publication at www.laboratorian.advanceweb.com by clicking on “Figures and Tables” then the title of the article.
Dr. Scanlan is assistant professor, Pathology Department, and director, Transfusion Medicine, at Oregon Health Sciences University, Portland.
