Case A8: Severe Hemolytic Transfusion Reaction Involving a Student
Case Study A8 was motivated by a case involving a student medical laboratory technologist during internship in a transfusion service.
This case study is partly fictionalized to include educational enhancements designed to emphasize learning points related to technical errors, root cause analysis, legal concepts, risk management, and student training.
This case's format is different from typical serologic cases (which focus on a patient's laboratory and clinical data and the resulting serologic investigation). Instead, various issues related to the case are discussed, along with links to external resources.
The case is relevant for all health professionals (practitioners, students, and educators).
Upon completion of this exercise, participants should be able to:
Define root cause analysis (RCA) and describe typical steps in an RCA investigation
Discuss ways to categorize human errors as causes of transfusion-associated adverse events
- Regarding risk management:
- Provide a definition and explain its relationship to quality management
- Describe how risk management typically functions in a hospital setting
- Discuss disclosure of unanticipated outcomes as part of risk management
- Differentiate between disclosure of an unanticipated outcome and an admission of liability
- List and describe four elements of negligence
State the standard of conduct to which health professional students are legally held
Explain the legal importance of student supervision
Describe regulations and standards involving:
- reporting of serious adverse events
- disclosure of unanticipated patient outcomes
- provision of patient care by student health practitioners
This case concerns an adverse event involving a medical laboratory technology student in the transfusion service (TS) of a large tertiary care hospital. The student was being supervised by an experienced, exemplary technologist who was also responsible for working on the bench and processing routine work. The TS laboratory performs antibody screens using gel technology followed by an electronic crossmatch for patients who lack clinically significant antibodies.
The lab's policy is to initially supervise students very closely and then, depending on performance (which is documented daily), to gradually allow students to perform with less supervision. Regardless of the intensity of supervision, the policy requires that supervising technologists always read the results of student tests.
The student was in the second week of a 6-week TS rotation. On the day in question the student did gel antibody screens on a batch of 5 patients in the late afternoon.
One of the 5 patients had a positive (3+) antibody screen ("Patient A") but, because blood was not ordered and unlikely to be required for the type of surgery, the patient specimen was set aside for antibody identification the next day.
One of the 4 patients with a negative antibody screen ("Patient B" - an 70-year old male scheduled for liver resection for metastatic colorectal cancer) had an electronic crossmatch performed for 3 units of RBC.
Early the next morning Patient "B" was transfused with 2 units of RBC.
When the morning shift began in the laboratory, an antibody identification panel on Patient A was unexpectedly negative, as was the repeat antibody screen. Antibody screens were then repeated for all patients in the batch and one (Patient B) was positive. Patient B was later found to have an anti-Fya and anti-c.
Immediately upon discovering the mix-up and positive antibody screen on patient B, the ward was contacted to stop any transfusion in progress, to inquire about Patient B's condition, and to monitor him for signs of a possible hemolytic transfusion reaction (HTR). Subsequently, Patient B was found to be experiencing a severe HTR and the TS medical director was consulted to help manage it.
Investigating the cause
The student and supervising technologist were questioned in private, both individually and together, by the medical director and laboratory supervisor. The student could not recall making an error and thought that patient plasma had been pipetted correctly for each patient. The supervising technologist recalled not seeing the student actually pipette patient plasma into the gel cards but did read the results of all indirect antiglobulin tests (IATS) in the batch.
By chance, staff were able to retrieve gel cards from the biohazard garbage and identify that Patient B had less volume than usual in the antibody screen tests, consistent with no plasma having been added. The conclusion was that there was a pipetting error in which Patient B's plasma was not added to Patient B's gel antibody screen cards but rather to Patient A's tests.
Patient B died.
The hospital's Risk Management Office was contacted and the chief counsel discussed the case with the TS medical director and Patient B's physician.
A series of group meetings were held with the TS laboratory supervisor, student, supervising technologist, and TS clinical instructor all being present.
Chief Medical Examiner was notified and investigated the death.
The TS medical director disclosed and explained what had happened to the patient's family.
For educational purposes this case will discuss:
Basics of root cause analysis
Ways to categorize errors
Basic concepts of risk management
Elements of negligence
Standard care expected of students
Student supervision during clinical training
Standards related to reporting serious adverse events and provision of patient care by student health practitioners
To test your knowledge and as an advance organizer for the discussion section, read and consider these questions:
What is root cause analysis (RCA)? What types of adverse events merit RCA?
List examples of errors in the TS laboratory that can cause severe transfusion-related adverse events.
What is the purpose of risk management? Is it about avoiding litigation or improving quality of patient care or both?
What conditions must be present for negligence to occur?
Are staff who supervise students liable for errors made by students?
Are there standards related to what types of adverse events must be reported and to whom? Give an example.
Proceed to Discussion (includes interactive questions with feedback):
- Part 1: Root cause analysis
- Part 2: Testing errors
- Part 3: Risk management
- Part 4: Supervision of students
- Part 5: Regulations and standards
This case involves a transfusion-related death that was disclosed to the patient's family and involved a student error.
The Medical Examiner's investigation concluded that the patient's condition was such that he would have died even if the incompatible RBC were not transfused, but that the transfusions and resulting transfusion reaction likely contributed to death happening faster.
The student who made the pipetting error was closely observed for the remainder of the internship and passed her clinical rotation.
The supervising medical technologist had acted within the framework of training in the department. Missing the abnormal volume in the gel card was deemed an inadvertent human error for which the technologist was not disciplined.
TS Laboratory ("The System")
The transfusion service laboratory (leadership and staff) reviewed its processes for training and supervising students and new staff, its process for performing batch testing; the timing of follow-up investigations, and related risk management issues. Some processes were found to be suitable and others were changed to improve the system.
Despite the hospital lacking a policy of error disclosure, the medical director of the transfusion service, in consultation with the patient's physician and risk management office, and in the presence of a member of the facility's patient support team, disclosed and explained what had happened to the patient's family.
The patient's family conveyed to the medical director that they appreciated the honesty in explaining what had happened. After two years (the statute of limitations on law suits for personal injuries in the hospital's location), the family had not filed a law suit.
This quiz is offered as a self assessment.
Most medical errors are due to latent errors. What are latent errors?
Does root cause analysis (RCA) apply to near misses or only to actual adverse events?
RCA has several purposes. Which purpose is missing from the following list? To identify:
How it happened
Why it happened
Human errors can be classified in many ways. Why is it important to classify errors into distinct categories?
Provide two main goals of risk management.
Why is disclosure of medical errors controversial?
List four essential elements of negligence from a legal perspective.
What standards of conduct are student health professionals held to legally?
Can health professionals be held legally responsible for errors made by students they are supervising?
- Do blood safety standards include:
- reporting of serious adverse events?
- disclosure of unanticipated outcomes to patients?
Callum JL, Kaplan HS, Merkley LL, Pinkerton PH, Rabin Fastman B, Romans RA, et al. Reporting of near-miss events for transfusion medicine: improving transfusion safety. Transfusion 2001;41:1204?11.
Kaplan HS, Callum JL, Fastman BR, Merkley LL. The medical event reporting system for transfusion medicine: Will it help get the right blood to the right patient? Transfus Med Rev 2002 Apr.;16(2):86-102.
Myhre BA, McRuer D. Human error-a significant cause of transfusion mortality. Transfusion 2000 Jul;40(7):879-85.
Siegenthaler MA, Schneider P, Vu DH, Tissot JD. Haemovigilance in a general university hospital: need for a more comprehensive classification and a codification of transfusion-related events. Vox Sang 2005 Jan;88(1):22-30
Barach P, Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. Br Med J 2000;320: 759.
Berry DB. The physician's guide to medical malpractice. Proc (Bayl Univ Med Cent) 2001 January; 14(1): 109–112.
Butters JM, Strope JL. Legal standards of conduct for students and residents: implications for health professions educators. Acad Med 1996 Jun;71(6):583-90.
Chassin MR, Becher, EC. The wrong patient. Ann Intern Med 4 June 2002 Jun2;136(11):826-33.
Hébert PC, Levin AV, Robertson G. Bioethics for clinicians: 23. Disclosure of medical error. CMAJ 2001 Feb 20; 164 (4).
Hurwitz B. Legal and political considerations of clinical practice guidelines. Br Med J 1999 Mar 6;318:661-4.
Kuhn AM, Youngberg BJ. The need for risk management to evolve to assure a culture of safety. Qual Saf Health Care 2002;11:158-62.
Lawton R, D Parker D. Barriers to incident reporting in a healthcare system. Qual Saf Health Care 2002;11:15-8.
Liang BA. A system of medical error disclosure. Qual Saf Health Care 2002;11:64-8.
Phillips E. Managing legal risks in preceptorships. Can Nurse 2002 Oct;98(9):25-6.
Online Tools and Resources
Canadian Standards Association. Blood and blood components (Z902-15).
Clinical risk management (Royal Children's Hospital; Melbourne, Australia)
Canada: TTISS (Transfusion Transmitted Injuries Surveillance System - Archived)
UK SHOT Program
Washington University. Teaching module. Talking about harmful medical errors with patients.