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Case Study A8: Severe Hemolytic Transfusion Reaction Involving a Student 

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NOTES  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). - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

• Learning outcomes

• Original case scenario

• Questions to be considered

• Discussion

• Summary

• Quiz

• Further Reading

LEARNING OUTCOMES

Upon completion of this exercise, participants should be able to

1. Define root cause analysis (RCA) and describe typical steps in an RCA investigation
2. Discuss ways to categorize human errors as causes of transfusion-associated adverse events

3. Regarding risk management:

   1. Provide a definition and explain its relationship to quality management

   2. Describe how risk management typically functions in a hospital setting

   3. Discuss disclosure of unanticipated outcomes as part of risk management

   4. Differentiate between disclosure of an unanticipated outcome and an admission of liability

4. List and describe four elements of negligence 

5. State the standard of conduct to which health professional students are legally held

6. Explain the legal importance of student supervision

7. Describe regulations and standards involving 
   1. reporting of serious adverse events
   2. disclosure of unanticipated patient outcomes
   3. provision of patient care by student health practitioners

ORIGINAL CASE SCENARIO

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. DAY ONE 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. DAY TWO 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. DAY THREE Patient B died.  FOLLOW-UP  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.  The Chief Medical Examiner was notified and investigated the death.  The TS medical director disclosed and explained what had happened to the patient's family.

GOALS OF THIS CASE STUDY 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 of care expected of students Student supervision during clinical training  Standards related to  reporting serious adverse events provision of patient care by student health practitioners

QUESTIONS TO BE CONSIDERED 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.

DISCUSSION

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

SUMMARY

This case involves a transfusion-related death that was disclosed to the patient's family and involved a student error. 

Medical Examiner. 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.

Student. The student who made the pipetting error was closely observed for the remainder of the internship and passed her clinical rotation

Clinical supervisor. 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.

Medical Director.  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.

Patient's family. The patient's family conveyed to the medical director that they appreciated the honesty approach 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.

FINAL QUIZ 

• This quiz is offered as a self assessment. 

1. Most medical errors are due to latent errors. What are latent errors?

2. Does root cause analysis (RCA) apply to near misses or only to actual adverse events?

3. RCA has several purposes. Which purpose is missing from the following list? To identify:

   1. What happened 

   2. How it happened 

   3. Why it happened 

4. Human errors can be classified in many ways. Why is it important to classify errors into distinct categories?

5. For each of the following MERS-TM error category, match each concrete example with the most appropriate error category.  (An error category may have none, one, or more than one example associated with it.)

 

Error category	Examples
rule-based: coordination Lack of task coordination within healthcare team	technologist fails to add anti-D to Rh typing test tube
knowledge-based Inability of individuals to apply existing knowledge to a novel situation	nurse fails to confirm patient identity before starting transfusion
rule-based: verification Failure to correctly assess a situation, including related patient conditions and materials to be used, before beginning a task	physician fails to notify lab that patient is on fludarabine thinking that pharmacy has already done so
skill-based: slip Failures in performing highly developed skills	nurse fails to take patient's vital signs following completion of transfusion
rule-based: monitoring Monitoring of process or patient status	phlebotomist pre-labels patient's blood specimen
rule-based: intervention Selecting wrong rule or procedure (planning) or executing a procedure incorrectly	technologist misses identifying one antibody in a  patient with multiple antibodies

 

6. Provide two main goals of risk management.

7. Why is disclosure of medical errors controversial?

8. List four essential elements of negligence from a legal perspective. 

9. What standards of conduct are student health professionals held to legally?

10. Can health professionals be held legally responsible for errors made by students they are supervising?

11. Do blood safety standards include: 
    1. reporting of serious adverse events?
    2. disclosure of unanticipated outcomes to patients?

Suggested answers to quiz