Hemovigilance overview MCQs With Answer

Introduction: Hemovigilance overview MCQs With Answer is designed for M.Pharm students to strengthen their understanding of the hemovigilance system, transfusion safety, and adverse reaction management. This set reviews critical concepts such as surveillance processes, reporting and investigation procedures, common transfusion reactions (acute hemolytic, febrile non-hemolytic, allergic, TRALI, TACO), causality assessment, and preventive strategies like leukoreduction and donor screening. Questions emphasize clinical roles, data use for quality improvement, and practical steps in lookback and traceability. Use these MCQs to test knowledge, prepare for exams, and develop the clinical reasoning needed for effective participation in hospital hemovigilance programs.

Q1. What is the best definition of hemovigilance?

• A targeted safety program limited to laboratory testing of blood donors
• A national law governing blood transfusion services only
• A systematic process for monitoring, reporting, investigating and preventing adverse events related to blood transfusion across the transfusion chain
• An auditing tool for pharmaceutical production of blood-derived medicines

Correct Answer: A systematic process for monitoring, reporting, investigating and preventing adverse events related to blood transfusion across the transfusion chain

Q2. What is the primary objective of a hemovigilance system?

• To increase blood donation rates
• To ensure financial sustainability of blood banks
• To monitor and improve the safety and quality of blood transfusion and related processes
• To develop new blood-derived pharmaceuticals

Correct Answer: To monitor and improve the safety and quality of blood transfusion and related processes

Q3. Which of the following components is NOT normally part of a hemovigilance program?

• Detection and reporting of adverse reactions
• Investigation and root-cause analysis
• Manufacturing of blood components
• Feedback, corrective actions and preventive measures

Correct Answer: Manufacturing of blood components

Q4. A transfusion reaction characterized by fever, chills, and no evidence of hemolysis is most consistent with which diagnosis?

• Acute hemolytic transfusion reaction (AHTR)
• Febrile non-hemolytic transfusion reaction (FNHTR)
• Transfusion-related acute lung injury (TRALI)
• Transfusion-associated circulatory overload (TACO)

Correct Answer: Febrile non-hemolytic transfusion reaction (FNHTR)

Q5. Which mechanism most commonly underlies acute hemolytic transfusion reactions?

• Complement-mediated destruction due to recipient antibodies against donor red cell antigens
• Bacterial contamination of platelet products
• Allergic reaction to plasma proteins
• Volume overload in a patient with heart failure

Correct Answer: Complement-mediated destruction due to recipient antibodies against donor red cell antigens

Q6. What is the predominant cause of febrile non-hemolytic transfusion reactions in modern practice?

• Transmission of viral pathogens
• Leukocyte-derived cytokines and recipient anti-leukocyte antibodies
• Hypersensitivity to donor plasma proteins
• Bacterial endotoxin contamination

Correct Answer: Leukocyte-derived cytokines and recipient anti-leukocyte antibodies

Q7. Which statement best differentiates TRALI from TACO?

• TRALI is caused by volume overload; TACO is an immune-mediated lung injury
• TRALI presents with non-cardiogenic pulmonary edema often within 6 hours and is immune or biologically mediated; TACO is circulatory overload with cardiogenic features
• Both are always bacterial in origin
• TACO occurs only with platelet transfusions; TRALI occurs only with red cells

Correct Answer: TRALI presents with non-cardiogenic pulmonary edema often within 6 hours and is immune or biologically mediated; TACO is circulatory overload with cardiogenic features

Q8. The primary purpose of a lookback investigation in hemovigilance is to:

• Determine donor eligibility criteria
• Identify and notify recipients of blood components from a donor later found to be positive for an infectious marker
• Calculate blood bank financial performance
• Replace outdated laboratory equipment

Correct Answer: Identify and notify recipients of blood components from a donor later found to be positive for an infectious marker

Q9. Which of the following actions is a core prevention strategy to reduce febrile non-hemolytic transfusion reactions?

• Universal irradiation of blood products
• Leukoreduction of blood components
• Using only whole blood transfusions
• Removing plasma from all donors

Correct Answer: Leukoreduction of blood components

Q10. Which blood component is most commonly associated with TRALI events?

• Washed red blood cells
• Plasma-rich components such as fresh frozen plasma and platelet concentrates
• Leukoreduced packed red cells
• Albumin solutions

Correct Answer: Plasma-rich components such as fresh frozen plasma and platelet concentrates

Q11. Which of the following best describes the role of a clinical pharmacist in hemovigilance?

• Only dispensing blood components in the pharmacy
• Participating in reporting adverse transfusion reactions, causality assessment, guideline development, and educating staff on appropriate transfusion practices
• Replacing laboratory staff in crossmatching
• Only recruiting blood donors

Correct Answer: Participating in reporting adverse transfusion reactions, causality assessment, guideline development, and educating staff on appropriate transfusion practices

Q12. In causality assessment of transfusion reactions, which category indicates a clear temporal relationship with no other plausible explanation?

• Unlikely
• Possible
• Probable or likely
• Unassessable

Correct Answer: Probable or likely

Q13. Which statement is TRUE about donor hemovigilance?

• It focuses only on infectious disease testing and ignores donor adverse events
• It includes monitoring and reporting post-donation adverse events such as vasovagal reactions and managing donor follow-up
• Donor hemovigilance is only necessary for paid donors
• It replaces all pre-donation screening procedures

Correct Answer: It includes monitoring and reporting post-donation adverse events such as vasovagal reactions and managing donor follow-up

Q14. Which of the following is NOT typically a data element collected in a hemovigilance report?

• Patient identifiers and clinical context of transfusion
• Blood component type, volume and transfusion time
• Brand and batch number of unrelated non-transfusion drugs given months earlier
• Clinical signs, investigations, outcome and causality assessment

Correct Answer: Brand and batch number of unrelated non-transfusion drugs given months earlier

Q15. How are hemovigilance findings most effectively used at institutional level?

• To publish only in academic journals without operational changes
• To inform training, revise transfusion policies, implement corrective actions and monitor outcomes
• To limit transfusions by arbitrary quota systems
• To delay reporting until annual review

Correct Answer: To inform training, revise transfusion policies, implement corrective actions and monitor outcomes

Q16. Which international entity provides standardized definitions and recommendations that many hemovigilance systems reference?

• World Trade Organization (WTO)
• International Society of Blood Transfusion (ISBT) working parties and WHO guidance
• International Monetary Fund (IMF)
• World Health Organization for pharmaceuticals only, not for blood

Correct Answer: International Society of Blood Transfusion (ISBT) working parties and WHO guidance

Q17. Which transfusion reaction typically presents with hypotension, hemoglobinuria and rising serum bilirubin intra- or post-transfusion?

• Allergic urticarial reaction
• Acute hemolytic transfusion reaction (AHTR)
• Febrile non-hemolytic reaction
• Transfusion-associated GVHD

Correct Answer: Acute hemolytic transfusion reaction (AHTR)

Q18. What is the recommended initial action when a suspected severe transfusion reaction occurs at bedside?

• Continue transfusion and observe for 24 hours
• Stop the transfusion immediately, maintain IV access with normal saline, notify blood bank and treat patient per protocol
• Discard the tubing and start a new unit immediately
• Only notify the donor center

Correct Answer: Stop the transfusion immediately, maintain IV access with normal saline, notify blood bank and treat patient per protocol

Q19. Which of the following best describes traceability within hemovigilance?

• Tracking transfusion reactions only for donors over 60 years
• Ability to link each blood unit from donor to recipient and vice versa for investigation and lookback
• Recording only the blood type without donor identification
• Tracing financial transactions between blood centers

Correct Answer: Ability to link each blood unit from donor to recipient and vice versa for investigation and lookback

Q20. Which reporting timeline is generally expected for serious transfusion reactions in many hemovigilance systems?

• Report within 24 hours of recognition
• Report only at monthly intervals
• Report after 6 months when annual data are compiled
• No reporting is required for serious reactions

Correct Answer: Report within 24 hours of recognition

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