What is the role of haemovigilance (blood safety surveillance) in patient care?

Haemovigilance: A Critical Safety System for Blood Transfusion

Haemovigilance is a systematic surveillance program that monitors the entire blood transfusion chain—from donor collection through patient follow-up—to detect, analyze, and prevent adverse events, ultimately reducing morbidity and mortality associated with transfusion. 1, 2

Core Function and Purpose

Haemovigilance serves as a comprehensive quality improvement tool that tracks unexpected or undesirable effects throughout the transfusion process 3, 2. The system operates through three essential mechanisms:

• Traceability: Complete tracking of blood products from donors to recipients, which is a legal requirement with 100% traceability mandated 4, 5
• Spontaneous adverse event reporting: Collection of data on transfusion complications, procedural incidents, and reactions in both donors and patients 2, 6
• Rigorous information management: Systematic analysis of transfusion-related data to identify patterns and implement corrective measures 5

Impact on Patient Safety and Clinical Outcomes

The most critical finding from haemovigilance systems is that the majority of serious, preventable adverse reactions result from clerical errors—particularly failures in final bedside identity verification between patient and blood product. 1 This directly addresses the most serious transfusion outcome: ABO incompatibility from wrong blood administration 4.

Haemovigilance data have demonstrated that:

• Blood transfusion has achieved relatively high safety standards compared to other medicinal drugs, particularly in Europe 1
• The majority of serious adverse reactions and events occur within the hospital setting, not during collection or processing 1
• Well-functioning systems have documented the success of safety interventions, proving their effectiveness in reducing harm 1

Specific Clinical Applications

Prevention of Fatal Complications

The system specifically monitors and prevents life-threatening complications that directly impact mortality:

• TRALI (transfusion-related acute lung injury): Now identified through haemovigilance as requiring immediate intervention 7
• TACO (transfusion-associated circulatory overload): Recognized as the most common cause of transfusion-related mortality and major morbidity 8
• Bacterial infections and hemolytic reactions: The majorly reported problems requiring systematic tracking 3

Quality Improvement Through Data Analysis

Haemovigilance extends beyond safety surveillance to improve appropriate blood use 1. The system:

• Identifies patterns in transfusion practice that may indicate overuse or inappropriate use 4
• Supports restrictive transfusion strategies that reduce blood product exposure by approximately 40% without increasing mortality 7
• Provides data to support patient blood management programs, which are now standard of care in the UK National Health Service 4

Operational Requirements

Mandatory Documentation and Traceability

Every transfusion must be documented with 100% traceability as a legal requirement, including 4:

• Documentation in patient records (anaesthetic chart or drug/fluid prescription chart)
• Confirmation of transfusion per local policy
• Complete tracking from donor to recipient

Staff Training and Competency

All staff involved in transfusion administration must be trained and competency-assessed per local policy 4, 9. This addresses the finding that clerical errors cause most preventable serious reactions 1.

Monitoring and Surveillance

Haemovigilance requires systematic monitoring throughout transfusion 8:

• Vital signs before transfusion start
• Observations at 15 minutes after start of each unit
• Assessment within 60 minutes of transfusion end
• Documentation of any adverse reactions or events

International Collaboration and Standardization

The International Haemovigilance Network (IHN), International Society of Blood Transfusion (ISBT), and World Health Organization collaborate to support both developing and established systems 2, 6. Key achievements include:

• Harmonized definitions for most adverse reactions, validated internationally 2
• Freely available resources and tools housed on the ISBT website for countries establishing haemovigilance programs 6
• Demonstrated that different organizational structures can achieve similar safety outcomes 1

Common Pitfalls and How to Avoid Them

The most critical pitfall is inadequate final bedside identity verification, which causes most serious preventable reactions 1. Avoid this by:

• Implementing mandatory two-person independent checks at bedside (per local policy) 4
• Verifying all four core identifiers on compatibility labels immediately before transfusion 8
• Never bypassing identity verification procedures, even in urgent situations

Underreporting of adverse events compromises system effectiveness 2. Ensure:

• Clear reporting pathways are established and communicated to all staff
• Staff understand that reporting contributes to system-wide safety improvements
• Both serious and minor events are captured for pattern analysis

Broader Applications

Haemovigilance systems can extend surveillance to 1:

• Alternatives for allogeneic blood transfusion (e.g., cell salvage devices)
• Other human products including cells, tissues, and organs
• Quality aspects beyond safety, such as appropriate utilization

Not all countries have haemovigilance systems in place, representing a significant gap in transfusion safety globally 2. Where systems exist, they have proven instrumental in changing policy, products, and practice to improve donor safety, optimize product use, and enhance clinical outcomes 2.