Overview

The establishment of systems to ensure that all donated blood is screened for transfusion-transmissible infections is a core component of every national blood programme. Globally, however, there are significant variations in the extent to which donated blood is screened, the screening strategies adopted and the overall quality and effectiveness of the blood screening process. As a result, in many countries the recipients of blood and blood products remain at unacceptable risk of acquiring life-threatening infections that could easily be prevented.

These recommendations are designed to support countries in establishing effective national programmes to ensure 100% quality-assured screening of donated blood for transfusion-transmissible infections. In countries where systems are not yet fully in place, the recommendations will be helpful in instituting a step-wise process to implement them.

Contents

• Preface
• Key recommendations
• 1. Introduction
  • 1.1 CONTEXT
  • 1.2 CONSTRAINTS AND CHALLENGES
  • 1.3 AIM AND OBJECTIVES
  • 1.4 TARGET AUDIENCE
  • 1.5 METHODOLOGY
• 2. National blood screening programme for transfusion-transmissible infections
  • 2.1 DEVELOPING A NATIONAL BLOOD SCREENING PROGRAMME
  • 2.2 NATIONAL POLICY ON BLOOD SCREENING
  • 2.3 NATIONAL SCREENING STRATEGY
  • 2.4 ORGANIZATION AND MANAGEMENT
  • 2.5 FINANCIAL AND HUMAN RESOURCES
  • 2.6 EVALUATION, SELECTION AND VALIDATION OF ASSAY SYSTEMS
  • 2.7 LABORATORY QUALITY SYSTEMS
  • 2.8 PROCUREMENT AND SUPPLY OF ASSAYS AND REAGENTS
  • 2.9 STORAGE AND TRANSPORTATION
  • 2.10 REGULATORY MECHANISMS
• 3. Screening assays
  • 3.1 TYPES OF ASSAY
  • 3.2 SELECTION OF ASSAYS
  • 3.3 CRITICAL ASSAY CHARACTERISTICS
  • 3.4 EVALUATION OF ASSAYS
  • 3.5 MONITORING ASSAY PERFORMANCE
  • 3.6 USE OF AUTOMATION FOR PERFORMING ASSAYS
  • 3.7 NEW ASSAYS AND TECHNOLOGIES
• 4. Screening for transfusion-transmissible infections
  • 4.1 TRANSFUSION-TRANSMISSIBLE INFECTIONS
  • 4.2 TRANSFUSION-TRANSMISSIBLE INFECTIOUS AGENTS FOR WHICH UNIVERSAL SCREENING OF ALL DONATION IN ALL COUNTRIES IS RECOMMENDED
  • 4.3 TRANSFUSION-TRANSMISSIBLE INFECTIONS FOR WHICH UNIVERSAL SCREENING IS RECOMMENDED IN SOME COUNTRIES OR FOR WHICH SELECTIVE SCREENING IS RECOMMENDED
  • 4.4 EMERGING AND RE-EMERGING INFECTIONS
  • 4.5 CLINICALLY INSIGNIFICANT TRANSFUSION-TRANSMISSIBLE INFECTIONS
• 5. Blood screening, quarantine and release
  • 5.1 BLOOD SCREENING PROCESS
  • 5.2 APPROACHES TO BLOOD SCREENING
  • 5.3 POOLING FOR SEROLOGICAL ASSAYS
  • 5.4 SEQUENTIAL SCREENING
  • 5.5 BLOOD SCREENING AND DIAGNOSTIC TESTING
  • 5.6 EMERGENCY SCREENING
  • 5.7 SCREENING PLASMA FOR FRACTIONATION
  • 5.8 PRE-DONATION TESTING
  • 5.9 QUARANTINE OF BLOOD AND BLOOD COMPONENTS PRIOR TO RELEASE OR DISCARD
  • 5.10 RELEASE OF BLOOD AND BLOOD COMPONENTS
  • 5.11 LONG-TERM STORAGE OF DONATION SERUM/PLASMA SAMPLES
• 6. Confirmatory testing and blood donor management
  • 6.1 CONFIRMATORY TESTING STRATEGIES
  • 6.2 INTERPRETATION AND USE OF CONFIRMATORY RESULTS
  • 6.3 MANAGING BLOOD DONORS
• 7. Quality systems in blood screening
  • 7.1 THE ELEMENTS OF QUALITY SYSTEMS
  • 7.2 ORGANIZATIONAL MANAGEMENT
  • 7.3 STANDARDS FOR QUALITY SYSTEMS
  • 7.4 DOCUMENTATION
  • 7.5 TRACEABILITY
  • 7.6 TRAINING
  • 7.7 ASSESSMENT
  • 7.8 MAINTENANCE AND CALIBRATION
• References
• Glossary
• Acknowledgments

Development of this publication was supported by Cooperative Agreement No. U62/PS024044-05 from the Department of Health and Human Services/Centers for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Global AIDS Program (GAP), United States of America. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC.

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

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