| Preface | p. vii |
| Introduction | p. ix |
| Organization | p. 1 |
| Organization | p. 1 |
| Executive Management | p. 1 |
| Quality System | p. 1 |
| Policies, Processes, and Procedures | p. 2 |
| Emergency Preparedness | p. 2 |
| Communication of Concerns | p. 2 |
| Resources | p. 3 |
| Resources | p. 3 |
| Human Resources | p. 3 |
| Equipment | p. 4 |
| Equipment | p. 4 |
| Selection of Equipment | p. 4 |
| Qualification of Equipment | p. 4 |
| Use of Equipment | p. 4 |
| Unique Identification of Equipment | p. 4 |
| Equipment Monitoring and Maintenance | p. 4 |
| Storage Devices for Blood, Components, Reagents, Tissue, and Derivatives | p. 5 |
| Alarm Systems | p. 5 |
| Warming Devices for Blood and Components | p. 6 |
| Computer Systems | p. 6 |
| Supplier and Customer Issues | p. 8 |
| Supplier and Customer Issues | p. 8 |
| Supplier Qualification | p. 8 |
| Agreements | p. 8 |
| Incoming Receipt, Inspection, and Testing | p. 8 |
| Process Control | p. 10 |
| Process Control | p. 10 |
| General Elements | p. 10 |
| Collection and Production of Components | |
| Information, Consents, and Notifications | p. 15 |
| Care of Donors | p. 16 |
| Donor Qualification | p. 16 |
| Additional Apheresis Donor Qualification Requirements | p. 18 |
| Blood Collection | p. 21 |
| Preparation/Processing of Components | p. 23 |
| Testing of Donor Blood | p. 29 |
| Final Labeling | p. 31 |
| Final Inspection | p. 32 |
| Transfusion-Service-Related Activities | |
| Samples and Requests | p. 32 |
| Serologic Confirmation of Donor Blood ABO/Rh (including autologous units) | p. 33 |
| Pretransfusion Testing of Patient Blood | p. 33 |
| Selection of Compatible Blood and Components for Transfusion | p. 35 |
| Crossmatch | p. 35 |
| Special Considerations for Neonates | p. 37 |
| Selection of Compatible Blood and Components in Special Circumstances | p. 37 |
| Final Inspection Before Issue | p. 38 |
| Administration of Blood and Components | p. 40 |
| Rh Immune Globulin | p. 42 |
| Requirements for Labeling Blood and Components | p. 44 |
| Requirements for Storage, Transportation, and Expiration | p. 48 |
| Requirements for Allogeneic Donor Qualification | p. 56 |
| Documents and Records | p. 62 |
| Documents and Records | p. 62 |
| Documents | p. 62 |
| Records | p. 62 |
| Retention of Donor/Unit Records | p. 64 |
| Retention of Patient Records | p. 68 |
| Retention of Other Documents and Records | p. 72 |
| Retention of Tissue Records | p. 75 |
| Retention of Derivative Records | p. 76 |
| Deviations, Nonconformances, and Adverse Events | p. 77 |
| Deviations, Nonconformances, and Adverse Events | p. 77 |
| Nonconformances | p. 77 |
| Fatality Reporting | p. 78 |
| Adverse Events Related to Donation | p. 78 |
| Adverse Events Related to Transfusion | p. 78 |
| Assessments: Internal and External | p. 82 |
| Assessments: Internal and External | p. 82 |
| Management of Assessment Results | p. 82 |
| Monitoring of Blood Utilization | p. 82 |
| Process Improvement through Corrective and Preventive Action | p. 83 |
| Process Improvement Through Corrective and Preventive Action | p. 83 |
| Corrective Action | p. 83 |
| Preventive Action | p. 83 |
| Quality Monitoring | p. 83 |
| Facilities and Safety | p. 84 |
| Facilities and Safety | p. 84 |
| Safe Environment | p. 84 |
| Biological, Chemical, and Radiation Safety | p. 84 |
| Discard of Blood, Components, Tissue, and Derivatives | p. 84 |
| List of Blood Component Descriptions | p. 85 |
| Glossary | p. 89 |
| "Crosswalk" Between the 25th and 26th Editions of Standards | p. 95 |
| Index | p. 101 |
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