In the AABB Standards for Transfusion Services 25th edition Section 7.0 provides specific requirements for deviation, nonconformances, and adverse events:
"The blood bank or transfusion service shall have policies, processes, and procedures to ensure the capture, assessment, investigation, and monitoring of deviations from meeting, or failing to meet, specified requirements. The responsibility for review and authority for the disposition of nonconforming blood, components, tissue, derivatives, critical materials, and services shall be defined. Deviations, nonconformances, and adverse events shall be reported in accordance with specified requirements and to outside agencies as required."
