Blood and/or blood components may be issued for research, for reagent and, in exceptional cases, for therapeutic use when they do not conform to specified requirements. Each Blood Establishment must have written instructions detailing the circumstances under which such concessionary issues can be made and the procedures to be followed.
For major non-conformances in components intended for therapeutic use (e.g. an HLA-matched platelet that is significantly below specified cell counts, extension of shelf life for an autologous donation or, in extreme circumstances, a donor sample not tested for mandatory microbiological marker etc.) the instructions should, as a minimum, include the following:
Issues of non-conforming components should be subjected to a formal review process.
Minor non-conformances in components intended for therapeutic use (e.g. non-critical blood pack faults, minor label issues) should be referred for assessment by the quality manager.