Everything that is not compliant with SOP, guidelines, national and international standards, and legal requirements could affect the quality and safety of the cellular products and all processes. To guarantee the safety of cellular products, to protect recipients, donors, and personnel, it is necessary to have in place a robust system for reporting, investigating, and resolving all occurrences: errors, accidents, adverse events, biological product deviations, and complaints.
In some case, the management of adverse events and other type of deviations is included in hospital management, but even in this case, the transplant programme quality system should have specific SOP that includes a system to manage any issues, actions to prevent adverse events and deviations, and a description of the step to resolve them.
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