Facilities must ensure that there is a system in place to detect, report, investigate, document and follow up all errors, adverse events and reactions affecting donors and those which could affect the quality of HPC components and which may be attributable to their collection and processing.
These systems must also apply to any serious adverse events and reactions observed after administration of HPC components.
Documentation of these events shall be reviewed by the facilities’ directors as appropriate.
The Designated Individual must ensure that these events are notified to the HTA within 24 hours of discovery.
Facilities must ensure that appropriate corrective actions are taken and that recall procedures are in place to enable it to recall any component(s) related to serious adverse events and reactions.