CHAPTER V

HAEMOVIGILANCE

Traceability
Article 14
1
Member States shall take all necessary measures in order to ensure that blood and blood components collected, tested, processed, stored, released and/or distributed on their territory can be traced from donor to recipient and vice versa.
To this end, Member States shall ensure that blood establishments implement a system for identification of each single blood donation and each single blood unit and components thereof enabling full traceability to the donor as well as to the transfusion and the recipient thereof. The system must unmistakably identify each unique donation and type of blood component. This system shall be established in accordance with the requirements referred to in Article 29(a).
With regard to blood and blood components imported from third countries, Member States shall ensure that the donor identification system to be implemented by blood establishments permits an equivalent level of traceability.
2
Member States shall take all necessary measures in order to ensure that the system used for the labelling of blood and blood components collected, tested, processed, stored, released and/or distributed on their territory complies with the identification system referred to in paragraph 1 and the labelling requirements listed in Annex III.
3
Data needed for full traceability in accordance with this Article shall be kept for at least 30 years.

Notification of serious adverse events and reactions
Article 15
1
Member States shall ensure that:
- any serious adverse events (accidents and errors) related to the collection, testing, processing, storage and distribution of blood and blood components which may have an influence on their quality and safety, as well as any serious adverse reactions observed during or after transfusion which may be attributed to the quality and the safety of blood and blood components are notified to the competent authority,
- blood establishments have in place a procedure accurately, efficiently and verifiably to withdraw from distribution blood or blood components associated with the notification referred to above.
2
These serious adverse events and reactions shall be notified in accordance with the procedure and notification format referred to in Article 29(i).