Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance) (c. 61)

ANNEX I Record of data on traceability as provided for in Article 4

BY BLOOD ESTABLISHMENTS

1. Blood establishment identification

2. Blood donor identification

3. Blood unit identification

4. Individual blood component identification

5. Date of collection (year/month/day)

6. Facilities to which blood units or blood components are distributed, or subsequent disposition.

BY FACILITIES

1. Blood component supplier identification

2. Issued blood component identification

3. Transfused recipient identification

4. For blood units not transfused, confirmation of subsequent disposition

5. Date of transfusion or disposition (year/month/day)

6. Lot number of the component, if relevant.