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•  Yes
•  No

All donor testing (at work up) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority:

•  Yes
•  No

HLA typing for patient specific request is performed in an appropriately accredited laboratory:

•  Yes
•  No

•  Yes
•  No

•  Yes
•  No

•  Yes
•  No

•  Yes
•  No

•  Yes
•  No

Donor clearance to donate is confirmed by a medical doctor, following as a minimum the donor exclusion criteria in Annex 1 of EU Directive 2006/17/EC:

The party providing the Cell Product must exclude Donors when:

• They are pregnant;
• They are breastfeeding;
• There is the potential for transmission of inherited conditions;
• There is evidence of any other risk factors for transmissible diseases on the basis of a risk assessment, taking into consideration Donor travel and exposure history and local infectious disease prevalence;
• There is presence on the Donor’s body of physical signs implying a risk of transmissible disease(s);
• There is a history of a disease of unknown aetiology;
• There is a risk of transmission of diseases caused by prions;
• There is systemic infection which is not controlled at the time of donation, including bacterial diseases, systemic viral, fungal or parasitic infections, or significant local infection in the tissues and cells to be donated;
• There is history of chronic, systemic autoimmune disease that could have a detrimental effect on the quality of the Cell Product;
• There is recent history of vaccination with a live attenuated virus where a risk of transmission is considered to exist;
• There is ingestion of, or exposure to, a substance (such as cyanide, lead, mercury, gold) that may be transmitted to recipients in a dose that could endanger their health.

•  Yes
•  No