Commentaries: Art. 37

Holders of a licence to handle blood or labile blood products must immediately take the necessary protective measures if they notice that:
1. at the time of donation the donor did not fulfil the criteria required to be considered a suitable donor;
2. the tests for transmittable diseases have not been carried out in accordance with the regulations;
3. the donor has undergone seroconversion or has contracted a blood-borne infection;
4. the recipient of a donation develops a post-transfusion infection which could be traced back to the donor;
5. serious defects in relation to the GMP rules described in Annex 1 have occurred during the blood collection process or the manufacturing of labile blood products.
The measures that will be taken if the situations described in paragraph 1 letters b–e occur must be reported to Swissmedic.
Measures taken in the event of occurrences described in paragraph 1 letters c and d may involve investigations into previous donations or other donors.
Institutions which use blood and labile blood products in patients must inform the manufacturers on request of the relevant information about use of the labile blood product and about the conclusion of the tracing procedure if investigations as described in paragraph 3 are carried out.