Table 3. Evaluation of Adverse Events Severity [1-5].

Event description	Report to competent authority	Reference criterion
Bacterial infection of tissues or cells distributed for transplantation	Yes	1
Viral infection of tissues or cells distributed for transplantation: retrospective analysis demonstrates viral infection of tissues or cells previously tested and found negative	Yes	1
Documentation-evidence of infection in tissues undergoing the required sterilization procedure, which is used in many tissue establishments-tissues are not distributed	Yes	2
Incorrect type of tissue or cell: a different type of tissue or cell from that intended or requested/provided by the tissue establishment	Yes	1
An ovule has been fertilized with semen from another couple's husband	Yes	3
A bone marrow donation for a particular patient is lost during delivery to the transplantation hospital	Yes	4
Growth of bacteria is detected in an autologous umbilical cord blood collection. The cells are kept in storage in order to treat the patient with antibiotics, if any cells are used in the future	No
	Infection indexes should be reviewed during testing
An entire heart valve bank has been lost due to failure to refill a tank with liquid nitrogen	Yes	5
A cornea is rejected at the tissue establishment due to low cell count	No
	Non-regulatory action

Source: The EUSTITE project “European Union Standards and Training in the Inspection of Tissue Establishments” December, 2006 to December, 2009; exercise for inspectors training program; leading organization: Centro Nazionale di Trapianti.