ANNEX IV CELL AND/OR TISSUE DONATION AND PROCUREMENT PROCEDURES AND RECEPTION AT THE TISSUE ESTABLISHMENT AS REFERRED TO IN ARTICLE 5

2. Reception of the tissue/cells at the tissue establishment

2.1. When the retrieved tissues/cells arrive at the tissue establishment, there must be documented verification that the consignment, including the transport conditions, packaging, labelling and associated documentation and samples, meet the requirements of this Annex and the specifications of the receiving establishment.

2.2. Each establishment must ensure that the tissue and cells received are quarantined until they, along with the associated documentation, have been inspected or otherwise verified as conforming to requirements. The review of relevant donor/procurement information and thus acceptance of the donation needs to be carried out by specified/authorised persons.

2.3. Each tissue establishment must have a documented policy and specifications against which each consignment of tissues and cells, including samples, are verified. These must include the technical requirements and other criteria considered by the tissue establishment to be essential for the maintenance of acceptable quality. The tissue establishment must have documented procedures for the management and segregation of non-conforming consignments, or those with incomplete test results, to ensure that there is no risk of contamination of other tissues and cells being processed, preserved or stored.

2.4. The data that must be registered at the tissue establishment (except for donors of reproductive cells intended for partner donation) include:

(a)

consent/authorisation; including the purpose(s) for which the tissues and cells may be used (i.e. therapeutic or research, or both therapeutic use and research) and any specific instructions for disposal if the tissue or cells are not used for the purpose for which consent was obtained;

(b)

all required records relating to the procurement and the taking of the donor history, as described in the donor documentation section;

(c)

results of physical examination, of laboratory tests and of other tests (such as the autopsy report, if used in accordance with point 1.2.2.);

(d)

for allogeneic donors, a properly documented review of the complete donor evaluation against the selection criteria by an authorised and trained person;

(e)

in the case of cell cultures intended for autologous use, documentation of the possibility of medicinal allergies (such as to antibiotics) of the recipient.

2.5. In the case of reproductive cells intended for partner donation, the data to be registered at the tissue establishment include:

(a)

consent; including the purpose(s) for which the tissues and cells may be used (such as reproductive only and/or for research) and any specific instructions for disposal if the tissue or cells are not used for the purpose for which consent was obtained;

(b)

donor identification and characteristics: type of donor, age, sex, presence of risk factors and, in the case of a deceased donor, the cause of death;

(c)

partner identification;

(d)

place of procurement;

(e)

tissues and cells obtained and relevant characteristics.