Marginal note:Additional information

14. An establishment must provide the Minister, on written request, with any additional relevant information to demonstrate that the activities it carries out are in compliance with these Regulations, by the date specified in the Minister’s request.

Marginal note:Responsibility

15. A source establishment is responsible for the processing of cells, tissues and organs, whether the processing is carried out by the source establishment itself or by another establishment, and for determining whether the cells, tissues and organs are safe for transplantation.

Marginal note:Documented evidence

16. An establishment must have documented evidence that demonstrates that the activities, processes and technical procedures that it uses in processing cells, tissues and organs will consistently lead to the expected results.

Marginal note:When pooling permitted

17. An establishment may only pool cells, tissues or organs from different donors during processing to create a therapeutic dose for a single recipient.

Marginal note:Requirements — cell, tissue and organ donors

18. In assessing the suitability of a donor of cells, tissues or organs, except a donor of lymphohematopoietic cells, an establishment must perform all of the following steps:

• (a) obtain the donor information and history in accordance with sections 12.2 and 12.3 of the general standard;

• (b) determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.3 of the general standard and in Annex E to that standard;

• (c) perform a physical examination of the donor in accordance with section 13.2 of the general standard; and

• (d) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the general standard.

Marginal note:Plasma dilution algorithm

19. In assessing the suitability of a donor, an establishment must apply a plasma dilution algorithm if a donor pre-transfusion or pre-infusion blood sample is unavailable.

Marginal note:Additional exclusion criteria — tissue donors

20. In assessing the suitability of a tissue donor, except an ocular tissue donor, an establishment must perform both of the following steps:

• (a) determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.2 of the tissue standard; and

• (b) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the tissue standard.

Marginal note:Additional exclusion criteria — ocular tissue donors

21. In assessing the suitability of an ocular tissue donor, an establishment must determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in sections 13.1.3 to 13.1.6 of the ocular standard.