Evaluation and screening
10.—(1)  A licensee must implement a system for evaluating the medical fitness and suitability of every infant donor and mother of an infant donor (including a potential infant donor and the mother of a potential infant donor).
(2)  Without limiting paragraph (1), the licensee must, in relation to the mother of every potential infant donor —
(a)ensure that a medical practitioner reviews the clinical history, and conducts a clinical evaluation, of the mother; and
(b)obtain a declaration signed by the mother that contains, to the best of the knowledge of the mother at the time she makes the declaration, information relating to the matters specified in paragraph (3).
(3)  The matters mentioned in paragraph (2)(b) are the following:
(a)the medical history of the mother of the potential infant donor and every member of her immediate family;
(b)the medical history of the father of the potential infant donor and every member of the father’s immediate family;
[S 389/2023 wef 26/06/2023]
(c)[Deleted by S 389/2023 wef 26/06/2023]
(d)where the mother is bearing a potential infant donor conceived using a donated egg or donated sperm — the medical history of the donor of the egg or sperm and every member of that donor’s immediate family.
(4)  Without limiting paragraph (1), the licensee must ensure that the system mentioned in that paragraph provides for all of the following:
(a)the collection, from the time the licensee obtains a declaration mentioned in paragraph (2)(b) until the time the mother of an infant donor delivers the infant donor, of any information relating to the matters specified in paragraph (3) that is known or available to the licensee;
(b)the communication to the mother of the infant donor and (where the mother consents) the medical practitioner caring for the mother of —
(i)any abnormal finding that may have significant consequences for the health or fertility of the infant donor or mother; or
(ii)any incidental finding relating to the infant donor or mother.
(5)  A licensee must ensure that —
(a)the mother of an infant donor, in relation to an infectious disease specified in the first column of the Schedule, has undergone all of the tests specified opposite that infectious disease in the second column of the Schedule; and
(b)every test of the mother of an infant donor carried out in accordance with sub-paragraph (a) is carried out using appropriate test kits that have been validated for the purpose of donor testing.
(6)  A licensee must, in order to enable the conduct of any subsequent testing of the cord blood collected from an infant donor that may be necessary —
(a)collect —
(i)a sufficient quantity of cord blood in addition to the cord blood collected for transplant or other clinical use; and
(ii)blood samples of the mother of the infant donor; and
(b)ensure that the cord blood and blood samples mentioned in sub‑paragraph (a) are stored and available for any subsequent testing that may be necessary for the duration of the contract or other arrangement between the licensee and the mother of the infant donor for the collection and storage of the cord blood collected.
(7)  In this regulation, “immediate family”, in relation to an individual, means —
(a)the individual’s biological son or daughter;
(b)the individual’s biological father or mother;
(c)the individual’s biological brother or sister; and
(d)the individual’s biological grandfather or grandmother, whether paternal or maternal.
[S 389/2023 wef 26/06/2023]