Singapore legislation
Regulation 17
of Healthcare Services (Human Tissue Banking Service) Regulations 2023
Regulation 17
Evaluation and screening of donors
Subregulation 1
A licensee must implement a system for evaluating the medical fitness and suitability of every donor.
Subregulation 2
Without limiting paragraph (1), the licensee must ensure that the system mentioned in that paragraph includes all of the following matters:
the collection of information —
relating to the medical history of the donor known or available to the licensee;
relating to the medical history of the donor known or available to the donor or authorised person, as the case may be; and
where the medical history of the donor’s immediate family is relevant in determining the suitability of the human tissue collected — relating to the medical history of every member of the donor’s immediate family;
subject to paragraph (4), the signing of a declaration by the donor or authorised person (as the case may be), that all relevant information mentioned in sub‑paragraph (a)(ii) and (iii) has been disclosed to the licensee, to the best of the knowledge of the donor or authorised person (as the case may be), at the time of making the declaration;
a review by a medical practitioner of the information mentioned in sub‑paragraph (a);
where the donor is a living donor — a clinical evaluation of the donor conducted by a medical practitioner;
a requirement for the donor of a type of human tissue, in relation to every infectious disease applicable to that type of human tissue as specified in the first column of the Second Schedule, to undergo all of the tests specified opposite that infectious disease in the second column of that Schedule;
the conduct of all other necessary tests on the donor to assess whether the donor is eligible to donate the type of human tissue intended for donation.
Subregulation 3
Every test mentioned in paragraph (2)(e) must be conducted using an appropriate test kit that has been validated for the purpose of donor testing.
Subregulation 4
Paragraph (2)(b) does not apply where the human tissue is collected pursuant to —
section 4(1) of the Human Organ Transplant Act 1987;
a gift made by a deceased individual under section 3 of the Medical (Therapy, Education and Research) Act 1972; or
a donation under section 4 of the Medical (Therapy, Education and Research) Act 1972.
Subregulation 5
In this regulation —
Definition
“donor” includes a potential donor;
Definition
“immediate family”, in relation to an individual, means the individual’s biological parent or sibling.