Singapore legislation

Regulation 26

of Healthcare Services (Human Tissue Banking Service) Regulations 2023

Regulation 26

Return of human tissue

Subregulation 1

A licensee must ensure that the return of unused human tissue from the person to whom it was distributed to the custody of the licensee is carried out —

(a)

in a manner that preserves the biological and functional properties of the human tissue;

(b)

in a manner that minimises the risk of contamination of the human tissue; and

(c)

only where the criteria for the return of unused human tissue established by a Clinical Governance Officer are met.

Subregulation 2

Without limiting paragraph (1), a licensee must —

(a)

establish and implement policies and procedures for the return of unused human tissue;

(b)

document the policies and procedures mentioned in sub‑paragraph (a) and the criteria mentioned in paragraph (1)(c);

(c)

take appropriate measures to examine the integrity of the validated container and the human tissue for contamination and mishandling; and

(d)

take appropriate measures to ensure that any human tissue which may have been contaminated or mishandled is not placed back in the licensee’s inventory.