Singapore legislation
Regulation 33
of Healthcare Services (Human Tissue Banking Service) Regulations 2023
Regulation 33
Continuity of operations
Subregulation 1
A licensee must establish a contingency plan to ensure that the safety and quality, and, where applicable, the viability and potency, of all human tissue in the licensee’s custody are preserved in the event of any disruption to the licensee’s operations.
Subregulation 2
Without limiting paragraph (1), the contingency plan mentioned in that paragraph must include the following matters:
contracts or other arrangements for or in relation to the prompt restoration of the licensee’s operations or the transfer of human tissue in the licensee’s custody to another licensee;
processes to inform, without undue delay, a relevant donor of the proposed transfer or disposal of any human tissue as a result of the disruption to the licensee’s operations;
processes to obtain the express written consent of the relevant donor for the proposed transfer or disposal in the event of any disruption to the licensee’s operations;
where there is any human tissue in the licensee’s custody that was not collected by the licensee — processes to inform, without delay, the person from whom the licensee received the human tissue, of the proposed transfer or disposal of any human tissue as a result of the disruption to the licensee’s operations.
Subregulation 3
In this regulation, “relevant donor” means a donor who donated human tissue only for autologous use or use by a specified individual.