Singapore legislation

Regulation 2

of Healthcare Services (Blood Banking Service) Regulations 2021

Regulation 2

Definitions

Amended byS 388/2023 wef 26/06/2023S 388/2023 wef 26/06/2023S 388/2023 wef 26/06/2023

Subregulation 1

Amended byS 388/2023 wef 26/06/2023S 388/2023 wef 26/06/2023S 388/2023 wef 26/06/2023

In these Regulations, unless the context otherwise requires —[Deleted by S 388/2023 wef 26/06/2023][Deleted by S 388/2023 wef 26/06/2023](2) In these Regulations, blood or a blood component is treated as suitable for clinical use if —

(a)

the blood or blood component, as the case may be —

(i)

has undergone all of the tests specified in Part 1 of the Second Schedule; and

(ii)

in relation to an infectious disease specified in the first column of Part 2 of the Second Schedule, has undergone all of the tests specified opposite that infectious disease in the second column of Part 2 of that Schedule and is determined to not be infected with that infectious disease; and

(b)

every test mentioned in sub‑paragraph (a) is carried out using appropriate test kits that have been validated for the purpose of donor testing.

Definition

“acute hospital service”, “blood banking service”, “simple in vitro diagnostic test” and “specified person” have the meanings given by paragraph 2 of the First Schedule to the Act;

Amended byS 388/2023 wef 26/06/2023

Definition

“blood” means whole human blood;

Definition

“blood component” includes plasma, red blood cells, white blood cells, platelets and cryoprecipitate;

Definition

“blood donation site” means any premises or conveyance that is occupied or used by a licensee for the collection of blood or blood components and the storage of blood or blood components incidental to their collection;

Amended byS 388/2023 wef 26/06/2023

Definition

“Clinical Governance Officer” means a Clinical Governance Officer appointed by a licensee under section 24(2) of the Act;

Definition

“donor” means an individual who donates blood or any blood component;

Definition

“licensee” means a person who holds a licence to provide a blood banking service;

Definition

“personnel”, in relation to a licensee, means any individual employed or engaged by the licensee to assist the licensee in providing a blood banking service;

Definition

“specified infectious disease” means an infectious disease specified in the First Schedule.

Amended byS 388/2023 wef 26/06/2023