Definitions
2.—(1)  In these Regulations, unless the context otherwise requires —
[Deleted by S 388/2023 wef 26/06/2023]
“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;
[S 388/2023 wef 26/06/2023]
“blood” means whole human blood;
“blood component” includes plasma, red blood cells, white blood cells, platelets and cryoprecipitate;
“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;
[S 388/2023 wef 26/06/2023]
“Clinical Governance Officer” means a Clinical Governance Officer appointed by a licensee under section 24(2) of the Act;
“donor” means an individual who donates blood or any blood component;
“licensee” means a person who holds a licence to provide a blood banking service;
“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;
“specified infectious disease” means an infectious disease specified in the First Schedule.
[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.