2. In these Regulations, unless the context otherwise requires —
“applicable service” means a clinical laboratory service or a radiological service, as the case may be;
“business name” has the meaning given by regulation 48(2) of the General Regulations;
“calendar day” includes Saturday, Sunday and every public holiday;
[S 417/2023 wef 26/06/2023]
“Clinical Governance Officer” means a Clinical Governance Officer appointed by a licensee under section 24(2) of the Act;
“clinical laboratory service” has the meaning given by paragraph 2 of the First Schedule to the Act;
[S 417/2023 wef 26/06/2023]
“clinical laboratory service licensee” means a person who holds a licence to provide a clinical laboratory service;
“collaborative prescribing practitioner” has the meaning given by regulation 2 of the Healthcare Services (Collaborative Prescribing Service) Regulations 2023 (G.N. No. S 398/2023);
[S 417/2023 wef 26/06/2023]
“expiry date”, in relation to any reagent or testing material, means —
(a)
the date after which; or
(b)
the month and year after the end of which,
as the case may be, the reagent or testing material should not be used;
[S 417/2023 wef 26/06/2023]
“General Regulations” means the Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021);
“imaging modality” means —
(a)
any imaging modality set out in paragraph 1(a) of Part 2 of the Schedule;
(b)
bone densitometry; or
(c)
ultrasound;
[S 417/2023 wef 26/06/2023]
“imaging service” means the use of ionising or non ionising radiation for any of the following purposes:
(a)
examination of the body, or any matter derived from the body, of an individual;
(b)
assessment of the health or condition of an individual;
(c)
observation and diagnosis of a condition, disability, disease, disorder or an injury of the body or mind of an individual;
(d)
determining, predicting or providing a prognosis of the health or condition of an individual;
[S 417/2023 wef 26/06/2023]
“laboratory discipline” means any laboratory discipline set out in paragraph 1(a) of Part 1 of the Schedule;
[S 417/2023 wef 26/06/2023]
“laboratory discipline” has the meaning given by regulation 4(4);
“licence” means a licence under the Act authorising the licensee to provide an applicable service;
“licensee” means a clinical laboratory service licensee or a radiological service licensee;
“patient” —
(a)
in relation to a clinical laboratory service licensee, means the individual from whose body a specimen is derived for testing by or on behalf of the licensee; or
(b)
in relation to a radiological service licensee, means the individual for whom a radiological examination is performed by or on behalf of the licensee;
“personnel”, in relation to a licensee, means any individual employed or engaged by the licensee to assist the licensee in providing the applicable service;
“radioactive specimen” means any specimen —
(a)
on which a radioactive substance is applied for the purpose of a test or examination of the specimen; or
(b)
that is derived, obtained or excreted from an individual who was administered a radiopharmaceutical for the purpose of testing or examining the specimen, whether or not the specimen contains any radioactive substance;
[S 417/2023 wef 26/06/2023]
“radioactive substance” has the meaning given by section 2(1) of the Radiation Protection Act 2007;
[S 417/2023 wef 26/06/2023]
“radiological service” has the meaning given by paragraph 2 of the First Schedule to the Act;
[S 417/2023 wef 26/06/2023]
“radiological service licensee” means a person who holds a licence to provide a radiological service;
“radiopharmaceutical” means any unsealed source (within the meaning given by regulation 2 of the Radiation Protection (Ionising Radiation) Regulations 2023 (G.N. No. S 85/2023)) that is administered to a patient as a diagnostic agent;
[S 417/2023 wef 26/06/2023]
“requestor”, in relation to a patient, means —
(a)
the medical practitioner, dentist or collaborative prescribing practitioner who ordered a test or radiological examination for the patient; or
(b)
any person who is approved by the Director-General to request a licensee to conduct a test for the patient without a referral by a medical practitioner, dentist or collaborative prescribing practitioner;
[S 417/2023 wef 26/06/2023]
[Deleted by S 417/2023 wef 26/06/2023]
[Deleted by S 417/2023 wef 26/06/2023]
[Deleted by S 417/2023 wef 26/06/2023]
“simple in vitro diagnostic test” has the meaning given by paragraph 2 of the First Schedule to the Act;
[S 417/2023 wef 26/06/2023]
“specimen” has the meaning given by regulation 2 of the General Regulations;
[S 417/2023 wef 26/06/2023]
“temporary premises” means any premises other than permanent premises;
[S 417/2023 wef 26/06/2023]
“test” means an analysis or examination of a specimen conducted by a licensee in connection with the provision of a clinical laboratory service;
[S 417/2023 wef 26/06/2023]
“testing material” means any test kit, material, device, equipment, instrument or other article that is used to conduct a simple in vitro diagnostic test;
[S 417/2023 wef 26/06/2023]
“testing service” means the examination or testing of any matter derived, obtained or excreted from the body of any individual for the purpose of —
(a)
assessing the health or genetic predisposition of that individual or any other individual;
(b)
predicting or providing a prognosis of the health condition of that individual or any other individual;
(c)
diagnosing a condition, disability, disease, disorder or an injury of the body or mind of that individual or any other individual;
(d)
determining the intervention to be taken, or the effect of any intervention taken, of a condition, disability, disease, disorder or an injury of the body or mind of an individual;
(e)
ascertaining the result of a medical or surgical treatment given to that individual or any other individual; or
(f)
assessing the health, condition or suitability of any human biological material that is used, or is intended to be used, in relation to any healthcare service.