Healthcare Services (Nuclear Medicine Assay Service and Nuclear Medicine Imaging Service) Regulations 2021

No. S 1039

Healthcare Services Act 2020

(ACT 3 OF 2020)

Healthcare Services
(Nuclear Medicine Assay Service and
Nuclear Medicine Imaging Service)
Regulations 2021

In exercise of the powers conferred by section 57 of the Healthcare Services Act 2020, the Minister for Health makes the following Regulations:

PART 1

PRELIMINARY

Citation and commencement

1. These Regulations are the Healthcare Services (Nuclear Medicine Assay Service and Nuclear Medicine Imaging Service) Regulations 2021 and come into operation on 3 January 2022.

Definitions

2. In these Regulations, unless the context otherwise requires —

“applicable service” means a nuclear medicine assay service or nuclear medicine imaging service;

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

“collaborative prescribing practitioner” has the meaning given by regulation 56C(6) of the Private Hospitals and Medical Clinics Regulations (Rg 1);

“diagnostic radiographer” means a duly qualified allied health professional who is registered under the Allied Health Professions Act 2011 to practise radiography;

“duly qualified allied health professional” has the meaning given by section 3 of the Allied Health Professions Act 2011;

“examination” means a radiological examination of an individual conducted by a nuclear medicine imaging licensee at the licensed premises of or in the licensed conveyance used by the licensee in connection with the provision of a nuclear medicine imaging service;

“General Regulations” means the Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021);

“image”, in relation to a nuclear medicine imaging service, means an image produced in the course of the provision of that service;

“irradiating apparatus”, “radioactive material” and “radioactive substance” have the meanings given by section 2(1) of the Radiation Protection Act 2007;

“licensee” means a nuclear medicine assay licensee or a nuclear medicine imaging licensee;

“medical laboratory technologist” means an individual who holds at least a diploma or degree in biomedical science, biological science or medical technology;

“nuclear medicine assay licensee” means a person who holds a licence to provide a nuclear medicine assay service;

“nuclear medicine imaging licensee” means a person who holds a licence to provide a nuclear medicine imaging service;

“nuclear medicine technologist” means an individual who holds at least a diploma or degree in nuclear medicine technology;

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

“radiation safety officer” —

(a)	where a licensee uses any irradiating apparatus within the meaning given by regulation 2 of the Radiation Protection (Non‑Ionising Radiation) Regulations (Rg 1) — means an individual who is appointed by the licensee under regulation 40 of those Regulations as a radiation safety officer; or
(b)	in any other case — means an individual who is appointed by a licensee under regulation 53 of the Radiation Protection (Ionising Radiation) Regulations (Rg 2) as a radiation safety officer or deputy radiation safety officer;

“radiation therapist” means a duly qualified allied health professional who is registered under the Allied Health Professions Act 2011 to practise radiation therapy;

“radiopharmaceutical” means any radioactive material that is administered to a patient as a diagnostic or therapeutic agent;

“requestor” —

(a)	in relation to a test of a patient that is provided as part of a nuclear medicine assay service — means a collaborative prescribing practitioner, dentist or medical practitioner who ordered that test for the patient; or
(b)	in relation to an examination of a patient that is provided as part of a nuclear medicine imaging service — means a dentist or medical practitioner who ordered that examination for the patient;

“service modality” has the meaning given by regulation 4(3);

“specimen” means any matter derived from the body of an individual;

“test” means an analysis or examination of a specimen conducted by a nuclear medicine assay licensee in the licensed premises of or licensed conveyance used by the licensee in connection with the provision of a nuclear medicine assay service;

“test panel”, in relation to a nuclear medicine assay service, means a set of 2 or more tests provided as part of that service.

Application of Regulations

3. Unless otherwise expressly provided in these Regulations, the provisions of these Regulations —

(a)	apply in addition to the provisions of the General Regulations; and
(b)	prevail if, and to the extent that, there is any inconsistency between these Regulations and the General Regulations insofar as the matter relates to a licensee.

Specific services provided under licence

4.—(1) For the purposes of section 10(2)(c)(viii) of the Act, an applicant for the grant or renewal of a licence to provide an applicable service must specify in the licence application every service modality that the applicant provides, or intends to provide, as part of that service.

(2) A licensee who intends to provide any additional service modality as part of the applicable service must, no later than one month before the licensee intends to start providing that service modality, give written notice to the Director of the licensee’s intention.

(3) In this regulation, “service modality” —

(a)

in relation to a nuclear medicine assay service, includes in‑vitro assay; and

(b)

in relation to a nuclear medicine imaging service, includes the following:

(i)	planar nuclear medicine imaging and uptake studies;
(ii)	positron emission tomography‑computed tomography;
(iii)	positron emission tomography‑magnetic resonance;
(iv)	single-photon emission computed tomography‑computed tomography.

Made on 28 December 2021.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/12 Vol. 1]

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