Healthcare Services (Nuclear Medicine Service) Regulations 2023

No. S 412

Healthcare Services Act 2020

Healthcare Services
(Nuclear Medicine Service)
Regulations 2023

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 Service) Regulations 2023 and come into operation on 26 June 2023.

Definitions

2.—(1) In these Regulations —

“calendar day” includes Saturday, Sunday and every public holiday;

“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 licensee at any approved permanent premises of the licensee;

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

“imaging modality” means any imaging modality set out in paragraph 1 of the Schedule;

“in vivo assay procedure” means all of the following activities carried out by a licensee at any approved permanent premises of the licensee:

(a)	any process relating to the preparation, dispensing, radiolabelling, compounding and quality control of radiopharmaceuticals;
(b)	the administration of radiopharmaceuticals to a patient;
(c)	the derivation, after the administration of radiopharmaceuticals, of any specimen from the patient;

“irradiating apparatus”, “nuclear medicine service”, “radioactive material”, “radiopharmaceutical” and “simple in vitro diagnostic test” have the meanings given by paragraph 2 of the First Schedule to the Act;

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

“nuclear medicine imaging”, in relation to a nuclear medicine service, means the specified service for that service set out in paragraph 1 of the Schedule;

“nuclear medicine physician” means an individual who is registered under section 22 of the Medical Registration Act 1997 as a specialist in the branch of nuclear medicine;

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

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

“radiation safety officer” —

(a)	where a licensee uses any irradiating apparatus within the meaning given by regulation 2(1) 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 19 of the Radiation Protection (Ionising Radiation) Regulations 2023 (G.N. No. S 85/2023) 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;

“radioactive substance” has the meaning given by section 2(1) of the Radiation Protection Act 2007;

“requestor”, in relation to an examination, means a dentist or medical practitioner who ordered the examination for the patient;

“specimen” means any matter derived, obtained or excreted from the body of a patient for use in, or in connection with, the provision of a nuclear medicine service.

(2) For the purposes of these Regulations —

(a)

a nuclear medicine service is provided for an imaging purpose where the service is provided, through the use of an irradiating apparatus, for either of the following purposes:

(i)	the medical diagnosis of an individual;
(ii)	the monitoring of the effects of medical therapy on an individual;

(b)

a nuclear medicine service is provided for an in vivo assay purpose where the service is provided to enable or facilitate either of the following through the use of an assay:

(i)	the medical diagnosis of an individual;
(ii)	the monitoring of the effects of medical therapy on an individual; and

(c)

a nuclear medicine service is provided for a therapy purpose where the service is provided for the purpose of treating an ailment, or a condition, disease or disorder or an injury affecting any part of the body or mind of an individual.

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.

Notification of addition or removal of purposes for which nuclear medicine service provided

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 a nuclear medicine service must specify in the licence application every purpose for which the applicant provides, or intends to provide, the nuclear medicine service.

(2) A licensee that intends to provide a nuclear medicine service for any purpose which was not specified in the licence application mentioned in paragraph (1) must give written notice to the Director‑General of the licensee’s intention no later than 2 months before the licensee intends to start providing the nuclear medicine service for the purpose concerned.

(3) A licensee that intends to stop providing a nuclear medicine service for any purpose which was specified in the licence application mentioned in paragraph (1) must give written notice to the Director‑General of the licensee’s intention no later than 10 calendar days before the licensee intends to stop providing the nuclear medicine service for the purpose concerned.

Specified services

5.—(1) For the purposes of section 9A(1) of the Act, the services set out in the Schedule are specified services for a nuclear medicine service.

(2) For the purposes of section 11C(2)(d) of the Act, an applicant for approval to provide a specified service must specify every imaging modality that the licensee provides, or intends to provide, as part of the specified service.

(3) A licensee who is approved to provide nuclear medicine imaging and intends to provide any imaging modality which is not specified in the approval application mentioned in paragraph (2) must give written notice to the Director‑General of the licensee’s intention no later than 2 months before the licensee intends to start providing the imaging modality concerned.

(4) A licensee who is approved to provide nuclear medicine imaging and intends to stop providing any purpose which was specified in the approval application mentioned in paragraph (2) must give written notice to the Director‑General of the licensee’s intention no later than 10 calendar days before the licensee intends to stop providing the imaging modality concerned.

Prohibited service delivery modes

6. A licensee must not provide a nuclear medicine service —

(a)	at any premises other than permanent premises;
(b)	using a conveyance; or
(c)	by remote provision.

Made on 19 June 2023.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/31 Vol. 2]

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