Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021

No. S 1036

Healthcare Services Act 2020

(ACT 3 OF 2020)

Healthcare Services
(Clinical Laboratory Service and
Radiological 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 (Clinical Laboratory Service and Radiological 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 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;

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

“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 56C(6) of the Private Hospitals and Medical Clinics Regulations (Rg 1);

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

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

“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;

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

“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 to request a licensee to conduct a test for the patient without a referral by a medical practitioner, dentist or collaborative prescribing practitioner;

“specified test” has the meaning given by regulation 4(4);

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

“test” means an analysis or examination of a specimen conducted by a licensee in the licensee’s licensed premises in connection with the provision of the clinical laboratory service.

Application of Regulations

3. Unless otherwise expressly provided in these Regulations —

(a)	the provisions of these Regulations apply in addition to the provisions of the General Regulations; and
(b)	the provisions of these Regulations 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 a clinical laboratory service must specify in the licence application every laboratory discipline or specified test that the applicant provides, or intends to provide, as part of that service.

(2) 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 radiological service must specify in the licence application every imaging modality that the applicant provides, or intends to provide, as part of that service.

(3) A licensee who intends to provide any laboratory discipline, specified test or imaging modality (as the case may be) as part of the applicable service must, no later than one month before the licensee intends to start providing the laboratory discipline, specified test or imaging modality, give written notice to the Director of the licensee’s intention.

(4) In this regulation —

“imaging modality” includes —

(a)	plain X‑ray;
(b)	bone densitometry;
(c)	mammography;
(d)	fluoroscopy;
(e)	computed tomography;
(f)	cone beam computed tomography;
(g)	ultrasonography; and
(h)	magnetic resonance imaging;

“laboratory discipline” includes —

(a)	anatomic pathology;
(b)	chemical pathology;
(c)	clinical toxicology;
(d)	cytology;
(e)	cytogenetics;
(f)	haematology;
(g)	histocompatibility;
(h)	immunology;
(i)	medical microbiology;
(j)	transfusion medicine; and
(k)	molecular pathology;

“specified test” means any of the following:

(a)	human immunodeficiency virus screening;
(b)	human immunodeficiency virus confirmation;
(c)	pre‑implantation genetic testing for monogenic or single gene defects;
(d)	pre‑implantation genetic testing for chromosomal structural rearrangements;
(e)	acid‑fast bacilli smear testing;
(f)	glycated haemoglobin (haemoglobin A1c) testing;
(g)	malaria parasite testing;
(h)	molecular SARS‑CoV‑2 testing for Coronavirus Disease 2019 (COVID‑19).

Made on 28 December 2021.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/19 Vol. 1]

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