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No. S 1042

Healthcare Services Act 2020

(ACT 3 OF 2020)

Healthcare Services
(Exemption) Order 2021

In exercise of the powers conferred by section 53 of the Healthcare Services Act 2020, the Minister for Health makes the following Order:

Citation and commencement

1. This Order is the Healthcare Services (Exemption) Order 2021 and comes into operation on 3 January 2022.

Definitions

2. In this Order, unless the context otherwise requires —

“acute hospital” means a private hospital licensed as a medical hospital or a surgical hospital under section 7(1) of the Private Hospitals and Medical Clinics Act 1980;

“ad hoc blood donation site” means any premises —

(a)	that are used by a blood banking service licensee to enable the collection of blood; and
(b)	in respect of which the licensee is, due to circumstances beyond the licensee’s control, unable to apply under section 15(1)(a) of the Act to amend the licence to specify the premises in the licence earlier than one month before the date that the premises are to be used by the licensee;

“business name” has the meaning given by regulation 48(2) of the Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021);

“medical clinic” means any premises licensed to be used as a medical clinic under the Private Hospitals and Medical Clinics Act 1980.

Exemption relating to Clinical Governance Officers

3.—(1) Section 24(2) of the Act and regulation 5 of the Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021 (G.N. No. S 1036/2021) do not apply to a person (A) who holds a licence to provide a clinical laboratory service in respect of A’s appointment of an individual as a Clinical Governance Officer where the individual —

(a)	was, immediately before 3 January 2022, employed by A to manage any premises in which a clinical laboratory service is provided by A and continues to be so employed after that date; and
(b)	had, immediately before that date, held a valid licence under the Private Hospitals and Medical Clinics Act 1980 in relation to the use of the premises as a clinical laboratory.

(2) Paragraph (1) only applies so long as every laboratory discipline and specified test provided or that is to be provided as part of the clinical laboratory service was, immediately before 3 January 2022, also provided in the premises.

(3) Section 24(2) of the Act and regulation 6 of the Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021 do not apply to a person (B) who holds a licence to provide a radiological service in respect of B’s appointment of an individual as a Clinical Governance Officer where the individual —

(a)	was, immediately before 3 January 2022, employed by B to manage any premises in which a radiological service is provided by B and continues to be so employed after that date; and
(b)	had, immediately before that date, held a valid licence under the Private Hospitals and Medical Clinics Act 1980 in relation to the use of the premises as a clinical laboratory.

(4) Paragraph (3) only applies so long as every imaging modality provided or that is to be provided as part of the radiological service was, immediately before 3 January 2022, also provided in the premises.

(5) Section 24(2) of the Act and regulation 4 of the Healthcare Services (Cord Blood Banking Service) Regulations 2021 (G.N. No. S 1037/2021) do not apply to a licensee (C) in respect of C’s appointment of an individual as a Clinical Governance Officer where the individual —

(a)	was, immediately before 3 January 2022, employed by C to manage any premises in which a cord blood banking service is provided by C and continues to be so employed after that date; and
(b)	had, immediately before that date, held a valid licence under the Private Hospitals and Medical Clinics Act 1980 in relation to the use of the premises as a clinical laboratory.

(6) In this paragraph, “imaging modality”, “laboratory discipline” and “specified test” have the meanings given by regulation 4(4) of the Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021.

Exemption for business name used under Private Hospitals and Medical Clinics Act 1980

4.—(1) Section 29(1)(a) and (2) of the Act does not apply in relation to the use of a business name by a licensee who holds a licence under the Act for the provision of a licensable healthcare service specified in paragraph 1(a) or (b) of the First Schedule to the Act if —

(a)	the licensee had, immediately before 3 January 2022, held a valid PHMC licence; and
(b)	the licensee’s business name is identical to the business name used by the licensee under the PHMC licence,

for so long as the licensee continues to use that business name.

(2) In this paragraph, “PHMC licence” means a licence issued under section 6(2)(a) of the Private Hospitals and Medical Clinics Act 1980.

Exemption in relation to blood banking service provided in clinical laboratories and acute hospitals

5.—(1) Section 8 of the Act does not apply in relation to the provision of a blood banking service by a person who —

(a)

holds a valid licence to provide a clinical laboratory service;

(b)

provides the laboratory discipline of transfusion medicine in the provision of the clinical laboratory service; and

(c)

only carries out any one or more of the following activities in the provision of the blood banking service, for the purpose of providing the clinical laboratory service:

(i)	testing of blood or blood components;
(ii)	processing of blood or blood components;
(iii)	distribution of blood or blood components;
(iv)	storage of blood or blood components incidental to any activity mentioned in sub‑paragraphs (i), (ii) and (iii).

(2) Section 8 of the Act does not apply in relation to the provision of a blood banking service by a person who operates an acute hospital and only carries out any one or more, but not all, of the following activities in relation to blood or blood components for therapeutic transfusion, for the purpose of operating the acute hospital:

(a)	collection of blood or blood components;
(b)	distribution of blood or blood components;
(c)	storage of blood or blood components incidental to any activity mentioned in sub‑paragraph (a) or (b).

(3) Section 8 of the Act does not apply in relation to the provision of a blood banking service by a person who operates an acute hospital and who provides the blood banking service only to enable the therapeutic transfusion of blood or blood components collected from an individual (A) —

(a)	to A; or
(b)	to another individual specified by A.

Exemption in relation to blood banking service provided by medical clinic acting on behalf of licensee

6. Section 8 of the Act does not apply in relation to the provision of a blood banking service by a person who holds a valid licence for a medical clinic under the Private Hospitals and Medical Clinics Act 1980 in relation only to the carrying out of the following activities on behalf of another person who is licensed to provide a blood banking service:

(a)	collection of blood or blood components;
(b)	storage of blood or blood components incidental to sub‑paragraph (a).

Exemption in relation to blood banking service provided at ad hoc blood donation sites

7. Sections 9(1), 10(2)(c)(iv) and 15(1)(a) of the Act do not apply in relation to the provision of a blood banking service by a blood banking service licensee at an ad hoc blood donation site where only the following activities are carried out in the provision of the blood banking service at the ad hoc blood donation site:

(a)	collection of blood or blood components;
(b)	storage of blood or blood components incidental to sub‑paragraph (a).

Exemption in relation to clinical laboratory services provided by blood banking or cord blood banking licensee

8.—(1) Section 8 of the Act does not apply in relation to the provision of a clinical laboratory service by a person who holds a valid licence to provide a blood banking service and who —

(a)	conducts any test on any blood collected by the person as part of the person’s provision of a blood banking service, to ensure the suitability of the blood for transfusion; or
(b)	conducts any test on any blood collected from a donor or recipient to ensure the suitability of the donor’s blood for transfusion to the recipient, as part of the person’s provision of a blood banking service.

(2) Section 8 of the Act does not apply in relation to the provision of a clinical laboratory service by a person who —

(a)	holds a valid licence to provide a cord blood banking service; and
(b)	conducts any test on any cord blood collected by the person as part of the person’s provision of a cord blood banking service, to ensure the suitability of the cord blood for transplant.

Exemption in relation to clinical laboratory service provided by medical clinics

9. Section 8 of the Act does not apply in relation to the provision of a clinical laboratory service by a person who —

(a)	holds a valid licence to use any premises as a medical clinic under the Private Hospitals and Medical Clinics Act 1980;
(b)	provides a clinical laboratory service incidental to the provision of the services authorised under that Private Hospitals and Medical Clinics Act 1980 to be provided in the medical clinic by that person; and
(c)	complies with regulations 47 to 51 of the Private Hospitals and Medical Clinics Regulations (Rg 1).

Exemption in relation to certain licensable healthcare services provided by the National University of Singapore

10. Section 8 of the Act does not apply in relation to the provision of the following licensable healthcare services by the National University of Singapore:

(a)	clinical laboratory service;
(b)	radiological service;
(c)	nuclear medicine imaging service;
(d)	nuclear medicine assay service.

Exemption in relation to approved ART providers

11. Section 8 of the Act does not apply in relation to the provision of an antigen rapid test by an approved test provider under the Infectious Diseases (Antigen Rapid Test Providers) Regulations 2021 (G.N. No. S 267/2021).

Made on 29 December 2021.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/15 Vol. 1]