Healthcare Services (Outpatient Medical Service) Regulations 2023

No. S 410

Healthcare Services Act 2020

Healthcare Services
(Outpatient Medical 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 (Outpatient Medical Service) Regulations 2023 and come into operation on 26 June 2023.

Definitions

2.—(1)  In these Regulations —

“allied health professional” has the meaning given by section 2 of the Allied Health Professions Act 2011;

“blood transfusion service” means —

(a) the collection of whole blood, or any blood component or product that is derived from plasma, red blood cells, white blood cells or platelets from an individual for the purpose of administering it to that individual (as a patient) or another patient;

(b) the administration to a patient, by bolus injection or continuous infusion, of either or both of the following, whether obtained from the patient or one or more other individuals:

(i) whole blood;

(ii) any blood component or product that is derived from plasma, red blood cells, white blood cells or platelets; and

(c) the temporary storage of any whole blood or blood component or product that is derived from plasma, red blood cells, white blood cells or platelets for the purpose mentioned in paragraph (a) or (b);

“collaborative prescribing practitioner” and “collaborative prescribing service” have the meanings given by regulation 2 of the Healthcare Services (Collaborative Prescribing Service) Regulations 2023 (G.N. No. S 398/2023);

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

“enrolled nurse” means a person who is an enrolled nurse within the meaning of the Nurses and Midwives Act 1999 and holds a valid practising certificate under that Act;

“essential life‑saving measure” means any basic emergency procedure that may be carried out on a person for the purpose of resuscitating the person;

“expiry date” has the meaning given by regulation 2 of the General Regulations;

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

“haematology service” means the diagnosis or treatment by a medical practitioner who is registered under section 22 of the Medical Registration Act 1997 as a specialist in haematology, of a patient who has a disorder of the blood or bone marrow;

“healthcare professional” has the meaning given by regulation 2 of the General Regulations;

“health product” has the meaning given by section 2(1) of the Health Products Act 2007;

“licensee” means a person who holds a licence to provide an outpatient medical service;

“medicinal product” has the meaning given by section 3 of the Medicines Act 1975;

“MediShield Life Scheme” means the MediShield Life Scheme established by section 3 of the MediShield Life Scheme Act 2015;

“minor surgical procedure” has the meaning given by paragraph 2 of the First Schedule to the Act;

“nurse” means a registered nurse or an enrolled nurse;

“oncology service” means the diagnosis and treatment by a medical practitioner who is registered under section 22 of the Medical Registration Act 1997 as a specialist in oncology, of a person who has cancer;

“outpatient medical service” has the meaning given by paragraph 2 of the First Schedule to the Act;

“patient health record” means a record containing the personal data and medical information of a patient that is maintained by a licensee in relation to the provision of an outpatient medical service to the patient;

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

“pharmacist” means a person who is registered under the Pharmacists Registration Act 2007 and holds a valid practising certificate under that Act;

“registered nurse” means a person who is a registered nurse within the meaning of the Nurses and Midwives Act 1999 and holds a valid practising certificate under that Act;

“remote service kiosk”, in relation to the provision of an outpatient medical service by a licensee by remote provision, means an equipment or facility that —

(a) is provided by the licensee for any patient to receive the outpatient medical service by remote provision; and

(b) may include a booth or a vending machine or any similar equipment which dispenses any medicinal product or health product that is prescribed for the patient, or both;

“simple in vitro diagnostic test” has the meaning given by paragraph 2 of the First Schedule to the Act;

“software application” means a software application that operates on any computer or mobile device such as a smartphone;

“specimen” has the meaning given by regulation 2 of the General Regulations;

“temporary premises” means any premises other than permanent premises;

“testing material” means any test kit, material, device, equipment, instrument or other article that is used to conduct a simple in vitro diagnostic test.

(2)  For the purposes of these Regulations, a licensee is not to be treated as providing any outpatient medical service by remote provision to a patient, merely because —

(a) the licensee provides any information and communication technology to the patient to enable the transmission of data related to the patient’s health status between the patient and the licensee and the monitoring of the patient’s health by the licensee; or

(b) the licensee communicates with the patient remotely for administrative matters, including (but not limited to) the arrangement of the date of the patient’s next medical appointment.

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.

PART 2

LICENSING MATTERS

Specified services

4.  For the purposes of section 9A(1) of the Act, the services set out in paragraph 1 of the First Schedule are specified services for an outpatient medical service.

Prohibited service delivery modes

5.—(1)  A licensee must not provide an outpatient medical service using a conveyance that is not a vehicle.

(2)  A licensee must not provide a specified service set out in the first column of the Second Schedule by the service delivery mode or modes set out in the second column of that Schedule that corresponds with that specified service.

Prerequisites for application for approval of specified service

6.  A licensee may apply for approval to provide a blood transfusion service as a specified service for an outpatient medical service only if, in the course of providing the outpatient medical service, the licensee also provides, or intends to also provide, an oncology service or haematology service.

PART 3

REQUIREMENTS RELATING TO PERSONNEL

Qualifications, skills and competencies of Clinical Governance Officer

7.  For the purposes of section 24(3)(b) of the Act, an individual is suitably qualified to be appointed as a Clinical Governance Officer for an outpatient medical service or a specified service for an outpatient medical service if the individual —

(a) is registered under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner and holds a valid practising certificate under that Act;

(b) has one of the following:

(i) registration under section 22 of the Medical Registration Act 1997 as a specialist in any branch of medicine;

(ii) registration under section 22A of the Medical Registration Act 1997 as a family physician in the Register of Family Physicians;

(iii) full‑time work experience as a medical practitioner for a continuous period of at least 5 years or an aggregate period of at least 5 years during a continuous period of 10 years, in treating patients —

(A) in the provision of an outpatient medical service, outpatient renal dialysis service, acute hospital service or a community hospital service provided in a private hospital, medical clinic or healthcare establishment (as the case may be) licensed under the repealed Act; or

[S 840/2023 wef 18/12/2023]

(B) in the provision of an outpatient medical service, outpatient renal dialysis service, acute hospital service or a community hospital service licensed under the Act; and

(c) where the licensee is approved to provide an outpatient medical service by remote provision — has completed any course or programme relating to the remote provision of an outpatient medical service, that may be specified by the Director‑General.

General requirements relating to personnel

8.—(1)  A licensee must —

(a) establish, implement and regularly review policies and the appropriate processes for the training and competency assessment of the licensee’s personnel to ensure that the personnel are able to perform their work effectively, safely and in compliance with the applicable laws, guidelines, policies, processes, procedures and protocols; and

(b) monitor and regularly review the work performance of the licensee’s personnel to ensure compliance by the personnel with the applicable laws, guidelines, policies, processes, procedures and protocols.

(2)  A licensee who is approved to provide an outpatient medical service by remote provision must ensure that every medical practitioner or collaborative prescribing practitioner employed or engaged by the licensee and involved or intended to be involved in the remote provision, completes any training or course relating to the remote provision of an outpatient medical service, that may be specified by the Director‑General.

No employment or engagement of unauthorised persons to practise medicine

9.  A licensee must not employ or engage any person to practise medicine or do any act as a medical practitioner unless the person is a medical practitioner.

PART 4

PREMISES, CONVEYANCES, EQUIPMENT, ETC.

Standards for approved permanent premises

10.  A licensee must —

(a) ensure that every approved permanent premises is sufficiently spacious and appropriately equipped to enable the outpatient medical service (including any essential life‑saving measure) to be provided to patients in a proper, effective and safe manner;

(b) ensure that there is sufficient lighting and ventilation at every approved permanent premises;

(c) ensure that every approved permanent premises is designed, built and equipped to enable and facilitate —

(i) access to and from the approved permanent premises by patients with physical disability; and

(ii) movement within the approved permanent premises by patients with physical disability;

(d) if the licensee designates a separate area (called in this regulation the waiting area), whether inside or outside the approved permanent premises, where a patient may wait to receive the outpatient medical service or for any matter that is related to the provision of the outpatient medical service by the licensee, including making payment or collecting medicine, ensure that the waiting area is —

(i) within the direct line of sight of at least one personnel; and

(ii) sufficiently spacious and adequately equipped to ensure the reasonable comfort of every patient waiting in the waiting area;

(e) ensure that toilet facilities are available in every approved permanent premises, or assistance with toileting needs is provided to patients where needed;

(f) ensure that any care or treatment (other than an essential life‑saving measure) is provided to a patient only in an area at the approved permanent premises that is sufficiently spacious, appropriately equipped and, if necessary, partitioned (whether on a permanent or temporary basis) from the other parts of the approved permanent premises to ensure the patient’s comfort, safety and privacy; and

(g) prevent unauthorised access to every approved permanent premises.

Standards for approved conveyances

11.  A licensee must —

(a) ensure that every approved conveyance is sufficiently spacious and appropriately equipped to enable the outpatient medical service (including any essential life‑saving measure) to be provided to patients in a proper, effective and safe manner;

(b) ensure that there is sufficient lighting and ventilation in every approved conveyance;

(c) ensure that every approved conveyance is sufficiently spacious to enable at least one patient (whether or not disabled) to move into and within the approved conveyance and receive care and treatment from such number of personnel of the licensee as may be necessary, whether the patient is standing up, sitting or lying down;

(d) ensure that every approved conveyance is designed, built and equipped to enable and facilitate —

(i) access to and from the approved conveyance by patients with physical disability; and

(ii) movement within the approved conveyance by patients with physical disability;

(e) if the licensee designates a separate area (called in this regulation the waiting area), whether inside or outside the approved conveyance, where a patient may wait to receive the outpatient medical service or for any matter that is related to the provision of the outpatient medical service by the licensee, including making payment or collecting medicine, ensure that the waiting area is —

(i) within the direct line of sight of at least one personnel; and

(ii) sufficiently spacious and adequately equipped to ensure the reasonable comfort of every patient waiting in the waiting area;

(f) ensure that assistance with toileting needs is provided to patients where needed;

(g) ensure that there is a fire extinguisher in every approved conveyance;

(h) ensure that care or treatment (other than an essential life‑saving measure) is provided to a patient only in an area within the approved conveyance that is sufficiently spacious, appropriately equipped and, if necessary, partitioned (whether on a permanent or temporary basis) from the other parts of the approved conveyance to ensure the patient’s comfort, safety and privacy;

(i) ensure that every approved conveyance is not used for any purpose other than to provide the outpatient medical service by the licensee;

(j) prevent unauthorised access to every approved conveyance; and

(k) cause to be conspicuously displayed on every approved conveyance the business name by which the licensee provides the outpatient medical service.

Standards for facilities and equipment — general

12.—(1)  A licensee must ensure that every equipment or facility that is used in the licensee’s provision of the outpatient medical service is safe and effective.

(2)  Without limiting paragraph (1), a licensee must ensure that —

(a) every equipment or facility must be installed, and used or operated properly, in accordance with the instructions of the manufacturer of the equipment or facility;

(b) where the licensee is approved to provide the outpatient medical service using an approved conveyance, every equipment, instrument, appliance, material or facility that is necessary for the provision of the outpatient medical service is —

(i) fit for use in the approved conveyance;

(ii) if necessary, calibrated for use in the approved conveyance; and

(iii) securely fastened or stored in a manner so as not to pose a threat or risk to the safety of any person in the approved conveyance while the approved conveyance is in motion;

(c) where the licensee is approved to provide the outpatient medical service by remote provision — every equipment, instrument, appliance, material or facility that is necessary for the provision of the outpatient medical service by remote provision is checked regularly, and maintained properly and according to the manufacturer’s specification, so as to ensure that it is adequate, functional and effective; and

(d) where the possession, use or operation of any equipment or facility requires any certification or licence, at all times when the licensee is in possession of the equipment or facility —

(i) the licensee holds the valid certification or licence for the possession, use or operation of the equipment or facility; and

(ii) the equipment or facility is checked regularly, and maintained properly and according to the manufacturer’s specification, so as to ensure that it is adequate, functional and effective.

Standards for facilities and equipment — remote service kiosks

13.  Where a licensee is approved to provide an outpatient medical service by remote provision and the licensee carries out or intends to carry out the remote provision through one or more remote service kiosks, the licensee must —

(a) ensure that every remote service kiosk is kept clean and sanitary, by establishing, implementing and regularly reviewing measures and processes for regular cleaning and additional ad-hoc cleaning to minimise the spread of pathogenic organisms;

(b) ensure that every remote service kiosk is sufficiently spacious and appropriately equipped to enable the outpatient medical service to be provided to patients in a proper, effective and safe manner;

(c) ensure that the remote service kiosk is appropriately equipped to ensure every patient’s privacy and confidentiality of the process during which the outpatient medical service is provided to the patient;

(d) where a remote service kiosk includes a booth for a patient to receive the outpatient medical service, ensure that the booth has sufficient lighting and ventilation;

(e) regularly check and properly maintain every remote service kiosk so as to ensure that the remote service kiosk is at all times in a good state of repair;

(f) keep and maintain proper and accurate records of every check and maintenance that is conducted on every remote service kiosk under paragraph (e);

(g) where a remote service kiosk includes a vending machine or similar equipment which dispenses medicinal products or health products, prevent unauthorised access to the medicinal products or health products; and

(h) cause to be conspicuously displayed at or on the remote service kiosk —

(i) the business name by which the licensee provides the outpatient medical service;

(ii) the email address or telephone number at which the licensee may be contacted;

(iii) a statement that the remote service kiosk is being used by the licensee to provide the outpatient medical service by remote provision; and

(iv) a statement that any person who needs any essential life‑saving measure should not seek to receive such measure by remote provision from the licensee.

Environment cleaning

14.  A licensee must ensure that every approved permanent premises and every approved conveyance (as the case may be) is kept clean and sanitary by establishing and implementing measures and processes for regular cleaning and additional ad hoc cleaning to minimise the spread of pathogenic organisms.

Infection control

15.  A licensee must prevent the occurrence of, or manage, control and contain the spread of any infection that is, or is suspected to be, connected with the licensee’s provision of an outpatient medical service at any approved permanent premises, temporary premises or using any approved conveyance by ensuring that —

(a) only equipment, material or article that is reprocessed through high‑level disinfection or sterilisation in accordance with the specifications by the manufacturer of the equipment, material or article (as the case may be) and is not subsequently contaminated, is used in any endoscopic, operative or any other invasive procedure on a patient;

(b) every equipment, material or article that is used in every endoscopic, operative or any other invasive procedure is —

(i) reprocessed through high‑level disinfection or sterilisation in accordance with the specifications by the manufacturer of the equipment, material or article, as the case may be; and

(ii) kept and stored under the appropriate conditions to ensure that the equipment, material or article remains fit for use until it is used in the next endoscopic, operative or invasive procedure; and

(c) every equipment that is used to reprocess or sterilise any other equipment, material or article is checked regularly and maintained properly in accordance with the specifications by the manufacturer of the equipment, so as to ensure its proper and effective operation.

 

Made on 20 June 2023.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/22 Vol. 1]