Healthcare Services (Ambulatory Surgical Centre Service) Regulations 2023

No. S 411

Healthcare Services Act 2020

Healthcare Services
(Ambulatory Surgical Centre 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 (Ambulatory Surgical Centre Service) Regulations 2023 and come into operation on 26 June 2023.

Definitions

2.  In these Regulations —

“acute hospital service licensee” means a person who is licensed to provide an acute hospital service;

“ambulatory surgical centre service” has the meaning given by paragraph 2 of the First Schedule to the Act;

“anaesthesiologist” means a medical practitioner who is registered under section 22 of the Medical Registration Act 1997 in the branch of anaesthesiology;

“clinical privilege”, in relation to a medical practitioner or dentist, means the type or types of relevant procedures that the medical practitioner or dentist is permitted to provide;

“clinical support personnel” means any individual (other than a medical practitioner or dentist) who is —

(a) a healthcare professional; or

(b) any other personnel of the licensee who is involved in providing care directly to any patient;

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

“deep sedation” means a drug‑induced depression of a patient’s consciousness —

(a) during which the patient cannot be easily aroused but will respond purposefully following repeated or painful stimulation;

(b) where the patient’s ability to independently maintain ventilatory function may be impaired;

(c) where the patient may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate; and

(d) where the patient’s cardiovascular function is usually maintained;

“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 anaesthesia” has the meaning given by paragraph 2 of the First Schedule to the Act;

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

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

“licensee” means a person who holds a licence to provide an ambulatory surgical centre service;

“neuraxial anaesthesia” means the anaesthesia that is caused in a patient by the administration of an anaesthetic around the nerves of the central nervous system of the patient;

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

“nursing service” means the provision of nursing care to a patient to assist the patient in attaining, maintaining or recovering his or her health;

“operating theatre” means a room with an aseptic environment that is equipped and designed to support the safe performance of any relevant procedure that requires general anaesthesia;

“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 ambulatory surgical centre 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 ambulatory surgical centre service;

“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;

“relevant healthcare provider” means —

(a) a person who is licensed to provide an ambulatory surgical centre service;

(b) a person who is licensed to provide an acute hospital service;

(c) a person who was licensed under the repealed Act to use any premises as a private hospital; or

[S 842/2023 wef 18/12/2023]

(d) a person who was, under the repealed Act —

(i) licensed to use any premises as a medical clinic; and

(ii) approved to provide ambulatory surgery at those premises;

[S 842/2023 wef 18/12/2023]

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

“scope of practice”, in relation to a licensee, means the type or types of relevant procedures provided by the licensee;

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

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

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

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 Schedule are specified services for an ambulatory surgical centre service.

Prohibited service delivery modes

5.  A licensee must not provide an ambulatory surgical centre service by any of the following service delivery modes:

(a) at any premises other than permanent premises;

(b) using a conveyance;

(c) by remote provision.

PART 3

GOVERNANCE OF SERVICE

Establishment of technical and clinical standards

6.—(1)  A licensee must establish, implement and regularly review technical and clinical standards to govern the provision of the ambulatory surgical centre service.

(2)  The licensee must ensure that —

(a) every personnel complies with the technical and clinical standards mentioned in paragraph (1);

(b) there is active management and review of the quality of clinical services and patient safety in the provision of the ambulatory surgical centre service; and

(c) the licensee’s clinical support personnel are provided with adequate training and subject to regular competency assessments to enable them to perform their work effectively, safely and in compliance with the applicable laws, guidelines, policies, processes, procedures and protocols.

(3)  A licensee must ensure that the following are documented:

(a) the technical and clinical standards mentioned in paragraph (1);

(b) every review conducted under paragraph (2)(b).

Licensee must appoint persons to oversee nursing services

7.  A licensee must appoint one or more persons to oversee the nursing services provided in the course of the licensee’s provision of the ambulatory surgical centre service, each of whom must be a registered nurse who has obtained post‑registration qualification in operating theatre nursing.

Composition of quality assurance committee

8.—(1)  Every quality assurance committee appointed by a licensee must comprise not fewer than —

(a) where the licensee only provides dental procedures — 3 dentists;

(b) where the licensee does not provide dental procedures — 3 medical specialists; or

(c) where the licensee provides both dental and non‑dental procedures — 3 dentists or medical specialists.

(2)  The quality assurance committee mentioned in paragraph (1) must comprise at least 3 members who each has at least 3 years’ experience providing surgical or dental surgical services on behalf of a relevant healthcare provider, among whom are members with the following qualifications, whichever is applicable:

(a) where the licensee only provides dental procedures —

(i) a dentist who is registered under section 14C(1) of the Dental Registration Act 1999 as a specialist in a branch of dentistry within the licensee’s scope of practice and has surgical experience; and

(ii) a dentist —

(A) who is not registered under section 14C(1) of the Dental Registration Act 1999 as a specialist;

(B) who is registered under section 14C(1) of the Dental Registration Act 1999 as a specialist in a branch of dentistry within the licensee’s scope of practice but in a different branch of dentistry from the dentist mentioned in sub‑paragraph (i); or

(C) who is not, for the period the dentist is a member of the committee, employed, engaged or accredited by the licensee;

(b) where the licensee does not provide dental procedures —

(i) a medical specialist who is registered under section 22 of the Medical Registration Act 1997 as a specialist in a branch of medicine within the licensee’s scope of practice; and

(ii) a medical specialist —

(A) who is registered under section 22 of the Medical Registration Act 1997 as a specialist in a branch of medicine within the licensee’s scope of practice but in a different branch of medicine from the medical practitioner mentioned in sub‑paragraph (i); or

(B) who is not, for the period the medical practitioner is a member of the committee, employed, engaged or accredited by the licensee;

(c) where the licensee provides both dental and non‑dental procedures —

(i) a dentist who is registered under section 14C(1) of the Dental Registration Act 1999 as a specialist in a branch of dentistry within the licensee’s scope of practice and has surgical experience;

(ii) a medical specialist who is registered under section 22 of the Medical Registration Act 1997 as a specialist in a branch of medicine within the licensee’s scope of practice; and

(iii) a dentist mentioned in sub‑paragraph (a)(ii)(A), (B) or (C) or a medical practitioner mentioned in sub‑paragraph (b)(ii)(A) or (B).

(3)  In this regulation, “medical specialist” means a medical practitioner who is registered under section 22(1) of the Medical Registration Act 1999 as a specialist.

Additional functions and duties of quality assurance committee

9.  Every quality assurance committee appointed by the licensee has the following functions and duties, in addition to the functions and duties under regulation 21(2) of the General Regulations:

(a) to grant clinical privileges to every medical practitioner and dentist before the licensee employs or engages the medical practitioner or dentist, in accordance with the framework established by the licensee under regulation 10;

(b) to recommend processes and procedures to the licensee to ensure that a dentist or medical practitioner only performs relevant procedures within the scope of the clinical privileges granted;

(c) to review any case where a medical practitioner or dentist is suspected to have performed a relevant procedure outside the scope of the clinical privileges granted;

(d) to review the pathological report for every procedure performed as part of the ambulatory surgical centre service, within 3 months after the date of the report;

(e) to review every case where blood transfusion was required during or after a procedure, within 4 months after the blood transfusion was performed;

(f) to document and keep records of every review mentioned in paragraph (c), (d) or (e).

Licensee must establish credentialing framework

10.—(1)  A licensee must establish and implement a credentialing framework for the grant of clinical privileges to every medical practitioner and dentist employed or engaged by the licensee, taking into account the professional qualifications, experience, competency and skills of the medical practitioner or dentist, as the case may be.

(2)   A licensee must —

(a) grant clinical privileges to a medical practitioner or dentist employed or engaged by the licensee in accordance with the framework mentioned in paragraph (1);

(b) regularly review the clinical privileges granted to the medical practitioner or dentist to ensure that he or she continues to have the necessary professional qualifications, experience, competency and skills to be so granted those clinical privileges; and

(c) ensure that the medical practitioner or dentist only provides care or treatment or performs procedures within the scope of the clinical privileges granted.

(3)  A licensee must regularly review the credentialing criteria, processes and procedures under the framework mentioned in paragraph (1) to ensure that they are up to date.

PART 4

REQUIREMENTS RELATING TO PERSONNEL

No employment or engagement of unauthorised persons to practise medicine or dentistry

11.  A licensee must not employ or engage any person —

(a) to practise medicine or do any act as a medical practitioner unless the person is a medical practitioner; or

(b) to practise dentistry unless the person is a dentist.

Qualifications, skills and competencies for Clinical Governance Officer

12.  For the purposes of section 24(3)(b) of the Act, an individual is suitably qualified to be appointed a Clinical Governance Officer for an ambulatory surgical centre service or a specified service for an ambulatory surgical centre service if the individual —

(a) where the licensee only provides dental procedures —

(i) is registered under section 14(1) or (2) of the Dental Registration Act 1999 as a fully registered dentist;

(ii) holds a valid practising certificate under the Dental Registration Act 1999; and

(iii) has either of the following:

(A) registration under section 14C(1) of the Dental Registration Act 1999 as a specialist;

(B) at least 5 years of full‑time work experience within a period of 10 years providing dental surgical services on behalf of a relevant healthcare provider; or

(b) in any other case —

(i) is registered under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;

(ii) holds a valid practising certificate under the Medical Registration Act 1997; and

(iii) has either of the following:

(A) registration under section 22 of the Medical Registration Act 1997 as a specialist;

(B) at least 5 years of full‑time work experience within a period of 10 years providing surgical services on behalf of a relevant healthcare provider.

Surgical assistants for procedures

13.—(1)  A licensee must ensure that the number, qualifications and experience of persons assisting in a surgical procedure is adequate and appropriate to the type and nature of the surgical procedure.

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

(a) where the surgical procedure is a dental procedure — there is at least one registered nurse or dental surgery assistant with relevant operating theatre experience of not less than 6 months assisting the dentist in the surgical procedure; and

(b) where the surgical procedure is not a dental procedure — there is at least one registered nurse with relevant operating theatre experience of not less than 6 months assisting the medical practitioner in the surgical procedure.

Staffing requirements for post‑operative patient care

14.  A licensee must ensure that —

(a) there is an adequate number of nurses at each of the licensee’s approved permanent premises to monitor every patient at those premises who has undergone a relevant procedure; and

(b) there is an adequate number of medical practitioners at each of the licensee’s approved permanent premises to assess every patient at those premises and provide medical care or intervention if necessary.

Standards for healthcare professionals

15.—(1)  A licensee must establish, implement and regularly review processes and standards for every area of work undertaken by personnel who are healthcare professionals and clinical support personnel.

(2)  Without limiting paragraph (1), the licensee must—

(a) establish, implement and regularly review processes and standards for healthcare professionals and clinical support personnel undertaking any activity in the licensee’s provision of the ambulatory surgical centre service in the following areas:

(i) preparation, dispensing and administration of medication;

(ii) collection, packing and labelling of specimens;

(iii) precautions to be taken to avoid contamination and degradation of specimens;

(iv) proper and safe use of medical and surgical equipment, instruments, appliances, materials and facilities;

(v) prevention, management, control and containment of the spread of any infection at those approved permanent premises; and

(b) ensure that each healthcare professional and clinical support personnel has demonstrated, and documented to have demonstrated, that he or she is able to implement the processes or standards relevant to the area of work undertaken by the healthcare professional or clinical support personnel.

PART 5

REQUIREMENTS FOR PREMISES AND EQUIPMENT

Premises must be set up appropriately

16.  A licensee must ensure that —

(a) each approved permanent premises is sufficiently spacious and appropriately equipped to enable the ambulatory surgical centre service (including any essential life‑saving measure) to be provided to a patient in a proper, effective and safe manner;

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

(c) 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; and

(d) toilet facilities are available in each approved permanent premises, or assistance with toileting needs is provided to patients where needed.

Pre‑operative waiting area

17.  A licensee must ensure that each approved permanent premises includes an area that is designated for the use of patients undergoing preparation before an operation.

Operating theatre

18.  A licensee must ensure that every operating theatre at each approved permanent premises is appropriately designed, built, furnished and equipped to enable the provision of the ambulatory surgical centre service in a proper, effective and safe manner.

Recovery area

19.—(1)  A licensee must ensure that there are adequate and proper facilities to accommodate patients after undergoing any relevant procedure involving the administration of anaesthetics.

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

(a) there is a bed available for each patient who undergoes a relevant procedure, for the patient to rest and recover after the relevant procedure;

(b) the premises include an area that is designated for the use of patients recovering after an operation;

(c) there is adequate resuscitative equipment in the area mentioned in sub‑paragraph (b); and

(d) there is adequate space for the movement of personnel for the monitoring of patients and treatment of complications.

Observation area

20.  A licensee must ensure that each approved permanent premises includes an area that is designated for the use of patients who have been moved out of the recovery area mentioned in regulation 19, where the patients are observed and monitored by the licensee’s personnel and in which there is —

(a) adequate furniture for patients to sit or lie down;

(b) monitoring equipment; and

(c) a resuscitation trolley.

Holding area

21.  A licensee must ensure that —

(a) each approved permanent premises includes an area that is designated to hold bodies in the event that there is a death on the premises; and

(b) the temperature in the area mentioned in paragraph (a) is maintained at 18ºC or below.

Environment cleaning

22.  A licensee must ensure that every approved permanent premises 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.

Equipment sterilisation to prevent infection

23.  A licensee must prevent the occurrence of, or manage, control or contain the spread of, any infection that is, or is suspected to be, connected with the provision of an ambulatory surgical centre service by ensuring the following:

(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;

(c) each 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/2020/24 Vol. 1]