/akn/sg/act/sub_leg/2020/HSA-S423-2023

Healthcare Services (Community Hospital Service) Regulations 2023

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Type
Subsidiary Legislation
Status
In force
Enacted
2020
Sections
38

Quick answer

About this subsidiary legislation

Healthcare Services (Community Hospital Service) Regulations 2023 is Singapore Subsidiary Legislation, cited as Subsidiary Legislation HSA-S423-2023 2020, currently marked in force and first recorded in 2020.

Part 1

PRELIMINARY

Regulation 1

Citation and commencement

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These Regulations are the Healthcare Services (Community Hospital Service) Regulations 2023 and come into operation on 26 June 2023.

Regulation 2

Definitions

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In these Regulations, unless the context otherwise requires —“allied health professional” has the meaning given by section 2 of the Allied Health Professions Act 2011;“anaesthesia service” means a service that is provided to a patient undergoing a surgical or non‑surgical procedure, where the administration of an anaesthetic is required;“clinical privilege”, in relation to a medical practitioner or dentist, means the type or types of care, treatment or procedure that the medical practitioner or dentist is permitted to provide;“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);“compound”, in relation to a therapeutic product, means to formulate, mix, assemble, package or label the therapeutic product, with the intention of dispensing or administering the therapeutic product to a patient in accordance with the written instructions of a qualified practitioner;“community hospital service” has the meaning given by paragraph 2 of the First Schedule to the Act;“dietetic service” means any of the following:

(a)

assessing and determining a patient’s nutritional needs;

(b)

formulating and implementing a dietetic plan for a patient; (c)assisting a patient in making dietary changes to promote and optimise the overall health of the patient; “duly qualified allied health professional” has the meaning given by section 3 of the Allied Health Professions Act 2011;“emergency ambulance service” has the meaning given by paragraph 2 of the First Schedule to the Act;“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;“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);“haemodialysis” has the meaning given by paragraph 2 of the First Schedule to the Act;“health product” has the meaning given by section 2(1) of the Health Products Act 2007;“healthcare professional” has the meaning given by regulation 2 of the General Regulations;“licensee” means a person who holds a licence to provide a community hospital service;“medical condition”, in relation to a patient, includes the patient’s dental condition;“medical transport service” has the meaning given by paragraph 2 of the First Schedule to the Act;“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;“nursing personnel” means a registered nurse, an enrolled nurse or any other person who assists a registered nurse or an enrolled nurse in providing nursing care to patients;“nursing service” means the provision of nursing care to a patient to assist the patient in attaining, maintaining or recovering his or her health;“nutrition service” means the provision of food to any patient at any approved permanent premises;“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 a community hospital service to the patient;“peritoneal dialysis support” has the meaning given by paragraph 2 of the First Schedule to the Act;“personnel”, in relation to a licensee, means any individual employed or engaged by the licensee to assist the licensee in providing a community hospital service;“pharmaceutical service” means —

(a)

the procurement, storage and control, dispensing, distribution, supply and administration of medicinal products and health products stored at any approved permanent premises;

(b)

the preparation of medicinal products or health products, other than the compounding of therapeutic products, at any approved permanent premises; and

(c)

the counselling and monitoring of patient drug therapy;“pharmacist” means a person who is registered as a pharmacist under the Pharmacists Registration Act 2007 and holds a valid practising certificate under that Act;“practice of dentistry” has the meaning given by section 2 of the Dental Registration Act 1999;“qualified practitioner” means —

(a)

a medical practitioner; or

(b)

a registered dentist under the Dental Registration Act 1999 whose name appears in the first division of the Register of Dentists maintained and kept under section 13(1)(a) of 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;“rehabilitative service” means assisting or facilitating a patient in —

(a)

regaining the patient’s physical or cognitive ability that has been lost or impaired as a result of disease, injury or treatment; or

(b)

returning to the patient’s daily life and living in a normal or near‑normal way, and includes physical therapy, occupational therapy, speech and language therapy and cognitive therapy;“renal dialysis service” means the provision of haemodialysis or peritoneal dialysis support by a licensee only to patients who are admitted by the licensee to the licensee’s approved permanent premises, and includes the provision of any healthcare service that is incidental to the provision of haemodialysis or peritoneal dialysis support, other than a clinical laboratory service or radiological service;“resuscitation service” means the treatment of, or implementation of an emergency procedure on, a person for the purpose of resuscitating the person;“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Health Products Act 2007.

Definition

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

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Definition

“anaesthesia service” means a service that is provided to a patient undergoing a surgical or non‑surgical procedure, where the administration of an anaesthetic is required;

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Definition

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

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Definition

“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);

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Definition

“compound”, in relation to a therapeutic product, means to formulate, mix, assemble, package or label the therapeutic product, with the intention of dispensing or administering the therapeutic product to a patient in accordance with the written instructions of a qualified practitioner;

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Definition

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

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Definition

“dietetic service” means any of the following:

(a)

assessing and determining a patient’s nutritional needs;

(b)

formulating and implementing a dietetic plan for a patient; (c)assisting a patient in making dietary changes to promote and optimise the overall health of the patient;

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Definition

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

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Definition

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

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Definition

“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;

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Definition

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

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Definition

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

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Definition

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

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Definition

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

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Definition

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

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Definition

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

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Definition

“medical condition”, in relation to a patient, includes the patient’s dental condition;

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Definition

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

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Definition

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

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Definition

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

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Definition

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

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Definition

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

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Definition

“nursing personnel” means a registered nurse, an enrolled nurse or any other person who assists a registered nurse or an enrolled nurse in providing nursing care to patients;

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Definition

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

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Definition

“nutrition service” means the provision of food to any patient at any approved permanent premises;

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Definition

“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 a community hospital service to the patient;

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Definition

“peritoneal dialysis support” has the meaning given by paragraph 2 of the First Schedule to the Act;

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Definition

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

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Definition

“pharmaceutical service” means —

(a)

the procurement, storage and control, dispensing, distribution, supply and administration of medicinal products and health products stored at any approved permanent premises;

(b)

the preparation of medicinal products or health products, other than the compounding of therapeutic products, at any approved permanent premises; and

(c)

the counselling and monitoring of patient drug therapy;

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Definition

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

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Definition

“practice of dentistry” has the meaning given by section 2 of the Dental Registration Act 1999;

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Definition

“qualified practitioner” means —

(a)

a medical practitioner; or

(b)

a registered dentist under the Dental Registration Act 1999 whose name appears in the first division of the Register of Dentists maintained and kept under section 13(1)(a) of that Act;

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Definition

“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;

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Definition

“rehabilitative service” means assisting or facilitating a patient in —

(a)

regaining the patient’s physical or cognitive ability that has been lost or impaired as a result of disease, injury or treatment; or

(b)

returning to the patient’s daily life and living in a normal or near‑normal way, and includes physical therapy, occupational therapy, speech and language therapy and cognitive therapy;

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Definition

“renal dialysis service” means the provision of haemodialysis or peritoneal dialysis support by a licensee only to patients who are admitted by the licensee to the licensee’s approved permanent premises, and includes the provision of any healthcare service that is incidental to the provision of haemodialysis or peritoneal dialysis support, other than a clinical laboratory service or radiological service;

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Definition

“resuscitation service” means the treatment of, or implementation of an emergency procedure on, a person for the purpose of resuscitating the person;

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Definition

“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Health Products Act 2007.

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Regulation 3

Application of Regulations

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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

Regulation 4

Specified service

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For the purposes of section 9A(1) of the Act, the services set out in paragraph 1 of the Schedule are specified services for a community hospital service.

Regulation 5

Prohibited service delivery modes

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A licensee must not provide a community hospital 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

REQUIREMENTS RELATING TO PERSONNEL

Regulation 6

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

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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.

Regulation 7

Licensee must establish credentialing framework

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Subregulation 1

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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.

Subregulation 2

Suggest a correction

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 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.

Subregulation 3

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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

APPROVED PERMANENT PREMISES, EQUIPMENT, ETC.

Regulation 8

Approved permanent premises, equipment, etc.

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Subregulation 1

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A licensee must ensure that —

(a)

every approved permanent premises is operating at all times;

(b)

every approved permanent premises is designed and built in a manner that provides a proper, safe and conducive environment for the treatment of every patient, including a patient who suffers from a physical disability; (c)every approved permanent premises is adequately and properly equipped to address the mobility requirements of every patient, including a patient who suffers from a physical disability; and

(d)

a security system is established and implemented at every approved permanent premises to ensure the safety of the personnel, patients and visitors at every approved permanent premises.

Subregulation 2

Suggest a correction

A licensee must —

(a)

ensure that there is a process to facilitate prompt access to adequate supplies of equipment, materials and other supplies which are necessary for the provision of any community hospital service in a proper, effective and safe manner; and

(b)

where there is any instruction manual for any equipment or material mentioned in sub‑paragraph (a) — ensure that the instruction manual is made available for reference by any personnel who uses or intends to use the equipment or material.

Regulation 9

Backup utilities

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Subregulation 1

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A licensee must ensure that there is access to emergency power and lighting in every approved permanent premises to ensure the provision of a community hospital service in a proper, effective and safe manner.

Subregulation 2

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

(a)

the emergency power and lighting are sufficient to ensure that any procedure that has commenced may be safely completed; and

(b)

where any life support equipment is used, the life support equipment is connected to an emergency power supply at all times during its use.

Regulation 10

Notification of addition or removal of beds

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A licensee who intends to add or remove a bed at any approved permanent premises used for the provision of a community hospital service must, no later than 2 months before the bed is added or removed, notify the Director‑General of the intended addition or removal.

Part 5

REQUIREMENTS RELATING TO PATIENT CARE

Regulation 11

General requirements relating to patient care

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Subregulation 1

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A licensee must ensure that every patient is properly assessed and the appropriate care or treatment is provided to, or appropriate procedure is conducted on, the patient in a proper, effective and safe manner.

Subregulation 2

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A licensee must ensure the safety, comfort and privacy of every patient receiving care or treatment at any approved permanent premises.

Regulation 12

Staffing requirements

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Subregulation 1

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A licensee must ensure that there is an adequate number of personnel present at every approved permanent premises so as to enable the licensee to provide a community hospital service to every patient at those premises in a proper, effective and safe manner.

Subregulation 2

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

(a)

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; and

(b)

every patient is assigned an attending medical practitioner who has overall responsibility for the patient’s general medical condition.

Regulation 13

Informed care

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Subregulation 1

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A licensee must inform a patient or (if the patient is a minor or lacks mental capacity) a next‑of‑kin or carer of the patient of the following matters, as soon as practicable:

(a)

any change in the patient’s medical condition or the occurrence of any incident, that requires the patient to receive a new or different type of care, treatment or procedure;

(b)

any change in the patient’s care plan that will result in the patient receiving a new or different type of care, treatment or procedure.

Subregulation 2

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Subject to paragraph (3), where a patient requires a new or different type of care, treatment or procedure, the licensee must (as soon as practicable but before the care or treatment is provided to, or the procedure is conducted on, the patient) obtain the consent from the patient or (if the patient is a minor or lacks mental capacity) a next‑of‑kin or carer of the patient for the provision of the care or treatment or the conduct of the procedure.

Subregulation 3

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Paragraph (2) does not apply if the patient is assessed by a medical practitioner to be in a critical condition and needs to receive the care, treatment or procedure without delay.

Regulation 14

Transport of patients

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A licensee must not permit any person to offer, or provide, an emergency ambulance service or a medical transport service to any of the licensee’s patients at any approved permanent premises if the person does not hold a licence under the Act to provide an emergency ambulance service or a medical transport service, as the case may be.

Regulation 15

Requirement to provide certain aspects of community hospital service

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In the course of providing a community hospital service at any approved permanent premises, a licensee must ensure that each of the following aspects of the service is available to every patient who requires it:

(a)

nursing service;

(b)

nutrition service;

(c)

pharmaceutical service;

(d)

resuscitation service.

Regulation 16

Nursing service

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Subregulation 1

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A licensee must ensure that there is an adequate number of nursing personnel —

(a)

present at every approved permanent premises; and

(b)

who have the appropriate qualifications, experience and competency to provide timely and appropriate nursing care to the licensee’s patients.

Subregulation 2

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A licensee must ensure that the provision of any nursing service at every approved permanent premises is —

(a)

in accordance with the policies and procedures mentioned in paragraph (3) and the approved standards of nursing practice; and

(b)

under the supervision of a registered nurse.

Subregulation 3

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A licensee must establish, implement and regularly review written policies and procedures to provide guidance for the provision of any nursing service, including —

(a)

the assignment of a suitable nurse who possesses the appropriate qualifications, experience, competency and skills, to take charge of the nursing care of a patient, taking into account the patient’s medical needs and condition;

(b)

the prompt recognition of any untoward change in a patient’s condition to facilitate any appropriate intervention by a medical practitioner or another personnel with the necessary qualifications, experience, competency and skills; and

(c)

the determination of the care, treatment or procedure that needs to be provided to a patient according to the change in the patient’s medical needs and condition.

Subregulation 4

Suggest a correction

A licensee must ensure that —

(a)

within a reasonable period of time after a patient is admitted by the licensee to any approved permanent premises, a registered nurse assesses the nursing needs of the patient;

(b)

a nursing care plan is proposed for the patient;

(c)

the nursing care plan includes measures to continuously evaluate the patient for the purpose of determining, at any time, the patient’s state of health and the quality of nursing service provided to the patient;

(d)

a nurse is charged with the implementation of the nursing care plan for the patient;

(e)

every nursing service must be carried out in accordance with the nursing care plan; and

(f)

the implementation of the nursing care plan and the patient’s response to any nursing service are documented in accordance with the approved standards of nursing practice.

Subregulation 5

Suggest a correction

A licensee must ensure that there are close supervision, adequate training and regular competency assessments of every nursing personnel so as to enable the personnel to provide nursing care in a proper, effective and safe manner.

Definition

“approved standards of nursing practice” means the standards established by the Singapore Nursing Board for the practice of nursing in Singapore;

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Definition

“Singapore Nursing Board” means the Singapore Nursing Board established under section 3 of the Nurses and Midwives Act 1999.

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Regulation 17

Nutrition service

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A licensee must —

(a)

where a dietetic plan is formulated for a patient, ensure that food for the patient that is prepared or otherwise provided by the licensee, is prepared or provided in accordance with the dietetic plan; and

(b)

ensure that food provided by the licensee to every patient is prepared and served in a safe and hygienic manner.

Regulation 18

Pharmaceutical service

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Subregulation 1

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A licensee must ensure that the provision of a pharmaceutical service at any approved permanent premises is in accordance with the policies and procedures mentioned in paragraph (2) and under the supervision of a pharmacist.

Subregulation 2

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A licensee must establish, implement and regularly review policies and procedures to provide guidance for the provision of any pharmaceutical service, including —

(a)

the storage, preparation, dispensing and administration of any medicinal product or health product;

(b)

the proper and accurate keeping and maintenance of records relating to the storage, preparation, dispensing and administration of any medicinal product or health product;

(c)

the prevention of any mix up, contamination, or early degradation of any medicinal product or health product that is stored or used at the approved permanent premises;

(d)

the measures to prevent any medicinal product or health product that has been recalled from its manufacturer, from being dispensed or distributed; and

(e)

informing every patient who has been dispensed or administered or has consumed the medicinal product or health product mentioned in sub‑paragraph (d) of the recall.

Subregulation 3

Suggest a correction

A licensee must ensure that —

(a)

there is an adequate supply of medicinal products and health products at every approved permanent premises where a pharmaceutical service is provided; and

(b)

the medicinal products and health products are properly stored at the approved permanent premises.

Regulation 19

Resuscitation service

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Subregulation 1

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A licensee must, at all times, be capable of providing any resuscitation service to any person at any approved permanent premises.

Subregulation 2

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Without limiting paragraph (1), a licensee must —

(a)

establish, implement and regularly review emergency procedures which would ensure —

(i)

the rapid and accurate assessment of any person who is in need of any resuscitation service (called in this regulation the patient); and

(ii)

the timely delivery of any resuscitation service to the patient to stabilise or resuscitate the patient;

(b)

for every approved permanent premises, ensure that adequate and appropriate facilities, equipment and drugs for the implementation of any emergency procedure are readily available in all areas where patients receive accommodation, care or treatment;

(c)

ensure that only resuscitation drugs that have not passed their expiry dates and are fit for use and resuscitation equipment that is fit for use are made available for use in the provision of any resuscitation service; and

(d)

ensure that every personnel who provides any resuscitation service to a patient is adequately trained —

(i)

to provide the resuscitation service in a proper, effective and safe manner; and

(ii)

in the use of the equipment that is needed to deliver the resuscitation service.

Regulation 20

Anaesthesia service

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A licensee must not administer, or cause or permit to be administered, any anaesthetic to cause general anaesthesia in any patient.

Regulation 21

Dietetic service

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Subregulation 1

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Where a patient, in the course of receiving a community hospital service from a licensee, requires the provision of a dietetic service, the licensee must —

(a)

provide the dietetic service to the patient at the licensee’s approved permanent premises; or

(b)

make arrangements for a dietitian (who is not the licensee’s personnel) to provide the dietetic service at premises other than the approved permanent premises.

Subregulation 2

Suggest a correction

For the purposes of providing a dietetic service to a patient under paragraph (1)(a), the licensee must —

(a)

assess the medical condition of the patient and determine whether a dietetic plan needs to be formulated for the patient; (b)where it is determined that a dietetic plan needs to be formulated for the patient, ensure that the dietetic plan is formulated taking into account the patient’s medical condition, and meets the patient’s nutritional requirements; and

(c)

ensure that a dietitian assesses the nutritional value of any food provided by the licensee to the patient.

Regulation 22

Rehabilitative service

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Subregulation 1

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A licensee must establish, implement and regularly review processes and procedures to assess every patient as to whether the patient requires any rehabilitative service, and (if the patient so requires) the patient’s suitability to receive the rehabilitative service.

Subregulation 2

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Where a patient is assessed by a licensee to require, and to be suitable to receive, a rehabilitative service, the licensee must —

(a)

provide the rehabilitative service to the patient at the licensee’s approved permanent premises; or

(b)

make arrangements for a duly qualified allied health professional (who is not the licensee’s personnel and is trained in rehabilitation) to provide the rehabilitative service to the patient at premises other than the approved permanent premises.

Subregulation 3

Suggest a correction

For the purposes of providing a rehabilitative service to a patient under paragraph (2)(a), the licensee must ensure that —

(a)

a rehabilitative plan, that has been approved or endorsed by a duly qualified allied health professional for that service, is proposed and communicated to the patient; and

(b)

the rehabilitative service is provided by a personnel who is trained in rehabilitation, and in accordance with the rehabilitative plan.

Regulation 23

Application of regulations 24 to 27

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Regulations 24 to 27 apply to a licensee who provides a renal dialysis service at any approved permanent premises.

Regulation 24

Patients must be monitored when undergoing haemodialysis

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Subregulation 1

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A licensee must ensure that every patient undergoing haemodialysis at any approved permanent premises is monitored by a nursing personnel or a medical practitioner so that the patient can receive the appropriate and timely medical care in the event the patient’s condition deteriorates.

Subregulation 2

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Without limiting paragraph (1), a licensee must —

(a)

implement protocols for the recognition of any deterioration in a patient’s condition, provision of medical care and escalation for further medical care;

(b)

ensure that every medical practitioner, registered nurse and enrolled nurse employed or engaged by the licensee for the provision of the renal dialysis service is familiar with the signs and symptoms of patient deterioration and is able to identify these signs and symptoms;

(c)

ensure that any deterioration in a patient’s condition is brought to the attention of the appropriate personnel in a timely manner; and

(d)

ensure that all dialysis machines are equipped with the appropriate equipment or device —

(i)

to enable the licensee’s personnel to visually monitor the clinical and dialysis parameters of a patient undergoing haemodialysis; and

(ii)

that will give an audiovisual alarm if there is any machine fault detected, or if the patient’s clinical or dialysis parameters fall outside of the acceptable range during haemodialysis.

Regulation 25

Standards for equipment for renal dialysis service

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Subregulation 1

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A licensee must ensure that every piece of equipment used by or on a patient in the licensee’s provision of the renal dialysis service is safe and effective for clinical use.

Subregulation 2

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

(a)

every part of any equipment (other than any part designed for single use only) is appropriately disinfected or sterilised in accordance with the specifications by the manufacturer of the equipment before and after it is used for dialysis;

(b)

each equipment is installed, and used or operated properly, in accordance with the instructions of the manufacturer of the equipment; and

(c)

in relation to a licensee who provides haemodialysis —

(i)

where reusable dialysers are used — the dialysers are cleaned and prepared for reuse in the manner required or recommended in the manufacturer’s operator manual for the dialyser;

(ii)

any dialyser must only be used for one patient;

(iii)

each dialysis machine is drained, rinsed and disinfected after each dialysis, at the end of each day and at any other interval required or recommended in the manufacturer’s operator manual for the dialysis machine; and

(iv)

where there is a blood leak, the affected dialysis machine is rinsed and disinfected in the manner required or recommended in the manufacturer’s operator manual for the dialysis machine.

Regulation 26

Quality of water and dialysis fluid

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Subregulation 1

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A licensee who provides haemodialysis must ensure that any water or dialysis fluid used for haemodialysis meets the applicable chemical and microbiological standards, and is safe and appropriate for use.

Subregulation 2

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

(a)

the water used for haemodialysis is treated by reverse osmosis;

(b)

there are protocols and procedures on the collection and testing of the water and dialysis fluid;

(c)

the water and dialysis fluid are regularly tested for chemical and microbiological contaminants;

(d)

appropriate methods are used for the collection and testing of the water and dialysis fluid;

(e)

the water treatment equipment and haemodialysis water distribution systems are appropriately designed, built, and maintained to prevent treated water from being contaminated or exposed to the risk of being contaminated;

(f)

water treatment systems are isolated from the potable water supply;

(g)

the water treatment equipment and haemodialysis water distribution system include pressure gauges, flow meters, sample ports, and other ancillary equipment necessary to allow monitoring of the performance and the system as a whole;

(h)

there are protocols and procedures for the regular disinfection of all water treatment equipment and haemodialysis water distribution systems; and

(i)

records of each disinfection are kept.

Regulation 27

Prevention of transmission of blood borne viruses and pathogenic bacteria

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Subregulation 1

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A licensee who provides haemodialysis must ensure that there is no transmission of blood borne viruses and pathogenic bacteria between haemodialysis patients, and between any haemodialysis patient and any of the licensee’s personnel.

Subregulation 2

Suggest a correction

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

(a)

before a patient starts receiving haemodialysis, the patient must be tested to determine the level of each of the patient’s liver markers and for each specified infectious disease;

(b)

any patient who at any time has a liver marker which level is above the normal range or tests positive for any specified infectious disease is referred to an appropriate medical practitioner;

(c)

every specified patient receives haemodialysis in a different room or a physically segregated area from a patient who is not a specified patient;

(d)

for any period during which a licensee provides haemodialysis to a specified patient, any machine or equipment that has been used for a specified patient is not used for a patient who is not a specified patient;

(e)

where a dialyser has been used by a patient who has a specified infectious disease — the dialyser is not reused; and

(f)

where a dialysis machine has been used by a patient who has a specified infectious disease — the dialysis machine undergoes complete chemical disinfection after each such use, and the chemical disinfection is performed in accordance with the manufacturer’s recommendations.

Definition

“specified infectious disease” means any of the following infections:

(a)

Hepatitis B infection;

(b)

Hepatitis C infection;

(c)

human immunodeficiency virus infection;

Suggest a correction

Definition

“specified patient” means a patient with a Hepatitis B infection and is HbsAg positive or HBV DNA positive.

Suggest a correction

Regulation 28

Conduct of ultrasound imaging

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Subregulation 1

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A licensee must not conduct an ultrasound imaging on a patient unless a medical practitioner, dentist or collaborative prescribing practitioner who is the licensee’s personnel orders the ultrasound imaging for the patient.

Subregulation 2

Suggest a correction

A licensee must ensure that any ultrasound imaging conducted on a patient is conducted —

(a)

only as a service that is incidental to the provision of a community hospital service;

(b)

at the licensee’s approved permanent premises; and

(c)

by a personnel of the licensee, who has the appropriate qualifications, skills and competencies to conduct the ultrasound imaging.

Regulation 29

Testing of specimen

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A licensee must not test any specimen for a patient unless —

(a)

a medical practitioner, dentist or collaborative prescribing practitioner who is the licensee’s personnel orders the test for the patient; (b)the testing of the specimen only involves the conduct of a simple in vitro diagnostic test; and

(c)

the testing of the specimen is provided only as a service incidental to the provision of a community hospital service.

Regulation 30

Conduct of simple in vitro diagnostic test

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Subregulation 1

Suggest a correction

A licensee must ensure that any simple in vitro diagnostic test on a specimen or a patient must be conducted —

(a)

using testing material in respect of which —

(i)

the expiry date has not passed; and

(ii)

the personnel who is administering the test does not suspect or have any reason to suspect that the testing material is no longer fit for use; and

(b)

in accordance with the instructions specified by the manufacturer of the testing material.

Subregulation 2

Suggest a correction

A licensee must ensure that any testing material that may be used to conduct any simple in vitro diagnostic testing is stored under the conditions, and handled in the manner, specified by the manufacturer of the testing material so as to lower the risk of contamination, unnecessary exposure of the testing material to the environment and early deterioration of the testing material.

Part 6

INFECTION CONTROL, INCIDENT MANAGEMENT AND EMERGENCY PREPAREDNESS

Regulation 31

Infection control obligation

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Subregulation 1

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Without limiting regulation 41 of the General Regulations, a licensee must —

(a)

establish an infection prevention and control programme (called in this regulation the IPC programme) that satisfies the conditions mentioned in paragraph (2);

(b)

appoint an infection prevention and control committee to assist the licensee in establishing, implementing and regularly reviewing the IPC programme;

(c)

ensure that the infection prevention and control committee comprises the appropriate number of personnel with the appropriate qualifications, skills and competencies for the purpose of carrying out the licensee’s functions mentioned in sub‑paragraph (b); (d)keep proper and accurate records of —

(i)

the implementation of the IPC programme; and

(ii)

every infection prevention and control activity carried out at the approved permanent premises;

(e)

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

(f)

ensure that 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 (g)ensure that 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.

Subregulation 2

Suggest a correction

For the purposes of paragraph (1)(a), the IPC programme must be in writing and include the following matters:

(a)

standard operating procedures relating to the infection prevention and control of any infection at the licensee’s approved permanent premises;

(b)

policies and guidelines relating to the prevention, identification, control and management and elimination of any infection that is acquired in or brought into the licensee’s approved permanent premises, including the practice of good hand hygiene and in the use of personal protective equipment;

(c)

policies and the appropriate processes for the training and competency assessment of the licensee’s personnel to ensure that the personnel are familiar with and are able to comply with the matters mentioned in sub‑paragraphs (a) and (b);

(d)

surveillance plans to monitor every incident at the licensee’s approved permanent premises that involves an epidemiologically important organism or an infection that is acquired at the approved permanent premises;

(e)

plans to carry out regular audits on the personnel, patients and environment of the licensee’s approved permanent premises to ensure that the IPC programme is being implemented effectively.

Regulation 32

Emergency management system

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Subregulation 1

Suggest a correction

A licensee must establish, implement and regularly review an effective command and control system to manage both of the following:

(a)

an emergency at the approved permanent premises;

(b)

a medical emergency in Singapore.

Subregulation 2

Suggest a correction

Without limiting paragraph (1), the licensee must —

(a)

establish and equip an operationally‑ready emergency response team to manage an emergency mentioned in that paragraph; (b)establish, implement and regularly review processes and procedures to control and manage an emergency, including any radiation emergency or incident;

(c)

with respect to a radiation emergency or incident, establish, implement and regularly review processes and procedures to prevent, identify, control and manage any radiation emergency or incident, including strategies to isolate every area or patient who is affected by radiation, setting up isolation facilities for every affected patient, and the use of equipment to prevent, control and manage the spread of radiation;

(d)

review the processes and procedures mentioned in sub‑paragraph (b) annually;

(e)

train every personnel who is deployed to the emergency response team in the processes and procedures mentioned in sub‑paragraph (b); and

(f)

participate in any exercise specified by the Director‑General that is for the purpose of evaluating the emergency preparedness and response capabilities of the healthcare system in Singapore.

Subregulation 3

Suggest a correction

In this regulation, “command and control system” means a system comprising personnel, procedures, equipment and facilities (including information management facilities) which are necessary for the purpose of conducting any emergency management operation.

Part 7

MISCELLANEOUS

Regulation 33

Keeping of other records

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A licensee must maintain proper, complete and accurate records in respect of all of the following:

(a)

the qualifications and competencies (including training and competency assessments) of each personnel, that are relevant to the provision of the community hospital service;

(b)

every programme, policy, system, measure, protocol or process that the licensee is required to implement under these Regulations, and every activity undertaken under that programme, policy, system, measure, protocol or process;

(c)

the installation, maintenance, servicing and repair of all equipment used in the provision of the community hospital service.

Regulation 34

Price transparency

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A licensee must, upon request by a patient or any person who intends to receive a community hospital service from the licensee, inform the patient or person (as the case may be) of the applicable charges (including any administrative fee) for the community hospital service.

Regulation 35

Display of charges, etc.

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Subregulation 1

Suggest a correction

A licensee must ensure that the fees charged by the licensee for a community hospital service are displayed or otherwise made available at every approved permanent premises.

Subregulation 2

Suggest a correction

The charges mentioned in paragraph (1) for a community hospital service must include —

(a)

the consultation fee that is applicable to the patient; and

(b)

the ward charges.

Regulation 36

Disclosure of approved institution status

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Subregulation 1

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A licensee who is an approved institution must display or otherwise make available at every approved permanent premises, the fact that the licensee is an approved institution.

Subregulation 2

Suggest a correction

A licensee who is not an approved institution must not —

(a)

represent to any person or give any person the impression that the licensee is an approved institution; or

(b)

otherwise mislead any person as to whether the licensee is an approved institution.

Subregulation 3

Suggest a correction

In this regulation, “approved institution” means any of the following:

(a)

an approved medical institution within the meaning of regulation 2(1) of the Central Provident Fund (Medisave Account Withdrawals) Regulations (Rg 17);

(b)

an approved medical institution approved by the Minister under the MediShield Life Scheme Act 2015;

(c)

an accredited medical institution under any public scheme providing financial assistance that is established by the Government.

Regulation 37

Financial counselling

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Subregulation 1

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A licensee must, before providing any care or treatment to, or conducting a procedure on, a patient, provide the information on the fees charged by the licensee for the care, treatment or procedure, to the patient or (if the patient is a minor or lacks mental capacity) a next‑of‑kin or carer of the patient.

Subregulation 2

Suggest a correction

For the purposes of paragraph (1), the information on the fees payable for the care, treatment or procedure must include —

(a)

the estimated price range of the fees for the care, treatment or procedure;

(b)

the fee benchmark for the same or similar care, treatment or procedure that is published on the website of the Ministry of Health at https://www.moh.gov.sg (if available); (c)whether any part of the fees mentioned in sub‑paragraph (a) may be —

(i)

deducted from any medisave account; (ii)reimbursed under the MediShield Life Scheme; or

(iii)

reduced by any subsidy or grant under a public scheme; and

(d)

any other benefit that the MediShield Life Scheme provides to the patient in respect of the care, treatment or procedure, if any.

Subregulation 3

Suggest a correction

A licensee need not comply with paragraph (1) if the patient is assessed by a medical practitioner to be in a critical condition and needs to receive the care, treatment or procedure without delay.

Subregulation 4

Suggest a correction

The licensee must, after providing the information mentioned in paragraph (2) to the patient or the next‑of‑kin or carer of the patient, obtain an acknowledgment from the patient, next‑of‑kin or carer (as the case may be) and keep the acknowledgment as part of the patient’s patient health record.

Subregulation 5

Suggest a correction

In this regulation, “medisave account” means a medisave account maintained under section 13 of the Central Provident Fund Act 1953.

Regulation 38

Offences

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Subregulation 1

Suggest a correction

A person who contravenes regulation 6, 8(1) or (2), 9(1) or (2), 11(1) or (2), 15, 19(1) or (2), 20, 24(1) or (2), 25(1) or (2), 26(1) or (2), 27(1) or (2) or 31(1) shall be guilty of an offence.

Subregulation 2

Suggest a correction

A person who is guilty of an offence under paragraph (1) shall be liable on conviction —

(a)

to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both; and

(b)

in the case of a continuing offence, to a further fine not exceeding $1,000 for every day or part of a day during which the offence continues after conviction.

Common questions

What is Healthcare Services (Community Hospital Service) Regulations 2023?
Healthcare Services (Community Hospital Service) Regulations 2023 is Singapore Subsidiary Legislation, cited as Subsidiary Legislation HSA-S423-2023 2020, currently marked in force and first recorded in 2020.
Is Healthcare Services (Community Hospital Service) Regulations 2023 still in force?
Yes — Healthcare Services (Community Hospital Service) Regulations 2023 is currently in force.
When did Healthcare Services (Community Hospital Service) Regulations 2023 take effect?
Healthcare Services (Community Hospital Service) Regulations 2023 was first recorded in 2020.
How many regulations does Healthcare Services (Community Hospital Service) Regulations 2023 have?
Healthcare Services (Community Hospital Service) Regulations 2023 contains 38 regulations.
Where can I read the official version of Healthcare Services (Community Hospital Service) Regulations 2023?
The official text of Healthcare Services (Community Hospital Service) Regulations 2023 is published at sso.agc.gov.sg.