Healthcare Services (Outpatient Renal Dialysis Service) Regulations 2023

No. S 409

Healthcare Services Act 2020

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

Definitions

2.  In these Regulations —

“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);

“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);

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

“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 renal dialysis service;

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

“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;

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

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

“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 the outpatient renal dialysis 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;

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

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

(a) Hepatitis B infection;

(b) Hepatitis C infection;

(c) human immunodeficiency virus infection;

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

“supervising nurse”, in relation to an outpatient renal dialysis service, means the person appointed under regulation 9(1) as the supervising nurse for the outpatient renal dialysis service;

“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.

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 outpatient renal dialysis service.

Prohibited service delivery mode

5.—(1)  A licensee must not provide an outpatient renal dialysis service using a conveyance.

(2)  A licensee must not provide high dependency haemodialysis at any premises other than permanent premises.

Particulars required for licence application

6.  For the purposes of section 10(2)(c)(viii) of the Act, an applicant for the grant or renewal of a licence to provide an outpatient renal dialysis service must, where the applicant provides or intends to provide haemodialysis, state the number of haemodialysis stations used or to be used in the provision of the service.

Notification of addition or removal of haemodialysis stations

7.  A licensee who intends to add or remove a haemodialysis station for the provision of the outpatient renal dialysis service must, no later than 2 months before the haemodialysis station is added or removed, notify the Director‑General of the intended addition or removal.

PART 3

REQUIREMENTS RELATING TO PERSONNEL

Qualifications, skills and competencies of Clinical Governance Officer

8.  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 renal dialysis service or a specified service for an outpatient renal dialysis 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;

(b) is registered under section 22 of the Medical Registration Act 1997 as a specialist in the branch of renal medicine; and

(c) has at least 2 years of continuous and full‑time work experience in treating patients —

(i) in the provision of a renal dialysis service provided in a private hospital or medical clinic licensed under the repealed Act;

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

(ii) in the provision of an outpatient renal dialysis service licensed under the Act; or

(iii) in the provision of a renal dialysis service as part of an acute hospital service or community hospital service licensed under the Act.

Licensee must appoint supervising nurse

9.—(1)  A licensee must appoint, as the supervising nurse for the outpatient renal dialysis service, a person who —

(a) is a registered nurse;

(b) where the licensee provides haemodialysis — fulfils either of the following requirements:

(i) is certified in renal nursing and has at least 2 years of full‑time work experience in providing nursing services in relation to haemodialysis;

(ii) has at least 3 years of full‑time work experience in providing nursing services in relation to haemodialysis;

(c) where the licensee provides peritoneal dialysis support — fulfils either of the following requirements:

(i) is certified in renal nursing and has at least 2 years of full‑time work experience in providing nursing services in relation to peritoneal dialysis support;

(ii) has at least 3 years of full‑time work experience in providing nursing services in relation to peritoneal dialysis support; and

(d) has demonstrated the ability to manage the provision of nursing services in support of an outpatient renal dialysis service, including making the arrangements for medical and nursing care to be promptly provided to patients where necessary.

(2)  For the purposes of paragraph (1), a person is certified in renal nursing if the person has completed a course in renal nursing or dialysis nursing that is conducted by an organisation accredited by the Singapore Nursing Board or National Nursing Academy.

Standards for nursing personnel

10.—(1)  A licensee must establish and implement nursing standards that set out the scope of services that may be provided by any nursing personnel employed or engaged by the licensee to support the provision of an outpatient renal dialysis service, and all the skills and competencies required for those services.

(2)  Without limiting paragraph (1), the nursing standards mentioned in that paragraph must —

(a) include a training framework to ensure that each nursing personnel has the skills and competencies required for the service the nursing personnel provides; and

(b) be approved by a Clinical Governance Officer or the supervising nurse.

(3)  A licensee must ensure that —

(a) before any nursing personnel undertakes an activity in the provision of nursing services, the nursing personnel first receives training on the nursing standards applicable to the activity;

(b) a nursing personnel who does not have the necessary skills or competencies to undertake an activity in the provision of nursing services does not undertake that activity;

(c) the supervising nurse verifies and certifies each course of instruction or other type of training related to the required skills and competencies that is completed by each nursing personnel; and

(d) the supervising nurse keeps a record of each course of instruction or other type of training mentioned in sub‑paragraph (c) in relation to each nursing personnel.

PART 4

REQUIREMENTS RELATING TO PATIENT CARE

Additional function and duty of quality assurance committee

11.  In addition to the functions and duties under regulation 21(2) of the General Regulations, every quality assurance committee appointed by a licensee must review each occurrence of a patient contracting a specified infectious disease in the course of receiving an outpatient renal dialysis service from the licensee, to —

(a) identify the cause of the occurrence; and

(b) recommend to the licensee new policies or procedures, or changes to policies or procedures, to minimise any such future occurrence.

General requirements relating to provision of patient care

12.—(1)  A licensee must ensure that every patient is properly assessed and the appropriate care and treatment is provided to the patient in a proper, effective and safe manner.

(2)  A licensee must ensure that no personnel provides a service or does an act beyond his or her professional expertise and qualifications.

Nursing services

13.—(1)  A licensee must ensure that there is an adequate number of nursing personnel —

(a) present at each approved permanent premises during the period when any outpatient renal dialysis service is provided at the approved permanent premises;

(b) available at all times to be present in person at any temporary premises to provide nursing care to any patient receiving haemodialysis at the temporary premises; and

(c) who have the appropriate qualifications, experience and competency to ensure that timely and appropriate nursing care is provided to the licensee’s patients.

(2)  Without limiting paragraph (1), the licensee must allocate the appropriate nursing personnel commensurate to the number and type of patients expected at each premises at which the licensee provides an outpatient renal dialysis service, to ensure the safe provision of the outpatient renal dialysis service.

Patients must be monitored when undergoing haemodialysis

14.—(1)  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.

(2)  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 outpatient 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.

Essential life‑saving measures must be available

15.—(1)  A licensee must —

(a) ensure that adequate and appropriate facilities, equipment and drugs for the provision of any essential life‑saving measure to a patient are readily available at every premises where the outpatient renal dialysis service is provided; and

(b) at all times, be capable of providing any essential life‑saving measures to any patient who is at risk of death.

(2)  Without limiting paragraph (1), a licensee must ensure the following:

(a) 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 essential life‑saving measure;

(b) the establishment and implementation of protocols for —

(i) the rapid and accurate assessment of any patient who presents symptoms of being or feeling unwell;

(ii) any medical emergency related to the conduct of haemodialysis; and

(iii) any medical emergency related to the conduct of peritoneal dialysis by the patient or by the licensee where it is provided as part of peritoneal dialysis support;

(c) every personnel who provides any essential life‑saving measure to a patient is adequately trained —

(i) to provide the essential life‑saving measure in a proper, effective and safe manner; and

(ii) in the use of the equipment that is needed to deliver the essential life‑saving measure;

(d) the safe and timely conveyance of a patient to the care of an acute hospital licensee if the licensee’s personnel are unable to stabilise the patient’s condition.

(3)  A licensee must ensure that each protocol mentioned in paragraph (2)(b) is documented and that all personnel are trained and proficient in implementing the protocol.

Drugs used for outpatient renal dialysis service

16.  A licensee must ensure that —

(a) there is an adequate supply of the appropriate drugs at any premises where the outpatient renal dialysis service is provided, to safely and effectively conduct haemodialysis or provide peritoneal dialysis support; and

(b) a drug is not used for the outpatient renal dialysis service —

(i) after its expiry date; or

(ii) if there is any other reason for any personnel to suspect that the drug is no longer suitable to be used for the outpatient renal dialysis service.

Requirements for provision at temporary premises

17.—(1)  A licensee who is approved to provide an outpatient renal dialysis service using temporary premises must —

(a) ensure that in determining whether the outpatient renal dialysis service may be provided to a patient at any temporary premises in a proper, effective and safe manner, the licensee must take into account —

(i) the patient’s medical condition or history; and

(ii) the facilities, equipment, medical supplies and other resources that are available at the temporary premises;

(b) establish, implement and regularly review guidelines to assist the licensee in making the determination mentioned in sub‑paragraph (a);

(c) where the licensee provides haemodialysis at temporary premises — ensure that the personnel deployed to provide haemodialysis is a registered nurse or medical practitioner, who has the necessary experience, competency and skills to provide haemodialysis safely without supervision; and

(d) where the licensee provides peritoneal dialysis support at temporary premises — ensure that the personnel deployed to provide peritoneal dialysis support is an enrolled nurse, a registered nurse or a medical practitioner, who has the necessary experience, competency and skills to provide peritoneal dialysis support safely without supervision.

(2)  A licensee must ensure that every personnel who attends to a patient at any temporary premises carries proof of the personnel’s identity and his or her role or designation for which the personnel is engaged or employed by the licensee, and shows the proof to the patient.

Requirements for remote provision

18.—(1)  This regulation applies to a licensee who is approved to provide an outpatient renal dialysis service by remote provision.

(2)  Before a licensee provides any outpatient renal dialysis service to a patient by remote provision, the licensee must ensure that —

(a) the licensee’s personnel who is a healthcare professional first conducts a clinical assessment of the patient in person at any of the licensee’s approved permanent premises or temporary premises; or

(b) where it is not practicable for the patient to be clinically assessed in person before the outpatient renal dialysis service is provided remotely — the patient is given an appointment to be clinically assessed in person at any of the licensee’s approved permanent premises or temporary premises by a healthcare professional who is the licensee’s personnel.

Conduct of ultrasound imaging

19.—(1)  A licensee must not conduct any ultrasound imaging on a patient unless a medical practitioner or collaborative prescribing practitioner who is the licensee’s personnel orders the ultrasound imaging for the patient.

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

(a) only as a service incidental to the provision of an outpatient renal dialysis service;

(b) at the licensee’s approved permanent premises or temporary premises, as the case may be; and

(c) by the licensee’s personnel who is —

(i) a medical practitioner who is trained in the conduct of ultrasound imaging;

(ii) a radiographer who is a duly qualified allied health professional;

(iii) a sonographer; or

(iv) where ultrasound imaging is conducted only for the purpose of arteriovenous cannulation — a registered nurse or an enrolled nurse who is trained in conducting ultrasound imaging for the purpose of arteriovenous cannulation.

Testing of specimen

20.—(1)  Subject to paragraph (2), a licensee must not test any specimen for a patient unless —

(a) a medical practitioner 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 an outpatient renal dialysis service.

(2)  A licensee who is approved to provide an outpatient renal dialysis service by remote provision must not, in the course of providing the service by that service delivery mode, direct a patient to conduct a self‑administered test on himself or herself if the testing material for the self‑administered test is a “professional use only” medical device within the meaning given by regulation 2 of the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010).

Conduct of simple in vitro diagnostic test

21.—(1)  A licensee must ensure that any simple in vitro diagnostic test on a specimen or 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.

(2)  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.

Instructions for self‑collection of specimens

22.  Where any specimen is to be collected from a patient by the patient himself or herself, for the purpose of conducting any test on it (whether or not the test is to be self‑administered by the patient), a licensee must provide the patient with —

(a) instructions on how and when the specimen is to be collected; and

(b) the precautions that are to be taken to avoid contamination and degradation of the specimen.

 

Made on 20 June 2023.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/30 Vol. 1]