Healthcare Services (Outpatient Renal Dialysis Service) Regulations 2023

is a registered nurse;

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

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

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

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

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;

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

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.

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

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

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;

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;

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

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.

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

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

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

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

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;

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

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

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

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.

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

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

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;

the establishment and implementation of protocols for —

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

any medical emergency related to the conduct of haemodialysis; and

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;

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

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

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

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.

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 —

the patient’s medical condition or history; and

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

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

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

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.

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

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.

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

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

by the licensee’s personnel who is —

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

a radiographer who is a duly qualified allied health professional;

a sonographer; or

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.

a medical practitioner or collaborative prescribing practitioner who is the licensee’s personnel orders the test for the patient;

the testing of the specimen only involves the conduct of a simple in vitro diagnostic test; and

the testing of the specimen is provided only as a service incidental to the provision of an outpatient renal dialysis service.

using testing material in respect of which —

the expiry date has not passed; and

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

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

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;

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

in relation to a licensee who provides haemodialysis —

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;

any dialyser must only be used for one patient;

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

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.

a designated preparation area for the licensee’s personnel to perform the necessary preparation for conducting renal dialysis, which is safe and appropriate for its intended purpose;

where reusable dialysers are used for haemodialysis — adequate space and equipment to enable the proper cleaning, sterilisation and preparation of dialysers for reuse;

adequate space and equipment to enable the storage of medicinal products, health products and medical supplies in accordance with the manufacturer’s recommendations so that the integrity of the medicinal products, health products and medical supplies is maintained;

a clean area for the preparation and handling of medication to minimise contamination from environmental or other pathogens;

a dedicated room or area for the disposal of waste.

hand washing facilities are available in every approved permanent premises for the use of patients and visitors accompanying patients; and

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

the water used for haemodialysis is treated by reverse osmosis;

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

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

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

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;

water treatment systems are isolated from the potable water supply;

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;

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

records of each disinfection are kept.

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;

every patient is regularly tested to determine the level of each of the patient’s liver markers;

every patient is regularly tested for each specified infectious disease, other than a specified infectious disease in respect of which the patient has already tested positive;

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;

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

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;

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

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 that the chemical disinfection is performed in accordance with the manufacturer’s recommendations.

display or otherwise make available, at every approved permanent premises or temporary premises, the fact that the licensee is an approved institution; and

where the licensee provides the outpatient renal dialysis service by remote provision — ensure that the licensee’s personnel informs the patient of the fact that the licensee is an approved institution.

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

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

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

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

an accredited clinic under the scheme established by the Government known as the Community Health Assist Scheme or any other similar public scheme providing financial assistance established by the Government.

ensure that the fees charged by the licensee for an outpatient renal dialysis service are displayed or otherwise made available at every approved permanent premises or temporary premises, as the case may be; and

where the licensee provides the outpatient renal dialysis service by remote provision — ensure that the licensee’s personnel informs the patient of the fees.

consultation fees unless charged as part of dialysis fees;

dialysis fees (including medication and consumables where applicable);

vaccination services, where applicable; and

tests, procedures or other investigations, unless charged as part of dialysis fees.

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

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.