Healthcare Services (General) Regulations 2021

require or permit any person to carry out any transaction with the Director-General under the Act or these Regulations; and

issue any approval, licence, notice, determination or other document pursuant to or connected with a transaction mentioned in sub‑paragraph (a),using the electronic licensing system.

require or permit a person to carry out any transaction mentioned in paragraph (1)(a) in any other manner specified by the Director-General; or

issue any document mentioned in paragraph (1)(b) in any other manner that the Director-General thinks fit.

approval to provide a licensable healthcare service at any permanent premises;

approval to provide a licensable healthcare service using a conveyance;

approval to provide a licensable healthcare service by any other service delivery mode;

approval to provide a specified service.

in relation to an approval mentioned in paragraph (1)(a), (b) or (c) — 2 months before the licensable healthcare service is provided at the permanent premises, using the conveyance or by the service delivery mode, or the expiry of any such approval, as the case may be; or

in relation to an approval mentioned in paragraph (1)(d) — 2 months before the specified service is provided, or the expiry of any approval for the specified service, as the case may be.

ensure that every patient of the licensee continues to receive adequate and proper care or accommodation by another licensee;

ensure that the measures in regulation 39(1)(a), (b) and (c) are taken;

comply with every direction given by the Director-General in relation to the accommodation, care and medical information of the patients until the cessation of the licensable healthcare service or surrender of the licence, as the case may be.

the provisions of the Act and these Regulations, the licence conditions and all directions and codes of practice given or issued under the Act that are applicable to the licensee; and

the provisions of any other written law regulating or relating to the provision of any licensable healthcare service in a safe and proper manner, that are applicable to the licensee.

the licensee must ensure that the Principal Officer and every Clinical Governance Officer appointed by the licensee have the necessary authority and are adequately empowered to carry out their duties under the Act and these Regulations; and

the licensee must not obstruct the licensee’s Principal Officer or any of the licensee’s Clinical Governance Officers from carrying out his or her duties in compliance with the Act and these Regulations.

at the same time that the application for the grant or renewal of the licence, or approval for the specified service, is made; or

no later than 10 calendar days before the appointment.

in relation to the key appointment holder in respect of which the notice is given — about the matters mentioned in section 2(3)(a) to (d) of the Act; and

in relation to the Principal Officer in respect of which the notice is given —

that the person to be appointed as the Principal Officer is a suitable person to act as the licensee’s Principal Officer; and

about the matters mentioned in section 2(3)(a) to (d) of the Act.

that the person to be appointed as the Clinical Governance Officer is a suitable person to act as the licensee’s Clinical Governance Officer; and

about the matters mentioned in section 2(3)(a) to (d) of the Act.

the prescribed period for the appointment of another Principal Officer is 10 calendar days after the removal of the previously appointed Principal Officer; and

the prescribed period for the appointment of another Clinical Governance Officer is 20 calendar days (inclusive of the period for the application for the Director-General’s approval of the Clinical Governance Officer) after the removal of the previously appointed Clinical Governance Officer.

the prescribed period for the appointment of another Principal Officer is 10 calendar days after the previously appointed Principal Officer stops acting, or is unable to act, as Principal Officer; and

the prescribed period for the appointment of another Clinical Governance Officer is —

where the licensee had fewer than 10 calendar days’ prior notice of the previously appointed Clinical Governance Officer’s stopping, or inability, to act as Clinical Governance Officer, whether due to death or otherwise — 20 calendar days (inclusive of the period for the application for the Director-General’s approval of the Clinical Governance Officer) after the previously appointed Clinical Governance Officer stops acting, or is unable to act, as Clinical Governance Officer; and

in any other case — one calendar day (inclusive of the period for the application for the Director-General’s approval of the Clinical Governance Officer) after the previously appointed Clinical Governance Officer stops acting, or is unable to act, as Clinical Governance Officer.

to exercise oversight over the day-to-day provision of the licensable healthcare service by the licensee;

to ensure that the licensable healthcare service is, at all times, provided in a manner that ensures the safety, welfare and continuity of care of the licensee’s patients and customers; (c)where the licensee is approved to provide the licensable healthcare service at any permanent premises, at any premises other than permanent premises (called in this sub-paragraph temporary premises) or using any conveyance — to ensure the safe operation of every approved permanent premises, temporary premises and approved conveyance, and the safety of persons at every approved permanent premises, temporary premises and approved conveyance;

to oversee the implementation of processes to review and manage any clinical risk and enterprise risk that may arise in the provision of the licensable healthcare service, and ensure that the licensee and every personnel comply with the processes.

where a matter requires the Principal Officer’s attention —

the Principal Officer must be available to handle the matter; or (ii)if the Principal Officer cannot be so available, the Principal Officer must appoint a suitably qualified and competent employee of the licensee to handle the matter on the Principal Officer’s behalf;

the Principal Officer must at all times be contactable by any personnel.

if one or more Clinical Governance Officers are appointed — the Clinical Governance Officer who oversees the subject that the clinical matter relates; and

in any other case — any key appointment holder of the licensee who is a healthcare professional with clinical experience that is relevant to the licensable healthcare service.

to provide clinical governance and technical oversight over the licensable healthcare service or specified service, as the case may be;

to assist the licensee in the day‑to‑day management of the clinical and technical aspects of the licensable healthcare service or specified service, as the case may be;

to ensure the implementation and regular review of policies and systems for clinical governance, clinical risk management, effective quality management systems and any other clinical and technical related matters for the licensable healthcare service or specified service (as the case may be), so as to detect and address in a timely manner any risks affecting the safety and welfare of, or the continuity of care provided to, patients;

to ensure that any weakness or inadequacy related to any clinical or technical aspect of the licensable healthcare service or specified service (as the case may be) is promptly identified and remedied, including informing the licensee of the weakness or inadequacy, and proposing and implementing measures to prevent the recurrence of the weakness or inadequacy;

to ensure that the licensee’s personnel involved in the clinical or technical aspects of the licensable healthcare service or specified service (as the case may be) comply with the appropriate policies and processes concerning clinical and technical standards;

to ensure that there is close supervision, adequate training and regular competency assessments of the licensee’s personnel involved in the clinical or technical aspects of the licensable healthcare service or specified service (as the case may be), to enable them to perform their work effectively and safely;

to immediately notify the licensee of any matter within the Clinical Governance Officer’s purview that may affect compliance with any licence condition applicable to the licensable healthcare service or specified service, as the case may be.

where a matter requires the Clinical Governance Officer’s attention —

the Clinical Governance Officer must be available to handle the matter; or

if the Clinical Governance Officer cannot be so available, the Clinical Governance Officer must appoint a suitably qualified and competent personnel of the licensee to handle the matter on the Clinical Governance Officer’s behalf;

the Clinical Governance Officer must at all times be contactable by any personnel.

to devise and maintain a quality assurance programme for the purposes of evaluating and monitoring —

the quality and clinical appropriateness of the licensable healthcare service provided by the QAC licensee to patients; and

the procedures and practices of the QAC licensee in relation to the provision of the licensable healthcare service;

to identify —

any serious reportable event; or (ii)any case for peer review learning or mortality and morbidity review (called in this Part a PRL case or an MMR case, respectively), as the case may be, that has occurred or may occur in the course of providing, or in relation to the provision of, the licensable healthcare service by the QAC licensee;

to evaluate any serious reportable event, PRL case or MMR case (as the case may be) mentioned in sub‑paragraph (b), so as to assess whether the quality of the licensable healthcare service provided by the QAC licensee is, in the opinion of the QAC, acceptable; (d)to identify and develop solutions for any problem that has arisen or may arise in connection with any serious reportable event, PRL case or MMR case (as the case may be) mentioned in sub‑paragraph (b);

to make recommendations to the QAC licensee to improve the quality of the licensable healthcare service provided by the QAC licensee and to prevent the occurrence or recurrence of any serious reportable event, PRL case or MMR case (as the case may be) mentioned in sub‑paragraph (b), that was identified previously;

to monitor the implementation by the QAC licensee of the recommendations mentioned in sub‑paragraph (e);

to ensure that the requirements relating to QAC in these Regulations and any directive issued by the Director-General to the QAC licensee are complied with;

to conduct such other quality assurance activity or programme as the Director-General requires.

maintain an ongoing quality assurance programme in accordance with the licence conditions applicable to the QAC licensee;

ensure the timely identification and reporting of such cases for peer review learning and mortality and morbidity review and such serious reportable events as may be specified in the licence conditions; and

in the case of a QAC for MMR cases or serious reportable events, ensure that the QAC institutes an effective system for a root cause analysis of every MMR case or serious reportable event (as the case may be), and recommends appropriate solutions in a timely manner to prevent a further recurrence.

at least 6 members who are healthcare professionals each with at least 10 years of practice experience and who are in active practice, of whom at least 3 must each be an independent member; and

at least 3 other members who are not healthcare professionals.

who is not employed by the licensee; and

who does not have any interest (whether personal, professional or otherwise) in the outcome of the ethics review.

every patient of the licensee who enters into a transaction for the provision of a specified healthcare service or co‑located service makes an independent decision in relation to the transaction; (b)every advertisement relating to the licensee’s licensable service that also advertises a specified healthcare service or co‑located service is in compliance with the requirements in the Healthcare Services (Advertisement) Regulations 2021 (G.N. No. S 1033/2021) that apply to, or in relation to, an advertisement of a licensable healthcare service;

every advertisement that advertises a specified healthcare service or co‑located service but not the licensee’s licensable healthcare service must state that the service advertised —

is not licensed under the Act; but(ii)is permitted under the Act to be provided at the approved permanent premises or in the approved conveyance where the licensee’s licensable healthcare service is also provided;

the provision of the licensee’s licensable healthcare service is not adversely affected, and the privacy and safety of the licensee’s patients is not compromised, by the provision of any specified healthcare service or co‑located service; and

if the provision of a specified healthcare service or co‑located service is also for individuals other than the licensee’s patients —

there is a clear demarcation of the space used to provide the specified healthcare service or co‑located service; or (ii)where the space cannot be so demarcated —

there is a conspicuously displayed signage, or such other means of communication to the licensee’s patients as specified by the Director-General, stating that the specified healthcare service or co‑located service is not licensed under the Act; and (B)there is a written agreement between the licensee and the provider of the specified healthcare service or co‑located service (as the case may be) which stipulates clearly the respective responsibilities of the licensee and the provider in relation to the use of the approved permanent premises or approved conveyance.

the licensee does not make such transaction a condition for the provision to the patient of a licensable healthcare service, unless otherwise allowed by any written law or the applicable professional ethical guidelines or standards;

the licensee does not give the patient any incentive for such transaction that is connected to the provision of a licensable healthcare service; and (c)the licensee does not give the patient any incentive for the provision of a licensable healthcare service that is connected to such transaction.

the medicinal product or health product is packed and labelled appropriately; (aa)the label on the medicinal product or health product includes the expiry date of the product; and

the patient’s medication record contains adequate, accurate and relevant information to ensure that there is no error or confusion as to the medicinal product or health product prescribed, dispensed, administered or otherwise provided (as the case may be), and to ensure the proper and safe use of the medicinal product or health product by the patient.

ensure that the erroneous prescription is properly identified and recorded; and (b)take appropriate and timely measures to correct the error and prevent a recurrence.

that every medicinal product or health product is accurately prepared, dispensed and administered in accordance with a prescription that is issued by —

a dentist;

a medical practitioner; or

a collaborative prescribing practitioner in accordance with a collaborative practice agreement; and

the keeping and maintenance of proper and accurate records of each medicinal product or health product prepared, dispensed or administered under sub-paragraph (a).

immediately inform the patient of the deviation and the steps or measures to be taken to avoid or minimise patient harm; and

keep and maintain proper and accurate records of the deviation and when the patient was informed of the deviation under sub-paragraph (a).

in such a way that —

it is protected from the likelihood of contamination; and

the environmental conditions under which it is stored will not adversely affect its efficacy, quality and safety; and (b)in accordance with the manufacturer’s specifications.

if the expiry date is known — as soon as practicable after the expiry date of the product; and

in any other case — when the product shows its first sign of deterioration.

the personnel who is responsible for collecting the specimen checks and verifies the identity of the patient prior to the collection;

the specimen collected is the correct specimen for the type of test that is ordered by a requestor to be carried out for the patient; and

the container containing the specimen is labelled accurately and clearly with —

a name and reference number unique to the patient;

the site from which the specimen is collected, where relevant; and

where the test ordered by a requestor to be carried out for the patient requires the collection of more than one specimen, the sequence in which the specimen is collected.

implement a system where all relevant specimen collection information may be traced from an identifier on the container containing the specimen; or

include all relevant specimen collection information on the label on the container containing the specimen.

a licensee authorised to provide a clinical laboratory service; or

where the sample is intended to be sent for testing outside Singapore — a person who operates a clinical laboratory outside Singapore that is accredited by an accreditation body approved by the Director-General.

the container containing the specimen is kept safely in packaging that is appropriate for transportation; and (b)the specimen is transported in a manner that —

does not cause any confusion in the identification of the specimen;

preserves the integrity of the specimen; and

does not endanger public safety.

the findings of the test are brought to the attention of the requestor without undue delay;

the requestor reviews the findings in a timely manner;

the patient is informed, without undue delay, of the findings that, in the professional opinion of the requestor, are clinically significant;

the requestor advises the patient, based on the findings and without undue delay, on the patient’s condition, prognosis and clinical management.

the medical practitioner, dentist or collaborative prescribing practitioner who ordered the test for the patient; and

any medical practitioner, dentist or collaborative prescribing practitioner designated by the person mentioned in sub-paragraph (a) to carry out any duty mentioned in paragraph (3)(a), (b), (c) or (d).

name;

identification number or passport number;

gender;

date of birth.

residential address;

ethnic group;

date and time of every consultation, referral, admission, investigation and discharge;

admission forms and patient registration number for the visit, consultation or admission;

medical history, referral documents and declaration forms relating to the patient’s health or medical history;

clinical findings and progress notes;

clinical management and care plan containing details such as medication, nursing care, treatment, diet and allied health care;

allergies and other factors requiring special consideration;

results of laboratory tests;

reports of X-rays and other investigations;

vaccinations;

consent forms;

discharge summary containing details such as significant findings and events of the patient’s stay, the patient’s condition on discharge and recommendations and arrangements for future care;

records of any adverse event that occurred in the provision of the licensable healthcare service and the actions taken by the licensee’s personnel in response to the adverse event;

date and time of death (if the patient is deceased).

accurately and clearly sets out any follow‑up action identified by the licensee or any personnel as being appropriate and necessary for the patient; and

subject to paragraph (5), contains accurate information about whether that follow‑up action is taken, and if no follow-up action is taken, the reason for the failure to take that follow-up action.

the confidentiality, integrity and security of every patient health record is maintained at all times; and

every personnel handling any patient health record is aware of his or her role and responsibility in maintaining the confidentiality, integrity and security of the records.

implement adequate safeguards and appropriate protocols and processes to protect the patient health records against accidental or unlawful loss, modification or destruction, or unauthorised access, disclosure, copying, use or modification;

periodically monitor and evaluate the safeguards, protocols and processes mentioned in sub‑paragraph (a) to ensure that they are effective and being complied with by the staff involved in handling the patient health records; and

take reasonable care in the disposal or destruction of the patient health records so as to prevent unauthorised access to the records.

inform the patient of the cessation or transfer of care (as the case may be) within a reasonable period before the cessation or transfer of care, as the case may be;

consult the patient about the transfer or disposal of his or her patient health record;

transfer the patient health record or give a detailed medical report of the patient to —

the licensee that is taking over the care of the patient; or (ii)the patient or his or her authorised representative, upon request by the patient or authorised representative, as the case may be.

if the patient is a child — the patient’s parent, adoptive parent, step‑parent or guardian;

if the patient lacks capacity within the meaning of section 4 of the Mental Capacity Act 2008 —

a deputy appointed or deemed to be appointed for the person by the court under that Act with power in relation to the person for the purposes of these Regulations; or (ii)a donee under a lasting power of attorney registered under that Act with power in relation to the patient for the purposes of these Regulations;

if the patient is an adult who has capacity — a person whom the patient has authorised to act on the patient’s behalf for any matter (including legal proceedings) that requires information in his or her patient health record.

is issued by a personnel of the licensee who —

is a medical practitioner or dentist; and

had provided medical or dental care (as the case may be) to the patient; and

states the name and registration number of the medical practitioner or dentist who issued the medical certificate.

in relation to a dentist, means the registration number assigned to the dentist by the Singapore Dental Council upon registration under the Dental Registration Act 1999; or

in relation to a medical practitioner, means the registration number assigned to the medical practitioner by the Singapore Medical Council upon registration under the Medical Registration Act 1997.

if the patient is a child — the patient’s parent, adoptive parent, step‑parent or guardian;

if the patient is an adult who lacks capacity within the meaning of section 4 of the Mental Capacity Act 2008 — any of the following persons:

where there is a deputy appointed or deemed to be appointed for the patient by the court under that Act with power in relation to the patient for the purposes of these Regulations — the deputy;

where there is a donee appointed under a lasting power of attorney registered under that Act with power in relation to the patient for the purposes of these Regulations — the donee;

in any other case — any of the patient’s next of kin;

if the patient is an adult who has capacity — a person whom the patient has authorised to receive the bill on the patient’s behalf;

if the patient has died — any of the patient’s next of kin.

take effective measures to ensure the safe and proper use, storage and disposal of the biohazardous material or sharps;

establish policies and procedures to prevent any patient or personnel from contracting an infection resulting from exposure to biohazards or any sharps injury; and

ensure that each policy and procedure mentioned in sub-paragraph (b) is implemented.

any substance which contains toxins;

any biological waste;

any culture medium;

any contaminated blood, urine or faeces; and

any infected tissue or organ.

a clinical incident impacting or endangering public health or patient safety;

a clinical incident indicating that there is a systemic or process failure;

an incident of abuse or allegation of abuse, or of a breach of privacy, of any patient;

any compromise of data kept by the licensee, whether in electronic form or otherwise, that directly affects the safety or welfare of patients, or the confidentiality or security of data;

an incident impacting the structural safety (including fire safety) of any approved permanent premises or approved conveyance or any structure, facility, equipment or device used for the provision of the licensable healthcare service which requires an individual to enter the structure, facility, equipment or device.

to prevent or limit the occurrence of any incident mentioned in paragraph (1);

to minimise the harm to patients that may arise or has arisen as a result of such an incident; and

to prevent the recurrence of such an incident.

establish an effective emergency response plan to deal with or respond to any national emergency;

participate in national emergency efforts;

participate in the planning, design and conduct of national emergency preparedness exercises;

develop and implement emergency infection control measures (such as isolation facilities and infection control equipment) to control and prevent the spread of any infectious disease in an epidemic or a pandemic;

ensure that every personnel, whose responsibility includes the handling of national emergencies, is competent in responding to any national emergency, including, but not limited to, the wearing of the Personal Protective Equipment (PPE) safely and properly; (f)in relation to each premises or conveyance that the licensee uses for the provision of a licensable healthcare service —

ensure that there is at all times, at least one week’s supply of Personal Protective Equipment (PPE) available at the premises or conveyance for each personnel deployed at the premises or conveyance; or

implement processes to ensure that the licensee may, at any time, obtain at least one week’s supply of Personal Protective Equipment (PPE) for each personnel deployed at the premises or conveyance; and

ensure that each item of Personal Protective Equipment (PPE) given to the licensee’s personnel is fit for use and has not passed its expiry date, if any.

N95 face masks or masks of the equivalent standard;

isolation gowns or gowns of the equivalent standard;

examination gloves or gloves of the equivalent standard.

the business continuity plan must also establish the systems and set out the procedures necessary (including the measures specified in regulation 39(1)) for the transfer of the care of the licensee’s patients to another licensee in the event of the licensee’s death; and

the licensee must nominate a person to carry out the procedures mentioned in sub-paragraph (a) in the event of the licensee’s death.

take reasonable steps to ensure that the business continuity plan can be effectively followed if any contingency or disaster disrupts the licensee’s business of providing a licensable healthcare service;

periodically review the business continuity plan; and

implement changes, where necessary, to ensure the effectiveness of the business continuity plan.