Healthcare Services (Nuclear Medicine Service) Regulations 2023

No. S 412

Healthcare Services Act 2020

Healthcare Services
(Nuclear Medicine 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 (Nuclear Medicine Service) Regulations 2023 and come into operation on 26 June 2023.

Definitions

2.—(1)  In these Regulations —

“calendar day” includes Saturday, Sunday and every public holiday;

“diagnostic radiographer” means a duly qualified allied health professional who is registered under the Allied Health Professions Act 2011 to practise radiography;

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

“examination” means a radiological examination of an individual conducted by a licensee at any approved permanent premises of the licensee;

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

“imaging modality” means any imaging modality set out in paragraph 1 of the Schedule;

“in vivo assay procedure” means all of the following activities carried out by a licensee at any approved permanent premises of the licensee:

(a) any process relating to the preparation, dispensing, radiolabelling, compounding and quality control of radiopharmaceuticals;

(b) the administration of radiopharmaceuticals to a patient;

(c) the derivation, after the administration of radiopharmaceuticals, of any specimen from the patient;

“irradiating apparatus”, “nuclear medicine service”, “radioactive material”, “radiopharmaceutical” and “simple in vitro diagnostic test” have the meanings given by paragraph 2 of the First Schedule to the Act;

“licensee” means a person who holds a licence to provide a nuclear medicine service;

“nuclear medicine imaging”, in relation to a nuclear medicine service, means the specified service for that service set out in paragraph 1 of the Schedule;

“nuclear medicine physician” means an individual who is registered under section 22 of the Medical Registration Act 1997 as a specialist in the branch of nuclear medicine;

“nuclear medicine technologist” means an individual who holds at least a diploma or degree in nuclear medicine technology, radiation therapy or radiography;

“personnel”, in relation to a licensee, means an individual employed or engaged by the licensee to assist the licensee in providing a nuclear medicine service;

“radiation safety officer” —

(a) where a licensee uses any irradiating apparatus within the meaning given by regulation 2(1) of the Radiation Protection (Non‑Ionising Radiation) Regulations (Rg 1) — means an individual who is appointed by the licensee under regulation 40 of those Regulations as a radiation safety officer; or

(b) in any other case — means an individual who is appointed by a licensee under regulation 19 of the Radiation Protection (Ionising Radiation) Regulations 2023 (G.N. No. S 85/2023) as a radiation safety officer or deputy radiation safety officer;

“radiation therapist” means a duly qualified allied health professional who is registered under the Allied Health Professions Act 2011 to practise radiation therapy;

“radioactive substance” has the meaning given by section 2(1) of the Radiation Protection Act 2007;

“requestor”, in relation to an examination, means a dentist or medical practitioner who ordered the examination for the patient;

“specimen” means any matter derived, obtained or excreted from the body of a patient for use in, or in connection with, the provision of a nuclear medicine service.

(2)  For the purposes of these Regulations —

(a) a nuclear medicine service is provided for an imaging purpose where the service is provided, through the use of an irradiating apparatus, for either of the following purposes:

(i) the medical diagnosis of an individual;

(ii) the monitoring of the effects of medical therapy on an individual;

(b) a nuclear medicine service is provided for an in vivo assay purpose where the service is provided to enable or facilitate either of the following through the use of an assay:

(i) the medical diagnosis of an individual;

(ii) the monitoring of the effects of medical therapy on an individual; and

(c) a nuclear medicine service is provided for a therapy purpose where the service is provided for the purpose of treating an ailment, or a condition, disease or disorder or an injury affecting any part of the body or mind of an individual.

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.

Notification of addition or removal of purposes for which nuclear medicine service provided

4.—(1)  For the purposes of section 10(2)(c)(viii) of the Act, an applicant for the grant or renewal of a licence to provide a nuclear medicine service must specify in the licence application every purpose for which the applicant provides, or intends to provide, the nuclear medicine service.

(2)  A licensee that intends to provide a nuclear medicine service for any purpose which was not specified in the licence application mentioned in paragraph (1) must give written notice to the Director‑General of the licensee’s intention no later than 2 months before the licensee intends to start providing the nuclear medicine service for the purpose concerned.

(3)  A licensee that intends to stop providing a nuclear medicine service for any purpose which was specified in the licence application mentioned in paragraph (1) must give written notice to the Director‑General of the licensee’s intention no later than 10 calendar days before the licensee intends to stop providing the nuclear medicine service for the purpose concerned.

Specified services

5.—(1)  For the purposes of section 9A(1) of the Act, the services set out in the Schedule are specified services for a nuclear medicine service.

(2)  For the purposes of section 11C(2)(d) of the Act, an applicant for approval to provide a specified service must specify every imaging modality that the licensee provides, or intends to provide, as part of the specified service.

(3)  A licensee who is approved to provide nuclear medicine imaging and intends to provide any imaging modality which is not specified in the approval application mentioned in paragraph (2) must give written notice to the Director‑General of the licensee’s intention no later than 2 months before the licensee intends to start providing the imaging modality concerned.

(4)  A licensee who is approved to provide nuclear medicine imaging and intends to stop providing any purpose which was specified in the approval application mentioned in paragraph (2) must give written notice to the Director‑General of the licensee’s intention no later than 10 calendar days before the licensee intends to stop providing the imaging modality concerned.

Prohibited service delivery modes

6.  A licensee must not provide a nuclear medicine service —

(a) at any premises other than permanent premises;

(b) using a conveyance; or

(c) by remote provision.

PART 2

REQUIREMENTS RELATING TO PERSONNEL

Qualifications, skills and competencies of Clinical Governance Officer

7.—(1)  For the purposes of section 24(3)(b) of the Act and subject to paragraph (2), an individual is suitably qualified to be appointed as a Clinical Governance Officer for a nuclear medicine service or a specified service for a nuclear medicine 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;

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

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

(d) has at least 5 years of work experience, after obtaining the registration mentioned in sub‑paragraph (c), in providing the nuclear medicine service.

(2)  For the purposes of section 24(3)(b) of the Act, where —

(a) a licensee is approved to provide nuclear medicine imaging for a nuclear medicine service; and

(b) the licensee provides nuclear medicine imaging only for cardiac purposes,

an individual is suitably qualified to be appointed as a Clinical Governance Officer for nuclear medicine imaging if the individual —

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

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

(e) is registered under section 22 of the Medical Registration Act 1997 as a specialist in the branch of cardiology;

(f) holds a valid certification in nuclear cardiology by the Certification Board of Nuclear Cardiology, United States of America or an equivalent certification acceptable to the Director‑General; and

(g) has at least 5 years of work experience, after obtaining the certification mentioned in sub‑paragraph (f), in providing the nuclear medicine imaging service.

Duties and responsibilities of Clinical Governance Officer

8.—(1)  This regulation applies in addition to regulation 15(1) of the General Regulations.

(2)  A Clinical Governance Officer for a nuclear medicine service is responsible for —

(a) overseeing the conduct of examinations and in vivo assay procedures, and the provision of treatment, by the licensee;

(b) ensuring that the examinations and in vivo assay procedures are conducted, and the treatment is provided, in accordance with the correct methods and procedures for the examination, in vivo assay procedure or treatment concerned;

(c) implementing and overseeing a radiation safety programme to ensure the safety of personnel and patients and other individuals within or in the vicinity of the approved permanent premises of the licensee, including the proper handling, use and disposal of radioactive substances;

(d) evaluating new processes the licensee intends to implement for the provision of the nuclear medicine service, including processes relating to the preparation, dispensing, radiolabelling, compounding and quality control of radiopharmaceuticals;

(e) where the licensee intends to use any radiopharmaceutical (X) for the first time in the provision of the nuclear medicine service for a therapy purpose, evaluating X for all of the following:

(i) the safety and efficacy of X;

(ii) the necessity, advantages and disadvantages of using X, including —

(A) whether the licensee is using any other radiopharmaceutical for the same indication as the indication for which X is proposed to be used; and

(B) the comparative advantages and disadvantages of using X and the other radiopharmaceutical;

(f) where the licensee intends to provide any specified service for the nuclear medicine service, evaluating that specified service before the specified service is provided; and

(g) where the licensee is approved to provide nuclear medicine imaging and intends to provide any imaging modality, evaluating that imaging modality before the imaging modality is provided.

(3)  Where a licensee appoints a Clinical Governance Officer for nuclear medicine imaging, that Clinical Governance Officer is responsible for —

(a) overseeing the conduct of examinations by the licensee in relation to the provision of nuclear medicine imaging;

(b) ensuring that the examinations mentioned in sub‑paragraph (a) are conducted in accordance with the correct methods and procedures for the examinations;

(c) implementing and overseeing a radiation safety programme to ensure the safety of personnel and patients and other individuals within or in the vicinity of any part of the approved permanent premises that is used for the provision of nuclear medicine imaging, including the proper handling, use and disposal of radioactive substances;

(d) evaluating new processes the licensee intends to implement for the provision of nuclear medicine imaging, including processes relating to the preparation, dispensing, radiolabelling, compounding and quality control of radiopharmaceuticals; and

(e) where the licensee is approved to provide nuclear medicine imaging and intends to provide any imaging modality, evaluating that imaging modality before the imaging modality is provided.

(4)  Paragraph (3) does not prevent a Clinical Governance Officer for a nuclear medicine service from assuming responsibility for any matter mentioned in that paragraph despite the appointment of a Clinical Governance Officer for nuclear medicine imaging.

Appointment of section leader

9.—(1)  A licensee must, in relation to each purpose for which a nuclear medicine service is provided, appoint a suitably qualified person as the section leader for that purpose.

(2)  A section leader must be resident in Singapore.

(3)  A Clinical Governance Officer may be appointed as a section leader.

(4)  For the purposes of this regulation, an individual is a suitably qualified person if any of the following applies:

(a) in relation to the provision of the nuclear medicine service for an imaging purpose — the individual is a diagnostic radiographer, nuclear medicine technologist or radiation therapist who has at least 3 years of work experience in providing the nuclear medicine service for that purpose;

(b) in relation to the provision of the nuclear medicine service for an in vivo assay purpose — the individual is a diagnostic radiographer, nuclear medicine technologist, radiation therapist or radiochemistry personnel who has at least 3 years of work experience in providing the nuclear medicine service for that purpose;

(c) in relation to the provision of the nuclear medicine service for a therapy purpose, the individual is —

(i) a diagnostic radiographer, nuclear medicine technologist, radiation therapist or radiochemistry personnel who has at least 3 years of work experience in providing the nuclear medicine service for that purpose; or

(ii) a nuclear medicine physician who is registered under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner.

(5)  In this regulation, “radiochemistry personnel” means an individual who holds a diploma, degree or any higher educational qualification in chemistry, medical physics, nuclear medicine sciences, pharmaceutical services or radiochemistry.

Duties of section leader

10.—(1)  A licensee must ensure that every section leader appointed in relation to the provision of a nuclear medicine service for an imaging purpose or in vivo assay purpose does all of the following:

(a) assist the relevant Clinical Governance Officer in the day‑to‑day technical management of the service;

(b) supervise, train and guide personnel in the conduct of examinations or performance of in vivo assay procedures, as the case may be;

(c) assess and ensure the competency of personnel deployed to perform tasks in relation to the provision of the nuclear medicine service for an imaging purpose or in vivo assay purpose, as the case may be;

(d) evaluate any equipment before the equipment is used in the provision of the nuclear medicine service for an imaging purpose or in vivo assay purpose, as the case may be;

(e) monitor the performance of all examinations or in vivo assay procedures (as the case may be) conducted or performed, including ensuring the implementation of quality control measures;

(f) establish and review policies and procedures for the safe and effective conduct or performance of all examinations or in vivo assay procedures, as the case may be;

(g) resolve any technical issues that arise from the conduct or performance of any examinations or in vivo assay procedures, as the case may be;

(h) review all service records in relation to all examinations or in vivo assay procedures (as the case may be) conducted or performed.

(2)  A licensee must ensure that every section leader appointed in relation to the provision of a nuclear medicine service for a therapy purpose does all of the following:

(a) assist the relevant Clinical Governance Officer in the day‑to‑day management of all processes relating to the preparation, dispensing, radiolabelling, compounding and quality control of radiopharmaceuticals (called in this paragraph the applicable processes);

(b) supervise, train and guide personnel in the applicable processes;

(c) assess and ensure the competency of personnel deployed to perform tasks in relation to the preparation, dispensing, radiolabelling, compounding and quality control of radiopharmaceuticals;

(d) evaluate any process relating to the preparation, dispensing, radiolabelling, compounding and quality control of radiopharmaceuticals before the process is used;

(e) monitor the performance of all applicable processes;

(f) establish and review policies and procedures for the safe and effective performance of all applicable processes;

(g) resolve any technical issues that arise from the performance of all applicable processes;

(h) review all service records in relation to the applicable processes.

General requirements relating to personnel

11.—(1)  A licensee must ensure that each personnel —

(a) has the necessary qualifications, having regard to the type and nature of the work performed by that personnel;

(b) is assessed on the personnel’s competencies before the personnel is allowed to perform any task or provide any service in relation to the licensee’s provision of the nuclear medicine service;

(c) attends adequate training on a regular basis in relation to the provision of the nuclear medicine service;

(d) attends appropriate training on a regular basis in relation to radiation safety awareness; and

(e) is assessed periodically on the personnel’s competencies and work performance.

(2)  A licensee must ensure that any personnel who has less than 3 years of relevant experience does not perform any task or provide any service in relation to the provision of a nuclear medicine service except under the close supervision of —

(a) a Clinical Governance Officer; or

(b) another personnel with at least 3 years of relevant experience.

(3)  For the purposes of paragraph (2), the relevant experience of a personnel, in relation to a task performed or service provided in relation to the provision of the nuclear medicine service, means —

(a) where the task or service may be lawfully performed or provided only by an individual who is a healthcare professional or radiation safety officer — the personnel’s working experience in relation to the task or service after the personnel is registered as a healthcare professional or is appointed as a radiation safety officer, as the case may be; or

(b) in any other case — the personnel’s working experience in relation to the task or service.

(4)  This regulation does not affect any requirement for the appointment of any person by a licensee for or in relation to the provision of the nuclear medicine service under any other written law.

(5)  In this regulation, “healthcare professional” means —

(a) a duly qualified allied health professional;

(b) a medical practitioner;

(c) a registered nurse, enrolled nurse or registered midwife within the meaning of the Nurses and Midwives Act 1999 who holds a valid practising certificate under that Act; or

(d) a pharmacist who is registered under the Pharmacists Registration Act 2007 and holds a valid practising certificate under that Act.

Specific personnel

12.—(1)  A licensee must —

(a) employ or engage at least one individual who is a diagnostic radiographer, nuclear medicine technologist or radiation therapist (called in this paragraph the relevant individual); and

(b) ensure that the relevant individual, or where 2 or more relevant individuals are employed or engaged, at least one such individual, has at least 3 years of work experience in providing a nuclear medicine service.

(2)  A licensee must —

(a) employ or engage at least one medical physicist; and

(b) ensure that the medical physicist, or where 2 or more medical physicists are employed or engaged, at least one such individual, has at least 3 years of work experience in providing a nuclear medicine service.

(3)  A licensee must employ or engage at least one registered nurse who is assessed —

(a) by a Clinical Governance Officer to have appropriate competency in providing patient care in relation to the provision of a nuclear medicine service; and

(b) by any of the following persons appointed by the licensee to have appropriate competency in radiation safety:

(i) a medical physicist;

(ii) a nuclear medicine physician who is registered under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;

(iii) a radiation safety officer.

(4)  In this regulation —

“medical physicist” means an individual who has a degree in physics;

“registered nurse” has the meaning given by section 2 of the Nurses and Midwives Act 1999.

PART 3

PROCESSES, EQUIPMENT AND FITTINGS

Quality management system

13.—(1)  A licensee must establish and implement a quality management system in accordance with this regulation for the purposes of quality assessment and assurance of the nuclear medicine service provided by the licensee.

(2)  Without limiting paragraph (1), the quality management system mentioned in paragraph (1) must provide for all of the following:

(a) implementation of a system to ensure that the licensee’s personnel have appropriate accountability, roles and responsibilities in relation to the purposes mentioned in paragraph (1) and to provide for appropriate continuing educational programmes for the personnel;

(b) measures to ensure that the provision of the nuclear medicine service complies with —

(i) the Act and any other written law governing the nuclear medicine service;

(ii) the licence conditions imposed under section 13(1) of the Act; and

(iii) any conditions imposed on an approval granted under section 11B or 11D of the Act;

(c) implementation of protocols to ensure compliance with this Part and Parts 4 to 9 and for the physical safety of personnel, patients and visitors;

(d) identification of key performance indicators for assessing performance outcomes of the nuclear medicine service, including mechanisms for periodic monitoring and evaluation of those indicators;

(e) quality control measures for equipment used in the provision of the nuclear medicine service, including acceptance testing, quality control tests and regular monitoring of equipment performance;

(f) quality control measures for all radioactive substances kept and used by the licensee, including measures pertaining to —

(i) the acceptance, or rejection for quality or safety reasons, of all radioactive substances supplied to the licensee;

(ii) the safe and proper preparation, handling, transport and use of the radioactive substances; and

(iii) the regular testing of the quality and safety of the radioactive substances;

(g) maintenance of adequate and accurate documentation on the licensee’s use of radioactive substances;

(h) conduct of regular holistic analysis and reviews of all information relating to —

(i) the quality and safety of all radioactive substances kept and used by the licensee; and

(ii) the applicable licensee’s use of all radioactive substances;

(i) testing and monitoring of the radiation levels in the licensee’s approved permanent premises to ensure the safety of personnel, patients and visitors;

(j) systems and processes to ensure that regulations 16(3) and 20 are complied with;

(k) investigation of any occurrence or complaint that discloses or may disclose any weakness or inadequacy affecting the quality of the nuclear medicine service;

(l) identification and implementation of appropriate and effective actions to address any weakness or inadequacy mentioned in sub‑paragraph (k) and prevent a recurrence;

(m) validation of imaging procedures, in vivo assay procedures and methods of treatment;

(n) validation of all processes relating to the conduct or performance of any examination, in vivo assay procedure or method of treatment, as the case may be;

(o) a system to ensure the appropriate and adequate documentation of all quality assurance measures, policies and processes, which includes all of the following features:

(i) regular creation, review and updating of the documentation;

(ii) document control procedures;

(iii) processes to ensure that all personnel comply with sub‑paragraphs (i) and (ii);

(p) conduct of regular risk assessments of every activity conducted as part of the provision of the nuclear medicine service and, where necessary, the implementation of appropriate measures to mitigate or manage the risks identified in those assessments;

(q) quality control measures for —

(i) all images produced in the provision of the nuclear medicine service for an imaging purpose; and

(ii) all specimens derived in the provision of the nuclear medicine service for an in vivo assay purpose.

(3)  A licensee must review the effectiveness of the quality management system for the nuclear medicine service on an annual basis and ensure that the quality management system is updated periodically.

Equipment and fittings

14.—(1)  A licensee must ensure that —

(a) every approved permanent premises —

(i) has adequate space for the licensee to provide the nuclear medicine service in a safe manner; and

(ii) is adequately secured to prevent unauthorised access to the approved permanent premises; and

(b) every approved permanent premises, including every imaging room in the premises, complies with the requirements of, and is approved for use in accordance with, any written law relating to the storage, possession, use and disposal of irradiating apparatus.

(2)  A licensee must ensure that all of the following requirements are satisfied:

(a) in relation to the storage of materials and supplies used in the provision of the nuclear medicine service —

(i) adequate storage space is provided in every approved permanent premises;

(ii) the storage space provided is adequately secured; and

(iii) effective measures are in place to prevent any damage to, deterioration of, or unauthorised access to or use of, the materials and supplies;

(b) in relation to the receipt, use, preparation, administration, storage and disposal of radioactive substances —

(i) adequate space is provided in every approved permanent premises; and

(ii) the space provided is secure and access to the space is controlled;

(c) appropriate radiation shielding is provided in any part of every approved permanent premises where procedures involving the handling and use of radioactive substances are performed;

(d) every approved permanent premises complies with the requirements of, and is approved for use in accordance with, any written law relating to the storage, possession, use and disposal of radioactive substances;

(e) in relation to the storage of specimens derived in the provision of the nuclear medicine service —

(i) adequate storage space is provided in every approved permanent premises;

(ii) the storage space provided is adequately secured; and

(iii) effective measures are in place to prevent any damage to, deterioration of, or unauthorised access to or use of, the specimens;

(f) adequate decontamination equipment is provided at every approved permanent premises to ensure the safety of personnel, patients and visitors and prevent any contamination of specimens;

(g) adequate safety equipment, including safety cabinets, hand basins and emergency showers, is provided in every approved permanent premises;

(h) an adequate number of first‑aid kits for emergency use that are readily accessible to all personnel is provided.

(3)  A licensee must ensure that every approved permanent premises satisfies all of the following requirements:

(a) the approved permanent premises provides for the physical segregation of patients to whom radiopharmaceuticals have been administered from other individuals in the premises;

(b) a waiting area is provided at the approved permanent premises;

(c) the waiting area mentioned in sub‑paragraph (b) has adequate capacity and is separate from any room used for the administration of radiopharmaceuticals or any imaging room;

(d) the approved permanent premises is set up in a manner that ensures the privacy of patients;

(e) an adequate number of toilets are provided for the exclusive use of patients to whom radiopharmaceuticals have been administered.

PART 4

SAFETY REQUIREMENTS

Safety programme

15.—(1)  A licensee must develop and ensure the implementation of a safety programme setting out appropriate and effective safety measures to prevent the occurrence of any adverse incident and reduce any hazard at the licensee’s approved permanent premises.

(2)  Without limiting paragraph (1), the licensee must ensure that a safety programme contains appropriate and effective measures for —

(a) electrical safety and the safety of water supply and outlets;

(b) the handling and disposal of sharp apparatus and objects that can readily puncture or cut human skin when encountered;

(c) the safety of all personnel and patients during the conduct or performance of any examination or in vivo assay procedure or the provision of any treatment, as the case may be;

(d) waste management and spills management;

(e) ensuring that there is adequate ventilation and lighting for personnel to perform work safely;

(f) ensuring that patients are not exposed to unsafe levels of noise when undergoing any examination, in vivo assay procedure or treatment, as the case may be;

(g) ensuring that all safety or emergency equipment are kept in good working order and there is an adequate stock of materials required for the handling of any adverse incident or medical emergency; and

(h) ensuring the cleanliness of the approved permanent premises.

(3)  A licensee must keep and maintain up‑to‑date documentation of the policies and processes of the safety programme mentioned in paragraph (1) and make the documentation available to all personnel.

Radiation safety programme

16.—(1)  A licensee must —

(a) develop and ensure the implementation of a radiation safety programme;

(b) ensure that all personnel comply with the radiation safety programme; and

(c) maintain accurate and complete documentation for the radiation safety programme.

(2)  The licensee must ensure that the radiation safety programme mentioned in paragraph (1) complies with —

(a) any written law governing the preparation, storage, possession, use and disposal of radioactive substances; and

(b) in relation to the provision of the nuclear medicine service for an imaging purpose, any written law governing the storage, possession, use and disposal of irradiating apparatus.

(3)  A licensee must implement policies to protect pregnant personnel against radiation exposure in the course of work and in the licensee’s approved permanent premises.

(4)  A licensee must ensure that an adequate number of the following are available for use by all personnel:

(a) suitable radiation monitoring devices, including dose calibrators and radiation survey meters;

(b) suitable radiation shields and primary and secondary containers for transportation of radioactive substances within and outside the approved permanent premises.

Licensee must ensure personnel comply with safety plans and programmes

17.  A licensee must ensure that each personnel complies with the measures and procedures set out in —

(a) the safety programme mentioned in regulation 15(1); and

(b) the radiation safety programme mentioned in regulation 16(1).

Personal protective equipment must be provided

18.  A licensee must provide each personnel performing any work at any approved permanent premises with personal protective equipment that is appropriate for the work performed.

Administration and use of radiopharmaceuticals

19.  A licensee must ensure the safe administration and use of radiopharmaceuticals in accordance with safety protocols implemented by the licensee.

Pregnant women

20.  A licensee must implement policies on the safe performance of ionising radiological procedures, including the administration of radiopharmaceuticals, on pregnant women or women suspected to be pregnant.

Patients 12 years of age or younger

21.  In conducting or performing any examination or in vivo assay procedure on, or providing any treatment to, a patient who is 12 years of age or younger, a licensee must ensure that all personnel involved in conducting or performing the examination or in vivo assay procedure or providing the treatment (as the case may be) use paediatric-appropriate procedures and practices.

Adjunctive measures

22.  A licensee must ensure that every patient is provided with adjunctive measures which are appropriate in relation to the radiopharmaceuticals administered to that patient.

Essential life-saving measures must be available

23.—(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 approved permanent premises; and

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

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

(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; and

(b) 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.

 

Made on 19 June 2023.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/31 Vol. 2]