Healthcare Services (Nuclear Medicine Service) Regulations 2023

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:

the medical diagnosis of an individual;

the monitoring of the effects of medical therapy on an individual;

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:

the medical diagnosis of an individual;

the monitoring of the effects of medical therapy on an individual; and

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.

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

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

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

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

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

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 —

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

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

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

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

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

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

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;

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;

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;

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:

the safety and efficacy of X;

the necessity, advantages and disadvantages of using X, including —

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

the comparative advantages and disadvantages of using X and the other radiopharmaceutical;

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

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.

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

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

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;

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

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.

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;

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;

in relation to the provision of the nuclear medicine service for a therapy 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; or

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.

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

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

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;

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;

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;

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;

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

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

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);

supervise, train and guide personnel in the applicable processes;

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

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

monitor the performance of all applicable processes;

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

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

review all service records in relation to the applicable processes.

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

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;

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

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

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

a Clinical Governance Officer; or

another personnel with at least 3 years of relevant experience.

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

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

a duly qualified allied health professional;

a medical practitioner;

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

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

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

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.

employ or engage at least one medical physicist; and

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.

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

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

a medical physicist;

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;

a radiation safety officer.

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;

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

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

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

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

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

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

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;

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

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

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

the regular testing of the quality and safety of the radioactive substances;

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

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

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

the applicable licensee’s use of all radioactive substances;

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

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

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

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

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

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;

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

regular creation, review and updating of the documentation;

document control procedures;

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

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;

quality control measures for —

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

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

every approved permanent premises —

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

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

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.

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

adequate storage space is provided in every approved permanent premises;

the storage space provided is adequately secured; and

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

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

adequate space is provided in every approved permanent premises; and

the space provided is secure and access to the space is controlled;

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;

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;

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

adequate storage space is provided in every approved permanent premises;

the storage space provided is adequately secured; and

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

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;

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

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

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

a waiting area is provided at the approved permanent premises;

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;

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

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

electrical safety and the safety of water supply and outlets;

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

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;

waste management and spills management;

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

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;

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

ensuring the cleanliness of the approved permanent premises.

develop and ensure the implementation of a radiation safety programme;

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

maintain accurate and complete documentation for the radiation safety programme.

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

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.

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

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

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

at all times, be capable of providing any essential life‑saving measure 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; and

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.

ensure that the patient is regularly monitored throughout the procedure by the person who administered the anaesthetic, using the appropriate patient monitoring device; and

establish, implement and regularly review processes and procedures to ensure the continued monitoring and care of the patient mentioned in sub‑paragraph (a) after completion of the procedure mentioned in that sub‑paragraph.

before administering any type of specified anaesthetic to a patient, properly inform the patient of the risks and benefits of, and (if any) the alternatives to, that type of anaesthetic; and

having satisfied the condition mentioned in sub‑paragraph (a) in respect of a patient, keep and maintain proper and accurate records of this fact.

a specified anaesthetic is not offered or administered to any patient at any approved permanent premises unless the approved permanent premises has the appropriate equipment and facilities to ensure that the specified anaesthetic may be administered safely and effectively;

a specified anaesthetic is not offered or administered to any patient for whom that specified anaesthetic would be inappropriate; and

every medical practitioner who offers a specified anaesthetic to a patient documents the reasons for doing so.

the taking of a comprehensive medical history (including previous use of anaesthetics) of the patient;

physical examination of the patient; and

the conduct of relevant tests and investigations.

one or more of the licensee’s personnel observe and monitor the patient at intervals and for the length of time appropriate to the anaesthetic administered;

timely and appropriate post‑procedure treatment is given to the patient where necessary;

one or more of the licensee’s personnel assist the patient with toileting needs where necessary; and

adequate nutrition and hydration are given to or made available to the patient.

the attending medical practitioner (who is the licensee’s personnel) for a patient assesses whether the patient is fit for discharge;

where the attending medical practitioner for a patient is not available to assess whether the patient is fit for discharge, another medical practitioner (who is the licensee’s personnel) assesses the patient for that purpose instead;

a patient is discharged from the licensee’s care in accordance with the licensee’s policy on when a patient can be discharged after anaesthesia or sedation; and

a patient is not asked to leave the approved permanent premises before the patient is assessed to be fit for discharge.

the testing of the specimen is incidental to the provision of the nuclear medicine service;

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

a medical practitioner who is a personnel of the licensee orders the test for the patient.

the specimen must not be subject to more than minimal manipulation;

the testing must be conducted using beta scintillation or gamma counting.

includes all or any of the following:

measurement;

separation;

sterilisation;

concentration;

purification; and

does not include any of the following:

cell culturing;

cutting or sizing;

grinding;

shaping;

soaking in an antibiotic or antimicrobial solution;

irradiation;

lyophilisation;

freezing;

cryopreservation;

vitrification.

every examination is conducted on the correct patient; and

the examination of every patient is conducted at the part of the body or the site of the body part of the patient in accordance with the prescription of a dentist or medical practitioner.

there are protocols in place to ensure that the patient’s exposure to radiation is kept to a minimum; and

there are appropriate safety measures in place to protect any other individual against exposure to radiation.

the date, time and type of examination;

the name of the person who conducted the examination;

the name of the person who reported and issued the imaging report in respect of the examination;

each image obtained from the examination;

in relation to the examination —

information about the site of the anatomic site imaged; and

where any image is provided by the licensee directly to another person together with the radiological report —

the person to whom the image was provided; and

the mode by which the image was provided to that person;

in relation to any contrast agent administered to a patient during the examination —

the name and dose of the contrast agent;

the route and rate of administration of the contrast agent; and

any adverse reaction experienced by the patient following or associated with the administration of the contrast agent.

a test result for a patient deviates substantially from those earlier reported in respect of the patient; or

there is reason to suspect that the test result is inaccurate given the patient’s clinical presentation,the licensee must investigate the reason for the deviation or the suspected inaccuracy and take appropriate remedial action if applicable.

provide or arrange for the provision, by a medical practitioner, of pre‑treatment counselling to the individual;

conduct or arrange for the conduct, by a nuclear medicine physician, of an adequate and appropriate assessment of the individual’s suitability for the treatment to be provided; and

obtain the individual’s informed consent for the treatment to be provided.

monitoring of the patient’s condition after the treatment is provided;

discharge of the patient, including the provision of a written report on the treatment provided to the patient.

the patient’s safety, including —

the disease or condition for which the patient receives treatment; and

the condition of the patient’s health;

radiation safety, including —

the types and amounts of radiopharmaceuticals administered to the patient; and

the radiation risk that the patient poses to other persons after administration of the radiopharmaceuticals.