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. |
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| 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; |
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| | (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. |
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(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. |
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| (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. |
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| 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. |
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| (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. |
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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. |
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| 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. |
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(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. |
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| (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. |
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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. |
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(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. |
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(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. |
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