Skills and competencies of Clinical Governance Officer for clinical laboratory service
5. For the purposes of section 24(3)(b) of the Act, an individual is suitably qualified to be appointed a Clinical Governance Officer for a clinical laboratory service if the individual has —
(a)
all of the following skills and competencies:
(i)
registration under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;
(ii)
registration under section 22 of the Medical Registration Act 1997 as a specialist in the branch of pathology; or
(b)
all of the following skills and competencies:
(i)
registration under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;
(ii)
registration under section 22 of the Medical Registration Act 1997 as a specialist in the branch of haematology;
(iii)
a pass in the Fellowship of the Royal College of Pathology Part 1 and Part 2 examinations or other equivalent exit examinations from a professional board approved by the Director-General;
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(iv)
at least 5 years of work experience in a clinical laboratory licensed under the repealed Act or in the provision of a clinical laboratory service licensed under this Act, or another equivalent clinical laboratory outside of Singapore approved by the Director-General.
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Skills and competencies of Clinical Governance Officer for radiological service
6.—(1) For the purposes of section 24(3)(b) of the Act and subject to paragraph (2), an individual who has all of the following skills and competencies is suitably qualified to be appointed a Clinical Governance Officer for a radiological service:
(a)
registration under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;
(b)
registration under section 22 of the Medical Registration Act 1997 as a specialist in the branch of diagnostic radiology;
(c)
at least 5 years of work experience after obtaining the qualification mentioned in sub‑paragraph (b), in providing a radiological service.
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(2) Where a licensee provides a radiological service only for dental purposes, the licensee may appoint a person registered under section 14 of the Dental Registration Act 1999 as a Clinical Governance Officer for the radiological service.
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Additional duties and responsibilities of Clinical Governance Officer
7.—(1) In addition to regulation 14 of the General Regulations, a Clinical Governance Officer appointed by a clinical laboratory service must —
(a)
before the provision of any test or implementation of any test method, evaluate whether the test or test method performs in accordance with the manufacturer’s specifications (if any) and produces accurate results; and
(b)
implement and oversee the safety programme mentioned in regulation 14.
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(2) In addition to regulation 14 of the General Regulations, a Clinical Governance Officer appointed by a radiological service must —
(a)
before the provision of an imaging modality as part of the service, evaluate whether the imaging modality produces images of diagnostic quality; and
(b)
implement and oversee the safety programme mentioned in regulation 14.
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Licensee must appoint section leader
8.—(1) A clinical laboratory service licensee must, in relation to each specified service provided by the licensee, appoint as the section leader, a person who resides in Singapore.
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(2) A radiological service licensee must, in relation to each imaging modality or specified service provided by the licensee, appoint as the section leader a radiographer —
(a)
who resides in Singapore;
(b)
who is registered under section 16 of the Allied Health Professions Act 2011; and
(c)
who has at least 3 years of work experience in providing a radiological service in the imaging modality or specified service.
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(3) A person may be appointed as a section leader —
(a)
in relation to a clinical laboratory service — for more than one specified service; or
(b)
in relation to a radiological service — for more than one imaging modality or specified service.
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(4) A Clinical Governance Officer may be appointed as a section leader.
Duties of section leader
9. A licensee must ensure that every section leader appointed under regulation 8 does all of the following in relation to the imaging modality or specified service for which the section leader is appointed:
(a)
assist the relevant Clinical Governance Officer in the day‑to‑day technical management of the imaging modality or specified service;
(b)
supervise, train and guide each personnel under the charge of the section leader in conducting tests or radiological examinations under that imaging modality or specified service;
(c)
assess and ensure the competency of each personnel deployed to perform tasks for that imaging modality or specified service;
(d)
evaluate any test or equipment before it is used in the provision of the applicable service;
(e)
monitor the performance of all tests or radiological procedures carried out under the imaging modality or specified service that the section leader is appointed for, including ensuring the implementation of quality control measures;
(f)
establish and review policy and procedures for the safe and effective performance of all tests or radiological procedures carried out under the imaging modality or specified service for which the section leader is appointed;
(g)
resolve any technical issues that arise from the performance of all tests or radiological procedures carried out under the imaging modality or specified service that the section leader is appointed for;
(h)
review all service records in relation to the tests or radiological procedures carried out under the imaging modality or specified service for which the section leader is appointed.
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General requirements relating to personnel
10.—(1) A licensee must ensure all of the following in relation to each personnel:
(a)
each personnel is adequately trained for the work performed by the personnel and attends regular training in accordance with a continuing training programme;
(b)
each personnel has the relevant awareness and knowledge of, and attends regular training on, clinical laboratory safety measures or radiation safety, as the case may be;
(c)
each personnel is assessed periodically on the personnel’s competencies and work performance;
(d)
each of the following personnel is supervised by an experienced person when performing any task or providing any service in relation to the applicable service:
(i)
for a clinical laboratory service licensee — any personnel with less than 2 years of work experience in providing a clinical laboratory service;
(ii)
for a radiological service licensee — any personnel with less than one year of work experience in providing a radiological service;
(iii)
any personnel who has not been assessed by the relevant section leader or Clinical Governance Officer to be able to perform the task or provide the service competently without supervision.
(2) In this regulation, “experienced person” means —
(a)
the Clinical Governance Officer or the relevant section leader;
(b)
for a clinical laboratory service licensee — another of the licensee’s personnel with at least 5 years of relevant work experience and who is designated by the Clinical Governance Officer or the relevant section leader to provide supervision; or
(c)
for a radiological service licensee — another of the licensee’s personnel with at least 3 years of relevant work experience and who is designated by the Clinical Governance Officer or the relevant section leader to provide supervision.
