11.—(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 clinical laboratory service or radiological 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 for appropriate accountability, roles, responsibilities and continuing educational programmes;
(b)
measures to ensure that the provision of the service complies with any written law governing the service and licence conditions imposed under section 13(1) of the Act;
(c)
implementation of protocols to ensure compliance with Parts 4 to 6 and for the physical safety of the licensee’s personnel, patients and visitors;
(d)
identification of key performance indicators for assessing performance outcomes of the applicable service, including mechanisms for periodic monitoring and evaluation of these indicators;
(e)
quality control measures for equipment used in the provision of the applicable service, including acceptance testing, quality control tests and regular monitoring of equipment performance;
(f)
quality control measures for all specimens or radiological images kept or tested by the licensee, as the case may be;
(fa)
where the licensee provides any testing service on radioactive specimens —
(i)
quality control measures for all radioactive substances kept and used by the licensee, including measures pertaining to —
(A)
the acceptance, or rejection for quality or safety reasons, of all radioactive substances supplied to the licensee;
(B)
the safe and proper preparation, handling, transport and use of the radioactive substances; and
(C)
the regular testing of the quality and safety of the radioactive substances;
(ii)
the maintenance of adequate and accurate documentation on the licensee’s use of radioactive substances;
(iii)
the conduct of regular holistic analysis and reviews of all information relating to —
(A)
the quality and safety of all radioactive substances kept and used by the licensee; and
(B)
the applicable licensee’s use of all radioactive substances; and
(iv)
the testing and monitoring of the radiation levels in every approved permanent premises to ensure the safety of personnel, patients and visitors;
[S 417/2023 wef 26/06/2023]
(g)
systems and processes to ensure that regulation 32 is complied with;
(h)
the investigation of any occurrence or complaint that discloses or may disclose any weakness or inadequacy affecting the quality of the service;
(i)
the identification and implementation of appropriate and effective actions to address any weakness or inadequacy mentioned in sub‑paragraph (h) and prevent a recurrence;
(j)
the conduct of regular risk assessments of every activity conducted as part of the provision of the applicable service and, where necessary, the implementation of appropriate measures to mitigate or manage the risks identified in those assessments;
(k)
validation of test methods and imaging procedures, as the case may be;
(l)
validation of all processes relating to the performance of a test or radiological examination, as the case may be;
(m)
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 each personnel complies with sub‑paragraphs (i) and (ii).
(3) A licensee must review the effectiveness of the quality management system for the applicable service on an annual basis and ensure that the quality management system is updated periodically.
(4) In addition, a clinical laboratory service licensee must —
(a)
participate in and perform satisfactorily for the relevant external quality assessment programme for every test provided by the licensee; and
(b)
ensure that the Clinical Governance Officer or such other suitably qualified personnel designated by the Clinical Governance Officer reviews the results of the quality assessment programmes mentioned in sub‑paragraph (a) and implements appropriate and effective actions to address any weakness or inadequacy in the provision of the clinical laboratory service.