Regulation 13

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.