Singapore legislation

Regulation 74

of Healthcare Services (Nuclear Medicine Service) Regulations 2023

Regulation 74

Records — other matters

Subregulation 1

A licensee must keep and maintain proper, complete and accurate records in respect of all of the following:

(a)

the qualifications and competencies (including training attended and competency assessments completed) of each personnel that are relevant to the provision of the nuclear medicine service;

(b)

the quality management activities and measures taken by the licensee in connection with the provision of the nuclear medicine service (called in this regulation a quality record);

(c)

every programme, policy, system, measure, protocol or process that the licensee is required to implement under these Regulations, and every activity undertaken under that programme, policy, system, measure, protocol or process;

(d)

the monitoring of radiation levels in relation to the following:

(i)

the equipment used in the provision of the nuclear medicine service;

(ii)

the radioactive substances used in the provision of the nuclear medicine service;

(e)

the procurement, receipt, use, preparation, administration, storage and disposal of all radioactive substances in relation to the provision of the nuclear medicine service.

Subregulation 2

A quality record mentioned in paragraph (1)(b) must contain —

(a)

information relating to the quality management system mentioned in regulation 13;

(b)

a master list of the initials and signatures of each personnel;

(c)

the job descriptions, training and competency assessments for each personnel;

(d)

all information and documents related to the review of policies and processes implemented under regulation 13, and documentation of changes made to different versions of those documents;

(e)

details regarding the maintenance and calibration of each piece of equipment and instrument used in the provision of the nuclear medicine service; and

(f)

all quality control measures implemented.