Singapore legislation
Regulation 32A
of Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021
Regulation 32A
Conduct of simple in vitro diagnostic test
Subregulation 1
A radiological service licensee must ensure that any simple in vitro diagnostic test on a specimen or patient must be conducted —
using testing material in respect of which —
the expiry date has not passed; and
the personnel who is administering the test does not suspect or have any reason to suspect that the testing material is no longer fit for use; and
in accordance with the instructions specified by the manufacturer of the testing material.
Subregulation 2
A radiological service licensee must ensure that any testing material that is used to conduct any simple in vitro diagnostic testing is stored under the conditions, and handled in the manner, specified by the manufacturer of the testing material so as to lower the risk of contamination, unnecessary exposure of the testing material to the environment and early deterioration of the testing material.