Singapore legislation
Regulation 22
of Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021
Regulation 22
Standards for reagents
Amended byS 417/2023 wef 26/06/2023
A clinical laboratory service licensee must ensure all of the following regarding every reagent used in the provision of the clinical laboratory service:
(a)
regular evaluation of every reagent to ensure that it is capable of consistently producing accurate results in any test that it is intended to be used;
(b)
a reagent is not used in a test after its expiry date, or if there is any other reason for any personnel to suspect that the reagent is no longer suitable to be used in a test.