ensure that all tests conducted on donors by the licensee are appropriate, accurate and up‑to‑date;
(b)
before providing any test or implementing any test method, evaluate whether the test or test method produces accurate results;
[S 388/2023 wef 26/06/2023]
(c)
regularly evaluate and validate the effectiveness and performance of the tests mentioned in sub‑paragraph (a) by participating in a relevant external quality assurance programme; and
[S 388/2023 wef 26/06/2023]
(d)
ensure that a Clinical Governance Officer, or such other suitably qualified personnel designated by a Clinical Governance Officer —
(i)
reviews the results of the external quality assurance programme mentioned in sub-paragraph (c); and
(ii)
implements appropriate and effective actions to address any weakness or inadequacy in the provision of any test mentioned in sub-paragraph (a).
[S 388/2023 wef 26/06/2023]
(2) For the purposes of paragraph (1)(b), the licensee must —
(a)
evaluate the test or test method against the specifications provided by the manufacturer of that test or test method; or
(b)
establish the performance of the test or test method to ensure acceptable reproducibility, accuracy, sensitivity, specificity and precision in relation to the expected use of the test or test method.