Processing and testing of blood and blood components
16.—(1) A licensee must —
(a)
ensure that all tests conducted on blood and blood components 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 an appropriate 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 performance of the test or test method against the manufacturer’s specifications for 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.
(3) The licensee must implement and maintain an effective system for determining the suitability of all blood and blood components for clinical use.
(4) The licensee must implement appropriate and effective processes and protocols to prevent the contamination of blood and blood components during processing.