Regulation 19

ensure that all tests conducted on donors by the licensee are appropriate, accurate and up‑to‑date;

before providing any test or implementing any test method, evaluate whether the test or test method produces accurate results; (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

ensure that a Clinical Governance Officer, or such other suitably qualified personnel designated by a Clinical Governance Officer —

reviews the results of the external quality assurance programme mentioned in sub-paragraph (c); and

implements appropriate and effective actions to address any weakness or inadequacy in the provision of any test mentioned in sub-paragraph (a).

evaluate the test or test method against the specifications provided by the manufacturer of that test or test method; or

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.