Document ID: chunk:federal_register_of_legislation:F2022C00276:clause:1_9:p2
Version: federal_register_of_legislation:F2022C00276
Segment Type: clause
Provision Reference: sch 1 cl 9 (pt 2/2)
Character Range: 13289–14290

to a blood sample, and a pre-infusion sample is unavailable for testing, then:
 (a) an algorithm must be applied to assess the extent of plasma dilution; and
 (b) the extent of plasma dilution must be less than 50 per cent, unless use of samples with more than 50 per cent plasma dilution is validated by the manufacturer of the IVD medical devices or in-house IVD medical devices used for testing the sample.
 (9) Records must be maintained in relation to the following:
 (a) the tests performed in relation to blood samples and the results of those tests; and
 (b) the IVD medical device or in-house IVD medical device used for testing the samples; and
 (c) any test modifications; and
 (d) any evaluations of, or anomalies in, test results.
 (10) Procedures must be implemented for notifying a donor of HCT materials, a relevant health practitioner, a relevant hospital and any other relevant organisation, of a test result in relation to the donor that is indicative of a disease or carrier state.