Document ID: chunk:federal_register_of_legislation:F2022C00276:clause:1_11:p3
Version: federal_register_of_legislation:F2022C00276
Segment Type: clause
Provision Reference: sch 1 cl 11 (pt 3/3)
Character Range: 24927–25910

serum or plasma of a blood sample taken from a donor of HCT materials in accordance with subsection (3), (4) or (6) must be:
 (a) archived at or below minus 25°C, or in accordance with conditions that are validated or recommended by the manufacturer of the IVD medical device or in‑house IVD medical device used for testing the samples; and
 (b) retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature.
 (19) If:
 (a) an HCT product has not been released for supply; and
 (b) following the testing of a blood sample in relation to the product, a protocol or methodology for the testing changes;
then, the archived serum or plasma of the blood sample must be tested in accordance with the new protocol or methodology before the product is released for supply, unless the testing is not required on the basis of a risk assessment.