10. Requirements in relation to donor blood sampling, test kits, test protocols and test management
(1) To determine the infectious disease status of persons who are potential donors of human blood or blood components, human tissues or human cellular therapy products, samples of the person’s blood must be collected using aseptic procedures, and those samples must be tested in accordance with this section for the purpose of infectious disease screening.
(2) In the case of a living donor, blood sampling for testing must take place:
(a) no more than 7 days prior to, or 7 days after, collection of the blood, blood components, cells or tissues; or
(b) as required in another, current Therapeutic Goods Order made under section 10 of the Act that applies to the relevant product.
(3) In the case of a deceased donor, blood sampling for testing must be within the timeframe specified by the test method. The testing methodology must have been validated for cadaveric samples to include the relevant time period of sample collection following asystole. A blood sample taken up to 7 days prior to collection of the product may be used.
(4) For the manufacture of human blood and blood components, human tissue and human cellular therapy products, testing of the donor blood samples must be performed:
(a) as soon as practicable after collection of the blood sample for testing; or
(b) as required in another, current Therapeutic Goods Order made under section 10 of the Act that applies to the relevant product.
(5) The testing of blood samples from donors must take into account any factors which may cause plasma dilution sufficient to alter serology test results. Where a pre-infusion sample is unavailable for infectious disease testing and plasma dilution is suspected, then an algorithm must be applied to assess the degree of dilution. Plasma dilution must be less than 50% unless the use of samples with greater than 50% dilution is validated by the sponsor or manufacturer.
(6) The test kits/methodologies used for screening infectious diseases that are performed in accordance with subsection 11(3) tests must be:
(a) the most appropriate technology/ methodology for the sample being tested; and
(b) approved by the relevant regulatory authority in the country in which the testing is performed; and
(c) performed in a facility approved by the same authority to perform such testing; and
(d) considered acceptable by the TGA.
(7) The test kit/methodologies used for the testing of donor blood samples must be recorded in procedures and/ or the service agreement with the contracted testing laboratory.
(8) The results of the tests performed in accordance with subsection 10(4) must be evaluated prior to release of the product. If the results of the tests are not available, the product must be placed in quarantine until the results become available and are evaluated.
(9) Samples of serum or plasma taken from deceased or living donors, except when the donation is to be used exclusively for plasma for fractionation, must be:
(a) taken in accordance with subsections 10(2) or 10(3), or be samples taken from living donors at a minimum of 180 days after collection if samples are collected in accordance with paragraph 11(4)(c); and
(b) archived, unless otherwise justified, at or below minus 25°C (unless other conditions of storage are validated by the sponsor or manufacturer in relation to a different temperature, or as recommended by the test kit manufacturers); and
(c) retained for a minimum of 2 years after the expiry date of the products unless otherwise required in another, current Therapeutic Goods Order made under section 10 of the Act that applies to the relevant product.
(10) When the testing requirements mentioned in subsections 11(3), 11(4) or 11(5) change while a product is in storage, where possible the donor’s archived sample must be retested with the new screening test protocol prior to release of the product. The requirement to retest is to be determined by the sponsor or manufacturer based on a risk assessment, and after consultation with the TGA.
(11) Records on individual donors of the tests performed, test modifications, test results, analyses and any anomalies in the test results must be maintained.