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reg 9

Container to be sealed and labelled

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Part 2Collection, storage and testing of samples

9 Container to be sealed and labelled

(1) If a bodily sample is taken from a donor, the sampler shall ensure that:

(a)

the sample is placed in a container:

(i)

immediately after it is taken; and

(ii)

in the presence of the donor;

(b)

the container has not previously been used for any purpose;

(c) the container is sealed in a way that, if it were opened after being sealed, that fact would be evident on inspection of the container;

(d)

the container is labelled in a way that:

(i)

if the label, or part of the label, were removed; or

(ii)

if writing on the label were impaired by alteration or erasure,

the removal of the label or the impairment would be evident on inspection of the container;

(e)

the particulars on the label are inscribed in ink and include:

(i)

the full name of the donor;

(ii)

the date of birth and sex of the donor; and

(iii)

the date and time at which the sample was taken; and

(f) when paragraph (e) is complied with – the sampler and the donor sign the label in ink.

(2) If the donor is a person under the age of 18 years, the procedures specified in subregulation (1)(a) and (f) may be completed in the presence of the person who is responsible for the long-term care, welfare and development of the person under the age of 18 years.

(3) If the donor is a person who is suffering from a mental disability:

(a) the procedure specified in subregulation (1)(a) shall be completed in the presence of:

(i) a trustee or manager in relation to the person under a law of a State or Territory of the Commonwealth whose laws apply to the person; or

(ii) a person who is responsible for the care, welfare and development of the person suffering from a mental disability; and

(b) the procedure specified in subregulation (1)(f) is taken to be complied with only if the label is signed:

(i) by a trustee or manager in relation to the person under a law of a State or Territory of the Commonwealth whose laws apply to the person; or

(ii) by a person who is responsible for the care, welfare and development of the person suffering from a mental disability.

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