Schedule 2 Prescribed conditions—authorisations to carry on business of supply of semen
(Clause 10)
Semen may be stored only at:(a) the premises specified in the authorisation, or(b) a pathology laboratory accredited under section 23DN of the Health Insurance Act 1973 of the Commonwealth, or(c) a laboratory accredited for the storage of semen by an accrediting body of the Fertility Society of Australia, or(d) the premises of an exempt supplier.
(1) All donated semen (other than semen donated solely for the purpose of its use for the artificial insemination of the donor’s spouse) must be tested by culture of specimens in aerobic, anaerobic and carbon dioxide enriched environments.(2) If any semen is found by the tests referred to in subclause (1) to be positive for any pathogenic micro-organism, the semen must not be supplied for use for any therapeutic purpose unless that therapeutic purpose is approved by the Director-General.(3) Blood samples must be taken from all donors at the time of donation (or at an earlier time that is as close as practicable to that time) and at the expiry of the quarantine period referred to in clause 5, and must be tested for the prescribed contaminants using the tests approved by the Director-General.(4) If any blood is found by the tests referred to in subclause (3) to be positive for a prescribed contaminant:(a) the donor and the referring medical practitioner must be notified of the result, and(b) any stored semen, or semen subsequently obtained, from that donor must not be supplied for use for any therapeutic purpose unless that therapeutic purpose is approved by the Director-General, and(c) the cryo-storage vessel containing the semen must be prominently labelled to indicate the presence of a contaminant.
3 Labelling of straws of semen
Each straw containing donated semen must be labelled with a code that corresponds to an entry in the records showing the donor and the date of the donation.
4 Storage and transportation of semen
All semen must be stored and transported in cryo-storage vessels containing liquid nitrogen.
Semen must not be released for use until after the expiry of such quarantine period (if any) as may be recommended by the Fertility Society of Australia.
A quality assurance program, approved by the Fertility Society of Australia, must be established and maintained by the authorised supplier.
7 Facilities must comply with certain requirements
The facilities provided by the authorised supplier must meet the requirements of an accrediting body of the Fertility Society of Australia.
(1) The following records must be maintained by the authorised supplier in respect of each donation:(a) the full name and date of birth of the donor,(b) the donor’s written consent to the use of his semen for the artificial insemination of women,(c) the results of all tests performed in accordance with clause 2 (1) and (3),(d) the identification details referred to in clause 3,(e) the name of the medical practitioner to whom the semen is supplied,(f) any quality assurance records made for the purposes of clause 6.(2) The records required by subclause (1) must be retained at the premises specified in the authorisation:(a) in the case of records that relate to donors aged 20 years or over at the date of donation—for a period of not less than 10 years after the date of donation, or(b) in the case of records that relate to donors aged under 20 years at the date of donation—until the donor to whom the record relates attains, or would have attained, the age of 30 years.