Human Tissue Regulation 2000

Part 1 Preliminary

1 Name of Regulation

This Regulation is the Human Tissue Regulation 2000.

2 Commencement

This Regulation commences on 1 September 2000.

Note—

This Regulation replaces the Human Tissue Regulation 1995 which is repealed on 1 September 2000 under section 10 (2) of the Subordinate Legislation Act 1989.

3 Definitions

(1)  In this Regulation:

AS 3864—1997 means the Australian Standard entitled Medical refrigeration equipment—For the storage of blood and blood products and numbered AS 3864—1997, published by Standards Australia and in force on 1 September 2000.

Director-General means the Director-General of the Department of Health.

the Act means the Human Tissue Act 1983.

(2)  The explanatory note, table of contents and notes in the text of this Regulation do not form part of this Regulation.

Part 2 Prescribed definitions

4 Exempt suppliers of blood products

For the purposes of the Act, a body is an exempt supplier of blood products:

(a)  to the extent that the body supplies blood products that are therapeutic goods within the meaning of the Therapeutic Goods Act 1989 of the Commonwealth and that are registered goods within the meaning of that Act, or

(b)  to the extent that the body:

(i)  supplies blood products that are therapeutic goods within the meaning of the Therapeutic Goods Act 1989 of the Commonwealth and that are exempt goods for the purposes of Part 3 of that Act, and

(ii)  complies with the conditions (if any) of the relevant exemption that apply to the body.

5 Prescribed contaminants

The following organisms and substances are declared to be prescribed contaminants for the purposes of the Act:

Hepatitis B virus

Hepatitis B surface antigen

Hepatitis C virus

Hepatitis C antibody

Human T-lymphotropic virus Type-I (HTLV-I)

Human T-lymphotropic virus Type-I (HTLV-I) antibody

Human immunodeficiency virus

Human immunodeficiency virus antibody

Treponema pallidum

Treponema pallidum related antibody

Part 3 Designated specialists

6 Designated specialists

For the purposes of section 5 (2) (b) of the Act, the following classes of medical practitioners are prescribed:

(a)  Fellows of the Australian and New Zealand College of Anaesthetists,

(b)  Fellows of the Royal Australasian College of Physicians,

(c)  Fellows of the Royal Australasian College of Surgeons,

(d)  Fellows of the Royal Australian College of Obstetricians and Gynaecologists.

Part 4 Donations of blood or semen

7 Certificates relating to blood and semen donors

(1)  For the purposes of section 21C (1) and (2) of the Act, the prescribed form in relation to a donation of blood or semen made before 9 October 2000 is:

(a)  Form 1 of Schedule 1, except in the case of a form to be completed by a donor referred to in paragraph (b), and

(b)  Form 2 of Schedule 1, in the case of a form to be completed by a donor who donates blood solely for the purpose of clinical trials approved by the Director-General.

(2)  For the purposes of section 21 C (1) and (2) of the Act, the prescribed form in relation to a donation of blood or semen made on or after 9 October 2000 is:

(a)  Form 1 of Schedule 2, except in the case of a form to be completed by a donor referred to in paragraph (b), and

(b)  Form 2 of Schedule 2, in the case of a form to be completed by a donor who donates blood solely for the purpose of clinical trials approved by the Director-General.

8 Prescribed witnesses in relation to certificates by donors

(1)  For the purposes of section 21C (1) of the Act, the prescribed class of persons who can witness the signing of a certificate relating to the medical suitability of a donor of blood or semen is the class consisting only of persons:

(a)  who are medical practitioners or nurses employed where the blood is to be removed or where the semen is to be obtained or received, or

(b)  who:

(i)  are employed where the blood is to be removed or where the semen is to be obtained or received, and

(ii)  have been nominated by their employer as appropriate persons to witness signatures, and

(iii)  have been approved by the Director-General in writing as appropriate persons to witness signatures.

(2)  For the purposes of section 21C (2) of the Act, the prescribed class of persons who can witness the signing of a certificate relating to the medical suitability of a donor of blood or semen is the class consisting only of persons:

(a)  who are medical practitioners or nurses employed where the blood is to be removed or used or where the semen is to be obtained, received or used, or

(b)  who:

(i)  are employed where the blood is to be removed or used or where the semen is to be obtained, received or used, and

(ii)  have been nominated by their employer as appropriate persons to witness signatures, and

(iii)  have been approved by the Director-General in writing as appropriate persons to witness signatures.

(3)  For the purposes of section 21C (3) (a) and (b) of the Act, the prescribed class of persons who can witness the marking or signing of a certificate relating to the medical suitability of a donor of blood or semen is the class consisting only of persons:

(a)  who are medical practitioners or nurses employed where the certificate is signed, or

(b)  who:

(i)  are employed where the certificate is marked or signed, and

(ii)  have been nominated by their employer as appropriate persons to witness signatures, and

(iii)  have been approved by the Director-General in writing as appropriate persons to witness signatures.

9 Keeping of certificates

(1)  A certificate signed for the purposes of section 21C (1) of the Act must be retained, for a period of not less than 10 years from the date on which it was signed, by the person by whom the blood was removed or by whom the semen was obtained or received.

(2)  A certificate signed for the purposes of section 21C (2) of the Act must be retained, for a period of not less than 10 years from the date on which it was signed, by the person by whom the blood or semen was used.

(3)  If the person who removed or used the blood, or obtained, received or used the semen, did so in the person’s capacity as an employee or agent of some other person or body, that other person or body must retain the relevant certificate.

Maximum penalty: 2 penalty units.

Part 5 Regulation of business supplying blood, blood products or semen

10 Applications for authorisations

(1)  For the purposes of sections 21H and 21I of the Act, the prescribed particulars to be contained in or to accompany an application for an authorisation to carry on a business of supplying blood, blood products or semen are the following:

(a)  the full name and address of the applicant,

(b)  the type of business to be carried on,

(c)  the proposed name of the business,

(d)  the proposed location of the business (details of which are to include two copies of sketch plans of the premises at which it is proposed to carry on the business, drawn to a scale of at least 1:100 and showing the dimensions of each part of the premises and the use to which each part is to be put, with any proposed alterations or extensions to the premises shown by distinctive colouring or cross-hatching),

(e)  details of the management structure of the business (including the full names of key personnel involved in its administration),

(f)  the full name and qualifications of the person (or each person, if more than one is to be appointed) who will superintend the collection, testing, storage and supply of blood, blood products or semen and the keeping of records relating to that collection, testing, storage and supply,

(g)  in the case of a business to be conducted by a corporation:

(i)  the registered number (being the Australian Company Number or Australian Registered Body Number) of the corporation, and

(ii)  the full name and residential address of each director of the corporation, and

(iii)  the full name and residential address of the principal executive officer of the corporation, and

(iv)  the full name and residential address of the secretary of the corporation,

(h)  in the case of a business to be conducted by a corporation limited by shares:

(i)  the types of shares and the number of shares of each type issued, and

(ii)  in the case of a private corporation, the full name of, and the number of shares held by, each shareholder, and

(iii)  in the case of a public corporation, a list of the 20 largest shareholdings and of the full names of the holders of each of those shareholdings, and

(iv)  if shares in the corporation are held by another corporation, the name of the ultimate holding company of those shares.

(2)  In this clause:

ultimate holding company, in relation to a corporation, means a body corporate that is a holding company of the corporation and is not itself a subsidiary of any body corporate.

11 Qualifications for persons performing particular functions

(1)  The qualifications specified in this clause are prescribed for the purposes of section 21I (1) (c) of the Act.

(2)  A person employed to superintend the collection, testing, storage or supply of blood or blood products, or the keeping of records relating to that collection, testing, storage or supply, must be:

(a)  a Fellow of the Royal College of Pathologists of Australasia, or

(b)  a medical practitioner recognised by that College as a specialist pathologist.

(3)  A person employed to superintend the collection, testing, storage or supply of semen, or the keeping of records relating to that collection, testing, storage or supply, must be a medical practitioner.

(4)  A person employed to collect blood from donors must be:

(a)  a medical practitioner, or

(b)  a registered nurse, or

(c)  an enrolled nurse working under the direct supervision of a registered nurse.

12 Requirements for premises

(1)  The requirements specified in this clause are prescribed for the purposes of section 21I (1) (d) of the Act.

(2)  Premises used for carrying on the business of supplying blood or blood products must include the following:

(a)  a reception area,

(b)  an area set aside for the processing of blood for storage,

(c)  an area set aside for the storage of blood and blood products,

(d)  an area set aside for the secure storage of records relating to the collection, identification, testing, storage and supply of blood and blood products,

(e)  if blood is to be collected from donors at the premises:

(i)  a blood collection room, and

(ii)  a recovery and refreshment area,

(f)  if testing of blood for prescribed contaminants is to be carried out on the premises, a laboratory set aside for that purpose.

(3)  An area set aside for the storage of blood and blood products must be equipped with one or more refrigerators that comply with the relevant provisions of AS 3864—1997.

(4)  Premises used for carrying on the business of supplying semen must include the following:

(a)  a reception area,

(b)  an area set aside for the processing of semen for storage,

(c)  an area set aside for the storage of semen,

(d)  an area set aside for the secure storage of records relating to the collection, identification, testing, storage and supply of semen,

(e)  if semen is to be provided by donors at the premises, semen collection rooms,

(f)  if testing of semen for prescribed contaminants is to be carried out on the premises, a laboratory set aside for that purpose.

(5)  An area set aside for the storage of semen must be equipped with one or more cryo-storage vessels for the storage of semen in liquid nitrogen.

13 Conditions to which authorisations are subject

For the purposes of section 21I (3) of the Act:

(a)  the conditions set out in Schedule 3 are prescribed in respect of an authorisation to carry on the business of supplying blood or blood products, and

(b)  the conditions set out in Schedule 4 are prescribed in respect of an authorisation to carry on the business of supplying semen.

14 Prescribed quantities of blood, blood products and semen

For the purposes of section 21M (b) of the Act:

(a)  the prescribed quantity of blood is 1 litre, and

(b)  the prescribed quantity of blood products is, in relation to any particular kind of blood product, the quantity of blood products of that kind that is equivalent to the quantity of blood products of that kind that can be derived or extracted from 1 litre of blood, and

(c)  the prescribed quantity of semen is 1 millilitre.

Part 6 Miscellaneous

15 Savings provision

(1)  Any act, matter or thing that, immediately before the repeal of the Human Tissue Regulation 1995, had effect under that Regulation is taken to have effect under this Regulation.

(2)  Nothing in the Human Tissue Amendment (Donor Certificates) Regulation 2001 affects any requirement of this Regulation to retain any certificate under section 21C of the Act signed before the commencement of that Regulation or any other lawful requirement or authorisation relating to any such certificate.

cl 15: Am 6.4.2001.

Schedule 1 Forms relating to blood or semen donations (before 9 October 2000)

Form 1   Certificates

(Clause 7 (1) (a))

(Human Tissue Act 1983, section 21C)

*Part A Certificate by person donating blood

Before you give blood

There are some people in the community who MUST NOT donate blood because it may transmit infections to patients who receive it.

You must complete this form if you want to donate blood. If you do not know how to answer any of the questions, please check with the interviewing sister. It is against the law to knowingly make a false or misleading statement. If you do, you may receive a $5,500 fine or 1 year in prison, or both.

To the best of my knowledge my answers to the following questions are true

1 Have you any reason to believe that:
(a)  you have AIDS (Acquired Immune Deficiency Syndrome)?	Yes/No
(b)  you have been infected with the virus that causes AIDS (HIV)?	Yes/No
2 In the last 6 months have you had:
(a)  night sweats?	Yes/No
(b)  unexplained weight loss?	Yes/No
(c)  persistent fever?	Yes/No
(d)  diarrhoea?	Yes/No
(e)  swollen glands?	Yes/No
3 Have you had male to male sexual activity since 1977?	Yes/No
4 Have you had sexual activity with a bisexual male since 1977?	Yes/No
5 Have you had sexual activity with any person who may have been exposed to the virus that causes AIDS (HIV)?	Yes/No
6 Have you EVER injected yourself, or been injected with, any drug not prescribed by a doctor?	Yes/No
7 Have you EVER shared drug needles?	Yes/No
8 Have you been accidentally stuck with a used needle in the last 12 months?	Yes/No
9 Have you EVER been a male or female prostitute?	Yes/No
10 Have you had sexual activity with a male or female prostitute in the last 12 months?	Yes/No
11 Have you been tattooed within the last 12 months?	Yes/No
12 Have you received a blood transfusion or treatment with human blood products in the last 12 months?	Yes/No
13 In the last 2 years have you had jaundice or hepatitis, or been in close contact with any person with either of these illnesses?	Yes/No
14 Are the answers to questions 1–13 also correct for your present and past spouse(s) and present and past sexual partner(s)?	Yes/No

(Please do not sign the form yet.
Take it with you to the interviewer.)

Signature of Donor ............................................................
Name (print)............................................................

Signature of Witness ............................................................
Name (print)............................................................

Date ............................................................

*Part B Certificate by person donating semen

Before you donate semen

There are some people in the community who MUST NOT donate semen because it may transmit infections to patients who receive it.

You must complete this form if you want to donate semen. If you do not know how to answer any of the questions, please check with a nurse or medical practitioner. It is against the law to knowingly make a false or misleading statement. If you do, you may receive a $5,500 fine or 1 year in prison, or both.

To the best of my knowledge my answers to the following questions are true

1 Have you any reason to believe that:
(a)  you have AIDS (Acquired Immune Deficiency Syndrome)?	Yes/No
(b)  you have been infected with the virus that causes AIDS (HIV)?	Yes/No
2 In the last 6 months have you had:
(a)  night sweats?	Yes/No
(b)  unexplained weight loss?	Yes/No
(c)  persistent fever?	Yes/No
(d)  diarrhoea?	Yes/No
(e)  swollen glands?	Yes/No
3 Have you had male to male sexual activity since 1977?	Yes/No
4 Have you had sexual activity with a bisexual male since 1977?	Yes/No
5 Have you had sexual activity with any person who may have been exposed to the virus that causes AIDS (HIV)?	Yes/No
6 Have you EVER injected yourself, or been injected with, any drug not prescribed by a doctor?	Yes/No
7 Have you EVER shared drug needles?	Yes/No
8 Have you been accidentally stuck with a used needle in the last 12 months?	Yes/No
9 Have you EVER been a male or female prostitute?	Yes/No
10 Have you had sexual activity with a male or female prostitute in the last 12 months?	Yes/No
11 Have you been tattooed within the last 12 months?	Yes/No
12 Have you received a blood transfusion or treatment with human blood products in the last 12 months?	Yes/No
13 In the last 2 years have you had jaundice or hepatitis, or been in close contact with any person with either of these illnesses?	Yes/No
14 Are the answers to questions 1–13 also correct for your present and past spouse(s) and present and past sexual partner(s)?	Yes/No

(Please do not sign the form yet.
Take it with you to the interviewer.)

Signature of Donor ............................................................
Name (print)............................................................

Signature of Witness ............................................................
Name (print)............................................................

Date ............................................................

(* Delete whichever is inapplicable.)

Form 2   Certificate by person donating blood for use in clinical trial

(Clause 7 (1) (b))

(Human Tissue Act 1983, section 21C)

Certificate by person donating blood for use in a clinical trial

The following certificate must be completed and signed by any person who wishes to donate blood for the purposes of a clinical trial conducted by ............................................................
............................................................
at ............................................................

Please read it carefully.

It is against the law to knowingly make a statement which is false or misleading. If you do, you may receive a $5,500 fine or 1 year in prison, or both. If in doubt please consult a medical practitioner or nurse.

Certificate

I hereby certify that to the best of my knowledge all of the following statements are true:

1  I have reason to believe that I am carrying the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

2  I am donating blood solely for the purposes of its use in a clinical trial which is being conducted by ............................................................
at ............................................................

I am signing this certificate in the presence of a *medical practitioner/nurse/other person nominated for that purpose who is employed at the place I am attending.

Name: ..................................................
(Please print)
......................... (Signature of donor)
......................... (Signature of witness)
......................... (Date)

(* Delete whichever is inapplicable.)

Schedule 2 Forms relating to blood or semen donations on or after 9 October 2000

Form 1   Certificate

(Clause 7 (2) (a))

Form 1: Am 6.4.2001.

(Human Tissue Act 1983, section 21C)

Part A Certificate by person donating blood

Questions for people who want to donate blood

(Please circle your answers)

To the best of your knowledge have you:
1 in the last 6 months had an illness with swollen glands and a rash, with or without a fever?	Yes/No
2 ever thought you could be infected with HIV or have AIDS?	Yes/No
3 ever “used drugs” by injection or been injected, even once, with drugs not prescribed by a doctor or dentist?	Yes/No
4 ever had treatment with clotting factors such as Factor VIII or Factor IX?	Yes/No
5 ever had a test which showed you had Hepatitis B, Hepatitis C, HIV or HTLV?	Yes/No
6 in the last 12 months engaged in sexual activity with someone you might think would answer “Yes” to any of questions 1–5?	Yes/No
7 since your last donation or in the last 12 months engaged in sexual activity with a new partner who currently lives or has previously lived overseas?	Yes/No
Within the last 12 months have you:
8 had male to male sex?	Yes/No
9 engaged in sexual activity with a male who you think might be bisexual?	Yes/No
10 been a male or female sex worker (eg received payment for sex in money, gifts or drugs)?	Yes/No
11 engaged in sexual activity with a male or female sex worker?	Yes/No
12 been injured with a used needle (needlestick)?	Yes/No
13 had a blood or body fluid splash to eyes, mouth, nose or to broken skin?	Yes/No
14 had a tattoo (including cosmetic tattooing), skin piercing, electrolysis or acupuncture?	Yes/No
15 been imprisoned in a prison or lock-up?	Yes/No
16 had a blood transfusion?	Yes/No
17 had (yellow) jaundice or hepatitis or been in contact with someone who has?	Yes/No

I declare that I have understood the information on this form and answered the questions in the declaration to the best of my knowledge.

Signature of donor ............................................................
Name (please print)............................................................

Signature of witness ............................................................
Name (please print)............................................................

Part B Certificate by person donating semen

Questions for people who want to donate semen

(Please circle your answers)

To the best of your knowledge have you:
1 in the last 6 months had an illness with swollen glands and a rash, with or without fever?	Yes/No
2 ever thought you could be infected with HIV or have AIDS?	Yes/No
3 ever “used drugs” by injection or been injected, even once, with drugs not prescribed by a doctor or dentist?	Yes/No
4 ever had treatment with clotting factors such as Factor VIII or Factor IX?	Yes/No
5 ever had a test which showed you had Hepatitis B, Hepatitis C, HIV or HTLV?	Yes/No
6 in the last 12 months engaged in sexual activity with someone you might think would answer “Yes” to any of questions 1–5?	Yes/No
7 since your last donation or in the last 12 months engaged in sexual activity with a new partner who currently lives or has previously lived overseas?	Yes/No
Within the last 12 months have you:
8 engaged in sexual activity with a male?	Yes/No
9 been a sex worker (eg received payment for sex in money, gifts or drugs)?	Yes/No
10 engaged in sexual activity with a male or female sex worker?	Yes/No
11 been injured with a used needle (needle stick)?	Yes/No
12 had a blood or body fluid splash to eyes, mouth, nose or to broken skin?	Yes/No
13 had a tattoo (including cosmetic tattooing), skin piercing, electrolysis or acupuncture?	Yes/No
14 been imprisoned in a prison or lock-up?	Yes/No
15 had a blood transfusion?	Yes/No
16 had (yellow) jaundice or hepatitis or been in contact with someone who has?	Yes/No

I declare that I have understood the information on this form and answered the questions in the declaration to the best of my knowledge.

Signature of donor ............................................................
Name (please print)............................................................

Signature of witness ............................................................
Name (please print)............................................................

Form 2   Certificate by person donating blood for use in a clinical trial

(Clause 7 (2) (b))

(Human Tissue Act 1983, section 21C)

Certificate by person donating blood for use in a clinical trial

The following certificate must be completed and signed by any person who wishes to donate blood for the purposes of a clinical trial conducted by ............................................................
............................................................
at ............................................................

Please read it carefully.

It is against the law to knowingly make a statement that is false or misleading. If you do, you may receive a $5,500 fine or 1 year in prison, or both. If in doubt please consult a medical practitioner or nurse.

Certificate

I hereby certify that to the best of my knowledge all of the following statements are true:

1  I have reason to believe that I am carrying the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

2  I am donating blood solely for the purposes of its use in a clinical trial which is being conducted by ............................................................
at ............................................................

I am signing this certificate in the presence of a *medical practitioner/nurse/other person nominated for that purpose, who is employed at the place I am attending.

Signature of donor ............................................................
Name (please print)............................................................

Signature of witness ............................................................
Name (please print)............................................................

(* Delete whichever is inapplicable.)

Schedule 3 Prescribed conditions—authorisations to carry on business of supplying blood or blood products

(Clause 13 (a))

1 General

(1)  The collection, storage and supply of blood and blood products must be for the following purposes only:

(a)  the transfusion of blood back to the person from whom the blood was removed, or

(b)  the use of blood or blood products for other therapeutic purposes, or for medical purposes or scientific purposes, involving the treatment of the person from whom the blood was removed, or

(c)  the use of blood or blood products for the purpose of cross-matching with other blood or blood products.

(2)  Blood for storage or supply may be collected only at the premises specified in the authorisation or at the premises of an exempt supplier.

(3)  Blood and blood products 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)  the premises of an exempt supplier.

2 Attendance by medical practitioner

A medical practitioner must be in attendance whenever blood is being collected from a donor unless the donor:

(a)  falls within the criteria for acceptability of blood donors prepared by the Australian Red Cross National Blood Transfusion Committee, and

(b)  is not pregnant or, if pregnant, is not expected to give birth within the following 4 weeks.

3 Statement to be signed

(1)  An intending blood donor must be required to complete and sign a statement in or to the effect of:

(a)  Part A of Form 1 of Schedule 1—in the case of a donation made before 9 October 2000,

(b)  Part A of Form 1 of Schedule 2—in the case of a donation made on or after 9 October 2000.

(2)  If the intending donor is unable to complete and sign a statement in accordance with subclause (1), blood must not be collected from the intending donor unless:

(a)  the matter is referred to a medical practitioner, and

(b)  the medical practitioner to whom the matter is referred gives written authority for the collection of the blood, and

(c)  any conditions specified by the medical practitioner to whom the matter is referred are complied with.

4 Testing of blood

(1)  All donated blood must be tested for ABO and Rh (D) blood groups.

(2)  All donated blood must be tested for the prescribed contaminants using the tests approved pursuant to section 21DA (3) (b) (ii) or 21DA (4) (a) (ii) of the Act.

(3)  If any blood is found by the tests referred to in subclause (2) to be positive for a prescribed contaminant:

(a)  the donor and the referring medical practitioner must be notified of the result, and

(b)  the blood must not be supplied for use for any therapeutic purpose unless that therapeutic purpose is approved by the Director-General, and

(c)  the container of the blood must be prominently labelled with the biohazard symbol.

5 Labelling of containers of blood and blood products

(1)  The container of any donated blood, or of any blood product derived or extracted from donated blood, must be labelled with:

(a)  the name of the business conducted by the authorised supplier, and

(b)  a unique identification number, and

(c)  the product type, and

(d)  the blood group, and

(e)  the date of collection, and

(f)  the expiry date, and

(g)  the full name and date of birth of the donor, and

(h)  the signature of the donor.

(2)  Before any donated blood, or any blood product derived or extracted from donated blood, is released for use by the holder of the authorisation, its container must be labelled with the name of the medical practitioner requesting the blood or blood product.

(3)  The particulars referred to in subclause (1) (b), (c) and (d) must be printed in both of the following forms:

(a)  machine-readable barcode printed in accordance with specifications prepared by the Committee for Commonality in Blood Banking Automation, as published by the America Blood Commission, and

(b)  readable alpha-numeric form corresponding with the machine-readable code referred to in paragraph (a).

(4)  The identification number referred to in subclause (1) (b) must be integrated with the numbering system used throughout Australia by the Australian Red Cross Society.

6 Storage and transportation of blood and blood products

All blood and blood products must be stored and transported in refrigeration equipment that complies with the relevant provisions of AS 3864—1997.

7 Service and maintenance of equipment

All equipment must be properly serviced and maintained in good working order, and a record made of all servicing and maintenance of the equipment for the life of the equipment.

8 Certain blood and blood products to be discarded

Any blood or blood products must be discarded if the temperature during storage in the liquid state rises above 10°C for more than 30 minutes at any one time.

9 Emergency resuscitation equipment

Emergency resuscitation equipment must be immediately available at all times while blood is being collected from donors, and staff trained to use the equipment must be in attendance throughout the blood collection and recovery period.

10 Quality assurance

A quality assurance program, approved by the Director-General, must be established and maintained by the authorised supplier.

11 Records

(1)  The following records must be maintained by the authorised supplier in respect of each donation:

(a)  the donor’s written consent to the removal of blood from the donor’s body and the statement completed by the donor in accordance with clause 3 (1),

(b)  the results of all tests performed in accordance with clause 4 (1) and (2),

(c)  the details referred to in clause 5 (1),

(d)  the name of the requesting practitioner referred to in clause 5 (2),

(e)  any temperature monitoring records made for the purposes of clause 6,

(f)  any equipment maintenance records made for the purposes of clause 7,

(g)  any quality assurance records made for the purposes of clause 10.

(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 from 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.

Schedule 4 Prescribed conditions—authorisations to carry on business of supply of semen

(Clause 13 (b))

1 General

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.

2 Testing of semen and blood

(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 pursuant to section 21DA (3) (b) (ii) or 21DA (4) (a) (ii) of the Act.

(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.

5 Quarantine period

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.

6 Quality assurance

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.

8 Records

(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.