Health (Infectious Diseases) (Further Amendment)
Regulations 2005
S.R. No. 4/2005
TABLE OF PROVISIONS
Regulation
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Page
Objective
Authorising provisions
Commencement
Principal Regulations
Definition of pathology service
Notification of micro-organisms in food and water supplies
New heading for regulation 19
Notifiable diseases
Forms for notification by medical practitioners
New Schedule 7 substituted
1
1
1
2
2
2
2
2
3
10
SCHEDULE 7—Blood Donation Statement
10
New Schedule 8 substituted
13
SCHEDULE 8—Tissue Donation Statement
13
═══════════════
ENDNOTES
17
i
STATUTORY RULES 2005
S.R. No. 4/2005
Health Act 1958
Health (Infectious Diseases) (Further Amendment)
Regulations 2005
The Governor in Council makes the following Regulations:
Dated: 25 January 2005
Responsible Minister:
BRONWYN PIKE
Minister for Health
SUDHA KASYNATHAN
Acting Clerk of the Executive Council
1. Objective
The objective of these Regulations is to make
miscellaneous amendments to the Health
(Infectious Diseases) Regulations 2001.
2. Authorising provisions
These Regulations are made under sections 146,
390(1) and 391 of the Health Act 1958.
3. Commencement
(1) These Regulations, except regulation 11, come
into operation on the day after they are made.
(2) Regulation 11 comes into operation on 1 April
2005.
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4. Principal Regulations
In these Regulations, the Health (Infectious
Diseases) Regulations 20011 are called the
Principal Regulations.
5. Definition of pathology service
In regulation 4 of the Principal Regulations, for
the definition of "pathology service" substitute—
' "pathology service" means a service in which
human tissue, human fluids or human body
products are subjected to analysis for the
purposes of the prevention, diagnosis or
treatment of disease in human beings;'.
6. Notification of micro-organisms in food and water
supplies
In regulation 9 of the Principal Regulations—
(a) in sub-regulation (2)—
(i) omit ", food vehicle"; and
(ii) for "in Victoria, is" substitute "in
Victoria is"; and
(b) in sub-regulation (3), omit ' "food
vehicle",'.
7. New heading for regulation 19
For the heading to regulation 19 of the Principal
Regulations substitute—
"Tissue donations".
8. Notifiable diseases
In Schedule 3 to the Principal Regulations—
(a) in Group A, for "Diptheria" substitute
"Diphtheria";
(b) in Group C, for "Chlamydia trachomatis
genital infection" substitute "Chlamydia
trachomatis infection".
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9. Forms for notification by medical practitioners
In Schedule 4 to the Principal Regulations, for
Forms 3 and 4 substitute—
"Form 3: For Group D Notification for HIV—Strictly
Confidential
1. Identification
Name Code (First two letters of family name,
First two letters of given name)
Date of birth
Sex
2. Other characteristics
Country of birth
Indigenous status
If born overseas, year of arrival in Australia
Language other than English spoken at home
Residential postcode
Date of onset of illness
Current state of person:
If alive—date of most recent contact
If deceased—date of death
3. Notifying doctor
Name
Address
Hospital name (if appropriate)
Phone number
Signature
Date of notification
4. Reason for testing
Exposure risk (see section 6)
Investigation of clinical symptoms
Screening—
Blood, organ or semen donor
Insurance
Immigration
Antenatal
Confirmation of HIV positive status
Other
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5. Diagnosis
Date of first diagnosis of HIV infection
State/Territory of first diagnosis of HIV infection
CD4+ count or viral load at first diagnosis of HIV infection
or both
History of HIV seroconversion illness
Date of HIV seroconversion illness
Has the person had a previous HIV test
Date of last test
Result of last HIV test
Source of information on last test, patient, doctor or
laboratory
6. Exposure category
Note: More than one exposure category may be notified.
Person was interviewed in regard to exposure:
*Not at all (provide reasons)
*To a certain extent (provide the following details)
*In depth (provide the following details)
*Delete if inapplicable
Sexual exposure
Note: At least one of the following must be notified.
Sexual contact only with person of same sex
Sexual contact with both sexes (if female see section 6a)
Sexual contact only with person of opposite sex (see
section 6a)
Sexual contact with a person from another country (write
country)
No sexual contact
Sexual exposure not known
Vertical exposure
Mother with/at risk of HIV infection (see section 6b)
Blood exposure
Injecting drug use (detail)
Recipient of blood, blood products or tissue (detail)
Haemophilia/coagulation disorder (detail)
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Other exposure
History of tattoos (date/place)
History of ear/body piercing (date/place)
History of major/minor surgery (date/place)
Exposure other than those given above (type/date/place)
Exposure could not be established (detail)
6a. Sexual contact
Note: At least one of the following must be answered if
MALE reports sexual contact with person of
opposite sex or if FEMALE reports sexual contact
with either same or OPPOSITE sex.
Sex with bisexual male (women only)
Sex with injecting drug user
Sex with person from another country (write country)
Sex with a person who received blood, blood products or
tissue
Sex with a person with haemophilia/ coagulation disorder
Sex with person with HIV infection whose exposure is other
than those above (specify)
Sex with person with HIV infection whose exposure could
not be established
Heterosexual contact not further specified
6b. Vertical exposure category
Note: At least one of the following must be answered if
parent/guardian reports vertical exposure from
mother to child only.
Mother with/at risk of HIV infection due to—
Injecting drug use
Recipient of blood, blood products or tissue
Origin from another country (write country)
Has HIV infection, exposure not specified
Sex with bisexual male
Sex with injecting drug user
Sex with person who received blood, blood products or
tissue
Sex with person with haemophilia/coagulation disorder
Sex with person from another country (write country)
Sex with person with HIV infection, exposure not
specified
Other (specify)
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7. Donation of blood or other bodily fluid or tissue
prior to HIV diagnosis
Note: If this item is applicable, specify type of donation,
date and place of donation.
Timing of Notice
Written notification with details of the data elements listed
in items 1 to 7, within 5 days of the initial diagnosis.
__________________
Form 4: For Group D Notification for AIDS—Strictly
Confidential
1. Identification
Name Code (First two letters of family name, First two
letters of given name)
Date of birth
Sex
2. Other characteristics
Country of birth
Indigenous status
Residential postcode
If born overseas, year of arrival into Australia
Language other than English spoken at home
Current state of person—
 If person is alive, date of most recent contact
 If person has died, date of death
3. Notifying doctor
Name
Address
Hospital name (if appropriate)
Phone number
Signature
Date of notification
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4. Diagnosis
Date of AIDS diagnosis
Has the person previously been diagnosed with AIDS
elsewhere? Yes/No/Unknown
 If yes and diagnosis was in another State/Territory,
specify State/Territory and date
 If yes and diagnosis was overseas, specify country
and date
5. Laboratory tests
Date of first diagnosis of HIV infection
CD4+ count or viral load at AIDS diagnosis or both
Date of specimen collection for CD4+ count analysis
Note: The CD4+ count and viral load results need to be
forwarded as part of your notification when the
count and results are available.
6. Anti-retroviral therapy
Has the person been treated with anti-retroviral therapy?
If yes, specify month/year when started
7. Diseases indicative of AIDS at diagnosis
Note: At least one of the following must be notified. State
whether definite or presumptive.
Pneumocystis carinii pneumonia
Oesophageal candidiasis
Kaposi's sarcoma (specify site)
Herpes simplex virus of >1 month duration (specify site)
Cryptococcosis (specify site)
Cryptosporidiosis (diarrhoea >1 month)
Toxoplasmosis (specify site)
Cytomegalovirus (specify site)
Atypical Mycobacteriosis (specify type)
Pulmonary tuberculosis
Extrapulmonary tuberculosis
Lymphoma
Non-Hodgkin's lymphoma, primary of brain/CNS
Non-Hodgkin's lymphoma, other site (specify type)
HIV encephalopathy (includes AIDS Dementia Complex)
HIV wasting syndrome
Invasive cervical cancer
Recurrent pneumonia
Other (specify)
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8. Exposure category
Note: More than one exposure category may be notified.
Person was interviewed in relation to exposure:
*Not at all (provide reasons)
*To a certain extent (provide the following details)
*In depth (provide the following details)
*Delete if inapplicable
Sexual exposure
Note: At least one of the following must be notified.
Sexual contact only with person of same sex
Sexual contact with both sexes (if female see section 8a)
Sexual contact only with person of opposite sex (see
section 8a)
Sexual contact with a person from another country (write
country)
No sexual contact
Sexual exposure not known
Vertical exposure
Mother with/at risk of HIV infection (see section 8b)
Blood exposure
Injecting drug use (detail)
Recipient of blood, blood products or tissue (detail)
Haemophilia/coagulation disorder (detail)
Other exposure
Exposures other than those above apply (provide details)
Exposure could not be established (detail)
8a. Sexual contact
Note: At least one of the following must be answered if
MALE reports sexual contact with person of
opposite sex or if FEMALE reports sexual contact
with either same or OPPOSITE sex.
Sex with bisexual male (women only)
Sex with injecting drug user
Sex with person from another country (write country)
Sex with a person who received blood, blood products or
tissue
Sex with a person with haemophilia/coagulation disorder
Sex with person with HIV infection whose exposure is other
than those above (specify)
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Sex with person with HIV infection whose exposure could
not be established
Heterosexual contact not further specified
8b. Vertical exposure category
Note: At least one of the following must be answered if
parent/guardian reports vertical exposure from
mother to child only.
Mother with/at risk of HIV infection due to—
Injecting drug use
Recipient of blood, blood products or tissue
Origin from another country (write country)
Has HIV infection, exposure not specified
Sex with bisexual male
Sex with injecting drug user
Sex with person who received blood, blood products or
tissue
Sex with person with haemophilia/coagulation disorder
Sex with person from another country (write country)
Sex with person with HIV infection, exposure not
specified
Other (specify)
Timing of Notice
Written notification with details of the data elements listed
in items 1 to 8b, within 5 days of the initial diagnosis.
__________________".
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10. New Schedule 7 substituted
For Schedule 7 to the Principal Regulations
substitute—
'SCHEDULE 7
Regulation 18
Health (Infectious Diseases) Regulations 2001
BLOOD DONATION STATEMENT
There are some people who MUST NOT give blood as it
may transmit infections to those who receive it. To
determine if your blood or blood products will be safe to be
given to people in need, we would like you to answer some
questions. These questions are a vital part of our efforts to
eliminate any diseases from the blood supply.
All donations of blood are tested for the presence of
hepatitis B and C, HIV 1 and 2 (the AIDS virus), HTLV I
and II and syphilis. If your blood test proves positive for any
of these conditions, or for any reason the test shows a
significantly abnormal result, you will be informed.
All of the questions are important to answer. Answer each
question on the form as honestly as you can and to the best
of your knowledge. There are penalties, including fines and
imprisonment, for anyone providing false or misleading
information.
To the best of your knowledge have you:
1.
Had an illness with swollen glands
and a rash, with or without a fever in
the last 6 months?
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
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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 had sexual activity with a
new partner who currently lives or
has previously lived overseas?
YES/NO
Within the previous 12 months have you:
8.
Had male to male sex?
YES/NO
9.
Had sexual activity with a male who
you think might be bisexual?
YES/NO
10.
Been a male or female sex worker
(e.g. 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/body fluid splash to your
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
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This declaration is to be signed in the presence of a
Blood Service staff member. (Please read the following
statements.)
Thank you for answering these questions. If you are
uncertain about any of your answers, please discuss this
with your interviewer.
We would like you to sign this declaration in the presence of
your interviewer (a Blood Service staff member) to show
that you have understood the information on this form and
have answered the questions in the declaration to the best of
your knowledge.
Your donation is a gift to the Blood Service to be used to
treat patients, or in some circumstances, for teaching,
research, quality assurance or the making of essential
diagnostic reagents.
You may be asked by the Blood Service to undergo further
tests. A part of your donation may be stored for future
testing and research. Approval from the appropriate Human
Research Ethics Committee must be obtained before any
research is undertaken on blood samples.
Should you become unwell in the 5 days following your
donation with a cough, cold, diarrhoea or other infection or
become aware of any other reason why your blood should
not be used for transfusion, please call us on 13 14 95.
Declaration:
I agree to have blood taken from me under the above
conditions. I have been advised that there are some possible
risks associated with donating blood and that I must follow
the instructions of the Blood Service staff to minimise these
risks.
Donor (Please Print)
Surname
Given name
Date of birth
Signature
Please sign in the presence of the interviewer
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Witness (Please Print)
Surname
Given name
Interview date
Supplementary questions
Donor identity verified Yes/No
Donor weight
Donation number.
Even if you are unable to give blood today, we thank you for
coming and appreciate your willingness to be a blood
donor.'.
11. New Schedule 8 substituted
For Schedule 8 to the Principal Regulations
substitute—
'SCHEDULE 8
Regulation 19
Health (Infectious Diseases) Regulations 2001
TISSUE DONATION STATEMENT
There are some people who MUST NOT donate tissue as it
may transmit infections to those who receive it. To
determine if your tissue will be safe to be given to people in
need, we would like you to answer some questions. These
questions are a vital part of our efforts to eliminate any
diseases from the supply of donated tissue or semen.
In the case of donation of tissue, your blood is tested for the
presence of hepatitis B and C, HIV 1 and 2 (the AIDS
virus), HTLV I and II and syphilis and may be tested for the
presence of other infectious diseases. If your blood test
proves positive for any of these conditions, or for any reason
shows a significantly abnormal result, you will be informed.
All of the questions are important to answer. Answer each
question on the form as honestly as you can and to the best
of your knowledge. There are penalties, including fines and
imprisonment, for anyone providing false or misleading
information.
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To the best of your knowledge have you:
1.
Had an illness with swollen glands
and a rash, with or without a fever in
the last 6 months?
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 have you had 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.
Had sexual activity with a male who
you think might be bisexual?
YES/NO
10.
Been a male or female sex worker
(e.g. 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/body fluid splash to your
eyes, mouth, nose or to broken skin?
YES/NO
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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
This declaration is to be signed in the presence of a
Tissue Donation Service/Assisted Reproductive Service*
staff member. (Please read the following statements.)
Thank you for answering these questions. If you are
uncertain about any of your answers, please discuss this
with your interviewer.
We would like you to sign this declaration in the presence of
your interviewer (a person approved by the Tissue Donation
Service/Assisted Reproductive Service*) to show that you
have understood the information on the form and answered
the questions in the declaration to the best of your
knowledge.
Your donation is a gift to the Tissue Donation
Service/Assisted Reproductive Service* to be used to treat
patients, or in some circumstances, for teaching, research or
quality assurance.
You may be asked by the Tissue Donation Service/Assisted
Reproductive Service* to undergo further blood tests. A part
of your donation may be stored for future testing and
research. Approval from the appropriate Human Research
Ethics Committee must be obtained before any research is
undertaken on tissue samples.
Should you become unwell in the 5 days following a
donation, please call the Tissue Donation Service/Assisted
Reproductive Service*.
Declaration:
I agree to have blood taken from me under the above
conditions. I have been advised that there are some possible
risks associated with donating tissue and that I must follow
the instructions of the Tissue Donation Service/Assisted
Reproductive Service* staff to minimise these risks.
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Donor (Please Print)
Surname
Given name
Date of birth
Signature
Please sign in the presence of the interviewer
Witness (Please Print)
Surname
Given name
Signature
Interview date
Supplementary Questions
Donor identity verified Yes/No
Donor weight
Donation number:
*Delete whichever is inapplicable'.
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ENDNOTES
1
Reg. 4: S.R. No. 41/2001. Subsequently amended by S.R. Nos 82/2003 and
8/2004.
17
Endnotes