Untitled document

Health (Infectious Diseases) (Further Amendment) Regulations 2005

S.R. No. 4/2005

TABLE OF PROVISIONS

Regulation  Page

1.Objective

2.Authorising provisions

3.Commencement

4.Principal Regulations

5.Definition of pathology service

6.Notification of micro-organisms in food and water supplies

7.New heading for regulation 19

8.Notifiable diseases

9.Forms for notification by medical practitioners

10.New Schedule 7 substituted

SCHEDULE 7—Blood Donation Statement

11.New Schedule 8 substituted

SCHEDULE 8—Tissue Donation Statement

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ENDNOTES

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.

4.Principal Regulations

In these Regulations, the Health (Infectious Diseases) Regulations 2001[1] 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".

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

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)

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)

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

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)

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)
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.

__________________".

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

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

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

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.

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

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.

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.