Federal Register of Legislation - Australian Government

Primary content

National Cancer Screening Register Rules 2017

Authoritative Version
Rules/Other as made
These rules prescribe the requirement for mandatory notification to the Commonwealth Chief Medical Officer (CMO) including, who is required to notify, mandatory data sets and the timeframe for notification. From 1 December 2017, colposcopists and pathology practitioners will be required to notify prescribed cervical screening information to the CMO through the National Cancer Screening Register within 14 days.
Administered by: Health
Made 24 Nov 2017
Registered 29 Nov 2017
Tabled HR 04 Dec 2017
Tabled Senate 04 Dec 2017

 

National Cancer Screening Register Rules 2017

I, Greg Hunt, Minister for Health, make the following rules.

Dated               24 November 2017

Greg Hunt

Minister for Health

 

 

  

  

  


Contents

Part 1—Preliminary                                                                                                                                        1

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Definitions..................................................................................................................... 1

5............ Pathology services carried out on behalf of approved pathology practitioners.............. 2

Part 2—Requirement to notify—cervical cancer screening                                                   3

6............ Simplified outline of this Part........................................................................................ 3

7............ Purposes of this Part..................................................................................................... 3

8............ Colposcopies................................................................................................................. 3

9............ Pathology laboratory screening tests............................................................................. 4

 


Part 1Preliminary

  

1  Name

                   This instrument is the National Cancer Screening Register Rules 2017.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 December 2017.

1 December 2017

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under the National Cancer Screening Register Act 2016.

4  Definitions

Note:          A number of expressions used in this instrument are defined in the Act, including the following:

(a)    approved form;

(b)    individual healthcare provider;

(c)    screening;

(d)    screening test.

                   In this instrument:

accredited pathology laboratory has the same meaning as in the Health Insurance Act 1973.

Act means the National Cancer Screening Register Act 2016.

approved pathology practitioner has the same meaning as in the Health Insurance Act 1973.

healthcare identifier has the same meaning as in the Healthcare Identifiers Act 2010.

HPV is short for human papillomavirus.

medicare number has the same meaning as in Part VII of the National Health Act 1953.

pathology service has the same meaning as in the Health Insurance Act 1973.

provider number has the same meaning as in the Health Insurance Regulations 1975.

5  Pathology services carried out on behalf of approved pathology practitioners

                   For the purposes of this instrument, a pathology service is not taken to be carried out on behalf of an approved pathology practitioner if the service is not taken to be rendered on behalf of the approved pathology practitioner for the purposes of the Health Insurance Act 1973 (see section 3AA of that Act).

Part 2Requirement to notify—cervical cancer screening

  

6  Simplified outline of this Part

For the purposes of subsection 13(1) of the Act, this Part prescribes types of cervical cancer screening tests and, for each of those types of screening tests:

       (a)     the information that must be notified to the Commonwealth Chief Medical Officer; and

      (b)     the individual healthcare provider who must notify the information; and

       (c)     the time by which the information must be notified.

7  Purposes of this Part

                   This Part is made for the purposes of subsection 13(1) of the Act.

8  Colposcopies

             (1)  This section applies to a type of screening test to which all of the following paragraphs apply:

                     (a)  the screening test is associated with cervical cancer;

                     (b)  the screening test is a colposcopy;

                     (c)  the screening test is carried out by an individual healthcare provider;

                     (d)  the screening test is carried out other than as part of a clinical trial approved by an ethics committee (within the meaning of the Therapeutic Goods Act 1989).

Note:          Section 4 of the Act defines screening test to mean a test or procedure as part of screening.

             (2)  If a screening test of that type is carried out, the individual healthcare provider who carries out the screening test must, under subsection 13(1) of the Act, notify the Commonwealth Chief Medical Officer, by the end of 14 days after the day the colposcopy is completed, of the information specified in the following table.

 

Information for colposcopies

Item

Column 1

Information

1

The following information about the individual who undergoes the screening test:

(a) medicare number (if known by the individual healthcare provider);

(b) name;

(c) date of birth;

(d) Indigenous status (if known by the individual healthcare provider);

(e) country of origin (if known by the individual healthcare provider);

(f) preferred language (if known by the individual healthcare provider);

(g) address

2

The following information about the individual healthcare provider:

(a) name;

(b) clinic name;

(c) provider number

3

The following information about the screening test:

(a) date of screening test;

(b) indication for colposcopy;

(c) an indication as to whether the colposcopy was adequate or inadequate;

(d) visibility of transformation zone;

(e) the clinical diagnosis or impression formed at the time of the colposcopy;

(f) whether a biopsy is performed as part of the colposcopy episode of which the screening test is part;

(g) whether the individual who undergoes the colposcopy is pregnant at the time of the colposcopy;

(h) whether treatment is performed as part of the colposcopy episode of which the screening test is part

4

The following information about any treatment of the cervix that is associated with a precursor to cervical cancer and that is connected to the screening test:

(a) kind of treatment;

(b) if an excision was performed—excision type;

(c) if an excision was performed—modality or method used;

(d) if an ablation was performed—ablation type;

(e) whether hysterectomy was performed;

(f) anaesthetic type;

(g) location of treatment

             (3)  However, paragraphs (d), (e) and (f) in item 1 of the table in subsection (2) do not apply before 1 June 2018.

Note 1:       A notice given under subsection 13(1) of the Act must be in the approved form: see subsection 13(1) of the Act.

Note 2:       An individual may request that information relating to the individual that is notified under subsection 13(1) of the Act not be included in the register: see section 14 of the Act.

9  Pathology laboratory screening tests

             (1)  This section applies to a type of screening test to which all of the following paragraphs apply:

                     (a)  the screening test is associated with cervical cancer;

                     (b)  the screening test is:

                              (i)  an HPV test; or

                             (ii)  a cytology test; or

                            (iii)  a histopathology test;

                     (c)  the screening test is carried out by or on behalf of an approved pathology practitioner who is an individual healthcare provider;

                     (d)  the screening test:

                              (i)  is carried out in an accredited pathology laboratory; and

                             (ii)  is a pathology service of a kind in respect of which the laboratory is accredited;

                     (e)  the screening test is carried out other than as part of a clinical trial approved by an ethics committee (within the meaning of the Therapeutic Goods Act 1989).

Note:          Section 4 of the Act defines screening test to mean a test or procedure as part of screening.

             (2)  If a screening test of that type is carried out, the approved pathology practitioner must, under subsection 13(1) of the Act, notify the Commonwealth Chief Medical Officer, by the end of 14 days after the day the screening test is completed, of the information specified in the following table for the screening test.

 

Information for pathology laboratory screening tests

Item

Column 1

Screening test

Column 2

Information

1

Any screening test

The following information about the individual who undergoes the screening test:

(a) medicare number (if known by the approved pathology practitioner);

(b) healthcare identifier (if known by the approved pathology practitioner);

(c) name;

(d) date of birth;

(e) gender;

(f) Indigenous status (if known by the approved pathology practitioner);

(g) country of origin (if known by the approved pathology practitioner);

(h) preferred language (if known by the approved pathology practitioner);

(i) address

2

Any screening test

The following information about the approved pathology practitioner:

(a) provider number;

(b) healthcare identifier (if known by the approved pathology practitioner);

(c) name

3

Any screening test

The following information about the accredited pathology laboratory:

(a) healthcare identifier (if known by the approved pathology practitioner);

(b) name;

(c) address

4

Any screening test

The following information about the collection of the cervical sample, to the extent known by the approved pathology practitioner:

(a) address of the premises where the sample was collected;

(b) provider number of the individual healthcare provider who collected the sample;

(c) healthcare identifier of the individual healthcare provider who collected the sample;

(d) healthcare identifier of the healthcare provider organisation at whose premises the sample was collected

5

Any screening test

The following information about the request for the screening test, to the extent known by the approved pathology practitioner:

(a) address of the premises from which the request was made;

(b) provider number of the individual healthcare provider who made the request;

(c) healthcare identifier of the individual healthcare provider who made the request;

(d) healthcare identifier of the healthcare provider organisation from whose premises the request was made

6

Any screening test

The following information about the screening test:

(a) type;

(b) date;

(c) recommendation

7

HPV test

The following information about the HPV test:

(a) collection method;

(b) specimen site;

(c) reason for test;

(d) test result;

(e) name of test;

(f) collection media;

(g) batch information, unless the test is a diagnostic HPV test for:

(i) a symptomatic person; or

(ii) a person in the post treatment setting

8

Cytology test

The following information about the cytology test:

(a) specimen type;

(b) specimen site;

(c) reason for test;

(d) test result

9

Histopathology test

The following information about the histopathology test:

(a) specimen site;

(b) procedure used for obtaining specimen;

(c) test result

Note 1:       A notice given under subsection 13(1) of the Act must be in the approved form: see subsection 13(1) of the Act.

Note 2:       An individual may request that information relating to the individual that is notified under subsection 13(1) of the Act not be included in the register: see section 14 of the Act.