National Cancer Screening Register Rules 2017 (Cth)

National Cancer Screening Register Rules 2017

made under section 13 of the National Cancer Screening Register Act 2016

Compilation No. 02

Compilation date:1 July 2025

Includes amendments up to:F2025L00697

About this compilation

This compilation

This is a compilation of National Cancer Screening Register Rules 2017 that shows the text of the law as amended and in force on 1 July 2025 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Part 1—Preliminary

1

Name

This instrument is the National Cancer Screening Register Rules 2017.

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.

comparison test, in relation to a lung nodule observed in a lung cancer screening test conducted on an individual by or on behalf of a diagnostic radiologist, means a previous lung cancer screening test (if any) that satisfies both of the following conditions:

1. (a)

   the lung nodule was observed in the previous screening test;

2. (b)

   the diagnostic radiologist has access to the results of the previous screening test.

diagnostic radiologist means an individual who is registered:

1. (a)

   in the specialty of radiology; and

2. (b)

   with a field of speciality practice of diagnostic radiology;

under the Health Practitioner Regulation National Law set out in the Schedule to the Health Practitioner Regulation National Law Act 2009 of Queensland, as it applies (with or without modification) as a law of a State or Territory.

episode number means the unique identifier (comprising numbers, letters or both) that is attributed to an instance or event of healthcare during which a screening test is conducted.

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

HPV is short for human papillomavirus.

lung cancer screening category means the category of risk for a target lung noduledetermined in accordance with the nodule management protocol.

lung cancer screening test means a screening test to which section 12 applies.

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

National Lung Cancer Screening Program MBS item means an item in Schedule 1 to the Health Insurance (Section 3C General Medical Services – National Lung Cancer Screening Program) Determination 2025.

Note: By the operation of section 3C of the Health Insurance Act 1973, National Lung Cancer Screening Program MBS itemsare treated as if they are items in the diagnostic imaging services table made under section 4AA of that Act.

nodule management protocol means the NLCSP nodule management protocol, published by the Department, as existing on 1 July 2025.

Note: The nodule management protocol could in 2025 be viewed on the Department’s website (see Early Detection of Lung Cancer risk rating or PanCan risk rating means the malignancy risk of lung nodules calculated in accordance with the Brock University solitary pulmonary nodule malignancy risk in adults cancer prediction equation, as existing on 1 July 2025.

Note: The Brock University solitary pulmonary nodule malignancy risk in adults cancer prediction equation could in 2025 be viewed at the following website: 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.

smoking cessation advice means advice that is intended to help an individual stop smoking tobacco products.

target lung nodule has the meaning given by section 11A.

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 2—Requirement 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:

1. (a)

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

2. (b)

   the individual healthcare provider who must notify the information; and

3. (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. (1)

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

   1. (a)

      the screening test is associated with cervical cancer;

   2. (b)

      the screening test is a colposcopy;

   3. (c)

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

   4. (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. (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

1. (3)

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

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

   1. (a)

      the screening test is associated with cervical cancer;

   2. (b)

      the screening test is:

      1. (i)

         an HPV test; or

      2. (ii)

         a cytology test; or

      3. (iii)

         a histopathology test;

   3. (c)

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

   4. (d)

      the screening test:

      1. (i)

         is carried out in an accredited pathology laboratory; and

      2. (ii)

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

   5. (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. (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.

Part 3—Requirement to notify—lung cancer screening

10

Simplified outline of this Part

For the purposes of subsection 13(1) of the Act, this Part prescribes a type of lung cancer screening test and, for each screening test of that type:

1. (a)

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

2. (b)

   the individual healthcare provider who must notify the information; and

3. (c)

   the time by which the information must be notified.

11Purposes of this Part

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

11AMeaning of target lung nodule

1. (1)

   Subject to subsection (2), target lung nodule, in relation to a lung cancer screening test that is carried out by or on behalf of a diagnostic radiologist, means a lung nodule that:

   1. (a)

      is observed by the diagnostic radiologist from the screening test; and

   2. (b)

      is considered by the diagnostic radiologist not to be caused by an infectious or inflammatory process.

2. (2)

   If the diagnostic radiologist observes more than 4 lung nodules from the screening test that would (apart from this subsection) be target lung nodules, then:

   1. (a)

      the diagnostic radiologist must select 4 of those lung nodules; and

   2. (b)

      the diagnostic radiologist must ensure that no lung nodule that is selected belongs to a lower risk lung cancer screening category under the nodule management protocol than a lung nodule that is not selected; and

   3. (c)

      only the 4 lung nodules that are selected are taken to be target lung nodules in relation to the screening test for the purposes of this instrument.

12Lung cancer screening tests

1. (1)

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

   1. (a)

      the screening test is associated with lung cancer;

   2. (b)

      the screening test involves the use of low dose computed tomography;

   3. (c)

      a National Lung Cancer Screening Program MBS item applies to the screening test;

   4. (d)

      the screening test is carried out by or on behalf of a diagnostic radiologist who is an individual healthcare provider;

   5. (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. (2)

   If a screening test of that type is carried out, the diagnostic radiologist must, under subsection 13(1) of the Act, notify the Commonwealth Chief Medical Officer, by the end of 30 days after the day the screening test is completed, of the information specified in the following table for the screening test.

Information for lung cancer screening tests

Item

Column 1

Information

1

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

(a) given name (if known by the diagnostic radiologist);

(b) family name;

(c) medicare number or the number (if any) allocated to the individual by the Veterans’ Affairs Department (if known by the diagnostic radiologist);

(d) gender;

(e) date of birth;

(f) Indigenous status (if known by the diagnostic radiologist);

(g) country of birth (if known by the diagnostic radiologist);

(h) languages spoken at home (if known by the diagnostic radiologist);

(i) address;

(j) personal phone number (if known by the diagnostic radiologist);

(k) alternative phone number (if known by the diagnostic radiologist);

(l) whether the individual has a family history of lung cancer (if known by the diagnostic radiologist)

2

The healthcare identifier (if any) of the diagnostic radiologist

3

If the screening test was carried out at a radiology practice, the following information about the practice:

(a) healthcare identifier;

(b) name;

(c) address

4

If the screening test was carried out following a request by an individual healthcare provider for the screening test to be carried out—the following information about the individual healthcare provider who made the request:

(a) provider number (if known by the diagnostic radiologist);

(b) given name (if known by the diagnostic radiologist);

(c) family name (if known by the diagnostic radiologist);

(d) the date on which the individual healthcare provider made the request;

(e) if the individual healthcare provider works at a medical practice—the following information about the medical practice:

(i) healthcare identifier (if known by the diagnostic radiologist);

(ii) name;

(iii) address

5

The following information in relation to the screening test:

(a) date the screening test was conducted;

(b) date of any reports in relation to the screening test;

(c) episode number;

(d) radiation dose from the low dose computed tomography procedure expressed in CT dose index volume (milligray);

(e) name (if known) of any computer aided diagnosis, artificial intelligence, or volumetry software used to carry out or support the low dose computed tomography procedure used in the screening test;

(f) National Lung Cancer Screening Program MBS item number that applies to the screening test;

(g) date of the comparison test (if any);

(h) image quality of each scan produced from the screening test;

(i) whether there are any additional actionable findings (within the meaning of the nodule management protocol) from the screening test

6

The following information:

(a) whether the diagnostic radiologist considers that at least one lung nodule observed in the screening test is a target lung nodule;

(b) whether the diagnostic radiologist considers that at least one lung nodule observed in the screening test is likely to be caused by infection or inflammation;

(c) whether the diagnostic radiologist considers that at least one lung nodule observed in the screening test is likely to be benign (excluding any lung nodules that the radiologist considers likely to be caused by infection or inflammation)

7

The following information (if known by the diagnostic radiologist) in relation to each target lung nodule observed in the screening test:

(a) the nodule’s assigned nodule number;

(b) date the nodule was first visible on a screening test;

(c) series in which the target lung nodule was observed;

(d) image in which the target lung nodule was observed;

(e) anatomical location of the nodule;

(f) type of the nodule;

(g) whether the border of the nodule is spiculated;

(h) other descriptions of the nodule;

(i) total volume of the nodule (expressed in cubic millimetres);

(j) if the nodule is a subsolid nodule—the volume of the solid component of the nodule (expressed in cubic millimetres);

(k) mean diameter of the nodule (expressed in millimetres);

(l) if the nodule is a subsolid nodule—the mean diameter of the solid component of the nodule (expressed in millimetres);

(m) if the mean diameter of the nodule is measured using a measurement plane—which measurement plane was used; (n) thickness of the wall of the nodule (expressed in millimetres); (o) if there is no comparison test for the nodule—the Pan‑Canadian Early Detection of Lung Cancer (PanCan) risk rating for the nodule (expressed as a percentage); (p) lung cancer screening category for the nodule as determined in accordance with the nodule management protocol Note: See also subsection 11A(2), which relates to selecting up to 4 lung nodules to be target lung nodules.
8	The following information (if known by the diagnostic radiologist) in relation to each target lung nodule observed in the screening test for which there is a comparison test: (a) change in the total volume of the nodule compared to the total volume of the nodule observed in the comparison test for the nodule (expressed as a percentage); (b) based on the information referred to in paragraph (a) of this table item—the volume doubling time (expressed in days); (c) if the nodule is a subsolid nodule—change in the total volume of the solid component of the nodule compared to the total volume of the solid component of the nodule observed in the comparison test for the nodule (expressed as a percentage); (d) based on the information referred to in paragraph (c) of this table item—the volume doubling time (expressed in days); (e) change in the mean diameter of the nodule compared to the mean diameter of the nodule observed in the comparison test for the nodule (expressed in millimetres); (f) if the nodule is a subsolid nodule—change in the mean diameter of the solid component of the nodule compared to the mean diameter of the solid component of the nodule observed in the comparison test for the nodule (expressed in millimetres); (g) change in the thickness of the wall of the nodule compared to the thickness of the wall of the nodule observed in the comparison test for the nodule (expressed in millimetres); (h) description of the type of change to the nodule compared to the nodule observed in the comparison test for the nodule
9	Information on any findings or observations made by the diagnostic radiologist from the screening test in relation to the following body parts of the individual who underwent the screening test: (a) lungs; (b) pleura; (c) mediastinum; (d) cardiovascular; (e) abdomen; (f) thyroid; (g) breasts; (h) bones; (i) other body parts

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.

(3)

The information specified in the table in subsection (2) must be determined or calculated in accordance with the nodule management protocol (where applicable).

Example: Paragraph (i) of table item 7 of the table in subsection (2) requires the diagnostic radiologist to notify the total volume of each target lung nodule observed in the screening test (if this information is known by the diagnostic radiologist). In determining or calculating this information, the diagnostic radiologist must consider whether the nodule management protocol provides for the information to be determined or calculated in a certain way. If the nodule management does so, then the diagnostic radiologist must determine or calculate the information in that way.

(4)

If there is more than one comparison test in relation to a nodule observed in a lung cancer screening test (the current test) conducted on an individual by or on behalf of a diagnostic radiologist, for the purpose of notifying the Chief Medical Officer of information about the current test, the diagnostic radiologist is only required to notify information about one comparison test that the diagnostic radiologist is satisfied is relevant.

Part 4—Contents of the register—other information

13Simplified outline of this Part

For the purposes of paragraph 11(g) of the Act, this Part prescribes, for each individual, other information relevant to the purposes of the register that may be included on the register.

14Purposes of this Part

This Part is made for the purposes of paragraph 11(g) of the Act.

15Register may include other information

1. (1)

   This section applies to smoking cessation advice offered or provided to an individual in connection with a lung cancer screening test that the individual:

   1. (a)

      may undergo; or

   2. (b)

      will undergo; or

   3. (c)

      has undergone.

2. (2)

   For the purposes of paragraph 11(g) of the Act, the following information is prescribed:

   1. (a)

      whether the individual was offered smoking cessation advice;

   2. (b)

      whether smoking cessation advice was provided to the individual;

   3. (c)

      the type of smoking cessation advice offered or provided to the individual.

      Note 1: Paragraph 11(g) of the Act provides that the register may include, for each individual, any other information relevant to the purposes of the register and prescribed by the rules. Section 12 of the Act sets out the purposes of the register.

      Note 2: As the information prescribed by this subsection may be included on the register, section 17 of the Act authorises certain dealings in relation to the information.

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

Endnote 2—Abbreviation key

ad = added or inserted	o = order(s)
am = amended	Ord = Ordinance
amdt = amendment	orig = original
c = clause(s)	par = paragraph(s)/subparagraph(s)
C[x] = Compilation No. x	/sub‑subparagraph(s)
Ch = Chapter(s)	pres = present
def = definition(s)	prev = previous
Dict = Dictionary	(prev…) = previously
disallowed = disallowed by Parliament	Pt = Part(s)
Div = Division(s)	r = regulation(s)/rule(s)
ed = editorial change	reloc = relocated
exp = expires/expired or ceases/ceased to have	renum = renumbered
effect	rep = repealed
F = Federal Register of Legislation	rs = repealed and substituted
gaz = gazette	s = section(s)/subsection(s)
LA = Legislation Act 2003	Sch = Schedule(s)
LIA = Legislative Instruments Act 2003	Sdiv = Subdivision(s)
(md) = misdescribed amendment can be given	SLI = Select Legislative Instrument
effect	SR = Statutory Rules
(md not incorp) = misdescribed amendment	Sub‑Ch = Sub‑Chapter(s)
cannot be given effect	SubPt = Subpart(s)
mod = modified/modification	underlining = whole or part not
No. = Number(s)	commenced or to be commenced

Endnote 3—Legislation history

Name	Registration	Commencement	Application, saving and transitional provisions
National Cancer Screening Register Rules 2017	29 Nov 2017 (F2017L01547)	1 Dec 2017 (s 2(1) item 1)
National Cancer Screening Register Amending Rules 2018	1 June 2018 (F2018L00702)	1 June 2018 (s 2)	—
National Cancer Screening Register Amendment (National Lung Cancer Screening Program) Rules 2025	18 June 2025 (F2025L00697)	1 July 2025 (s 2(1) item 1)	—

Endnote 4—Amendment history

Provision affected	How affected
Part 1
s 2.........................................	rep LA s 48D
s 4.........................................	am F2025L00697
Part 2
s 8.........................................	am F2018L00702
Part 3
Part 3.....................................	ad F2025L00697
s 10........................................	ad F2025L00697
s 11........................................	ad F2025L00697
s 11A.....................................	ad F2025L00697
s 12........................................	ad F2025L00697
Part 4
Part 4.....................................	ad F2025L00697
s 13........................................	ad F2025L00697
s 14........................................	ad F2025L00697
s 15........................................	ad F2025L00697