Commonwealth legislation

National Cancer Screening Register Rules 2017

In ForceCTH

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

8/10 complexity

These Rules require certain health professionals to notify the Commonwealth Chief Medical Officer about specified cervical and lung cancer screening tests and related details, within set timeframes. They identify which provider must send the data, the exact data fields (from patient identifiers to technical imaging measurements), and when notices must be given.

The Rules affect diagnostic radiologists, approved pathology practitioners and clinicians doing colposcopies. They matter because they standardise what screening data enters the national register, and therefore shape reporting, recordkeeping and clinical workflows.

JSON API

Deep Dive

7,450 words · generated 21/06/2026

What it does

This instrument, the National Cancer Screening Register Rules 2017 (the Rules), prescribes mandatory notification requirements to the Commonwealth Chief Medical Officer for specified cervical and lung cancer screening tests, the data elements to be reported, who must report them, and the time by which reports must be made. It is made under the National Cancer Screening Register Act 2016 (see "Act" defined in the instrument at section 4 and authority at section 3). The Rules (in particular Part 2 and Part 3) implement subsection 13(1) of the Act by identifying the types of screening tests that trigger the notification obligation, the precise information to be provided for each test type, and the identity of the notifying healthcare provider (for example, individual healthcare provider, approved pathology practitioner, or diagnostic radiologist) together with reporting timeframes (for cervical-related pathology and colposcopies, generally by the end of 14 days after completion; for defined lung cancer screening tests, by the end of 30 days after completion) (see s6, s8(2), s9(2), and s12(2)).

Mechanically the instrument does four core things which practitioners must treat as binding instructions under the Act:

It defines and cross-references key terms used for the notification rules, including several that are imported from other statutes (see s4). Important definitions that affect obligations include "diagnostic radiologist", "approved pathology practitioner", "accredited pathology laboratory", "National Lung Cancer Screening Program MBS item", "nodule management protocol", "Pan‑Canadian Early Detection of Lung Cancer (PanCan) risk rating", "episode number", and "target lung nodule" (see s4 and s11A).
It prescribes detailed item-level datasets that must be included in a notice for colposcopies, pathology laboratory screening tests (HPV, cytology, histopathology) and lung cancer screening tests. These datasets include demographic identifiers, provider identifiers and identifiers for organisations and premises, specimen or imaging details, test results, procedural metadata, and, for lung screening, granular nodule descriptors (see s8 table, s9 table, s12 table).

Current sections

Direct links to the current provisions in National Cancer Screening Register Rules 2017.

Part 1

Preliminary

Part 1—Preliminary

1 Name

This instrument is the National Cancer Screening Register Rules 2017.

Authority

3 Authority

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

Definitions

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;

(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:

(a) the lung nodule was observed in the previous screening test;
(b) the diagnostic radiologist has access to the results of the previous screening test.

diagnostic radiologist means an individual who is registered:

(a) in the specialty of radiology; and
(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 nodule determined 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 items are 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 https://www.health.gov.au/resources/publications/nlcsp-nodule-management-protocol).

Pan-Canadian 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: https://www.uptodate.com/contents/calculator-solitary-pulmonary-nodule-malignancy-risk-in-adults-brock-university-cancer-prediction-equation.

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.

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.

Pathology services carried out on behalf of approved pathology practitioners

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

Part 2—Requirement to notify—cervical cancer screening

Simplified outline of this Part

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:

Purposes of this Part

7 Purposes of this Part

Colposcopies

8 Colposcopies

(b) the screening test is a colposcopy;

(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).

(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.

<table cellspacing="0" cellpadding="0" style="margin-left:5.65pt; border-collapse:collapse"><thead><tr><td colspan="2" style="width:404.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Information for colposcopies</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Item</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 1Information</td></tr></thead><tbody><tr><td style="width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1</td><td style="width:369.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">2</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">The following information about the individual healthcare provider:(a) name;(b) clinic name;(c) provider number</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">3</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">4</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr></tbody></table> ```

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

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.

Pathology laboratory screening tests

9 Pathology laboratory screening tests

(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).

(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.

<table cellspacing="0" cellpadding="0" style="margin-left:5.65pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:400.05pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Information for pathology laboratory screening tests</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Item</td><td style="width:66.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 1Screening test</td><td style="width:286.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 2Information</td></tr></thead><tbody><tr><td style="width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1</td><td style="width:66.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Any screening test</td><td style="width:286.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">2</td><td style="width:66.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Any screening test</td><td style="width:286.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">The following information about the approved pathology practitioner:(a) provider number;(b) healthcare identifier (if known by the approved pathology practitioner);(c) name</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">3</td><td style="width:66.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Any screening test</td><td style="width:286.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">The following information about the accredited pathology laboratory:(a) healthcare identifier (if known by the approved pathology practitioner);(b) name;(c) address</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">4</td><td style="width:66.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Any screening test</td><td style="width:286.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">5</td><td style="width:66.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Any screening test</td><td style="width:286.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">6</td><td style="width:66.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Any screening test</td><td style="width:286.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">The following information about the screening test:(a) type;(b) date;(c) recommendation</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">7</td><td style="width:66.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">HPV test</td><td style="width:286.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">8</td><td style="width:66.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Cytology test</td><td style="width:286.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">The following information about the cytology test:(a) specimen type;(b) specimen site;(c) reason for test;(d) test result</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">9</td><td style="width:66.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Histopathology test</td><td style="width:286.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">The following information about the histopathology test:(a) specimen site;(b) procedure used for obtaining specimen;(c) test result</td></tr></tbody></table> ```

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

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) 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: (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: (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 (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.

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

(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.

<table cellspacing="0" cellpadding="0" style="width:415.65pt; margin-left:5.65pt; border-collapse:collapse"><thead><tr><td colspan="2" style="width:404.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Information for lung cancer screening tests</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Item</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 1Information</td></tr></thead><tbody><tr><td style="width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1</td><td style="width:369.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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)</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">2</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">The healthcare identifier (if any) of the diagnostic radiologist</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">3</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">If the screening test was carried out at a radiology practice, the following information about the practice:(a) healthcare identifier;(b) name;(c) address</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">4</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">5</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">6</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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)</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">7</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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 protocolNote: See also subsection 11A(2), which relates to selecting up to 4 lung nodules to be target lung nodules.</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">8</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">9</td><td style="width:369.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr></tbody></table> ```

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).

Note: 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

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.

(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:

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.

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:

11 Purposes of this Part

11A Meaning of target lung nodule

12 Lung cancer screening tests

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

Note: 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.

Part 4 Contents of the register—other information

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;

(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:

(a) the lung nodule was observed in the previous screening test;
(b) the diagnostic radiologist has access to the results of the previous screening test.

diagnostic radiologist means an individual who is registered:

(a) in the specialty of radiology; and
(b) with a field of speciality practice of diagnostic radiology;

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 nodule determined 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 items are 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 https://www.health.gov.au/resources/publications/nlcsp-nodule-management-protocol).

Pan-Canadian 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: https://www.uptodate.com/contents/calculator-solitary-pulmonary-nodule-malignancy-risk-in-adults-brock-university-cancer-prediction-equation.

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.

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

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:

7 Purposes of this Part

8 Colposcopies

(b) the screening test is a colposcopy;

(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).

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

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

(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 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

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:

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

Note: 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.

Part 4—Contents of the register—other information

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.

(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:

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.

13 Simplified 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.

14 Purposes of this Part

15 Register may include other information

(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:

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.

Source text: opening excerpt

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

Part 3 Requirement to notify—lung cancer screening

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;

(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:

(a) the lung nodule was observed in the previous screening test;
(b) the diagnostic radiologist has access to the results of the previous screening test.

diagnostic radiologist means an individual who is registered:

(a) in the specialty of radiology; and
(b) with a field of speciality practice of diagnostic radiology;

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 nodule determined in accordance with the nodule management protocol.

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

National Cancer Screening Register Rules 2017

Plain English Summary

Deep Dive

What it does

Current sections

Preliminary

Authority

Definitions

Pathology services carried out on behalf of approved pathology practitioners

Requirement to notify—cervical cancer screening

Simplified outline of this Part

Purposes of this Part

Colposcopies

Pathology laboratory screening tests

Part 3—Requirement to notify—lung cancer screening

Part 4—Contents of the register—other information

10 Simplified outline of this Part

11 Purposes of this Part

11A Meaning of target lung nodule

12 Lung cancer screening tests

Part 4 Contents of the register—other information

Part 3—Requirement to notify—lung cancer screening

Part 4—Contents of the register—other information

13 Simplified outline of this Part

14 Purposes of this Part

15 Register may include other information

Source text: opening excerpt

Part 3 Requirement to notify—lung cancer screening

Main concepts

Who it affects

Key duties and rights

Penalties and enforcement

How it interacts with other laws

Amendment history

Litigation history

Gotchas

How to comply