{"id":"F2017L01547","name":"National Cancer Screening Register Rules 2017","slug":"national-cancer-screening-register-rules-2017","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":144356,"registerId":"commonwealth-F2017L01547-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"Part 1—Preliminary\n\n1 Name\n\nThis instrument is the National Cancer Screening Register Rules 2017.\n\n","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"3 Authority\n\nThis instrument is made under the National Cancer Screening Register Act 2016.\n\n","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"4 Definitions\n\nNote: A number of expressions used in this instrument are defined in the Act, including the following:\n\n(a) approved form;\n\n(b) individual healthcare provider;\n\n(c) screening;\n\n(d) screening test.\n\nIn this instrument:\n\naccredited pathology laboratory has the same meaning as in the Health Insurance Act 1973.\n\nAct means the National Cancer Screening Register Act 2016.\n\napproved pathology practitioner has the same meaning as in the Health Insurance Act 1973.\n\n> 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:\n\n (a) the lung nodule was observed in the previous screening test;\n (b) the diagnostic radiologist has access to the results of the previous screening test.\n\n> diagnostic radiologist means an individual who is registered:\n\n (a) in the specialty of radiology; and\n (b) with a field of speciality practice of diagnostic radiology;\n 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.\n\n> 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.\n\nhealthcare identifier has the same meaning as in the Healthcare Identifiers Act 2010.\n\nHPV is short for human papillomavirus.\n\n> lung cancer screening category means the category of risk for a target lung nodule determined in accordance with the nodule management protocol.\n\n> lung cancer screening test means a screening test to which section 12 applies.\n\nmedicare number has the same meaning as in Part VII of the National Health Act 1953.\n\n> 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.\n\n> 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.\n\n> nodule management protocol means the NLCSP nodule management protocol, published by the Department, as existing on 1 July 2025.\n\n> 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).\n\n> 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.\n\n> 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.\n\npathology service has the same meaning as in the Health Insurance Act 1973.\n\nprovider number has the same meaning as in the Health Insurance Regulations 1975.\n\n> smoking cessation advice means advice that is intended to help an individual stop smoking tobacco products.\n\n> target lung nodule has the meaning given by section 11A.\n\n","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Pathology services carried out on behalf of approved pathology practitioners","content":"5 Pathology services carried out on behalf of approved pathology practitioners\n\nFor 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).\n\n","sortOrder":3},{"sectionNumber":"Part 2","sectionType":"part","heading":"Requirement to notify—cervical cancer screening","content":"Part 2—Requirement to notify—cervical cancer screening\n\n","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Simplified outline of this Part","content":"6 Simplified outline of this Part\n\nFor 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:\n\n","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Purposes of this Part","content":"7 Purposes of this Part\n\n","sortOrder":6},{"sectionNumber":"8","sectionType":"section","heading":"Colposcopies","content":"8 Colposcopies\n\n(b) the screening test is a colposcopy;\n\n(c) the screening test is carried out by an individual healthcare provider;\n\n(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).\n\n(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.\n\n

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

\n```\n\n(3) However, paragraphs (d), (e) and (f) in item 1 of the table in subsection (2) do not apply before 1 December 2018.\n\nNote 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.\n\n","sortOrder":7},{"sectionNumber":"9","sectionType":"section","heading":"Pathology laboratory screening tests","content":"9 Pathology laboratory screening tests\n\n(b) the screening test is:\n\n(i) an HPV test; or\n\n(ii) a cytology test; or\n\n(iii) a histopathology test;\n\n(c) the screening test is carried out by or on behalf of an approved pathology practitioner who is an individual healthcare provider;\n\n(d) the screening test:\n\n(i) is carried out in an accredited pathology laboratory; and\n\n(ii) is a pathology service of a kind in respect of which the laboratory is accredited;\n\n(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).\n\n(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.\n\n

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

\n```\n\nNote 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.\n\n## Part 3—Requirement to notify—lung cancer screening\n\nFor 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:\n\n (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:\n (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:\n (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\n (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.\n\n (d) the screening test is carried out by or on behalf of a diagnostic radiologist who is an individual healthcare provider;\n (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).\n\n (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.\n\n

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

\n```\n\n> 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.\n\n> 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.\n\n (3) The information specified in the table in subsection (2) must be determined or calculated in accordance with the nodule management protocol (where applicable).\n\n> 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.\n\n (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.\n\n## Part 4—Contents of the register—other information\n\nFor 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.\n\n (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:\n\nNote 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.\n\nNote 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.\n\n## 10 Simplified outline of this Part\n\nFor 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:\n\n## 11 Purposes of this Part\n\n## 11A Meaning of target lung nodule\n\n (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:\n (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:\n (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\n (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.\n\n## 12 Lung cancer screening tests\n\n (d) the screening test is carried out by or on behalf of a diagnostic radiologist who is an individual healthcare provider;\n (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).\n\n (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.\n\n

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

\n```\n\n> 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.\n\n> 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.\n\n (3) The information specified in the table in subsection (2) must be determined or calculated in accordance with the nodule management protocol (where applicable).\n\n> 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.\n\n (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.\n\n## Part 4 Contents of the register—other information\n\nPart 1—Preliminary\n\n1 Name\n\nThis instrument is the National Cancer Screening Register Rules 2017.\n\n3 Authority\n\nThis instrument is made under the National Cancer Screening Register Act 2016.\n\n4 Definitions\n\nNote: A number of expressions used in this instrument are defined in the Act, including the following:\n\n(a) approved form;\n\n(b) individual healthcare provider;\n\n(c) screening;\n\n(d) screening test.\n\nIn this instrument:\n\naccredited pathology laboratory has the same meaning as in the Health Insurance Act 1973.\n\nAct means the National Cancer Screening Register Act 2016.\n\napproved pathology practitioner has the same meaning as in the Health Insurance Act 1973.\n\n> 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:\n\n (a) the lung nodule was observed in the previous screening test;\n (b) the diagnostic radiologist has access to the results of the previous screening test.\n\n> diagnostic radiologist means an individual who is registered:\n\n (a) in the specialty of radiology; and\n (b) with a field of speciality practice of diagnostic radiology;\n 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.\n\n> 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.\n\nhealthcare identifier has the same meaning as in the Healthcare Identifiers Act 2010.\n\nHPV is short for human papillomavirus.\n\n> lung cancer screening category means the category of risk for a target lung nodule determined in accordance with the nodule management protocol.\n\n> lung cancer screening test means a screening test to which section 12 applies.\n\nmedicare number has the same meaning as in Part VII of the National Health Act 1953.\n\n> 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.\n\n> 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.\n\n> nodule management protocol means the NLCSP nodule management protocol, published by the Department, as existing on 1 July 2025.\n\n> 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).\n\n> 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.\n\n> 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.\n\npathology service has the same meaning as in the Health Insurance Act 1973.\n\nprovider number has the same meaning as in the Health Insurance Regulations 1975.\n\n> smoking cessation advice means advice that is intended to help an individual stop smoking tobacco products.\n\n> target lung nodule has the meaning given by section 11A.\n\n5 Pathology services carried out on behalf of approved pathology practitioners\n\nFor 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).\n\nPart 2—Requirement to notify—cervical cancer screening\n\n6 Simplified outline of this Part\n\nFor 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:\n\n7 Purposes of this Part\n\n8 Colposcopies\n\n(b) the screening test is a colposcopy;\n\n(c) the screening test is carried out by an individual healthcare provider;\n\n(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).\n\n(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.\n\n

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

\n```\n\n(3) However, paragraphs (d), (e) and (f) in item 1 of the table in subsection (2) do not apply before 1 December 2018.\n\nNote 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.\n\n9 Pathology laboratory screening tests\n\n(b) the screening test is:\n\n(i) an HPV test; or\n\n(ii) a cytology test; or\n\n(iii) a histopathology test;\n\n(c) the screening test is carried out by or on behalf of an approved pathology practitioner who is an individual healthcare provider;\n\n(d) the screening test:\n\n(i) is carried out in an accredited pathology laboratory; and\n\n(ii) is a pathology service of a kind in respect of which the laboratory is accredited;\n\n(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).\n\n(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.\n\n

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

\n```\n\nNote 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.\n\n## Part 3—Requirement to notify—lung cancer screening\n\nFor 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:\n\n (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:\n (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:\n (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\n (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.\n\n (d) the screening test is carried out by or on behalf of a diagnostic radiologist who is an individual healthcare provider;\n (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).\n\n (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.\n\n

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

\n```\n\n> 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.\n\n> 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.\n\n (3) The information specified in the table in subsection (2) must be determined or calculated in accordance with the nodule management protocol (where applicable).\n\n> 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.\n\n (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.\n\n## Part 4—Contents of the register—other information\n\nFor 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.\n\n (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:\n\nNote 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.\n\nNote 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.\n\n## 13 Simplified outline of this Part\n\nFor 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.\n\n## 14 Purposes of this Part\n\n## 15 Register may include other information\n\n (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:\n\nNote 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.\n\nNote 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.","sortOrder":8}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"Compared to a narrow, earlier focus on cervical and pathology notifications, this version materially broadens the register’s scope by adding: (a) mandatory, granular reporting for lung low‑dose CT screening tied to National Lung Cancer Screening Program MBS items (section 12); (b) explicit, per‑nodule metrics and derived calculations (volume, PanCan risk, volume doubling time) and a requirement that those be determined according to an external nodule management protocol (section 12(3) and definitions); and (c) the ability to include smoking cessation advice data linked to lung screening (section 15). These additions expand both the types of screening the register covers and the technical depth of data collected, increasing the register’s operational remit beyond what earlier Parts addressing cervical screening and pathology notifications prescribed."},"complexity_factors":["Cross‑references to multiple external laws and instruments (Health Insurance Act 1973, Health Practitioner Regulation National Law, Healthcare Identifiers Act 2010, National Health Act 1953 and the 2025 Health Insurance determination).","Dependence on external, non‑statutory protocols and tools (the NLCSP nodule management protocol and the Brock/PanCan risk equation) for measurement and calculation (section 12(3) and definitions).","Large number of conditional fields (many table entries are required only 'if known by' the reporter).","Technical computations required (volume measures, percent change, volume doubling time) and instructions that those computations follow the nodule management protocol (table items 7–8; section 12(3)).","Nested conditional logic and exceptions (e.g., clinical trial exemptions, selection rules when >4 target nodules, choice of only one relevant comparison test when several exist) (section 11A(2); section 12(4)).","Multiple deadlines and different reporters across Parts: 30 days for lung screening radiologists, 14 days for cervical/pathology reporters (sections 8–9; 12).","Many discrete data elements per nodule and per test (detailed per‑nodule metrics plus test, patient, provider and software metadata — table items 1–9).","Interplay with Act-level rules (approved form, opt‑out by individuals, and authorised dealings) requiring cross‑consultation with the principal Act for implementation."],"plain_english_summary":"**What this instrument does (mechanically)\n\n- Requires detailed, timely reporting of lung cancer screening results to the Commonwealth Chief Medical Officer. Specifically, when a low‑dose CT screening done under the National Lung Cancer Screening Program (an MBS item) is performed by or on behalf of a diagnostic radiologist, that radiologist must notify a prescribed set of information to the Chief Medical Officer within 30 days (section 12).\n\n- Defines key terms and limits: \"target lung nodule\" is a nodule the radiologist observes and does not regard as infection/inflammation; if more than four such nodules are visible, the radiologist must select up to four according to risk rules (section 11A).\n\n- Prescribes precisely what must be notified about the patient, the radiologist/practice, the test itself, and each target nodule. Required items include patient identifiers and contact details, radiologist and practice identifiers, episode number, radiation dose, name of any computer‑aided diagnosis/AI/volumetry software used, MBS item number, comparison test date, image quality, presence of additional actionable findings, and detailed per‑nodule measures (volume, diameters, wall thickness, PanCan risk if no comparison, screening category under the nodule management protocol, and change measures when a comparison test exists) (section 12 table items 1–9). The instrument requires nodule measurements or calculations to follow the Department's nodule management protocol where applicable (section 12(3)).\n\n- Allows the register to include smoking cessation advice information linked to lung screening (whether advice was offered, whether provided, and type) (section 15).\n\n- Repeats and confirms reporting obligations and timelines for cervical screening and pathology laboratory tests (Parts 2 and earlier sections): most pathology and cervical screening notifications must be made within 14 days by the performing clinician or approved pathology practitioner (see sections 8–9).\n\nWho must report and who decides\n\n- Who reports: the diagnostic radiologist (the individual registered with a diagnostic radiology field) is the reporting party for lung LDCT screens (section 12). For pathology/cervical items, the approved pathology practitioner or the individual healthcare provider performs the notification duties (sections 8–9).\n\n- Who decides clinical choices captured by reporting: the diagnostic radiologist decides whether a nodule is a \"target lung nodule,\" which comparison test is relevant where multiple exist, and which up to four nodules to report if more than four meet the definition (section 11A; section 12(4)). The radiologist also supplies clinical judgements recorded in the report (e.g. likely infection, benign, screening category) (section 12 table item 6–7).\n\nWhy this matters (claimed purpose and practical effects)\n\n- Claimed purpose: to populate the National Cancer Screening Register with structured, standardised data that supports the register's statutory purposes (monitoring, program evaluation, follow up) (see Act cross‑references in instrument preamble and section 12). The rules themselves link measurement and calculation to the departmental nodule management protocol to standardise data (section 12(3)).\n\n- Practical effects and trade‑offs:\n - Compliance burden and costs: radiologists and radiology practices must collect, compute and transmit a substantial set of structured data (including volumetry and derived metrics like volume doubling time), and may need software/process changes to extract and send those fields within 30 days (section 12). Pathology providers face a 14‑day deadline for many cervical screening items (sections 8–9). These are direct administrative and IT costs paid by the reporting clinicians/practices.\n - Technical requirements and implementation risk: the rules require calculations to follow an external \"nodule management protocol\" and refer to the PanCan (Brock) risk equation; dependence on external protocols and on variations in how radiology systems record volumetry or measurement plane can produce inconsistent data unless local systems are updated (section 12(3); definitions). Calculating volume doubling time and percent changes is a non‑trivial technical step for many providers (table items 7–8).\n - Effects on clinical workflow and vendor requirements: reporting items such as the name of any AI/volumetry software used (section 12 table item 5(e)) and episode numbers may require integration between PACS/RIS, reporting templates and the register interface, or manual entry. That creates recurring operational costs and may favour larger providers able to invest in integration.\n - Data use, oversight and opt‑out: the instrument works with the Act's existing mechanics: reports must be in the approved form and individuals may request their information not be included in the register (Act sections 13 and 14 are repeatedly noted in the rules). Inclusion on the register enables authorised dealings under section 17 of the Act (the instrument notes this for smoking cessation information in section 15).\n - Incentive alignment: the centralised data supports program evaluation, quality assurance and epidemiology. The burden falls on private clinicians and pathology labs, who must collect and transmit more granular data than typical clinical reporting. The instrument makes the diagnostic radiologist the decision‑maker for selecting nodules and comparison tests (section 11A; section 12(4)), concentrating certain compliance choices at the treating clinician level.\n\nConcrete who‑pays / who‑decides / behaviour changes (plain statements)\n\n- Who pays: reporting clinicians and their practices (diagnostic radiologists, radiology practices, approved pathology practitioners) will incur the administrative, IT and time costs of complying with the notifications and deadlines (sections 8–9; 12).\n- Who decides: diagnostic radiologists decide which nodules count as \"target\" and which comparison test to use where multiple exist; they also supply the clinical judgements recorded (section 11A; section 12(4) and table items 6–7).\n- Behaviour likely to change: clinicians will capture and structure more imaging metrics (volumes, diameters, measurement plane, software used, image quality) and may adopt standardised reporting templates and volumetry tools; practices may invest in IT integration to meet deadlines and data fields (section 12 table items 5–9).\n\nMain qualifications and limits\n\n- The rules apply only to screening tests (not diagnostic CTs) as defined by the Act and only when a National Lung Cancer Screening Program MBS item applies (section 12(1)(b)–(c)).\n- Clinical trial activity approved by an ethics committee is exempted from the reporting requirement (sections 8(1)(d) and 12(1)(e)).\n- Many fields are required \"if known by\" the reporting practitioner; the rules thus tolerate incomplete data where the reporter legitimately does not have the information (repeated in table items across sections).\n\nKey sections to read for operational detail: definitions, section 11A (target lung nodule selection), section 12 (required lung screening notifications and deadlines), section 15 (smoking cessation data for inclusion on the register)."},"kimi_summary":{"_metrics":{"completionTokens":802},"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":true,"description":"The legislation has expanded significantly from its original 2017 scope. Initially focused solely on cervical cancer screening (colposcopies and pathology tests), it now includes comprehensive lung cancer screening requirements following the establishment of the National Lung Cancer Screening Program. The 2025 amendments add extensive technical reporting for low-dose CT scans, nodule tracking, smoking cessation advice recording, and complex radiological measurement protocols—transforming a relatively straightforward cervical screening register into a multi-cancer screening data system."},"complexity_factors":["Extensive cross-referencing to other legislation (Health Insurance Act 1973, Healthcare Identifiers Act 2010, Therapeutic Goods Act 1989, National Health Act 1953)","Multiple nested definitions with conditional logic (e.g., 'target lung nodule' definition with selection rules when >4 nodules found)","Detailed tabular reporting requirements with 9 separate items for lung cancer screening alone, many with sub-paragraphs","Technical medical terminology requiring specialised knowledge (e.g., 'subsolid nodule', 'spiculated border', 'volume doubling time', 'CT dose index volume')","External document incorporation by reference (nodule management protocol, PanCan risk rating equation) with specific version dates","Duplicated content in the provided text (Parts 3 and 4 appear twice, suggesting consolidation or amendment layering)","Conditional reporting triggers based on multiple cumulative criteria (e.g., 5 conditions must all apply for lung cancer screening tests)","Time-sensitive provisions with specific cut-off dates (e.g., 1 July 2025 for referenced protocols)"],"plain_english_summary":"This instrument requires healthcare providers to report cervical and lung screening tests and results to Australia’s National Cancer Screening Register so the Chief Medical Officer can record them, monitor participation and program effectiveness, and support appropriate follow-up. Colposcopy doctors and approved pathology labs must notify within 14 days; diagnostic radiologists reporting low-dose CT lung screens have 30 days and must include detailed nodule data and risk ratings.\n\nPeople can request their information be excluded from the register under the parent Act."}},"importantCases":[],"_links":{"self":"/api/acts/national-cancer-screening-register-rules-2017","history":"/api/acts/national-cancer-screening-register-rules-2017/history","analysis":"/api/acts/national-cancer-screening-register-rules-2017/analysis","conflicts":"/api/acts/national-cancer-screening-register-rules-2017/conflicts","importantCases":"/api/acts/national-cancer-screening-register-rules-2017/important-cases","documents":"/api/acts/national-cancer-screening-register-rules-2017/documents"}}