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National Cancer Screening Register Rules 2017

Authoritative Version
  • - F2017L01547
  • In force - Superseded Version
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Rules/Other as made
These rules prescribe the requirement for mandatory notification to the Commonwealth Chief Medical Officer (CMO) including, who is required to notify, mandatory data sets and the timeframe for notification. From 1 December 2017, colposcopists and pathology practitioners will be required to notify prescribed cervical screening information to the CMO through the National Cancer Screening Register within 14 days.
Administered by: Health and Aged Care
Registered 29 Nov 2017
Tabling HistoryDate
Tabled HR04-Dec-2017
Tabled Senate04-Dec-2017

EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health / Minister for Sport

 

National Cancer Screening Register Act 2016

 

National Cancer Screening Register Rules 2017

 

Outline

Subsection 13(1) of the National Cancer Screening Register Act 2016 (the Act) provides that the individual healthcare provider prescribed by the rules for a type of screening test or diagnosis prescribed by the rules must notify the Commonwealth Chief Medical Officer (CMO) in the approved form, by the time prescribed by the rules, of the information prescribed by the rules for the type of screening test or diagnosis.

 

Subsection 13(2) of the Act provides that a person is liable to a civil penalty if the person contravenes subsection 13(1). 

 

The civil penalty applicable for contravention of subsection 13(1) of the Act is 30 penalty units.

 

Pursuant to subsection 13(1) of the Act, the National Cancer Screening Register Rules 2017 (the Rules) prescribe:

·         the individual healthcare provider who must notify the CMO;

·         the type of screening test;

·         the information that must be notified; and

·         the prescribed timeframe the information must be notified.

 

The prescribed screening tests and when the prescribed timeframe commences for each screening test are as follows:

·         colposcopy – after completion of the colposcopy episode (whether diagnostic or therapeutic);

·         human papillomavirus (HPV) test ‑ after the pathology practitioner has received, tested and issued a report;

·         cytology test ‑ after the pathology practitioner has received, tested and issued a report, or a combined report where a HPV test was also undertaken; and

  • histology – after the pathology practitioner has completed testing (which may involve multiple examinations on the tissue) and issued a report.

 

Details of the Rules are set out in the Attachment.

 

The approved form for the purpose of subsection 13(1) of the Act is the Australian Government Department of Health National Cervical Screening Program Colposcopy & Treatment Form.

 

The Rules are a legislative instrument for the purposes of the Legislation Act 2003

The Rules commence on 1 December 2017.

 

Consultations

 

The Rules made under subsection 13(1) of the Act have been based on pre‑determined data requirements for the National Cervical Screening Program (NCSP). A Colposcopy Sub-group of the NCSP Quality and Safety Monitoring Committee considered the data requirements as part of the Quality Framework for the NCSP and determined the data items to enable reporting against agreed quality standards.  A colposcopy data collection form was developed initially by the Colposcopy Sub-group and further developed through consultations with the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and user-testing among colposcopists.

 

In November 2016, the Department of Health (the Department) surveyed colposcopists regarding the requirement to notify the CMO through the National Cancer Screening Register (the Register) and the colposcopy data collection form.  The survey results assisted the Department in developing the Rules and the Colposcopy & Treatment Form, the approved form for the purpose of subsection 13(1) of the Act.

 

The Department undertook user journey mapping in June 2017 with selected specialists who perform colposcopies in the public and private sectors to gain an understanding of the current practices and processes and how best to support colposcopists with notification to the CMO.  This enabled collation of information regarding the current business processes, reporting channels, frequency of notification, quality assurance reporting and other performance tracking methods to ensure quality reporting.  Findings from the user journey mapping supported the findings of the November 2016 survey.  

 

The Rules have also been based on the Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition), a National Pathology Accreditation and Advisory Council (NPAAC) document, one of several documents that support the standards for good medical pathology practice.  The Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition) is referred to as the NPAAC standards in this Explanatory Statement.

 

The Department engaged with the pathology sector on all aspects of laboratory notification requirements to the CMO.  Individual contact, group workshops and whole-of-sector teleconferences were the primary forms of pathology sector engagement.

 

The Department released a consultation package on 10 October 2017 which sought further stakeholder comments on the Rules.  The consultation package comprised the exposure draft, explanatory notes, FAQs for colposcopists and pathology practitioners and the Colposcopy & Treatment Form with instructions on how to lodge the form.  Peak bodies, including the Royal Australian College of General Practitioners, the Australian College of Rural and Remote Medicine, RANZCOG, the Australian Society for Colposcopy and Cervical Pathology and the Royal College of Pathologists of Australia were notified of the Department’s call for comments. 

 

Stakeholders were encouraged to provide written comments by 24 October 2017 on specific questions aimed at further informing the drafting of the Rules.

 

Comments from States and Territories have also led to the amendment and further refinement of this legislative instrument.

ATTACHMENT

 

 

DETAILS OF THE NATIONAL CANCER SCREENING REGISTER RULES 2017

 

Part 1—Preliminary

 

Rule 1 – Name

 

This rule provides that this instrument is the National Cancer Screening Register Rules 2017.

 

Rule 2 – Commencement

 

Subsection 1 of this rule provides that each provision of the instrument in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

The table in subsection 1 provides that the whole of this instrument commences on 1 December 2017.

 

Subsection 2 of this rule provides that any information in column 3 of the table is not part of this instrument but that information may be inserted, or information in it may be edited, in any published version of this instrument.

 

Rule 3 – Authority

 

This rule states that this instrument is made under the National Cancer Screening Register Act 2016 (the Act).

 

Rule 4 – Definitions

 

This rule notes that a number of expressions in this instrument are defined in the Act, including the following:

(a)   approved form

(b)   individual healthcare provider

(c)   screening

(d)  screening test

 

This rule provides definitions of terms used within this instrument:

·      accredited pathology laboratory has the same meaning as in the Health Insurance Act 1973 (the HI Act).

·      Act means the National Cancer Screening Register Act 2016.

·      approved pathology practitioner has the same meaning as in the HI Act.

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

·      HPV is short for human papillomavirus.

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

·      pathology service has the same meaning as in the HI Act.

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

 

Rule 5 - Pathology services carried out on behalf of approved pathology practitioners

 

This rule provides that for the purpose 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 rendered on behalf of the approved pathology practitioner for the purposes of section 3AA of the HI Act.

 

Part 2—Requirement to notify—cervical cancer screening

 

Rule 6 – Simplified outline of this Part

 

This rule provides a simplified outline of Part 2 of the instrument which prescribes the types of cervical cancer screening tests and, for each of those types of screening tests:

(a)   the information that must be notified to the CMO; and

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

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

 

Rule 7 - Purposes of this Part

 

This rule provides that Part 2 is made for the purposes of subsection 13(1) of the Act.

 

Rule 8 – Colposcopies

 

Subsection 1 of this rule applies to a type of screening test to which all the following paragraphs apply:

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

(b)   the screening test is a colposcopy;

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

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

 

The rule provides a note stating that section 4 of the Act defines screening test to mean a test or procedure as part of screening.

 

Screening tests carried out by colposcopists as part of a clinical trial approved by an ethics committee (within the meaning of the Therapeutic Goods Act 1989 (the TGA Act)) are exempted from the notification requirement of this instrument.  

 

An example of a clinical trial exempted from the notification requirement is the Compass Trial.

 

Subsection 2 of this rule provides that if a screening test of the type listed in subsection 1 is carried out, the individual healthcare provider who carries out the screening test must notify the CMO, by the end of 14 days after the day the colposcopy is completed, of the information specified.

 

Subsection 2 of this rule lists the prescribed information in the ‘Information for colposcopies’ table.

 

Item 1 – Information about the individual who undergoes the screening test (colposcopy)

(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

Item 2 – Information about the individual healthcare provider who undertook the screening test (colposcopy)

(a)   name;

(b)   clinic name;

(c)   provider number

Item 3 - Information about the screening test (colposcopy)

(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 (referred to as the primary colposcopy impression in the approved form);

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

(g)   whether the patient is pregnant at the time of the colposcopy;

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

Item 4 - Information about any treatment of the cervix

The information to be notified under this item is 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.

 

Subsection 3 of this rule provides that paragraphs (d), (e) and (f) in item 1 of the table in subsection (2) do not apply before 1 June 2018.  Pursuant to this subsection, Indigenous status, country of origin and preferred language are not required to be notified to the CMO prior to 1 June 2018, irrespective of whether this information is known by the individual healthcare provider.

 

This rule provides at Note 1 that a notice given under subsection 13(1) of the Act must be in the approved form.  The Australian Government Department of Health National Cervical Screening Program Colposcopy & Treatment Form is the approved form for the purpose of subsection 13(1) of the Act.

 

This rule provides at Note 2 that an individual may request that information relating to the individual’s cervical screening test result not be included in the Register as provided for in subsection 14(1)(c) of the Act.

 

Rule 9 - Pathology laboratory screening tests

 

Subsection 1 of this rule applies to a type of screening test to which all the following paragraphs apply:

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

(b)   the screening test is:

(i)    an HPV test; or

(ii)   a cytology test; or

(iii)  a histopathology test;

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

(d)   the screening test:

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

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

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

 

Screening tests carried out by approved pathology practitioners as part of a clinical trial approved by an ethics committee (within the meaning of the TGA Act), such as the Compass Trial, are exempted from the notification requirement of the Rules.

 

The rule provides a note stating that section 4 of the Act defines screening test to mean a test or procedure as part of screening.

 

Subsection 2 of this rule provides that if a screening test of the type listed in subsection 1 is carried out, the approved pathology practitioner must, under subsection 13(1) of the Act, notify the CMO, by the end of 14 days after the day the screening test is completed, of the information specified.

 

Subsection 2 of this rule lists the prescribed information in the ‘Information for pathology laboratory screening tests’ table.

 

Item 1 – Information about the individual who undergoes the screening test (HPV test, cytology test or histopathology 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

Item 2 – Information about the approved pathology practitioner who completes the screening test (HPV test, cytology test or histopathology test)

(a)   provider number;

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

(c)   name

Item 3 ‑ Information about the accredited pathology laboratory where the screening test is completed (HPV test, cytology test or histopathology test)

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

(b)   name;

(c)   address

Item 4 - Information about the collection of the cervical sample (for a HPV test, cytology test or histopathology test) 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

Item 5 - Information about the request for the screening test (HPV test, cytology test or histopathology 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

Item 6 ‑ Information about the screening test (HPV test, cytology test or histopathology test)

(a)   type;

(b)   date;

(c)   recommendation

 

The following items relate to information about a type of screening test that is completed by the approved pathology practitioner.

 

Item 7 – Information about the HPV test

(a)   collection method;

(b)   specimen site;

(c)   reason for test;

(d)   test result (referred to as ‘HPV test result – oncogenic HPV’ in the NPAAC standards);

(e)   name of test (referred to as ‘HPV test type’ in the NPAAC standards);

(f)   collection media (referred to as ‘HPV test sample’ in the NPAAC standards);

(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

Item 8 – Information about the cytology test

(a)   specimen type;

(b)   specimen site;

(c)   reason for test;

(d)   test result

Item 9 – Information about the histopathology test

(a)   specimen site;

(b)   procedure used for obtaining specimen;

(c)   test result.

 

This rule provides at Note 1 that a notice given under subsection 13(1) of the Act must be in the approved form.  The Australian Government Department of Health National Cervical Screening Program Colposcopy & Treatment Form is the approved form for the purpose of subsection 13(1) of the Act.

 

This rule provides at Note 2 that an individual may request that information relating to the individual’s cervical screening test result not be included in the Register as provided for in subsection 14(1)(c) of the Act.

 


 

Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

 

NATIONAL CANCER SCREENING REGISTER RULES 2017

 

This Rule is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the National Cancer Screening Register Act 2016

 

The National Cancer Screening Register Act 2016 (the Act) creates a legislative framework for the establishment and ongoing operation of the National Cancer Screening Register (the Register).

 

The Act authorises the collection, use and disclosure of information for the purposes of the Register to support the renewed National Cervical Screening Program (NCSP) and the expansion of the National Bowel Cancer Screening Program.

 

Overview of the National Cancer Screening Register Rules 2017

 

Pursuant to subsection 13(1) of the Act, the National Cancer Screening Register Rules 2017 (the Rules) prescribe:

·         the individual healthcare provider who must notify the Chief Medical Officer (CMO);

·         the type of screening test;

·         the information that must be notified; and

·         the prescribed timeframe the information must be notified.

 

Human rights implications

 

The Rules engage the following rights:

 

·           Protection of privacy and reputation (Article 17 of the International Covenant on Civil and Political Rights (ICCPR); and

·           Right to health (Articles 2 and 12(1) of the International Covenant on Economic, Social and Cultural Rights (ICESCR).

 

Protection of privacy and reputation

 

Article 17 of the ICCPR prohibits arbitrary or unlawful interference with an individual’s privacy, family, home and correspondence.  For interferences with privacy not to be arbitrary, they must be reasonable in the particular circumstances.  Reasonableness, in this context, incorporates notions of proportionality to the end sought and necessity in the circumstances.

 

The Rule engages Article 17 of the ICCPR by provisions that prescribe the collection of individuals’ cervical screening test results, results of relevant follow-up procedures up to and including the diagnosis (or clearance) of cancer, and treatment in relation to pre-cancerous abnormalities to be notified to the CMO through the Register.

 

Once notified to CMO pursuant to the Rules, the information will be afforded the protections provided in Part 3 of the Act.  Individuals’ privacy is maintained, not diminished in the Act, specifically:

 

·           section 17 imposes limitations on how information in the Register is collected, recorded, used and disclosed;

·           section 18 imposes a criminal penalty of imprisonment for 2 years or 120 penalty units, or both, for a person making a record of, using or disclosing protected information without authorisation;

·           section 22A requires notification of data breaches and the taking of certain actions in relation to data breaches by the Secretary of the Department of Health and a contracted service provider or former contracted service provider, and imposes a civil penalty of up to 100 penalty units for failure by a contracted service provider or former contracted service provider to comply with section 22A; and

·           section 22B makes an unauthorised recording, use or disclosure of information in the Register, or a failure to comply with the requirements under section 22A an interference with privacy for the purpose of the Privacy Act 1988, and clarifies the functions and powers of the Information Commissioner.

 

The Act includes provisions allowing individuals to opt out of participation in the Register and/or screening programs, including requesting that their screening test results not be included in the Register.  These provisions in the Act are also noted in the Rules.  Requests about participation in the Register are described in section 14 of the Act.

 

Right to health

 

The Rules engage articles 2 and 12 of the ICESCR by assisting the progressive realisation of the rights of everyone by all appropriate means to the enjoyment of the highest attainable standard of physical and mental health. 

 

According to the World Health Organisation, the aim of screening is “to reduce the burden of disease in the community, including incidence of disease, morbidity from the disease or mortality.  This is achieved by intervening to reduce individual risk of the disease or detecting the disease earlier on average than is usually the case in the absence of screening and thereby improving disease outcome.” 

 

The Rules provide a legislative basis for the collection of individuals’ cervical screening test results.  A ‘positive’ screening test identifies people who are at increased likelihood of having the condition and who require further investigation to determine whether or not they have the disease or condition.

 

The Rules assist the advancement of the human right to health by prescribing the types of screening tests, the individual healthcare provider who must notify information about the screening test, the information that must be notified, and the timeframe for notifying the information.

 

The notification requirement in the Rules supports the screening processes and clinical pathways and the monitoring of program quality, safety and effectiveness, and provides a safety net function for the renewed NCSP.  

 

The cervical screening test information notified by prescribed individual healthcare providers for the purpose of section 13 of the Act will be used to facilitate screening invitations, recall and clinical decision-making, thereby supporting early detection and prevention of cancer through population-based screening. 

 

Conclusion

 

The Rule is compatible with human rights because it advances the protection of human rights, specifically the protection of privacy and reputation and the right to health.

 

 

The Hon Greg Hunt MP, the Minister for Health /

Minister for Sport