National Cancer Screening Register Rules 2017 made under section 13 of the National Cancer Screening Register Act 2016 Compilation No. 01 Compilation date: 1 June 2018 Includes amendments up to: F2018L00702 About this compilation This compilation This is a compilation of National Cancer Screening Register Rules 2017 that shows the text of the law as amended and in force on 1 June 2018 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents Part 1—Preliminary 1 Name 2 Commencement 3 Authority 4 Definitions 5 Pathology services carried out on behalf of approved pathology practitioners Part 2—Requirement to notify—cervical cancer screening 6 Simplified outline of this Part 7 Purposes of this Part 8 Colposcopies 9 Pathology laboratory screening tests Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Part 1—Preliminary 1 Name This instrument is the National Cancer Screening Register Rules 2017. 2 Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument 1 December 2017. 1 December 2017 Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument. (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument. 3 Authority This instrument is made under the National Cancer Screening Register Act 2016. 4 Definitions Note: A number of expressions used in this instrument are defined in the Act, including the following: (a) approved form; (b) individual healthcare provider; (c) screening; (d) screening test. In this instrument: accredited pathology laboratory has the same meaning as in the Health Insurance Act 1973. Act means the National Cancer Screening Register Act 2016. approved pathology practitioner has the same meaning as in the Health Insurance Act 1973. healthcare identifier has the same meaning as in the Healthcare Identifiers Act 2010. HPV is short for human papillomavirus. medicare number has the same meaning as in Part VII of the National Health Act 1953. pathology service has the same meaning as in the Health Insurance Act 1973. provider number has the same meaning as in the Health Insurance Regulations 1975. 5 Pathology services carried out on behalf of approved pathology practitioners For the purposes of this instrument, a pathology service is not taken to be carried out on behalf of an approved pathology practitioner if the service is not taken to be rendered on behalf of the approved pathology practitioner for the purposes of the Health Insurance Act 1973 (see section 3AA of that Act). Part 2—Requirement to notify—cervical cancer screening 6 Simplified outline of this Part For the purposes of subsection 13(1) of the Act, this Part prescribes types of cervical cancer screening tests and, for each of those types of screening tests: (a) the information that must be notified to the Commonwealth Chief Medical Officer; and (b) the individual healthcare provider who must notify the information; and (c) the time by which the information must be notified. 7 Purposes of this Part This Part is made for the purposes of subsection 13(1) of the Act. 8 Colposcopies (1) This section applies to a type of screening test to which all of the following paragraphs apply: (a) the screening test is associated with cervical cancer; (b) the screening test is a colposcopy; (c) the screening test is carried out by an individual healthcare provider; (d) the screening test is carried out other than as part of a clinical trial approved by an ethics committee (within the meaning of the Therapeutic Goods Act 1989). Note: Section 4 of the Act defines screening test to mean a test or procedure as part of screening. (2) If a screening test of that type is carried out, the individual healthcare provider who carries out the screening test must, under subsection 13(1) of the Act, notify the Commonwealth Chief Medical Officer, by the end of 14 days after the day the colposcopy is completed, of the information specified in the following table. Information for colposcopies Item Column 1 Information 1 The following information about the individual who undergoes the screening test: (a) medicare number (if known by the individual healthcare provider); (b) name; (c) date of birth; (d) Indigenous status (if known by the individual healthcare provider); (e) country of origin (if known by the individual healthcare provider); (f) preferred language (if known by the individual healthcare provider); (g) address 2 The following information about the individual healthcare provider: (a) name; (b) clinic name; (c) provider number 3 The following information about the screening test: (a) date of screening test; (b) indication for colposcopy; (c) an indication as to whether the colposcopy was adequate or inadequate; (d) visibility of transformation zone; (e) the clinical diagnosis or impression formed at the time of the colposcopy; (f) whether a biopsy is performed as part of the colposcopy episode of which the screening test is part; (g) whether the individual who undergoes the colposcopy is pregnant at the time of the colposcopy; (h) whether treatment is performed as part of the colposcopy episode of which the screening test is part 4 The following information about any treatment of the cervix that is associated with a precursor to cervical cancer and that is connected to the screening test: (a) kind of treatment; (b) if an excision was performed—excision type; (c) if an excision was performed—modality or method used; (d) if an ablation was performed—ablation type; (e) whether hysterectomy was performed; (f) anaesthetic type; (g) location of treatment (3) However, paragraphs (d), (e) and (f) in item 1 of the table in subsection (2) do not apply before 1 December 2018. Note 1: A notice given under subsection 13(1) of the Act must be in the approved form: see subsection 13(1) of the Act. Note 2: An individual may request that information relating to the individual that is notified under subsection 13(1) of the Act not be included in the register: see section 14 of the Act. 9 Pathology laboratory screening tests (1) This section applies to a type of screening test to which all of the following paragraphs apply: (a) the screening test is associated with cervical cancer; (b) the screening test is: (i) an HPV test; or (ii) a cytology test; or (iii) a histopathology test; (c) the screening test is carried out by or on behalf of an approved pathology practitioner who is an individual healthcare provider; (d) the screening test: (i) is carried out in an accredited pathology laboratory; and (ii) is a pathology service of a kind in respect of which the laboratory is accredited; (e) the screening test is carried out other than as part of a clinical trial approved by an ethics committee (within the meaning of the Therapeutic Goods Act 1989). Note: Section 4 of the Act defines screening test to mean a test or procedure as part of screening. (2) If a screening test of that type is carried out, the approved pathology practitioner must, under subsection 13(1) of the Act, notify the Commonwealth Chief Medical Officer, by the end of 14 days after the day the screening test is completed, of the information specified in the following table for the screening test. Information for pathology laboratory screening tests Item Column 1 Column 2 Screening test Information 1 Any screening test The following information about the individual who undergoes the screening test: (a) medicare number (if known by the approved pathology practitioner); (b) healthcare identifier (if known by the approved pathology practitioner); (c) name; (d) date of birth; (e) gender; (f) Indigenous status (if known by the approved pathology practitioner); (g) country of origin (if known by the approved pathology practitioner); (h) preferred language (if known by the approved pathology practitioner); (i) address 2 Any screening test The following information about the approved pathology practitioner: (a) provider number; (b) healthcare identifier (if known by the approved pathology practitioner); (c) name 3 Any screening test The following information about the accredited pathology laboratory: (a) healthcare identifier (if known by the approved pathology practitioner); (b) name; (c) address 4 Any screening test The following information about the collection of the cervical sample, to the extent known by the approved pathology practitioner: (a) address of the premises where the sample was collected; (b) provider number of the individual healthcare provider who collected the sample; (c) healthcare identifier of the individual healthcare provider who collected the sample; (d) healthcare identifier of the healthcare provider organisation at whose premises the sample was collected 5 Any screening test The following information about the request for the screening test, to the extent known by the approved pathology practitioner: (a) address of the premises from which the request was made; (b) provider number of the individual healthcare provider who made the request; (c) healthcare identifier of the individual healthcare provider who made the request; (d) healthcare identifier of the healthcare provider organisation from whose premises the request was made 6 Any screening test The following information about the screening test: (a) type; (b) date; (c) recommendation 7 HPV test The following information about the HPV test: (a) collection method; (b) specimen site; (c) reason for test; (d) test result; (e) name of test; (f) collection media; (g) batch information, unless the test is a diagnostic HPV test for: (i) a symptomatic person; or (ii) a person in the post treatment setting 8 Cytology test The following information about the cytology test: (a) specimen type; (b) specimen site; (c) reason for test; (d) test result 9 Histopathology test The following information about the histopathology test: (a) specimen site; (b) procedure used for obtaining specimen; (c) test result Note 1: A notice given under subsection 13(1) of the Act must be in the approved form: see subsection 13(1) of the Act. Note 2: An individual may request that information relating to the individual that is notified under subsection 13(1) of the Act not be included in the register: see section 14 of the Act. Endnotes Endnote 1—About the endnotes The endnotes provide information about this compilation and the compiled law. The following endnotes are included in every compilation: Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Abbreviation key—Endnote 2 The abbreviation key sets out abbreviations that may be used in the endnotes. Legislation history and amendment history—Endnotes 3 and 4 Amending laws are annotated in the legislation history and amendment history. The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation. The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law. Misdescribed amendments A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation "(md)" added to the details of the amendment included in the amendment history. If a misdescribed amendment cannot be given effect as intended, the abbreviation "(md not incorp)" is added to the details of the amendment included in the amendment history. Endnote 2—Abbreviation key o = order(s) ad = added or inserted Ord = Ordinance am = amended orig = original amdt = amendment par = paragraph(s)/subparagraph(s) c = clause(s) /sub‑subparagraph(s) C[x] = Compilation No. x pres = present Ch = Chapter(s) prev = previous def = definition(s) (prev…) = previously Dict = Dictionary Pt = Part(s) disallowed = disallowed by Parliament r = regulation(s)/rule(s) Div = Division(s) exp = expires/expired or ceases/ceased to have reloc = relocated effect renum = renumbered F = Federal Register of Legislation rep = repealed gaz = gazette rs = repealed and substituted LA = Legislation Act 2003 s = section(s)/subsection(s) LIA = Legislative Instruments Act 2003 Sch = Schedule(s) (md) = misdescribed amendment can be given Sdiv = Subdivision(s) effect SLI = Select Legislative Instrument (md not incorp) = misdescribed amendment SR = Statutory Rules cannot be given effect Sub‑Ch = Sub‑Chapter(s) mod = modified/modification SubPt = Subpart(s) No. = Number(s) underlining = whole or part not commenced or to be commenced Endnote 3—Legislation history Name Registration Commencement Application, saving and transitional provisions National Cancer Screening Register Rules 2017 29 November 2017 (F2018L00702) 1 December 2017 National Cancer Screening Register Amending Rules 2018 1 June 2018 (F2018L00702) 1 June 2018 Endnote 4—Amendment history Provision affected How affected s 8(3) am, 2018 F2018L00702