Version No. 001 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Version as at 1 October 2015 TABLE OF PROVISIONS Regulation Page 1 Objectives 1 2 Authorising provision 1 3 Commencement 1 4 Types of cancer or precursor diagnosis required to be reported 1 5 Entities required to report cancer or precursor 2 6 Diagnosis reports 2 Schedule 1—Prescribed information for centre, hospital or service 4 Schedule 2—Prescribed information for pathology service 6 ═══════════════ Endnotes 8 1 General information Error! Bookmark not defined. 2 Table of Amendments 10 3 Amendments Not in Operation 11 4 Explanatory details 12 i Version No. 001 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Version as at 1 October 2015 1 Objectives The objectives of these Regulations are to prescribe— (a) the types of cancer, or precursors to cancer, a diagnosis of which must be reported to the Secretary under the Improving Cancer Outcomes Act 2014; and (b) who must report that diagnosis; and (c) the form of the reports, the time within which they must be made and the information to be included in them. 2 Authorising provision These Regulations are made under section 28 of the Improving Cancer Outcomes Act 2014. 3 Commencement These Regulations come into operation on 1 October 2015. 4 Types of cancer or precursor diagnosis required to be reported For the purposes of section 9(1) of the Improving Cancer Outcomes Act 2014, the prescribed types of cancer or precursors to cancer are those specified in Schedule 1 of "Reportable Cancers Guide to identification of cancers reportable to the 1 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Schedule 1—Prescribed information for centre, hospital or service Secretary", as published by the Department of Health and Human Services from time to time. 5 Entities required to report cancer or precursor For the purposes of section 9(1) of the Improving Cancer Outcomes Act 2014, the following persons and organisations are prescribed— (a) any of the following as defined by section 3(1) of the Health Services Act 1988— (i) a day procedure centre; (ii) a denominational hospital; (iii) a private hospital; (iv) a privately-operated hospital; (v) a public health service; (vi) a public hospital; (b) any radiotherapy service that provides a service for treating cancer patients involving the use of ionising radiation, including external beam, superficial and orthovoltage radiotherapy, particle beam therapy and brachytherapy; (c) any pathology service that provides a service for testing for cancer, or a precursor to cancer, of a type prescribed by regulation 4. 6 Diagnosis reports For the purposes of section 9(3) of the Improving Cancer Outcomes Act 2014— (a) a report of a diagnosis of cancer or a precursor to cancer is in the prescribed form if it contains the prescribed information; and (b) the prescribed time within which a report must be made is— 2 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Schedule 1—Prescribed information for centre, hospital or service (i) for a centre, hospital or service referred to in regulation 5(a) or (b), 60 days from the date the person in charge of the centre, hospital or service becomes aware that a person has cancer, or a precursor to cancer, of a type prescribed by regulation 4; and (ii) for a pathology service referred to in regulation 5(c), 30 days from the date the person in charge of the place where the testing is done becomes aware that a test indicates that a person has cancer, or a precursor to cancer, of a type prescribed by regulation 4; and (c) the prescribed information to be included in a report is— (i) for a centre, hospital or service referred to in regulation 5(a) or (b), the information set out in Schedule 1; and (ii) for a pathology service referred to in regulation 5(c), the information set out in Schedule 2. 3 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Schedule 1—Prescribed information for centre, hospital or service Schedule 1—Prescribed information for centre, hospital or service Regulation 6(c)(i) Name of centre, hospital or service Hospital identification number Hospital unit record number Patient details: Medicare number (if known) Individual Health Identifier (if known) Family name Given name(s) Maiden name (if applicable) Address Postcode Date of birth Sex Country of birth Aboriginal or Torres Strait Islander status Language spoken at home (if known—please specify) Details of doctor in charge of case: Medicare provider number (if known) Name Address Telephone number Details of general practitioner: Medicare provider number (if known) Name Address Telephone number 4 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Schedule 1—Prescribed information for centre, hospital or service Date of first admission for this cancer Date of diagnosis of this cancer Eastern Cooperative Oncology Group (ECOG) performance status at time of diagnosis (if known) Vital status Date of discharge from centre/hospital/organisation Investigations relevant to diagnosis of cancer Primary site of cancer Laterality of primary site of cancer Morphology of primary cancer Grade/differentiation of primary cancer Stage of cancer at diagnosis Cancer staging system (to be reported in accordance with the "Victorian Cancer Staging Reporting Guidelines" as published by the Department of Health and Human Services from time to time) Treatment details for each primary tumour: Details of initial treatment Details of treatment of recurrence(s) (if any) Cancer recurrence information: Date of cancer recurrence Site(s) of cancer recurrence Name of person completing form Date of completing form 5 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Schedule 2—Prescribed information for pathology service Schedule 2—Prescribed information for pathology service Regulation 6(c)(ii) Name of pathology service Pathology group identification number Laboratory case reference number Patient details: Medicare number (if known) Individual Health Identifier (if known) Family name Given name(s) Address Postcode Date of birth Sex Country of birth Aboriginal or Torres Strait Islander status (if known) Language spoken at home (if known—please specify) Details of doctor responsible for case: Medicare provider number (if known) Name Address Details of reporting pathologist: Medicare provider number (if known) Name Date of report 6 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Schedule 2—Prescribed information for pathology service Structured pathology report or the following minimum information: Primary site of cancer Laterality of primary site Cancer morphology type Tumour size Depth of invasion Metastatic sites Number of nodes sampled Number of nodes positive Date of diagnosis Stage of cancer at diagnosis Grade/differentiation Name of person completing form Date of completing form ═══════════════ 7 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Endnotes Endnotes 1 General information See www.legislation.vic.gov.au for Victorian Bills, Acts and current authorised versions of legislation and up-to-date legislative information. The Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015, S.R. No. 107/2015 were made on 22 September 2015 by the Governor in Council under section 28 of the Improving Cancer Outcomes Act 2014, No. 78/2014 and came into operation on 1 October 2015: regulation 3. The Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 will sunset 10 years after the day of making on 22 September 2025 (see section 5 of the Subordinate Legislation Act 1994). INTERPRETATION OF LEGISLATION ACT 1984 (ILA) Style changes Section 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act. References to ILA s. 39B Sidenotes which cite ILA s. 39B refer to section 39B of the ILA which provides that where an undivided regulation, rule or clause of a Schedule is amended by the insertion of one or more subregulations, subrules or subclauses the original regulation, rule or clause becomes subregulation, subrule or subclause (1) and is amended by the insertion of the expression "(1)" at the beginning of the original regulation, rule or clause. Interpretation As from 1 January 2001, amendments to section 36 of the ILA have the following effects: • Headings All headings included in a Statutory Rule which is made on or after 1 January 2001 form part of that Statutory Rule. Any heading inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule. This includes headings to Parts, Divisions or Subdivisions in a Schedule; Orders; Parts into which an Order is divided; clauses; regulations; rules; items; tables; columns; examples; diagrams; notes or forms. See section 36(1A)(2A)(2B). • Examples, diagrams or notes All examples, diagrams or notes included in a Statutory Rule which is made on or after 1 January 2001 form part of that Statutory Rule. Any examples, diagrams or notes inserted in a Statutory Rule which was made before 8 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Endnotes 1 January 2001, by a Statutory Rule made on or after 1 January 2001, form part of that Statutory Rule. See section 36(3A). • Punctuation All punctuation included in a Statutory Rule which is made on or after 1 January 2001 forms part of that Statutory Rule. Any punctuation inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule. See section 36(3B). • Provision numbers All provision numbers included in a Statutory Rule form part of that Statutory Rule, whether inserted in the Statutory Rule before, on or after 1 January 2001. Provision numbers include regulation numbers, rule numbers, subregulation numbers, subrule numbers, paragraphs and subparagraphs. See section 36(3C). • Location of "legislative items" A "legislative item" is a penalty, an example or a note. As from 13 October 2004, a legislative item relating to a provision of a Statutory Rule is taken to be at the foot of that provision even if it is preceded or followed by another legislative item that relates to that provision. For example, if a penalty at the foot of a provision is followed by a note, both of these legislative items will be regarded as being at the foot of that provision. See section 36B. • Other material Any explanatory memorandum, table of provisions, endnotes, index and other material printed after the Endnotes does not form part of a Statutory Rule. See section 36(3)(3D)(3E). 9 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Endnotes 2 Table of Amendments There are no amendments made to the Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 by statutory rules, subordinate instruments and Acts. 10 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Endnotes 3 Amendments Not in Operation There are no amendments which were Not in Operation at the date of this publication. 11 Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015 S.R. No. 107/2015 Endnotes 4 Explanatory details Table of Applied, Adopted or Incorporated Matter The following table of applied, adopted or incorporated matter is included in accordance with the requirements of regulation 5 of the Subordinate Legislation Regulations 2014. Statutory rule provision Title of applied, adopted or incorporated document Matter in applied, adopted or incorporated document Regulation 4 "Reportable Cancers - Guide to identification of cancers reportable to the Secretary" as published by the Department of Health and Human Services from time to time Schedule 1 Schedule 1 "Victorian Cancer Staging Reporting Guidelines" as published by the Department of Health and Human Services from time to time The whole 12