EXPLANATORY STATEMENT
HEALTH INSURANCE ACT 1973
Health Insurance (Accredited Pathology Laboratories – Approval)
Amendment Principles 2017 (No. 2)
Section 23DNA of the Health Insurance Act 1973 (‘the Act’) provides for the Minister to determine the principles to be applied in exercising his or her powers under section 23DN of the Act to approve in principle, or refuse to approve, premises as an accredited pathology laboratory. The current principles determined under section 23DNA are the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002 (‘the Principles’).
With the exception of some basic tests conducted by some medical practitioners within their own medical practice, Medicare benefits for pathology services are only payable when they are rendered in an accredited pathology laboratory. The Principles operate to ensure minimum acceptable standards in pathology laboratories at which Medicare eligible pathology services are provided.
Schedule 1 of the Principles specifies accreditation materials that set out relevant standards against which applicants for accreditation are to be assessed. These documents are developed and maintained by the National Pathology Accreditation Advisory Council (NPAAC) or endorsed by NPAAC as supplementary accreditation materials. The accreditation process of pathology laboratories is administered by the Department of Human Services, while the National Association of Testing Authorities (NATA) is the currently recognised independent assessment body that conducts the accreditation assessment of pathology laboratories, in conjunction with the Royal College of Pathologists of Australasia.
The purpose of the Health Insurance (Accredited Pathology Laboratories – Approval) Amendment Principles 2017 (No. 2) (‘the Amending Principles’) is to:
- amend the NPAAC accreditation materials listed in Schedule 1 of the Principles; and
- add a new Schedule 2 to the Principles, listing the NPAAC accreditation materials to apply from 1 December 2017 in place of those in Schedule 1.
The list of NPAAC accreditation materials in Schedule 1 of the Principles will be amended to replace reference to the Requirements for Gynaecological (Cervical) Cytology (Second Edition 2014) with reference to the third edition of this document, published in 2017. Reference to the National Association of Testing Authorities Field Application Document (NATA FAD) will also be removed.
From 1 December 2017 the applicable NPAAC accreditation materials will be those specified in Schedule 2 of the Principles. The only difference from the materials specified in Schedule 1 will be that the Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017) will replace two cervical cytology standards listed in table items 8 and 9 of Schedule 1 of the Principles.
These documents form part of the ongoing process of creating and refining the pathology accreditation requirements to maintain their currency and to ensure they reflect contemporary clinical best practice. They should be read in conjunction with the NPAAC overarching document, the Requirements for Medical Pathology Services, which sets out the core elements of good laboratory practice, in addition to the other materials that form the national pathology accreditation framework. This helps assure the quality of Australian pathology services.
Requirements for Gynaecological (Cervical) Cytology (Third Edition 2017)
These Requirements outline minimum standards for good laboratory practice for pathology laboratories using conventional methods to report cervical cytology, including liquid based methods.
In consideration of the delayed implementation of the National Cervical Screening Program (NCSP), the requirement relating to report turn around times for laboratories in the Requirements for Gynaecological (Cervical) Cytology (Second Edition 2014) has been amended from a mandatory requirement to a guiding commentary. The amendment is in recognition of the workforce pressures for pathology laboratories in this interim period and is intended to allow laboratories to meet the accreditation standard for the interim period until the National Cervical Screening Program comes into effect on 1 December 2017.
These revised Requirements will apply from the day after the Amending Principles are registered on the Federal Register of Legislation. The document will be published and available before this date.
National Association of Testing Authorities Field Application Document (NATA FAD)
NPAAC, as the pathology standard-setting body, no longer endorses the NATA FAD as a supplementary accreditation material. The document is considered to be a historical tool based on case studies, rather than an interpretative tool to the legislated pathology accreditation materials. Accordingly, the reference to the document in the Pathology Principles will be be removed from the accreditation materials and thereby will no longer to be used for the purposes of assessing pathology laboratories for the purpose of Medicare approval.
Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017)
These Requirements outline minimum standard for good laboratory practice for the use of Human Papillomavirus (HPV) Nucleic Acid Testing (NAT) as the primary screening method for cervical cancer screening with reflex liquid based cytology in cases positive for oncogenic HPV types.
The National Cervical Screening Program (NCSP) will soon change from a two yearly Pap smear screening to a five yearly primary HPV screening. As a consequence, NPAAC has reviewed its current suite of cervical cytology standards and developed a new pathology quality standard for cervical screening titled Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017).
The Requirements have been developed with a risk based approach and reflect best practices that assure quality pathology services and safeguards the welfare of patients in Australia. The Requirements provide guidance for laboratories when using HPV NAT tests as a primary screening test in a population of both vaccinated and unvaccinated women and are aimed at minimising the potential risk of women being exposed to a prolonged interval of time without observation. These Requirements also form the accreditation materials for the purposes of pathology laboratory accreditation in this field.
Assessment against the document will commence from 1 December 2017, which coincides with the implementation date of the Renewed National Cervical Screening Program. The document will be published and available before this date to provide sufficient notification of the accreditation requirements to pathology laboratories and relevant stakeholders.
These Requirements will replace both the Performance Measures for Australian Laboratories Reporting Cervical Cytology (Third Edition 2015) and the Requirements for Gynaecological (Cervical) Cytology (Third Edition 2017).
CONSULTATIONS
In accordance with established NPAAC public consultation and drafting processes, the proposed Requirements was circulated to pathology stakeholders and relevant parties, including pathology laboratories, Approved Pathology Practitioners, proprietors of pathology laboratories, particularly those that provide cervical screening services, jurisdictional cervical screening registers, state and territory health representatives, peak pathology, scientific and medical organisations and consumers.
Submissions were received from a broad range of stakeholder groups and the final proposed pathology standard takes into consideration the comments received. Feedback from stakeholders was overall supportive of the proposed Requirements and recognised to be an important part of the implementation plan for the National Cervical Screening Program. A further round of consultation with some targeted stakeholders was undertaken to ensure concerns with the proposed quality control measures were sufficiently addressed.
The final draft of the accreditation material was endorsed by NPAAC in January 2017 and recommended for inclusion in the Principles and for publication.
With respect to the proposed amendment to the Requirements for Gynaecological (Cervical) Cytology, a limited consultation was undertaken with key stakeholder organisations in view of the urgent timeframes for the revised Requirements to allow laboratories to continue to comply with the regulatory requirements. Consulted stakeholder organisations included the Royal College of Pathologists, Public Pathology Australia, Pathology Australia, Catholic Health Australia, Royal Australasian College of General Practitioners, Australian Medical Association and state and territory health departments on the proposed amendment.
The comments received to date have been supportive of the proposed requirements and it is expected that there will be no significant objections to the proposal given the measure is intended to alleviate workforce pressures for pathology laboratories in the interim of the implementation of the National Cervical Screening Program.
NATA and the Royal College of Pathologists of Australasia have been advised of the proposed removal of the NATA FAD as a Supplementary Accreditation Material for the purposes of laboratory assessment for Medicare purposes.
The Office of Best Practice Regulation (OBPR) has confirmed that the proposed amendments do not require a Regulation Impact Statement (OBPR ID 21782).
All NPAAC documents are available free of charge from the NPAAC website –
www.health.gov.au/npaac.
The references to the NPAAC documents specified in Schedules 1 and 2 are to those documents as in force at the time the Amending Principles are made.
The Amending Principles commence the day after they are registered on the Federal Register of Legislation.
The Amending Principles are a legislative instrument for the purposes of the Legislation Act 2003.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Accredited Pathology Laboratories – Approval)
Amendment Principles 2017 (No. 2)
This Legislative Instrument 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 Legislative Instrument
Section 23DNA of the Health Insurance Act 1973 (‘the Act’) provides for the Minister to determine the principles to be applied in exercising his or her powers under section 23DN of the Act to approve in principle, or refuse to approve, premises as an accredited pathology laboratory. The current principles determined under section 23DNA are the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002 (‘the Principles’).
With the exception of some basic tests conducted by some medical practitioners within their own medical practice, Medicare benefits for pathology services are only payable when they are rendered in an accredited pathology laboratory. The Principles operate to ensure minimum acceptable standards in pathology laboratories at which Medicare eligible pathology services are provided.
Schedule 1 of the Principles specifies accreditation materials that set out relevant standards against which applicants for accreditation are to be assessed. These documents are developed and maintained by the National Pathology Accreditation Advisory Council (NPAAC) or endorsed by NPAAC as supplementary accreditation materials. The accreditation process is administered by the Department of Human Services, while the National Association of Testing Authorities (NATA) conducts the accreditation assessment, in conjunction with the Royal College of Pathologists of Australasia.
This Legislative Instrument makes amendments to the Principles to:
- amend the NPAAC accreditation materials listed in Schedule 1 of the Principles; and
- add a new Schedule 2 to the Principles, listing the NPAAC accreditation materials to apply from 1 December 2017.
From the day after registration of the Legislative Instrument the list of NPAAC accreditation materials in Schedule 1 of the Principles will be amended to replace reference to the Requirements for Gynaecological (Cervical) Cytology (Second Edition 2014) with reference to the third edition of this document, published in 2017. Reference to the National Association of Testing Authorities Field Application Document (NATA FAD) will also be removed.
From 1 December 2017 the applicable NPAAC accreditation materials will be specified in Schedule 2 of the Principles. The only difference from the materials specified in Schedule 1 is that the Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017) will replace two cervical cytology standards listed in table items 8 and 9 of Schedule 1 of the Principles.
Human rights implications
This Legislative Instrument does not engage any of the applicable rights or freedoms.
Changes to accreditation materials applying from the day after registration of the Instrument
The turn- around times for reports has been modified to a best practice guideline in the Requirements for Gynaecological (Cervical) Cytology (Third Edition 2017) with the aim of allowing pathology laboratories to continue to meet the accreditation requirements in the interim of the implementation of the National Cervical Screening Program. The Requirements set out standards for using conventional methods for cervical cytology. These Requirements will be superseded by the Requirements for Laboratories Reporting Tests for the National Cervical Screening Program that will come into effect on 1 December 2017.
The removal of the reference to the NATA FAD from the Supplementary Accreditation Materials is a consequence of a recommendation by NPAAC.
Changes to the accreditation materials applying from 1 December 2017
The NPAAC accreditation materials listed in Schedule 2 are the same as those listed in Schedule 1, other than the replacement of both the Performance Measures for Australian Laboratories Reporting Cervical Cytology (Third Edition 2015) and the Requirements for Gynaecological (Cervical) Cytology (Third Edition 2017) by the Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017).
The new NPAAC Requirements are an integral part of the implementation plan for the National Cervical Screening Program (NCSP) and is an ongoing process of refining accreditation requirements to maintain their currency and to ensure they reflect contemporary clinical best practice with a comprehensive format. This helps assure the quality of Australian pathology services. The NCSP will soon change from a two yearly Pap smear screening to a five yearly primary Human Papillomavirus (HPV) screening. As a consequence, a new pathology quality standard for cervical screening, the Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017), has been developed that will supersede the existing cervical cytology standards. The document has been developed with a risk based approach to ensure best practices that assures the quality of Australian pathology services and safeguards the welfare of patients.
The Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017) provide guidance for laboratories when using HPV Nucleic Acid Tests as a primary screening test in a population of both vaccinated and unvaccinated women. These also form the accreditation materials for the purposes of pathology laboratory accreditation in this field.
The standards do not impose any obligations on individuals. The standards promote the right to health as they are aimed at ensuring pathology laboratories providing Medicare-eligible pathology services provide safe and high quality services.
Patient access to Medicare rebates for pathology services is not affected by these amendments.
Conclusion
This Legislative Instrument is compatible with human rights as it does not engage any of the applicable rights or freedoms.
Maria Jolly
First Assistant Secretary
Medical Benefits Division
Department of Health