Health Insurance (Accredited Pathology Laboratories—Approval) Amendment Instrument (No. 1) 2018

EXPLANATORY STATEMENT

HEALTH INSURANCE ACT 1973

Health Insurance (Accredited Pathology Laboratories – Approval)

Amendment Instrument (No. 1) 2018

Section 23DNA of the Health Insurance Act 1973 (‘the Act’) provides for the Minister for Health 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 2017 (‘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 by or on behalf of an approved pathology practitioner, in an accredited pathology laboratory operated by an approved pathology authority. The Principles approved under section 23DNA operate to ensure that appropriate standards are met and maintained in pathology laboratories at which Medicare eligible pathology services can be provided

The Principles set out the criteria for different categories of accredited pathology laboratories and specify the standards that must be met as part of the accreditation assessment for each category of laboratory and kinds of services provided in that laboratory. The overarching objectives of the Principles include promoting the delivery of reliable test results and reducing the risk of misdiagnosis in the provision of pathology services.

The Schedule to 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 Instrument (No. 1) 2018 (‘the Amendment Instrument’) is to amend the Principles to reflect the changes to the provisions (including the categories of laboratories) relating to the supervision arrangements for pathology laboratories to ensure alignment with the accreditation standard for the supervision and clinical governance of pathology laboratories. Additionally, to amend the Schedule to the Principles to incorporate references to the following revised accreditation standards that will replace the current documents listed in the Schedule to the Principles, namely the:

• Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018);
•    Requirements for Medical Pathology Services (Second Edition 2018);
• Requirements for the Development and Use of In-house Diagnostic Medical Devices (Fourth Edition 2018);
• Requirements for Quality Control, External Quality Assurance and Method Evaluation (Sixth Edition 2018); and
• Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 2018).

The Amendment Instrument also returns the Performance Measures for Australian Laboratories Reporting Cervical Cytology (Third Edition 2015) as an accreditation material, which was previously applicable to the accreditation assessment of laboratories prior to the commencement of the current Principles (prior to 29 September 2017). As part of the last amendment to the Principles the accreditation material was superseded by the Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017). However, since then NPAAC has recommended that this standard should continue to apply to allow laboratories to complete their reporting requirements against the performance measures for cervical cytology testing. Thus, this standard is again included in the list of applicable accreditation materials.

The review of these pathology accreditation standards is 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. Copies of the pathology accreditation materials are published on the NPAAC website and can be accessed from -http://www.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-publication.htm. The pathology accreditation standards are aimed at assuring the quality of Australian pathology services.

CONSULTATIONS

In accordance with established NPAAC public consultation and drafting processes, the five revised documents were circulated for comment to all pathology stakeholders and relevant parties. This included pathology laboratories, state and territory representatives, peak pathology organisations and consumers.

Submissions were received from a broad range of stakeholder groups. All stakeholder comments were considered and the respective documents revised accordingly. Feedback from stakeholders was overall supportive of the proposed requirements.

With respect to the Requirements for Supervision in Clinical Governance for Medical Pathology Laboratories, it should be noted that during the extended document review period there have been four public consultation phases that have included all pathology laboratories, all pathology practitioners, all pathology authorities, jurisdictions and key stakeholder organisations. In addition there has been targeted consultation with relevant key stakeholders to inform the finalisation of the accreditation standards. States and territories have had representatives on NPAAC that have had the opportunity to contribute to the standards process, including providing any comments on potential regulatory imposts.

All of the issues raised in the public consultation phases have been considered and the document has been revised accordingly. Submissions were received from a broad range of stakeholders including a variety of pathology laboratories, state and territory health departments, relevant stakeholder organisations, key pathology, medical and scientific organisations and consumers.

Given the extended review period, pathology stakeholders have been aware of the document review and are anticipating the publication of the revised standards. NPAAC endorsed and recommended the revised Supervision in Clinical Governance Requirements as an accreditation material that reflects a contemporary, risk based governance framework that aims to minimise potential risks to patient safety and improves the quality of pathology services and patient health outcomes.

The independent assessing body has advised that there are up to 15 pathology laboratories that are currently non-conformant with the current supervision accreditation requirements, including a number in Victoria. This may pose challenges with conforming to the revised Requirements that are unchanged in intent. Victoria Health have expressed concerns with the ability of a number of their laboratories to conform to the proposed supervision requirements as a consequence of historical organisational structures that are focussed on a scientific workforce and an industrial awards system that is not necessarily aligned with the current pathology accreditation requirements. There are ongoing discussions with relevant parties on how to facilitate these pathology laboratories in being able to meet the revised accreditation requirements.

The Office of Best Practice Regulation (OBPR) has confirmed that the proposed amendments do not require a Regulation Impact Statement (OBPR reference numbers 23547, 23050 and 23526).

In accordance with section 14 of Legislation Act 2003, the Pathology Principles 2017 incorporates other legislation as in force from time to time. Other documents are incorporated as in force at the time this legislative instrument takes effect.

Unless otherwise stated, all references to legislation in the legislative instrument are references to that legislation as in force from time to time.

The accreditation materials listed in the Schedule to the Principles, as amended, are all NPAAC documents and are available on the NPAAC website –

www.health.gov.au/npaac.

The Amendment Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Sections 1-4 of the Amendment Instrument and Schedule 1 to the Principles commence on the day after the instrument is registered in the Federal Register of Legislation.  Schedule 2 to the Principles contains the primary amendments, including references to the five revised accreditation materials that are applicable accreditation materials that commence on 1 December 2018.

Details of the legislative instrument are set out in Attachment A. Summary of the revised pathology accreditation materials is at Attachment B.

ATTACHMENT A

Details of the Health Insurance (Accredited Pathology Laboratories-Approval) Amendment Instrument (No. 1) 2018

1.  Name of legislative instrument

Section 1 provides that the title of the legislative instrument is the Health Insurance (Accredited Pathology Laboratories-Approval) Amendment Instrument (No. 1) 2018 (the Amendment Instrument)

2.  Commencement

Subsection 2(1) provides for commencement dates of each of the provisions specified in Column 1 of the table, in accordance with Column 2 of the table. In accordance with Column 2 of the table, sections 1-4 and Schedule 1 to the Amendment Instrument commence the day after the instrument is registered in the Federal Register of Legislation. This has the effect that the standards described in the accreditation material titled Performance Measures for Australian Laboratories Reporting Cervical Cytology (Third Edition 2015) apply from the day after the day the instrument is registered. The other primary amendments including the categories of pathology laboratories and the standards described in the five accreditation materials that were published in 2018, commence operation from 1 December 2018.

Subsection 2(2) provides that any information in Column 3 of the table is not part of the instrument.  Information may be inserted in Column 3, or information in it may be edited, in any published version of the instrument.

3.  Authority

Section 3 provides for the authority for the Principles and that is made under subsection 23DNA(1) of the Health Insurance Act 1973 (the Act).

4.  Schedules

Section 4 provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the instrument has effect according to its terms.

There are two Schedules in the instrument:

(a)   Schedule 1 that lists amendments to the Principles commencing on the day after registration of the instrument; and

(b)   Schedule 2 that lists amendments to the Principles commencing on 1 December 2018.

Schedule 1 – Amendments commencing on the day after registration

Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2017 (the current Principles)

Item 1

Item 1 amends Schedule 2 to the current Principles by adding at the end of the table the following standard as item 21:

Performance Measures for Australian Laboratories Reporting Cervical Cytology (Third Edition 2015) published in 2015.

Schedule 2 – Amendments commencing on 1 December 2018

Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2017 (the current Principles)

Items 1 and 2

Items 1 and 2 are technical amendments that have the effect of relocating the current note to the section heading under section 5 under the current Principles to the end of subsection 5(1) of the amended Principles. The note relates to a number of expressions used in the Principles that are defined in the Act. Section 5 is the interpretation provision for the current Principle.

Item 3

Item 3 is a consequential amendment arising from the repeal of Schedules 1 and 2 to the current Principles and replaced by new Schedule 1 from 1 December 2018 (item 33 refers).  The definition of accreditation materials in subsection 5(2) now refers to the documents mentioned in Schedule 1.

Item 4

Item 4 inserts a new definition of designated person in subsection 5(2) that is an expression referred to in the new categories of laboratories under the amended Principles. A designated person is a person who is designated in an application for approval under section 23DN of the Act as the person responsible for a pathology premises’ compliance with relevant standards.

Item 5

Item 5 inserts a new definition of “group of pathology testing” in subsection 5(2) that is an expression referred to in the new categories of laboratories under the amended Principles.  Group of pathology testing means a group of items in the pathology services.

Item 6

Item 6 repeals paragraph (b) of the definition of independent body in subsection 5(2), and is substituted by a new paragraph (b). This amendment removes the limitation of NATA being the only independent body for the purpose of accreditation assessments of category of laboratories. In addition to NATA, any other organisation approved by the Minister under subsection 5(3) of the Principles can be approved as an independent body (Item 13 refers).

Item 7

Item 7 omits the phrase “being a body recognised by the Commonwealth through a Memorandum of Understanding as the national body in Australia for laboratory accreditation” in the definition of NATA under subsection 5(2). The definition now only refers to the name of the body and the ACN number.

Item 8

Item 8 is a consequential amendment arising from the amendments to section 17 and 18 (Items 30-32). Item 8 omits the phrase “relevant requirements of these Principles including section 17 and 18” and substitutes “section 18” in the definition or relevant standards under subsection 5(2) as the standards are now specified in section 18 to these Principles.

Item 9

Item 9 inserts a definition of scope of practice in subsection 5(2) that is an expression used in the new categories of laboratories set out in new section 17. Scope of practice means the discipline and areas of testing in which a person has been trained and successfully examined or assessed as competent by the relevant College, professional society, or credentialing body; and met current Continuing Professional Development and recency of practice requirements.

Items 10 and 11

Items 10 and 11 repeal the definitions of “scientist” and “senior scientist” in subsection 5(2) of these Principles as they are no longer required.

Items 12 and 13

Item 13 amends subsection 5(3) to the effect that the Minister can now approve an organisation to be an independent body in relation to a category or categories of laboratories, and not limited to a category M laboratory. Item 12 is a technical amendment, so that the approval granted by the Minister is subject to subsection 5(4), not subsection 5(2).

Items 14 and 15

Items 14 and 15 are technical amendments. As subsection 5(3) refers to an approval of an organisation as an independent body, paragraph 5(4)(a) should refer to “an organisation” and not a body (Item 14 refers). Item 15 omits the reference to “this instrument” and substitutes it with “these Principles”.

Items 16-23, 25, 27 and 29.

The amendments made by Items 16-23, 25, 27 and 29 in relation to sections 7,8 and 9 make it clear that a special adviser appointed by the Minister may prepare an assessment report, or under paragraph 8(2)(b) vary the report. Thus, Item 21 omits the words “the independent body later varies the report or accreditation action” and substitutes it with “the report or accreditation action is later varied”, as the variation can be made by the special adviser.

Item 24

Item 24 repeals paragraph 9(2)(a) which has the effect of removing subparagraph (ii) of the current paragraph 9(2)(a) of these Principles. Current subparagraph 9(2)(a)(ii) allows for the independent body preparing the assessment report, where they consider it necessary, to also apply additional standards, in addition to the relevant standards in the assessment report. The Principles as amended no longer allow the independent body to apply additional standards in addition to relevant or specified standards.

Item 26

Item 26 is consequential to the amendment made by Item 24.

Items 30 and 31

Items 30 and 31 repeal existing section 17, and insert a new section 17 describing the categories of laboratories. The categories of the laboratories are described in the Table under new subsection 17(1). The new categories emphasise the supervision requirements and the role of the designated person in the direction, control and supervision of the different laboratories. In the case of GX, GY and B laboratories, the designated person is a pathologist who is responsible for direction and control of the laboratories who is located in the GX laboratory, but not necessarily the direct supervision of its testing activities. Both Category GY and B laboratories are related by an appropriate arrangement to a GX laboratory.

New subsection 17(2) now provides that the appropriate arrangement referred to in the table in subsection 17(1) means a written arrangement that includes provision for the direction, control and supervision of the relevant laboratory.

Item 32

Item 32 repeals existing section 18 and inserts a new section 18. New section 18 imposes substantial obligations and responsibilities on the designated person that include mandatory qualifications, management of the laboratories, the laboratories’ compliance with standards, and clinical governance, and supervision of staff.

New subsection 18(1) provides that premises must be under the direction, control and supervision of a designated person, and imposes an obligation that a designated person must have the qualifications, competency and relevant scope of practice to fulfil his or her obligations under section 18. Thus, this could mean that a deficiency of a designated person on these matters could be a basis for a conclusion that the premises in question do not comply with the relevant standards.

New subsection 18(2) provides that the designated person is responsible for the premises’ compliance with relevant standards. The relevant standards are those standards listed and referred to as accreditation materials in Schedule 1 to these Principles.

New subsection 18(3) provides that without limiting subsection 18(2), the designated person is responsible for compliance with the standards of direction, control and supervision that apply to the relevant category of laboratory under the accreditation material titled Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018), including in relation to clinical governance of the laboratory and oversight and management of the laboratory.

New subsection 18(4) provides that the designated person may only supervise pathology testing within his or her scope of practice (refer to Item 10 for the definition).

New subsection 18(5) makes it clear that the responsibilities of a designated person under this section may be delegated but only in accordance with the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018).  This document is an accreditation material listed in Schedule 1 to these Principles.

Item 33

Item 33 repeals Schedules 1 and 2 to these Principles and substitutes it with new Schedule 1.

New Schedule 1 lists the accreditation materials that set out standards that must be met as part of the accreditation assessment for each category of laboratory and kinds of services provided in the laboratory. Most of the documents listed in Schedule 1 have been applicable since October 2017, except for the following:

(a)   Performance Measures for Australian Laboratories Reporting Cervical Cytology (Third Edition 2015), but noting that this standard was applicable prior to 29 September 2017 (the commencement date of the current Principles) and that this standard re-commences operation on the day after the registration of this Amending instrument;

(b)   Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018);

(c)   Requirements for Medical Pathology Services (Second Edition 2018);

(d)   Requirements for the Development and Use of In-house Diagnostic Medical Devices (Fourth Edition 2018);

(e)   Requirements for Quality Control, External Quality Assurance and Method Evaluation (Sixth Edition 2018); and

(f)    Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 2018).

ATTACHMENT B

Requirements for the Clinical Governance and Supervision of Medical Pathology Laboratories (Fourth Edition 2018)

Effective supervision of pathology laboratories is considered to be one of the key elements for ensuring the safe operation of pathology laboratories. The provision of quality pathology services relies on the collaborative working relationship between pathologists, clinical scientists, scientists, technicians and other laboratory staff.

As part of the continuous refinement of the pathology accreditation framework, the National Pathology Accreditation Advisory Council (the ministerially-appointed pathology expert committee) has reviewed and revised the current Requirements for the Supervision of Medical Pathology Services (2007 Edition). The proposed revised standard is titled Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018) and clarifies the clinical governance and supervision arrangements for pathology laboratories and the respective responsibilities of laboratory staff.

The review of the pathology laboratory Supervision Requirements has occurred over a protracted period of time due to the complexity of the issues and changing profile of the pathology sector. The revised Supervision Requirements has a risk based approach to the supervision of pathology services outlining the minimum best practice governance structures for laboratories that are aimed to ensure that all testing is supervised by persons who are appropriately qualified, competent, have a relevant scope of practice and are accountable for the testing performed. The intent of the Requirements is unchanged; however, they have been revised to provide greater clarity. If laboratories are compliant with the current supervision accreditation requirements, there are expected to be minimal, if any, changes of significance with the transition to the proposed requirements. The revised supervision Requirements may even provide some flexibility for some category of laboratories with their supervision arrangements. It should be noted that the accreditation requirements are focused on a medical governance framework and do not relate to laboratories’ administrative structures or industrial awards.

The revised standard reflects the same intent as the current Requirements. However, it provides greater clarification and reflects a risk based focus to the supervision of pathology services. For example, it;

• outlines a proper clinical governance and supervision framework applicable to all categories of laboratories;
• provides for a risk based approach to the provision of laboratory supervision;
• provides clarification of the description of the categories of pathology laboratories, the competencies and roles of key pathology laboratory staff;
• provides clarification that supervision of groups of tests are to be supervised by a designated person who must be a Pathologist, and the delegation of responsibilities, subject to category of laboratory;
• describes mitigation strategies for suboptimal or inappropriate supervision practices;
• provides guidance on meaningful supervision and performance measures; and
• provides more flexibility in practices to continue the provision of quality pathology services.

The existing pathology services statutory framework attributes the accountability and responsibility for ensuring that there is proper supervision for rendering of the pathology service to pathologists in the laboratory, such as the Pathology Undertakings.

The proposed revised accreditation materials will have a transition date, as reflected in the commencement date of the application of the standards that will allow laboratories to have sufficient notice for compliance before the accreditation requirements come into effect.

Requirements for Medical Pathology Services (Second Edition 2018)

This document (the Requirements Standard) is the overarching standard that details the minimum acceptable standards for good laboratory practice that is applicable to all medical pathology testing. The Requirements Standard has been revised to reflect a risk based approach and current best practice. It aims to ensure the safe performance of pathology testing and delivery of quality results for the benefit of patient outcomes.

Requirements for the Development and Use of In-house In Vitro Diagnostic Medical Devices (Fourth Edition 2018)

The Requirements for the Development and Use of In-house In Vitro Diagnostic Medical Devices (IVDs) outlines the principles and assessment criteria by which in-house IVDs must be designed, developed, produced, validated and monitored for use by medical laboratories in Australia. A fundamental principle embodied in the IVD Requirements Standard is that all in-house tests must be produced in a manner whereby they are safe and perform as intended.

As part of the TGA regulatory requirements all in-house IVDs must be assessed by the National Association of Testing Authorities, Australia to this accreditation standard in conjunction with the international standard for medical pathology laboratories - ISO 15189.

Requirements for Quality Control, External Quality Assurance and Method Evaluation (Sixth Edition 2018)

The document titled Requirements for Quality Control, External Quality Assurance and Method Evaluation outlines the general features that an internal quality control system and an external quality assurance program must have to provide an effective monitoring strategy for the various pathology disciplines. The revised document also provides guidance on method evaluation for laboratories. The standards set out in this document provide clearer guidance on the minimum standards considered acceptable when participating in quality control, external quality assurance programs and method evaluation. Failure of quality control can potentially cause risks to patients and all methods should undergo validation/verification to demonstrate fitness for their intended purpose.

Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 2018)

The document titled Requirements for the Retention of Laboratory Records and Diagnostic Material details the minimum standards for retention of laboratory records and materials. These standards have been developed with a risk based approach and are important for medical pathology services to assure they provide high quality pathology services. Individual laboratories may choose to exceed these minimum standards based on their respective practices.

The standards set out in this document have been revised to reflect a risk based approach and current best practice.

 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 Instrument (No.1) 2018

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

The Minister determines 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 2017 (‘Pathology Principles 2017’).

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 by or on behalf of an approved pathology practitioner, in an accredited pathology laboratory operated by an approved pathology authority. The Principles approved under section 23DNA operate to ensure that appropriate standards are met and maintained in pathology laboratories at which Medicare eligible pathology services can be provided.

The Principles set out the criteria for different categories of accredited pathology laboratories and specify the standards that must be met as part of the accreditation assessment for each category of laboratory and kinds of services provided in that laboratory. The overarching objectives of the Principles include promoting the delivery of reliable test results and reducing the risk of misdiagnosis in the provision of pathology services.

The Schedule to 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 Instrument (No.1) 2018 (‘the Amendment Instrument’) is to amend the Pathology Principles 2017 to reflect the changes to the provisions (including the categories of laboratories) relating to the supervision arrangements for pathology laboratories to ensure alignment with the accreditation standard for the supervision and clinical governance of pathology laboratories. Additionally, it amends the Schedule to the Principles to incorporate references to the following revised accreditation standards that will replace the current documents listed in the Schedule to the Principles, namely the:

• Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018);
•    Requirements for Medical Pathology Services (Second Edition 2018);
• Requirements for the Development and Use of In-house Diagnostic Medical Devices (Fourth Edition 2018);
• Requirements for Quality Control, External Quality Assurance and Method Evaluation (Sixth Edition 2018); and
• Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 2018).

The Amending Instrument also returns the Performance Measures for Australian Laboratories Reporting Cervical Cytology (Third Edition 2015) as an accreditation material, which was previously applicable to the accreditation assessment of laboratories prior to the commencement of the current Principles (prior to 29 September 2017). As part of the last amendment to the Pathology Principles the accreditation material was superseded by the Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017). However, since then NPAAC has recommended that this standard should continue to apply to allow laboratories to complete their reporting requirements against the performance measures for cervical cytology testing. Thus, this standard is again included in the list of applicable accreditation materials.

The review of these pathology accreditation standards is 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. Copies of the pathology accreditation materials are published on the NPAAC website and can be accessed from - http://www.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-publication.htm. The pathology accreditation standards are aimed at assuring the quality of Australian pathology services.

This Legislative Instrument does not make any substantive changes to the law.

Human rights implications

The International Covenant on Economic, Social and Cultural Rights recognises that individuals have the right to the enjoyment of the highest attainable standard of health, including a right to a system of health protection.

The Amendment to the Pathology Principles 2017 will maintain rights to access quality, safe, clinically relevant and cost effective Medicare eligible pathology services.

If the new Instrument is not made, pathology premises will be assessed to the current accreditation standards rather than the more up to date accreditation standards for the purposes of accreditation assessments. This would not have an effect on the Australian public’s access to Commonwealth subsidised pathology services, however, would have a potential impact on people’s right to quality health services and social security.

The Amendment Instrument promotes the right to health as the accreditation standards are aimed at ensuring pathology laboratories providing Medicare-eligible pathology services deliver high quality services.

Conclusion

This Legislative Instrument is compatible with human rights as it maintains existing arrangements and the protection of human rights.

David Weiss

First Assistant Secretary

Medical Benefits Division

Department of Health