Health Insurance (Accredited Pathology Laboratories—Approval) Amendment Instrument (No. 2) 2018

EXPLANATORY STATEMENT

HEALTH INSURANCE ACT 1973

Health Insurance (Accredited Pathology Laboratories – Approval)

Amendment Instrument (No. 2) 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 Primary 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 primary purpose of the Health Insurance (Accredited Pathology Laboratories – Approval) Amendment Instrument (No. 2) 2018 (‘the Amendment Instrument’) is to amend the Principles to delay the commencement date for application of the revised supervision accreditation requirements from 1 December 2018 to 1 August 2019 and provide for consequential amendments in view of this extended commencement date. The delay in implementation extends the transition period for pathology laboratories to meet the revised supervision standards. In addition, the accreditation material titled Requirements for Medical Pathology Services is being updated to align definitions with the Supervision Requirements in the most recent edition (Third Edition 2018).

A short review of the standards set out in the 2018 Supervision Requirements was undertaken recently in response to concerns raised by the pathology sector including:

about the role of Clinical Scientists, in the supervision of pathology testing and the recognition of qualifications for Clinical Scientists in Artificial Reproductive Technology (ART) laboratories;
the exclusion of use of in-house in-vitro diagnostic tests and scope of testing in Category S laboratories;
what is meant by normal working hours; and
the proposed implementation date.

In response to concerns and a recommendation from NPAAC, minor modifications have been made to the 2018 Supervision Requirements to provide further clarification of the supervision requirements and facilitate the continued operations of specialised laboratories (or Category S laboratories).

The date of effect of the 2018 Supervision Requirements also been changed from 1 December 2018 to 1 August 2019. This will extend the transition period by several months (from the initial proposed date of effect) to provide laboratories more time to make arrangements to meet the revised supervision accreditation requirements.

As a consequence of the amended 2018 Supervision Requirements and deferred commencement date to 1 August 2019, the Requirements for the Supervision of Pathology Laboratories 2007 edition will continue to remain as the accreditation material until such time it is superseded by the commencement of the revised 2018 Supervision Requirements (Fifth Edition).

A copy of the revised pathology accreditation material has been 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 framework is aimed at assuring the quality of Australian pathology services.

CONSULTATIONS

The usual established standards development protocol includes a public consultation phase. However, the amendments to the 2018 Supervision Requirements were in response to concerns raised by some members of the pathology sector and there has been communication between NPAAC and the pathology sector on the proposed modifications to the Supervision Requirements. There has been overall support for the proposed amendments to the accreditation requirements and the revised implementation date.

In addition there have been four public consultation phases that have included all pathology laboratories, all pathology practitioners, all pathology authorities, jurisdictions and key stakeholder organisations and targeted consultation with relevant key stakeholders to inform the finalisation of the accreditation standards.

The Office of Best Practice Regulation (OBPR) has confirmed that the proposed amendments do not require a Regulation Impact Statement (OBPR reference number 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.

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

ATTACHMENT A

Details of the Health Insurance (Accredited Pathology Laboratories-Approval) Amendment Instrument (No. 2) 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. 2) 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, the Amendment Instrument delays the commencement of the application of the 2018 Supervision Requirements until 1 August 2019. This has the effect of reinstating the 2007 Edition of the Requirements for the Supervision of Pathology Laboratories as the accreditation material for an interim period from 1 December 2018, rather than implementing new supervision standards in the 2018 accreditation material titled “Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018)” (the 2018 Supervision Requirements).

The other consequential amendments, including the categories of pathology laboratories and reference to the revised Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fifth Edition 2018) as an accreditation material that was re-published in November 2018, commence operation from 1 August 2019.

3. Authority

Section 3 provides for the authority for the Amendment Instrument 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 1 December 2018; and

(b) Schedule 2 that lists amendments to the Principles commencing on 1 August 2019.

Schedule 1 – Amendments commencing on 1 December 2018

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

Items 1-2 and 4

Items 1-2 and 4 repeals definition of terms that are only relevant to the accreditation material titled “Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018)”. Thus, the following definitions are repealed:

(a) designated person;

(b) group of pathology testing; and

Item 3

Item 3 omits section 18 and substitutes “relevant requirements of these Principles including Sections 17 and 18” in the definition or relevant standards under subsection 5(2).

Item 5

Item 5 reinstates the definitions of scientist and clinical scientist in subsection 5(2) that are consistent with the requirements set out in the accreditation material titled Requirements for the Supervision of Pathology Laboratories (2007 Edition).

Item 6

Item 6 repeals the table that includes a description of category of laboratories and reinstates the previous table describing of category of laboratories that are set out in set out in the accreditation material titled Requirements for the Supervision of Pathology Laboratories (2007 Edition).

Item 7

Item 7 repeals subsection 17(2) that defines the term “appropriate arrangement” referred to in the table in the repealed subsection 17(1). The term “appropriate arrangement” is not referred to in the reinstated table in subsection 17(1) (Item 6 refers).

Item 8

Item 8 repeals section 18 and substitutes it with provisions that provide for the previous requirements for supervision and the respective responsibilities required for each respective category of laboratory. These requirements are consistent with standards set out in the accreditation material titled Requirements for the Supervision of Pathology Laboratories (2007 Edition).

Item 9

Item 9 repeals item 17 of the table in Schedule 1 and substitutes it with the accreditation material titled Requirements for Medical Pathology Services (Third Edition 2018).

Item 10

Item 10 repeals item 19 of the table in Schedule 1, and substitutes it with the accreditation material titled Requirements for the Supervision of Pathology Laboratories (2007 Edition).

Schedule 2 – Amendments commencing on 1 August 2019

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

Item 1

Item 1 inserts 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 2

Item 2 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 3

Item 3 is a consequential amendment arising from the amendments to Sections 17 and 18. It 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 supervision standards are now only specified in section 18 to these Principles.

Item 4

Item 4 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 the 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 5 and 6

Item 5 repeals the definitions of “scientist” and “senior scientist” in subsection 5(2) of these Principles as they are no longer required. These definitions are included in the 2018 Supervision Requirements.

Items 7 and 8

Items 7 substitutes a new table describing the categories of laboratories that are consistent with the accreditation material titled Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fifth Edition 2018). 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.

Item 8 includes new subsection 17(2) that 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 9

Item 9 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. The supervision requirements are consistent with the standards set out in the accreditation material titled Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fifth Edition 2018).

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 any of these matters could be a basis for a conclusion that the premises in question do not comply with the relevant standards.

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.

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 (Fifth Edition 2018), including in relation to clinical governance of the laboratory and oversight and management of the laboratory.

Subsection 18(4) provides that the designated person may only supervise pathology testing within his or her scope of practice.

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 (Fifth Edition 2018). This document is an accreditation material listed in Schedule 1 to these Principles.

Item 10

Item 10 repeals Schedules 1 table item 19 and includes reference to the Requirements for Supervision in the Clinical Governance of Medical Pathology Services (Fifth Edition 2018) published in November 2018.

ATTACHMENT B

Requirements for the Clinical Governance and Supervision of Medical Pathology Laboratories (Fifth 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 revised standard titled Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018) (2018 Supervision Requirements) clarifies the clinical governance and supervision arrangements for pathology laboratories and the respective responsibilities of laboratory staff. The revised standard was to commence on 1 December 2018.

However, since the publication of the Requirements for Supervision in Clinical Governance (Fourth Edition 2018), there have been a number of concerns raised by the pathology sector, including:

about the role of Clinical Scientists, in the supervision of pathology testing and the recognition of qualifications for Clinical Scientists in Artificial Reproductive Technology (ART) laboratories;
the exclusion of use of in-house in-vitro diagnostic tests and scope of testing in Category S laboratories;
what is meant by normal working hours; and
the proposed implementation date.

NPAAC has given further consideration to the key issues and has recommended a number of modifications to the 2018 Supervision Requirements in response to the key issues raised by the pathology sector. The amendments include:

inclusion of additional qualifications criteria for Clinical Scientists, particularly for ART and Bone Marrow Transplant laboratories, in the definition for Clinical Scientist;
removal of the provision that the Designated Person in a Category S laboratory be “on site”;
removal of the current statement regarding exclusion of in-house IVDs in Category S laboratories;
removal of the provision that lists allowed extended tests for Category S ART laboratories;
removal of the words in the S4.3 “ …and for patients of the practice…”;
inclusion of a definition for normal working hours;
clarification of supervision arrangements for Category GY and Category B laboratories; and
clarification of supervision arrangements for leave coverage.

In addition to noting the sector’s concerns, NPAAC has recommended the date of effect of the 2018 Supervision Requirements be changed from 1 December 2018 to 1 August 2019. This would extend the transition period by several months (from the initial proposed date of effect) to provide laboratories more time to make arrangements to meet the revised supervision accreditation requirements.

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 accreditation requirements are focused on a medical governance framework and do not relate to laboratories’ organisational structures or workplace industrial awards.

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.2) 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’).

A short review of the standards set out in the 2018 Supervision Requirements was undertaken recently in response to concerns raised by the pathology sector. In response to concerns and a recommendation from NPAAC, minor modifications have been made to the 2018 Supervision Requirements to provide further clarification of the supervision requirements and facilitate the continued operations of specialised laboratories (or Category S laboratories).

The date of effect of the 2018 Supervision Requirements has also been changed from 1 December 2018 to 1 August 2019. This will extend the transition period by several months (from the initial proposed date of effect) to provide laboratories more time to make arrangements to meet the revised supervision accreditation requirements.

As a consequence of the amended 2018 Supervision Requirements and deferred commencement date to 1 August 2019, the Requirements for the Supervision of Pathology Laboratories 2007 Edition will continue to remain as the accreditation material until such time it is superseded by the commencement of the revised 2018 Supervision Requirements (Fifth Edition).

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.

Pathology premises will be assessed to the current 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 nor 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

Administered by Department of Health, Disability and Ageing

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