Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2007 (No. 3)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L04720 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

HEALTH INSURANCE ACT 1973

SECTION 23DNA

 

HEALTH INSURANCE (ACCREDITED PATHOLOGY LABORATORIES –

APPROVAL) PRINCIPLES 2007

 

Section 23DNA of the Health Insurance Act 1973 (the Act) provides for the Minister to

determine the principles to be applied by the Minister in exercising powers under section 23DN of the Act to approve in principle, or not to approve, premises as an accredited pathology laboratory.

 

Medicare benefits, apart from some basic tests conducted by treating medical practitioners on their own patients, are not payable in respect of pathology services unless they are rendered in an accredited pathology laboratory.  The accreditation principles operate to ensure minimum acceptable standards in pathology laboratories.  The principles as determined also make reference to National Pathology Accreditation Advisory Council (NPAAC) accreditation documents, which are standards, guidelines and other assessment aids that must be taken into account during the accreditation process.  Medicare Australia administers the accreditation process and the National Association of Testing Authorities, Australia (NATA) conducts the accreditation assessment, in conjunction with the Royal College of Pathologists Australasia (RCPA).

 

  1. NPAAC has also endorsed the following revised NPAAC document, which forms part of the Amendments to the Principles (No.3), Schedule 1 Part 1 of the Principles:

 

Requirements for Supervision of Pathology Laboratories (Revised document)

 

This document was first published in 1999.  It details the standards used to assure the safety, quality and efficacy of pathology testing through effective supervision. 

 

Laboratories have been categorised into groups to facilitate the definition of appropriate levels of supervision for particular types of laboratories.  There are five categories of laboratories.  These are defined by who is responsible for the day-to-day supervision:

  • Category GX (General)
  • Category GY (General)
  • Category B (Branch)
  • Category M (Medical Practice)
  • Category S (Specialised).

 

This document revision was a short, focussed review and was conducted by NPAAC to address specific issues.  These included:

a) clarification of the wording to ensure that supervisory obligations for the pathologist are specified for Category GX and GY.

b) clarification of the supervisory obligations in the circumstances of a part-time pathologist as well as for a laboratory operating for less than full-time hours of operation.

 

The Requirements for the Supervision of Pathology Laboratories (2007) document will be included in the list of accreditation materials, with effect on and after 1 January 2008.

 

Schedule 2 of the Amendment Principles (No.3) sets out the intended changes and links the inclusion of the revised Supervision document to the Amendment Principles (No.2), which have a commencement date of 1 January 2008.

 

Consultation

 

In line with the established NPAAC public consultation and drafting process, the draft document was circulated for comments to:

 

  • all laboratories within Australia
  • NPAAC members, including State and Territory representatives
  • peak pathology industry and professional organisations

 

The document was also posted on the NPAAC website.

 

All submissions from the respective public consultation phases for this document were considered by NPAAC in the finalisation of the document.  All issues of concern were resolved through the drafting process and the impact on industry has been assessed as minimal.

 

 

2.             NPAAC has endorsed the following revised NATA document, which forms part of the Amendments to the Principles (No.3), Schedule 1 Part 2 of the Principles:

 

AS 4633 (ISO 15189) Field Application Document – Supplementary Requirements for Accreditation in the Field of Medical Testing – published in August 2007.

 

This document also provides interpretive detail of the NPAAC standards.  Technical notes are also available to assist laboratories in relation to particular technical issues. 

The first NATA Field Application Document was implemented in 2000 and this will be the fifth edition of the document titled.

 

This document, known widely as the NATA Field Application Document (FAD), provides an explanation of the applications of ISO 15189 to the various disciplines of pathology testing and also a description of the NATA/RCPA accreditation procedures applied in this field.  Medical testing laboratories must comply with this document, all relevant clauses of ISO 15189, the NATA Rules, NPAAC standards and relevant statutory requirements for accreditation to be granted and continued. 

 

The NATA FAD August 2007 document will be included in the list of accreditation materials from the day after the draft Health Insurance (Accredited Pathology Laboratories - Approval) Amendment Principles 2007 (No. 3) (the draft Amendment Principles) are registered. For example, if the draft Amendment Principles are registered on 1 December 2007, the document will be included in the list of accreditation materials on and after 2 December 2007.

 

Consultation

 

As part of the NATA document drafting process and public consultation, the NATA FAD August 2007 document was circulated for comment to:

  • NATA’s  Medical Testing staff and Senior Technical Management
  • Medical Testing Accreditation Advisory Committee members (who represent professional societies including the Australian Institute of Medical Scientists (AIMS), Australasian Association of Clinical Biochemists (AACB) and the Australian Society for Microbiology (ASM)
  • the Royal College of Pathologists Australasia (RCPA)
  • NPAAC members, including State and Territory representatives
  • the Document Review and Liaison (DRL) Committee, which is an NPAAC subcommittee.

 

All submissions from the respective public consultation phases for this document were considered by NPAAC in the finalisation of the document.  All issues of concern were resolved through the drafting process and the impact on industry has been assessed as minimal.

 

 

Overview

The Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2007 were enacted to establish the principles for accrediting pathology laboratories under the Health Insurance Act 1973. This legislative instrument was introduced to address the need for standardised accreditation criteria to ensure that pathology services provided in Australia meet minimum quality standards. The Health Insurance Act 1973 was enacted by the Parliament of Australia and aims to regulate health insurance and related services. The policy objective of these principles is to facilitate the approval of pathology laboratories by ensuring they adhere to nationally recognised standards, thus enabling the payment of Medicare benefits for pathology services rendered in these accredited facilities. The principles were developed with extensive consultation with industry stakeholders and professional bodies to ensure they are practical and effective in maintaining high standards in pathology services.

Scope and Application

The Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2007 applies to all pathology laboratories within Australia seeking accreditation under the Health Insurance Act 1973. The principles are designed to ensure minimum acceptable standards in pathology laboratories, which are essential for the provision of Medicare benefits for pathology services. Accredited pathology laboratories must comply with the principles and the relevant NPAAC accreditation documents to be eligible for Medicare benefits. The principles are administered by Medicare Australia, while the accreditation assessments are conducted by the National Association of Testing Authorities, Australia (NATA) in conjunction with the Royal College of Pathologists Australasia (RCPA). Laboratories are categorised into five groups based on the level of supervision required, with the supervision requirements detailed in the Requirements for Supervision of Pathology Laboratories document. The principles also reference the NATA Field Application Document, which provides interpretive detail of the NPAAC standards and technical notes to assist laboratories in complying with accreditation requirements. The application of the principles may be extended or restricted through subordinate instruments, and the amendments are subject to consultation with relevant stakeholders before finalisation.

Key Provisions

The Health Insurance Act 1973 (the Act) sets out various provisions for the accreditation of pathology laboratories, with Section 23DNA being particularly relevant. This section (23DNA) provides the Minister with the authority to establish principles that must be applied when approving, or declining to approve, premises as accredited pathology laboratories. Such accreditation is essential because Medicare benefits for pathology services are generally not payable unless the services are performed in an accredited laboratory, with some exceptions for basic tests conducted by treating medical practitioners on their own patients. The purpose of these accreditation principles is to ensure that pathology laboratories meet minimum acceptable standards. The obligations imposed by the Act on the parties involved, particularly the laboratories, include adherence to the accreditation principles as determined by the Minister. These principles make specific references to the standards, guidelines, and assessment aids published by the National Pathology Accreditation Advisory Council (NPAAC), which must be considered during the accreditation process. The administration of the accreditation process falls to Medicare Australia, while the actual assessment is conducted by the National Association of Testing Authorities, Australia (NATA), in conjunction with the Royal College of Pathologists Australasia (RCPA). Laboratories must therefore ensure they meet the standards outlined in the NPAAC accreditation documents and comply with any additional requirements specified by Medicare Australia, NATA, and RCPA. Breach of the accreditation requirements set forth in the Act can lead to significant consequences. The Act does not explicitly state civil or criminal penalties for non-compliance, but failure to meet the accreditation standards could result in the laboratory being deemed non-compliant, which would affect its ability to bill Medicare for services rendered. Additionally, there may be reputational damage and loss of trust from patients and healthcare providers. The absence of specific penalties in the Act suggests that the primary enforcement mechanism is through the accreditation process itself, where non-compliant laboratories would not receive approval and thus would not be eligible to bill Medicare for pathology services.

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Area of Law
Health Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Licensing & Registration
Compliance Obligations
Consultation Requirements
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Accredited Pathology Laboratories
NPAAC
NATA

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.