Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2007 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L03584 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 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 determined accreditation principles operate to ensure minimum acceptable standards in pathology laboratories. The determined principles also make reference to National Pathology Accreditation Advisory Council (NPAAC) documents which are standards, guidelines and other assessment aids that must be taken into account during the accreditation process. The Medicare Australia administers the accreditation process.

 

NPAAC has endorsed the following revised documents, which are now included in Schedule 1 of the Principles:

 

1. Requirements for the Retention of Laboratory Records and Diagnostic Material (Revised Document)

 

This is the fourth edition of the NPAAC Requirements for the Retention of Laboratory Records and Diagnostic Material.  Since the revision of the last edition in 2002, there have been significant developments in Australian laboratory practice.  All pathology laboratories are required to maintain a formal quality system and must be accredited to AS 4663;2004 (ISO 15189;2003)-Medical laboratories - Particular requirements for quality and competence.  In addressing these developments, NPAAC has completely revised the requirements for retention and has adopted principles to create a uniform and integrated approach to retention requirements. 

 

2. Requirements for Cytogenetic Testing (Revised Document)

 

Cytogenetics is the study of genetic material (chromosomes) at the cellular level.  This is the second edition of this document developed by NPAAC and based on guidelines developed by the Human Genetics Society of Australasia (HGSA).  This document has been revised to align it with current practices.  It is intended to be used in cytogenetic laboratories to provide guidance on good laboratory practice in relation to cytogenetics and by assessors carrying out laboratory accreditation assessments. 

 

3. Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials (Revised Document)

 

Pathology specimens and associated materials must be transported and packaged in a suitable manner.  This is to protect the safety of everyone required to handle the specimens and packages and to ensure material is maintained under suitable conditions to retain specimen integrity for accurate diagnosis.  This document has been updated to better assist laboratories preparing policies and procedures for packaging and transportation of specimens. 

 

This document is a compilation of various existing legislative requirements into one easy reference source.  It has been developed to incorporate legislative/or obligation of from Australia Post, International Air Transport Association (IATA) and Transport Australia.  Initial feedback has noted that it is most helpful to have all transport related obligations listed in one publication.

 

4. Requirements for Information Communication (Revised Document)

 

This document was last revised in 1998.  In the interim, changes in technology have been significant.  To facilitate the secure and private transmission of pathology orders and results, laboratories must be able to ensure the confidentiality, authenticity, integrity and availability of these messages.  It has been identified that updated advice on appropriate standards would significantly assist laboratories when upgrading and maintaining Laboratory Information Systems.

 

The integration of computer systems and telecommunication systems offers faster transfer of pathology requests and reports.  This document is designed to guide laboratories in relation to the transfer of pathology data via intra and inter laboratory information systems in a manner that is secure and that preserves the integrity of data.   

 

Many laboratories have sought guidance from NATA regarding problems they have experienced with new information technology systems not delivering results as desired.  Third parties are also unclear about the handling of electronic results.  The revised requirements now necessitate laboratories to have procedures in place to ensure private information is handled safely to minimise negative impact on patients.

 

5. Classification of Human Genetic Testing (Supplementary Guideline)

 

Results from genetic tests can have serious social and personal implications.  For some time now, pathology laboratories have suggested that guidance should be available to their staff and requesters as to when patients would benefit from pre-test counselling.

 

This new document will become a supplementary guide to the already published NPAAC document “Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis (2006).  The supplementary guideline provides additional information about aspects of the standards and guidelines, and includes information on decision making regarding pre-testing counselling.

 

This supplementary guidance expands the existing two Levels of testing, as described in the published 2006 NPAAC document, and allows the requesting practitioner and laboratory staff to know what counselling a patient should require.   The majority of requests for genetic testing for diagnostic or medical screening purposes will be Level 1.  These tests require the usual degree of pre-test advice and consent.  A  Level 2 test requires professional genetic counselling and consent. 

 

It is proposed that the next time the full document Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis (2006) is reviewed, this supplementary guide will be incorporated in the appendix of the document.

 

This amendment also makes a number of minor drafting corrections to the Principles.

 

Consultation

 

As part of the established NPAAC public consultation and drafting process, all documents prepared by NPAAC are circulated for comments to:

 

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

 

During the public consultation phase, documents are also posted on the NPAAC website.

 

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

 

Implementation

 

The revised Principles come into effect on 1 January 2008.

 

Overview

The Health Insurance Act 1973 was enacted to regulate and standardise health insurance practices in Australia, ensuring that all insured parties receive equitable and accessible healthcare services. A significant issue this Act addresses is the need for stringent quality and safety standards in pathology laboratories, ensuring that Medicare benefits are only payable for services rendered in facilities meeting these standards. Section 23DNA of the Act allows the Minister to establish accreditation principles for pathology laboratories, which are overseen by the Minister and implemented by Medicare Australia. These principles, determined to ensure minimum acceptable standards, are crucial in maintaining the integrity and reliability of pathology services provided to the public. The policy objective behind this legislative framework is to safeguard patient welfare by enforcing high-quality standards in pathology laboratories, thus ensuring that pathology services provided to insured individuals meet nationally recognised benchmarks. The principles were updated in 2007 to incorporate revised documents endorsed by the National Pathology Accreditation Advisory Council (NPAAC). These updates addressed advancements in laboratory practices and technology, ensuring that the accreditation process remains relevant and effective. The revised principles include updated requirements for laboratory record retention, cytogenetic testing, packaging and transport of pathology specimens, information communication, and the classification of human genetic testing. This amendment aimed to harmonise laboratory practices with contemporary standards and technological advancements, ensuring that pathology services are delivered with the utmost precision and care. The implementation of these revised principles was set to take effect from 1 January 2008, ensuring that all accredited pathology laboratories comply with the updated standards.

Scope and Application

The Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2007, as stipulated under section 23DNA of the Health Insurance Act 1973, applies to pathology laboratories seeking accreditation in Australia to provide services eligible for Medicare benefits. The Minister for Health is responsible for determining the principles that will govern the approval process, ensuring that only those laboratories meeting the minimum acceptable standards, as referenced in National Pathology Accreditation Advisory Council (NPAAC) documents, can operate as accredited facilities. These principles are integral to maintaining the quality and integrity of pathology services across the nation. The geographic reach of this legislation is nationwide, applying uniformly throughout all states and territories of Australia. Notably, the Act does not specify exclusions or exemptions, implying that all pathology laboratories aiming to provide services that attract Medicare benefits must adhere to the determined principles. The implementation of these principles is facilitated by Medicare Australia, which oversees the accreditation process. The revised principles, incorporating updated NPAAC documents, took effect from 1 January 2008, marking a significant step towards enhancing the standards and practices within Australian pathology laboratories.

Key Provisions

The key sections of the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2007 include Section 23DNA, which allows the Minister to determine the principles that will be applied in approving premises as an accredited pathology laboratory. These principles ensure that only laboratories meeting minimum acceptable standards can render pathology services for which Medicare benefits are payable. The principles also reference documents from the National Pathology Accreditation Advisory Council (NPAAC), which are used as standards, guidelines, and assessment aids during the accreditation process. The Medicare Australia administers this accreditation process, ensuring that all pathology services meet the necessary requirements for Medicare benefits. Under this legislation, the obligations imposed on the parties include the necessity for all pathology laboratories to maintain a formal quality system and be accredited to AS 4663;2004 (ISO 15189;2003). Laboratories must adhere to the revised NPAAC documents, which outline specific requirements for laboratory records retention, cytogenetic testing, packaging and transport of pathology specimens, information communication, and classification of human genetic testing. Laboratories must implement procedures to ensure that their practices meet these standards, safeguarding patient information and ensuring accurate diagnosis. In terms of penalties and consequences for non-compliance, the legislation does not explicitly state specific offences, penalties, or civil/criminal consequences. However, failure to meet the accreditation requirements could result in the laboratory not being recognised as an accredited pathology laboratory. Consequently, services rendered in such a non-compliant laboratory would not be eligible for Medicare benefits. This omission of explicit penalties highlights the importance of compliance to avoid financial and operational repercussions for the laboratories and potential health implications for patients due to non-compliance with standards.

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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.