National Pathology Accreditation Scheme

Overview

Pathology services are a vital clinical service that underpin Australia’s high-performing healthcare system. Pathology services are regulated primarily through the Health Insurance Act 1973, which establishes the legislative framework that links pathology accreditation to eligibility for Medicare benefits. Together with associated legislative instruments, this framework underpins the National Pathology Accreditation Scheme (NPAS) and ensures pathology services meet nationally consistent safety and quality standards. 

The Pathology Standards focus on areas of high potential risk and the prevention of harm. They cover patient safety, communication, supervision, and technical and specific requirements for good medical practice.

We are responsible for supporting the National Pathology Accreditation Advisory Council (NPAAC) to develop and maintain the Pathology Standards.  We work with accrediting agencies, pathology practices, experts, consumers, professional bodies and government agencies to fulfil this function.

The Australian Government Department of Health, Disability and Ageing develops policy and holds regulatory responsibility for pathology in Australia. Learn more about pathology regulation and legislation on the Department’s website.
 

Developing  Pathology Standards  

The Commission develops and amends Pathology Standards with the support and oversight of NPAAC. We provide structured, consultative and evidence based processes that prioritise pathology work according to patient safety risks, system impact and national policy needs. This approach ensures pathology standards remain current and effective, while operating within a stable legislative framework that supports continuous improvement in safety and quality.

When new standards or amendments to standards are required, we support NPAAC to:

• identify emerging safety, quality or system risks in pathology practice
• review clinical evidence, international standards and regulatory requirements
• establish expert working groups involving pathologists, scientists, regulators, consumers and jurisdictional representatives
• conduct public and targeted consultations
• draft standards that are fit for purpose, nationally consistent and compatible with accreditation processes. 

View the Pathology Standards
 

Contact us

We welcome feedback from the pathology sector to help us identify emerging issues and better support pathology services. If you have feedback or questions, please contact our National Pathology Standards Team directly with feedback or queries. 

You can also sign up for news and updates on the Pathology Standards or contact the Safety and Quality Advice Centre.
   

How do we ensure pathology services are meeting the Standards?

We use a process called accreditation to ensure pathology services are meeting the Pathology Standards. This provides assurance to the community that an expected standard of safety and quality is being met. To deliver services eligible for Medicare benefits, pathology practices must be accredited to the Pathology Standards that are relevant to the services they provide. Services Australia regulates eligibility for claiming of pathology services under Medicare. 

The National Pathology Accreditation Scheme provides the legislative framework for the coordination of pathology accreditation.
 

How does a pathology service achieve accreditation?

Laboratories undergo regular independent assessments conducted by assessors from the approved accrediting agency. These assessments evaluate whether laboratories comply with the Pathology Standards applicable to the services they deliver, through audits, site visits, review of records and corrective action processes.

Services Australia regulates eligibility for claiming pathology services under Medicare. Contact Services Australia for more information on the application and claims process.
 

Contact an approved pathology accrediting agency

As part of the National Pathology Accreditation Scheme, pathology laboratories must be independently assessed against the relevant pathology standards. The information below explains the role of the approved accrediting agency in this process and where to go for further resources.

The National Association of Testing Authorities, Australia (NATA) independently assess pathology laboratories across Australia to ensure they meet the requirements of the relevant pathology standards. They do this in accordance with the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2017.

NATA can grant, refuse or revoke accreditation.
 

National Pathology Accreditation Advisory Council

The National Pathology Accreditation Advisory Council (NPAAC) is responsible for developing and maintaining the Pathology Standards.

NPAAC is a statutory committee established under subsection 9(1) of the National Health Act 1953 through an Order in Council. The Order in Council outlines NPAAC’s role, membership and function.

NPAAC membership consists of pathology experts from various professional and scientific organisations and representatives from state, territory and federal government. 

NPAAC members are ministerially appointed.