Pathology 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.
The Commission is 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.
Have your say on Pathology Remote Working
Your views will help guide the development of a remote working framework that supports safe, high-quality pathology services while meeting existing regulations.
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New Standards
In force April 2026
The amended Requirements for the In-House In Vitro Diagnostic Medical Devices (Fifth Edition, 2025) now includes a standard for Companion Diagnostics.
In force March 2026
These editions replace the Requirements for medical testing for human genetic variation (Third Edition) and Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) (Fourth Edition).
The standards
The Pathology Standards are categorised into four tiers:
- Tier 1 – The principles
- Tier 2 – Overarching standards for all pathology services
- Tier 3A – Supervisory requirements for pathology laboratories
- Tier 3B – Technical and specific detailed requirements for good medical practice in all pathology services
- Tier 4 – Technical publications for specific areas of pathology.
The Pathology Standards currently in force are published here and listed in Schedule 1 of the Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017.
Tier 3B – Technical and specific detailed requirements for good medical practice in all pathology services
- Requirements for the estimation of measurement of uncertainty (2007 Edition)
- Requirements for the packaging and transport of pathology specimens and associated materials (Fifth Edition)
- Requirements for quality control, external quality assurance and method evaluation (Sixth Edition 2018)
- Requirements for the retention of laboratory records and diagnostic material
- Requirements for information communication and reporting (Fifth Edition)
- Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (Fifth Edition)
- Guidelines for Approved Pathology Collection Centres (Requirements for medical pathology specimen collection) (Third Edition 2013)
Tier 4 – Technical publications for specific areas of pathology
Anatomical pathology
- Requirements for the performance of anatomical pathology cut-up (Fourth Edition 2013)
- Requirements for the facilities and operation of mortuaries (Third Edition 2013)
- Requirements for use of digital images as alternative to direct microscopy (First Edition 2021)
Cervical Screening Standards
Genetic pathology
- Requirements for Medical Testing for Human Genetic Variation (Fourth Edition, 2025)
- Requirements for human medical genome testing utilising massively parallel sequencing technologies (First Edition 2017)
Haematology
- Requirements for transfusion laboratory practice (Fifth Edition)
- Requirements for procedures related to the collection, processing, storage and issue of human haemopoietic progenitor cells (Sixth Edition 2021)
Microbiology
- Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) (Fifth Edition, 2025)
- Requirements for medical testing of microbial nucleic acids (Second Edition 2013)
Reproductive technologies
Point of care
Superseded standards
- Requirements for the development and use of in-house in vitro diagnostic medical devices (IVDs) (Fourth Edition 2018)
- Requirements for medical testing for human genetic variation (Third Edition)
- Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) (Fourth Edition)
External resources
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.