2023Publication, report or update
What does this mean for Australian pathology laboratories?
The HIV and HCV testing standard sets out the minimum standards for good pathology practice for testing for HIV and HCV in Australia. The fourth edition of the standard incorporates the Public Health Laboratory Network’s recently updated laboratory case definition for confirmatory testing for HIV.
If your laboratory provides testing for HIV and HCV, you will be required to comply with the latest edition of the standard.
Additional requirements may exist for laboratories that test under the conditions of a licence to the Australian Code of Good Manufacturing Practice (GMP) for Human Blood and Tissues issued by the Therapeutic Goods Administration. These requirements do not attempt to incorporate requirements for GMP licensure.
When does the new edition testing standard come into effect?
The fourth edition of the HIV and HCV testing standard will come into effect following an update to Schedule 1 of the Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017. Stakeholders will be notified when this occurs.
More information
Contact the Safety and Quality Advice Centre or sign up to the pathology standards newsletter.