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New Reporting Requirements for Victorian Pathology Services

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This article applies to pathology service providers in Victoria.

Public Health and Wellbeing Further Amendment Regulations 2022 (Vic)

Relevant provisions of the Public Health and Wellbeing Further Amendment Regulations 2022 (Vic) (the Amending Regulations) commenced on 1 January 2023, amending the Public Health and Wellbeing Regulations 2019 (Vic) (the Regulations).  The Amending Regulations insert a new reporting obligation on pathology services (being services in which human tissue, human fluids or human body products are subjected to analysis for the purposes of the prevention, diagnosis or treatment of disease in human beings) to report on tests undertaken at the service in relation to notifiable conditions.

This change aims to provide ‘timely notification of information about testing for those conditions that require monitoring, surveillance or investigation, to enable analysis of the epidemiology and testing patterns for those conditions.’

Notification required by pathology services

Section 128 of the Public Health and Wellbeing Act 2008 (Vic) requires the person in charge of a pathology service to notify the Secretary of the Department of Health and Human Services (the Secretary) of the prescribed notification details in accordance with either the Regulations or an Order in Council, as applicable, if a pathology service:

  • performs a test on a sample in Victoria, or at the request of a pathology service from Victoria; and
  • the pathology service in Victoria believes on the basis of the supplied address of a person that they have a permanent or temporary address in Victoria; and
  • the result of the test indicates the person has, or may have, a notifiable condition.

The Amending Regulations create, under Regulation 92 and Part 1 of the new Schedule 4A of the Regulations, additional reporting requirements in relation to three notifiable conditions – namely, the chlamydia trachomatis infection, influenza and Respiratory Syncytial Virus (RSV).

The new Regulation 92(ba) of the Regulations prescribes Part 2 of Schedule 4A of the Regulations as the relevant notification details that are to be included in a notification to the Secretary for those conditions listed in Part 1 of Schedule 4A, being:

  • the age, sex, residential postcode and Aboriginal or Torres Strait Islander status of the person tested;
  • the notifiable condition and test type, test result, specimen type and collection date; and
  • the name of both the person authorising the result and the pathology service, the pathology service’s address, contact telephone number, NATA accreditation number and report date.
Timing of notification

In accordance with amendments to Regulation 94 of the Regulations, the notification details for all tests performed during a weekly period in relation to each condition listed in Part 1 of Schedule 4A must be provided to the Secretary in writing within 5 business days from the end of that weekly period.

Penalty

Failure by a pathology service to provide such notifications under Section 128 of the Act to the Secretary, including the relevant notification details and within the specified timeframe, carries a penalty of 60 penalty units, being $11,095.20.

Conclusion

Organisations should ensure that their processes are updated to include the additional reporting requirements for tests conducted in relation to chlamydia trachomatis, influenza and RSV.

How Health Legal can help:

For further information please contact the Health Legal and Law Compliance team via our contact page here.