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Advisory GP18/04: Notification of significant risk

To describe the requirements for accrediting agencies to notify the Australian Commission on Safety and Quality in Health Care (the Commission) of significant and ongoing risks of patient harm identified during the assessment of general practices.

Advisory details

Item Details
Advisory number GP18/04
Version number 4.0
Trim number D23-22896
Publication date 5 September 2023
Replaces Version 3.0 published on 6 November 2020
Compliance with this advisory Mandatory
Information in this advisory applies to
  • All approved accrediting agencies
  • All general practices
Key relationship
Attachment  
Notes  
Responsible officer Margaret Banks

Director, National Standards

Phone: 1800 304 056

Email: AdviceCentre@safetyandquality.gov.au
To be reviewed September 2025

Purpose

To describe the requirements for accrediting agencies to notify the Australian Commission on Safety and Quality in Health Care (the Commission) of significant and ongoing risks of patient harm identified during the assessment of general practices.

Issue

The Commission coordinates the National General Practice Accreditation Scheme (the Scheme). This includes receiving information about the assessments of general practices, including notification of significant risks identified during the assessment of a general practice.

Clause 6.8.2 of the Policy – Approval under the National General Practice Accreditation (NGPA) Scheme to conduct assessments mandates accrediting agencies to meet the requirements for notification of significant risks outlined by the Commission.

Accrediting agencies, assessors, and general practices require clarification of ‘significant risk’ processes to ensure when they are identified at assessment, reporting is in line with the requirements of NGPA Scheme.

A definition of significant risk for general practices is linked below:


Requirements

Where an assessor is on site and identifies one or more significant risk(s), the following actions are to be taken:

  1. The assessors are to notify both the general practice and the accrediting agency that a significant risk(s) of serious patient harm has been identified, and they are to discuss the immediate actions to be taken, outline the process for developing a risk mitigation plan, and describe the process for reporting and the requirements for an on-site final assessment
  2. If the significant risk(s) results in a cold chain breach, the assessor and/or the accrediting agency ensures the general practice immediately reports the breach as per the National vaccine storage guidelines - Cold chain breach protocol
  3. The assessors and/or the accrediting agency are to develop a risk mitigation plan with the general practice. They may use the template provided by the Commission
  4. The accrediting agency is to forward the risk mitigation plan to the Commission within two business days of the significant risk(s) being identified
  5. The Commission will advise the Department of Health and Aged Care of the significant risk as soon as practicable
  6. The general practice is to take immediate action to mitigate the significant risk(s)
  7. The general practice is to identify and notify patients that may have been harmed due to the significant risk. The general practice is to conduct an open disclosure with the patients and offer them ongoing care
  8. The accrediting agency must follow up on the progress of the risk mitigation plan five business days after the significant risk was identified and report to the Commission
  9. If the significant risk(s) has not been reduced from high to medium probability, the Commission may report the significant risk(s) to the relevant body, such as the Department of Health and Aged Care, local Public Health Unit, and/or relevant health care complaints commissioners
  10. General practices that has a significant risk(s) identified will have their final assessments conducted on site
  11. The accrediting agency is to document the significant risk(s) and the risk mitigation plan in the general practice’s assessment report.

A flow chart of the significant risk reporting procedures is linked below:


Completion of the online submission form constitutes notification to the Commission.

For accrediting agencies

Accrediting agencies are to:

  • Inform their clients about the requirements of general practices when a significant risk(s) is identified during assessment and the process that will be followed such as:
    • The general practice will undergo an on-site final assessment
    • Information on the significant risk(s) will be provided to the Commission, the Department of Health and Aged Care and if applicable, to local Public Health Unit, relevant health care complaints commissioners, and/or relevant national boards.
  • Include relevant clauses in any contractual arrangements to give effect to the requirements in this Advisory
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