Advisory GP18/04: Notification of significant risk

Advisory details

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.

Clarification of the significant risk management processes is provided to ensure accrediting agencies, assessors, and general practices comply with risk mitigation and reporting requirements.

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

Definition of significant risk for general practice

2023

Other resource

Requirements

Where an assessor identifies one or more significant risk(s) during an assessment, they are to:

1. Notify the general practice and their accrediting agency that a significant risk(s) of serious patient harm has been identified
2. Discuss with the general practice the immediate actions to be taken
3. Outline for the general practice the process for immediately developing a risk mitigation plan and provide a link to this Advisory
4. Describe the process for reporting and follow up assessment of significant risks.

The accrediting agency, in collaboration with their assessors are to: 

1. Ensure the general practice immediately reports the breach as per the National vaccine storage guidelines - Cold chain breach protocol if the significant risk(s) relates to a cold chain breach
2. Develop a risk mitigation plan with the general practice

Significant risk mitigation plan template

2024

Template, survey or form

3. Forward the risk mitigation plan to the Commission within two business days of the significant risk(s) being identified 
4. Follow up on the progress of the risk mitigation plan within five business days of the notification of the significant risk and report to the Commission if action has not been taken by the general practice
5. Document the significant risk(s) and the risk mitigation plan in the general practice’s assessment report.

The Commission is to: 

1. Advise the Department of Health and Aged Care of the significant risk as soon as practicable
2. 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 
   • relevant health care complaints commissioners.

The general practice is to: 

1. Take immediate action to mitigate the significant risk(s)
2. Identify and notify patients that may have been harmed due to the significant risk
3. Conduct an open disclosure with the patients and offer them ongoing care if significant harm has occurred
4. Participate in an on-site final assessment for general practices with dedicated physical premises.
5. Participate in a virtual final assessment for general practices without dedicated physical premises.

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

Notification of significant risk process flow chart - National General Practice Accreditation Scheme

2024

Other resource

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.