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Advisory PCHS26/03: Notification of significant risk for the National Safety and Quality Primary and Community Healthcare Standards

To describe the Commission's requirements for the notification of significant patient risks identified during the assessment of a healthcare service to the National Safety and Quality Primary and Community Healthcare Standards (Primary and Community Healthcare Standards).

Advisory details

Item Details
Advisory number PCHS26/03
Version number 1.0
Publication date March 2026
Replaces Nil
Compliance It is mandatory for approved accrediting agencies to implement this Advisory
Applicable to
  • All approved accrediting agencies
  • All healthcare services
Key relationship  
Attachment(s)  
Note(s)  
Responsible officer Christina Lane
Manager, Primary Health Care and National Standards
Email: AdviceCentre@safetyandquality.gov.au
Review date February 2028

Purpose

To describe the Australian Commission on Safety and Quality in Health Care’s (the Commission) requirements for the notification of significant patient risks identified during the assessment of a healthcare service to the National Safety and Quality Primary and Community Healthcare Standards (Primary and Community Healthcare Standards).

Issue

Clause 7.5 of Appendix 4 of the Policy – Approval under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme to conduct assessments outlines the significant reporting requirements for agencies approved to assess to the Primary and Community Healthcare Standards.

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

A significant risk, for the purpose of assessments to the Primary and Community Healthcare Standards, is defined by a high or extreme risk rating. More information is available in Definition of a significant risk.


Requirements

Where an assessor identifies one or more significant risks that could result in significant harm to patients while they are conducting an assessment, the following actions are to be taken.

  1. Assessors must notify both the healthcare service and their accrediting agency as soon as practical when a significant risk to patients has been identified.
  2. The healthcare service must:
    1. discuss the immediate actions to be taken with the assessors and/or the accrediting agency
    2. develop and submit an action plan to mitigate the significant risk, in line with the requirements outlined in Attachment 1, to the accrediting agency within 48 hours of the risk being identified
    3. complete the action plan before the final assessment
    4. undertake a virtual or on-site final assessment, depending on the assessment model used and the assessment cycle at which the healthcare service was when the significant risk was identified. Refer to information in Table 1.

Table 1: Final assessment requirement if a significant risk has been identified

Assessment model Assessment cycle Final assessment
Model 1
(Desktop assessment)
Cycle 1 Virtual
Cycle 2, and subsequent cycles (if approved)
  • On site for healthcare services with facilities and equipment to support physical examinations of, or therapies or procedures upon patients
  • Otherwise, virtual
Model 2
(Desktop + virtual assessment)
All cycles Virtual
Model 3
(Announced on-site assessment)
On site
Model 4
(Short-notice on-site assessment)
  1. The accrediting agency must:
    1. notify the Commission and/or the relevant regulator that a significant risk has been identified, in line with the requirements outlined in Attachment 2, within 48 hours of the risk being identified
    2. conduct a virtual or on-site final assessment to verify whether the action plan has been implemented in full and determine the assessment outcome
    3. document the significant risk and the final action plan in the healthcare service’s assessment report.

A template of the significant risk mitigation action plan, including an example of a significant risk, has been provided for guidance. Healthcare services may choose to use the template.

Inadequate or incomplete mitigation of the significant risk may result in relevant actions being rated ‘not met’ at final assessment, preventing the healthcare service from achieving accreditation.

Completion of the online submission form constitutes notification of a significant risk to the Commission

For accrediting agencies

Accrediting agencies are to:

  • inform their clients about the requirements of healthcare services when a significant risk(s) is identified during assessment and the process that will be followed such as
    • the healthcare service will undergo a virtual or on-site final assessment
    • information on the significant risk(s) will be provided to the Commission and if applicable
      • the regulator
      • the Department of Health, Disability and Ageing
      • the local Public Health Unit
      • relevant health care complaints commissioners
      • relevant national boards.
  • include relevant clauses in any contractual arrangements to give effect to the requirements in this Advisory.

Attachments

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