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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 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).

Advisory details
 

ItemDetails
Advisory numberPCHS26/03
Version number1.0
Publication dateMarch 2026
ReplacesNil
ComplianceIt 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 officerChristina Lane
Manager, Primary Health Care and National Standards
Email: AdviceCentre@safetyandquality.gov.au
Review dateFebruary 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.

Definition of a significant risk - National Safety and Quality Primary and Community Healthcare Standards
 

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 modelAssessment cycleFinal assessment
Model 1
(Desktop assessment)		Cycle 1Virtual
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 cyclesVirtual
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.

Significant risk mitigation action plan for the National Safety and Quality Primary and Community Healthcare Standards

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

Table 2: Information requirements of the significant risk mitigation action plan

RequirementDescription
Healthcare service information
  • Healthcare service name, address, and facility ID
  • Healthcare service contact
  • Accrediting agency
Significant risk information
  • Date significant risk/s was identified
  • Description of the significant risk/s identified
  • Initial risk rating (High or Extreme)
  • Action/s required
  • Timeline for implementation
  • Person/s responsible
Progress report
  • Action/s undertaken within 48 hours
  • Risk rating following immediate action/s
  • Follow up requirements
Outcome of final assessment
  • Date of final assessment
  • Evidence reviewed by the accrediting agency
  • Final risk rating

Table 3: Information collected through online form for notification of significant risk

RequirementDescriptionRequirements
Accrediting agency informationAccrediting agency contactIncluding name, email address and phone number
Healthcare service informationHealthcare service detailsName and address of the healthcare service provider
Facility IDID issued by the Commission
Organisation contactIncluding name, title/position and phone number
Assessment informationStandard being assessed 
Assessment stage
  • Model 1 (Desktop assessment)
  • Model 2 (Desktop + virtual assessment)
  • Model 3 (Announced on-site assessment)
  • Model 4 (Short-notice on-site assessment)
  • Out-of-cycle assessment
Assessment cycleFirst or subsequent cycles
Number of assessors  
Date significant risk was identified  
Description of the significant risk 
Relevant actions in the standard 
Action taken by the assessor and/or accrediting agency 
Upload the action plan 

Last updated: 13 March 2026