Advisory AS18/09: Notification of significant risk

Advisory details

Purpose

To describe the requirements for accrediting agencies to notify regulators and the Australian Commission on Safety and Quality in Health Care (the Commission) of significant patient risks identified during the assessment of health service organisations.

Issue

Accrediting agencies have signed declarations as part of the conditions of approval to notify the health service organisation, the relevant regulator and the Commission ^[1] when a significant patient risk is identified during assessment of a health service organisation.

Ministers have tasked the Commission with the coordination of the Australian Health Service Safety and Quality Accreditation Scheme. This includes receiving information about the assessments of health service organisations, including notification of significant risk.

Requirements

Risk is one where there is a high probability of a substantial and demonstrable adverse impact for patients if the practice is to continue. In each case, a significant risk will be sufficiently serious to warrant an immediate response to reduce the risks to patients. This may include interventions or changes to systems, the clinical care service environment, or clinical practice, or where there are multiple unmet actions that impact several safety and quality systems. While the focus of reporting by assessors will be on significant risks of patient harm, it will not necessarily exclude other significant risks.

Where an assessor identifies one or more significant risks that could result in significant harm to patients while they are onsite in a health service organisation, the following actions are to be taken:

1. Assessors are to notify both the health service organisation and their accrediting agency that a significant patient risk has been identified
2. Assessors and/or the accrediting agency are to discuss immediate action to be taken with the health service organisation and require them to develop and submit a plan of action to remedy the risk within 48 - hours
3. The accrediting agency is to notify the relevant regulator and the Commission within 48 - hours that a significant patient risk has been identified and provide a copy of the action plan as soon as practical.

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

Notification of Significant Risk: Submission form

The requirements of the online form are listed below.

• About the agency
  • Accrediting agency name
  • Accrediting agency contact
  • Email address
• About the health service organisation
  • Organisation name
  • Address
  • Facility ID
  • Organisation contact person, title or position and phone number
• About the assessment
  • Standard being assessed
  • Assessment cycle (interim assessment, standard assessment, mandatory repeat assessment, out-of-cycle assessment)
  • Stage (initial or final)
  • 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
  • Did the organisation provide an action plan? (yes, no)
  • Copy of the organisation's action plan

Accrediting agencies are to inform their client and include relevant clauses in any contractual arrangements that information on significant patient risk will be provided to the regulators and the Commission when it is required by regulation, or policy of a government agency.

• ^{[1] Policy – Approval under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme to conduct accreditations of health service organisations using the Scheme’s standards}