Advisory GP18/04: Notification of significant risk

To describe the requirements for accrediting agencies to notify the Commission and relevant state and territory health care complaints bodies of significant risks of patient harm that pose an ongoing risk to public health and safety that are identified during the assessment of general practices.

National General Practice Accreditation Scheme: Advisory details

Item Details
Advisory number GP18/04
Version number 3.0
Trim number D17-45231
Publication date 6 November 2020
Replaces Version 2.0 published on 1 February 2020
Compliance with this advisory Mandatory
Information in this advisory applies to All approved accrediting agencies assessing general practices
Key relationship Not applicable
Attachment Nil
Notes Updated to align to with Policy – Approval under the National General Practice Accreditation (NGPA) Scheme to conduct accreditation of general practices using the Royal Australian College of General Practitioners (RACGP) Standards for general practices
Responsible officer

Margaret Banks
Director, National Standards
Phone: 1800 304 056

To be reviewed 6 November 2022


To describe the requirements for accrediting agencies to notify the Commission, and relevant state and territory health care complaints bodies, of significant and ongoing risks of patient harm identified during the assessment of general practices.


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

  1. Assessors are to notify both the practice and their accrediting agency that a significant risk of serious patient harm has been identified
  2. Assessors and/or the accrediting agency are to discuss with the practice the immediate action to be taken and require them to develop a plan of action to mitigate the identified significant risk(s)
  3. The general practice is to address the significant risk(s) identified and immediately take steps to implement the plan. The plan is to be forwarded to the accrediting agency and the Commission within two business days of the identified significant risk(s)
  4. The accrediting agency must notify the Commission, the relevant state and territory health care complaints body and the regulation body (if applicable, for example the Public Health Unit), as soon as practical of a significant risk(s) being identified
  5. Assessors and/or the accrediting agency must document the significant risk(s) identified and the developed action plan in the general practice’s assessment report.

Accrediting agencies are to inform their client, and include relevant clauses in any contractual arrangements, about the process that will be followed if a significant risk(s) are identified during assessment, including information about the significant risk(s) will be provided to the Commission, the relevant state or territory health care complaints bodies and regulation body if applicable. The regulation body may be, for example, the Public Health Unit for vaccines administered under the National Immunisation Program Schedule.

Definition of significant risk

Australian general practices generally do not pose a significant risk of harm to patients. However, from time to time, lapses and errors may occur that result in an increased risk of harm to patients accessing care from a general practice.

significant risk is one where there is a high probability of a substantial and demonstrable serious adverse impact for patients who access care from the general practice. In each case, a significant risk will be sufficiently serious to warrant an immediate response to reduce the risk to patients (see table of examples below). This may include interventions or changes to the practice’s policies, procedures or management systems; the clinical care environment; or clinical practice.

Risks that have already been identified by the practice, such as those identified through the review of a near miss or critical incident, and which are subject to existing quality improvement plans and effectively mitigated, would not be considered a significant risk for the purposes of this advisory.

Significant risks for the purposes of this advisory are those risks that at the time of the assessment have not previously been identified by the practice; are systemic in their origin; are not currently controlled; or have not been sufficiently mitigated so as to prevent the possibility of serious patient harm.

Assessors and/or accrediting agencies can use the following sample risk matrix to help determine if an identified risk/s of patient harm constitutes a significant risk/s as defined by this advisory.

Table 1: Risk analysis matrix

Likelihood Negligible Minor Moderate Major Extreme
Rare Low Low Low Medium High
Unlikely Low Medium Medium High Very high
Possible Low Medium High Very high Very high
Likely Medium High Very high Very high Extreme
Almost certain Medium Very high Very high Extreme Extreme
Low risk Manage by routine procedures
Medium risk Manage by specific monitoring or audit procedures

High risk
Very high risk
Extreme risk

This is serious and must be addressed immediately.

The magnitude of the consequences of an event, should it occur, and the likelihood of that event occurring, are assessed in the context of the effectiveness of existing strategies and control.

Source: Australian Guidelines for the Prevention and Control of Infections in Health Care (Table A2.1)

The following list provides some examples of significant risks for general practices. They are intended to be examples only. This list is not exhaustive and should not be exclusively used to identify significant risks.

Examples of significant risks in a general practice may include, but are not limited to:

Risks Impact
Staff do not routinely use processes to correctly identify a patient before care is administered or before personal information is accessed and used Patients are misidentified and experience preventable harm, such as an allergic reaction to prescribed medications or inaccurate referrals
Processes for correctly cleaning, disinfecting and sterilising reusable medical devices are not performed to the required standard Preventable infections are transmitted to patients
Medicines that are required to be stored in a secure location are left unlocked and are accessible to the general public Patients or staff may inappropriately access controlled medicines and experience an adverse reaction
Processes for managing temperature-sensitive medicines do not exist or are not followed by staff Vaccines or other patient medicines cannot be dispensed or administered because they are not available, or they are administered but are ineffective
Processes to check and follow up clinically significant test results do not exist or are insufficient Patients do not receive necessary follow up care and experience preventable harm

The Health Practitioner Regulation National Law 2009 (the National Law) requires registered health practitioners, employers and education providers to report to the Australian Health Practitioner Regulation Agency (AHPRA) any instances of ‘notifiable conduct’ by individual registered health practitioners. Notifiable conduct by individual registered health practitioners does not fall under the definition of significant risk for the purposes of this advisory and is not required to be reported to the Commission or the relevant state or territory health care complaints body. Assessors and/or accrediting agencies that observe any conduct by individual registered health practitioners that constitutes notifiable conduct during an assessment are required to follow the mandatory reporting processes as outlined by AHPRA.