Incident Management

Section: Governance	Ref. No: G15
Policy Name: Open Disclosure and Statutory Duty of Candour
Last Review: September 2024	Next Review: September 2027

Purpose

This procedure outlines the requirements of open disclosure and statutory duty of candour (SDC). 

It ensures patients are informed in an honest and open manner about an adverse event and any implications for their care. 

It provides guidance to both medical and nursing staff on the open disclosure and statutory duty of candour process. 

Definitions 

A non-conformance occurs when GEDS systems and processes do not meet what is expected or required. A requirement is a need, expectation, or obligation. It can be stated or implied by an organization, its customers, or other interested parties. 

An “Incident” is an event that has occurred where the outcome is not within the normal expectations related to that event. There may also have been potential for harm to a person or actual harm such as in personal injury. This harm or incident may involve staff, visitors or clients and patients. Adverse events are incidents. 

Adverse events are unintended outcomes of care –sometimes these have been experienced before and are known complications of operations or other procedures –at other times, they are the result of a mistake or a series of mistakes 

Serious adverse patient safety event (SAPSE) is an event of a prescribed class or category that: 

• occurred while the patient was receiving health services from a health service entity; and 
• in the reasonable opinion of a registered health practitioner, has resulted in, or is likely to result in, unintended or unexpected harm (which includes moderate harm, severe harm or prolonged psychological harm) being suffered by the patient. 

This includes an event that is identified following discharge from the health service entity. 

Statutory Duty of Candour (SDC) must be performed if a patient suffers a SAPSE in the course of receiving health services. The health service entity responsible for providing those services must provide them with: 

• a written account of the facts 
• an apology for the harm suffered 
• a description of the health service entity’s response to the event, and 
• the steps that the health service entity has taken to prevent re-occurrence of the event. 

Open disclosure describes the way clinicians communicate with patients who have experienced harm during health care. Open disclosure is intended to: 

• assist patients that have experienced harm 
• guide clinicians, the clinical workforce and health service organisations in supporting patients that have experienced harm 
• ensure that health service organisations learn from adverse events. 

Admission of liability – An “admission” of liability is a statement by a person that proves or tends to prove a person’s or organisation’s liability in negligence for harm or damage caused by another. There is a clear distinction between an admission of fact on the one hand (“we lacerated your liver during the course of the operation”), versus an admission of liability for negligence (” the liver laceration constitutes a breach of my duty of care to you and that breach has caused you injury”). 

Expression of regret – An expression of sorrow for the harm experienced by the Patient. 

Low level incident – A low level incident is where there is no permanent injury or increased level of care required and refers to incidents resulting in negligible or minor consequences. 

High level incident – A high level incident is any incident resulting in a Sentinel Event or Serious Incident. A high level incident can also be an event that results in major or catastrophic consequences for the patient. Open disclosure – The process of open discussion of adverse events that result in unintended harm to a patient while receiving health care and the associated investigation and recommendations for improvement. 

Responsibilities 

The process of Open Disclosure and Statutory Duty of Candour (SDC) is undertaken by the patient’s medical practitioner at GEDS along with the Director of Nursing or delegate. 

The management of the open disclosure and statutory duty of candour processes will give due regard to and be consistent with Glen Eira Day Surgery legal obligations and insurance requirements. 

The process of open disclosure and statutory duty of candour will not state or agree liability for harm caused to the patient by any GEDS employee, state or agree that another health care professional is liable for harm to the patient or state or agree that GEDS is liable for the harm caused to the patient. 

Procedure

Open Disclosure 

The main elements of open disclosure are: 

• an apology or expression of regret, which should include the words ‘I am sorry’ or ‘we are sorry’ 
• a factual explanation of what happened 
• an opportunity for the patient to relate their experience of the adverse event 
• a discussion of the potential consequences of the adverse event 
• an explanation of the steps being taken to manage the adverse event and prevent recurrence. 

Open disclosure is a discussion and an exchange of information that may take place in one conversation or over one or more meetings. Examples of phrases that may be useful include: 

“I am very sorry this has happened”; 

“I am sorry that this hasn’t turned out as expected” 

Statutory Duty of Candour 

Health services are required to provide a patient with a Statutory Duty of Candour (SDC) when they have suffered a serious adverse patient safety event (SAPSE) while receiving healthcare at their facility. The SDC builds on the principles and elements of open disclosure within the Australian Open Disclosure Framework, currently used for all cases of harm and near miss. SAPSEs are classified as an ISR 1 or 2 event (refer to SAPSE definition9 ) and sentinel events are a subset of a SAPSE. 

Considerations when determining if an event is a SAPSE 

When assessing a HAC (hospital acquired complication) to determine if it fits the definition of a SAPSE, there must be a linkage to an adverse event. Consider the following when determining an event meets the SAPSE definition: Consent- As part of the consent process, all patients need to be provided a clear indication of the risks, benefits and alternatives for any procedure. A HAC would not be considered a SAPSE when it is a recognised complication of the procedure, or where procedural risks are high due to surgical or patient factors and the patient has been informed and has consented appropriately. 

When a patient has suffered a SAPSE, the health service (GEDS) is legally required to provide the patient, and/or their next-of-kin (NOK)/carer, with: 

• a written account of the facts regarding the SAPSE 
• an apology for the harm suffered by the patient 
• a description of the health services response to the event 
• the steps that the health service has taken to prevent re-occurrence of the event 

The health service is required to comply with timelines and requirements set out in the Victorian Duty of Candour Guidelines (legislative instrument), as set out within the SDC Process Flowchart (Policy 15A). 

Requirements 

The steps set out in these Guidelines that must be followed are the Requirements below. The remainder of the Guidelines include recommendations that the health service entities may consider when discharging the SDC. 

Stage 1:

Apologise and provide initial information

Requirement 1: The health service entity must provide a genuine apology for the harm suffered by the patient and initial information, as early as practicable (and no longer than 24 hours) after the SAPSE has been identified by the health service entity.

Requirement 2: The health service entity must take steps to organise an SDC meeting within 3 business days of the SAPSE being identified by the health service entity. 

Stage 2:

Hold the SDC meeting

Requirement 3: The SDC meeting must be held within 10 business days of the SAPSE being identified by the health service entity.

Requirement 4: The health service entity must ensure that it provides the following in the SDC meeting: – an honest, factual explanation of what occurred in a language that is understandable to the patient; – an apology for the harm suffered by the patient; – an opportunity for the patient to relate their experience and ask questions; – an explanation of the steps that will be taken to review the SAPSE and outline any immediate improvements already made; and – any implications as a result of the SAPSE (if known) and any follow up for the patient. 

Requirement 5: The health service entity must document the SDC meeting and provide a copy of the meeting report to the patient within 10 business days of the SDC meeting. 

Stage 3:

Complete a review of the SAPSE and produce report

Requirement 6: The health service entity must complete a review for the SAPSE and produce a report outlining what happened and any areas identified for improvement. If the SAPSE is classified as a sentinel event, the health service entity must also outline in the report clear recommendations from the review findings. 

Requirement 7: The report created from Requirement 6 must then be offered to the patient within 50 business days of the SAPSE being identified by the health service entity. If the SAPSE involves more than one health service entity, this may be extended to 75 business days of the SAPSE being identified by the initial health service entity. 

Documentation and reporting 

Requirement 8: The health service entity must ensure that there is a record of the SDC being completed,including clear dates of when the SAPSE occurred and when each stage of the SDC was completed.

Requirement 9: The health service entity must report its compliance with the SDC as legally required 

Quarterly mandatory reporting of Statutory Duty of Candour is required via Health collect portal Health Collect Portal via AIMS form. This reporting is required even if the number of events is zero. 

Where patients do not want to be involved in the SDC process Patients may opt out from participating in the SDC process or from receiving information from a health service entity. If a patient confirms that they wish to opt out of the SDC process, the health service entity must: – ask them to sign a statement to this effect and store this in an appropriate location;18 and -provide a point of contact, such as a consumer liaison officer, if the patient wishes to re-initiate the SDC process at any time. When a patient has opted out, the relevant health service entity does not have to comply with the Requirements in these Guidelines, or the SDC process within the relevant Acts. 

If the event is classified as a sentinel event, they must also comply with any relevant timelines within the Victorian sentinel event guide. 

The Medical Advisory Committee (MAC) at GEDS has determined that ‘ Any unforeseen incident that has resulted in a significant adverse event that is deemed by the doctor’ be classified as SAPSEs and require the Statutory Duty of Candour process to be followed: 

Staff Support 

GEDS supports a “no blame” culture where staff are able and encouraged to recognise and report adverse events and are supported through the open disclosure process. Opportunities for a debrief following a sentinel or serious incident will be given. 

Risk Management and Preventative Actions Framework 

The GEDS Business Management and Governance Framework, Clinical Governance Framework, Non-Conformance and Incident Management Policy and Risk Management and Preventative Action Policy form the framework for integrated risk management and system improvement. 

Outcomes of investigations are to focus on improving systems of care and will be reviewed for their effectiveness. 

Good Governance 

The GEDS clinical risk management and quality improvement processes through the clinical governance frameworks ensures adverse events are investigated and analysed to find out what can be done to prevent their recurrence. 

Prioritisation 

As soon as a Serious Incident is identified, the first priority will be prompt and appropriate clinical care and prevention of further harm. The Director of Nursing or designee should gather any evidence that will assist in investigating the incident. 

Documentation 

The open disclosure process shall be accurately recorded as per Policy G 13 – Patient and Client Feedback. 

A formal letter from the Medical Director and/or Chair of the MAC will be sent to the patient (and support person if relevant) on conclusion of the investigation. The letter will provide an acknowledgment of the incident, an expression of regret along with an opportunity to ask any further questions or receive support. An explanation of what has been put into place to prevent a recurrence will be given. 

The Statutory Duty of Candour process uses the documents Safer Care Victoria documents and guidance. Patient documentation packs have been provided within the SDC folder that is kept in the nurse’s station in recovery. 

Legislation, References and Standards 

Health Services Act 1988 (amended 1st March 2020) 

Health Services (Private Hospitals and Day Procedure Centre’s) Regulations 2002 

Health Services (Health Service Establishments) Regulations 2013 (amended 22nd October 2019) 

Health Legislation Amendment (Quality and Safety) Act 2022 

Australian Commission on Safety and Quality in Health Care. National Clinical Governance Framework. Sydney: ACSQHC; 2017. 

Australian Commission on Safety and Quality in Health Care. National Safety and Quality Health Service Standards. 2nd ed. – version 2. Sydney: ACSQHC; 2021. 

Safer Care Victoria. Victorian Duty of Candour Framework. Victoria: SCV; October 2022 

Safer Care Victoria. Victorian Duty of Candour Guidelines. Victoria: SCV; October 2022 

Associated Documents 

GEDS Business Management System and Governance Framework 

GEDS Clinical Governance Framework Policy 

GEDS Medical Bylaws 

GEDS Incident Register 

GEDS Risk Register 

Policy 10 – Non-Conformance and Incident Management 

Policy G 10A – Incident Reporting Form 

Policy G 11 – Risk Management and Preventative Action 

Policy G 11A – Risk Assessment Form 

Policy G 13 – Patient and Client Feedback 

Policy G 13A – Patient Feedback and Complaints 

Policy 15A – Statutory Duty of Candour Process Flowchart 

Review History 

Date	Detail	Who
Nov 2022	Document created	DON/QC
Feb 2023	Document amended to add SDC	DON/QC
Sept 2024	Document amended to add mandatory reporting of SDC and steps of SDC	DON/QC
October 2024	Document amended to reflect MAC definition of SAPS and SDC	MAC