The Open Disclosure Framework at Ballarat Health Services is part of the routine response to adverse events resulting in patient harm and is part of broader safety and quality requirements at both state and national level. The Open Disclosure process is underpinned by 8 principles, which have been endorsed by the Australian Commission on Safety and Quality in Health Care (ACHS, 2017).

These include:

• Open and timely communication

• Acknowledgment

• Apology or expression of regret

• Supporting, and meeting the needs and expectations of patients, their family and carers

• Supporting, and meeting the needs and expectations of those providing health care

• Integrated clinical risk management and systems improvement

• Good governance

• Confidentiality

Open Disclosure facilitates open communication with patients and/or their support person about an incident that resulted in harm to the patient while they were receiving care. This will include an expression of regret that the event has occurred and a factual explanation of what happened and an opportunity for the patient and family to be heard.

A clear and consistent approach to discussion and exchange of information takes place between clinicians and the person (consumer/participant) receiving health care or their family/carers when an adverse event happens. This discussion is to adhere to the Australian Open Disclosure Framework.

Open disclosure can :

• improve patient safety through improved understanding of how things go wrong

• clarify what caused things to go wrong and how to prevent them in the future

• increase trust between patients and healthcare providers

• assist patients to become more active partners in their care

Apology: An expression of sorrow, sympathy and (where applicable) remorse by an individual, group or institution for a harm or grievance. It should include the words 'I am sorry' or 'we are sorry'. An apology may also include an acknowledgment of responsibility, which is not an admission of liability.

Adverse Event: An incident in which harm resulted to a person receiving health care. (This term is used interchangeably with 'incident' or 'harmful incident').

Carer: A person who provides unpaid care and support to family members and friends who have a disability, mental illness, chronic condition, terminal illness or general frailty. Cares include parents and guardians caring for children.

Clinical risk management: Clinical, administrative and manufacturing activities that organisations undertake to identify, evaluate and reduce the risk of injury to patients and visitors, and the risk of loss to the organisation itself.

Consumer - Consumer is a patient, resident, participant, client, relative, carer, friend, visitor, supplier, external agency/service provider, or other member of the public

Harm: Impairment of structure or function of the body and/or any deleterious effect arising there for, including disease, injury, suffering, disability and death. Harm may be physical, social or psychological. A near miss should receive the same level of scrutiny as an incident that resulted in actual injury or harm; and must be reported and documented in the medical record.

High level response: A comprehensive open disclosure process usually in response to an adverse event resulting in death or major permanent loss of function, permanent or considerable lessening of body function, significant escalation of care or major change in clinical management (e.g. admission to hospital, surgical intervention, or emotional distress. See 'Issues to consider' section for guidance on when a High level response is appropriate.

Incident:  See Adverse Event

Low level response: A brief open disclosure process usually in response to an adverse event resulting in no permanent injury, requiring no increased level of care (e.g. transfer to operating theatre or intensive care unit), and resulting in no, or minor, psychological or emotional distress (e.g. near misses and no-harm incidents.). See 'Issues to consider' section for guidance on when a Low level response is appropriate.

Open Disclosure: Discussion of adverse events that result in harm to a patient while receiving health care with the patient, their family and carers.

Risk management: The design and implementation of a program to identify and avoid or minimise risk to patients, employees, volunteers, visitors and the institution.

High or low level response?

Table 1: Potential responses to various situations and incidents

Table 2: Criteria for determining the appropriate level of response

Duty of Candour

• The Victorian government has proposed legislative reform as recommended in the Targeting Zero report of 2019

• Introduction of a statutory Duty of Candour is planned in in late 2021 or 2022

• Open Disclosure in response to significant adverse patient safety events, and the offer of a copy of internal review to the patient will be required by law

Admission of liability

Health Service clinical staff should be aware of the risk of making an admission of liability during open disclosure.

Apologising does not constitute admission of liability

Do not:

• speculate on the cause of an incident if unknown

• apportion blame

• state or agree that they, other clinicians or the health service are liable for the harm caused

Senior Clinical Staff Leadership

It is expected that Senior Clinical staff will drive and encourage participation in the Open Disclosure process and ensure that ALL open disclosure discussions are documented in the medical record as required by the National Safety and Quality Health Service Standard 1 and Accreditation Surveyors. The use of the Open Disclosure tools should also be used to assist in the Open Disclosure process. (See appendices)

Tools to assist in the Open Disclosure process.

A series of tools and documents to guide clinical staff through the open disclosure process are attached in the appendix.

The e3 elearning module 'Open Disclosure Information' is also available to all BHS staff (and should be accessed via the URL listed below in the 'References' section, using the Mozilla Firefox browser).

These can be used to aid in preparation for open disclosure and ensure documentation of the process occurs.

Leading the open disclosure process

A Low level open disclosure response (see 'High or Low level response?' section above) will:

• Be managed at Unit or Department level

• Be undertaken by the senior staff member/ clinician determined to be the most appropriate following discussions within the clinical team

• Consist of the initial disclosure discussion with the patient, family or carer. This is considered an adequate disclosure process for this level of incident. (See Key elements below)

A High level open disclosure response (see 'High or Low level response?' section above) will:

• Be the most senior clinician who is responsible for the care of the patient where possible

• Involve discussion as soon as possible following the event (no later than 24 hours post notification) between the most senior treating clinician, the Clinical Director, and the Unit Manager

• Offer support of the consumer liaison officer if ongoing support and communication to the patient and carer/families is required during a more formal meeting process

• Proceed following the key elements of the open disclosure process below

Key elements of the open disclosure process

1. Detecting and assessing incidents

• Detect adverse events through a variety of mechanisms

• Provide prompt clinical care to the patient to prevent further harm

• Assess the incident for severity of harm and level of response

• Provide support for staff

• Initiate a response, ranging from lower to higher levels

• Notify relevant personnel and authorities. ( i.e. Governance & Risk Management Unit, Director or Manager)

• Ensure privacy and confidentiality of patients and clinicians is observed

2. Signalling the need for open disclosure

• Acknowledge the adverse event to the patient, their family and carers including an apology or expression of regret. This can be done prior to the result of any investigation being known.

• A lower-level response can conclude at this stage

• Signal the need for open disclosure

• Negotiate with the patient, their family and carers or nominated contact person:

1. the formality of open disclosure required

2. the time and place for open disclosure

3. who should be there during open disclosure

• Provide written communication

• Provide a health service contact for the patient, their family and carers

• Avoid speculation and blame

• Maintain good verbal and written communication throughout the open disclosure process

3. Preparing for open disclosure

• Hold a multidisciplinary team discussion to prepare for open disclosure

• Consider who will participate in open disclosure

• Appoint an individual to lead the open disclosure based on previous discussion with the patient, their family and carers

• Gather all the necessary information

• Identify the health service contact for the patient, their family and carers (if this is not done already)

An Open Disclosure checklist is attached to the appendix for use

4. Engaging in open disclosure

• Provide the patient, their family and carers with the names and roles of all attendees

• Provide a sincere and unprompted apology or expression of regret including the words 'I am sorry' or 'we are very sorry'.

• Clearly explain the incident

• Give the patient, their family and carers the opportunity to tell their story, exchange views and observations about the incident and ask questions

• Encourage the patient, their family and carers to describe the personal effects of the adverse event

• Agree on, record and sign an open disclosure plan

• Assure the patient, their family and carers that they will be informed of further investigation findings and recommendations for system improvement

• Offer practical and emotional support to the patient, their family and carers

• Support staff members through out the process

• If the adverse event took place in another health service organisation ,include relevant staff if possible

• If necessary, hold several meetings or discussion to achieve these aims

5. Providing follow-up

• Ensure follow-up by senior clinicians or management, where appropriate

• Agree on future care

• Share the findings of investigations and the resulting practice changes

• Offer the patient, their family and carers the opportunity to discuss the process with another clinician (e.g. General Practitioner)

6. Completing the process

• Reach an agreement between the patient, their family, carers and the clinician, or provide an alternative course of action

• Provide the patient, their family and carers with a final written and verbal communication, including investigation findings

• Communicate the details of the adverse event, and outcomes of the open disclosure process, to other relevant clinicians

• Complete the evaluation survey

7. Maintaining documentation

• Keep the patient record up to date

• Maintain a record of the open disclosure process

• File documents relating to the open disclosure process in the patient medical record

• Provide the patient with the documentation throughout the process

An Open disclosure 'documentation and discussion' template is attached to the appendix for use

Key components of open disclosure discussions

1.   Introductions

The patient, their family and carers are told the name and role of everyone attending the meeting, and this information is also provided in writing.

2. Saying sorry

A sincere and unprompted apology or expression of regret is given on behalf of the health service and clinicians, including the words I am or we are sorry. Examples of suitable and unsuitable phrasing of an apology are provided in the resource titled Saying Sorry: a guide to apologising and expressing regret in open disclosure (appendix item)

3. Factual explanation: providers

A factual explanation of the adverse event is provided, including the known facts and consequences of the adverse event, in a way that ensures the patient, their family and carers understand the information, and considers any relevant information related earlier by the patient, family and carers. Speculation should be avoided.

4. Factual explanations: patient, family and carer/s

The patient, family and carers have the opportunity to explain their views on what happened, contribute their knowledge and ask questions (the patient's factual explanation of the adverse event). It will be important for the patient, their family and carers that their views and concerns are listened to , understood and considered.

5. Personal effect of the adverse event

The patient, family and carers is/are encouraged to talk about the personal effect of the adverse event on their life.

6. Plan agreed and recorded

An open disclosure plan is agreed on and recorded, in which the patient, their family and carer(s) outline what they hope to achieve from the process and any questions they would like answered. This is to be documented and filed in the appropriate place and a copy provided to the patient, their family and carers.

7. Pledge to feed back

The patient, their family and carers is assured that they will be informed of any further reviews or investigations to determine why the adverse event occurred, the nature of the proposed process and the expected time frame. The patient, their family and carers are given information about how feedback will be provided on the investigation findings, by whom and in what time frame, including any changes made to minimise the risk of recurrence.

8. Offer of support

An offer of support to the patient, their family and carers should include:

1. ongoing support including: reimbursement of out-of-pocket expenses incurred as a result of the adverse event; consumer liaison office support and communication

2. assurance that any necessary follow-up care or investigation will be provided promptly and efficiently

3. in the relevant settings, clarity on who will be responsible for providing ongoing care resulting from the adverse event

9. Support for staff

Staff are supported by their colleagues, managers and health service organisation, both personally (emotionally) and professionally, including through appropriate training, preparation, debrief and feedback.

10. Other health service organisations

In cases where the adverse event spans more than one location or service, relevant clinicians and staff will ensure, where possible, that all relevant staff from these additional institutions are involved in the open disclosure process.

If necessary, hold several meetings or discussions to achieve these components

Other considerations:

It is not necessary to cover every component in the first disclosure meeting. For instance, a full explanation of why an adverse event occurred may not be possible until associated investigations are completed and the causative factors are known.

A written account of the open disclosure meeting should be provided to the patient, their family and carers and a copy filed in the patient record.