Australian Open Disclosure Framework: Key Elements and Process

This document outlines the Australian Open Disclosure Framework, a crucial guide for healthcare professionals in managing adverse events and communicating with patients, their families, and carers. The framework emphasizes open and timely communication, acknowledging adverse events, offering apologies or expressions of regret, and providing support to all involved. It details key elements of the open disclosure process, including detecting and assessing incidents, signaling the need for open disclosure, preparing for and engaging in open disclosure discussions, providing follow-up, and completing the process. The framework also highlights the key components of open disclosure discussions, such as introductions, expressions of regret, factual explanations, and offers of support. Furthermore, it underscores the importance of integrated clinical risk management, good governance, and confidentiality in ensuring patient safety and improving healthcare systems. The framework aims to foster transparency, accountability, and continuous improvement in healthcare settings.

Australian Open Disclosure Framework
Supporting materials and resources
Open disclosure principles, elements
and process
Open disclosure principles, elements and process 1

© Commonwealth of Australia 2013
This work is copyright. It may be reproduced in whole or in part for study or training purposes subject to
the inclusion of an acknowledgment of the source. Requests and inquiries concerning reproduction and
rights for purposes other than those indicated above requires the written permission of the Australian
Commission on Safety and Quality in Health Care, GPO Box 5480 Sydney NSW 2001 or
[e-mail]
Suggested citation
Australian Commission on Safety and Quality in Health Care (2013) Open disclosure principles, elements
and process ACSQHC, Sydney.
Acknowledgment
Many individuals and organisations have freely given their time, expertise and documentation to support
the review of the Open Disclosure Standard. In particular, the Commission wishes to thank members of
the Open Disclosure Advisory Group for their significant contribution in the drafting of this document. The
involvement and willingness of all concerned to share their experience and expertise is greatly
appreciated.
Open disclosure principles, elements and process 2

Contents
1. Principles of open disclosure...............................................................................................4
2. Key elements of the open disclosure process.....................................................................6
3. Key components of open disclosure discussions..............................................................8
4. Open disclosure flow chart.....................................................................................................10
Open disclosure principles, elements and process 3

1. Principles of open disclosure
1. Open and timely communication
If things go wrong, the patient, their family and carers should be provided
with information about what happened in a timely, open and honest
manner. The open disclosure process is fluid and will often involve the
provision of ongoing information.
2. Acknowledgement
All adverse events should be acknowledged to the patient, their family and
carers as soon as practicable. Health service organisations should
acknowledge when an adverse event has occurred and initiate open
disclosure.
3. Apology or expression of regret
As early as possible, the patient, their family and carers should receive an
apology or expression of regret for any harm that resulted from an adverse
event. An apology or expression of regret should include the words ‘I am
sorry’ or ‘we are sorry’, but must not contain speculative statements,
admission of liability or apportioning of blame.
4. Supporting, and meeting the needs and expectations of patients, their
family and carer(s)
The patient, their family and carers can expect to be:
 fully informed of the facts surrounding an adverse event and its
consequences
 treated with empathy, respect and consideration
 supported in a manner appropriate to their needs.
5. Supporting, and meeting the needs and expectations of those
providing health care
Health service organisations should create an environment in which all staff
are:
 encouraged and able to recognise and report adverse events
 prepared through training and education to participate in open
disclosure
 supported through the open disclosure process.
6. Integrated clinical risk management and systems improvement
Thorough clinical review and investigation of adverse events and adverse
outcomes should be conducted through processes that focus on the
management of clinical risk and quality improvement. Outcomes of these
reviews should focus on improving systems of care and be reviewed for
their effectiveness. The information obtained about incidents from the open
disclosure process should be incorporated into quality improvement activity.
Open disclosure principles, elements and process 4

7. Good governance
Open disclosure requires good governance frameworks, and clinical risk
and quality improvement processes. Through these systems, adverse
events should be investigated and analysed to prevent them recurring.
Good governance involves a system of accountability through a health
service organisation’s senior management, executive or governing body to
ensure that appropriate changes are implemented and their effectiveness
is reviewed. Good governance should include internal performance
monitoring and reporting.
8. Confidentiality
Policies and procedures should be developed by health service
organisations with full consideration for patient and clinician privacy and
confidentiality, in compliance with relevant law (including federal, state
and territory privacy and health records legislation). However, this
principle needs to be considered in the context of Principle 1: Open and
timely communication.
Open disclosure principles, elements and process 5

2. Key elements of the open disclosure process
1. Detecting and
assessing
incidents
 Detect adverse event 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
 Ensure privacy and confidentiality of patients and clinicians are
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.
 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
o the formality of open disclosure required
o the time and place for open disclosure
o who should be there during open disclosure
 Provide written confirmation
 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)
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 or we are 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 throughout the process
Open disclosure principles, elements and process 6

 If the adverse event took place in another health service
organisation, include relevant staff if possible.
 If necessary, hold several meetings or discussions 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. a general
practitioner)
6. Completing
the process
 Reach an agreement between the patient, their family and carers
and the clinician, or provide an alternative course of action
 Provide the patient, their family and carers with 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 surveys
7. Maintaining
documenta-
tion
 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 record
 Provide the patient with documentation throughout the process
Open disclosure principles, elements and process 7

3. Key components of open disclosure discussions
1. Introductions
The patient, their family and carers is 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
healthcare 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 available at
www.safetyandquality.gov.au/opendisclosure
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 explanation: 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 timeframe, 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:
a. ongoing support including reimbursement of out-of-pocket expenses incurred as a
result of the adverse event
b. assurance that any necessary follow-up care or investigation will be provided
promptly and efficiently
c. in the relevant settings, clarity on who will be responsible for providing ongoing care
resulting from the adverse event
Open disclosure principles, elements and process 8

d. contact details for any relevant service they wish to access
e. information about how to take the matter further, including any complaint processes
available to them
9. Support for patients and staff
The patient, their family and carers engages in open disclosure with staff. Staff are
supported by their colleagues, managers and health service organisation, both personally
(emotionally) and professionally, including through appropriate training, preparation and
debrief.
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.
Open disclosure principles, elements and process 9

4. Open disclosure flow chart
Figure 1: Higher-level response (S: section in the Australian Open Disclosure
Framework)
Open disclosure principles, elements and process 10

Figure 2: Lower-level response
Open disclosure principles, elements and process 11