NOTE General FAQs and FAQs for clinicians are also available at www.safetyandquality.gov.au/opendisclosure
Why is open disclosure important?
As knowledge about health grows and the use of new technologies increases, the provision of health care is becoming more complex. In this context, health service organisations need to create an environment that encourages identifying and reporting adverse events so that opportunities for learning can be identified and acted on. In working towards an environment that is as free as possible from adverse events, there is a need to move away from blaming individuals to focusing on establishing systems of organisational responsibility.
In this context open disclosure can:

improve patient safety and quality of care through organisational learning

increase trust between patients and their clinicians

assist patients and their families and carers recover from healthcare harm

support staff through understanding and managing unintended patient harm.
Is open disclosure practice mandatory?
Open disclosure is an accrediting activity in the National Safety and Quality Health
Service Standards (NSQHS Standards).
The ten NSQHS Standards are intended to protect the public from harm and to improve the quality of health service provision. The first standard, Governance for safety and quality in health service organisations , requires that health service organisations “implement governance systems to set, monitor and improve the performance of the organisation and communicate the importance of the patient experience and quality management to all members of the workforce.”
Criterion 1.16 of Standard 1 describes implementing an open disclosure process.
Health service organisations are required to have an open disclosure program in place, and to ensure that the clinical workforce is trained in open disclosure processes.
I nformation on the NSQHS Standards accreditation scheme is available at www.safetyandquality.gov.au
Open disclosure FAQs: health service managers 1

What information should be provided to patients regarding open disclosure?
Informing patients, families or support persons about what can be expected during their hospital stay is an important element in the duty of health service organisations.
As well as informing them of what to expect normally, the information should also detail what to expect if something should go wrong. However it is important that this information be presented in the context of the larger framework of open communication with patients throughout their episode of care.
Possible communications strategies include:
1. Include the following information in a range of formats such as an information sheet, brochure or on the hospital website:
If something goes wrong during your care at hospital you can expect that:
 a member of your health care team will discuss with you what happened and any treatment that may be required as a result; and
 information will be provided to you on how the hospital is investigating what happened and what steps they are taking to prevent it from happening to someone else.
A patient information booklet and brochure have been developed for this purpose and are available from www.safetyandquality.gov.au/opendisclosure
2. Provide open disclosure information booklets and/or leaflets for patients and their carers when an adverse event occurs. These are available at www.safetyandquality.gov.au/opendisclosure
What information should be provided to staff regarding open disclosure?
A patient safety awareness culture should be fostered through communicating with staff about adverse events, including recommendations to minimise the risk of recurrence and consequent implementation of changes.
Health service organisations should identify a staff member responsible for communicating with staff on these issues.
Information may be provided by:
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electronic messages to all staff

verbal reporting and discussions at staff meetings and shift handovers

the immediate replacement of outdated policies and guidelines in departmental information sources

regular clinical meetings to discuss recommendations, changes to be implemented and management of clinical risk as a routine part of the education and training of all staff

clinical risk handbooks

newsletters

notice boards.
Where there has been a critical incident or sentinel event, or one that attracts media attention, a bulletin should be sent to staff to ensure that they have access to accurate information prior to seeing media reports. Staff should also be advised of the person responsible for media liaison and public enquiries.
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As a manager, when should I be involved in the open disclosure process?
There will be some situations where you should take an active role in the disclosure interview. This may be where:

A critical or sentinel event has occurred, and your participation may help to provide assurance to the patient and their family that the incident is viewed seriously by the organisation.
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The senior clinician involved requests your support.

The investigation has revealed management issues in the causes of the event.
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Where there has been a breakdown in the relationship between the patient and the healthcare team.
What can I do as a manager to assist implementation of open disclosure?
The manager’s role in assisting implementation of open disclosure is to create an organisational framework and culture that:
 puts patients’ interests first, before that of the organisation, colleagues or self

focuses on system improvement, not blaming individuals

provides a supportive environment for staff involved in an adverse event

ensures policies and guidelines that align with the Australian Open Disclosure
Framework are developed and implemented.
Should adverse events be disclosed to patients where no harm is apparent?
While disclosure is required where harm has occurred, it may be appropriate to disclose even where no harm is immediately apparent. If there is reasonable likelihood of harm resulting in the future as a result of the adverse event, then disclosure should be initiated. This is a matter of judgement by the healthcare team.
Disclosing to the patient following the event allows them to take an active part in their care and to know potential signs and symptoms they should look out for. This will reduce the patient’s concerns about any delays in their recovery and help to build trust between the patient and clinicians (see Australian Open Disclosure Framework
Section 2.3).
How can I decide when something has happened that requires disclosure?
Open disclosure is required where a patient has suffered some unintended harm
(physical or psychological) as a result of treatment. This may be a recognised complication, unanticipated incident, or a result of human or systems error. If the decision is made that the incident does not require disclosure this should be a decision that is defensible in public, and should be noted in the patient record (see
Australian Open Disclosure Framework Sections 2 and 7).
Are there circumstances in which unintended harm has occurred and disclosure is not required?
The Australian Open Disclosure Framework advises that patient preference should be considered in relation to open disclosure, that is, there may be some cases where the timing of providing the open disclosure information could have a significant effect on the patient’s ability to make decisions regarding their life. These decisions should
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be made on a case-by-case basis and the reasons for non-disclosure at that particular moment must be documented in the patient record. There is flexibility in determining the timing of disclosure to patients and their carers depending on several factors, including the condition of the patient and the availability of their support person (see Australian Open Disclosure Framework Section 9.2)
What should I do if a patient has suffered harm while under the care of a clinician or team from another institution or from outside your area of responsibility?
An adverse event may have occurred in an organisation or in another ward or department other than that in which it is identified. For example, it may be recognised that a post-operative patient in the ICU has suffered an adverse event during the surgery. First, establish whether the disclosure process has been initiated. If not, notify the senior clinician looking after the patient or the individual responsible for clinical risk in your own organisation (this should be determined by local policy). That person should establish whether:

the adverse event has already been recognised

the process of open disclosure has commenced elsewhere

investigations are in progress.
If not, the open disclosure process should be initiated. Whenever possible, the investigation of the adverse event and the disclosure process should occur in the health care organisation where the adverse event originated. When this is not possible, the most senior clinician now looking after the patient should initiate the disclosure process. Care should be taken to disclose only known facts (see
Australian Open Disclosure Framework Section 2.5).
What should I do where there has been an adverse event and the clinical team is unwilling to initiate the disclosure process?
Your organisation should have policies and guidance on the mechanism and reporting lines when this occurs, particularly in the case of the adverse event requiring immediate medical care. Maintain open communication with staff and explain the open disclosure process. Be supportive and help staff establish what to discuss with the patient. If there is still an obvious reluctance to participate, you should explore the reasons why there is an unwillingness to disclose.
If staff members are concerned about litigation or loss of reputation, encourage them to contact their medical defence organisation or professional indemnifier to clarify their position. You may wish to facilitate the open disclosure process by offering to organise a meeting of the team or by providing assistance with the disclosure interview.
Does it cause more harm to let patients know when an adverse event has occurred?
All adverse events that have, or may have, caused harm or may have done so require disclosure. A patient may be unnecessarily concerned about a delay in their recovery or may not know why they are experiencing certain symptoms.
An example of this could be someone who bled more than expected in surgery. The patient feels tired and listless, and is unsure why. Several days later, blood tests indicate there is a need for a transfusion. Telling the patient of the blood loss and the potential signs and symptoms when it occurred initially, would have allowed the patient more active participation in their care and caused them less worry. They are
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then more able to watch for signs that will guide them to seek medical intervention that may be required to prevent further harm.
What are the rights of clinicians involved when an adverse event occurs and the open disclosure process is initiated?
Clinicians have rights that should be considered during the open disclosure process.
The most relevant rights are:

The right to seek appropriate legal advice and to disclose information to legal advisers in a manner that ensures that it attracts legal professional privilege

The right to be treated fairly by the institution and to receive natural justice and procedural fairness

The right not to be defamed
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The right – and on some occasions, the contractual obligation – to seek appropriate advice and guidance from their indemnity insurers or medical defence organisations.
What preparation is required for open disclosure discussions?
Preparation is important to ensure open disclosure meetings go as well as possible.
Preparing for open disclosure will depend on your role in the process.
Firstly, open disclosure requires a specific set of skills. Health service organisations should ensure that:

there is trained expertise amongst staff to lead open disclosure

just-in-time information is provided to staff participating in open disclosure
 all staff are aware of the organisation’s commitment to openly disclose adverse events and that they are encouraged, and will be supported, to do so.
When it is time to participate in open disclosure, the key elements which need to be in place include:

establishing the facts (clinical and other facts)

identifying immediate support needs for everyone involved

assessing the event to determine the appropriate response

identifying who will take responsibility for discussion with the patient

considering the appropriateness of engaging patient support at this early stage, including the use of a facilitator or a patient advocate

ensuring everyone involved maintains a consistent approach in any discussions with the patient

considering legal and insurance issues and notify the relevant people

considering how to address issues regarding ongoing care such as billing and other costs, which should be addressed at the earliest opportunity

ensuring the patient record is up to date.
If participating with colleagues in open disclosure, preparatory meetings should be held to understand the issues and the individual responsibilities at the meeting.
It may be appropriate to rehearse some aspects of the conversation, such as the apology or expression of regret with the team. Often it is useful to go through the main elements of the information, including the apology or expression of regret.
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Preparation should be balanced by responding appropriately to the patient and the way the meeting progresses. Patients may not feel that the discussion is sincere if it is stilted or otherwise perceived as insincere.
What contributes to successful open disclosure?
Following are some key actions by providers that can contribute to successful open disclosure:
 Establishing a good rapport and relationship with patients (and their support persons) from the very start of the episode of care.
 Ensuring informed consent is obtained and that the patient has reasonable expectations prior to undergoing the care, treatment or procedure.
 Accurately conveying the risks involved in the procedure and in health care generally.
 Ensuring that patient’s support persons are identified formally.
 Acknowledging an unexpected event as soon as possible even if further investigation is required.
 Not speculating on the causes of an incident, making unrealistic promises or blaming yourself or others
 Being respectful to the patient, their support person and your colleagues at all times.
 Demonstrating remorse and compassion when talking to patients.
 Listening actively to the patient during disclosure discussions and being aware of your body language.
 Supporting your colleagues.
 Preparing for participation in open disclosure.
Does open disclosure create legal liability?
Open disclosure encourages clinicians to acknowledge that an adverse event has happened and to apologise or express regret for what has occurred.
Open disclosure does not, of itself, create legal liability. Acknowledging an adverse event, apologising or expressing regret, is not an admission of liability. Liability is established by a court and is based on an evidentiary matrix which may, in part, be based on statements made either before or after the event.
Health service organisation staff must be aware of the risk of making an admission of liability during open disclosure. In any discussion with the patient and their support persons during open disclosure, staff should take care not to speculate on the cause of an incident or pre-empt the results of any investigations. They must not apportion blame, or state or agree that they, other clinicians or health service organisations are liable for the harm caused to the patient.
The Australian Open Disclosure Framework provides guidance on what, and what not, to say when conducting open disclosure discussions, and highlights legal issues which should be considered, such as freedom of information, privacy, defamation, and qualified privilege.
Open disclosure FAQs: health service managers 6

Does an apology or an expression of regret mean admitting liability?
Legal advice suggests that an apology is not an admission of liability and that there are no legal impediments to an appropriately worded apology. It is not an admission of liability to:

Say the words I am or we are sorry

Explain how an adverse outcome occurred

Acknowledge that the patient is not happy with the outcome

Express your concern for the patient.
However, speculative statements and apportioning of blame to oneself, other individuals or institutions must be avoided.
Examples that may be useful are:
“I am very sorry this has happened”;
“I am sorry that this hasn’t turned out as expected”.
For more information see Australian Open Disclosure Framework Section 1.5 and
10.2, and additional resources Open disclosure: Guide for health service managers and Saying Sorry: a guide to apologising and expressing regret during open disclosure, both available at www.safetyandquality.gov.au/opendisclosure
Will open disclosure increase litigation?
There is no conclusive evidence that open disclosure either increases or decreases litigation. Current literature states that if a patient is told about an adverse event and they are treated quickly and harm prevented or minimised, the patient may be less inclined to pursue legal action.
In taking an active approach, you or your clinical staff may be able to talk to the patient in a way that defuses anger and restores trust. In some cases it may be appropriate, after consultation with the clinical team, management and insurers, to recommend a prompt and fair out of court settlement. When you offer support for follow up or additional treatment, i t doesn’t necessarily mean your organisation is accepting liability. For more information see Australian Open Disclosure Framework
Section 4.3 Open disclosure: Guide for health service managers and Saying Sorry: a guide to apologising and expressing regret during open disclosure, both available at www.safetyandquality.gov.au/opendisclosure ).
Litigation may be reduced if patients appreciate the fallibility and honesty of the clinician. If you or your clinical team do not disclose and serious mistakes come to light later on, the patient may think it is an attempt to cover up and become angry and litigious.
Further open disclosure information
Further information is available from:
Australian Commission on Safety and Quality in Health Care
Level 7, 1 Oxford St, Darlinghurst, NSW 2010
GPO Box 5480, Sydney NSW 2001
Tel: (02) 9126 3600 mail@safetyandquality.gov.au
www.safetyandquality.gov.au/opendisclosure
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