Open Disclosure FAQs for clinicians

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Frequently asked questions about open disclosure: clinicians

NOTE FAQs for health service managers are also available at www.safetyandquality.gov.au/opendisclosure

Contents

1. Background and ethical basis ................................................................................ 1

2. Legal issues .......................................................................................................... 2

3. The Australian Open Disclosure Framework ......................................................... 4

4. Specific questions about the process .................................................................... 5

1. Background and ethical basis

What is open disclosure?

Open disclosure describes the way clinicians communicate with patients 1 who have experienced harm during health care. Open disclosure is intended to:

assist patients that have experienced harm

guide clinicians, 2 the clinical workforce 3 and health service organisations in supporting patients that have experienced harm

ensure that health service organisations learn from adverse events.

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’

1 In this document, ‘patient’ also refers to support persons such as family members and carers.

2 Clinician is defined as "a healthcare provider, trained as a health professional. Clinicians include registered and non-registered practitioners, or a team of health professionals providing health care who spend the majority of their time providing direct clinical care".

3 Clinical workforce is defined as "the nursing, medical and allied health staff who provide patient care and students who provide patient care under supervision. This may also include laboratory scientists".

Open disclosure FAQs: clinicians and healthcare providers 1

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.

When health care does not go to plan, evidence suggests that patients want to know and understand what happened and why. They want to feel there is genuine regret that the event occurred and they want to know that steps will be taken to minimise the risk of similar events occurring again.

Why is open disclosure important?

For clinicians there is often uncertainty and confusion about disclosing information when health care does not go to plan. Actively and openly managing such incidents, including through the exchange of timely and appropriate information, is important for:

the recovery process of patients

clinicians to manage their involvement in, and recovery from, adverse events

health service organisations to learn from errors.

Ideally health service organisations should create environments that encourage identifying and reporting of adverse events. Part of this process requires moving away from blaming individuals to focusing on systems that reduce the possibility of human error.

Practising open disclosure can assist health service organisations develop a reporting culture as it supports clinicians managing unintended patient harm.

When is open disclosure required?

Open disclosure is required when a patient has suffered unintended harm during health care. This may be a recognised complication, unanticipated incident, or a result of human or systems error.

If it is agreed by the clinical team that, due to exceptional circumstances, an incident will not be disclosed, this should be noted in the patient record along with reasons for it (see the Australian Open Disclosure Framework Sections 2 and 7 for more detail).

2. Legal issues

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.

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Clinicians must be aware of the risk of making an admission of liability during open disclosure. In any discussion with the patient during open disclosure, clinicians 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.

There is minimal evidence to suggest either an increase or decrease of medico-legal risk due to open disclosure. Anecdotally, patients are motivated to litigate by a sense that information is being withheld, or that communication has been insufficient, or inappropriate, after adverse events.

Does apologising or expressing 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.

Examples that may be useful include:

“I am very sorry this has happened”;

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

For further information, see the Australian Open Disclosure Framework Section 1.5 and Part B, and the support resource Saying Sorry: a guide to apologising and expressing regret in open disclosure both of which are available from www.safetyandquality.gov.au/opendisclosure

In some circumstances, clinicians may feel it more appropriate to express regret rather than apologise.

Whether apologising or expressing regret, speculative statements must be avoided as should apportioning of blame to oneself, other individuals or institutions.

Is open disclosure practice mandatory?

Open disclosure is an accrediting activity under the National Safety and Quality

Health Service (NSQHS) Standards. Criterion 1.16 of Standard 1 requires the implementation of an open disclosure process.

This means that health service organisations accredited to the NSQHS Standards

(including public and private hospitals, day surgery units and dental clinics) must implement open disclosure in accordance with the Australian Open Disclosure

Framework.

More information on the evaluation requirements and criteria for open disclosure under the NSQHS Standards accreditation scheme is available at www.safetyandquality.gov.au/our-work/accreditation/

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3. The Australian Open Disclosure Framework

What is the Australian Open Disclosure Framework?

The Australian Open Disclosure Framework (the Framework) was released in 2013 by the Australian Commission on Safety and Quality in Health Care. The Framework is an updated and revised version of the national Open Disclosure Standard, which was released in 2003.

The Framework was developed with input from consumers, clinicians, indemnity insurers, health departments and health service organisations from across the country.

The Framework reflects the latest evidence and practice of open disclosure. It provides a framework for clear and consistent communication by health service organisation staff with patients when health care does not go to plan. It includes guidance on discussing what has happened, why the incident occurred, and what is being done to minimise the risk of it happening again.

Why was the Australian Open Disclosure Framework developed?

The Framework is designed to assist clinicians and health service organisations implementing and practicing open disclosure. It is a nationally consistent basis for open disclosure in Australia. The Framework encourages greater openness about adverse events in health care so that the causes of events can be understood and changes made to minimise the risk of similar events occurring again. It also means that consumers can expect to be treated with respect and consideration whenever and wherever their health care does not go to plan.

When health care does not go to plan, patients and their carers want to know and understand what happened and why. They want to feel there is genuine regret that the event occurred and they want to know that steps will be taken to minimise the risk of similar events occurring again. The Framework is designed to assist health service organisations meet these expectations and to communicate them openly and fully with patients following adverse events.

For clinicians, there is often uncertainty and confusion about disclosing information when health care does not go to plan. Actively and openly managing such incidents, including through the exchange of timely and appropriate information, is important both for patients, and their carers, to recover. It is also important for clinicians to manage their involvement in, and recovery from, adverse events.

Openly discussing adverse events is important for improving the safety and quality of care provided. A key step in this process is health service organisations encouraging greater openness in response to adverse events.

Finally, the skills that clinicians practice and develop through open disclosure have other applications. They include interpersonal skills, communication, active listening and empathy. Patients commonly value communication skills over other medical skills. Enhancing communication skills can help a clinician build and maintain trust with their patients and build inter-professional relationships. These can all enhance clinical practice.

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How is the Australian Commission on Safety and Quality in Health Care assisting with implementation of the Australian Open Disclosure Framework?

The Commission ensures that the Framework reflects the latest evidence, practice and advice on conducting, and participating in, open disclosure.

It makes available a range of resources and materials for public and private facilities that implement and practice open disclosure.

The Framework and support materials are available at www.safetyandquality.gov.au/opendisclosure

4. Specific questions about the process

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 empathy, and genuine remorse and compassion as appropriate, 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.

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

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 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.

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.

Does it cause more harm to let patients know when an adverse event has occurred?

All adverse events require some level of disclosure. Open disclosure encourages prompt and open communication after adverse events because not doing so can create other harms or mean that appropriate action is not taken to rectify the harm.

A patient may be unnecessarily concerned about a delay in their recovery or may not know why they are experiencing certain symptoms in the absence of information.

Informing them of unintended outcomes means that the patient can more actively participate in their care, can understand the progress of their recovery and can provide important information to their attending clinicians as best as possible throughout the episode of care.

Should adverse events be disclosed to patients when no harm is apparent?

While disclosure is required when harm has occurred, it may be appropriate to disclose even when no harm is immediately apparent. This is a matter of judgement by the healthcare team.

The Australian Open Disclosure Framework suggests that if there is reasonable likelihood of further future harm resulting from the adverse event, disclosure should be initiated.

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Disclosing to the patient following the event allows them to take an active part in their care and to know potential signs and symptoms for which they should be alert. This will reduce the patient’s concerns about any delays in their recovery and help to build trust between the patient and clinician (see Australian Open Disclosure Framework

Section 2.3).

When an adverse event occurs and open disclosure is initiated, what can involved clinicians expect?

An important element of open disclosure is ensuring that clinicians involved in adverse events are supported emotionally and provided with appropriate advice.

They should be provided with access to assistance and provided with the necessary information and support for them to fulfil their open disclosure role. The Framework encourages clinicians involved in adverse events to:

communicate promptly and openly with patients

be treated fairly by the institution and to receive natural justice and procedural fairness

not to be defamed

seek appropriate advice and gui dance from their “indemnifiers” (be they insurers or medical defence organisations)

seek appropriate legal advice and disclose information to legal advisers in a manner that ensures that it attracts legal professional privilege.

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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