Open

Disclosure
Standard

GA

A NATIONAL STANDARD FOR OPEN COMMUNICATION IN PUBLIC AND

PRIVATE HOSPITALS, FOLLOWING AN ADVERSE EVENT IN HEATH CARE
 Open
Disclosure
Standard
A NATIONAL STANDARD FOR OPEN COMMUNICATION IN
PUBLIC AND PRIVATE HOSPITALS, FOLLOWING AN ADVERSE
EVENT IN HEATH CARE

First published in July 2003 by

the Former Australian Council
for Safety and Quality in Health Care

Reprinted April 2008

ACKNOWLEDGEMENTS

The Australian Commission on Safety and Quality in Health Care acknowledges the
development of this publication by the former Australian Council for Safety and
Quality in Health Care.

The Commission acknowledges the significant role played by the Standards

Development Committee who volunteered their time and expertise to develop the
Open Disclosure Standard: A National Standard for open communication in public
and private hospitals, following an adverse event in health care. The Commission
also acknowledge stakeholders involved in the consultation and development of the
Standard with particular thanks to Rohan Hammett, Louise Kershaw and Julie Bate
for their significant contributions. In addition the key role played by Standards
Australia is acknowledged by the Commission.

© Commonwealth of Australia 2008

This work is copyright. Apart from any use permitted under the Copyright Act 1968, no part
may be reproduced without prior permission from the Commonwealth Department of Health
and Ageing.

Disclaimer
While this document gives some guidance on legal issues, it does not claim to provide legal
advice. Hospitals and other organisations implementing the Standard will need to seek their
own legal advice on implementing the Standard. Organisations implementing the Standard
remain fully responsible for managing their legal risks
The following organisations were voting members of the Standards Development
Committee who participated in the development and endorsement of this standard:

Association for Teachers of Ethics and Law in Australia and New Zealand Medical
Schools
Australian College of Health Service Executives
Australian Council on Healthcare Standards
Australian Health Ministers’ Advisory Council
Australian Insurance Law Association
Australian Medical Association
Committee of Presidents of Colleges
Commonwealth Department of Health and Ageing
Consumers’ Health Forum
Health Consumers Council
Health Professions Council of Australia
Maternity Alliance
Medical Defence Association of South Australia
Medical Error Action Group
National Council of Health Complaints Commissioners
National Rural Health Alliance
Australian Nursing Federation
Pharmaceutical Society of Australia
Plaintiff’s Lawyers Association
Private Healthcare Industry Quality and Safety Committee (PHIQS)
Royal Australian College of General Practitioners (NSW)
Royal College of Nursing, Australia
Royal Australasian College of Medical Administrators
PREFACE

The Open Disclosure Standard was an initiative of the former Australian Council for
Safety and Quality in Health Care. The Standard aims to promote a clear and
consistent approach by hospitals (and other organisations where appropriate) to
open communication with patients and their nominated support person following an
adverse event. This includes a discussion about what has happened, why it
happened and what is being done to prevent it from happening again. It also aims to
provide guidance on minimising the risk of recurrence of an adverse event through
the use of information to generate systems improvement and promotion of a culture
that focuses on health care safety. The Standard was prepared by the Standards
Australia Committee on Open Disclosure and informed by external national
consultation undertaken during 2002.

The Standard provides a framework designed to be used in the development, or

upgrading, of an organisation’s internal policies, processes and practices regarding
adverse events and open communication. The framework has been developed
initially for application in hospitals. It may require some modification before it is
appropriate for implementation in other health care environments. Organisations will
need to consider implementing the process outlined in this Standard within their
existing internal policies, which may need to be changed or upgraded to facilitate the
open disclosure process, and with due consideration given to legal and insurance
requirements and risks.

The Standard is divided into two sections.

Section A provides an overview of the Standard. It also includes a brief discussion on

why the Standard was developed, key issues for consideration when implementing
open disclosure and the scope of the Standard.

Section B describes the open disclosure process.

TABLE OF CONTENTS

SECTION A KEY ISSUES FOR CONSIDERATION .................................................................. 1

1 INTRODUCTION ..................................................................................................................... 1

1.1 Background ................................................................................................................... 1

1.2 Principles for open disclosure ....................................................................................... 2

1.3 Development of local policies ....................................................................................... 3

2 SCOPE ......................................................................................................................... 5

3 KEY TERMS ......................................................................................................................... 6

4 PATIENT ISSUES.................................................................................................................... 6

4.1 Communication ............................................................................................................. 6

4.2 Advocacy and support................................................................................................... 7

4.3 Particular patient circumstances ................................................................................... 8

5 STAFF ISSUES ....................................................................................................................... 8

6 ORGANISATIONAL ISSUES................................................................................................... 9

6.1 General ......................................................................................................................... 9

6.2 Organisational responsibilities .................................................................................... 10

6.3 Responsibility of the governing body and chief executive officer (CEO)..................... 10

7 LEGAL CONSIDERATIONS .................................................................................................. 10

7.1 General Introductory ................................................................................................... 10

7.2 General ....................................................................................................................... 10

7.3 Admission of liability.................................................................................................... 11

7.4 Protection of communications and documents from disclosure .................................. 11

7.5 Legal professional privilege......................................................................................... 12

7.6 Qualified privilege legislation....................................................................................... 12

7.7 Freedom of information (FOI) legislation..................................................................... 13

7.8 Privacy and confidentiality........................................................................................... 14

7.9 Defamation.................................................................................................................. 14

7.10 Insurance considerations ............................................................................................ 14

SECTION B THE OPEN DISCLOSURE PROCESS ................................................................ 16

8 PRIVACY AND CONFIDENTIALITY...................................................................................... 16

9 INCIDENT DETECTION OR RECOGNITION ....................................................................... 16

9.1 General ....................................................................................................................... 16

9.2 Identifying an adverse event ....................................................................................... 16

9.3 Priority ......................................................................................................................... 16

9.4 Adverse events occurring elsewhere .......................................................................... 16

9.5 Criminal or intentionally unsafe act ............................................................................. 17

10 INITIATING THE OPEN DISCLOSURE PROCESS ............................................................. 17

10.1 Initial assessment to determine level of response ...................................................... 17

10.2 Management of low-level incident............................................................................... 18

10.3 Management of high-level incidents ........................................................................... 18

10.4 Choosing the individual to make the disclosure .......................................................... 19

10.5 Content of initial disclosure discussion with the patient .............................................. 20

10.6 Notification .................................................................................................................. 21

11 DOCUMENTATION............................................................................................................... 22

11.1 General ....................................................................................................................... 22

11.2 Health care records..................................................................................................... 22

11.3 Incident report ............................................................................................................. 22

12 GRADING THE EVENT TO DETERMINE

THE LEVEL OF INVESTIGATION ......................................................................................... 23

13 THE INVESTIGATION .......................................................................................................... 23

13.1 The investigation and analysis .................................................................................... 23

13.2 The personnel to be involved ...................................................................................... 24

14 PRELIMINARY FOLLOW-UP................................................................................................ 25

14.1 Preliminary follow-up with the patient and their support person.................................. 25

14.2 Preliminary follow-up with staff ................................................................................... 25

15 RECOMMENDATIONS AND IMPLEMENTATION ............................................................... 26

15.1 Communication of recommendations to management................................................ 26

15.2 Responsibility of management .................................................................................... 26

15.3 Implementation of recommendations .......................................................................... 26

16 COMPLETING THE PROCESS............................................................................................ 27

16.1 Communication to patient ........................................................................................... 27

16.2 Continuity of care ........................................................................................................ 27

 16.3 Communication with the GP, residential facility and other community care providers 28

16.4 Monitoring improvements............................................................................................ 28

16.5 Communication of changes to staff............................................................................. 28

16.6 Communication of lessons learned throughout the health system.............................. 28

APPENDIX A GLOSSARY.......................................................................................................... 29

APPENDIX B FINANCIAL SUPPORT ........................................................................................ 32

APPENDIX C PARTICULAR PATIENT CIRCUMSTANCES ...................................................... 33

C.1 General ....................................................................................................................... 33

C.2 When a patient dies .................................................................................................... 33

C.3 Children....................................................................................................................... 34

C.4 Patients with mental health issues .............................................................................. 34

C.5 Patients with cognitive impairment.............................................................................. 34

C.6 Patients who do not agree with the information provided ........................................... 34

C.7 Patients with language or cultural diversity considerations......................................... 35

C.8 Aboriginal or Torres Strait Islander patients................................................................ 36

C.9 Patients with other communication requirements ....................................................... 36

APPENDIX D EXAMPLE OF MATRIX FOR

INITIAL ASSESSMENT OF LEVEL OF RESPONSE ........................................ 37

APPENDIX E EXAMPLE OF INCIDENT GRADING MATRIX .................................................... 38

SECTION A KEY ISSUES FOR CONSIDERATION

1 INTRODUCTION

1.1 Background
Open disclosure is the open discussion of incidents that result in harm to a patient
while receiving health care. The elements of open disclosure are an expression of
regret, a factual explanation of what happened, the potential consequences and the
steps being taken to manage the event and prevent recurrence.
The Open Disclosure Standard forms part of wider national initiatives of
Commonwealth, State and Territory governments, through the Australian
Commission on Safety and Quality in Health Care, to promote a safer and better
health care system. Australia’s health care system provides high quality
services. As knowledge about health grows and the use of new technologies
increases, the provision of health care is becoming more complex and
sometimes things go wrong.
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 focussing on establishing
systems of organisational responsibility while at the same time maintaining
professional accountability. In this context, health care organisations need to foster
an environment where people feel supported and are encouraged to identify and
report adverse events so that opportunities for systems improvements can be
identified and acted on.
Ensuring that communication is open and honest, and that it is immediate is
important to improving patient safety. While open disclosure is already occurring in
many areas of the health system, this Standard is about facilitating more consistent
and effective communication following adverse events. This includes
communication between the following:
a) Health care professionals.
b) Health care professionals and patients and their support person.
c) Health care professionals, health care managers and all staff.
Effective communication for patients commences from the beginning of an episode
of health care and continues throughout the entire episode.
For health care professionals, there is an ethical responsibility to maintain honest
communication with patients and their support person, even when things go wrong.
By ensuring that there is good communication when an adverse event occurs, we
can begin to look at ways to prevent them from recurring.
The Standard also aims to foster commitment from health care organisations to –
d) provide an environment where patients and their support person receive the
information they need to understand what happened;
e) create an environment where patients, their support person, health care
professionals and managers all feel supported when things go wrong;
f) build investigative processes to identify why adverse events occur; and

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g) bring about any necessary changes in systems of clinical care, based on the
lessons learned.
In implementing open disclosure, each organisation will operate –
h) within its own policies, procedures and processes;
i) within existing or upgraded integrated risk management frameworks and quality
improvement processes;
j) in accordance with applicable Commonwealth State/Territory laws and
regulatory regimes; and
k) within particular requirements of insurance and employment contracts.

1.2 Principles for open disclosure

This Standard was developed within complex and dynamic processes. It attempts
to address the interests of consumers, health care professionals, managers and
organisations, and other key stakeholder groups. Several themes were consistently
raised and have become principles on which the Standard is built. They include the
following:
1. Openness and timeliness of communication – When things go wrong, the
patient and their support person should be provided with information about what
happened, in an open and honest manner at all times. The open disclosure
process is fluid and may involve the provision of ongoing information.
2. Acknowledgment – All adverse events should be acknowledged to the patient
and their support person as soon as practicable. Health care organisations
should acknowledge when an adverse event has occurred and initiate the open
disclosure process.
3. Expression of regret – As early as possible, the patient and their support
person should receive an expression of regret for any harm that resulted from
an adverse event.
4. Recognition of the reasonable expectations of patients and their support
person – The patient and their support person may reasonably expect to be
fully informed of the facts surrounding an adverse event and its consequence,
treated with empathy, respect and consideration and provided with support in a
manner appropriate to their needs.
5. Staff support – Health care organisations should create an environment in
which all staff are able and encouraged to recognise and report adverse events
and are supported through the open disclosure process.
6. Integrated risk management and systems improvement – Investigation of
adverse events and outcomes are to be conducted through processes that
focus on the management of risk (see AS/NZS 43601). Outcomes of
investigations are to focus on improving systems of care and will be reviewed
for their effectiveness.
7. Good governance – Open disclosure requires the creation of clinical risk and
quality improvement processes through governance frameworks where adverse
events are investigated and analysed to find out what can be done to prevent
their recurrence. It involves a system of accountability through the

1
Australian/New Zealand Standard for Risk Management

2
 organisation’s chief executive officer or governing body to ensure that these
changes are implemented and their effectiveness reviewed.
8. Confidentiality – Policies and procedures are to be developed by health care
organisations with full consideration of the patient’s, carer’s and staff’s privacy
and confidentiality, in compliance with relevant law, including Commonwealth
and State/Territory Privacy and health records legislation.

1.3 Development of local policies

The Open Disclosure Standard provides a flexible framework designed to be used
by organisations, health care professionals and managers when developing or
amending policies and procedures for open disclosure. It is essential that each
organisation’s policy and procedure meets its unique needs and resource
availability, while reflecting the specific legal, regulatory, institutional and cultural
considerations relevant to them.
In particular, policies need to take into account the following:
a) The requirements of those who provide insurance to health care organisations
and professionals, both of which should be involved in the policy development
at an early stage including pro-actively educating their constituents involved in
open disclosure.
b) The necessity of appropriate training and education for relevant staff to ensure
a coordinated and informed approach to open disclosure and avoid admissions
of liability (in either verbal or documentary form).
c) The need for involvement of consumers and health care professionals in
developing policies and processes.
A summary of the open disclosure process is demonstrated in the flow chart on the
next page.

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 Patient information and consent process
9
Incident detection, prevent further harm, provide appropriate care, identify support for staff and patients

Discuss care plan w ith patient and their support person

10.1
Where it is considered that
Assess level of response determined by incident severity* harm may be due to an
intentionally unsafe or criminal 9.5
Notify senior health care professional act refer to disciplinary
guidelines. 10.1

High level response 10.1

10.2 Low Level Response
Notify person responsible for clinical risk management
10
Team discussion

Ongoing feedback and support for patients, carers and staff.

Identify support for staff, identify support for patient and their
support person 10
Know n facts, discussion w ith patient, expression of
10.5 regret, care plan, patient support

Evaluation of Open Disclosure Process

Discussion w ith patient and their support person. Know n facts, 10.5
expression of regret, care plan, patient support, staff support by
person responsible for clinical risk management w here needed.

Grade level of investigation by person responsible for clinical risk

10.2 Local review and changes w here indicated 12
management.

Multidisciplinary team meeting to establish facts. 13

13.3 In depth investigation - communication w ith clinical team

12 Report event to risk management unit Follow up discussions w ith patient and their support person 14

Communication of results of investigation and recommendations to

clinical team 14.2

Grade Level of investigation by person responsible Recommendations to management - Evaluation and implementation of improvement w ithin 15
for clinical risk six months

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*Consider legal or insurance issues and risks and Feedback to health care Feedback to patient and
respond w here appropriate. Feedback to staff
system support person

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2 SCOPE
The Open Disclosure Standard provides a framework for communication with
patients and their support person following an adverse event. This framework is
designed to be used by public and private hospitals, health care professionals and
managers when developing or amending their policies and procedures for open
disclosure to patients and their support person, following an adverse event. The
Standard is based on concepts and principles that should be broadly applicable to
other health care and community settings.
There is no agreed universal definition of “adverse event”. For the purposes of this
Standard, an "adverse event" is defined as “an incident in which unintended harm
resulted to a person receiving health care”.
Adverse events also include harm to patients arising from the environment of
care for which the hospital is responsible. At times, the patient's perspective on
whether he or she has suffered “harm” may differ from the views of the health care
professional or the organisation. In this instance, the patient’s view should trigger
the open disclosure process, regardless of whether an initial assessment
suggests a recognised complication, or clinical or system error.
The following factors are outside the scope of this Standard:
a) Consent process
Consent by a patient for treatment is a major legal issue for all health care
professionals. There is a body of law on what does and does not constitute
consent. There is also legislation in the States and Territories dealing with the issue
in relation to particular people, e.g. children. The law imposes on health care
professionals the duty to warn of risks and options, and discussion of potential
outcomes. While the consent process is integral to the patient/provider relationship,
it is not considered necessary to discuss this issue in detail as “consent” in the
open disclosure process will be no different to what is required in the ordinary
health care context.
b) Costs incurred by patients
General suggestions about managing costs incurred by the patient are made in
Appendix B.
c) Disciplinary processes
Disciplinary processes vary between jurisdictions and particular organisations.
Information about disciplinary processes is outside the scope of this Standard.
However, it is important to ensure that the open disclosure investigation is
continued, even when a referral is made to a disciplinary process, as useful
information for system improvement may emerge.
Organisations should have guidelines in place on how and when to make a referral
to a disciplinary process. In developing and amending these guidelines, care
should be taken to avoid potential conflict between disciplinary and open disclosure
investigations. This includes ensuring that the rights of the person subject to the
disciplinary process are recognised and respected, such as the right to be given an
opportunity to respond to findings by the open disclosure investigation and to have
legal, union or other representation.

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3 KEY TERMS
A full Glossary of terms used in this Standard is included at the end of this
document (Appendix A). For the purpose of this Standard, the following terms are
defined as indicated.

a) Adverse event
An incident in which unintended harm resulted to a person receiving health care2.

b) Expression of regret
An expression of sorrow for the harm experienced by the patient.

c) Individual responsible for clinical risk

Health care organisations need to designate responsibility for the management of

risks associated with the delivery of clinical care. The person responsible needs to
be of sufficient seniority to have credibility and be able to drive change to effect
improvements. He or she will oversee the implementation of the open disclosure
process within the organisation.

d) Support person
Information about an adverse event will be given to a patient’s nominated “support”
person in appropriate circumstances, taking account of the patient’s wishes,
Confidentiality and privacy requirements and the organisation’s internal policies.
The nominated support person/persons may be any individual, identified by the
patient as a nominated recipient of information regarding their care. This may
include family, friend, partner or those who care for the patient.
In cases of a dispute between, say, family and partners or friends about who should
receive information, the patient’s wishes, expressed on the admission form, should
be paramount. In addition, some people have a legal relationship which entitles
them to receive information (for example, in some cases, a parent, legal guardian
or an executor).
Given the complexities, references in this Standard to “support person” should be
read with the words, “where appropriate”.
However, it is highly recommended that nominated support persons be involved in
the open disclosure process from the outset so as to be able to give appropriate
support and care to the patient.

4 PATIENT ISSUES

4.1 Communication
Health care organisations need to create an environment that facilitates open and
effective communication. Policies and practices should address the following:

2
Wilson, Runciman, Gibberd (1995) Quality in Health Care Study, Medical Journal of Australia 163 (9):
458-471.

6
a) They should ensure early identification of the patient’s needs including, but not
limited to, documentation at the time of admission of –
· the names of particular individuals to provide assistance and support to the
patient;
· the names of those individuals (who may be different to the patient’s next of
kin or those identified above) that the patient has chosen to receive
information about their health care, and any restrictions on disclosure; and
· whether an interpreter service may be required for the patient. (See
Appendix C.7 and C.9).
b) They should encourage patients to notify the clinical team of any issues or
conditions that may affect their care.
c) Where an adverse event has occurred, policies and practices should provide
assurance that an ongoing care plan will be developed in consultation with the
patient and their support person, and that the plan will be followed through;
facilitate inclusion of the patient’s support person in discussions about an
adverse event where the patient agrees.
d) Policies, processes and practices should provide appropriate opportunities for
the patient and their support person to obtain information about the adverse
event.
e) They should provide information about the open disclosure process to patients
and their support person in verbal and written format. For low level response
events where requested and for high level response events as a matter of
course.
f) Where a patient has died as a result of an adverse event, subject to the
requirements of the coroner and legislation, policies and practices should
ensure that the support person is provided with known information, care and
support. The support person should also be referred to the coroner for more
detailed information.

4.2 Advocacy and support

Patients and their support persons may need considerable help and support after
experiencing an adverse event. Support may be provided by families, other support
persons, social workers, religious representatives and, where available and
appropriate, trained patient advocates. Where a patient needs more detailed long-
term emotional support, the organisation should provide advice to the patient on
how to gain access to appropriate counselling services.
Health care organisations should provide the following to patients:
a) Information including contact details on services provided by social workers,
religious representatives and trained patient advocates who can provide
emotional support, help patients identify the issues of concern, support patients
at meetings with staff and provide information about appropriate community
services.
b) Contact details of a staff member who will maintain an ongoing relationship
with the patient. Where possible restrict telephone use to arranging meetings
or relaying specific information. More detailed discussion or explanation should
be conducted via face-to-face meetings where appropriate.

7
c) Information on how to make a complaint, including contact details for the
relevant State/Territory health complaints agency (see AS 4269–1995
Complaints handling) and on rights to access their medical records.

4.3 Particular patient circumstances

When considering open disclosure, the approach may be modified by consideration
of the patient’s personal circumstances. Appendix C provides advice on
managing –
a) when a patient dies;
b) patients who are children;
c) patients with mental health issues;
d) patients with cognitive impairment;
e) patients who do not agree with the information provided;
f) patients with special language or cultural considerations (including recent
migrants and visitors);
g) patients from Aboriginal and Torres Strait Islander communities; and
h) other patients with special communication needs (eg, hearing, sight or mobility
impaired).

5 STAFF ISSUES
When a patient suffers an adverse event, individual staff members involved in the
clinical care of the patient may also require emotional support and advice. Staff
involved in the open disclosure process should be provided with access to
assistance, support and the information they need to fulfil the role required of them.
To support staff, health care organisations should –
a) provide advice and training on the management of adverse events,
communication skills and the need for practical, social and psychological
support, as part of a general training program in the management of clinical
risk for all staff, as well as particular training on the open disclosure process;
b) actively promote an environment that fosters peer support and discourages the
attribution of blame;
c) ensure that staff are not discriminated against because of their involvement in
open disclosure processes;
d) provide facilities for formal or informal debriefing of the staff involved in an
adverse event, where appropriate, as part of the support system and separate
from the requirement to provide statements for the purposes of investigation.
(see clauses 7.5, 7.6, 7.8);
e) provide information to staff involved in the adverse event on the investigation
and its outcomes (see clause 14.2);
f) provide information on the support systems currently available for staff
distressed by adverse events (Doctors Health Advisory Service, medical
defence organisations, professional and collegiate associations and trade
unions, hospital counsellors, employee assistance scheme, referral to

8
 specialised mental health care where appropriate) and encourage timely
consultation with these organisations and advisers; and
g) give consideration to developing specific systems of support in their own
institutions or in collaboration with neighbouring facilities.
The interests and circumstances of individual staff may not be the same as the
organisations or of other staff, particularly where it appears that the incident may
lead to disciplinary proceedings or give rise to legal liability. Organisations must
also take into account in their policies and practices the rights of health care
professionals. This should include ensuring in policies and practices that –
h) the open disclosure process focuses on safety and not attributing blame,
leaving issues relating to individuals to disciplinary processes, if this is
considered appropriate;
i) criticism and adverse findings against individual professionals is avoided. If
adverse findings do have to be made, treat the professional fairly and afford
natural justice, including giving the person the opportunity to comment on any
adverse findings and taking those comments into account. This will also help to
avoid defamatory statements (both verbal and written); and
j) recognise the obligation and/or right of professionals to seek appropriate
advice and guidance from their indemnifiers and other relevant advisers and to
act in accordance with such advice.

6 ORGANISATIONAL ISSUES

6.1 General
Good governance and quality assurance require that organisations shall be able to
demonstrate that they learn from and improve their performance through
continuous monitoring, and by reviewing the systems and processes in place for
meeting their objectives and delivering appropriate outcomes. Health care
organisations need to ensure appropriate direction and internal control through a
system of governance. It is imperative that each facility and its management,
including boards of governance and quality councils, show the capacity and
willingness to learn from adverse events and to disseminate learning for the wider
good of the community.
Health care organisations should –
a) acknowledge that health care is inherently risky and that there is a need to
reduce risk wherever possible;
b) create a culture and system to encourage notification and open and honest
communication of adverse events;
c) avoid unnecessary punitive action against those involved in an adverse event,
while ensuring appropriate professional accountability; and
d) foster community awareness of the occurrence of adverse events to users of
the health service and promote open disclosure to patients.
The organisation will need to determine whether the open disclosure process is to
be implemented into existing systems and policies, such as risk management and
identification of adverse events, or whether those systems need to be amended to
take account of the open disclosure process.

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6.2 Organisational responsibilities
Health care organisations should ensure that they –
a) have in place integrated risk management and quality improvement processes;

b) provide training and support to staff in communication skills, investigation and

grading of adverse events, risk management and management of legal issues;
c) actively promote and disseminate information about open disclosure policy and
procedures to staff and patients;
d) designate key staff to participate in and have responsibility for patient safety,
quality improvement and risk management;
e) have established systems to identify adverse events;
f) have in place mechanisms for investigation of adverse events and analysis of
factors causing adverse events;
g) have in place processes for implementing change to improve health care
safety; and
h) implement appropriate monitoring and review mechanisms for the open
disclosure process.

6.3 Responsibility of the governing body and chief executive officer (CEO)
A health care organisation’s governing body, through the CEO, will have ultimate
responsibility for ensuring that appropriate policies, processes and practices are in
place and that, if necessary, changes occur to improve patient safety. They should
also ensure that those with operational responsibility for an organisation have the
means to implement recommended changes.

7 LEGAL CONSIDERATIONS

7.1 General introductory

It is not considered that these legal issues should inhibit implementation of the
Open Disclosure Standard, but facilitate its practical application.

7.2 General
An organisation’s internal open disclosure policy and training materials need to pay
due regard to and be consistent with relevant legal obligations. Insurance issues
will also need to be taken into account. In a hospital setting there is a complex web
of relationships, with attendant rights, roles and responsibilities. A range of health
care professionals are likely to be involved in an adverse event. Responsibilities
will be owed to the patient and the organisation, although the specific legal basis of
the relationship with the organisation will vary depending on whether the health
care professional is regarded at law as an employee or as an independent
contractor.
These legal issues need to be considered prior to and during the investigation.

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The legal implications of the open disclosure process will vary between jurisdictions
and types of organisations (eg, public and private). Organisations need to consider
the legislation applying to them, both Commonwealth and State/Territory and
general law principles.
Key legal and insurance issues are discussed in the following clauses.

7.3 Admission of liability

In discussions with the patient and their support person under the open disclosure
process, health care professionals may –

a) acknowledge that an adverse event has occurred;

b) acknowledge that the patient is unhappy with the outcome;

c) express regret for what has occurred;

d) provide known clinical facts and discuss ongoing care (including any side effects
to look out for);

e) indicate that an investigation is being, or will be undertaken to determine what

happened and prevent such an adverse event happening again;

f) agree to provide feedback information from the investigation when available; and

g) provide contact details of a person or persons within the health care organisation
whom the patient can contact to discuss on-going care (see clause 16.1).

Health care professionals need to be aware of the risk of making an admission of

liability during the open disclosure process. In any discussion with the patient and
their support person during the open disclosure process, the health care professional
should take care not to –

h) state or agree that they are liable for the harm caused to the patient;

i) state or agree that another health care professional is liable for the harm caused
to the patient; or

j) state or agree that the health care organisation is liable for the harm caused to
the patient.

7.4 Protection of communications and documents from disclosure

Communications and documents (including emails) produced in response to an
adverse event may have to be disclosed later in any legal proceedings or, for public
hospitals, in response to a freedom of information application.
It is therefore important that care is taken in all communications and documents,
stating as fact, only what is known to be correct.

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In some circumstances, which should be detailed in the organisation’s open
disclosure policy, it may be necessary to undertake the open disclosure process in
tandem with other legal or investigative processes so as to appropriately utilise –
a) legal professional privilege; or
b) qualified privilege legislation.

7.5 Legal professional privilege

It may be that the organisation or legal adviser requires particular documents to be
created (e.g, reports, witness statements) for the purpose of obtaining or giving
legal advice on the incident or for use in legal proceedings, should this eventuate.
If so, the organisation should be able to claim that those communications and
documents attract legal professional privilege and do not have to be disclosed to a
third party (usually the patient in any legal proceedings) or in a freedom of
information application.
However legal professional privilege applies only in limited circumstances and a
number of important principles need to be considered:
a) The principle provides that confidential communications, including documents,
between a lawyer and client made for the dominant purpose of the client
obtaining, or the lawyer giving legal advice, or for use in existing or
contemplated litigation, are protected from disclosure.
b) A communication can be verbal or in writing.
c) Legal professional privilege belongs to the client (not the lawyer) who is
receiving the legal advice or legal services. This is the organisation which is
obtaining the legal advice. Health care professionals, both those employed by
the organisation or who are independent contractors, may have sought their
own legal advice and then claimed legal professional privilege for
communications between them and their lawyers.
d) The client can waive legal professional privilege so that the protection no
longer applies. A waiver can be express or implied. If protection is sought, it is
important not to do anything that inadvertently discloses the communication or
document so that it is no longer confidential.

7.6 Qualified privilege legislation

The Commonwealth and all States have enacted legislation that protects
from disclosure to third parties certain information generated as a result of
particular quality assurance activities.3
The Commonwealth and State legislation (but not the ACT’s) requires that persons
who acquire information solely as a result of their membership of or an association
with a committee or project that attracts qualified privilege, must not make a record
of or divulge information to any person, with limited exceptions.

3
Health Act 1993 (ACT), Health Administration Act 1982 (NSW) (ss.20D-20K), Health Services Act
1991 (Qld) (ss. 30-38), Health Commission Act 1976 (SA) (s. 64D), Health Act 1997 (Tas), Health
Services Act 1988 (Vic) (s. 139), Health Services (Quality Improvement) Act 1994 (WA) and
Health Insurance Act 1973 (Cth) (Part VC).

12
Many of the adverse events which trigger the open disclosure process will not
trigger a quality assurance activity under the legislation (assuming that the
legislation applies in a particular case), and accordingly, in many cases of an
adverse event, that legislation and the qualified privilege will not apply. In these
circumstances, the open disclosure process will not be affected by the quality
assurance legislation.
Where the quality assurance legislation does apply, however, information and
documentation arising as part of the quality assurance investigation may not be
disclosed under the open disclosure process. Accordingly, in those circumstances
where qualified privilege will apply to the investigation, organisations and health
care professionals need to be aware that their ability to disclose information to a
patient or support person pursuant to the open disclosure process will be restricted.
In some jurisdictions it is possible to release some information. In developing open
disclosure policy, organisations need to consider specific conditions on release of
information covered by qualified privilege legislation.
A health care organisation which has the qualified privilege legislation available to it
should include in its internal open disclosure policy, the circumstances where it is
likely that a quality assurance activity under the legislation will be invoked.

7.7 Freedom of information (FOI) legislation

Public hospitals are subject to FOI legislation, which varies across jurisdictions.
The Commonwealth, the States and Territories have enacted FOI
Legislation4. Generally, FOI legislation creates a right to access information
contained on records held by government agencies (subject to some exceptions
and exemptions) and a right to bring about amendments to records containing
personal information which is incomplete, out of date or misleading.
Health care professionals should take into consideration, when creating documents
as part of the open disclosure process, that the document may become available to
the patient. Every effort should be made to ensure that the documents are accurate
and are written in appropriate language.
In particular, documents should restrict themselves to clinical facts which have
been verified, as far as is possible, as accurate and should not –
a) attribute blame to any health care professional or the health care organisation;
b) record opinions about staff, patients, support persons or others, unless those
are expert opinions with supporting evidence for the opinion recorded; or
c) contain statements about another person which are, or are likely to be,
defamatory.

4
Freedom of Information Act 1982 (Cth), Freedom of Information Act 1989 (NSW), Freedom of
Information Act 1982 (Vic), Freedom of Information Act 1992 (Qld), Freedom of Information Act
1991 (SA), Freedom of Information Act 1992 (WA), Freedom of Information Act 1991 (Tas),
Freedom of Information Act 1989 (ACT), Information Act (NT)

13
7.8 Privacy and confidentiality
In some jurisdictions, patients have rights to privacy and confidentiality of personal
information or health records by virtue of legislation.5
There is also an implied obligation of confidentiality at common law (owing to the
nature of the relationship between a health care professional and a patient)
although legal rights to confidentiality are difficult to enforce, and some breaches of
confidence are without legal remedy.
Organisations and health care professionals will have to have regard to obligations
of privacy of patients, staff and others, when conducting investigations, creating
reports and making any disclosures under the open disclosure process. Care will
also have to be taken to ensure that any information obtained as part of the open
disclosure investigation is recorded and stored in accordance with the legislation.
Organisations should develop their own guidelines to ensure that the relevant
privacy principles and other obligations of confidentiality are adhered to during the
open disclosure process. It is important to note that this legislation also provides
patients with the right to access information about their care such as their medical
record.
The safest way to ensure there is not a breach of privacy or confidentiality is to
obtain the consent of the patient to disclose specified information to nominated
persons. This can be done at the time of admission.

7.9 Defamation
In the context of open disclosure it is possible that a health care professional or
other person could be defamed by virtue of a statement, either verbal or written,
“published” by, for example, an organisation or health care professional to another
person. For example, this could occur by a health care professional alleging that
another is incompetent.
It is only necessary, for an action for defamation to arise, for the communication to
be made to one other person.
It is not even necessary for a person to be referred to by name, in order to be
defamed, if it can be shown that the person could be readily identified.
Accordingly, health care organisations should ensure that health care
professionals, in their training in open disclosure, are informed that they must be
careful about information recorded and what is said to and about others during the
open disclosure process.

7.10 Insurance considerations

An adverse event may involve more than one insurer because of the range of
health care professionals that may make up a multidisciplinary team. The interests
of these parties may be conflicting and therefore it is important that those involved

5
Privacy Act 1988 (Cth), For information on State and Territory Privacy Laws see
http://www.privacy.gov.au/privacy_rights/laws

14
in the adverse event are fully aware of their own responsibilities in regard to their
relevant insurance policies.
Medical defence organisations and other indemnifiers may provide medico-legal
advisory services to their members (and those insured) and may wish to discuss
and assist in the open disclosure process.
Many policies of insurance granted by insurers and medical defence organisations
will require the insured to notify and take early advice from the insurer of an
adverse event, usually within a certain period of time following the adverse event
(“the notification requirement”).
These policies may also set out other requirements which the indemnifiers impose
on the organisation, such as what can or cannot be said by staff before the insurer
is notified of the adverse event (if the event is one requiring such notification). Each
health care organisation should, in order to ensure that the organisation complies
with the indemnifier’s requirements, ensure that –
a) their insurers are consulted regarding notification requirements prior to
implementing an open disclosure policy;

b) the manager responsible for overseeing the management of adverse events is

aware of what events are to be notified under an insurance policy in force in
respect of that organisation and the requirements for the timing of relevant
notifications; and

c) health care professionals are instructed to report adverse events to the manager
promptly.

15
SECTION B THE OPEN DISCLOSURE PROCESS

8 PRIVACY AND CONFIDENTIALITY

All discussions should occur with regard to ethical and legal requirements relating
to Confidentiality and Privacy of patients and staff (see clause 7).

9 INCIDENT DETECTION OR RECOGNITION

9.1 General
The open disclosure process commences with the recognition that the patient has
suffered unintended harm during their treatment. Hospitals must develop
appropriate mechanisms to identify adverse events.

9.2 Identifying an adverse event

An adverse event might be identified –
a) by a staff member at the time of the incident;
b) by staff retrospectively when an unexpected outcome is detected;
c) by a patient or carer who expresses concern or dissatisfaction with the
patient’s health care, either at the time of the Incident or retrospectively;
d) through established complaints mechanisms;
e) through incident detection systems, such as Incident reporting or medical
record review; and
f) from other sources, such as detection by other patients, visitors, students or
other hospital staff.

9.3 Priority
As soon as an adverse event is identified, the first priority is prompt and
appropriate clinical care and prevention of further harm. Where additional treatment
is required this should occur, where reasonably practical, after a discussion and
with the agreement of the patient. Responsible managers should be advised and
should gather any evidence that will assist in investigating the event.

9.4 Adverse events occurring elsewhere

An adverse event may have occurred in an organisation other than that in which it
is identified. The individual who first identifies the possibility of an earlier adverse
event should notify the individual responsible for clinical risk in the organisation in
which it was identified. That person should establish whether –
a) the adverse event has already been recognised;

16
b) the process of open disclosure has commenced elsewhere; and
c) investigations are in progress.
If the open disclosure process has not already commenced in the other
organisation, the open disclosure process should be initiated. The investigation of
the adverse event and the disclosure process should occur, where possible, in the
health care organisation where the adverse event took place.

9.5 Criminal or intentionally unsafe act

Adverse events are almost always unintentional. If, at any stage following an
adverse event, it is considered that the harm may be the result of a criminal or
intentionally unsafe act, then the initial response should proceed as follows:
a) The individual responsible for clinical risk and the chief executive officer (CEO)
should be notified immediately.
b) Management should follow their local complaints and disciplinary process
and/or refer the matter to the appropriate authority. (The disciplinary process is
outside the scope of this Standard).

10 INITIATING THE OPEN DISCLOSURE PROCESS

10.1 Initial assessment to determine level of response

All incidents should be assessed initially by the first member of the clinical team to
detect the incident. He/she will do an initial assessment of the level of response
required and notify a senior health care professional to confirm their evaluation.
For a low-level incident, this senior health care professional may be a nurse
manager, nurse specialist, staff specialist, registrar, resident medical officer or
allied health care professional. This should be determined by the type of event and
the organisation’s particular policy. For a high-level incident, this will be the senior
health care professional responsible for the patient. The organisation’s policy
should also specify when to notify and involve the CEO and other management.
The level of response required will be determined by the impact or consequence of
the incident. (See Appendix D for an example of a decision matrix to determine the
level of response).
a) Low-level response
A low-level response should be used for those adverse events where there is no
permanent injury or increased level of care (eg transfer to operating theatre or
intensive care unit) required.
b) High-level response
A high level response will be determined by the impact or consequences of the
incident, that is –
· death or major permanent loss of function;
· permanent lessening of body function; or
· a need for surgical intervention, transfer to a higher level of care (eg transfer to
intensive care unit) or major change in clinical management.

17
The individual responsible for clinical risk should be notified immediately of a high-
level response and be available to provide support and advice during the open
disclosure process if required.

10.2 Management of low-level incident

The person detecting the incident and the senior health care professional will
decide who should manage the disclosure discussion with the patient and if support
is required.
It is likely that in most cases where a low-level response is indicated, the disclosure
process will be completed with the initial disclosure discussion with the patient. The
content of this discussion is set out in clause 10.5. Unless there are specific
indications or the patient requests it, the disclosure process and the investigation
and implementation of changes will occur at local service delivery level, with
participation of those directly involved in the event. Reporting to management will
occur through standard incident reporting mechanisms and will be analysed to
detect high-frequency events. Review will occur through aggregated trend data,
local investigation or, where trend data indicates a pattern of related events, an in-
depth investigation. (For grading the level of investigation see clause 12)

10.3 Management of high-level incidents

10.3.1 Preliminary team discussion

The multi-disciplinary team and all other staff involved in the adverse event,
including the most senior health care professional, will communicate as soon as
possible after the event to –
a) establish the basic clinical and other facts;
b) assess the event to determine the level of response;
c) identify who will take responsibility for discussion with the patient and their
support person;
d) consider the appropriateness of engaging patient support at this early stage,
including the use of a facilitator or a patient advocate (see clause 4.2);
e) identify immediate support needs for staff involved;
f) ensure that all team members maintain a consistent approach in any
discussions with the patient and their support person; and
g) consider legal and insurance issues, both for the organisation and health care
professionals, and notification to relevant people (see clause 10.6).

10.3.2 Timing
The initial disclosure discussion with the patient and their support person should
occur as soon as possible after recognition of the adverse event. Factors to
consider when considering timing of the disclosure discussion include –
a) clinical condition of the patient;
b) availability of key staff;
c) availability of the patient's support person;

18
d) availability of support staff;
e) patient preference;
f) privacy and comfort of the patient; and
g) emotional and psychological state of the patient.

10.4 Choosing the individual to make the disclosure

10.4.1 General
The individual making the disclosure should be the most senior health care
professional who is responsible for the care of the patient. For high-level incidents,
that person should have the support of a senior staff member with good
communication skills. The person disclosing should ideally have the following
characteristics –
a) be known to the patient;
b) be familiar with the facts of the incident and care of the patient;
c) be of sufficient seniority to be credible;
d) have received training in open disclosure;
e) have good interpersonal skills;
f) be able to communicate clearly in everyday language;
g) be able and willing to offer reassurance and feedback to the patient and his/her
support persons; and
h) be willing to maintain a medium to long-term relationship with the patient where
possible.
In all cases that require a high-level response, the decision on who will make the
disclosure should be made in consultation with the person responsible for clinical
risk. If for any reason the senior health care professional is unable to make the
disclosure, a substitute will need to be selected but, ideally, the senior health care
professional should still be present at the discussion.

10.4.2 Use of a substitute health care professional to disclose

In exceptional circumstances, where it is not possible for the most senior health
care professional responsible for the clinical care of the patient to be present, an
appropriately senior person, trained in open disclosure processes, should take
responsibility for the disclosure discussion.
The qualifications, training and scope of responsibility of the substitute person
should be well delineated. This will assist effective communication with the patient
or their support person without jeopardising the rights of health care professionals,
or their relationship with the patient. The substitute person may be the individual
responsible for clinical risk or someone of similar expertise.

10.4.3 Assistance with initial disclosure discussion

The person who will be disclosing should be able to nominate someone to assist
them with the disclosure interview. Ideally this would be someone with experience
or training in communication and open disclosure.

19
10.4.4 Consultation with patient regarding the individual to make the disclosure
If, for any reason, it becomes clear during the initial disclosure discussion that the
patient would prefer to speak to a different health care professional, the patient’s
wishes should be respected and a substitute, in consultation with the patient,
should be provided.

10.4.5 Responsibilities of junior health care professional

Junior clinical staff or those in training should not carry out the disclosure except
where –
a) the incident is minor;
b) the senior health care professional responsible for the care of the patient is
present for support;
c) the patient agrees;
d) the junior staff member has received adequate training to undertake the
disclosure; and
e) the junior staff member is willing to participate in the process.

10.4.6 Adverse events related to the physical environment of care

In a case relating to injury within the environment of care, a senior manager of the
relevant service will be responsible for disclosure (relating of the accident). A senior
member of the multi-disciplinary team should be present to assist at the initial
disclosure discussion (e.g. domestic supervisor assisted by the senior nurse
manager in a case where a patient has slipped on a wet floor). The health care
professional responsible for treating the injury should also be present to assist in
providing information on what will happen next and the likely effects of the injury.

10.5 Content of initial disclosure discussion with the patient

The initial disclosure discussion is the first part of an ongoing communication
process. Many of the points raised in the initial disclosure discussion may need to
be expanded upon in any subsequent meetings with the patient and their support
person.
It is important not to speculate, attribute blame to yourself or other individuals,
criticise individuals or admit liability. All known facts relevant to the adverse event
can be made available to the patient and their support person, subject to any legal
restrictions that may apply (see clause 7).
The discussion should include –
a) an introduction of all people attending, including their role;
b) an expression of empathy and regret for the harm that has occurred;
c) disclosure only of facts known at that time as agreed between the
multidisciplinary team;
d) listening to the patient’s and/or their support person's understanding of what
happened and address any questions or concerns they may have;
e) indicating to the patient and their support person that their views and concerns
are being heard and considered seriously;

20
f) a discussion about what will happen next (return to operating theatre, need for
more investigations, see another specialist etc);
g) information on likely short-term effects (and long-term effects if known,
however this information may need to be delayed to a second or subsequent
meeting);
h) assurance to the patient and their support person that they will be informed of
further investigation that will take place to determine why the adverse event
occurred, the nature of the proposed process and expected timeframe. Also
provide information on how feedback will be provided on the findings of the
investigation any changes made to prevent recurrence and if delays in the
process are experienced the reasons for those delays;
i) an offer of support to the patient and their support person; and
j) information to the patient and/or support person on how to take the matter
further, including any complaint processes available to them.

10.6 Notification

10.6.1 Individual/manager with designated responsibility for clinical risk

In all cases the individual with responsibility for management of clinical risk within
the organisation should be informed of an adverse event by telephone,
electronically or by completion of an incident form depending on the level of
response decided upon. This person will then grade the incident to determine the
level of investigation.

10.6.2 Insurers
Insurers of organisations and insurers of individual practitioners will have to be
notified in accordance with the particular contractual obligations for timely
notification.

10.6.3 Management
Notification of management will usually occur via the individual responsible for
clinical risk. However, when a major incident occurs that may attract media
attention or where a criminal act is suspected, the CEO should be notified
immediately, in accordance with the organisation’s incident policy.

10.6.4 General Practitioner(GP), residential facility and other community care

providers
The referring GP, residential facility or other community care provider should be
contacted at an early stage so that he/she is informed and can offer their support
and continuing care to the patient and carer. This should be with the patient’s
agreement.

10.6.5 Unexpected or untimely death – the coroner

Cases of untimely or unexplained death and suspected unnatural deaths must be
reported to the coroner as required by State or Territory legislation. A coroner may
request that the case not be discussed with other parties until he/she has

21
considered the facts. It may be that this will not preclude an Expression of Regret
from the organisation to the patient’s Support Person/family (however advice
should be sought from the coroner as to whether this will breach the requirement
not to discuss the matter). In this situation, it should be made clear to the family
that a discussion of the facts and any further concerns will be arranged at a date to
suit both parties, after the coroner’s assessment is finished.

10.6.6 Notification to relevant statutory and other appropriate authorities

Where there are adverse outcomes health care organisations may need to respond
to a variety of external requirements, reviews or queries, including requirements of
State, Territory and Commonwealth regulatory bodies. The organisation’s policy on
adverse events and open disclosure should clearly state these requirements to
ensure that an organisation’s legal and insurance needs are met.

11 DOCUMENTATION

11.1 General
The disclosure of an adverse event and the facts relevant to it must be properly
recorded. Documentation includes medical records, incident reports and records of
the investigation process.

11.2 Health care records

Medical records should document –
a) the time, place, date of the disclosure discussion and the name and
relationships of those present;
b) the plan for providing further information to the patient and their support
person;
c) offers of support and the response received;
d) questions posed by the patient or their support person and the answers given;
e) plans for follow up as discussed with the patient;
f) progress notes relating to the clinical situation and accurate summary of all
points explained to the patient and their support person; and
g) copies of letters sent to the patient, their support person and GP.

11.3 Incident report

Clinical or other staff should submit an initial incident report in accordance with the
organisation’s policy on adverse events or incident reporting.

22
12 GRADING THE EVENT TO DETERMINE THE LEVEL OF
INVESTIGATION
All adverse events should be subjected to an appropriate level of investigation and
analysis to determine the cause. Not all adverse events require a major
investigative process. Many will be resolved with a limited internal management
process. Cumulated data for both high level and low level incidents should be
reviewed centrally. Incidents should be graded by the person responsible for
clinical risk and according to –
a) the extent of the injury including its physical and where appropriate financial
consequences; and
b) the likelihood of recurrence of the incident.
The matrix obtained by correlating these parameters will determine the potential
risk to patients and the organisation. A sample grading matrix is provided in
Appendix E.

13 THE INVESTIGATION
If the investigation is being carried out under qualified privilege legislation, legal
advice should be taken on the extent of protection provided for documents and
communications, as well as whether, and how, any information collected or findings
made can be disclosed to patients or others.
If the investigation is being conducted with the involvement of lawyers (sometimes
at the instigation of insurers), advice should also be sought on whether documents
or communications as part of the investigations are privileged from disclosure and
what can be properly disclosed without inadvertently losing the privileged
protection.

13.1 The investigation and analysis

The investigation will take place within an appropriate framework (eg clinical
governance/clinical risk/quality improvement), as follows:
a) Once the preliminary decisions relating to initial disclosure are made, the
investigation process should proceed according to how the adverse event has
been graded and should be commenced immediately. It is important that the
investigation begins promptly while memories are fresh and before evidence is
lost or destroyed.
b) In serious adverse events (major or sentinel health event), a root cause
analysis, or another investigation method of similar intensity, should be
considered. In these circumstances, the services of outside experts may also
be used. Cases of moderate severity may be investigated by a small number of
designated people. Low-risk cases may be investigated by a small team or
subjected only to aggregate review (data trending). The decision about the
level of investigation should be determined by grading the event to determine
the level of investigation (see clause 12) and be in accordance with the
organisation’s policy.
c) If there is concern about the capacity to obtain detailed information in the
absence of protection of communications and documents from disclosure, the
investigating team should consider seeking appropriate legal advice as soon as

23
 the adverse event occurs and/or invoking qualified privilege legislation if this is
appropriate. (see clause 7.6).
d) The incident investigation should –
· identify the reasons for the adverse outcome;
· identify underlying systems failures;
· make recommendations that indicate that “lessons have been learned”;
· identify improvement strategies to reduce the risk of future harm;
· identify reasons why no improvement can be made, if this is the case; and
· satisfy obligatory reporting requirements.

13.2 The personnel to be involved

13.2.1 General
An individual who has the knowledge and status to make authoritative
recommendations should conduct the investigation in association with appropriate
clinical advisers. This will usually be a senior health care professional or manager
(as designated in the organisation’s policy). All health care professionals involved
in the incident should be given the opportunity to have input into the investigation.

13.2.2 Investigator's role

The investigator will –
a) actively plan and manage the investigation, and determine the scope of the
investigation and issues raised;
b) be impartial and not advocate for any parties associated with the investigation;
c) collect the facts (staff, patient, carer statements or interviews) retain damaged
equipment and arrange for an inspection or make direct observation of the
scene;
d) identify appropriate standards, policies, processes and practice of care relevant
to the case;
e) review available information from audit, Incident reporting or other sources that
relate to the subject matter of the investigation;
f) assemble and analyse the information, and seek advice on matters outside
their expertise; and
g) as far as possible make findings of fact, root causes and recommendations to
support system changes to prevent recurrence of such adverse events.

13.2.3 Multi-disciplinary team

In most cases, a multi-disciplinary group will be involved in the investigation, the
determination of the causes of the event and in recommending improvement
strategies.

24
14 PRELIMINARY FOLLOW-UP

14.1 Preliminary follow-up with the patient and their support person
The preliminary follow-up discussion with the patient and their support person is an
important step in the open disclosure process (unless the incident is minor and
where no follow-up is required) and should be guided by the following:
a) The senior health care professional involved in the adverse event should be
involved in the follow up discussion.
b) The discussion should occur at the earliest practical opportunity and may vary
from a few days after the event to the first follow-up appointment.
c) Feedback should be given on the progress to date and should provide
information on the investigation process. In some instances the process may
be completed at this time.
d) There should be no speculation or attribution of blame. Similarly, the person
disclosing the adverse event must not criticise others or comment on matters
outside their own experience.
e) The patient and support person should be offered an opportunity to discuss the
situation with another relevant professional, where appropriate.
f) A written record of the discussion should be made and filed, according to
internal policy and legal requirements.
g) All queries should be responded to appropriately within an environment that
encourages and supports the patient and their support person, and addresses
their concerns.
h) If completing the process at this point, the patient and their support person
should be asked if they are satisfied by the investigation and explanation, and
a note of this made in the patient’s records (see clause 11.2). Written
information about the adverse event and its management should be provided to
the patient and their support person for all high level incidents and where
requested for low level incidents (see clause 16.1).
i) Consideration should be given to involving with the patient’s permission, the
GP, residential facility or community care provider in the discussion.
j) The patient should be provided with details of a person to contact if further
issues arise.

14.2 Preliminary follow-up with staff

The results of the investigation and recommendations for improvement should be
communicated to the multi-disciplinary team involved in the incident (see clause 5).

25
15 RECOMMENDATIONS AND IMPLEMENTATION

15.1 Communication of recommendations to management

On completion of the investigation, the investigator or committee (in conjunction
with clinical advisers) will make recommendations for action to management and
clinical staff, based on an assessment of causation.
Recommendations to improve public health and safety may also be generated
through a coroner's inquest or other external inquiries. These should also be
incorporated into outcomes of other investigation processes.

15.2 Responsibility of management

15.2.1 General
It is the responsibility of management to –
a) consider all recommendations for improvement;
b) decide which recommendations are to be implemented;
c) delegate responsibility for implementation;
d) allocate adequate resources to make changes required;
e) implement a mechanism for reporting on changes made and outcomes of these
changes; and
f) document reasons for a decision not to implement recommendations.

15.2.2 Governing body

The organisation’s governing body will have ultimate responsibility for ensuring the
safety of patients and that resources are made available for implementing
recommended changes.

15.2.3 Chief executive officer

The CEO has operational responsibility for ensuring that the organisation has
appropriate adverse event detection, investigation, support and improvement
processes in place.
Organisations will ensure that the CEO has the authority to –
a) implement recommendations of the investigation team where appropriate; and
b) effect change through the operational management system.

15.3 Implementation of recommendations

15.3.1 General
Systems improvements based on the accepted recommendations will be
implemented through the framework for achieving improved outcomes. This may be
a committee designated to oversee quality assurance, clinical risk and/or patient
safety, or the clinical governance unit. Any recommendations accepted by

26
management for implementation should be the subject of a detailed action plan that
lists –
a) actions to be taken;
b) those responsible for implementing the changes;
c) the timeframe for completion; and
d) mechanisms for monitoring and evaluating improvement.
Some recommendations may first require trialing to evaluate their effectiveness. All
changes should be made within six months of management receiving
recommendations.

15.3.2 Implementation of urgent changes

Where information comes to light at an early stage which requires immediate action
to prevent further damage occurring, the hospital will have a mechanism in place
for its urgent implementation.

16 COMPLETING THE PROCESS

16.1 Communication to patient

After completion of the investigation, feedback to the patient may take the form of a
face-to-face interview, a letter or both. The interview and/or letter will include –
a) reference to the clinical and other relevant facts;
b) reference to details of the concerns or complaints of the patient and support
person;
c) an expression of regret for the harm suffered;
d) a summary of the factors contributing to the adverse event; and
e) information on what has been and will be done to avoid repetition of the
adverse event, and how these improvements will be monitored.
It is expected that in most cases there will be complete disclosure of the findings of
the investigations. In some cases, information may be withheld or restricted. This
may occur for example where it is considered that disclosure of information will
adversely affect the health of the patient; where investigations are pending coronial
processes; where contractual arrangements with insurers preclude disclosure of
specific information or where information is protected from disclosure (see clause
7). In this case, the patient will be informed of the reasons for the restriction.

16.2 Continuity of care

When a patient has been harmed during the course of treatment and requires
further therapeutic management or rehabilitation, discussion should be held with
the patient to ensure that they are clearly informed of their proposed ongoing
clinical management. Discharge planning should ensure ongoing care is provided
where it is required as a consequence of the adverse event.

27
16.3 Communication with the GP, residential facility and other community care
providers
When the patient is leaving the care of the organisation, the patient should be
asked if he or she agrees to a discharge letter being forwarded to the GP,
residential facility or community care provider. Subject to the patient’s consent, the
letter should contain summary details of –
a) the nature of the adverse event and the continuing care and treatment;
b) the current condition of the patient;
c) clinical investigations; and
d) recent results.

16.4 Monitoring improvements

Any recommendations for systems improvements and changes implemented
should be monitored for effectiveness in preventing recurrence. The individual with
responsibility for management of clinical risk should develop a plan for monitoring
implementation and effectiveness of changes.

16.5 Communication of changes to staff

Effective communication with staff is a vital step in ensuring that recommended
changes are fully implemented and monitored. It will also facilitate the move
towards increased awareness of patient safety issues and the value of open
disclosure.

16.6 Communication of lessons learned throughout the health system

The health care industry should provide a mechanism to ensure that health care
organisations can disseminate information about factors that cause adverse events
in a meaningful and useable format to prevent recurrence across organisational
boundaries.

28
APPENDIX A GLOSSARY
There is a valid ongoing discussion on the meaning of some of the terms used in
the Standard. However, for the purpose of this Standard, the following meanings
have been used.

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") on the
other.
Adverse event – An incident in which unintended harm resulted to a person
receiving health care6.
Adverse outcome – An outcome of an illness or its treatment which has not met
the health care professional’s or the patient’s expectation for improvement or cure.
Carer(s) – Family, friend or those identified by the patient as providing care for
them.
Circumstance – All the factors connected with or influencing an event, agent or
person.
Clinical risk management – The process of risk management as it relates to
clinical care.
Complication – An adverse event related to medical intervention or disease,
especially an event that is a known potential consequence of, or that sometimes
occurs in relation to, the patient’s disease or its treatment.
Disability – Any type of impairment of body structure or function, activity limitation
and/or restriction of participation in society.
Event – Something that happens to or with a person. (See Incident).
Expression of regret – An expression of sorrow for the harm experienced by the
patient.
Harm – Death, disease, injury, suffering, and/or disability experienced by a person.
Hazard – The potential for harm arising from an intrinsic property or circumstance.
Health care professional – A doctor, dentist, nurse, pharmacist, allied health care
professional, or registered alternative health care practitioner. They may be
employed by the hospital or self employed.
Health care record – A collection of data and information gathered or generated to
record clinical care rendered to an individual. A comprehensive, structured set of
clinical, demographic, environmental, social, and financial data and information,
documenting the health care given to a single individual.

6
Wilson, Runciman, Gibberd (1995) Quality in Health Care Study Medical Journal of Australia 163 (9):458-
471.

29
Hospital – An institution or organisation in which health care is the main service
provided.
Incident – An event or circumstance which could have, or did lead to unintended
and/or unnecessary harm to a person, and/or a complaint, loss or damage.
Injury – Damage to tissues caused by an agent or circumstance.
Integrated risk management – a process of assessing all of an organisation's
risks and developing strategies to coordinate the management of those risks,
including financial, operational, and clinical. It uses a structured and disciplined
approach with a key focus of aligning strategy, processes, people, technology and
knowledge and should be integral to the culture of the organisation
Liability – Responsibility for an action in a legal sense.
Morbidity – The negative consequences (symptoms, disabilities or impaired
physiological state) resulting from disease, injury or its treatment.
Mortality – Death from disease or injury.
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.
Qualified privilege legislation – Qualified privilege legislation varies between
jurisdictions but generally protects the confidentiality of individually identified
information that became known solely as a result of a declared safety and quality
activity. Certain conditions apply to the dissemination of information under qualified
privilege. 7
Risk – The likelihood that someone or something that is valued will be harmed by a
particular hazard.
Root cause analysis – A systematic process whereby the factors which
contributed to an incident are identified.
Safety – A state in which risk has been reduced to an acceptable level.
Sentinel health event – Events in which death or serious harm to a patient has
occurred, for example:
a) An unexpected occurrence involving death or serious physical or psychological
Injury, or the risk thereof.
b) An incident with actual or potential serious harm, or death.
c) A condition that can be used to assess the stability or change in health levels
of a population, usually by monitoring mortality statistics. Thus, death due to
acute head injury is a sentinel health event for a class of severe traffic injury
that may be reduced by such preventive measures as use of seat belts and
crash helmets.
Staff – Any one working within a hospital, including self-employed professionals
such as visiting medical officers.
Standard – Sets out agreed specifications and/or procedures designed to ensure
that a material, product, method or service is fit for the purpose and consistently
performs the way in which it was intended.

7
The Public Interest in Qualified Privilege. Australian Council for Safety and Quality in Health Care 2001

30
Suffering – Experiencing anything subjectively unpleasant. This may include pain,
malaise, nausea and/or vomiting, loss, depression, agitation, alarm, fear, grief or
humiliation.
Support person – Information about an adverse event will be given to a patient’s
nominated “support” person in appropriate circumstances, taking account of the
patient’s wishes, confidentiality and privacy requirements and the organisation’s
internal policies. The nominated support person/persons may be any individual,
identified by the patient as a nominated recipient of information regarding their
care. This may include family, friend, partner or those who care for the patient. (see
Clause 3 for further clarification)
System failure – A fault, breakdown or dysfunction within operational methods,
processes or infrastructure.
Systems improvement – The changes made to dysfunctional operational methods
processes and infrastructure to ensure improved quality and safety.
Treatment – The way an illness or disability is managed by drugs, surgery,
physiotherapy or other intervention to affect an improvement in or cure of the
patient’s condition.

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APPENDIX B FINANCIAL SUPPORT
Patients experiencing an adverse event often indicate that bearing the costs of care
is the determining factor in initiating litigation, particularly if they are also faced with
loss of earnings.
Health care organisations should develop guidelines in consultation with insurers
and other relevant agencies for providing assistance to patients who have
experienced adverse events and where preliminary investigation indicates that this
would be appropriate. For example, health care organisations may consider
offering financial or other support at an early stage.
It is recommended that any of the above only be undertaken on written legal advice
and with prior consultation with the insurer (particularly if the insurer is to meet the
cost).

32
APPENDIX C PARTICULAR PATIENT CIRCUMSTANCES

C.1 General
Knowing how to enable or enhance communication with a patient is important to
facilitating an effective open disclosure process. In many ways, all these things are
simply being “consumer-centred”, thoughtful and respectful of the needs of each
patient and their support person.

C.2 When a patient dies

Where an adverse event has resulted in a patient’s death, it is crucial that
communication is sensitive, empathic and open. Establishing open channels of
communication may also allow the carer to indicate if he or she needs grief
counselling assistance at any stage.
A death suspected to be a result of an "adverse event," maybe reportable to the
coroner. It is necessary to ensure that family, carers or the patient’s support person
are kept up to date with what is happening and that personal contact is maintained
by someone from the health care organisation throughout the coronial process.
This will be subject to requirements of the coroner and legislative provisions. For
example, the coroner may direct that the matter not be discussed.
There is considerable variation between State/Territory coronial legislation and
individual coroners, including differences in disclosure or non-disclosure of
information. Occasions may arise where an individual coroner requests that
discussion of the case between hospital staff and family should not take place until
he or she has considered the evidence. Directions for disclosure of information
should be included in local guidelines. However, if the coroner so directs, it should
be made clear to the family that a discussion of the facts and any residual concerns
will be arranged at a date to suit both parties after the completion of the coronial
inquiry which may include an inquest.
The functions of the coroner includes determination of the identity of the deceased
person, as well as the manner and cause of death. The coroner has the power to
require a post-mortem and to require the production of medical records, including
private clinical records and hospital records, for the purpose of the coronial inquiry.
The coroner's brief (or coroner’s file) is the file of information about the death
collected by the police, on behalf of the coroner. It includes medical reports, the
results of investigations, scientific reports, and witness statements. Relatives of the
deceased are usually given a copy of the brief, except where the coroner or
State/Territory legislation requires the investigation to remain confidential.
The coroner does not determine any criminal or civil liability. However, the
investigation can provide valuable insight into causes of the adverse event. The
coroner can make recommendations on public health and safety which should be
channelled into the appropriate mechanisms for implementing changes for systems
Improvement throughout the health sector.

33
C.3 Children
Where an adverse event involves children, the clinical team will, together with the
parents/carers need to make informed but complex assessments of what the child
should be told. In the case of young people close to the age of capacity, the
involvement of parents in the process will be comparable to that of consent for
treatment involving the child, weighing up the young person’s maturity. There is
often conflict between a young person asserting (or entitled to) autonomy and
parental authority. States/Territories have legislation that generally protects health
care professionals who act on the instructions of parents of children under 18 from
civil liability for lack of consent by the young person. The involvement of young
people in the open disclosure process will have to be assessed by the clinical team
on a case-by-case basis, taking account of whether the child is mature enough to
receive the information and having regard to the wishes of the young person and
the parents where appropriate.

C.4 Patients with mental health issues

There are several main factors to consider in open disclosure to patients with
mental health issues irrespective of whether the patient is subject to mental health
legislation, which varies between jurisdictions. Disclosure of information relating to
treatment issues, including open disclosure of adverse events, applies equally to
people with a mental illness as to others. Patients are entitled to all relevant details
concerning their treatment, including instances where an adverse event occurs,
with the timing of the disclosure subject to the clinical team’s assessment of how
this will affect the health of the patient and the patient’s ability to understand what is
said (clause 10.3.2).

C.5 Patients with cognitive impairment

There are many individuals in the community with conditions that limit their ability to
understand what is happening to them. Where possible, patients with a cognitive
impairment should be involved directly in communications about what has
happened to them, according to the level of their capacity to understand.
The person may have a legal guardian, or an attorney appointed under an enduring
power of attorney. It should not be assumed that because a person is named in an
order or power of attorney that that person has the legal right to act in all
circumstances on behalf of the person. It will be necessary to determine the actual
legal effect of any such relationships, which vary according to the terms of each
guardianship order or power of attorney (only some jurisdictions permit a power of
attorney to give the attorney right to consent to treatment on behalf of the person).
These issues must be carefully considered in assessing whether disclosure of an
adverse event and decisions to be taken can be made to or by a third party in the
absence of the patient’s informed consent to do so.

C.6 Patients who do not agree with the information provided

Sometimes, despite the best efforts of health care staff or others, the relationship
between the patient and/or carer and the health care professional breaks down.
The patient and/or their support person may not accept the information provided or
may not wish to participate in the open disclosure process. In this case, the
following strategies may assist:

34
a) Deal with the problem earlier rather than later.
b) Where the patient agrees, ensure that their support person is involved in
discussions from the beginning.
c) Ensure the patient has access to support services, as described in clause 4.2.
d) Where the senior health care professional is not aware of the relationship
breakdown, provide mechanisms for communicating early warning signs (eg
patient communicating concern to other members of the team, lodging a
Freedom of Information application).
e) Offer the patient and support person another contact person with whom they
may feel more comfortable. This could be another member of the treating team
or the individual with responsibility for clinical risk.
f) Use a mediation or conflict resolution service to help identify the issues
between the health care organisation and the patient, and to look for a mutually
agreeable solution.
g) Involve the services of the local health complaints office if the patient wants to
lodge a formal complaint.
h) Assess whether sufficient weight has been given to the patient’s version of
events and whether reasonable efforts have been made to seek information
from all key witnesses, including witnesses identified by the patient or carer.
Trust needs to be rebuilt where there has been a breakdown in the relationship
between the patient and provider.

C.7 Patients with language or cultural diversity considerations

Where the patient and/or their support person come from linguistically or culturally
different backgrounds to the service provider, communication can be more
challenging. For example, if English is a patient’s second language, they may have
difficulty with medical terms, even if they otherwise are very proficient. The ability of
health care professionals to communicate well can be similarly restricted. Equally, if
a patient is from a background where people are particularly intimidated by
authority figures, or she is a woman whose cultural or other experience makes it
difficult for her to talk to a male about intimate issues, the selection of an
inappropriate health care professional to provide information may significantly limit
effective communication. These issues need to be considered when disclosing after
an adverse event.
The need for interpreter services should be identified as soon as the patient makes
contact with the service. A space on the admission sheet should be provided to
identify the first language of all patients and also their preferred language of
communication. For migrants and others who have been educated in English, there
will be no need to consider translation services but care should be taken with those
who have learned English later in life. When an adverse event occurs, the physical
effects of the illness and the emotional impact may render a normally fluent
speaker less able to communicate well.
Where someone has difficulty communicating in English or at the patient’s request,
a professional interpreter or a health care professional who can speak the patient’s
language should be used. The use of family (or other support person) to interpret
should be avoided except in an emergency. An interpreter from the same language
and cultural background may also be able to advise on other issues (e.g. whether
the gender of the health care professional who makes the disclosure is an issue

35
that needs to be considered). These issues should be discussed with the
interpreter beforehand so that the open disclosure process is culturally and
linguistically appropriate from the outset.

C.8 Aboriginal or Torres Strait Islander patients

There are diverse cultural and linguistic groupings within the collective descriptor
“Aboriginal and Torres Strait Islander people”. The experience of Aboriginal people
is that there are very real barriers to communication with health service providers
not merely with respect to language but in the context of underlying principles and
beliefs regarding health matters. Every effort needs to be made to ensure that the
appropriate people in the context of the patient’s needs are included in discussions,
with the patient’s agreement in relation to adverse events and their investigation
and management.

C.9 Patients with other communication requirements

Other communication requirements are likely to arise. For example, an older
person may have a hearing impairment or a memory or concentration impairment.
People with disabilities may have communication difficulties. For example, a blind
person will not be able to read a printed pamphlet; a deaf person may need an
interpreter.
For someone with a mobility disability, the discussions should be held in a readily
accessible place. For example, it is little use arranging a meeting, in a place that a
person in a wheelchair cannot access, or where there are large distances to walk
(as often occurs in hospitals) when the patient or support person has limited
mobility.

36
APPENDIX D EXAMPLE OF MATRIX FOR INITIAL ASSESSMENT OF
LEVEL OF RESPONSE
The following table is an example of a matrix to assess the level of response. The
matrix used will vary depending on local policies.

Assessment of level of response

Level of Consequence Action
Response
High Death or major permanent Immediately notify individual
loss of function not related responsible for clinical risk
to the natural condition of management.
the patient
Disclosure by senior
Permanent lessening of medical practitioner or
bodily function not related alternate with support where
to underlying condition of indicated
patient or where surgical
intervention or transfer to
higher level of care
required (eg transfer to
ICU)
Low No permanent Injury nor Local management, incident
increased level of care report.
required
Disclosure by senior health
care professional

37
APPENDIX E EXAMPLE OF INCIDENT GRADING MATRIX

The following table is an example of a matrix for grading an Incident to determine

the level of investigation required. The matrix used will vary depending on the
policy of the organisation.
The tables are reproduced from AS/NZS 4360 Risk management. It is strongly
recommended that users of the Open Disclosure Standard consult the complete
AS/NZS 4360 for the context in which this table is presented and for detailed
information on its use and application.

TABLE 1 QUALITATIVE MEASURES OF CONSEQUENCE OR IMPACT

Level Descriptor Example detail description

1 Insignificant No injuries, low financial loss

2 Minor First aid treatment, on-site release immediately contained, medium

financial loss

3 Moderate Medical treatment required, on-site release contained with outside

assistance, high financial loss

4 Major Extensive injuries, loss of production capability, off-site release with

no detrimental effects, major financial loss

5 Catastrophic Death, toxic release off-site with detrimental effect, huge financial
loss

1. Measures used should reflect the needs and nature of the organisation and activity under study.

TABLE 2 QUALITATIVE MEASURES OF LIKELIHOOD

Level Descriptor Description

A Almost certain Is expected to occur in most circumstances

B Likely Will probably occur in most circumstances

C Possible Might occur at some time

D Unlikely Could occur at some time

E Rare May occur only in exceptional circumstances

2. These tables need to be tailored to meet the needs of an individual organisation.

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TABLE 3 QUALITATIVE RISK ANALYSIS MATRIX—LEVEL OF RISK
Likelihood Consequences

Insignificant Minor Moderate Major Catastrophic

1 2 3 4 5

A (almost certain) H H E E E

B (likely) M H H E E

C (moderate) L M H E E

D (unlikely) L L M H E

E (rare) L L M H H

3. The number of categories should reflect the needs of the study.

Legend:

E extreme risk; immediate action required

H high risk; senior management attention needed

M moderate risk; management responsibility must be specified

L low risk; manage by routine procedures

39