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Policy No.: D0434
Patient incident management
and open disclosure
Policy Directive
Version No.: V2.3
Approval date: 15/05/2020
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Contents
1. Policy Statement .................................................................................................................. 4
2. Roles and Responsibilities .................................................................................................. 5
2.1 Chief Executive (CE) - SA Health is responsible for: ................................................ 5
2.2 Local Health Network (LHN) governing boards and Chief Executive Officers will: ... 5
2.3 Chief Medical Officer, Chief Public Health Officer and Chief Psychiatrist ................ 5
2.4 Chief Executive Officers or Chief Operating Officers of Local Health Networks, SA
Ambulance Service and statewide clinical support services ............................................... 5
2.5 Directors, heads of service/departments and other senior managers ...................... 6
2.6 Director, Safety and Quality, Department for Health and Wellbeing ......................... 6
2.7 LHN / SA Ambulance Service (SAAS) Safety and Quality Risk Managers / Clinical
Governance ......................................................................................................................... 6
2.8 Clinical Educators ..................................................................................................... 7
2.9 All SA Health staff, students and contractors ............................................................ 7
3. Policy Requirements............................................................................................................ 7
3.1 Standards .................................................................................................................. 7
3.2 Components of incident management and open disclosure ..................................... 8
3.3 Initial steps after a patient incident .......................................................................... 10
3.3.1 Identification and immediate action after a patient incident .................................... 10
3.3.2 Preservation of evidence surrounding incidents ..................................................... 10
3.4 Open disclosure (OD) ............................................................................................. 11
3.4.1 Direct Personal Response ...................................................................................... 11
3.4.2 Level 1 and Level 2 Open disclosure ...................................................................... 12
3.4.3 Patient considerations in preparing for open disclosure ......................................... 13
3.4.4 Deferral of open disclosure ..................................................................................... 13
3.4.5 Engaging in open disclosure discussions ............................................................... 14
3.4.6 Completing and documenting the open disclosure process ................................... 14
3.5 Legal aspects of open disclosure ............................................................................ 15
3.6 Reporting of patient incidents.................................................................................. 15
3.6.1 Using Safety Learning System (SLS) to report an incident .................................... 16
3.7 The patient incident manager .................................................................................. 16
3.8 Initial review by the patient incident manager ......................................................... 17
3.9 Level of escalation/notification for patient safety incident(s) ................................... 18
3.10 Patient incident investigation and analysis ............................................................. 19
3.10.1 Patient Incident Reviewers ...................................................................................... 19
3.10.2 Investigation of SAC 3 or SAC 4 incidents .............................................................. 19
3.10.3 Investigation of SAC 1 and SAC 2 incidents ........................................................... 20
3.10.4 Investigation of cluster incidents ............................................................................. 20
3.10.5 Actions arising from investigation and analysis ...................................................... 20
3.11 Legal aspects of review, investigation and analysis of incidents ............................ 21
3.11.1 Release of information about patient incidents ....................................................... 21
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3.12 Education and training requirements ...................................................................... 22
4. Implementation & Monitoring ............................................................................................. 22
5. National Safety and Quality Health Service Standards ..................................................... 25
6. Definitions .......................................................................................................................... 25
7. Associated Policy Directives / Policy Guidelines and Resources ..................................... 27
8. Document Ownership & History ........................................................................................ 28
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Patient incident management and open disclosure
Policy Directive
1. Policy Statement
SA Health recognises that effective incident management and open disclosure processes are
attributes of high-quality health service organisations, and important parts of healthcare quality
improvement and a patient-centred approach to care.
A patient incident is any event or circumstance which could have (near miss) or did lead to
unintended and/or unnecessary psychological or physical harm to a patient, that occurred during
an episode of health care.
Open disclosure is the process of providing an open, consistent approach to communicating with
patients/consumers, their family, carer and/or support person following a patient incident. This
process includes expressing regret or saying sorry.
SA Health is committed to continuous quality improvement and an environment, in which there is:
recognition that patient incidents usually have many contributing factors that are mostly related
to the systems of care, rather than an individual, and that active reporting and management of
patient incidents by the whole clinical team lead to timely action to eliminate or reduce risk
conduct and documentation of an appropriate open disclosure process, irrespective of whether
or not harm resulted from the incident, and this is :
o a critical element of clinical communication,
o a patient/consumer right,
o a core professional requirement and
o a health service obligation
an expectation that the patient and carers will be supported to recover from a patient incident
through being:
o informed of the facts surrounding a patient incident, its consequences for them, and the
steps being taken to prevent recurrence, and provided opportunity to ask questions
o treated with empathy and respect and supported in a manner appropriate to their needs
o offered and/or assisted to access support or make a complaint, in addition to treatment and
care provided by the clinical treating team
o assured of their privacy and confidentiality
a focus on quality improvement in an open, just and transparent culture of patient incident
management that includes support for staff affected by the incident
a system of accountability through which a health service organisation s senior management,
executive or governing body ensures that:
o appropriate system improvements are implemented and their effectiveness is monitored
o individual staff are held accountable for their role
o patients and carers are supported to participate, and
o the effectiveness of the patient incident management and investigation systems is reviewed
education and training and support to maintain a competent and capable workforce, and
recognition that teamwork and mutual respect are key defences against system failure.
All health services will have established systems for safety and quality improvement that focus on
the timely reporting of all incidents and near misses and take action to reduce patient harm. This
will also include regular review of the open disclosure processes and patient experience from
incidents.
This policy directive describes a standardised system for managing patient incidents that ensures
all staff:
use the SA Health incident management reporting system called Safety Learning System
(SLS) for reporting and documenting the management and open disclosure of patient incidents
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provide appropriate feedback to, and engage with patients/consumers, their family, carer
and/or support person, including open disclosure
respond effectively to patient incidents, and promote safety and quality improvement through
sharing lessons learned from single (or groups of) patient incidents
take action, in collaboration with consumers, and service providers external to SA Health to
improve the safety and quality of services; and
maintain compliance with relevant law and codes of conduct in relation to transparent and fair
treatment, privacy and confidentiality of both patient and clinician.
This policy directive is to be read / administered in conjunction with:
the accompanying toolkit for patient incident management and open disclosure
SA Health Lookback Review policy directive
Health Care Act and Regulations 2008 and SA Government Gazette 11 July 2019
Australian Open Disclosure Framework (Australian Commission on Safety and Quality in
Health Care - ACSQHC)
Version 2 of the National Safety and Quality Health Service Standards.
2. Roles and Responsibilities
2.1 Chief Executive (CE) - SA Health is responsible for:
ensuring services across SA Health operate in accordance with this policy.
2.2 Local Health Network (LHN) governing boards and Chief Executive Officers will:
ensure that the open disclosure and reporting and management of patient incidents across SA
Health is in accordance with this policy and legislative requirements
explicitly supports incident management and open disclosure as a patient or consumer right,
organisational requirement and opportunity to learn from incidents
ensure that resources are available to enable implementation of incident management and
open disclosure including the education and training of appropriate staff
participate in the SA Health response and management of complex and/or serious or cluster
incidents that carry organisational risk, including public communication and briefing to the
Minister of Health.
2.3 Chief Medical Officer, Chief Public Health Officer and Chief Psychiatrist
provide advice, lead or participate as required in review of patient incidents and/or review of
services where incidents have occurred, in order to fulfil relevant legislative requirements.
2.4 Chief Executive Officers or Chief Operating Officers of Local Health Networks, SA
Ambulance Service and statewide clinical support services
ensure the health services within their area of control have systems in place which facilitate
the effective reporting and management of all incidents and open disclosure in accordance
with this policy, National Safety and Quality Health Service Standards and legislative
requirements
allocate sufficient human and material resources to enable effective incident management and
open disclosure to operate across all areas within their area of control, and appropriate data
capture and analysis to inform planning and evaluation
delegate the day-to-day responsibility for establishing and monitoring the implementation of
this policy to the relevant senior managers
ensure that all incidents that have the potential to result in substantial liability and/or have the
potential to attract significant media attention and or require external review are immediately
escalated to the Chief Executive SA Health using RIB and recommended process (section
3.9)
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provide advice and assistance to Chief Executive SA Health and Director of Safety and
Quality, DHA about the SA Health response and management of complex and/or serious
incidents that carry organisational risk.
have staff training programs in place for incident reporting, different types of investigation,
appropriate escalation to senior managers, review and open disclosure of patient incidents,
including the use of the SLS.
2.5 Directors, heads of service/departments and other senior managers
assign appropriate levels of responsibility for the timely investigation, review, management
and open disclosure of incidents, and for implementation of activities to improve safety and
quality of services
ensure that there are procedures in place to guide the investigation, review and open
disclosure of patient incidents
support staff to participate in patient incident investigations, reviews and open disclosure,
including Part 7 committee, mortality review and RCA investigations as appropriate.
2.6 Director, Safety and Quality, Department for Health and Wellbeing
establish, maintain and review the effectiveness of the Patient Incident Management and
Open Disclosure Policy Directive
support the implementation of the policy through facilitating the development, dissemination
and implementation of training, tools, resource materials and evaluation of these
support the continual improvement of the Safety Learning System, by maintaining systems for;
o governance of the SLS, including approval of change requests
o review of data quality and data integrity
o data security and protection of personal information
support the Safety and Quality Unit role as SLS System Administrator, including management
of vendor contracts and liaison with eHealth
support the development and publishing of a suite of data indicators relating to incident
management that will be used to monitor trends and inform planning. This will include, but not
be limited to incident data, hospital, ambulance, and emergency department data
review reported incidents and investigation reports, conducting trend analysis and develop and
disseminate statewide strategies for system improvement
provide advice to health services in response to specific queries about incident management
and management
provide advice and assistance to CE and LHN and CEOs of statewide clinical support services
about the SA Health response and management of complex and/or serious incidents that carry
organisational risk.
2.7 LHN / SA Ambulance Service (SAAS) Safety and Quality Risk Managers / Clinical
Governance
ensure that patients and carers are involved in the analysis of incidents, and the planning of
activities to improve safety and quality
monitor all SAC 1 and 2 incidents and other harmful incidents within their area of
responsibility, to ensure correct investigative processes are followed
provide advice (Clinical Incident Briefing) and assistance to LHN CEOs and Director Safety
and Quality, Department for Health and Wellbeing about the response and management of
complex and/or serious incidents that carry organisational risk
SLS User Administration role - ensure that staff have appropriate level of log-in access to SLS
and user profiles that enable notification of incidents as required by their role
ensure that all managers are investigating incidents to the level required, and the patient
incident module of SLS is used to document the investigation processes
ensure that managers and committees are able to access reports and data to identify trends
and areas requiring support for quality improvement
ensure that all staff are aware that personal information in SLS must be protected and kept
securely in the same way as personal information in a medical record
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data security data custodians ensure that any internal or external requests for data or
information from the SLS are considered for approval by LHN Safety and Quality Manager
and/or Director Safety and Quality Unit, DHA, and are in accord with Health Care Act 2008,
Mental Health Act 2009 and Freedom of Information Act 1991.
ensure data quality and integrity, including correct classification of patient incidents and
adequate information provision
participate in governance of the SLS system assist staff to formulate SLS Change requests,
for local endorsement and submission to DHA SLS Support team for approval and action
collaborate with clinical educators to ensure that
o all staff have skills and knowledge required to record an incident (be an SLS notifier)
o all managers have skills and knowledge required to review and manage patient incident
types, including those requiring escalation to senior managers and/or Safety and Quality
managers
2.8 Clinical Educators
assist Safety and Quality staff and SLS Administrators to ensure that staff have skills and
knowledge about reporting, managing and openly disclosing patient incidents, required for
their role through including these topics in training curricula.
2.9 All SA Health staff, students and contractors
report all identified patient incidents into the SLS
participate in relevant patient incident management and open disclosure training
support consumers/patients and carers to report patient incidents, and to engage with the
process of incident investigation
commence and/or participate in the open disclosure process as appropriate
participate in the investigation of incidents as required
participate in the implementation of recommendations arising from the investigation of
incidents
encourage colleagues to report and/or notify incidents and near misses that have been
identified.
All SA Health employees or persons who provide health services on behalf of SA Health will
comply with this policy directive.
This policy directive does not apply to the management of incidents that are reported into other
modules of the SLS such as:
the Consumer Feedback module such as complaints and commendations
the Security Incident module, such as fire, flood, or other emergency code incidents and
notification by security officers to SA Police about weapon possession or alleged criminal acts
the Work Health and Safety module, such as hazards and harm to workers, or notification to
SafeWork SA.
A patient incident investigation will not involve the review, investigation or management of issues
related to the competence of individual health practitioners. These matters must be separately
investigated and resolved by Workforce staff, in accordance with the SA Health (Health Care Act)
Human Resources Manual.
3. Policy Requirements
3.1 Standards
The National Safety and Quality Health Service Standards set criteria against which health
services are assessed and accredited.
The health service organisation has a patient incident management and investigation system that:
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supports staff, patients and family/carer to recognise and report patient incidents, and use the
patient incident management module of the SLS to document the investigation and analysis of
incidents and open disclosure processes in an accurate and timely manner
initiates and provides open and timely communication, that is, an appropriate open disclosure
response, with the patient, and carers where appropriate, after a patient incident, and that this
includes an acknowledgement of the incident, an expression of regret and provision of
ongoing information as required
ensures that staff have the skills and knowledge required for their roles and are supported
after distressing incidents
involves staff and patients and family/carer in the investigation and analysis of patient
incidents when appropriate
provides timely feedback from the analysis of patient incidents to the governing body, staff and
consumer groups; and ensures that recommendations for quality improvement are
implemented and monitored
recommends that organisational risks identified during the analysis of patient incidents are
referred to the Risk Manager
meets statutory and other requirements for:
o reporting or notification to external organisations and bodies of incidents involving patients
o investigation, analysis, documentation and protection of information gained during these
processes.
3.2 Components of incident management and open disclosure
After a patient incident, two separate but linked and related processes are initiated:
open disclosure - that will assist the patient and carers in their recovery from the incident, and
guide the health workforce and health service organisations in supporting patients who have
experienced harm
incident reporting, investigation, analysis and action to change practices - these benefit staff,
the health service and the patient through improvement of safety and quality of services and
the opportunity to support staff who have been involved in a distressing incident.
The linking of open disclosure and incident management is essential to ensure that:
patients and family/carer can contribute to the investigation, and are informed of the
recommendations arising and actions taken or planned to prevent recurrence and improve
safety and quality of the service
health service organisations learn from the investigation of incidents and from the patient and
family/carer perspectives.
Professional codes of conduct require participation in incident management and open disclosure,
for example Good medical practice: a code of conduct for doctors in Australia, 2014.
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Diagram 1 Summary of patient incident management and open disclosure
The patient incident management and investigation system has a number of steps and processes
that include open disclosure with the patient (Diagram 1). The toolkit that accompanies this policy
includes additional information. These steps are:
identification, and immediate action
care of, and communication with the patient, including open disclosure and management of a
complaint, if required
care of staff involved
reporting into SLS, documentation and/or onward notification to senior managers
review of the notifiers report
classification, investigation and analysis of the individual patient incident, including decision
about type of investigation required
assisting in analysis of groups of patient incidents, or data arising, in conjunction with the
relevant governance committee, for example all incidents in one part of a health service, or a
group of like incidents such as pressure injuries
implementing action(s) to improve safety and quality, both locally, across health services and
across SA Health as applicable.
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Where an incident has occurred sensitive, empathetic, open and honest communication with the
patient and their family/carer is essential. Open disclosure steps include:
acknowledgement of the incident, and offering, initiating or signalling the need for open
disclosure
preparing for, and engaging in open disclosure discussion, including expressing regret
providing follow up to patient and family/carer, including actions taken as a result of the
investigation
completing the process and maintaining documentation.
3.3 Initial steps after a patient incident
Identification and immediate action after a patient incident 3.3.1
A patient incident might be identified:
by a clinician, staff member or student at the time of the incident, or when an unexpected
outcome is detected
through established consumer feedback or complaints mechanisms
through other review systems, such as audit or review of medical records
by the patient and family/carer, other patients, visitors, students or other staff, at the time of
the incident or later.
All SA Health employees or those providing a service on behalf of SA Health including students
and staff of a health service that is providing services under contract with SA Health, who observe
or become aware that a patient incident or near miss has taken place are required to:
ensure that any person affected by the incident is safe and all necessary steps are taken to
support and treat the person/s and prevent further injury
inform a line manager
preserve evidence (section 3.3.2), within the constraints of providing safe clinical care in the
situation
report the incident into SLS, and document information in the medical record.
Patients and their family/carer should be encouraged to report incidents to the clinical team. Staff
are required to act on such reports, by reporting into the SLS.
The line manager or the treating clinician may be responsible for the initial acknowledgement and
completion of a Level 2 open disclosure process.
Managers are required to provide or arrange support, team or individual de-briefing and/or
counselling services to staff involved in a distressing patient incident.
Preservation of evidence surrounding incidents 3.3.2
If the matter has been referred to the SA Coroner, SafeWork SA or SA Police or other external
agencies, there are requirements for preservation of evidence that should be adhered to.
If this cannot be done, use a SA Health owned digital camera to document the scene prior to the
environment being disturbed. Images should be uploaded into the Documents tab in the managers
section of the SLS incident report.
Any relevant equipment, disposables and the environment involved must be left as it was at the
time the incident occurred, where practicable. Avoid altering equipment settings and connections.
If, for safety reasons this is not possible:
document any changes and attach this documentation to relevant equipment, and
isolate and secure the relevant equipment, accessories, disposables and associated
packaging.
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If there is no feasible alternative to the continued use of the equipment or clinical environment,
preservation of evidence will take second place to the provision of safe services to clients and the
emotional well-being of those involved.
3.4 Open disclosure (OD)
Open disclosure is defined as a process of providing an open, consistent approach to
communicating with consumers/patients and their carer/support persons following a patient
incident.
Open disclosure is:
a patient and consumer right, and a legal obligation. Part 3 of Health and Community Services
Complaints Act 2004 includes a Charter of Health and Community Services Rights (the
HCSCC Charter). The HCSCC Charter of Rights states that any incidents involving consumers
are managed openly to ensure improvements.
a core health professional requirement (Good medical practice: a code of conduct for doctors
in Australia 2014 section 6.2) and other Australian health professional codes
an attribute of high-quality health service organisations (required by the NSQHS Standard 1)
and an important part of healthcare quality improvement
guided by the Australian Open Disclosure Framework (Australian Commission on Safety and
Quality in Health Care - ACSQHC).
Aims of open disclosure include continuation or restoration of a therapeutic relationship and patient
trust in clinicians and the healthcare system. To this end:
all patient incidents except near misses should be acknowledged or openly disclosed to the
patient and their carer/support person within 24 hours if practicable, and unless there are
reasons for deferral (section 3.4.3).
the treating clinical team has the primary responsibility for open disclosure.
If the incident occurred during the episode of care that was provided by a health service under
contract with SA Health or an LHN, the service is expected to provide open disclosure. The
exception is for SAC 1 and 2 incidents, when it is expected that both the contracted service and
the referring LHN or SA Health representative service responsible will actively participate in the
Level 1 Open Disclosure process.
There are circumstances in which the service that is primarily responsible for the incident has no
relationship with the patient, or is unable to provide open disclosure, for example due to location.
Examples include the statewide services such as SA Pathology, or emergency services such as
SA Ambulance or MedStar. These services must provide relevant information about the incident to
enable the treating clinical team to provide open disclosure on their behalf. The exception is for
SAC 1 and 2 incidents, when it is expected that the service responsible will actively participate in
the Level 1 Open Disclosure process.
Open disclosure Tools 4. 5, 6, and 7 provide information for consumers and family/carers. Open
disclosure is not a one-way provision of information it is a discussion between two parties and an
exchange of information that may take place in several meetings over a period of time.
The offer of open disclosure may be refused, and this can be documented in the SLS incident. As
part of these discussions, patients should be informed about processes and options for making a
complaint, if they wish to. Open disclosure may not resolve patient or carer concerns.
Direct Personal Response 3.4.1
A Direct Personal Response (DPR) is an element of the National Redress Scheme; the scheme
provides acknowledgment and support to people who experienced child sexual abuse in
institutions across Australia. If a victim of child sexual abuse applies to the scheme and are offered
redress they can also ask for a DPR from the institution responsible for the abuse. Whilst a DPR is
very similar to open disclosure there are specific requirements that support the process of
providing a DPR, for more information visit the SA Health web site
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Level 1 and Level 2 Open disclosure 3.4.2
The level of open disclosure process required will depend on the outcome and circumstances of
the incident (Table 1):
Level 1, which is a response to a patient incident with a Safety Assessment Code rating of 1 or
2 (actual SAC) that is, more serious incidents or significant patient or family/carer concern,
and
Level 2, which is a response to incidents with a Safety Assessment Code rating of 3 or 4
(actual SAC) that is, less serious incidents.
Table 1: Criteria for levels 1 and 2 Open disclosure response
Open
Disclosure
Incident type Criteria Requirements, timelines and
documentation
Level 1
High level
response
SAC 1 or 2 incidents and others
where there is:
death or major permanent loss of
function
permanent or considerable
lessening of body function
significant escalation of care or
major change in clinical
management (eg admission to
hospital, surgical intervention, a
higher level of care, or transfer to
intensive care unit)
major psychological or emotional
distress
significant patient or carer
concern arising from any incident
actual or potential media
attention
cluster incidents
extreme and unexpected poor
outcome or avoidable
complication of care.
An Open Disclosure Facilitator must
be present or lead the process.
The senior treating clinician must be
present.
The process must be initiated in a
timely manner, and should be within
hours of the incident when
practicable.
The health service must nominate a
contact person who is not part of the
treating team for the patient and
family/carer.
A professional interpreter must be
present if English is not the primary
language.
A consumer advocate or equivalent
support person can be present if the
patient requests.
The process and the outcome must
be recorded in the SLS in the
managers section of the patient
incident.
The Safety, Quality and Risk
Manager can provide advice.
Level 2
Low level
response
SAC 3 or 4 incidents where there is :
no permanent injury
no increased level of care
required (eg no transfer to
operating theatre or intensive
care unit)
no, or minor, psychological or
emotional distress.
The OD process can be conducted
by the patient incident manager or a
senior member of the patient s
clinical team.
The process can occur at or near the
time that the incident is identified, but
should be completed within 24 hours
if practicable.
The process and the outcome should
be documented in the SLS in the
managers section of the incident.
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Level 1 open disclosure cannot be delegated to junior staff. An open disclosure cannot be
delegated to administrative staff or students.
The steps staff take through Open disclosure process for Level 1 and 2 are illustrated in flowcharts
(Tools 18 and 19). Steps include preparation, engaging in open disclosure, providing follow-up and
completing and documenting the process.
Patient considerations in preparing for open disclosure 3.4.3
There is preparation required to ensure that the open disclosure discussion includes the most
appropriate people and an optimal outcome is achieved. Preparation is described in detail in Tool 1
Quick guide and Tool 3 Comprehensive guide. The checklist in Tool 9 will assist in tracking the
completion of open disclosure steps.
Tool 10 describes patient considerations to ensure that the individual s needs are best addressed,
including when application for deferment of the process may be warranted.
A professional interpreter, communication aid or device, or a third party who understands the
communication needs of the patient may be required.
If an incident involves a person under 18 years, the clinical team will, together with the parents or
authorised caregivers, need to make informed but complex assessment of their involvement. A
psychologist can assist. In the case of young people who may have legal competency, the
involvement of parents in the process will be comparable to that of consent for treatment involving
the child, and the team will need to weigh up the young person s maturity, age and the wishes of
the young person and the parents, where appropriate.
Disclosure of information relating to treatment, including open disclosure of any incident applies
equally to people with a mental health condition, irrespective of whether the patient has capacity
and/or is subject to an inpatient or community treatment order. Similarly, patients with a cognitive
impairment should be involved directly in communications about what has happened to them. The
timing of the disclosure is subject to the clinical team s assessment of how this will affect the
patient s health, and their ability to understand what is said.
The Chief Psychiatrist and Community Visitors have powers of inspection under the Mental Health
Act 2009, and may be involved with incidents occurring in mental health treatment centres.
Incidents that resulted from actions to a patient by other patients or other persons such as visitors,
may require consideration of level 1 open disclosure to restore trust in the safety of the service. An
example may be where a patient is pushed to the floor and harmed by another patient or visitor.
If the incident resulted in a death is required to be reported by the appropriate medical officer to
the SA Coroner, families may need information about the coronial process and autopsy (if
applicable).
Deferral of open disclosure 3.4.4
Prompt open disclosure may not be indicated in every situation. For example, if the physical or
mental health of the patient precludes them participating.
If staff consider that deferral is in the best interests of the patient:
the rationale for deferral and plans for when open disclosure will take place must be clearly
documented in the patient s medical record and the management section of the SLS
the patient incident manager or treating clinician needs to seek approval from local Safety and
Quality or Risk Manager, using the SLS email tab for communication.
The patient, their family/carer may also request deferral. In this case, a decision not to openly
disclose must be justified as being in the patient s best interest, and:
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the rationale for deferral and plans for when open disclosure will take place must be clearly
documented in the patient s medical record and the management section of the SLS
where possible, the decision should be independently verified by a practitioner or colleague
who was not involved in the incident. This verification must also be documented in the
patient s medical record and the management section of the SLS.
If there is a disagreement or dispute, advice should be sought from Safety and Quality or Risk
Manager in the LHN or Statewide Support Service, or the Safety and Quality Unit of the
Department for Health and Wellbeing or HealthSentinelEvents@sa.gov.au . If open disclosure with
the patient is deferred, but is held with the patient s family/carer or other relevant persons in the
meantime, the process must recommence with the patient at a later date.
There are rare situations when Open Disclosure may not be appropriate, including some instances
of self-harm, suicide or criminal acts. It is recommended that advice is sought from the Safety and
Quality Unit and/or the Office for the Chief Psychiatrist. Other forms of counselling or debriefing for
persons involved may be required.
In rare circumstances a cluster incident may occur and following investigation it is apparent that no
harm has occurred. In these circumstances the Chief Executive SA Health may give consideration
to the requirement for open disclosure to be waived. Any consideration of waiving must be briefed
to the Chief Executive and include a description of the incident and subsequent investigation and
rationale for waiving the open disclosure process.
Engaging in open disclosure discussions 3.4.5
The important elements of open disclosure from a patient or consumer perspective are:
an expression of regret, which should include the words I am sorry or we are sorry that this
has happened
a factual explanation of what happened
an opportunity for the patient, their family/carer to relate their experience and ask questions
a discussion of the potential consequences of the incident
an explanation of the steps being taken to prevent recurrence.
Resources have been developed to assist the patient and family/carer to understand and engage
with the open disclosure process (Tools 4, 5, 6, and 7). Tool 2 describes appropriate
communication for saying sorry, that should be used by staff.
Information arising from open disclosure may be used in the investigation of the incident. Staff can
advise the patient and family/carer about what is being done to investigate the incident.
Tools 13, 14 and 15 assist staff to track and document the process.
Completing and documenting the open disclosure process 3.4.6
Completing the open disclosure process with patients and carers includes:
reaching an agreement regarding future care, ongoing support and restorative action between
the patient, their family/carer and health service
offering the patient, their family/carer final written and verbal communication, including
recommendations arising from the investigation findings.
Additional steps that may be required include:
offering the patient, their family/carer the opportunity to discuss the process with another
clinician (eg a general practitioner)
additional meetings and following up any outstanding concerns that the patients or family/carer
have
providing information to support the patient and family/carer to take an alternative course of
action if an agreement cannot be reached
encouraging patients and staff to complete open disclosure evaluation surveys (Tools 15 and
16).
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Completing the open disclosure process includes communicating the recommendations for
minimising recurrence that have arisen from the incident investigation and outcomes of the open
disclosure process to patient, carer and staff. Communicating with staff is achieved through:
documentation of the incident management and open disclosure process in the medical record
recording the completion of Open Disclosure in SLS. The SLS Topic Guide and SLS Guide
How to manage a patient incident provide further information.
3.5 Legal aspects of open disclosure
Open disclosure does not, of itself, create legal liability. Acknowledging an incident, and
expressing regret that it has happened, is not an admission of liability. Liability is established by a
court and is based on an evidentiary matrix which may, in part, be based on statements made
either before or after the event.
However, clinicians must be aware of the risk of making an admission of liability during open
disclosure. In any discussion with the patient during open disclosure, clinicians should take care
not to:
speculate on the cause of an incident
pre-empt the results of any investigations
attribute or apportion blame, or criticise individuals
state, imply or agree that they, other clinicians or health service organisations are liable for the
harm caused to the patient.
Further information is available through the training that is available for staff who have a role in
leading Level 1 Open Disclosure processes (Open Disclosure facilitators) and the Australian Open
Disclosure Framework (Australian Commission on Safety and Quality In Health Care). This
resource also provides guidance on other legal issues such as freedom of information, privacy,
defamation, and qualified privilege.
If the patient has a legal guardian or a substitute decision maker appointed through an advance
care directive or enduring power of medical attorney or enduring power of guardianship it will be
necessary for staff to determine the legal effect of any such relationships in assessing whether any
decisions needed after disclosure of an incident can be made by a third party in the absence of the
patient s informed consent to do so.
3.6 Reporting of patient incidents
There is a requirement for accurate and factual documentation in the patient s medical records,
including care and treatment provided before, during and after an incident.
Any patient incident reporting required by legislation or relevant Department of Health or local
health service policy or procedures, should be followed, for example some patient incident
reporting is required by the Mental Health Act 2009.
All patient incidents must be reported into the patient incident module of the SLS, via the online
web form, within 24 hours or as soon as practicable.
The staff member who becomes aware of, or observes the patient incident, or has the most
information about the incident must make the initial report into the patient incident module. This
task cannot be allocated to non-clinical staff unless they discover or are involved in the incident.
Students can submit a report if they were involved in the incident, but must discuss with their
supervisor and include their supervisor s name in the Other people involved section of SLS. Local
arrangements with contracted service providers to facilitate incident reporting into the SLS are
required because they cannot access the SLS.
Many hospital acquired complications, side effects of treatment or unexpected poor outcomes from
treatment or care are preventable or avoidable, and have serious impacts on patients and health
services. These must be reported, openly disclosed and investigated in accordance with this policy
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directive, so that contributory factors can be understood and risk treatments and controls put in
place to reduce risk of recurrence.
The final long term outcome of a patient incident may be unknown at the time of reporting and
investigation, for example incidents involving babies where there may be potential developmental
delay, or delay in treatment of a progressive condition. Where there is potential for harm, that is,
the longer term sequelae of the incident are unknown, a report should be made.
Using Safety Learning System (SLS) to report an incident 3.6.1
The SLS is the SA Health governance system for recording reports, management, analysis of all
patient related incidents, including documentation of recommendations and actions taken to
reduce likelihood of reoccurrence. The staff member who is reporting a patient incident is termed
the SLS notifier.
A link to the SLS web form can be found by clicking the start button > Corporate programs > SAH
applications > Safety Learning System.
All staff can access SLS to report an incident. SLS will prompt the notifier to provide the required
information. This includes a brief, factual description of what happened and where; and what the
outcome was harm, no harm or near miss (as known at the time of the data entry).
The notifier assigns an initial Safety Assessment Code (SAC). This is done by assessing both the
actual known consequence (harm) of that incident and the likelihood (frequency) of this type of
incident occurring again.
Once the report is submitted, an email is automatically sent by the SLS to the patient incident
manager to inform them that an incident has occurred in their area of responsibility.
There are SLS guides and topic guides to assist notifiers to report, classify and assign Safety
Assessment Code ratings to incidents.
Patient incidents are classified according to a 3 tier classification (levels 1, 2, and 3). SLS Topic
guides provide assistance with classification of some types of incidents.
The location of the incident is usually where the incident occurred, for example the fall occurred in
x Local Health Network (LHN) or statewide service, y hospital, ward z. In SLS this is termed the
location exact . SA Ambulance Service defines the location by the team involved. The patient
incident manager for the area where the incident occurred is given primary responsibility for the
investigation and to take steps to prevent recurrence.
For a health service provided by a provider under a contract with SA Health, the location is the SA
Health service that notifies the incident on behalf of that service, usually the referring SA Health
service.
Some patient incidents are known to have occurred in one area, but are reported by another area,
for example ward Y identifies that two doses of a medication were omitted by ward X, prior to the
patient transfer. The incident location is entered as ward X, and the manager of ward X
investigates.
The responsibility for patient incidents that involve more than one LHN or statewide service, or
require transfer from one LHN to another is determined by relevant Managers of Safety, Quality
and Risk and is described in the SLS Guide How to Manage a patient incident.
3.7 The patient incident manager
In general, the patient incident manager has responsibility for coordinating all the activities required
for patient incident management, and for implementing any changes in the area for which they
have responsibility that will result in safety and quality improvement. Examples of staff who can be
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patient incident managers include the senior nurse on a ward, the head of a unit or the team leader
for an allied health team.
To preserve security of the system, managers/supervisors are required to apply for log-in access
(manager access) to be able to:
receive email notification of incidents occurring in that area
log in and read the notifiers report, and add information to the SLS incidents within their area
of responsibility, and
act as a reviewer as required for other incident managers
document open disclosure processes.
Applications for patient incident manager access (log-in or user access) are made by completing
the SLS User Access Request form and forwarding to the Clinical SLS Site Administrator who then
verifies that, in order to fulfil the role of patient incident manager, the nominated staff member:
holds a position that requires them to be a patient incident manager
has completed the SA Health eLearning course Patient incidents and open disclosure
has read and understood the SLS guide How to manage a patient incident, that includes
practical information and information about legal aspects of incident management
has access to other relevant training, mentoring and troubleshooting as required.
3.8 Initial review by the patient incident manager
The notifier s report of the patient incident should be reviewed by the patient incident manager as
soon as practicable, or at least within two (2) working days of the incident being reported.
At a minimum, the initial review of an incident should include:
verifying the incident classification
updating what is known about the patient outcomes, for example a fracture resulting from the
fall
the status of the open disclosure process
patient characteristics, for example age, co-morbidities
incident characteristics, for example when, where the incident occurred
contributing factors
organisational outcomes the potential effect of the incident on the organisation
verifying the Safety Assessment Code (SAC) rating, especially if SAC 1 or SAC 2.
After this review the patient incident manager must decide:
what further information, and what type of investigation is required?
what level of open disclosure is required? If open disclosure has already occurred ensure that
the process is completed. If the incident is serious, discuss with the LHN Safety, Quality and
Risk team.
who else should be involved in investigation of the incident, as a reviewer or a staff member
with a more senior role?
what other requirements there may be for additional notification or escalation to senior
management?
There are some categories of incident that require more than one report. The patient incident
manager should be aware of, and may be required to participate in other types of investigation in
these situations. For example:
a patient incident of challenging behaviour may require additional reporting of a Security
incident if security officers attend. In this example, the security manager investigates the
security response, and the patient incident manager investigates the events leading to the
unsuccessful de-escalation
when a patient incident also involved harm to an employee or student, there is a requirement
to report into the Worker incident module of SLS.
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The SLS allows for linkage of incidents. Advice and training can be sought from the relevant SLS
Administrator or Managers of Safety, Quality and Risk, and additional information is included in
the SLS guide How to manage a patient incident.
Events that are reported into the restricted access Notification module of SLS by designated senior
managers, for example alleged criminal acts or alleged professional misconduct, may also require
another report into the patient incident module:
if there was a patient incident
if there is a need to investigate if there were any systemic factors that contributed to the
occurrence of the patient incident.
In these cases, the investigation of the patient incident is conducted and documented in
accordance with this policy directive. Advice from the Department for Health and Wellbeing Safety
and Quality Unit via HealthSentinelEvents@sa.gov.au should be sought to ensure that the
investigation and documentation of the patient incident is limited to the appropriate scope, so as to
not impede other investigative processes.
3.9 Level of escalation/notification for patient safety incident(s)
Patient incident managers need to be aware of the requirements for notifying senior managers of
the health service about SAC 1 and SAC 2 patient incidents and suspected cluster incidents, both
verbally and in writing (the SLS Send an Email tab can be used). (Table 2)
Within 24 hours of confirmation that an incident is a SAC 1 or 2, or a Sentinel Event or adverse
incident, the local Manager of Safety, Quality and Risk or delegated staff must
email HealthSentinelEvents@sa.gov.au and provide the CEO of the LHN or statewide service with
a briefing. The CEO notifies the Deputy Chief Executive and other relevant executive(s) using a
Clinical Incident Briefing (CIB). The CIB is uploaded into SLS in the Documents tab. It can be
uploaded as a level 1 secure document if it is judged to require this additional security.
Table 2 - Guiding principles for level of escalation of significant patient incidents
Written brief
required
When
To LHN or
statewide service
CEO, or Chief
Psychiatrist
SAC 1 and SAC 2 (except falls incidents)
external agencies eg SAPOL, SA Coroner, SAICORP notified or
involved with the patient incident. (Note for example that not all
deaths requiring coronial notification have an associated patient
incident).
the patient incident was a system error or failure but no patient has
suffered actual or likely harm (cluster incidents without harm) and
a lookback review is planned / required
To SA Health
DCE or relevant
Executive(s)
the patient incident was a system error or failure, and more than
one patient has suffered actual harm or potential for a future
harmful outcome (cluster incidents with harm) and a lookback
review is planned / required
media attention is probable
external agencies involved eg SAPOL, AHPRA, SA Coroner
an external or independent review is planned, eg by SA experts
external to the LHN or statewide service
the patient incident involves more than one LHN, or LHN and
statewide service
response and actions are required by more than one executive, eg
People and Culture, eHealth
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3.10 Patient incident investigation and analysis
Investigation of a patient incident leads to understanding about when and how the healthcare led
to the adverse outcome for the patient. For example, was there treatment specific harm;
psychological harm; or harm due to over-treatment, delayed or inadequate diagnoses or system
failure?
Most patient incidents result from a complex system of interaction between healthcare
professionals, treatment procedures and medical equipment. Analysis of incidents determines
which contributing factors may have led to an incident occurring.
Investigation and analysis of avoidable complications of care, side effects of treatment or
unexpected outcomes from treatment or care, enables:
identification of contributory factor(s) or cause(s) such as a system issue for example delay,
error or failure in patient assessment, staff or patient factors, equipment, information or
communication, procedures or coordination of care
identification of strategies to predict and/or prevent that complication or adverse outcome next
time, or for other patients.
Methods that may be used for the review and investigation of patient incidents include
interdisciplinary team review, root cause analysis (RCA), audits or reviews of medical records by
peers or by committees such as mortality review committees, Part 7 Incident review committees or
committees with these functions. These are described in detail in the SLS guide How to manage a
patient incident.
Patient Incident Reviewers 3.10.1
Patient incident managers should use SLS to request other staff with log-in access to be a
reviewer. Reviewers are expected to provide specialist comment and review or analysis of the
incident. Some reviewers, for example Biomedical Engineers can also ensure that appropriate
notifications are made, for example to the Therapeutic Goods Administration.
Patient incident reviewers can include content experts and managers from workgroups such as
Work Health and Safety, Mental Health, Security Services, Biomedical Engineering, SA Pharmacy,
SA Pathology, SA Medical Imaging, Infection control, Radiation Safety Officers, SA Ambulance or
Drug and Alcohol Services SA, or Consumer Liaison officers (or equivalent).
Investigation of SAC 3 or SAC 4 incidents 3.10.2
All SAC 3 or 4 incidents should be investigated, analysed and closed within 30 calendar days of
reporting.
The investigation or review of SAC 3 and 4 patient incidents can be managed by the relevant
patient incident manager. This is called a managers review. As well as the review of the
information provided by the notifier, investigation should include, at a minimum:
discussion with notifier and other staff as appropriate
discussion with patient involved (this can be part of the open disclosure process)
review of careplan, medical record, and any physical evidence
review of any relevant procedure(s) or protocol(s)
contribution by patient incident reviewer(s) if required.
This investigation will assist in identifying the factors that contributed to the incident, and plan
action that will reduce or eliminate risk of recurrence.
Interdisciplinary team review within 48 hours is recommended for harmful incidents and repeat
incidents such as repeat falls and other SAC 3 and 4 rated patient incidents. This team activity
promotes shared team learning, and engagement with the patient. Guidance about the conduct of
a team review is provided in the SLS guide How to manage a patient incident.
The recommendations arising from a team review are documented in the managers section of
SLS. Changes to the patients care plan are documented in the medical record.
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Investigation of SAC 1 and SAC 2 incidents 3.10.3
The most serious incidents will be rated as SAC 1 or SAC 2 by the patient incident manager
(actual SAC). The steps are illustrated in the flowchart Reporting and management requirements
for Safety Assessment Code (SAC) 1 notifiable incidents.
All patient incidents confirmed as SAC 1 or SAC 2 require:
detailed and thorough investigation/review, possibly using RCA processes or review by Part 7
committee, to identify actions to minimise recurrence, to be completed within 70 calendar
days. SAC 2 falls incidents only require post fall team review
level 1 open disclosure response
coordination with Safety and Quality or Risk Manager of the LHN or Statewide Support
Service
provision of a Clinical Incident Brief (CIB) to LHN or Statewide Service CEO or Chief
Psychiatrist
de-briefing or counselling as required for staff involved
The Structured review tab of the SLS includes functions for recording and tracking these
investigations. Access to this tab has limited access. Use of this tab enables monitoring of types
and completion of investigation of SAC 1 and SAC 2 incidents. Reports 1 and 2 that contain the
outcome of any protected investigation must be uploaded into the SLS as a level 1 secure
document.
Advice can also be obtained from the Department for Health and Wellbeing Safety and Quality Unit
at email HealthSentinelEvents@.sa.gov.au.
Investigation of cluster incidents 3.10.4
These are a group of incidents or occurrences that have system-wide safety implications, that is,
they involve a system failure or multiple systems failure that does, or has the potential to
compromise the safety of more than five patients.
Examples of this type of incident include a missed diagnosis of a progressive condition due to a
systemic issue/error with a test, or under- or over-dosing of medication due to an incorrect
protocol. There are incidents where the eventual outcome or impact on an individual patient is
unknown at the time, or the outcome for each individual may vary between patients, depending on
their individual response.
If a cluster incident is identified, the Chief Executive Officer of the LHN or statewide service must
be briefed within 24 hours using an RIB and the process described in 4.9.
A master incident must be reported into SLS. Individual patient incidents will each then be linked
to the master incident.
The appropriate investigation methodology for a cluster incident is a lookback review, initially to
assess the scope and numbers of patients affected, and coordinate the appropriate response.
Guidance on investigation and reporting into SLS is provided in the SA Health Lookback review
policy directive.
Actions arising from investigation and analysis 3.10.5
Incident management is a key quality improvement activity, and as such has 2 main parts.
1. Incident reporting, providing the measures (the data).
2. Incident review, investigation, analysis, informing the action taken to minimise risk or
prevent recurrence
After analysis, the patient incident manager is responsible for:
implementing local changes or actions to reduce risk, and
referring any recommendations for action to the relevant governance committee or senior
manager(s). This includes recommendations for system change
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recording recommendations arising from investigation and analysis in the medical record and
in the SLS.
3.11 Legal aspects of review, investigation and analysis of incidents
All entries made into the SLS should be written as factual objective statements.
Information contained in the SLS is not prohibited from disclosure unless:
it is information gathered at the request of a Part 7 Committee; or
it is information gathered as the result of an RCA commissioned under Part 8 of the Health
Care Act; or
it is personal information that is protected from disclosure by section 93 of the Health Care Act
or s.106 or the Mental Health Act 2009; or
it is personal information that meets the criteria for an exemption under the Freedom of
Information Act 1991
Some committees are authorised under Part 7 of the Health Care Act to undertake quality
improvement activities and may review patient incidents. The information gained by these
committees is prohibited from disclosure. Activities of a Part 7 committee include:
the assessment or evaluation of the quality of services provided by the health service
the making of recommendations to improve the provision of services provided
the monitoring of the implementation of any recommendations or other initiatives that are
relevant to improving the quality of services provided.
It should be noted that both Part 7 and Part 8 of the Health Care Act prohibit the use of these parts
to investigate the competence of a particular person in providing health services. The RCA policy
and the Part 7 Committees policy provide further information.
It is the responsibility of all staff to identify and raise genuine complaints about a practitioner whose
conduct or performance is a risk to patients and/or may meet the grounds for voluntary or
mandatory notification under the Health Practitioner Regulation National Law or the National Code
of Conduct for Unregistered Health Practitioners, or the legal requirement to report to the
Independent Commissioner against Corruption (ICAC). It may be appropriate to report a health
practitioner who has inappropriately reported or managed patient incidents to AHPRA or HCSCC.
Release of information about patient incidents 3.11.1
Parts 7 and 8 of the Health Care Act 2008 protect information gained as the result of or in
connection with an authorised activity, or a root cause analysis, from being disclosed, except in in
the very limited circumstances allowed by the Act. There are substantial penalties under the Health
Care Act for releasing information protected by Part 7 or 8 to someone who is not authorised to
receive that information.
Section 93 of the Health Care Act 2008 and Section 106 of the Mental Health Act 2009 also
protects personal information from disclosure.
Any staff receiving a request for information about an incident, a review done by a Part 7
Committee or an RCA must direct the request to the LHN Safety and Quality or Risk Managers or
Department for Health and Wellbeing Safety and Quality Unit (HealthSentinelEvents@sa.gov.au).
This includes, but is not limited to requests from:
Freedom of Information officers
Australian Health Practitioner Regulation Agency (AHPRA)
SA State Coroner
consumers
lawyers
the media
SA Ombudsman.
Health and Community Services Complaints Commissioner
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Patient confidentiality and privacy are to be maintained in accordance with the SA Health Privacy
Policy, and professional codes of conduct.
3.12 Education and training requirements
All staff involved with direct provision of services to patients must be able to report a patient
incident into the SLS, and be able to participate in the investigation of incidents and level 2 open
disclosure. All such staff must be aware of their responsibilities in reporting incidents, and
providing an appropriate open disclosure response.
The interactive eLearning course is designed for completion by all staff, and introduces incident
investigation and open disclosure. The SLS guide How to report a patient incident provides
information for all staff.
All patient incident managers must acquire the skills and knowledge they require to fulfil their roles
and responsibilities in patient incident management, including open disclosure, incident
classification and SAC rating, investigation, using SLS, escalation of serious incidents, and taking
action to improve safety. The SLS Guide How to manage a patient incident provides further
information.
Patient incident managers require skills and knowledge in analysis of single incidents, serious
incidents, and in analysis of aggregated incident types for the purpose of quality improvement.
Nominated Open Disclosure Facilitators, RCA team leaders and Part 7 committee chairs all require
specialised training to equip them with knowledge and skills for these roles.
The managers and staff of a Safety and Quality and Risk Unit or equivalent, including the
designated SLS Administrators, can provide advice to staff and executives, and have a role in staff
education. These teams are able to authorise access to SLS for patient incident manager. Safety
and Quality managers have considerable expertise in SLS and patient incident management.
Further information for these staff is available from Department for Health and Wellbeing Safety
and Quality Unit.
4. Implementation & Monitoring
Health services are required to evaluate the effectiveness of their incident management system,
and the open disclosure processes outlined in this Policy Directive. Table 3 summarises a number
of indicators and measures.
This includes evaluation or gap analysis of staff knowledge and skills to effectively use the features
of the SLS as the key enabling tool for all phases of incident management, and to use the data and
information for planning quality improvement.
Evaluation measures require linkage with regular committee-led activities for safety and quality,
clinical governance and risk management. These provide a comprehensive picture of the impact of
incident management, and monitoring of the progress with improvement initiatives.
The Local Health Network Analytic and Reporting System (LARS)and QIP Hub will be used to
display indicators for patient incidents relevant to the National Safety and Quality Health Service
Standards, and other indicators, drawing from data captured in the SLS. The SLS retains the more
comprehensive set of data, and indicators can be reported directly from SLS in a variety of
formats.
Health services should aim for minimisation of both numbers of patient incidents and harm
resulting from patient incidents. An indicator of a positive safety culture is preparedness to report
incidents and near misses. Decrease in harm is a useful measure of improvement.
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Table 3 Evaluation and indicators
A health service may require a number of measures to indicate its
performance in patient incident management. These include:
Data source
Timely /
appropriate
reporting of
patient
incidents by
notifiers
All patient incidents and near misses are recorded in
SLS.
All incident reports;
contain adequate and appropriate information
All medical records include details of the incidents and
any diagnosis and/or care provided as a result of the
patient incident.
All staff have knowledge and skills in principles and
practice, including use of SLS appropriate to their role.
Clinical audit of
medical record
or Sunrise EMR
and comparison
with SLS reports
Audits of SLS
data quality
Audits of staff
knowledge,
skills
Effective
review and
management of
individual
incidents
All patient incidents are reviewed within timelines.
Incident managers are reviewing all incidents, and SLS
is used to document the review.
All incident managers are investigating patient incidents
to the level required, and SLS is used to record the
investigation processes.
All recommendations and/or actions arising are
documented in SLS.
All SAC 1 and SAC 2 incidents have timely review
according to this policy, and documentation uploaded
into SLS.
All recommendations and/or actions arising are
completed in timely fashion.
All incident managers have appropriate knowledge and
skills in principles and practice, including use of SLS in
reporting /documenting investigation and follow-up
actions.
All incident managers request input from reviewers
appropriately.
All incident managers are using SLS for documentation
for individual patient incidents of;
post incident team review
other results of investigation
open disclosure processes
SAC 1 and 2 processes
implementation of recommendations / actions
arising.
All incident managers are using SLS to house relevant
documents, eg documents generated during an
investigation of a patient incident.
SLS
Audits of SLS
data quality
Audits of staff
knowledge,
skills
SLS
Administrators
All SLS Administrators have knowledge and skills to
undertake their role. (SLS Administrators guide)
DHW SLS
training records
Records of IHI
training
completed
Relevant staff
education and
training
Training provided that meets the skills and
knowledge requirements of their role
Staff participation in training.
The quantity, quality and type of training offered, and
to which staff, is monitored and evaluated.
All managers and committee members have
Records of
clinical
education
Completion of
on-line module
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appropriate knowledge and skills in principles and
practice of data analysis and quality improvement.
There are sufficient staff with RCA training, and
Open Disclosure Facilitator training
Open
disclosure
Proportion of all SAC1 and 2 incidents openly disclosed
(target 95%)
Proportion of patient incidents where open
disclosure discussion provided, by either the
notifier or manager
Number of open disclosure processes that
commenced and concluded in a reporting period
The number and percentage of open disclosure
processes referred to mediation
The number and percentage of open disclosures
triggered by complaints, incident notification,
case note review, general observation or
patient/consumer request.
Numbers of staff with OD facilitator training
Managers completions of the Open disclosure
questions in the managers section of SLS.
Survey results of staff experience of open
disclosure
Survey results of consumers experience with
open disclosure
SLS incident
report
Staff and
consumer
surveys
regarding open
disclosure
Consumer or
patient
feedback
Complaints or concerns relating to incident management
and/ or open disclosure.
Patients are encouraged to complete open disclosure
evaluation surveys (Tool 15).
SLS - consumer
feedback
Post incident
follow-up with
staff
Documentation of staff follow-up, eg team or individual
de-brief, team learning, referral for counselling (EAP).
Patients and staff are encouraged to complete open
disclosure evaluation surveys (Tool 16).
SLS
Use of SLS
data
Report or data
generation
There is regular review and analysis by clinical
managers and committees of data from groups of
incidents:
One, or a group of locations, eg surgical division
One or more classification, eg pressure injury
Numbers and rates of incidents by
Area / location and
classification and
consequence / SAC rating
Actions arising are documented, and completed in timely
fashion.
Quality improvement activities arising are documented,
and completed in timely fashion.
Committee
minutes,
agendas
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5. National Safety and Quality Health Service Standards
The Australian Commission on Safety and Quality in Health Care has developed the National
Safety and Quality Health Service Standards (the Standards).
The Standards provide a nationally consistent and uniform set of measures of safety and quality
for application across a wide variety of health care services. They propose evidence-based
improvement strategies to deal with gaps between current and best practice outcomes that affect a
large number of patients.
This policy is relevant to all National Safety and Quality Health Service Standards. The Standards
specifically require services to have the ability to monitor and respond to incidents for some
Standards - medication safety, clinical handover, blood and blood products and falls.
Patient safety incidents must be recognised, reported and analysed, and this information used to
improve quality of care and safety systems.
6. Definitions
A full glossary of terms, including additional explanations, is available.
In the context of this document:
actual SAC means: the Safety Assessment Code rating applied to a patient incident by
the patient incident manager after investigation and analysis (SAC matrix)
adverse event means: a term used by Therapeutic Goods Administration (TGA) for
reportable unwanted and sometimes harmful occurrences from using medicines, vaccines
or medical devices (collectively known as therapeutic goods)
adverse outcome means: a poorer than expected outcome for the patient from treatment
avoidable complication of care (or potentially avoidable complication of care, or hospital
acquired complication of care) means: a known or unexpected complication of care, or
side effect of treatment that may have been prevented
carer(s) means: a term that includes family, relative, support person, person responsible,
substitute decision-maker and significant others, but not paid carers or volunteers
clinician means: a healthcare provider. Clinicians include registered and non-registered
health practitioners
contributing factors means: the circumstances, actions or influences which are thought
to have played a part in the origin or development of an incident, or to increase the risk of
an incident. Examples include human factors or system factors
degree of harm means: the severity and duration of any harm, and any treatment
implications, that result from an incident
disclosure means: the act of making something known or revealed or uncovered. To
disclose, in relation to information, means to give, reveal or communicate in any way
National Standard
1
Clinical
Governance
National
Standard 2
Partnering
with
Consumers
National
Standard 3
Preventing &
Controlling
Healthcare-
Associated
Infection
National
Standard 4
Medication
Safety
National
Standard 5
Comprehensiv
e Care
National
Standard 6
Communica
ting for
Safety
National
Standard 7
Blood
Management
National
Standard 8
Recognising &
Responding to
Acute
Deterioration
? ? ? ? ? ? ? ?
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error means: a failure to carry out a planned action as intended, or application of an
incorrect plan. An error can be by omission (not doing the right thing) or by commission
(doing the wrong thing)
health service means: all public health organisations, including statewide clinical support
services that are the responsibility of SA Health
health service manager or supervisor means: the staff member who is responsible for
the activities of a particular location for example ward or team manager or medical head of
unit
incident (patient incident) means: any event or circumstance which could have (near miss)
or did lead to unintended and/or unnecessary psychological or physical harm to a person
or consumer / patient that occurs during an episode of health care
harmful incident means: any event or circumstance which resulted in unintended and/or
unnecessary psychological or physical harm to a patient during an episode of health care
cluster incident means: a type of adverse incident where there is a group or series of
harmful incidents that are the result of one systemic error or issue, and that involves a
systems failure or multiple systems failure that does or has the potential to place more
than five patients directly at risk
near miss means: a patient incident that did not cause harm, but had the potential to do
so
no harm means: the incident occurred and the patient was exposed but no harm resulted
adverse incident means: any of the classes of patient incident, including Sentinel events,
as defined by the South Australian Government Gazette
incident classification means: the category of incident determined by its clinical features
such as relating to a pressure injury or the provision of a treatment or procedure
incident investigation means: a detailed systematic inquiry conducted to ascertain the
underlying causes and facts of a patient incident
incident management means: all the activities involved in the reporting, notification or
documentation of an incident or near miss, including the review, investigation and analysis
of the individual incident, and the analysis of groups of incidents, or data arising, for the
purpose of improvement of the safety and quality of the health service and the care
provided
incident review means: the initial review of the notifier s report of an incident submitted
into SLS, done by the patient incident manager
open disclosure means: a process of providing an open, consistent approach to
communicating with consumers / patients and their family or carer and/or support persons
after an incident
open disclosure facilitator means: an SA Health staff member who has completed the
prescribed face to face open disclosure training to be able to conduct level 1 open
disclosure
patient means: a person currently receiving health services from an SA Health service or a
service funded by SA Health. For the purpose of this document patients, consumers and
clients and residents (of residential care facilities operated by SA Health) are equivalent
terms
patient incident manager means: the senior staff member of a clinical area or service
who is responsible for the conduct of all activities to do with the management of the patient
incident, and who has been verified by the SLS Administrator or Safety and Quality
Manager(s) to have relevant knowledge and skills
patient outcome means: the impact upon a patient which is wholly or partially attributable
to an incident
Part 7 committee means: a committee that is formed in accordance with the requirements
of, and under the protection of, Part 7 of the Health Care Act 2008
quality means: the degree to which health services for individuals and populations
increase the likelihood of desired health outcomes and are consistent with current
professional knowledge (ACSQHC)
risk means: the probability that an incident will occur
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root cause analysis (RCA) means: a method of investigating incidents, using a
systematic iterative process whereby the factors that contribute to an incident are identified
by reconstructing the sequence of events to elucidate underlying root causes (contributing
factors or hazards)
safety means: the reduction of risk of unnecessary harm associated with health care to an
acceptable minimum (ACSQHC)
Safety Assessment Code (SAC) means: a numerical score applied to a patient incident
which is based on the consequence of the incident and its likelihood of a recurrence. The
score is determined by the use of the SAC Matrix
Safety Learning System (SLS) means: The electronic system and database used in SA
Health for reporting information about all phases of patient incident management.
system failure means: fault, breakdown or dysfunction within an organization s
operational methods, processes or infrastructure
team review means: a brief, informal team meeting that occurs as soon as possible after
the incident and where the inter-professional team reviews the incident, with the patient
and carer if possible.
7. Associated Policy Directives / Policy Guidelines and Resources
Accreditation policy
Advance Care Directives policy
Complaints about a health practitioner policy directive
Consent to Medical Treatment and Health Care policy guideline
Consumer Feedback Management policy directive
Coronial Process and Coroners Act 2003 policy directive and policy guideline, and the
Coroners Inquest procedure
Framework for Active Partnership with Consumers and the Community directive
Lookback Review policy directive
The Health Care Act 2008 Part 7 Committees policy directive
The Health Care Act 2008 Part 8 Root Cause Analysis policy directive
Reporting and management of incidents of suspected or alleged sexual assault of an adult, or
sexual misconduct by an adult, within SA Health facilities and services policy directive
Root Cause analysis policy directive
South Australian legislation
Civil Liability Act 1936
Consent to Medical Treatment and Palliative Care Act1995
Coroners Act 2003
Freedom of Information Act 1991
Health and Community Service Complaints Act 2004
Health Care Act 2008
Health Care Regulations 2008
Health Practitioner Regulation National Law (South Australia) Act 2010
Independent Commissioner Against Corruption Act 2012
Mental Health Act 2009
Radiation Protection and Control Act 1982 and associated regulations
South Australian Carers Recognition Act 2005
Work Health and Safety Act 2012
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References and other resources
AMA Position Statement on Quality and Safety in Hospital Practice (2013)
Australian Open Disclosure Framework. Australian Commission on Safety and Quality in
Health Care
Code of Ethics for the South Australian Public Sector.
SA Health Privacy Policy
National Safety and Quality Health Service Standards June 2012. Australian Commission on
Safety and Quality in Health Care
National Codes of Conduct. Australian Health Practitioner Regulation Agency (AHPRA).
SA Health Guide for Engaging with Consumer and the Community
The South Australian Government Gazette
Your Rights and Responsibilities A Charter for Users of the South Australian Public Health
System
8. Document Ownership & History
Approval
Date Version
Who approved New /
Revised Version Reason for Change
15/05/2020 V2.3 Director, Safety and Quality
Minor changes to reflect the introduction of
the Governing Boards
Insertion of clause in s3.4.4 so the CE can
waive the requirement for OD in rare cases
Insertion of clause 3.4.1 DPR
Change of template
29/09/2017 V2.2 Executive Director, Quality Information and Performance
Minor changes to
s 4.11 relating to the protection of SLS
information
03/01/2017 V2.1 Executive Director, Quality Information and Performance
Minor changes to
s4.4 open disclosure of near miss
incidents, some criminal and self-harm
incidents and for some service
providers
s 4.11 after removal of protection of
SLS information under Part 7 of Health
Care Act 2008
s 4.9 regarding notification to
executives and briefing to DHA
14/07/2016 V2 Portfolio Executive
Updated information and integration of :
Incident Management Policy D0162
Open Disclosure Policy D0247
Incident Management Policy Guideline
incorporating Open Disclosure
Response G0075
Document developed by: Safety and Quality, Commissioning and Performance
File / Objective No.: 2018-12727 | A2535847
Next review due: 01/02/2022
Policy history: Is this a new Policy Directive (V1)? N
Does this Policy Directive amend or update an existing Policy
Directive version? Y
If so, which version? V2.2
Does this Policy Directive replace another Policy Directive with a
different title? N
If so, which Policy Directive (title)?
ISBN No.: 978-1-76083-367-1
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01/07/12 V1.2 Operational Safety and Quality Committee
Amended to reflect Contact Centre (1800
NOTIFY) telephone number
06/10/11 V.1.1 Portfolio Executive - OOS Amended to reflect intro of SLS and OD
06/10/09 V.1 Portfolio Executive Incident Management(D0162) PE Approved version.
22/11/14 V1.2 V3 - 22/11/14 - current - Updated review date Updated review date
17/09/12 V.1.1 Operational Safety and Quality Committee
Update to reflect the restructures within the
portfolio and are not material in nature
06/10/11 V.1 Portfolio Executive Open Disclosure Policy Directive (D0247) PE Approved version
dd/mm/yy V2.0 <approving authority> eg. Formally reviewed in line with 1-5 year scheduled timeline for review.
dd/mm/yy V1.1 <approving authority> eg. Amended department name to Department for Health and Wellbeing .
dd/mm/yy V1.0 <approving authority> Original <approving authority> approved version.
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