Open Disclosure
Communication with Patient/
Family following adverse events.
Purpose of Open Disclosure
 To
identify and appropriately manage
patients who have experienced an
adverse or unexpected outcome while
receiving health care
 Adverse
event = an incident in which
unintended harm resulted to a person
receiving health care
Procedure
 Detecting
and assessing incidents
– Medical
– Nursing
– Other staff
– Established complaints procedures
– Incident reporting
Actions after identification of
an incident
Address immediate clinical
management issues
Identify support for staff / patient
Determine level of response according
to incident severity
Implement Open Disclosure process
Determining the Level of
Response
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Low level
Near misses/no-harm incidents
No permanent injury
No increased level of care required
No, or minor psychological or emotional distress
High Level
Death or major permanent loss of function
Permanent or considerable lessening of body function
Significant escalation of care/change in clinical management
Major psychological or emotional distress
At the request of the patient
Elements of Open Disclosure

An apology or expression of regret
 A factual explanation of what has happened
 An opportunity for the patient, their family/carer
to relate their experience
 A discussion of the potential consequences of
the adverse event
 An explanation of the steps being taken to
manage the event and prevent recurrence
Low Level Response

Inform person in charge/ consultant of event
and patient outcome
 Communication strategy outlined by Registrar
and Nurse in charge
 Open discussion with patient / support person
(or nominated contact person
 Documentation and Incident report
 Investigation/local review & follow up as
appropriate
High Level Response
 Inform Head of Unit or Duty Consultant (acts as
Consultant coordinator)
 Ensure physical needs of patient attended to
 Consider requirement for support to:
 staff
 Patient, family/carer
 Inform admin/ Clinical Risk Manager
High Level Response
cont……
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Preliminary team discussion
– Ascertain facts
– Decide who will be involved in the discussion with
patient: should include senior clinician
– Consider legal and insurance issues
– Determine the content of the discussion and
ensure consistent approach by all team members
– Determine a suitable time for disclosure
discussion
Discussion with Patient
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Introduction of the people present
Acknowledge that an adverse event has occurred or
that something didn’t go to plan
Expression of apology/regret for what has occurred
Provide known clinical facts and discuss ongoing
care
Listening to the patient’s understanding of events and
addressing queries and concerns
Indicate that a review or investigation is being or will
be undertaken to determine what happened and to
prevent the adverse event from happening again
Agree to provide feedback information from the
investigation when available.
Discussion with Patient
cont….
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Assurance that the patient will be kept informed of
progress in the investigation
Advocacy and ongoing support
Information on how to take the matter further if
needed
Nominated key contact for further information
provision
Reimbursement of out-of-pocket expenses and
ongoing care cost (as appropriate)
Examples of appropriate phrases
during an apology
 ‘I am/we are sorry for what has occurred’
 Factual statements explaining how the incident
occurred
‘this incident occurred because the wrong label was
mistakenly placed on your specimen sample’
 Explaining what is being done to ensure it does not
happen again.
‘we are currently investigating exactly what caused
this breakdown in the process and will inform you of
the findings, and steps taken to try to prevent
recurrence, as soon as we know’
After-care

Formulate a management plan for follow-up
 Reporting & communication
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GP
Quality manager
DMS / DON
Other eg coroner
Documentation
– Medical record
– Incident form
Checklist
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D
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Distress acknowledged
Irritation / anger / reactions accepted
Sorry: expression of regret
Careful listening
Let patient ask questions
Other helpful information given
Suggestions / solutions
Extra contact and meetings
Recent developments to assist Open Disclosure

Many staff already undertake most of the tasks associated
with open disclosure in their discussions with family
members and patients after an adverse event.

The Australian Commission on Quality and Safety in
Healthcare endorsed the Australian Open Disclosure
Framework in March 2013. The OD Framework will replace
the Open Disclosure Standard.
Changes to Law
Section 14J of the Wrongs Act 1958 provides that:
“ In a civil proceeding where the death or injury of a person is an
issue or is relevant to an issue of fact or law, an apology does not
constitute –
a) an admission of liability for the death or injury; or
b) an admission of unprofessional conduct, carelessness,
incompetence or unsatisfactory professional performance,
however expressed, for the purposes of any act regulating
the practice or conduct of a professional occupation.”
This applies whether or not the apology is made orally or in writing or
before or after the proceedings were commenced.
However, a statement will still be admissible with respect to a fact in
issue or tending to establish a fact in issue.
Open Disclosure and legal obligations
The Open Disclosure Standard specifically acknowledges that an
organisation’s open disclosure policy needs to pay due regard with
relevant legal obligations, including insurance issues and
responsibilities of various groups of healthcare professionals.
The Standard states:
“That health service organisation staff should take care not to:
(i)
apportion blame, or state or agree that they, other
clinicians or the health service organisations are liable
for the harm caused to the patient;
(ii)
speculate on the causes of an incident or pre-empt the
results of any investigations”.
Freedom of Information
The Freedom of Information Act applies to documents concerning a
patient in a public hospital in Victoria.
The Open Disclosure Standard states that:
“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 healthcare professional or to the
organisation:
(b)
record opinions about staff, patients, support persons or
others, unless those are expert opinions with supporting
evidence with the opinion recorded; or
(c)
contain statements about another person which are, or
are likely to be, defamatory.”
Insurance considerations

The Standard recognises that there may be obligations of the insured
person to its insurer and to medical defence organisations. Obligations
include the requirement to notify and take early advice from the insurer
of an adverse event.

The Standard anticipates that healthcare organisations will ensure that:
– the insurer is consulted;
– the Designated Risk Manager is responsible for advising the insurer
of adverse events; and
– Healthcare professionals are instructed to report adverse events to
the Manager promptly.
Summary
The Standard recognises the importance of:
– making no admission of liability;
– The privacy and confidentiality which attaches to patient records;
– The importance of legal professional privilege; and
– The interests of insurers.
The Consumer Perspective
What consumers want
What consumers want is to know about:
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harmful errors that affect them,
information about what happened,
why the error happened,
how the error’s consequences will be mitigated and
how recurrences will be prevented.
Case 1
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A patient is found to have a retained pack
after a life-saving laparotomy. It is discovered
only several weeks after the initial surgery on
investigation of ongoing abdominal pain. She
needs to return to theatre for removal of the
pack. A different surgical unit is now looking
after the patient.
 Should disclosure occur?
 Who should disclose?
 Who should be involved?
Case 2
 A patient
undergoes a routine D&C.
During the operation the uterus is
inadvertently perforated. This causes no
ill effect for the patient.
 Should disclosure occur?
 If so, when and by whom?
Case 3
 A deceased
patient is being transported
to the hospital mortuary. During transfer
from the trolley he is accidentally
dropped and the body sustains a broken
arm.
 Should
disclosure occur?
 Who should contact the family?
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Case 4
A. An elderly patient with dementia is given the
wrong medications following admission. There is
short term effect requiring additional medications. No
adverse outcome and the patient is unaware of the
incident.
Should disclosure occur?
If so, to whom and by whom?
B. A similar incident occurs with a 25 year old
unconscious, ventilated patient in ICU. Only fluid
challenge was required and it was not clear whether
the wrong medication was the cause of hypotension.
 Does the process differ from that above? Should
disclosure occur?
 If so, to whom and by whom?
Case 5

A complaint is received by the Patient Liaison
Manager regarding communication issues on
the ward. During investigation it is found that
the patient has had a prolonged postoperative recovery because of delay in
diagnosis and delay in time to theatre. This is
unrelated to the original complaint and
patient’s family are unaware of the adverse
event.
 Should disclosure occur?
 How should this be undertaken?
 Don’t
forget to
hand in the
evaluation