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  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……  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  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….  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 – GP – Quality manager – DMS / DON – Other eg coroner  Documentation – Medical record – Incident form

Checklist  DDistress acknowledged  IIrritation / anger / reactions accepted  SSorry: expression of regret  CCareful listening  LLet patient ask questions  OOther helpful information given  SSuggestions / solutions  EExtra 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 The OD Framework will replace the Open Disclosure Standard.

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. Changes to Law

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:  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  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?

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 post- operative 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?

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