Open disclosure policy

Purpose

Open disclosure is a patient and consumer right and an essential professional requirement of health care in Australia. It is directed and guided by the Australian Open Disclosure Framework.

At Templestowe Day Surgery (TDS), open disclosure is managed through thorough clinical review and investigation of adverse events and related outcomes, with a focus on clinical risk, quality improvement and preventing recurrence.

This policy sets out the practices required at TDS. All staff are encouraged and supported to use the Corrective Action Report (CAR) system to report clinical incidents, near misses and adverse events.

Scope

This policy applies to all staff at TDS, including all credentialed medical and other practitioners.

Definitions

• Adverse event: an incident that results, or could have resulted, in harm to a patient or consumer. A near miss is a type of adverse event.
• Australian Open Disclosure Framework: a framework for health service organisations and clinicians to communicate openly with patients when health care does not go to plan.
• Near miss: an incident or potential incident that was averted and did not cause harm, but had the potential to do so.
• Open disclosure: an open discussion with a patient and their family or carer about an incident that resulted in harm to the patient while receiving health care. It includes an expression of regret and a factual explanation of what happened, the potential consequences, and the steps taken to manage the event and prevent recurrence.

Key elements of open disclosure

• Patients and carers will be given information about what incidents and concerns are, and how to report them.
• Prompt clinical care will be provided following an adverse event to prevent further harm.
• Staff will be supported at all times by their colleagues and TDS managers, both personally and professionally, including through appropriate training, preparation and debriefing.
• Patient and clinician privacy and confidentiality will be maintained at all times.
• Staff may report adverse events anonymously.
• Adverse events will be raised with the senior doctor as soon as practicable after they occur.
• Adverse events will be documented using the TDS Corrective Action Report (CAR) system.
• The senior clinician on duty (doctor, Director of Nursing or senior registered nurse) will assess the incident for severity of harm and level of response, and document this in the CAR.
• The relevant professional indemnity insurers will be informed if there is a perceived risk of material, financial or reputational damage arising from the incident.

Responding to an adverse event

When notified of an adverse event, the senior clinician will:

• provide assistance to the staff member who reported it
• acknowledge the event with the patient and family and provide an appropriate apology or expression of regret. This should include the words “I am sorry” or “we are sorry”, but must not include speculation, an admission of liability or the apportioning of blame (see the Commission’s guidance on open disclosure)
• help the staff member to begin an investigation
• determine whether the event needs to be reported to other authorities
• notify relevant staff of the incident and their involvement in the investigation, and provide ongoing support
• ensure the privacy and confidentiality of patients and clinicians are maintained at all times.

The patient and family must at all times be treated with empathy, respect and consideration, and supported in a way that meets their needs.

The open disclosure process

1. Preparing for open disclosure

• Hold a team discussion to prepare for open disclosure.
• Consider who will take part in open disclosure.
• Appoint someone to lead the open disclosure, based on earlier discussion with the patient, their family and carers.
• Gather all the necessary information.
• Identify a health service contact for the patient, their family and carers, if this hasn’t already been done.
• Agree with the patient, their family and carers, or their nominated contact person, on the formality of the open disclosure, the time and place, and who should attend.
• Provide written confirmation.
• Avoid speculation and blame.

2. Engaging in open disclosure

• Give the patient, their family and carers the names and roles of all attendees, verbally and in writing.
• Provide a sincere and unprompted apology or expression of regret, including the words “I am sorry” or “we are sorry”.
• Clearly explain the incident, giving a factual account of what happened in an open and honest manner. Communicate in a way that suits the person’s situation, culture and level of understanding, and avoid speculation.
• Give the patient, family and carers the opportunity to tell their story, share their views and observations about the incident, and ask questions.
• Encourage them to describe the personal effects of the adverse event. It’s important that they know their views and concerns are listened to, understood and considered.
• Agree on, record and sign an open disclosure plan.
• Assure them that they will be told about further investigation findings and recommendations for system improvement.
• Offer practical and emotional support to the patient, their family and carers.
• Support staff members throughout the process.
• Maintain good verbal and written communication throughout.

3. Providing follow-up

• Ensure follow-up by senior clinicians where appropriate.
• Agree on future care.
• Share the findings of investigations and the resulting changes to practice.
• Offer the patient, family and carers the opportunity to discuss the process with another clinician, such as their GP.

4. Completing the process

• Reach agreement between the patient, their family and carers and the clinician, or provide an alternative course of action.
• Give the patient, their family and carers final written and verbal communication, including how feedback on the investigation findings will be provided, by whom and when, and any changes made to reduce the risk of recurrence.
• Communicate the details of the adverse event, and the outcomes of the open disclosure process, to other relevant clinicians.
• Complete the evaluation surveys.
• Publish the event and its outcome on the TDS website, in accordance with the Health Services (Private Hospitals and Day Procedure Centres) Regulations 2013.

A full explanation of why an adverse event occurred may not be possible until related investigations are complete and the contributing factors are known. More than one meeting with the patient and family may be needed to fully resolve the matter.

5. Maintaining documentation

• Document the process in the patient’s record at each step, including what the patient and family hope to achieve and any questions they raise.
• Provide a copy to the patient, their family and carers.
• Keep a separate record of the open disclosure process.

Support for patients and families

An offer of support must be made to the patient, their family and carers. This should include:

• ongoing support, including reimbursement of out-of-pocket expenses incurred as a result of the adverse event
• assurance that any necessary follow-up care or investigation will be provided promptly and efficiently
• clarity about who will provide ongoing care resulting from the adverse event
• contact details for any relevant service, and information about how to take the matter further, including available complaint processes such as the Victorian Health Complaints Commissioner (phone 1300 582 113).

Education and training

• Staff must complete training on commencement, with annual updates, in the management of incidents, adverse events and the open disclosure process.
• All education is documented by the Director of Nursing, and records are maintained.
• All staff must be prepared to take part in open disclosure.

Reporting and audit

• The complaints and informed consent processes are linked to the Open Disclosure Framework, so related incidents are collected, managed and reviewed for ongoing quality improvement and risk management.
• Incidents, including open disclosure events, are recorded and compiled on an ongoing basis by the Director of Nursing.
• All serious incidents and open disclosure events are reported quarterly to the Medical Advisory Committee to ensure appropriate follow-up has occurred.
• The incident management and open disclosure systems are audited at least annually to ensure they are consistent with the Australian Open Disclosure Framework and are being implemented appropriately at TDS.
• Incident data is analysed, and trends and opportunities for improvement are identified.

References and supporting documents

References

• Australian Commission on Safety and Quality in Health Care. Australian Open Disclosure Framework.
• NSQHS Standards Day Procedure Services Accreditation Workbook (October 2017).
• Health Services (Private Hospitals and Day Procedure Centres) Regulations 2013 (Vic).

Supporting documents

• Minutes of Medical Advisory Committee meetings
• Minutes of Board of Management meetings
• Open disclosure consumer brochure
• TDS Corrective Action Report (CAR) form and register

Appendix A: Open disclosure process summary

1. Detect the clinical incident or adverse event. Minimise the risk of further harm, provide appropriate clinical care, and support the patient and staff. Refer to the Director of Nursing, Medical Director or complaints process as needed.
2. Manage and report the incident. Meet statutory and mandatory reporting requirements and any medico-legal obligations. Escalate to the sentinel event response process where required.
3. Inform the patient. Patients must be told about the probable or definite occurrence of a clinical incident that has resulted in, or is expected to result in, harm. This includes sentinel events.
4. Begin the open disclosure process. Initial disclosure should happen as soon as possible, within 24 hours. Decide who will lead the disclosure and how meetings will be run, and confirm the process under which the incident will be investigated and information released.
5. Notify the patient and express regret. Give the patient the facts of the incident without speculation. An apology or expression of regret must not include any admission of fault or liability. Develop an agreed plan for the patient’s ongoing care.
6. Investigate. Carry out a comprehensive and systematic analysis of the facts to identify contributing factors, seeking legal advice where needed, and develop and implement recommendations.
7. Complete the process. Prepare a final report for the patient, taking into account any restrictions on disclosing information, approved by the relevant parties. Share feedback with the healthcare providers involved.