Medico Legal Feature Open Disclosure

This article principally addresses the latter process. The more formal process that is usually adopted for more severe injuries will be referred to using capitals – “Open Disclosure”.

Australia has amassed internationally recognised expertise in this field following the endorsement of an “Open Disclosure Standard” (the Standard) in 2003 by Australian Health Ministers. The Standard was developed by the former Australian Council for Safety and Quality in Health Care. In 2008 Australian Health Ministers agreed to work towards universal adoption of the Standard in all health care facilities. Currently all State Health Services (with the exception of NT) have incorporated the Standard into health care policy. It has similarly been adopted in the UK, Canada, New Zealand and many states in the USA. Considerable research has continued in Australia into the impact that open disclosure has on a range of outcomes. A national review of the Standard is currently being undertaken by the Australian Commission on Safety and Quality in Health Care (ACSQHC) and this article incorporates recommended changes to the Standard.

Open disclosure recognises that adverse events, defined as an incident in which a person receiving health care is harmed, are inevitable and unavoidable outcomes arising from the provision of health care. Harm is defined as including physical, social or psychological injury.

The process of Open Disclosure involves:

1. An open and timely acknowledgement to the patient and/or their support persons that an adverse event has occurred.
2. An apology or expression of regret that includes the words “I/We are sorry”.
3. A factual discussion of the event and consequences, including an opportunity for the patient to relate their experiences.
4. An explanation of the steps being taken to manage and investigate the incident and prevent recurrence.

Content of initial disclosure discussion

The initial discussion should occur as soon as possible, even if all the facts are not yet known, and may be the first step of an ongoing communication process. Points raised in the initial disclosure discussion may need to be expanded upon in any subsequent meeting with the patient and their support person.

It is important not to speculate, attribute blame to yourself or other individuals, criticise individuals or admit liability.

Depending on the severity of the adverse event and the formality of the disclosure process, the following points may require consideration:

a. preliminary multidisciplinary team discussions (agreed facts, responsibilities for discussions, staff support, timing, availability legal and insurance issues)

b. an introduction to the patient and/or support person(s) of all people attending, including their role

c. disclosure of facts known at that time (this may require prior multidisciplinary team agreement)

d. listening to the patient’s and/or their support person’s understanding of what happened and address any questions or concerns they may have

e. indicating to the patient and their support person that their views and concerns are being heard and considered seriously

f. a discussion about what will happen next (return to the operating theatre, need for more investigations, see another specialist, etc.)

g. information on likely short-term effects (and long-term effects if known, however this information may need to be delayed to a second or subsequent meeting)

h. assurance to the patient and/or their support person that they will be informed of further investigations that will take place to determine why the adverse event occurred, the nature of the proposed process and expected timeframe. Also provide information on how feedback will be provided on the findings of the investigation, any changes made to prevent recurrence and, if delays in the process are experienced, the reasons for those delays

i. an offer of support to the patient and their support person

j. information to the patient and/or support person on how to take the matter further, including any complaint processes available to them.

k. Documentation.^1,2

Why is open disclosure important?

The Medical Board of Australia’s Code of Conduct states: Good medical practice in relation to risk management involves being aware of the importance of the principles of open disclosure and a non-punitive approach to incident management.

Open disclosure is thought to strengthen the doctor/patient relationship through promotion of trust and improved communication. Ethical considerations also dictate that patients should remain informed of their health care outcomes, allowing them to make informed decisions about subsequent treatment.

Perhaps the most important role of open disclosure is that it fosters the reporting of adverse events and promotes a cultural change that recognises that blame is unhelpful. This in turn allows system improvements that help to understand and reduce future adverse events.

Although there is some support in the literature that Open Disclosure reduces patient litigation, the evidence is still unclear. Several US centres have adopted Open Disclosure and early settlement protocols, and these have been successful in reducing litigation costs. It is likely that Open Disclosure has little impact on litigation frequency for high severity adverse events.

Open Disclosure or open disclosure?

A more formal process is indicated where the outcome includes death or permanent loss of function or where the adverse event has resulted in a major escalation of care/change in clinical management. Relevant health department and hospital policy documents may provide assistance in triaging adverse events to one or other process. Irrespective of the process ultimately adopted, clinicians are able to follow the general open disclosure principles as soon as they are aware of an adverse event.

When should Open Disclosure occur?

Open disclosure should be considered whenever there is a perception (by the patient or treating clinicians) that an adverse event has occurred. Low level adverse events may require nothing more than a brief informal discussion.

Conclusion

MDA National is supportive of the open disclosure process. Members should seek our assistance if an adverse event occurs and they are required or wish to participate in a formal Open Disclosure session as this will usually relate to a significant adverse outcome. Early advice can assist in supporting the Member through what can be a difficult and stressful time, provide a better understanding of important legal issues such as the implications of any apology, and facilitate appropriate communication with other parties involved in the process.

We believe that adequate training and support for practitioners are critical components to the success and acceptance of Open Disclosure. We advise our Members to always familiarise themselves with the Open Disclosure policies in their workplace.

Our aim is to ensure that our Members’ interests are protected while they focus on the interests of their patients.

Also see our article: "A medical administrator's view of open disclosure".

¹ Open Disclosure Standard 2003. Australian Commission on Safety and Quality in Healthcare.

² Section 9 and 10 Australian Open Disclosure Framework (Consultation Draft 2012 updated 2014). Australian Commission on Safety and Quality in Healthcare. Available at: safetyandquality.gov.au/sites/default/files/migrated/Australian-Open-Disclosure-Framework-Feb-2014.pdf