Introduction

Many thousands of healthcare interventions occur daily across Australia and New Zealand with surgical teams working to deliver the best possible patient outcomes.  Healthcare interventions inherently carry risks, and things do not always go to plan.  Adverse events sometimes occur and may cause harm to patients. Open disclosure describes the way clinicians communicate with, and support patients, and their family and carers, who have experienced harm, during health care resulting from an adverse event.1 

Open disclosure is important, complex and challenging for all participants.  The opportunity for discussion following an adverse event has been shown to be as important as understanding the reasons behind what transpired.2 Managing adverse events with compassion and transparency builds trust in relationships between patients, surgeons and health services.2  Open disclosure also results in broader benefits through reflective learning, improved clinical communication and systems improvement.3 

RACS position

The Royal Australasian College of Surgeons (RACS) supports surgeons engaging in open disclosure as an integrated component of patient care when an adverse event occurs. Patients should be fully informed of the inherent and real risks with any surgical procedure.  However, adverse events may occur and sometimes relate to system errors or other unanticipated events which fall outside the informed consent process.

 

When adverse events occur, open disclosure frameworks are necessary to assist healthcare teams to respond effectively with transparency and compassion.  RACS endorses:

  • the Australian Commission on Safety and Quality in Health Care (ACSQHC) National Guidelines for Open Disclosure4 and the ACSQHC Australian Open Disclosure Framework1 and
  • Medical Council of New Zealand (MCNZ) Disclosure of harm following an adverse event.5

RACS recognises policy and legal frameworks vary between jurisdictions across Australia and New Zealand. RACS recommends surgeons be familiar with legislation, resources, training, and support available relating to open disclosure, and to be transparent, factual and empathetic in open disclosure processes.  The College offers training in this area as part of the Care of the Critically Ill Surgical Patient (CCrISP ®) course.  

Informed consent

Informed consent and open disclosure are inherently linked.  An effective informed consent process can reduce the potential psychological and emotional effects an adverse event may have on a patient and their family.1 However, adverse events may also relate to events which fall outside the consent process.  Informed consent is usually limited to cover a procedure, and across the entire patient journey from admission to discharge, an adverse event may also occur remote from the surgical procedure.  

During the consent process, treating clinicians have an obligation to inform patients about the potential risks and benefits of the treatment options available and support the patient to make an informed choice. In an emergency, where immediate intervention is necessary, it may not be possible to provide complete information or obtain  written consent.  In most surgical scenarios, with the exception of some emergency procedures, the surgeon will openly discuss the risks and benefits of the procedure prior to the operation. The likelihood of complications and the degree of certainty regarding a therapeutic outcome will be outlined during this process.

 

The law has always recognised that a doctor has a duty to warn a patient of a material risk inherent in any proposed procedure or treatment.

 

A risk will be considered material if, in the circumstances of the particular case, a reasonable person in the position of the patient, if warned of the risk, would be likely to attach significance to it, or if the medical doctor is, or should reasonably be, aware that the particular patient, if warned of the risk, would be likely to attach significance to it.

 

Thus, when considering the need to inform a patient of a particular risk, there will be two separate matters that require consideration:

  1. Would a reasonable person, in the position of the patient, be likely to attach significance to the risk? (ie. may change their mind about the treatment)
  2. Is the doctor aware, or should the doctor be reasonably aware, that this particular patient would be likely to attach significance to that risk? (ie. may change their mind about the treatment).

Informed consent should be obtained and documented, with the patient acknowledging in writing they have understood the information. RACS provides further guidance on this topic and in-depth consideration of these issues in the Informed Consent position paper and policy.6

The open disclosure process

Open disclosure is a discussion and exchange of information which may take place in several encounters with the patient, their family and carers.4 This may vary depending on the context, type of adverse event, level of response required, and patient circumstances.  Health Services and executive leadership should ensure adequate support, systems and training are available to healthcare teams to deliver open disclosure.  It is preferable if the most senior surgeon involved, actively participates in this process. Once an adverse event has occurred, a healthcare team should:

  • establish the relevant facts
  • assess the event and the level of response required
  • §notify the relevant hospital executive member to activate a support structure through a quality unit for the clinical team, patient and carers
  • identify who will lead and be involved in the open disclosure process
  • consider whether additional investigation or reporting is required in consultation with the hospital executive director involved
  • identify other support and needs (this should form part of the hospital-based support service)
  • ensure all appropriate staff are sufficiently informed to enable a consistent response to the patient
  • consider whether their Medical Defence Organisation should be informed

The elements of open disclosure should include:

  • an apology or expression of regret
  • a factual explanation of what happened5
  • an opportunity to ask questions
  • an opportunity for the patient, their family and carers to relate their experience
  • a discussion of the potential consequences of the adverse event
  • an explanation of the steps being taken to manage the adverse event and prevent recurrence.

Open disclosure is separate from any investigation and review process.7 Open disclosure processes should avoid:

  • speculation on the causes of an incident
  • assigning blame or implying legal liability to any individual, group or system
  • pre-emptive speculation of the results of reviews and investigations

Following an initial discussion, patients should be kept appropriately informed.  Where needed, recommendations for further remedial care should be made as soon as possible.  Further communication and follow up should consider the circumstances of the patient, context of the adverse event and response required. The role of the hospital executive member and the quality unit is important in this process to help support all involved. 

Legislation

Legislation relating to open disclosure differs in jurisdictions across Australia and New Zealand.  RACS recommends surgeons consult relevant legislation relating to their jurisdiction and seek appropriate advice. 

 

A key issue with differences in legislation across jurisdictions are the variations in the levels of protection provided to healthcare professionals in the open disclosure process.  An ongoing challenge associated with implementing open disclosure processes is reluctance from surgeons to participate.8 This can often stem from a concern an apology or expression of regret may be interpreted as an admission of fault or liability.9 An apology does not constitute an admission of fault or liability.  Medical negligence is a decision made by a court and has a specific set of requirements which need to be met before such a decision is reached.  RACS would welcome further legislative reform, which provides a consistent approach to this issue and greater legal clarity, protection and guidance for surgeons and other staff during open disclosure.10 

Training in open disclosure

RACS encourages Health Services to conduct regular training sessions in open disclosure, to build staff competence in managing responses to adverse events, and to provide a quality department led by an executive sponsor to give guidance and support. RACS recommends all surgeons be aware of their legal obligations, and health services provide relevant information to surgeons and patients within their care. The College’s Care of the Critically Ill Surgical Patient (CCrISP ®) course provides training in open disclosure processes.  

Associated documents

Informed Consent Position Paper (2019)

References

  1. Australian Commission on Safety and Quality in Health Care (ACSQHC). Australian Open Disclosure Framework [Internet]. 2013. From: http://www.safetyandquality.gov.au/wp-content/uploads/2013/03/Australian-Open-Disclosure-Framework-Feb-2014.pdf.
  2. Aaliyah Eaves-Leanos JD. Open disclosure of Adverse Events: Transparency and Safety in Health Care. Surgical Clinics of North America. 2012; 92 (1): 163-77.
  3. Studdert DM. Disclosure of medical injury. In: Healy J, Dugdale P, editors. Patient safety first: responsive regulation in health care. Sydney: Allen and Unwin, 2009.
  4. Australian Commission on Safety and Quality in Health Care (ACSQHC).Open disclosure [Internet]. 2019. From: https://www.safetyandquality.gov.au/our-work/clinical-governance/open-disclosure 2019.

     

  5. Medical Council of New Zealand. Disclosure of harm following an adverse event [Internet]. From: http://www.mcnz.org.nz/assets/News-and-Publications/Statements/Disclosure-of-harm.pdf.
  6. Royal Australasian College of Surgeons. Informed Consent Policy [Internet]. 2014. From: http://www.surgeons.org/media/312206/2014-08-29_pos_fes-pst-042_informed_consent.pdf. 2014.
  7. Western Australian Health Department. Communication and Disclosure: Requirements for Health Professionals Working in Western Australia [Internet]. 2012. From: http://www.health.wa.gov.au/CircularsNew/attachments/395.pdf.
  8. Studdent DM, Piper D, Iedema, R. Legal aspects of Open Disclosure II: Attitudes of health professionals – findings from a national survey. Medical Journal Australia, 2010; 193 (6): 351-55.
  9. Finlay A, Stewart C, Parker M. Open disclosure: Ethical, professional and legal obligations and the way forward for regulation. Medical Journal Australia. 2013; 198 (8): 445-48.
  10. Studdert DM, Richardson MW. Legal aspects of Open Disclosure: A review of Australian Law. Medical Journal Australia. 2010; 193 (5): 273-76.

Key words

Open disclosure, adverse event, informed consent