Open Disclosure

Reviewed and revised 22 May 2023

OVERVIEW

• Open Disclosure is the process of communicating with a patient and/or their support person(s) about a patient-related incident or harm caused during the process of healthcare
• Open disclosure after adverse health care events is a national standard in Australia, has been implemented in state health policy documents, and is included in the Medical Board of Australia’s code of conduct for doctors
  • 2003 National Open Disclosure Standard
  • 2013 Australian Open disclosure Framework (ASCQHC)

IMPORTANCE

Actively and openly managing such incidents, including through the exchange of timely and appropriate information, is important for:

• The recovery process of patients and next-of-kin
• clinicians to manage their involvement in, and recovery from, adverse events
• Health service organizations to learn from errors

Practicing open disclosure can assist health service organizations develop a reporting culture as it supports clinicians managing unintended patient harm.

Effective and timely communication, transparency and establishing a rapport with the patient and/or family along with an apology when incidents occur might mitigate potential legal action.

APPROACH TO OPEN DISCLOSURE

• Meet the family in an appropriate setting with appropriate support people present
• Acknowledge the incident and its impact
• Explain the known clinical facts concerning what happened
• Apologize for what has occurred (state “I am/ We are sorry”)
• Provide an opportunity for the patient and/or support person to be heard and share their experience
• Reassure and agree on a plan for ongoing care, including steps taken to manage the event and prevent recurrence.
• Take responsibility and provide reassurance
• Investigate the incident to learn what has happened
• Feedback to patient and staff
• Document by incident reporting tool and in the patient’s medical record

KEY PRINCIPLES

• open timely communication
• acknowledgement to the patient/ support person(s) as soon as possible
• unambiguous expression of regret
• supporting the needs and expectation of the patient, family, carers, and support person(s)
• supporting and meeting the needs of healthcare providers
• integrated risk management and systems improvement
• effective governance, including performance monitoring and improvement
• confidentiality
• open, fair, and just culture

BARRIERS TO IMPLEMENTATION OF OPEN DISCLOSURE

• appropriate timing and place, especially if ongoing clinical responsibilities
• perceptions of legal risk
• lack of education and training
• reluctance to admit error
• uncertainty concerning what and how much to disclose
• variations in state and territory “apology laws”

TIPS

• an apology is appropriate as soon as harm to a patient is suspected, even if a ll the clinical facts are not yet known
• a open disclosure process is often appropriate in “near miss” situations even when no actual harm has occurred to a patient
• even if detection of an event or harm from the event is delayed, initiation of open disclosure is still appropriate
• be aware of your hospital’s guidelines for clinical incident response and open disclosure. Some may distinguish between “low level” open disclosure (e.g. where no actual harm occurs) and “high level” open disclosure (e.g. where serious harm occurs).

STATUTORY DUTY OF CANDOUR (VICTORIA, AUSTRALIA)

Statutory Duty of Candour (SDC) is a legal obligation in Victoria, Australia, under the Health Services Act 1988.

• it requires that the patient or their support person(s) (e.g. NOK, MDM, or nominated person) be receive an apology and are communicated with open and honestly when a SAPSE (Serious Adverse Patient Safety Event) occurs.
• as such it is a special example of Open Disclosure, which should still proceed for any adverse events not considered a SAPSE.

SAPSE

• A SAPSE is a serious adverse patient safety event that occurred while the patient was receiving health services from a health service entity, and in the reasonable opinion of a registered health practitioner, has resulted in, or is likely to result in, unintended or unexpected moderate or severe harm, or prolonged psychological harm being suffered by the patient
  • Severe Harm means harm that causes a permanent lessening in the functioning of an individual that is unrelated to the natural course of a person’s illness or underlying condition including harm that can lead to a person experiencing a permanent impairment of disability, or death.
  • Moderate Harm means harm that requires a moderate increase in treatment to a patient, such as an unplanned or unexpected return to surgery, but does not includes harm that causes permanent damage or injury to an individual.
  • Prolonged psychological harm means psychological harm which a patient has experienced, or is likely to experience, for a continuous period of at least 28 days.
• equivalent to an ISR 1 (death) or 2 (major harm) event within public health services (Victorian Health Incident Management System Scale).
  • not all ISR 1 and ISR 2 events are SAPSEs, only those that result in unexpected or unintended harm.
  • SAPSE is unlikely if the following criteria are met:
    • included in informed consent given by pateint
    • complication occurred despite a correctly performed procedure
    • care was escalated appropriately once the complication was identified

Key requirements of SDC are that patient/ support person(s) must be provided with:

1. a written account of the facts regarding the SAPSE; and
2. an apology for the harm suffered by the patient; and
3. a description of the health service entity’s response to the event; and
4. the steps that the health service entity has taken to prevent re-occurrence of the event

Time course of requirements of SDC:

• <24h of event – health service must provide apology
• <3 days of event – SDC meeting must be arranged <3 days after event
• <10 days of event – SDC meeting must be held
• <10 days after SDC meeting – provide patient with meeting report
• <50 days – complete SAPSE review report (75 days if more than one health service entity)
• when SDC completed – clear records of SDC process must be kept and appropriately reported

Other considerations

• patients may opt out of the SDC process
• a “protected SAPSE review” may (rarely) take place where it is considered that discussions may lead to unintended or perverse outcomes if details of the discussion were relied upon as evidence in legal proceedings.

References and links

Journal articles

• Finlay AJ, Stewart CL, Parker M. Open disclosure: ethical, professional and legal obligations, and the way forward for regulation. The Medical journal of Australia. 198(8):445-8. 2013. [pubmed]
• Koh TH, Alcock G. Open disclosure: appropriate timing is crucial. International journal for quality in health care : journal of the International Society for Quality in Health Care / ISQua. 19(5):326. 2007. [pubmed]
• Lamb R. Open disclosure: the only approach to medical error. Quality & safety in health care. 13(1):3-5. 2004. [pubmed]
• McLennan SR, Truog RD. Apology laws and open disclosure. The Medical journal of Australia. 198(8):411-2. 2013. [pubmed]
• Parker M. A fair dinkum duty of open disclosure following medical error. Journal of law and medicine. 20(1):35-43. 2012. [pubmed]

FOAM and web resources

• Cognitive Institute – Open Disclosure Documents (2023)
• Department of Health, Victoria – Clinical Risk Management (2023)
• Department of Health, Victoria – Open disclosure following adverse events in health services (2023)
• Safer Care Victoria – Duty of Candour (learning resources, 2023)