Open Disclosure - What You Need to Know

Open disclosure is the process of managing a medical incident; from the initial post-incident discussion with the patient and/or carer, through to changes in practice systems to prevent a recurrence. Open disclosure is ultimately about ensuring that health care systems are adapted in light of adverse events, to optimise patient safety.

The process begins with providing the patient with full and frank disclosure of the circumstances that led to the incident. This step is accompanied by an expression of regret or apology. Most states have 'benevolent gesture' legislation that excludes an apology as an admission of liability. However care must be taken not to admit liability. Guidance on the appropriate language is available in the Open Disclosure Standard.¹

The second phase in the process is to investigate the event and determine what, if any, changes need to be made to improve the delivery of health care. Depending on the severity of the event, the investigation may range from an informal review by the staff involved through to a full root cause analysis (RCA). There are a number of incidents that are described as 'sentinel events,' such as death from ABO incompatible blood transfusion, retained surgical instruments, wrong site surgery etc, that automatically require an RCA. RCA provides a severity assessment code (SAC) and events that rank as SAC 1 require analysis. Following an RCA, recommendations are made to the hospital executive in the form of changes that would reduce the risk of recurrence.

The Open Disclosure Standard was commissioned by the Safety and Quality Council. It was developed in conjunction with Standards Australia. The Working Party consisted of members of the learned colleges, medical indemnity insurers, plaintiff lawyers, consumers and Federal and State Health Departments. The drafts were circulated for wide consultation. There was consensus from all parties that open disclosure is the correct thing to do following an adverse incident. The Standard was launched in July 2003 and several hospital sites were selected for a national pilot study.

The concept of open disclosure is not new. Many doctors have kept their patients fully informed when there has been an unexpected outcome. The benefits to the patient include:

• Timely and appropriate treatment
• Prevents the patient worrying about the aetiology
• Enables informed decisions about future care
• Encourages more realistic expectations
• Promotes trust
• Provides the opportunity for compensation or a waiver of fees.²

Conversely some doctors have been anxious about discussing an incident with patients. They express concerns about the potential for patient's anger, fear of a claim, damage to reputation and loss of clinical privileges. Furthermore there is an urban myth that indemnity insurers prefer doctors not to enter such discussions. It is important that doctors are reassured that open disclosure is supported across the medical indemnity industry. The evidence to date is that patients want to know the details of the treatment and do want an apology when things go wrong. Invivo supports open disclosure and encourages doctors to follow the Standard - bearing in mind that the discussion must not include an admission of liability.

The reason for supporting open disclosure is because it is ethical and provides the setting for good ongoing care. The literature from the Veterans Hospital in Kentucky suggests that open disclosure leads to a reduction in litigation.³ If this did occur, it is a fringe benefit rather than the motivation to comply with the Standard. A recent study using a mathematical model does not support this finding.⁴ Invivo will be monitoring the results of the pilot study. We will be keen to ensure that systems changes are made following any RCA recommendations. The benefit for the medical profession must be that health systems are modified to provide a safe working environment for health care delivery.

Penny Johnston
Loss Prevention Manager, Invivo

References

1. Open Disclosure Standard, Australian Council for Safety and Quality in Health Care. Standards Australia 2003.
2. Wu AW. Cavanaugh TA. McPhee SJ. Lo B. Micco GP. To Tell the Truth: Ethical and Practical Issues in Disclosing Medical Mistakes to Patients. Journal of General Internal Medicine. 12(12):770-5, 1997 Dec.
3. Kraman SS. Hamm G. Risk Management: Extreme Honesty may be the Best Policy. Annals of Internal Medicine. 131(12):963-7, 1999 Dec 21.
4. Studdert DM. Mello MM. Gawande AA. Brennan TA. Wang YC. Disclosure of Medical Injury to Patients: An Improbable Risk Management Strategy. Health Affairs. 26(1):215-26, 2007 Jan-Feb.