• adverse events
• medical errors
• disclosure

The best way to improve disclosure of adverse events (where the term “adverse event” means injury caused by the provision of health care rather than the patient's illness, whether or not the event resulted from a clearly identifiable error or mistake) to patients and their families is to create a system for overseeing disclosure that is an integral part of a healthcare organisation's patient safety programme. Cultural, legal, regulatory, and financial barriers prevent clinicians and healthcare organisations from disclosing adverse events,^1–3 despite the ethical obligations of clinicians and healthcare organisations to do so.^4–7 Applying a systematic continuous quality improvement model to disclosure of adverse events like the one proposed by Liang⁸ in this issue of QSHC can help to overcome barriers to disclosure.

Effective disclosure of adverse events requires commitment to honesty and openness even when telling the truth may lead to loss of reputation, legal liability, or regulatory scrutiny. For clinicians the professional responsibilities of telling the truth and patient advocacy support disclosure of adverse events.^{6, 7} From an organisational perspective, successful disclosure systems require a willingness to put the interests of patients and families first, and to maintain transparency, honesty, and trust. Patient safety systems only work when there is an atmosphere that permits and supports open exchange of information, whether it is through reporting systems, disclosure, or investigation of the root causes of adverse events.⁹ Disclosure of adverse events can enhance patient safety by reinforcing the values important to a culture of safety—honesty, respect, and transparency.

Disclosure partly depends on whether other parts of the patient safety system are working. It cannot occur unless adverse events are identified in a timely manner and brought to the attention of the disclosure programme. Without investigation of adverse events, it can be difficult to know what to disclose.

At the heart of an effective disclosure system are clear policies that provide guidance on whether and what to disclose, who should disclose, and how disclosure should occur. Determining whether to disclose is complicated by the many different types of adverse events and the differing amounts of harm they cause. Patients want to be informed of even minor adverse events,¹⁰ but others argue that patients need to be informed of adverse events only when these events result in harm to the patient.¹¹ Liang suggests that near miss errors should be disclosed “to provide opportunities for systems learning that may be important for potentially serious adverse events”.⁸

“At the heart of an effective disclosure system are clear policies that provide guidance on whether and what to disclose, who should disclose, and how disclosure should occur.”

Given the practical limits of time and availability of staff to make disclosures and the relatively low likelihood that disclosures of near misses would elicit information that could not be obtained through a near miss reporting system, it makes sense to focus disclosure on adverse events that cause harm. The standard of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)—the body that accredits US hospitals—that went into effect in June 2001 requires hospitals to encourage disclosure of “unanticipated outcomes” and therefore supports disclosure of events that have actually harmed patients. When is the harm caused too trivial to disclose? Has the patient who received the wrong medication but only had a temporary drop in blood pressure suffered enough harm to have the event disclosed? Systematising the process of disclosure will enable clinicians, administrators, and attorneys responsible for managing adverse events to build a consensus about whether disclosure is necessary.

Determining who should disclose an adverse event is also controversial and systems have chosen different approaches. The system in place at the Kentucky Veterans Affairs Medical Center, Lexington¹³ and the model proposed by Liang⁸ remove the clinician from the disclosure process and instead place responsibility and the process of disclosure with organisational leaders and a risk management team. In contrast, the University of Pittsburgh-Presbyterian Medical Center policy places responsibility for notifying the patient or family about the adverse event on the attending physician.¹⁴ The interpretation provided by the JCAHO standard requires the “responsible licensed independent practitioner or his or her designee [to] clearly explain the outcome of any treatments or procedures.”¹²

Deciding who should disclose reflects the underlying philosophy of the organisation. If safety is seen primarily as an organisational/systems issue, then the organisation should bear complete responsibility for the disclosure process. If clinicians are seen as primarily responsible for assuring safety, then it makes sense for clinicians to take the lead in disclosing. In reality, responsibility for patient safety is shared by clinicians and the organisation/system within which they work. The best system encourages involvement of clinicians within an organisational process that is supportive of disclosure. Even if primary responsibility rests with a disclosure team, clinicians should be given the opportunity to participate in the process of disclosure. If either clinician disclosure or organisation led disclosure is the default policy, the decision as to who should lead the disclosure process should be made on a case by case basis that takes account of the nature of the adverse event, the relationship between the patient and the clinician involved, and the skill of the clinician in effectively disclosing the adverse event.

Once the decision has been made to disclose and responsibility for disclosure has been determined, attention must be paid to the manner in which disclosure occurs. Policies and procedures should incorporate Buckman's principles for breaking bad news.¹⁵ This approach is useful in communicating bad news to patients and can be taught to clinicians and other participants who need to improve their communication skills.

Creating a system for managing disclosure of adverse events to patients and/or family members is critical to improving patient safety. As organisations struggle to implement patient safety techniques and change their culture to one of openness and honesty, disclosure of adverse events should be seen as an opportunity for organisations to demonstrate their commitment to putting the needs of patients first. There is no single solution that will work in every organisation, but those organisations that choose a systematic approach are most likely to succeed.