Risk Management _ __________________________________________________________________________
STATEMENTS ENDORSING DISCLOSURE
Organization
Statement
American Medical Association
Code of Medical Ethics (8.6 Promoting Patient Safety) Patients have a right to know their past and present medical status, including conditions that may have resulted from medical error. Open communication is fundamental to the trust that underlies the patient-physician relationship, and physicians have an obligation to deal honestly with patients at all times, in addition to their obligation to promote patient welfare and safety. Concern regarding legal liability should not affect the physician’s honesty with the patient. Individual physicians who have been involved in a (possible) medical error should: • Disclose the occurrence of the error, explain the nature of the (potential) harm, and provide the information needed to enable the patient to make informed decisions about future medical care. • Acknowledge the error and express professional and compassionate concern toward patients who have been harmed in the context of health care. • Explain efforts that are being taken to prevent similar occurrences in the future. • Provide for continuity of care to patients who have been harmed during the course of care, including facilitating transfer of care when a patient has lost trust in the physician.
National Quality Forum Safe Practice 7
Following serious unanticipated outcomes, including those that are clearly caused by systems failures, the patient and, as appropriate, the family should receive timely, transparent, and clear communication concerning what is known about the event.
Source: [26; 125]
Table 4
As discussed, apology statutes now protect physicians and other healthcare professionals who apologize, but not all states have enacted apology statutes, and the statutes vary across states. In addition, the majority of physicians are unfamiliar with their state statutes. Physicians are encouraged to talk to their state medical associations and legal counsel to determine how best to comply with their state’s apology statute. Most physicians are uncomfortable with disclosing errors and, because they have not received formal training in how to conduct such a discussion, they are unclear about how much information to provide and what words and phrases to use [122; 128]. As a result, physicians who disclose errors often provide minimal information and express incomplete apologies [115; 117]. Guidelines have been developed to help physicians disclose errors in a way that provides patients (and family) with the information they desire [126; 129; 130]. These guidelines recommend: • Disclose the error as soon as possible; do not wait for the patient (or family) to ask. • Be prepared for strong emotions. • Tell what you know; focus on what happened and the possible consequences. • Accept responsibility for the outcome, but avoid attributions of blame. • Express apology and regret. • Outline a plan of care to address the harm and to prevent recurrence. • Offer to get second opinions, when appropriate.
• Suggest a family meeting (with the option of having lawyers present). • Document the disclosure discussion. • Offer to have follow-up meetings if the patient desires. The impact of full disclosure on malpractice liability is unclear [117; 122]. Early reports of full-disclosure policies at two institutions (the University of Michigan and the Lexington Veterans Affairs Medical Center, Kentucky) indicated that such policies can reduce the number of malpractice claims, increase the number of settled claims, and decrease legal expenses [91; 131]. Studies in which individuals are presented with clinical scenarios or vignettes involving adverse events have also sug- gested that patients would be less likely to sue if physicians provided disclosure and an apology [73; 115; 116; 121; 132]. However, there is no conclusive evidence demonstrating that disclosing errors decreases the likelihood of litigation [113; 122]. Some have argued that uniform disclosure of errors may actually lead to an increase in malpractice claims [91]. MANDATE FOR INFORMED CONSENT Informed consent requires patients to sign a document stating that they understand the risks and benefits of a procedure or treatment plan and alternative treatment options. However, the principle of informed consent extends beyond the signed form. The process of informed consent helps patients assume an active role in healthcare decision making and aids in the management of patients’ expectations, both of which can reduce the likelihood of a malpractice claim [133].
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