Medical error calls for honest disclosure

Steps should be taken to encourage and support doctors in reporting adverse events to patients who have been harmed and their families.

Reply: Physicians strive to do no harm. Nonetheless, they seldom promise to disclose medical errors or mistakes that do harm to their patients. Disclosure is a professional responsibility that is desired by patients, endorsed by ethicists and professional organizations, and increasingly required by regulatory and government bodies. Although few now question the imperative to be honest and forthcoming following an injury, full disclosure communication with patients and families after an adverse event is still not the norm throughout the United States.

Common barriers to open communication around patient harm events include fear of lawsuits and retribution, a culture of "shame and blame," not wanting to "turn in" fellow practitioners, not having enough information to explain what happened and a desire to avoid bad publicity. Many also believe that caregivers lack the necessary communication skills to openly and effectively discuss medical errors, mistakes or harm with their patients.

Full disclosure of a medical error is defined as a communication between a health care professional and a patient, family members or the patient's proxy that acknowledges the occurrence of an error, discusses what happened and describes the link between the error and outcomes in a manner that is meaningful to the patient. Disclosure is based on the principle that all patients have a right to know the details associated with unexpected outcomes that occur during their care. Disclosure of medical errors and other relevant information after an unexpected adverse event provides opportunities for compassionate, professional and patient-centered care. It also allows for increased learning that could translate into safer systems-based practices and possible repair of patient-caregiver-health system trust.

Transparency and honesty begin with an organizational culture that openly reports adverse patient events, including near misses and unsafe conditions. The Joint Commission requires the establishment of a reporting system for adverse events by accredited organizations. Despite these mandates and perceived benefits of reporting, one survey of physicians in teaching hospitals revealed that only 54.8% of participating physicians knew how to report medical errors and only 39.5% knew what errors to report. Another survey found that only 31% of interns or residents reported receiving instruction in error disclosure techniques.

At our institution, the University of Illinois Medical Center at Chicago, we have implemented a disclosure program with the following elements, which we believe are integral to a comprehensive response to unexpected adverse events involving patient harm:

• Reporting. Notifying patient safety or risk management personnel about unexpected adverse events involving patient harm.
• Investigation. Undertaking a rapid, detailed investigation using standard root cause analysis techniques of the event to determine whether an error was made in the process.
• Communication. Creating programs for providing ongoing communication with patients and families after an unexpected adverse event without regard to cause of the event.
• Apology and remedy. In the event of an error, providing an apology and an appropriate remedy.
• Improvement. Linking process improvements identified in the root cause analysis with patient and family involvement.

A core set of principles must be considered for any communication after an unanticipated outcome in an effort to maintain the bond between the patient and the physician, but the conversation may take several paths. And while all communications should take into account the distress level of the patient and family, this empathy should not be confused with apology. The unanticipated outcome may or may not be the result of error, mistakes or negligence, and an apology given when no medical error contributed to the outcome may be interpreted as an expression of remorse combined with an admission of fault or responsibility with legal and insurance coverage implications. If inappropriate care did contribute to the unanticipated outcome, effectively linking the inappropriate care to the unanticipated outcome is a key element of the communication.

Throughout the disclosure process, the health care team must be prepared to use clear and simple language that is understandable for a lay audience. Talking about the medical facts and the source of error in medical jargon that a patient cannot understand can result in communication breakdown. If English is not the patient's native language, the error disclosure team should engage translational services to avoid relying on friends or family, who, although well-intentioned, may misrepresent the explanations provided. Just as important, caregivers must be sensitive to cultural norms that may color patients' perspectives of health, death and dying.

Disclosure, like informed consent, is a process, not a single event or single discussion. The process does not end with disclosing the errors or mistakes to the patient and settling on a plan of remediation. In addition to guiding the optimal management of the error that occurred, the root cause analysis of the adverse event should be used to develop and implement patient safety improvements aimed at preventing a recurrence of the system breakdowns that contributed to the event. Improving patient outcomes while reducing medical errors is dependent on the organizational learning that results from complete transparency and extreme honesty associated with unanticipated outcomes and associated errors.

The true value of transparency rests with the ability of organizations to rapidly investigate, analyze and learn from unanticipated outcomes. In addition to establishing whether an error caused the unanticipated outcome, the root cause analysis also can identify process breakdowns and opportunities to improve practices or individual performances. Identified potential process improvements should contain specific practice changes with measurable quality or safety indicators for long-term tracking of effectiveness. Those overseeing the investigation also are ideally situated to ensure that individuals involved with serious medical errors, the "second patients," receive emotional support and expert help following adverse events through care-for-the-caregiver programs. This requires personnel trained in process improvement, quality management and "second patient" issues to facilitate the team's inquiry.

From an academic standpoint, residency programs that adhere to the foundations of medical error disclosure can align training and assessment to all six areas of the Accreditation Council of Graduate Medical Education's core competencies: patient care; medical knowledge; practice-based learning and improvement; interpersonal and communication skills; professionalism; and systems-based practice.

Transparency related to unexpected adverse outcomes, including full disclosure of medical errors, is central to the patient safety movement. A handful of organizations have implemented disclosure initiatives with a compensation component. The experiences from the Veterans Affairs Hospital in Lexington, Ky., the University of Michigan Health System and the University of Illinois Medical Center at Chicago provide some encouragement to the health care community regarding the financial viability of a disclosure process.

The disclosure program at UIMCC continues to evolve as we learn from each disclosure. Our comprehensive disclosure program provides a clear process to follow once an adverse event has been detected and has encouraged the adoption of a safety culture. Specialized training is required for personnel involved in the communication of adverse events to maintain trust between the physician and the patient.

One strength of the UIMCC program is the engagement of patients and their families as part of the investigation and improvement processes, thereby encouraging an ongoing relationship with the patient and family. Overall, disclosure programs implemented with a commitment to honesty and in a comprehensive manner with appropriate training and education should lead to reduced patient harm and improved processes, while engendering a safety culture in health care.

David Mayer, MD, co-executive director, Institute for Patient Safety Excellence; vice chair of safety and quality, Dept. of Anesthesiology; associate professor of anesthesiology, University of Illinois Medical Center at Chicago

Timothy McDonald, MD, JD, co-executive director, Institute for Patient Safety Excellence; chief safety and risk officer for health affairs, and professor of anesthesiology and pediatrics, University of Illinois Medical Center at Chicago