Disclosure of Adverse Events: A Principled Approach to Doing the Right Thing

David J. Birnbach and Timothy B. McDonald

Human beings, no matter how well trained or well intentioned, make mistakes. Although there is no debate regarding the issue of human error, the medical community has not agreed on how best to disclose these errors when they occur. Plastic surgery is no exception. In fact, this specialty brings its own set of challenges. Many of the performed procedures are elective in nature. Many patients have very unrealistic expectations. Even when plastic and reconstructive surgeons clearly communicate the potential positives and negatives of a procedure before it occurs, patients may be disappointed. When patients believe that they have been harmed, the integrity of the individual practitioner is often defined by how he or she responds, whether the harm is real or perceived.

Across the spectrum of medical specialties, adverse outcomes are an uncomfortable reality of medical care.1 When an unanticipated outcome occurs, physicians may deny, minimize, rationalize, and blame others, including the patient. On the other hand, some physicians may embrace a commitment to an open inquiry and honest communication after a bad outcome using a “principled approach.”² This approach is based on a theoretical framework that is optimally enacted immediately after any adverse event.^3,4

A shift from the perception of error as a moral failure, as well as fear of legal repercussions, is essential to counterbalance the “shame and blame” culture and move to a new paradigm of disclosure.³ In addition, disclosure is by nature a time-sensitive event and to be successful must adhere to a specific time frame.

Given the medical complexity of error and disclosure, this chapter focuses on one systematic approach to generate an understanding of the inherent value of disclosure.

Creating a Culture That Facilitates Disclosure

In an arena of extreme complexity, mistakes, whether a result of human error or system error, are inevitable. It has been suggested that health care is unsafe.⁵ In a specialty that performs elective procedures, plastic surgeons are not immune. Often they are at even more at risk because of variations in outcomes and expectations. The way that many physicians typically address errors reflects the previously embraced “shame and blame” culture instead of one that promotes sharing and learning. So how does the health care profession in general, and surgery in particular, make the shift from “deny and defend” to a “communicate and respond” strategy?⁶

Before medical disclosure can become standard practice, a “just culture” must be established. This is true of all specialties of medicine and in every hospital and health care setting. In a just culture, a clear distinction exists between blame-free and culpable actions. In this environment, leadership does not seek to punish unintentional errors and understands that human beings are fallible. Furthermore, physicians and other providers are more likely to report errors, near misses, and error-likely situations, helping the entire institution to learn and improve.

This does not mean that those who make preventable errors are not accountable, but it focuses on improving the systems that allow errors to occur. Moreover, even when an error occurs that does not result in patient harm, physicians have an ethical obligation to share the information to prevent future harm to another patient. After all, an error that occurs in one hospital or surgical center can easily occur at a different location, and today’s “near miss” can be tomorrow’s “hit” to a less lucky individual.

A just culture can be achieved by fostering and maintaining a work environment that encourages disclosure without fear of reprisal or retribution.7 According to the Canadian Medical Practice Association,⁸ in this environment health care providers, patients, and those in leadership positions share a collective commitment to processes that are anchored in fairness and trust. A just culture that encourages learning from adverse events to strengthen the system and protect patients is a prerequisite if the principled approach, as discussed in the next section, is to be applied and embraced.

The Principled Approach

Barriers to Honest Communication

Although apologizing to patients when something goes wrong should be a simple matter, it is fraught with difficulties and complications.⁹ In fact, many practitioners support medical disclosure yet lack the education about how to do so in an appropriate manner.⁴ Fear of litigation; humiliation; perceived risk to income, hospital privileges, and license; and the uncertainty of outcome are all barriers to medical disclosure. However, physician failure to disclose, or delegating the management of harm to the legal community, has arguably not prevented any of those feared outcomes and perhaps severely damaged the reputation of the medical profession. Furthermore, the approach to management of bad outcomes in the past has often prevented essential learning to improve patient safety.

In most cases, patients want and respond well to full disclosure. Moreover, patients often react unfavorably to what they perceive as a lack of transparency or a “partial apology,” one that is limited to an expression of sympathy without acknowledging details or fault. In fact, it has been suggested that full disclosure may tip the balance to give the physician the benefit of the doubt.¹⁰

To advance the safety of patients and the reputation of the medical profession, barriers to honest communication need to be evaluated. To reduce the concerns regarding a culture of “shame and blame” and to facilitate open dialogue both with the patient and within the institution, health care organizations are creating programs for guidance and education about the specifics of disclosure. One such program is the principled approach presented in this chapter.

Understanding the Principled Approach

The principled approach to patient harm follows six specific steps, highlighted in the following sections:

1. The immediate response

2. Reporting of harm

3. Investigation

4. Communication: initially and in follow-up

5. Identification of process and performance improvement opportunities

6. The necessary follow-up

The Immediate Response

Responding to patient safety events and appropriately reporting them are the first steps in any principled process to patient harm. Reporting triggers the institutional response process, while the health care team responds to the immediate medical needs of the patient. Most hospitals encourage health care professionals, especially physicians, to report any patient safety incident to the Safety, Quality, and/or Risk Management Department. Reports are generally made by telephone, handwritten letters, online, or in person. Hospitals are mandated by the Centers for Medicare and Medicaid (CMS) and The Joint Commission (TJC) to provide for a reporting process for patient harm events. Furthermore, some studies have specific requirements for error reporting.

It is incumbent upon physicians to understand and appreciate the reporting process used in any hospital where they work. Of importance, all physicians need to recognize the importance of their role in taking care of the patient when harm occurs and ensuring that neither the patient nor the family is abandoned during this critical time.

Benefits of Reporting

Reporting is essential if, as a specialty, surgeons are to ultimately learn, improve, and regain the confidence of their patients. The benefits of rapid institutional reporting of patient safety events within the organization provide substantial incentive for all physicians to report and encourage reporting harm events. These benefits include the following:

• Activation of the internal patient safety and risk management processes, including a crisis management plan, if indicated

• Preservation of data and information

• Opportunity to trigger immediate support for the patient, family, and care professionals

• Initiation of a “quality committee” investigation and the “legal privilege” most states afford such investigations

• Establishment of a communication link with the harmed patient and his or her family

As with documentation in the medical record, when reporting a patient safety event, physicians should optimally provide the necessary factual information to commence an investigation, while avoiding speculation with incomplete facts. Most significantly, this document should not be an exercise in “finger-pointing” or used to start what has been characterized as a “chart war.”

Another benefit of disclosure relates to the issue of litigation. Contrary to urban myth, reports indicate that only a minority of patients who sue their physicians state that obtaining financial compensation is their primary goal in malpractice suits.11,12 Furthermore, it appears that the act of disclosure reduces the incidence of malpractice lawsuits.¹³

Investigation

As advocates for quality medical care and patient safety, some physicians with previous specialized training possess unique skills for participating in the investigation of serious adverse outcomes. Patients and families want and deserve the “facts” after a harm event, but this is not an easy task. An appropriate investigatory process is generally needed to provide them with the necessary and adequate information. The physician assigned to this role should commit to participating in any institutional root cause analysis or other investigatory process after a serious harm event. Such investigations should try to avoid the traditional “shame and blame” approach to adverse events and instead focus on systems-based issues and identification of possible areas of improvement.

Nonetheless, before they know all the facts, patients and families are still entitled to effective communication in the early aftermath of a harm event. David Marx,¹⁴ in his important book Whack-a-Mole: The Price We Pay for Expecting Perfection, advocates that we abandon the “no harm, no foul” approach to liability and institute meaningful tort reform, revise regulations that outlaw human error, and reconsider society’s perception of both wrongdoers and injured victims.

Communication

Once harm occurs, honest and effective communication is essential to maintain trust between the patient and the physician. Every hospital should have a designated individual who is uniquely positioned to facilitate such communication. This is generally not the physician who performed the surgery. In many hospitals, because of their immediate availability on a 24-hour basis, this person is a hospitalist. Although some conversations can wait, others cannot. For the patient who has experienced an unexpected outcome, every hour that goes by without effective communication constitutes more harm, anger, and an adversarial stance.

Honest and effective communication after a harmful adverse event is not just the right thing to do, but the smart thing to do as well. It has been suggested that patients and families sue, in large part, because they perceive a lack of transparency, abandonment, or “cover-up.”¹¹ In that landmark study, Vincent and colleagues reported that “The decision to take legal action was determined not only by the original injury, but also by insensitive handling and poor communication after the original incident.” A transparent process with open lines of communication and disclosure of all pertinent information can mitigate those patient and family perceptions.²

Box 11.1 Benefits of Apology

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