Adverse Events and Unanticipated Outcomes : Comprehensive Disclosure

Introduction

Unfortunately, adverse events and unanticipated outcomes occur during the course of the delivery of health care. Up to 13.5% of Medicare beneficiaries experienced an adverse event during a health care episode. However, such events do not necessarily mean that the clinician made a mistake, was negligent, or deviated from the standard of care. What such events do mean is that something, for whatever reason, did not go as anticipated or planned. Whenever an adverse event or unanticipated outcome occurs, patients and their families not only want but are entitled to a full explanation about what has happened to them during the course of their care, and why. Knowing how to effectively disclose an adverse event or unanticipated outcome, regardless of its etiology, can have a significant and beneficial impact on all aspects of the eventual outcome of the disclosure, including maintaining a trusting patient-physician relationship and helping to reduce any potential professional liability exposure. Adverse events or unanticipated outcomes compounded by poor patient-physician relationships pose the greatest professional liability risks.

The practice of anesthesiology has long been at the forefront of efforts to improve patient safety, but special challenges exist when adverse events or unanticipated outcomes involve anesthesia providers. Whereas patients can pick their surgeon and often the hospital or outpatient facility in which to have their procedure, in most cases they do not pick their anesthesiologist and often do not meet this provider until shortly before the procedure. As a result, there is essentially no preprocedure relationship during which a rapport or trust can be established. However, the anesthesia provider must be actively involved in the disclosure of an anesthesia-related event, and how this, along with the documentation, are handled can often make the difference between an understanding patient and one that becomes litigious.

In addition to being the right and ethical thing to do, full disclosure of an adverse event or unanticipated outcome has been a requirement of The Joint Commission since 2001. It requires that any unanticipated event that has significant clinical implications for the patient, whether temporary or permanent, be disclosed. Full disclosure is also encouraged by other organizations, such as the National Quality Forum, which considers full disclosure one of its safe practices for health care. In addition, in several states, disclosure is also a statutory requirement.

Why disclose?

• The Joint Commission requires disclosure.

• State law may require disclosure.

• It is what patients expect.

• It provides an opportunity for an apology and lessens anger.

• It improves patient and physician trust.

• It promotes patient safety and quality improvement.

• It sets the stage for early intervention.

• It helps minimize potential professional liability risk exposure.

• It is the right thing to do regardless.

Preparing for Disclosure

A full and open disclosure should occur whenever something does not go quite right or as planned, even if the event was not related to a deviation from the standard of care and did not cause a permanent injury. Although timely disclosure is essential, it must be done in a coordinated, thoughtful, and empathic manner. Each institution should actively assess its disclosure culture to facilitate best practices. Preparation for disclosure is an important first step and involves a team, not just the involved clinician. The prep team may include individuals who will not be involved in the actual disclosure but can be helpful in the necessary debriefing session to understand the event and its implications; in determining what should be disclosed, who should do the disclosure, and how it should be disclosed; and in preparing an anticipated course of action after the disclosure. All members of the prep team, including the clinicians that will be performing the disclosure, as well as the individual who will remain the primary contact person for the patient and family, need to be aware of and understand what the disclosed information will be. This allows for consistent messaging and conveys that we are all working together.

Disclosure

In most cases, disclosure should be done as soon as possible, even if all the facts and circumstances of the event are not yet known. Optimally, disclosure should occur face-to-face with the patient and/or family/substitute decision maker. Disclosure should only include factual and objective information as it is known at the time of the disclosure. It is never appropriate to speculate, assign blame, criticize other clinicians, or editorialize about the circumstances surrounding the event or the facts that have yet to be determined. Timely disclosure helps to avoid the patient and family questioning why you waited so long to disclose the event and helps eliminate the misconception that you were hesitant to inform them of its occurrence or are attempting to hide or withhold information. Full disclosure often is not achieved in the initial disclosure discussion and can at times be an ongoing process. Although it is important to have at least the preliminary facts at the time of the initial disclosure, it is not necessary to have all the answers, and it is impossible to predict what a patient’s and/or family member’s questions might be. It is imperative to let the patient and their family know that as more information and facts become known, they will be shared with them. If, during the course of disclosure, questions are asked that do not currently have an answer, it is always appropriate to say, “I don’t know, but I will find out more information and return to discuss this with you.”

Whenever possible and if appropriate, disclosure should be performed by a small disclosure team that includes the anesthesia provider who was involved in the event, as this demonstrates accountability and responsibility. In most cases, especially in situations where the patient may not have previously met the involved anesthesiologist, it is helpful to have the patient’s surgeon or primary care provider also present for the disclosure. This not only provides the patient with the familiar face of a clinician with whom the patient already has a trusting and ongoing patient-physician relationship, it also provides the attendance of the clinician best qualified to answer the patient’s questions (e.g., “What does this mean for my health?” or “Does this change my prognosis?”). In addition, because the information that is disclosed to the patient has the potential to be overwhelming, the presence of the clinician who will remain involved in the patient’s follow-up care will allow that individual to be helpful to the patient in his or her subsequent attempts to recall the disclosure discussion accurately.

Another key member of the disclosure team is the nurse manager on the unit where the patient will be after the event. Involvement of the nurse manager in the disclosure discussion will ensure that this individual is aware of exactly what the patient and family were told and what their reaction was to the disclosed information. The nurse manager can then share this information with the nursing staff on the unit. The nursing staff will have much more ongoing and frequent contact with the patient and family and will often be the ones that the patient or family will initially approach with subsequent questions about the event. It is important that the nursing staff be aware of the event and know to whom they can refer any questions that the patient or family may have. By being part of the disclosure team, the nurse manager can serve not only as the contact person for the patient and family but also for the nursing staff.

Likewise, it is important to have a family member present for the disclosure whenever possible, as this allows for someone else to not only hear and remember the facts but also provide emotional support to the patient. However, it is essential to understand that family members may also be affected by the information, and just as it is important to care for the patient after disclosure of an adverse event, it is equally important to care for the family. This may involve requesting other departments such as patient and guest services, pastoral care, or social work to assist in providing support and helping both the patient and the family cope.

Depending on the nature of the event, it may be helpful to also have that facility’s chief medical officer or patient safety officer present for the disclosure as well. This will help to demonstrate that such events, regardless of the circumstances, are taken seriously by administration and will be used to evaluate the care provided and subsequently institute change if needed. It is important for patients and their families to know that the health care facility will use the adverse event or unanticipated outcome as a learning experience in its efforts to prevent similar occurrences in the future.

Discussing Potential Compensation

If the patient or family unexpectedly raises the issue of compensation during the initial disclosure discussion, the most appropriate response is to inform them that their concerns about compensation will be shared with the appropriate administrators and that someone will get back to them. Do not make any promises regarding potential compensation. However, there may be situations in which the adverse event or unanticipated outcome to be disclosed does involve a deviation from the standard of care that has resulted in a significant and/or permanent injury. In these situations, and after a discussion with hospital administration and appropriate members of senior management during the disclosure prep meeting, it may be appropriate to initiate a compensation discussion by tactfully assuring the patient and family that the hospital/facility will work with them to address their potential future economic needs. Although most often it is best to leave any discussion of compensation for a future meeting, after the patient’s immediate medical needs are met, it is important for the patient and family to know that this will be eventually discussed. There is precedent for significant economic compensation in litigation cases related to anesthetics.