Introduction
An important part of a physician’s role is ensuring patients are kept fully informed so they can be active participants in their health care decisions. For many years, fear of litigation kept physicians from disclosing information about adverse and unwanted events to patients. However, the American Academy of Family Physicians (AAFP) strongly believes that patients should be informed about all aspects of their health care, regardless of whether disclosure of an unanticipated clinical outcome might lead to litigation. With rare exceptions, it is the ethical choice for physicians to be fully open with patients about things that went wrong or did not go as anticipated. This disclosure must be done properly. One useful source of disclosure training and resources for physicians is the Communication and Optimal Resolution (CANDOR) toolkit developed by the Agency for Healthcare Research and Quality (AHRQ).1
In the context of disclosure, it is important to understand what adverse events are and the factors that contribute to them. A number of different definitions of adverse events exist, many of which include ideas about near misses or preventable harm. Preventable harm is usually associated with a lack of communication between the physician and the patient/caregiver about a medication, condition, or situation. Examples include a missed symptom, a forgotten allergy, or an unforeseeable problem (e.g., unknown allergy, complication in a procedure). In these cases, effectively communicating about the situation is the step forward needed to improve patient/caregiver understanding and repair the relationship between the patient/caregiver and the medical community.
More than 39 states, the District of Columbia, and Guam have passed so-called apology laws that protect physicians from litigation because of a disclosure.2 These laws recognize and reinforce the importance of allowing physicians to discuss adverse and unwanted events freely and openly with patients and their families. Four states (Colorado, Georgia, Iowa, and Utah) have taken their apology laws further by enacting CANDOR legislation that provides even more legal coverage for physicians to disclose unanticipated clinical outcomes.3,4 This legislation applies to CANDOR discussions, a form of honest communication between a clinician or health care facility and a patient who has experienced an adverse medical incident related to patient care.5 The discussion occurs in a way that preserves the physician-patient relationship, allows for open communication, and supports improvements in patient safety.
Although physician participation in disclosure conversations may not increase liability,6 states with CANDOR laws have taken steps to ensure that information shared during specific CANDOR discussions is protected. For example, the Utah Medical Candor Act, which was enacted in May 2022, establishes a voluntary process for clinicians and health care facilities to have structured CANDOR discussions with patients and families after a medical error or adverse event.7 Patients participating in CANDOR discussions are not prevented from pursuing malpractice claims. However, these discussions are facilitated with legal counsel present, so communications conducted under the medical CANDOR process are confidential and privileged.8 Additionally, health care professionals who are not participating in the process are protected by restrictions on what participating clinicians may and may not share.
Disclosure: Definition and Key Considerations
Disclosure involves communicating information to patients and their families. By contrast, reporting is the official representation of the situation, facts, and findings to an authority (e.g., hospital board, medical board). The Health Insurance Portability and Accountability Act (HIPAA) defines disclosure as the “release, transfer, provision of access to, or divulging in any manner of information outside the entity holding the information.”9 Disclosure is not an admission of guilt or fault. It should communicate the facts of the adverse or unwanted event that occurred without any speculation regarding how or why it happened.
Appropriate disclosure should also describe steps that will be taken to investigate how to correct the outcome or prevent a similar outcome in the future. Studies have shown that when this type of disclosure follows a sincere expression of sympathy, it gives the parties involved a sense of inclusion, a feeling of control over unexpected events, and a direction for moving forward.10 It can also reduce the frustration, anger, and helplessness that often arise from these situations.
Various studies have considered what types of interactions and communication styles work best to convey sincerity. Evidence has shown that an apology is more effective when it is a communication of sympathy rather than a means to achieve a goal.11 It is important for the apology to be an act of true compassion, not an admission of fault or a contrivance to avoid a negative communication or punitive action. This approach conveys that the physician wants to work through the situation with the patient and help everyone involved understand what happened.
Potential Benefits and Downsides of Disclosure
Since 2000, major patient safety and physician organizations representing adult and pediatric care have agreed that disclosure of adverse events to patients is an ethical duty and a best practice.12,13 Disclosure processes should be viewed as part of high-quality care and inform care delivery improvement. Medical systems can facilitate structured disclosure. Resources such as the AHRQ’s CANDOR toolkit provide communication and documentation training for clinical teams, as well as integrating risk management and patient safety activities. When appropriate disclosure is done systematically, it reduces patient experience of harm and does not appear to increase liability risk.14,15 In addition, a systematic disclosure process that includes support for clinician well-being may reduce negative and career-limiting physician responses following an error.16,17
There are potential downsides to communicating errors to patients and their families. For example, as previously noted, most states provide some protection for disclosure of errors, but the majority of these states have only partial apology laws.18 Such laws protect expressions of regret but do not preclude error disclosure from being admitted as evidence in litigation. Some evidence indicates that partial apology laws may increase total malpractice payments for claims and lawsuits.19 This may be one reason that there are conflicting data regarding whether disclosure reduces malpractice claims.20
Another potential downside is that an apology may lead to more conflict if the patient perceives that the physician is insincere and/or defensive, is hiding something, or has ulterior motives (e.g., trying to avoid punishment), or if the apology does not include an offer to repair the damage.18 Thus, physicians untrained in properly disclosing errors to patients may bring about worse outcomes. It is imperative for apologies to be appropriately sincere, sympathetic, and transparent.
Because physicians lead the care team, they often end up assuming most, if not all, of the blame for an error, even when others played a role.21 One study found that physicians were more likely to shoulder all of the blame for an error without divulging how other people were involved because they did not want to be perceived as blaming team members.21 Many physicians report that the disclosure process can have negative effects on their mental health and emotional well-being, especially when they feel unsupported by their institution.22 In fact, clinicians who experience emotional consequences after an error or adverse event have been described as “second victims.”17 This psychological distress is worrisome in a profession that is already experiencing an epidemic of burnout and even suicide.23,24
Ideally, a culture of error disclosure would spur an institution’s efforts to improve care quality. However, some data suggest that when institutions reduce the likelihood of a malpractice claim by offering financial compensation in addition to an error disclosure, such compensation programs may hide data on medical errors.18 These programs can also decrease the impetus to fix system-level issues that contribute to unanticipated clinical outcomes.
State, Hospital, and Practice Disclosure Policies
Each state, hospital, and practice may have its own policy regarding disclosure and may have resources available to support physicians in this complex situation. Malpractice insurance carriers may also provide resources, such as educational courses on the benefits of appropriate disclosure. The AAFP encourages physicians to be aware of current policies and procedures that affect their individual practice situation, including the policies of their employer, hospital, state medical board, and malpractice insurance carrier. In some cases, one or more of these entities may require physicians to report incidents prior to disclosure or in addition to disclosure. Failure to report may have negative consequences, including the potential for disciplinary action on the physician’s license or loss of malpractice coverage. Physicians should also be aware that resignation of clinical privileges during an investigation is reportable to the National Practitioner Data Bank.
Federally Qualified Health Centers and CANDOR
CANDOR legislation has not yet been tested with the Federal Tort Claims Act liability coverage held by most physicians working at a federally qualified health center (FQHC). CANDOR processes may run parallel to peer review processes, which are guided by state law. However, as of November 2022, there is no federal peer review protection. A CANDOR process may be conducted under a “gap coverage” policy obtained by an FQHC, but the communications produced in a CANDOR process may not be protected from admission to court in a subsequent lawsuit. Physicians who work at an FQHC are advised to work with local counsel when deciding whether to participate in CANDOR processes.
Conclusion
More and more states are passing legal protections for disclosure by physicians that is performed within commonly accepted standards. The AHRQ’s CANDOR program offers training and a toolkit to aid in disclosures. Physicians are advised to know their state and local policies and seek out guidance from their quality or risk management office, if necessary. When done properly, disclosure of unanticipated clinical outcomes is legally defensible, and it is now considered one of a physician’s ethical duties. The AAFP fully supports physicians in disclosure, as do many other professional societies.
References
(March 2006 BOD) (October 2023 COD)