Announcing harm associated with care: an ethical and safety imperative

The occurrence of a healthcare-associated harm represents a complex and delicate reality in a patient's healthcare journey. Whether it is a complication inherent to their pathology, a therapeutic risk, a malfunction, or an error, the impact on the patient can be considerable, ranging from physical and psychological repercussions to social and material consequences. Faced with such situations, the disclosure of a healthcare-associated harm is not limited to a simple transmission of information; it constitutes a fundamental ethical and legal imperative, as well as a key lever for improving professional practices and promoting a culture of safety in care. This article explores in depth the issues, steps, and best practices related to the disclosure of a healthcare-associated harm, based on the recommendations and principles set out in the sources provided.

Understanding the importance of disclosing harm associated with care

Care-associated damage is the consequence of an undesirable event, the origin of which can be diverse: a complication linked to the patient's pathology, a therapeutic hazard, a malfunction or an error. Depending on the case, the damage may have physical, psychological or even social and material repercussions. First and foremost,disclosing damage involves establishing a dialogue between caregiver and patient, with the aim of maintaining or restoring a genuine relationship of trust. It is also part of an approach toimproving professional practices, contributing to the development of a culture of safe care.

For the patient, even in the absence of an adverse event, illness and the need for care engender a feeling of vulnerability. The occurrence of harm can profoundly alter their perception of their illness and its evolution, arousing complex emotions such as sadness, anxiety, anger, or loss of confidence. When the harm results from an error committed by a professional in whom the patient had placed their trust, distress and anger can be exacerbated by denial or lack of communication, often referred to as the "wall of silence."

Following damage, patients have clear expectations: to understand what happened, the consequences for their health, why the event occurred and what corrective action is being taken to avoid its recurrence. Patients also expect recognition of their damage, transparent communication, acknowledgement of their pain (physical and psychological) andempathetic expression of regret, even apology in the event of error. By opting for open and honest communication, professionals acknowledge the impact of the damage and the patient's suffering, which is the first step towards restoring trust and dignity.

Announcing harm has significant benefits for the caregiver-patient relationship. It helps maintain or restore trust between the two partners and helps ensure continuity of care. Quality communication, even in a strong emotional context, can pave the way for appeasement for both parties, transforming an adverse event into an individual and collective benefit. By taking into account the needs of the patient, professionals and healthcare facilities project a positive image. In addition, the announcement is part of a risk management approach, encouraging a thorough analysis of the causes of adverse events and the implementation of corrective actions. When carried out well, the announcement can also limit the risk of litigation by meeting the patient's expectations for information and recognition.

The legal and ethical framework of information and disclosure

Disclosing a harm associated with care is not only a moral and ethical duty, but also a legal obligation. Pursuant to Article L.1111-2 of the Public Health Code and Article 35 of the Code of Medical Ethics, everyone has the right to be informed about their state of health in a clear, fair and appropriate manner, as part of an individual interview. This information is due by every healthcare professional.

Article L.1142-4 of the French Public Health Code specifies that any person who is a victim, or believes themselves to be a victim, of damage attributable to a prevention, diagnosis, or care activity must be informed by the professional or hospital concerned about the circumstances and causes of this damage. This information must be provided no later than fifteen days following the discovery of the damage or the express request of the patient, during an interview in which they may be assisted. Thus, information is a patient right. The V2010 certification procedure for healthcare hospitals also includes "informing the patient in the event of damage related to care" as a requirement.

The ethical foundations of disclosure are based on the principles of transparency, honesty, and respect for patient autonomy. Informing the patient of adverse events, including those that have caused harm, allows them to understand what happened and make informed decisions about their health. Hiding harm, whether due to an error or not, is detrimental because it deprives the patient of essential information and hinders the safety of the healthcare system.

The expectations of patients regarding information following harm are multiple and include not only an explanation of the facts, but also recognition of the harm suffered and the expression of regret or apology, particularly in the event of a proven error. Meeting these expectations helps to strengthen patient trust in the caregiver and limit the likelihood of litigation.

Announcing harm is fully part of a risk management approach. It allows us to identify adverse events, analyze their causes, implement corrective actions, and monitor these actions. Establishing a safety culture, based on a pedagogical and non-punitive vision of error, transparent communication between professionals, and patient involvement, is essential to improving the quality and safety of care.

Preparing the announcement: a key step for constructive dialogue

Preparing for the announcement is a critical step in ensuring a constructive and respectful discussion with the patient. All healthcare professionals must be prepared for this situation, which may arise during their career.

Initial and continuing training of professionals is essential. Some authors even consider the identification and announcement of harm as a medical skill in its own right. This training should address communication in difficult situations, active listening, empathy, and the management of emotions, both those of the patient and those of the professional. Training sessions, such as simulations or peer-to-peer practice analysis groups, can be beneficial.

In a healthcare facility, it is essential to implement a policy for reporting care-related harm, formalized and disseminated to all professionals and patients. This policy should define the objectives, the key stages of the announcement and identify the resources made available to professionals, particularly in terms of support. The institution must commit to creating a climate of trust that encourages the reporting of adverse events and to conducting the necessary investigations objectively.

Support for professionals involved in an adverse event is essential. These professionals may experience shame, guilt, frustration, or anxiety. The establishment of a support unit offering listening, advice, and guidance is essential, as well as a repeated offer of personalized support independent of the hospital institution.

Prior to the patient interview, it is crucial to gather all available information regarding the adverse event, analyze the causes, and anticipate the consequences for the patient. It is also important to determine who will participate in the meeting and who will follow up, to plan the time and place of the announcement, and to prepare what will be said to the patient, anticipating their needs, including linguistic ones (presence of an interpreter if necessary). It is important to gather information on the patient's experience in order to provide the best possible support and to better understand their reactions. An internal preparatory staff meeting should be held as soon as possible after the event occurs.

The preparation of the announcement should be adjusted according to the degree of urgency. In certain situations requiring rapid communication (wrong surgical site, wrong product administered, etc.), the preparatory steps can be condensed or even postponed to a later time for a more relaxed discussion.

Making the announcement: empathetic and transparent communication

The first appointment with the patient is a crucial step in preserving a relationship of trust. The announcement should be considered as a continuous communication process, aimed at informing, supporting the patient, and consolidating the relationship.

The timing of the announcement should be as soon as possible after the damage is detected, preferably within 24 hours, and always within the legal 15-day period following the discovery or the patient's request. The location must be quiet, comfortable, and conducive to confidentiality. In a healthcare facility, a private room or a dedicated office is appropriate. In a private practice, the announcement can be made during a consultation or a specific appointment.

The choice of participants for the initial meeting depends on several factors (type of event, local policy, etc.). In general, the healthcare professional responsible for care and having the most consistent relationship with the patient is best suited to lead the interview. The patient should be informed in advance of the individuals considered and may request that certain individuals not be present. They should also be informed of their option to be accompanied (relative, trusted person, etc.). Depending on the hospital's policy and the severity of the harm, a member of management, the CME, or the risk management coordinator may attend the interview. It is important that a professional is not left alone with the patient, without giving an impression of being overwhelmed (maximum 3 people). Students and interns may attend the announcement, but should in no case make it alone. In private practice, the interview most often takes place face-to-face.

Communication during the announcement must be sincere, transparent, and empathetic. It is essential to acknowledge the harm suffered by the patient from the beginning of the conversation. For example, one can say: "we regret that you have had such a difficult experience". Then, it is necessary to explain the known and verified facts in a simple and understandable way, specifying the implications for the patient's future. It is important to explain what is known about why the adverse event occurred, without making speculations. If the event was avoidable, it must be stated. It is also important to explain one's own role in the event, avoiding blaming others or "the system".

Expressing regret is a key element of the announcement process. In the event of a proven error, the presentation of sincere apologies is essential. It is also necessary to tell the patient what will be done now to take care of him and how the event may impact his long-term care. The organization must commit to mitigating the impact on the patient's long-term health. If the event was avoidable, the patient should be told what should have happened and what will be done differently to prevent a similar event from happening again.

It is crucial to meet the patient's needs by offering medical, psychological, social, or spiritual support as needed. It is also necessary to provide a single point of contact for monitoring the process and to schedule follow-up appointments.

Traceability of the exchange in the medical record is essential. It is necessary to document the day, time, place, participants, facts presented, support offers, patient reactions, questions raised and answers provided, as well as the follow-up plan and contact details of the referring professional. A team debriefing after the interview allows for the sharing of information exchanged.

The aftermath of the announcement: a continuous and personalized process

Announcing a harm can be an ongoing process, requiring the organization of follow-up appointments when the patient expresses the need, when the investigation of the causes was incomplete, or when the organization of assistance is slow to be implemented. These appointments help to reassure the patient and show them the interest in their case.

During follow-up appointments, it is important to provide additional information as it becomes known and to inform the patient of the corrective actions implemented if the investigation was not completed during the first interview. It is also necessary to ensure the effective implementation of the proposed care and support services. The expression of regret, or even the presentation of new apologies, is necessary if appropriate. With the patient's consent, it is advisable to inform the attending physician of the damage and what was said. Each follow-up appointment must be recorded in the medical record. In the long term, it is important to organize feedback to the professionals concerned and to evaluate the impact of the approach.

Throughout the process, it's essential to maintain sincere, transparent and empathetic communication. Don't be surprised if patients react differently, as this often reflects their suffering. In the particular case of a proven error, the patient may be invited to meet another professional to facilitate dialogue. It is also crucial to consider the psychological and professional consequences for the caregivers involved.

Managing special situations: serial events and deaths

Announcing harm may take specific forms in certain situations. In the event of serial adverse events, involving several patients (radiotherapy overdose, insufficient disinfection, etc.), a special procedure must be integrated into the hospital's announcement policy. The announcement must be rapid, simultaneous for all patients concerned, and precede any media communication. A planning effort is necessary to ensure empathetic and individual communication, anticipating the psychological stress of patients recalled for examinations. Public communication is often provided by the hospital in conjunction with the health authorities.

When the adverse event has resulted in death, the emotional burden is significant for those around the patient and the caregivers. All the recommendations in the guide apply, with an emphasis on understanding, listening, respect, and empathy. If the family is not present, the physician should notify them by telephone without announcing the death, indicating that the situation is serious. The reception of the family should be personalized and prepared. The physician in charge of the patient announces the death while being assisted by a member of the team, using simple words such as "death" or "dead". They should give the family the opportunity to speak, answer their questions, express their regrets, and offer their condolences. The team should allow the family to see the body of the deceased and respect their rituals. Information on procedures and bereavement should be provided. The possibility of subsequent contact with the physician is offered.

Communicating with a patient with a mental illness or limited understanding requires individualizing the approach based on the disorders presented. It is important to assess the patient's possible level of understanding, if necessary with the help of a referring psychiatrist or a family member. The duration of the appointment should be longer, and the language adapted. The patient's mental state and the possibilities of mobilizing their environment must be taken into account. The elements justifying a limitation or non-communication of information must be justified in the medical record and transmitted to the referring physician.

Pitfalls to avoid and best practices for a successful announcement

For a successful announcement, it is essential to avoid certain pitfalls and follow best practices. One must not deny one's own emotions, remain isolated, refuse to allow the patient to be accompanied, show aggression, use medical jargon, speculate on the facts, blame someone, deny or conceal the damage, make the patient feel guilty, deny one's own responsibility, or provide contradictory information.

The ten essential steps for disclosing harm are:

• Acquire/improve communication knowledge and skills.
• Communicate respectfully, clearly, sincerely, and transparently with the patient.
• Communicate about known and certain facts.
• Acknowledge the damage.
• Expressing regret or even apologies.
• Meeting the needs of the patient.
• Consider the patient's entourage (with their consent).
• Respect confidentiality.
• Respect the patient's individuality.
• Meeting the needs of professionals (support).

Active listening is a key skill for creating a climate conducive to patient expression and helping them verbalize their feelings and questions. It is important to remain focused on the other person, even if the professional is not in a position of neutrality. Empathy makes it possible to show understanding and support in the face of the patient's suffering. Ethical questioning can help the professional to assume and manage the difficulties encountered in this approach. The principles of beneficence, non-maleficence and autonomy are important elements for reflection.

Finally, it is essential to evaluate the announcement process through monitoring the number of complaints, reported and analyzed adverse events, as well as through satisfaction surveys of patients and healthcare providers. This evaluation allows for continuous improvement of practices.

In conclusion, the disclosure of a healthcare-associated harm is a complex process that requires specific communication skills, rigorous preparation, an empathetic and transparent attitude, as well as consideration of legal and ethical aspects. It represents a fundamental commitment to the patient, contributing to the restoration of trust, the improvement of the safety of care, and the evolution towards a culture of transparency and responsibility within healthcare facilities and in the practice of healthcare professionals.

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