Practice Tips

Adverse Events

Despite the best efforts of healthcare professionals, adverse events sometimes happen in healthcare settings. When a patient experiences a negative outcome, there is an expectation that the healthcare establishment will deal with the event openly and honestly. The parties involved should accept appropriate responsibility, express sympathy, and work to prevent the event from happening in the future if the event is determined to have been preventable. The informed consent process is the first step in addressing adverse events in advance, helping the patient understand the risks, benefits, and alternatives to their care plan. A proper informed consent process can ease disclosure discussions after the fact, should an adverse event occur.

Disclosure as a Communication Tool

Healthcare providers may have a legal, regulatory, and ethical obligation to disclose adverse events to patients. The American Medical Association Opinion 8.12 states, "It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients." The opinion states that when a patient suffers a significant adverse event that may have resulted from a physician’s mistake amounting to a medical error, then the physician is ethically required to inform the patient of all the facts necessary to ensure their understanding of what happened. Adverse events need to be communicated and dealt with effectively regardless of whether an error occurred, however.

While there is an expectation that disclosure will happen, it can be a difficult process. When handled poorly, disclosure can do damage to the patient-provider relationship, subject the provider to legal liability they otherwise would not face, and jeopardize medical professional liability insurance coverage.

When a patient experiences an adverse event or unanticipated outcome, they may assume that a medical error occurred, but this is often not the case. It is human nature to speculate about the cause of an adverse event without first knowing all the facts, leading to false conclusions that should never be part of a disclosure conversation. Initial disclosure discussions should focus on the patient’s current medical state and the best options for mitigating the injury and moving forward.

Lack of training about making the patient disclosure, lack of professional and administrative support, and fear of a malpractice suit all contribute to the reluctance to communicate with the patient. Disclosure after an adverse event or unanticipated outcome will not necessarily prevent a malpractice claim. However, timely communication with the patient and family, expression of sympathy, and factual disclosure of what occurred can help to maintain the patient-provider relationship.

Disclosure is Not a Cost-savings Tool

According to the American Society for Healthcare Risk Management, disclosure is not intended to be a risk management technique that an organization uses to prevent people from filing malpractice claims or requesting compensation. Organizations should not view disclosure as a cost-saving or liability-avoidance tool. It should be viewed as a pathway to foster patient and family trust and assist the patient’s understanding of their condition, including past and future care.

Disclosure Policies and Discoverability

Organizations should develop their disclosure policy consistent with their state statutes regarding apologies and peer review protections, and medical professional liability insurance policies addressing disclosures. Please see our template for the policy. In addition, risk managers should be familiar with their malpractice insurance carrier’s position on disclosures, apologies, and offers of compensation made by the insured or policyholder without the insurer’s participation. When an adverse event or unanticipated outcome occurs, it is imperative to inform the insurer as soon as possible and take advantage of their disclosure resources to help guide the process forward and avoid costly mistakes. While it is clear that patients have a right to be informed of adverse events and unanticipated outcomes related to their care, controversies continue to surround how the information should be delivered, who should deliver it, and how it may impact legal liability and insurance coverage for that liability.

Models for Managing the Disclosure Process

An organization’s protocol for managing the disclosure process will depend on its size, complexity, and staff members' strengths. Several models exist, and organizations should review models and determine which model or combination of models best fits their organization’s needs and the demands of the state and federal laws applicable to their operations. ASHRM’s Monograph, Disclosure of Unanticipated Events: The Next Step in Better Communications, identifies four approaches that have emerged as workable options.

• One-Person Model: One person, frequently the risk manager, coordinates all disclosure discussions. This model might be a good fit for a small organization and can ensure consistency in the process. However, the model places a tremendous amount of responsibility on one individual for coaching clinicians, among other tasks, and it is limiting in that it depends on one person to have the necessary skills to conduct the disclosure process.
  
• Team Model: In this approach, organizations choose members who are identified as effective and knowledgeable communicators with highly developed interpersonal skills. This group receives training in effective communication skills and the disclosure policies of the organization, with the expectation that members of the group will coach clinicians and accompany them to disclosure discussions.
  
• Train-the-Trainer Model: This model would work best for medium—to large-sized organizations. In this model, a large group of providers and other staff receive training with the expectation that they train a certain number of other staff members annually. This approach spreads the disclosure skills and responsibilities throughout the organization. However, quality control and division of labor might be issues with this approach.
  
• Just-in-Time Coaching Model: In this model, providers present at the time of the event and disclose what is known to the patient at the time. The providers receive just-in-time coaching from an individual, oftentimes the risk manager, prior to the disclosure discussion. This model is quick, direct, and easy, but it poses the greatest risk of missing disclosure goals, exposing providers to liability, and causing complications in the patient-provider relationship.

Each model burdens the employee(s) involved when their disclosure duties take them away from their other, regular duties. Whichever model or combination of models an organization chooses to follow, the involved provider’s presence during the disclosure discussion is important from the patient’s perspective and should be expressly considered before each disclosure.

Steps in the Process

• Preparation: Preparation for the disclosure is essential but sometimes an overlooked element of the process. In preparation, the facts of the care and the adverse event or unanticipated outcome should be reviewed with the practitioners involved in order to identify any disagreements in advance. What are the known facts, as opposed to speculation about what happened? What caused the adverse event or unanticipated outcome? How will it affect the future care of the patient? What additional information will become available and when, and will it be disclosed to the patient? Who should be involved in the disclosure? Where should the disclosure take place? Who should take notes of the disclosure meeting? Where should the notes or other documentation of the disclosure be kept (but always outside the patient’s medical chart)?
  
• Outside consultations: After the scope and content of the disclosure and its participants have been determined, the organization should reach out to its legal counsel and medical professional liability insurer before delivering the disclosure. As noted in a later section, each state has different laws providing varying degrees of “safe harbor” for making disclosures without putting the providers in needless legal jeopardy, including what may be said in the disclosure and when the disclosure must be held in order to be protected.
  
• Starting the conversation: The start of the disclosure sets the tone for the entire discussion. Begin the process by ensuring that participants know HIPAA privacy obligations incumbent on the facility and its practitioners and expressly confirming that the patient is comfortable with the discussion going forward with the parties who are present. Be aware of the patient’s and family’s health literacy and their ability to understand the information presented to them. Avoid technical medical jargon and be prepared to explain medical conditions and treatments in terms that the patient or family will understand. Remember that even highly educated individuals can have difficulty understanding medical terms while they are in a state of shock or grief, so always confirm the parties’ understanding of what was disclosed.
  
• Presenting the facts: Avoid speculation and untested theories during the disclosure. Describe only what is known at the current time. Explain the next steps that will be taken, such as further investigation of the adverse event or unanticipated outcome and whether the results will be shared with the patient; the additional treatment the patient will receive and by whom and at whose cost; and what steps will be taken to prevent the event from occurring in the future, if appropriate.
  
• Conveying sympathy: It is vital that providers or others involved in the disclosure sincerely acknowledge the patient’s and/or family’s grief and suffering without implying fault.
  • Be honest, sympathetic, and compassionate.
  • Encourage the patient and family to express their feelings, thoughts, fears, and anger.
  • Listen and be responsive to the expressed concerns, keeping closely to what is known.
  • Respond to questions with honest answers, to include “we don’t know” if that is the true answer.
  • Ask open-ended questions to engage the patient and family like, "Is there something you would like to ask?"
    
• Topics to avoid: There are a number of topics that the provider and staff involved in the disclosure discussion with the patient or family must avoid:
  
  • Mention of medical professional liability insurance coverage or the involvement of a claims adjuster.
  • Critical remarks about the facility, organization, or other providers or staff.
  • Comment about peer review and quality improvement review activities or conclusions. (Peer review and quality analyses may lose their statutory protection if shared outside the committee setting.)
  • Reference to conversations with or advice from legal counsel.
  • Statements that state laws do not include among the protections available for disclosures.
    
• Concluding the discussion: Summarize for the family the facts of the conversation and ensure their understanding. If helpful to focus the patient or family, repeat any questions they raise and your responses. Be sure that the patient and family know who will follow up with them after the discussion, if appropriate. Address any actions that the patient or family needs to take. Provide them with contact information for whom to call if they have further questions or need clarification or assistance.
  
• Documentation: Documentation of the disclosure conversation should reflect the material content, including a summary of the questions and answers, the plans proposed, the follow-up responsibilities of the participants, and the contact people identified for the organization and for the patient or family. Additionally, document the patient’s and family’s apparent understanding of the process and how it was confirmed during the discussion. Documentation of the disclosure meeting should not be placed in the EMR, EHR, or otherwise in the patient’s medical chart unless legal counsel and the hospital’s medical professional liability insurer direct otherwise. Do not alter the record after the fact, unless to add necessary information about events or discussions that take place following the initial disclosure discussion.
  • Clinical details recorded IN THE CHART by the most knowledgeable member of the healthcare team should include, and be limited to:
    • Objective details of the event, including date, time, and place
    • The patient’s condition immediately before time of the event
    • Medical intervention and patient response
    • Notification of physician
  • Documentation of the conversation held with patient/family should NOT be entered in the chart and should include:
    • Time, date, and place of discussion
    • Names and relationships of those present at the discussion
    • The discussion of the unanticipated outcome
    • Patient reaction and level of understanding exhibited by the patient
    • That any additional information has been shared with the patient, family, and legal representative if appropriate
    • Any offer to be of assistance and the response to it
    • Questions asked by the patient and family and responses to the questions
    • A notation that as further information becomes available, this information will be shared with the patient, family, or legally authorized representative
    • Next steps to be taken by the patient and any providers or the facility staff
    • Any follow-up conversations
  • No derisive comments about other providers or facilities or self-serving entries should be made.

Legal Protection Around Apology

Some states have passed legislation prohibiting providers’ apologies or benevolent gestures from being used as evidence of negligence in malpractice suits under the right circumstances.  Generally, however, admissions of fault are not protected. Expressions of sympathy and concern for the patient are encouraged without an admission of fault. Here are some of the highlights of the laws that may be applicable to disclosures made to patients or their families:

• Maine’s “Communications of Sympathy or Benevolence” statute:
  
  • Protected expressions are not permitted evidence in a civil lawsuit or an arbitration for professional negligence
  • Protected expressions are ones of apology, sympathy, commiseration, condolence, compassion, or a “general sense of benevolence”
  • Such expressions are protected if
    • related to the discomfort, pain, suffering, injury, or death of the patient or family and
    • those sequelae are the result of an “unanticipated outcome” and
    • made by a health care practitioner or provider or by an employee of them and
    • made to “the alleged victim” or their relative or representative
  • Statements of fault are not protected and are admitted in evidence for a jury or arbitrator to hear
    
• Vermont’s “Expression of Regret or Apology” statute:
  
  • Protected expressions are not permitted evidence in a civil lawsuit, arbitration, mediation, or administrative proceeding against the health care provider or facility
  • Protected expressions may not be examined by deposition or otherwise with respect to the expression of regret, apology, or explanation
  • Protected expressions are only oral, not in writing
  • Protected expressions are ones of regret or apology, but good faith explanations of how medical errors occurred might also be protected
  • Such expressions are protected if made within 30 days of when the provider or facility knows or should have known of the consequences of the potential adverse outcome
    
• New Hampshire’s “Evidence of Admissions of Liability” statute:
  
  • Protected expressions are not permitted evidence in a medical injury lawsuit as evidence of an admission of liability
  • Protected expressions are ones of sympathy, compassion, commiseration, or a “general sense of benevolence”
  • Such expressions are protected if
    • relating to the pain, suffering, or death of an individual and
    • made to that individual or the individual’s family
  • Statements of fault, negligence, or culpable conduct are not protected and are admitted in evidence for a jury to hear
    
• Massachusetts’s “Statements or Conduct Expressing Regret, Apology, Condolence by Health Care Provider” statute:
  
  • Protected expressions are not permitted evidence in a claim, complaint, or civil action brought by or on behalf of a patient experiencing an unanticipated outcome in any judicial or administrative proceeding
  • Protected expressions are ones of benevolence, regret, apology, sympathy, commiseration, condolence, compassion, mistake, error, or a general sense of concern
  • Such expressions are protected if
    • made by a health care practitioner or health care provider, facility, or an employee or agent of a health care provider or facility and
    • made to the patient, a relative of the patient, or a representative of the patient and
    • relate to the unanticipated outcome of medical care
  • Protected expressions lose the statute’s protection and are permitted in evidence if
    • the maker of the statement or a defense expert witness
    • when questioned under oath during the litigation about facts and opinions regarding any mistakes or errors that occurred
    • makes a contradictory or inconsistent statement as to material facts or opinions

See the citations for the full Maine, New Hampshire, Vermont, and Massachusetts apology statutes below.

Maintaining the Provider-Patient Relationship

Ongoing rapport following disclosure is key to maintaining the provider-patient relationship. Inattention to a patient’s concerns and expectations can damage this rapport irreparably, so it is important to be responsive to their questions and care needs.

However, avoid direct contact with a patient who leaves your care or is represented by an attorney relating to the adverse event or unanticipated outcome.

Caring for the Provider

Often, providers involved in an adverse event or unanticipated outcome have feelings of shame, guilt, and sadness. Some providers and staff have reported that they find little support within their organizations. When providers or staff are not supported, it creates a culture in which they and others are reluctant to report, disclose, and contribute to solutions.

Efforts have been made in recent years to better support the providers and staff involved in adverse events, unanticipated outcomes, and medical errors. Organizations such as the Agency for Healthcare Research and Quality and the University of Missouri Health Care have resources available to help with developing programs to support providers.

State Apology Statutes

Maine:
https://legislature.maine.gov/statutes/24/title24sec2907-2.html
Vermont:
https://legislature.vermont.gov/statutes/section/12/081/01912
New Hampshire:
https://www.gencourt.state.nh.us/rsa/html/LII/507-E/507-E-mrg.htm
Massachusetts:
https://malegislature.gov/Laws/GeneralLaws/PartIII/TitleII/Chapter233/Section79L

References and Resources:

American Society of Healthcare Risk Management, Monographs: www.ashrm.org

• Disclosure of Unanticipated Events: The Next Step in Better Communication
• Disclosure of Unanticipated Events: Creating an Effective Communication Policy
• Disclosure: What Works Now and What Can Work Even Better