Disclosure of Unanticipated Events

In July 2002, TJC released The Joint Commission Patient Safety Standards, which states, “Patients and, when appropriate, their families are to be informed about the outcomes of care, including unanticipated events.” There is no clear information from TJC or agreement among institutions about what is required to meet this standard. Controversy exists over the types of conditions and the severity of the outcomes that should trigger this requirement for disclosure to the patient or family. Some suggest that it should be managed as part of the sentinel event process required by TJC, encouraging the health care facility to conduct a root cause analysis. Many health care facilities have created policies that determine when disclosure is required based on when the patient is substantially harmed. However, what constitutes substantial harm remains an issue of debate. Harm may be viewed from a patient or family’s subjective view, or it may require a more concrete approach, such as the need for additional medical care or diagnosis of a patient’s injury.

This TJC standard has created much discussion and different views about what information must be shared with patients and their families. The debate is likely to continue and produce more regulations in the future. In Canada, the judiciary has declared that health care providers should disclose any and all substantive risks related to a procedure that any reasonable individual would wish to know to provide informed consent for surgery or anesthesia. Being honest about care is always good policy, but a policy mandating disclosure of unanticipated events can be fraught with legal peril. If an adverse event occurs, the practitioner should seek risk management or legal advice to determine what information should be disclosed and the mechanism by which the information should be conveyed to the family. In many cases, avoiding a misunderstanding is crucial and may determine whether a frivolous lawsuit results.

Managing Adverse Outcomes

An adverse event is an event that occurs during patient care that can cause an undesirable or unanticipated outcome. Adverse outcomes include the following:

Patient injuries are adverse outcomes. A patient’s care plan that is changed and requires an unanticipated escalation of care also is an adverse outcome. These situations may result in two types of discontent for patients and their families: disappointment in the medical outcome and disappointment with the way health care providers discuss the issues.

Preliminary research suggests that families and patients are much more distressed and disappointed when the health care providers who do not present straightforward, honest information or are perceived to be hiding the truth and facts. This has been the message of the Sorry Works movement, which advocates a proactive approach to patients and their families or legal guardians to fully disclose and discuss adverse events such as an untoward incident, therapeutic misadventure, iatrogenic injury, or undesirable outcome.

Communication must start with the medical or surgical team as they try to evaluate the unanticipated outcome, its cause, and its subsequent treatment. The entire team must fully comprehend the facts and come to a mutual understanding of the sequence and timing of the occurrence. Disclosures should be made after information has been gathered and analyzed and practitioners are comfortable with their position. Health care providers and risk management personnel should be consistently involved in the investigation and communication with the patient and family. Patients and their families desire and deserve a discussion of what transpired, an apology (e.g., Sorry Works program) that the unanticipated outcome occurred, and assurances that there will be ongoing dialogue to clarify the events and the future for the patient and family. Families also want reassurance that the event will not happen to other patients and that something good may come out of this experience through system improvements.

However, communication is often very difficult after such an event. Guilt, speculation based on incomplete information, and the need to blame something or someone can interfere with the investigative process and with communication with the patient and family.

In some centers, there is direct communication with the patient and family concerning an apology and settlement if it is determined there was an error by the hospital or the medical team. There is considerable support for apologizing for the unanticipated event, regardless of whether an error precipitated it. This process does not imply guilt, and most states have passed legislation to protect apologies from being used in litigation. However, a statement of fact that posits the cause of harm is not protected from discovery in a legal action. Rather, most legislation is intended to protect statements of empathy, such as, “I’m sorry you have experienced this unanticipated outcome.” Other types of statements, such as, “I’m sorry the nurse or doctor gave too much of the medication,” are not protected from discovery in a lawsuit.

In some cases, the cause of the unanticipated event cannot be ascertained in a timely manner to a reasonable degree of certainty (i.e., the legal standard that an expert must meet). When this occurs, a candid discussion of the situation should take place with the family members, and they should be informed that further investigation is anticipated, the results of which will be communicated to them. Families often seek legal assistance because an event occurred that resulted in questions that they think were not adequately addressed by the hospital or members of the medical team (e.g., an event occurred but no one followed up with the family to explain in lay terms what had transpired).

Who Should Anesthetize Children?

Occasionally, when a child who has a significant medical problem presents for elective surgery at a location that does not routinely provide care for a child with a complex medical problem, an adverse outcome may result. The resulting lawsuit may be difficult to defend. The nature of the anesthesia services that are appropriate to perform in a particular location and the qualifications of those who provide the services must be addressed in the policies and procedures of the facility to avoid such an event, although guidelines in this area typically are arbitrary. Children in certain age groups with certain medical conditions and in certain types of emergencies should be designated for referral to a center that is more appropriately equipped or staffed to deliver expert care.

Issues of Consent and Assent

Consent is a process that provides patients and families with sufficient information to allow them to make an informed decision about whether to proceed. The anesthesiologist must provide sufficient information in terms that are understandable by adults with a grade 5 or equivalent education. In most instances, the patient must be an adult (18 years of age or older) to consent to a procedure. However, in some states, minors are allowed to make decisions independently, without the participation of a parent or guardian. In some circumstances, the court has the authority to override the parent’s rights based on the best interests of the patient. An example is providing lifesaving blood transfusions for children of parents who are Jehovah’s Witnesses. Knowledge of these special provisions for minor consent in the state’s laws is important. Virginia addressed the issue of pediatric assent and adult neglect in 2007 (VA code §63.2-100 et seq.). Assent may be given when a 14-year-old with a life-threatening condition or elective surgical issue is sufficiently mature to agree to the proposed treatment (see later for a complete definition). Dissent is when the child refuses. A judge threatened to remove a 14-year-old boy from his parents because they refused chemotherapy for lymphoma and instead trusted in prayer and herbal remedies.¹¹ These discussions and decisions are influenced by the severity of the issues and whether the procedure is elective or necessary to treat a life-threatening problem.

A common difficulty that arises with consent for minors is identifying the adult who is legally responsible to provide consent. State law governs who makes health care decisions for minors, and these laws vary from state to state. As an example, when the parents of a child are divorced, the custodial parent is most often the health care decision maker. However, this designation may vary based on the parents’ custody agreement and according to state law. Reviewing the custody agreement is not feasible, and most often, the arbiter must rely on what a parent says. If questions or concerns remain regarding the appropriate decision maker, a facility administrator, risk manager, or legal advisor should be consulted. Lack of consent from the appropriate decision maker is the same as no consent, which can lead to liability.

The issue of assent deserves special consideration. Assent is defined as agreeing to something after thoughtful consideration. Children may not be able to assent to a procedure because they are unqualified to have thoughtful consideration. At what age and under what circumstances the minor’s wishes should be followed because they mature enough to engage in thoughtful consideration is unclear. Unless there is a specific state law that grants decision-making authority to a minor in the current circumstances, the issue of a minor’s assent is an ethical one, rather than a legal matter. Knowing whether the issue is ethical or legal is important in minimizing liability risks. If an older minor patient does not want a surgical procedure, a discussion should be held with the legally responsible adult, and any differences should be resolved before surgery. Even if the parents or guardians wish to proceed and the child does not, it is usually best to delay surgery and have a focused discussion to ensure that the wishes and thoughts of the minor patient have been considered and respected. Knowledge of state law and a low threshold for seeking consultation with the hospital lawyer are indicated in this situation.¹¹

Communication with Patients and Families

The preoperative visit is an opportunity to develop rapport with the child and the family. It is important to establish a shared relationship, because children and families who feel they have communicated well preoperatively with their health care provider usually do not sue if there is an adverse outcome. Unfortunately, the time for preoperative evaluation and discussion is greatly limited. The physician should review the record before interviewing the child to focus the discussion and be aware of any underlying issues so that they can be directly addressed during the interview session. One technique for developing rapid communication with the child and the family is to recognize that they have major concerns about the surgical procedure, such as pain management, severe anxiety, nausea and vomiting, and safety issues. The anesthesiologist should clarify how he or she will address these issues preemptively so that the child and family understand that they have an advocate who can ensure safety and comfort throughout surgery (see also Chapter 4). The next step is to determine whether the child and family have specific concerns or suggestions. If the child has had multiple operations, the anesthesiologist should inquire whether any anesthetic technique has proved superior to others and incorporate it when possible. If the lines of communication have been opened before an unanticipated outcome occurs, it will be easier to maintain rapport, which reduces the likelihood of a lawsuit being filed.

Unanticipated Event Resulting in Patient Injury or Death

When a medical error in providing anesthesia results in injury or death, an anesthesia caregiver’s worst nightmare has come true. One example of an unanticipated event is a perioperative allergic reaction such as latex anaphylaxis.¹² This event may be avoided by a careful preoperative history, and anticipation and preparation for this possibility can aid treatment. Little has been done to develop an algorithm for management of an adverse outcome that results in injury or death. An algorithm published by the Anesthesia Patient Safety Foundation emphasizes the need for an incident manager, who is the person who takes charge of the administrative aspects of the situation while the anesthesia caregivers continue to manage the patient’s problems.¹³

Step 1 in this algorithm is taking care of the patient. Step 2 is making plans for dealing with the family, which can be done with the help of the surgical team, the anesthesia team, and/or the risk management team. Most anesthesia caregivers have an enormous emotional jolt of depression and guilt over the bad outcome because the American system of teaching through negative reinforcement suggests that they must have done something wrong. This likely response needs to be recognized by the anesthesia caregiver, so that when the issues are discussed with the family, the caregiver can avoid his or her own emotions taking over and instead focus on known facts while offering appropriate empathy to the family. Full disclosure (previously discussed) remains a critical issue, along with complete and accurate charting and discussion of the child’s care with other key providers to ensure that there is a mutual understanding of what transpired and that the documentation is consistent.¹⁴ The family will understandably be very emotional and angry. A note should be entered into the child’s chart providing a summary of these family discussions.