In 1999, the Institute of Medicine issued the report To Err is Human, which claimed that medical injury is a major cause of preventable injury in the US. This was followed in 2001 by Crossing the Quality Chasm, which detailed six aims for the redesign of health care: care must be safe, effective, patient centered, timely, efficient, and equitable. The report emphasized the duty to place patients’ interests first. These reports resulted in a systematic focus on reducing preventable injury to patients and eliminating “never events.” Part of the strategy was the standardization of processes built around best practices. One such example is the preoperative briefing in which patient identity, team identity, operation to be performed, and surgical side and site are all confirmed. The standardization of this best practice is intended to eliminate surgical errors such as wrong side, wrong site, wrong operation, wrong patient.
Despite significant advances in patient safety and overall health care quality, adverse events do occur. These events may be traumatic for the patient and the entire treatment team. There can be many different emotions, and health care providers often feel like they are not well equipped in how to address the patient, family, and other members of the team. Some hospitals and health care organizations have groups of people, such as administrators and peer support individuals, who come together and assist after an adverse event occurs. However, many times support is unavailable, particularly if the event happens at night, on the weekends, or in hospitals or health care organizations without a team who can assist.
Regardless of the resources available, it is important to know how to respond if you are involved in an adverse event. This is where ProNobis Health can help. Responding to an adverse event requires the art and the science of medicine. We want to take the available research on best practices and combine them with human values to guide you through responding to an adverse event. The process we propose can also be applied to hospital or health care organization teams charged with responding to adverse events. We want to give you guidance to help you address an adverse event that may involve you.
An adverse event occurs when harm comes to a patient from medical care rather from the disease process itself. As a result of the adverse event, patients may experience a disability that can prolonged hospitalization. An adverse event may or may not result from a medical error. An example of an adverse event not caused by a medical error is a hospital-acquired infection, such as a urinary tract infection that a patient may develop postoperatively while he or she had an indwelling urinary catheter. An example of an adverse event that resulted from a medical error is a miscalculated dose of heparin that led to bleeding.
Some adverse events are considered preventable, such as the examples above. All medical errors are preventable adverse events. Also, some preventable adverse events are system errors in which a device or piece of equipment does not function as it should. Unpreventable adverse events occur when a complication could not have been reasonably prevented given the current state of knowledge. Unpreventable adverse events are not due to an error or system failure. They can be common, well-known hazards of high-risk therapy, or rare but known risks of ordinary treatments. These are generally understood and accepted by patients in order to receive the benefit of treatment. For example, a patient who presents with a perforated sigmoid diverticulum who goes on to develop an abscess despite antibiotics and optimal management has an unpreventable adverse event.
Some adverse events are called ameliorable in that the severity of the event could have been lessened had other actions or procedures been followed. An example would be a patient who falls in the hospital but does not injure herself. After the initial fall, no measures are put into place to reduce the risk of a second fall. The patient falls again, breaks her hip, and has an intracranial hemorrhage. The major injury from the second fall could have been reduced had measures been implemented after the first fall, and the adverse event is considered ameliorable.
Near misses are instances in which a medical error would have occurred had the act not been intercepted or interrupted. An example is a patient brought in for a RIGHT inguinal hernia repair, but whose LEFT groin is prepped for surgery. Before making an incision, the surgeon double-checks the site and side and realizes that the wrong side was prepped. No incision was made and no harm occurred, though it could have, had the surgeon not double-checked the side and site. That is a near miss.
A medical error is failure of a planned action to be completed as intended or use of the wrong plan to achieve a goal. Medical errors can be errors of commission, in which something was done which should not have been done, or omission in which something was not done but should have been. An example of a medical error of commission is a patient being given medication that was intended for another patient. An example of a medical error of omission is not diagnosing and treating a septic patient within a reasonable period of time.
It has been said that one of the greatest barriers to error prevention in health care is a culture that punishes people who make mistakes. This involves, in part, recognizing that adverse events are often part of a system failure rather than the fault of an individual. A just culture abides by a model of shared accountability, in which the organization is accountable for its systems, and the staff has accountability for reporting errors and opportunities for system improvement. By creating a just culture in which individuals are not punished when an adverse event occurs, people are encouraged to speak up either when they are involved in the event or when they observe one. This represents a significant shift in culture. Focusing on systems rather than individuals, a culture shift can occur that promotes speaking up about adverse events in order to improve processes and prevent future adverse events.
Responding to Adverse Events
Despite robust systems, a just culture, and highly trained staff, adverse events in health care will occur. It is important to have a process for responding to an adverse outcome. What we at ProNobis Health propose is an ethically sound, patient-centered model that values transparency, cause analysis, care for the caregiver, and organizational learning.
- Take care of the patient. If harm has occurred, alert the team and initiate measures to treat any harm that has occurred, and minimize further harm. Explain to the patient and the family what is being done in terms of treatment and why. At this point, the root cause of the harm may not be established. It can be confusing to everyone to conjecture or form subjective impressions about what caused the adverse event. The focus should be on explaining what steps are being taken to stabilize the patient and the options for treating any injury.
- Communicate about the event.
- Who? In disclosing an adverse event, it is important to have a person of trust, likely the attending physician, present as well as the person with the most information about the event. This may or may not be the same person. In addition, it is important to have someone skilled at mediation and trained in communication techniques such as active listening. It can be difficult for medical personnel to communicate clearly about the event as well as the plan to care for any injury that has resulted, and at the same time be effective mediators. In order to offer support, at least two people from the medical team should be present. It will also be important to establish who, or what group, will be responsible for future communication with the patient and family.
- When? Communicate with the patient and the family as soon as possible after the adverse event is identified and the patient’s needs have been met. Ask the patient and the family if they are ready to talk. Even if all the details are still being investigated, share whatever information is known. Let the patient and family know that they will be informed as more information emerges. Early acknowledgement has been identified as one of the critical elements in maintaining trust. Patients are more likely to consider litigation if they perceive that the adverse event was not disclosed early or if there is a sense that attempts have been made to cover up the event. In a 1994 article in the Lancet about patients pursuing medical negligence claims, 21% reported explanations within a few days, and 37% indicated that they never received an explanation.
- What? Communicate the facts as they are understood at the time. In the same Lancet article, 91% of those surveyed who sought legal remedy cited a desire for more information as their main motivation. Let the patient and family know that how the adverse event happened and why it happened are also being investigated, and that the information will be shared with them once it emerges. Let them know that there will be ongoing conversations. Speculating about the how and why at this point may give the patient and family inaccurate information that could lead to mistrust in the future. Assure the patient that there will be careful analysis and review of the event. Also communicate steps that are being taken immediately to mitigate the effects of the adverse event. A key point to communicate is that through investigation and analysis, systematic measures will be put into place to prevent the event from happening again.
- How? Information should be conveyed honestly and in a manner that expresses empathy and respect for the patient and the family. Patients want honest and compassionate disclosure. Often physicians and treatment teams have many emotions of their own when an adverse event occurs involving a patient, and this can affect the content and quality of discussions with the patient and family. This is where a mediator or communication consultant can be useful to help facilitate the conversation. Ineffective communication that is defensive or becomes adversarial with the patient or family is not productive. Additionally, patients want an admission of responsibility after an adverse event, as well as a sincere apology. A sincere apology will often help preserve trust between the patient, family, and physician. Some physicians are hesitant to offer an apology because of fear that it can be used as an admission of guilt or fault. A sincere apology of sympathy, such as “I am sorry that this happened to you” is an appropriate expression of empathy after an adverse event. Failure to admit error and express regret adds insult to injury. Patients and their families often have complex emotions after an adverse event that complicate the vulnerability of illness. The purpose of accepting responsibility and offering an apology is to restore trust and help rebuild the relationship.
- Report the event to appropriate parties. Once the adverse event is identified, it is important to contact your Risk Management and/or Med-Legal Department. There may be a team at your facility that can help you talk with the family and facilitate communication. There may be specific reporting requirements. If there was a system error, particularly if a device or equipment malfunctioned, it is important to sequester the device. Depending on the event, a peer review or quality assurance process may need to be followed. As well, it is important to document adverse events in the medical chart. Record the facts, response, plan, and communication with the family. Avoid speculation and blame, maintaining a neutral tone.
- Follow-up and closure. Unless the patient and family specifically request a different physician, work to maintain the relationship with the patient and family, even if it is uncomfortable or awkward. Work also to restore trust and repair the relationship. Convey new information as it emerges, making sure that both the family and any other stakeholders are kept updated. An ombudsman or mediator may be very helpful. Inform the patient of the measures that have been implemented to prevent the event from happening in the future. Listen to and address any new areas of concern that might emerge. Continuing to engage with the patient and family, if at all possible, will lead to better feelings for them as well as for you.
The Second Victim
An adverse event or medical error can be traumatic for the physician as well as the treatment team. There can be many emotions and the physician and team can be the second victims of the event. Disclosure, discussion, and ongoing relationship with the patient and family can help with healing after the event. However, the emotional distress after an adverse event can be significant, particularly if it is left unaddressed. Guilt, shame, and self-doubt, if not dealt with, can lead to depression, burnout, and posttraumatic stress disorder (PTSD). Scott, Hirschinger, and Cox in their article called “The natural history of recovery for the healthcare provider ‘second victim’ after adverse patient events” describe six stages of recovery for second victims after adverse events:
- Stage 1: Chaos and accident response
- Stage 2: Intrusive reflections
- Stage 3: Restoring personal integrity
- Stage 4: Enduring the inquisition
- Stage 5: Obtaining emotional first aid
- Stage 6: Moving on
The first three stages are associated with realizing the event. When the event is realized, there is an initial focus on caring for the patient while facts are being gathered and involved parties notified. With so many things going on at once, there may be chaos. Also, while trying to care for the patient, the physician may be distracted with his or her own reflection and emotion, and it may be difficult to think clearly. Flashbacks of the event may occur and be accompanied by feelings of inadequacy or guilt. Physicians may feel like no one can relate to the experience of being part of an adverse event. That can be isolating. There can be concerns about reputation and career. Getting support from a colleague, friend, or family member who will listen can help restore personal integrity.
During Stage 4 (enduring the inquisition), the physician has to recount the events often to hospital administrators or med-legal teams. There can be anxiety about litigation, judgment, or career.
In Stage 5 (obtaining emotional first aid), the physician identifies someone with whom the experience and associated emotions can be processed. For many, it can be difficult to find out where to go for professional support. Hospital wellness committees can often help with identifying support and assistance.
The sixth and last stage (moving on) can entail dropping out, surviving, or thriving. Although colleagues, family members, and friends usually encourage moving on after an adverse event, some clinicians find it difficult to put the event behind them and either leave their role or change their practice location. Other physicians continue to shoulder memories of the event and experience complicated emotions. They hang on to the experience and perform at the expected level, getting through by surviving. Physicians who are able to make some good come from the event fare the best and are described as thriving. Often this means implementing some practice or system improvement after the event.
After an adverse event occurs, it is clear that the greatest healing for both the family and for the second victims takes place if something is learned from the event that leads to a positive change in systems or practice that prevents the event from happening in the future. Patients, families, and physicians all seem to be positively invested in having some benefit come from an adverse event. Organizations that adopt a just culture may focus on what can be learned and implemented into their systems to raise awareness and increase patient safety. Organizations that also care for the second victims of adverse outcomes show dedication to the well-being of their staff. Truly good organizations will be concerned not only about their interests, but also those of the patients, families, and physicians.
Massachusetts Coalition for the Prevention of Medical Errors. When things go wrong: responding to adverse events. A consensus statement of the Harvard Hospitals. Burlington (MA): MCPME; 2006. Available at: http://www.macoalition.org/documents/respondingToAdverseEvents.pdf. Retrieved July 26, 2016.
Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994;343:1609–13. [PubMed]
Scott SD, Hirschinger LE, Cox KR, McCoig M, Brandt J, Hall LW. The natural history of recovery for the healthcare provider “second victim” after adverse patient events. Qual Saf Health Care 2009;18:325–30. [PubMed] [Full Text]