Special Issue: Dealing with Adverse Events

Sally T. Trombly, RN, MPH, JD

Despite our efforts, adverse events do occur. Properly dealing with those instances can limit harm, suffering, and conflict as well as prevent future similar occurrences. After an adverse event, support and care must, of course, be rendered to the patient. Less obvious, but of great importance, is communication with the patient and family, including disclosure and attention to the psychological and emotional needs of all involved.

Adverse Events Require Communication and Disclosure

As long as there are humans involved in giving and receiving health care we can expect there will be times when things do not go perfectly. Formalizing the handling of and response to near-misses and actual adverse events has become commonplace in other industries, such as manufacturing and aviation, but only in recent years has the health care sector begun to more broadly apply comparable concepts to the array of services it provides to the public.

New Expectations

In 2001, as part of its accreditation standards, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) instituted a requirement for disclosure of “unanticipated outcomes” targeted at events meeting JCAHO’s criteria for designation as a sentinel event. An institutional policy was required, but there was no guidance about addressing disclosure of near misses, admissions of error or fault, or documenting the discussion. No mention of apology appeared in the requirements at all. What resulted were situations where both patients/families and the care providers involved in disclosure discussions would come away feeling something was missing—patients and families saying, “No one ever said they were sorry this happened,” and care providers concerned that if they said they were sorry it could be construed as an admission of liability.

As the initial efforts around disclosure have evolved, a more open and balanced way of thinking about disclosure has emerged. This framework recognizes and acknowledges that the disclosure process is not a one-time event. It also places more emphasis on fostering trust and collaboration between patient(s) and caregiver(s) during the ongoing process. There are also now a number of states with statutes that protect expressions of sympathy and compassion from introduction into evidence as an admission of liability in a medical malpractice lawsuit and, in some cases, protect statements of fault made in connection with an apology by a health care provider or institution. Other states have taken legislative and/or regulatory steps to address the issue of disclosure of unanticipated outcomes and adverse events to patients. The Medical Care Availability and Reduction of Error Act by Pennsylvania in 2002 requires a hospital, an ambulatory surgical facility, or a birth center to notify a patient (or the patient’s family) of a “serious event” in writing within 7 days. The Act defines a serious event as “an event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient.”1 The medical facility is required to provide written notification within 7 days of the occurrence/discovery of a serious event to the affected patient (or under certain circumstances, to a family member). The Act specifies that the notification does not constitute an acknowledgement or admission of liability.

Communication Factors

Most adverse events are not caused exclusively by a single individual or due solely to the patient’s particular disease processes. The situation that arises is more likely to be one in which there has been an adverse event or a poor outcome that involves multiple caregivers and may or may not involve negligence. Patients and families (as well as the caregivers involved) may experience stress not just around the event or outcome itself, but see it increased by subsequent communications and interactions that are not handled well or do not meet their needs at the point in time.

In such complex situations, multiple factors influence the ability of care providers to communicate effectively and for patients and families to assimilate information exchanged during the disclosure process. These can include inappropriate speculation by care providers unable to step back and deal with their own feelings about the event or who may feel compelled to quickly provide an explanation even though all relevant facts are not yet known. In addition, individual patients and/or family members may not be emotionally ready to listen and fully comprehend, due to feelings of anger or denial over the situation that has arisen. This highlights the importance of recognizing both the readiness and current information needs of the parties participating in the disclosure conversations. In this setting, the existing relationship between the patient/family and the care providers involved faces some of its greatest challenges.

What should go into open and balanced conversations about an adverse event or outcome? Are there ways to meet what may be differing needs of participants on both sides? An obvious first step is to address the patient’s immediate clinical needs, the scope of which will vary depending on the situation. The content of an initial conversation related to the event or outcome may be somewhat limited due to the particular clinical circumstances, but should convey the facts needed to make immediate care decisions. The information should be delivered with sensitivity, keeping the patient’s and family’s best interests in mind, and meeting the patient’s need to know.

When a caregiver (or a member of a caregiver’s family) is the patient and experiences an adverse event, his/her response is comparable to that of patients who are not clinicians.2 So one way for caregivers to foster understanding of the value of empathetic disclosure conversations is to envision themselves as the patient (or family member) and think about what questions they would have in that role, and what they’d want to hear. Things that most patients and families want to have included in the conversations include a sincere apology, reassurance that there will be an opportunity for ongoing dialogue, an appropriate investigation of the event or outcome, and the identification/remediation of problems that contributed to the event or outcome focused toward preventing someone else from experiencing the same situation. In addition, the patient would also be awaiting assurance that everything possible is being done to minimize the effects of the mishap. Depending on the situation, conversations may occur over a period of time as additional information becomes available or previous discussions need to be re-reviewed or clarified.

The Impact of Disclosure Conversations

There continue to be questions as to whether disclosure conversations, if done in a timely and open manner, can help to reduce professional liability risk exposure. So far, data on the effects of timely and open disclosure conversations on professional liability risk exposure have been mostly anecdotal or based on research using scenarios and/or mock trials.3 In addition, a universal difficulty in quantifying the effectiveness of disclosure conversations is related to the variety of professional liability coverage mechanisms present in private practice settings and health care systems in this country and the interaction of those mechanisms with the federal and state legal systems.

Example 1: The Veterans Affairs Medical Center in Lexington, Kentucky. This institution has received favorable publicity for its proactive program of disclosure of adverse events and offers of settlement to patients/families treated within its facilities.3 What has garnered less notice is the fact that in their system, 1) an individual whose disability becomes increased as a result of an adverse event can have his/her existing compensation level raised, 2) individual federal employees (including physicians) are not named as defendants in lawsuits (the federal government is), and 3) for lawsuits that do arise, the government does not face punitive damages. These factors limit the ability to successfully apply this model in private sector health care systems.

Example 2: COPIC Insurance Company insures more than 80% of the privately insured physicians in Colorado. In 2000, COPIC launched its “3Rs Program,” which stands for Recognize, Respond, and Resolve unanticipated medical outcomes.4 Insured physicians enroll prospectively in the program and agree to accept certain responsibilities. These include the responsibility to initiate the 3R program process by reporting the incident to COPIC and being directly involved in the subsequent processes and interactions. The program offers patients compensation for loss of time ($100/day up to $5,000) and reimbursement for out-of-pocket medical expenses (up to $25,000) paid by the patient. Patients retain the right to pursue legal action, but become ineligible to continue program participation if they submit a written demand for compensation, an attorney or the state Board of Medicine becomes involved, or legal action is instituted. Program data through 2004 indicate payments ranging from $95 to $30,000 occurred in 305 of 930 qualifying incidents.4 A recent study based on a series of focus groups with participants recruited from COPICÕs open and closed 3R cases concluded the collaborative process offered benefits for both patients and providers, and helps reinforce the importance of communication in the relationship between patients and their caregivers.5

The Value of Disclosure Conversations

Disclosure and apology, done well, should not increase potential liability. On the other hand, disclosure and apology done in an insensitive manner, based on speculation, or not at all, may ultimately result in deterioration or destruction of trust and the relationship between the patient and caregivers.

According to Dr. Lucian Leape, a noted patient safety researcher, at least 1 trial attorney for plaintiffs has told him “that two-thirds of his clients would go away if doctors and hospitals told them what happened and apologized.” This plaintiff’s attorney also said he puts the physician in a malpractice case on the witness stand near the end of a trial and asks, “When this happened did you tell the patient you were sorry?” If the answer is, “No, I didn’t,” the plaintiff’s attorney says the jurors get dollar signs in their eyes. “So,” he concludes, “It”s smart to say ‘I’m sorry.’ “6

Ms. Trombly is the Executive Director of the Dartmouth-Hitchcock Risk Management Program in Lebanon, NH, and is a member of the APSF Board of Directors.

References

  1. Medical Care Availability and Reduction of Error Act (MCare) of March 20, 2002. P.L. 154, Act 13, Sec. 302 (Pennsylvania). Available at: http://www.mcare.state.pa.us/mclf/lib/mclf/hb1802.pdf. Accessed February 14, 2006.
  2. Closed Claim Abstract: MD Becomes Patient, Error Victim. Resource Risk Management Foundation of the Harvard Medical Institutions, June 2005. Available at: www.rmf.harvard.edu/patientsafety/resource/archive/0506/case.asp. Accessed 2/11/2006.
  3. Kachalia A, Shojania KG, Hofer TP, et al. Does full disclosure of medical errors affect malpractice liability? The jury is still out. Jt Comm J Qual Saf2003;29:503-11.
  4. COPICÕs 3Rs Program Newsletter. COPIC Insurance Company, Denver, CO 2005;2(1). Available at: http://callcopic.com/publications/3rs/vol_2_issue_1_jun_2005.pdf. Accessed February 14, 2006.
  5. Duclos CW, Eichler M, Taylor L, et al. Patient perspectives of patient-provider communication after adverse events.Int J Qual Health Care 2005;17:479-86.
  6. The Power of Apology. Resource, Risk Management Foundation of the Harvard Medical Institutions June 2005. Available at: www.rmf.harvard.edu/ patientsafety/resource/archive/0506/feature1.asp. Accessed February 11, 2006.