Ever since we set up our first guidelines on responding to serious incidents in the early 1990’s (see our July 24, 2007 Patient Safety Tip of the Week “Serious Incident Response Checklist”) we have always included a section for notifying the patient and/or family that errors had occurred in their care. The patient safety movement has adopted that approach and much has been written about the role of disclosure and apology after medical errors. Yet we continue to see hospitals struggle with “how do we do it?” even once they have bought into the basic concept. Fortunately, there is a wealth of resources available to help healthcare organizations learn how to do it.
Some of the best resources are the Canadian Patient Safety Institute Disclosure Guidelines (which we’ll call “the Canadian guidelines”), When Things Go Wrong. Responding to Adverse Events. A Consensus Statement of the Harvard Hospitals (which we’ll refer to as “the Harvard guidelines”), and the American College of Physician Executives toolkit (which we’ll call “the ACPE toolkit”).
Why do we recommend disclosure and apology? Simply put: it’s the right thing to do. It is a moral imperative and it is the only way to maintain the physician-patient relationship and keep the patient at the center of the healthcare system. The fear that disclosure increases the risk of malpractice suits and settlements also was probably erroneous and it is becoming increasingly clear that failure to disclose is a much bigger risk when it comes to malpractice risk.
When to invoke the disclosure and apology process is usually a matter of common sense but most guidelines recommend each organization have its own policy that includes a threshold for disclosure. Most of the serious adverse events requiring disclosure are obvious but you may have to decide individually when to disclose things like near misses.
Following are some of the key issues you need to address in the disclosure and apology process. The Canadian guideline also has a nice checklist and algorithm to help you remember key things to do at each stage of the disclosure process.
Our recommendation is that you let the patient/family know about the incident as soon as possible. Obviously, you need to know enough about the event or incident to be able to discuss it with them. But sometimes you may not have all the details early on (for example, you may not yet have done your root cause analysis). It is okay to tell them that a serious incident did take place and that your investigation will be taking place within a few days and that you will keep them posted regularly on the status of that investigation. Let them know that you are doing this to help ensure that similar events will be prevented in the future. You need to show honesty, contrition, and empathy in order to build a trusting relationhip with that patient or family. If you wait to disclose that an incident occurred, the patient or family is likely to find out about it in other ways, your credibility will suffer and you will lose the opportunity to develop a rapport with them.
Who should notify the patient/family?
Generally this should be the person with direct responsibility for care of that patient, most often the attending physician. However, there are times when someone who has developed a special rapport with the patient/family may be more appropriate. And there are times when the medical director (or CMO or VPMA) is the most appropriate person. In most cases, since adverse outcomes are usually the result of a cascade of errors rather than the result of actions of a single individual, the attending physician should play a major role in the notification even regardless of whether he/she was part of that cascade of errors. The Harvard guidelines stress that the attending physician should assume responsibility even if he/she did not make the mistake(s) that caused the injury. Both the physician and the hospital need to take responsibility and accountability and show remorse to the patient/family. That is a critical part of the apology process and lets the patient/family understand that you are both human and truly sorry for what happened to the patient and not just sorry for what it might do to your reputation. If the involved physician is not present when the incident is disclosed, culpability or insensitivity or both are often implied by the patient/family. The Harvard guidelines also mentions “joint apologies” where the person who made a significant error may join with the attending physician at the time of disclosure and apology.
If the care team is different after the incident (eg. the patient has been transferred to the ICU), it may be wise to have attending physicians from both the new and old teams present.
If the attending physician is not comfortable or very inexperienced in dealing with patients/families under such circumstances, either an experienced person (eg. medical director or CMO) should accompany that physician or some coaching or other preparation should take place.
Both the Canadian and Harvard guidelines strongly suggest organizational training programs to prepare physicians for dealing with disclosure. Housestaff should also participate in any such training offered.
Where should the initial meeting take place?
Obviously, the meeting needs to take place in a quiet, comfortable setting where interruptions will not occur. The patient and family need to have the opportunity to ask questions and not feel intimidated. The Harvard Guidelines suggest a single patient room as a good setting or a private office for ambulatory communications. They caution against summoning the patient/family to the executive suite and note you should never use double rooms, open spaces of any sort, waiting rooms or hallways for such conversations.
What should be disclosed?
As above, you should disclose the facts as they become known. Sometimes early after an error and adverse outcome, the causes and root causes are not yet known. Be careful about speculating about those causes. Rumors can often run rampant after an adverse event and do not help either the injured patient, the family or the healthcare organization. If you tell a patient or family what you think might be the cause and that turns out not to be the case, your credibility may be damaged. So disclose what you know to be fact and emphasize to the patient/family that you will share with them all the other facts as they become known. And then follow up on that promise!
While lawyers will tell you never to use terms or phrases like “mistake” or “error”or “we screwed up”, you do need to convey to the patient/family that you are both honest and sorry for what happened so sometimes you need to use language they understand. The Harvard guideline suggests ways like:
The Canadian Guideline specifically excludes the word “error”, citing our well-known concept that most cases of adverse patient outcomes are due to system issues. Keep in mind that, while we understand the systems nature of errors that give rise to adverse patient outcomes, patients and families and the public don’t have the same level of understanding of those complex issues. Therefore, be very careful about “blaming the system” because patients/families may feel you are trying to divert responsibility. They are looking for someone to take individual responsibility. Both the Harvard and Canadian guidelines have excellent examples of some of the words used in effective communication with patients/families after an adverse event.
At the time of disclosure and apology, the attending physicians (and hospital administration or other leaders) need to make it clear to the patient family what will be done to deal with the clinical effects of the adverse event. It is especially important that the patient/family have an ongoing trust after an event since many of the same healthcare workers will still be involved in the care of the patient.
Very important is the manner in which disclosure and apology occur. You need to use language and terminology that the patient/family clearly understands, also taking into account cultural and language considerations. Make sure you listen carefully and allow adequate time for patients/families to ask questions and seek clarification. And never forget that body language may convey much more than verbal language.
In our November 2007 What’s New in the Patient Safety World column “Snippets” we discussed an article “Guilty, Afraid, and Alone — Struggling with Medical Error“ by Tom Delbanco and Sigall Bell in the October 25, 2007 issue of the New England Journal of Medicine that provides insights gleaned from interviews with patients and families that had been affected by medical error. Some of their findings were quite surprising. Patients and their families often feared further harm, even retribution, if they express their feelings too forcefully. Family members often have a profound sense of guilt, that they didn’t watch carefully enough and were not able to prevent their loved one from suffering in an incident. That is why it is extremely important to do the disclosure in a manner that makes the patient and family feel comfortable speaking up and allowing both adequate time to ask questions and avoiding any semblance of intimidation.
Following up is critical and presents an opportunity to develop rapport and trust that may have been impossible at the first meeting. The main goal of the follow meetings is to keep the patient/family apprised of what the investigation has revealed and what actions are being implemented to prevent recurrences. The patient/family should be told at the initial meeting when they can expect a followup. If there are delays in that followup, the patient/family should be informed and an apology for the delay is appropriate.
As the findings of the incident investigation and root cause analysis become available, the patient/family should be made aware of the findings and the actions that will be taken to prevent similar incidents in the future. Followup does not end on discharge from the hospital. Communications should continue after discharge or transfer. All the while, patients should be supported in medical, social and psychological spheres. The Harvard guideline has good sections on such support and an excellent section on financial support for patients harmed in adverse events.
You should document when and where the meetings took place, who was there, what was said, the questions and issues raised, responses given, and what arrangements were made for followup (who, when, what).
The Canadian guideline also includes sections on disclosure of events involving children, those with impaired cognition or impaired capacity, those with language/cultural diversity, and those in research settings. There is also a section addressing disclosure involving multiple patients, a topic we have previously discussed (see our June 16, 2009 Patient Safety Tip of the Week “Disclosing Errors That Affect Multiple Patients”).
Pennsylvania has a law that requires hospitals to provide to the patient (or appropriate family member or other designee) a written notification of a serious event involving that patient within 7 days. A recent article (Cherry 2010) provides some step-by-step practical advice to help hospitals accomplish that. One very wise piece of advice they offer is not to have more hospital representatives at that meeting than the patient and family have. That is to help avoid creating an atmosphere that the patient/family might feel is intimidating. Also, this meeting is a time to show humililty and let them know that you have human feelings and its very difficult to convey those traits with “opposing teams” sitting across from each other at a board room table. So keep it small. Their recommendation is that the hospital have the physician responsible for the patient’s care, the chief medical officer (CMO or VPMA), the risk manager, and perhaps the Chief of Service of the involved department. Our own recommendation is to leave out the “risk manager”. You may include your head of quality improvement or patient safety director, especially if you feel they likely be serving as the key liaison for future meetings with the patient and family. Important: no lawyers (on either side)! Another important recommendation is active listening. We have seen far too many such meetings where the hospital staff dominate the conversation. This is an opportunity for the patient and family to speak, express their concerns, and ask questions. They should feel they are encouraged to ask questions and expect that those questions will be answered honestly. They stress the value of apology, not only in humanizing the staff, but also in de-escalating tensions, creating a more level playing field, and leading to a more trusting relationship.
The Other Victims
While the patient is obviously the focus of the disclosure and apology process, the involved caregiver(s) are also victims in a sense and need support. Sadness, sense of failure, guilt, isolation, and loss of self-esteem may be overwhelming to some caregivers. Organizations need to recognize this and ensure support is available to caregivers involved in such incidents. We actually include this as an item in our Serious Incident Response Checklist. Such support may include various types of counseling, appropriate temporary adjustment of responsibilities (being careful to ensure that such adjustment is not mistaken as punitive or a sign of loss of confidence in the individual), and the general support that is a feature of the culture of safety. Participation in the root cause analysis and development of strategies to prevent future incidents may also have therapeutic value for the caregiver.
The article mentioned above “Guilty, Afraid, and Alone — Struggling with Medical Error“ (Delbanco 2007) provides excellent insight into how those emotions in clinicians may further compound the emotions the patient or family is going through. They note that physicians experience guilt after a medical error but also have fear after an incident – fear about their reputation, job, license, career. That fear, often compounded by imprudent advice from attorneys and administrators, may lead to them becoming isolated and being perceived as cold and impersonal by the very patients and families looking for empathy and support.
Even caregivers not directly involved in the incident may experience similar emotions. We often do debriefing sessions after serious incidents even when no errors occurred. Staff generally feel much better after such sessions.
Susan Carr recently summarized findings at a forum on support for clinicians involved in adverse events, identifying numerous barriers that lead to underutilization of such support services.
Emotions Are Not Static
We have noticed that both patients/families and involved caregivers often go through stages after a serious incident in which a patient is injured that are very similar to the stages made famous by Kubler-Ross in “On Death and Dying”. Those stages include denial/isolation, anger, bargaining, depression, acceptance. You need to recognize that these emotional stages are part of a normal evolution and that anger may later convert a very positive emotion. Most in the patient safety movement know the story of the unfortunate death of Josie King at Johns Hopkins and how the anger initially shown by her parents later gave way to a profound understanding of the complex issues in patient safety and the emergence of her mother, Sorrel King, as one of the leading patient safety advocates in the world.
More than 30 states now have “apology laws” where statements made during apology to patients are not to be used in litigation. Most of these laws are too new for us to tell whether they will have a significant positive impact on the frequency of sincere apology.
Update: See also our November 2010 What’s New in the Patient Safety World Column “”
Massachusetts Coalition for the Prevention of Medical Errors. When Things Go Wrong. Responding to Adverse Events. A Consensus Statement of the Harvard Hospitals. 2006
Canadian Patient Safety Institute. Canadian Disclosure Guidelines. May 2008
The American College of Physician Executives. Disclosure and Apology Toolkit.
Delbanco T, Bell SK. Guilty, Afraid, and Alone — Struggling with Medical Error. NEJM 2007; 357:1682-1683
Cherry RA, Marcus L, Dorn B. Reporting Adverse Events to Patients: A Step-by-Step Approach. Physician Exec. 2010; 36: 4-9 May–June 2010
The Josie King Foundation
Carr, Susan. Disclosure and Apology. What’s Missing? Advancing Programs that Support Clinicians. Patient Safety and Quality Healthcare. March/April 2010