Disclosing Medical Error

1. Disclosing Medical Error Ethan Cumbler M.D. Assistant Professor of Medicine Hospitalist Section University of Colorado Hospital 2007

2. To Err Is Human • In our first module we talked about medical errors and their contributors including individual and systems issues. • In our second module we further explored why individual physicians make judgment errors with a focus on cognitive dispositions to respond (heuristic failures). • In this module we will discuss what to do once the error has occurred.

3. We Currently Don’t Disclose Completely • The estimated disclosure rate is approximately 30%-50% across a number of surveys in Europe and America. • In one study of house staff, 50% did not discuss a serious clinical error with medical colleagues, and only 25% disclosed them to the patient or the patient’s family.

4. Why Don’t We Disclose? • Desire to avoid conflict • Desire to avoid shame • Preservation of our self image • Desire not to lose the trust of the patient • Particularly if the event did not result in harm • Fear of increasing chance of litigation • We don’t know how to do it well.

5. What Are the Consequences? • Patients who discover error causing an adverse event later are likely to lose trust. • May be more likely to pursue legal action • Secrecy interferes with the patient-physician bond. • A culture of non-disclosure prevents open discussion of errors, which impairs the ability of the system to improve.

6. What does the evidence show? • Open discussion of events in trauma M+M does not influence litigation. • 98% of patients report desiring disclosure of even minor errors. • 12% of patients report that they would sue for a moderate severity error if the physician informed the patient about the error. • 20% of patients report they would sue if they discovered the moderate severity error from another means. • 36% of parents report that they would be less likely to pursue legal action if an error involving their children was disclosed. • The other 63% said they would still sue. • The Lexington Kentucky VA instituted a disclosure/apology/compensate policy. Afterwards their claims payment rate went from one of the highest in the nation to one of the lowest.

7. Colorado Has One Of The Strongest Legal Protections For Apologies • A 2003 Colorado statute reads, “In any civil action brought by an alleged victim of an unanticipated outcome of medical care….any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence which are made by a health care provider….related to the discomfort, pain, suffering, injury, or death of the alleged victim as the result of the unanticipated outcome of medical care shall be inadmissible as evidence of an admission of liability.”

8. Errors Occur Frequently • Many you never find out about • A large percentage are discovered before the error actually reaches the patient. • The majority of those that do reach the patient do not result in significant harm. • A small fraction are preventable and will result in adverse events. • You need to determine how you will approach disclosure for all forms of error.

9. Would You Disclose? • Would you disclose an error that did not reach the patient and thus did not cause an adverse event? • Would you disclose an error that led to minor harm? • Would you disclose an error that led to a major harm? • Would you disclose an error that led to fatality?

10. CASE EXAMPLE • A 36 year old with DM type I presented with DKA. Once her anion gap had closed, the attending discussed the plan of action with the resident including giving a dose of 70/30 prior to breakfast and turning off the insulin drip 1 hour after the 70/30 is given. • The resident orders the insulin 70/30 IV. • The computer system does not allow 70/30 to be ordered IV, so the nurse orders it SQ to get it out of the pharmacy and then administers it IV. • The patient is held in the ICU another day, and blood sugars remain acceptable.

11. CASE STUDY • Would you tell the patient about the error? • How would you tell her? • How would you assign responsibility during this conversation?

12. Australian Open Disclosure ProjectKey Findings • Patients’ desire to be informed of patient safety issues that have affected them • Recognition of the distress they have experienced • A sincere and compassionate expression of regret • A simple and factual explanation of what occurred • An explanation of what can be done to redress the harm done • Note--there may be desires that patients do not acknowledge such as the desire to see a responsible party suffer.

13. What Are The Components of An Apology? • Acknowledgement of the offense • Explanation (note: this is not the same as excuse) • Expression of remorse, shame, humility • Reparation

14. How do you accomplish this? • Preparation • Setting • Participants • Content • Body Language

15. Preparation • Make sure the facts are known completely before disclosure. • It is appropriate to tell a patient or family that an adverse event is being investigated prior to your full discussion with them. • It is frequently wise to discuss the event and error with another physician. The emotional impact of feeling responsible for a major adverse event can influence your take on the case. • Discuss an medical error leading to major adverse event especially if it involves other individuals with risk management prior to talking to family

16. Setting • The setting should be one that conveys calm. • Participants should be at the same level, preferably sitting. • Avoid interruptions.

17. Participants • Avoid having too many people present. • Avoid finger pointing between participants. • You may want a representative from other disciplines (nursing, pharmacy) if the explanation of the error involves processes with which you are not familiar. • You may want the patient care advocate. • You may want a representative from risk management.

18. Content • One of the goals of disclosure is to be open and avoid the perception by the patient of a cover-up. • This perception can be created by the “pseudo-disclosure” where the adverse event is discussed but the fact that a medical error contributed to the adverse event is avoided. • Avoid becoming defensive. • Keep it simple.

19. Content • Review the events. Make sure all participants are on the same page regarding the facts. • State explicitly that an error occurred contributing to the adverse event. • Explain how the error occurred. • Express personal regret for the adverse event, i.e., empathize. • Take responsibility. If you are not personally responsible, then you can still take responsibility as a representative of the medical system in which the error occurred. • Apologize personally if this is appropriate.

20. Content • Offer concrete actions that will be taken to rectify the situation (you will need risk management to assist with any financial promises). • Discuss how this event will create change in your actions or in the system.

21. Body Language • Patient and physician at the same level • Open body posture (not crossing arms or legs) • Leaning forward • Avoiding expressions of psychomotor agitation (tapping feet). • Unconscious mimicry of body position • Eye contact

22. Why do Apologies Fail • Appearing insincere • Overly vague--“I am sorry for any errors that were made.” • Using passive tense--“Mistakes were made.” • Adding conditions--“If any errors occurred, then I am sorry.” • Unacceptable explanations--“I had to leave the surgery to go to the bank.” • Arrogance--“Even the best doctors make mistakes at times.” • A botched apology may be worse than no apology at all.

23. Case Study • REMOVED FOR PEER REVIEW CONFIDENTIALITY

24. References • Wu AW, Folkman S, McPhee SJ, Lo B. So House Officers Learn From Their Mistakes? JAMA 1991;265:2089-2094 • Gallagher TH, Waterman AD, Garbutt JM, et al. US and Canadian Physicians’ Attitudes and Experiences Regarding Disclosing Errors to Patients. Arch Intern Med 2006;166:1605-1611 • Boyle D, O’Connell D, Platt FW, Albert RK. Disclosing Errors and Adverse Events in the Intensive Care Unit. Crit Care Med 2006;34:1532-1537 • Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and Physicians’ Attitudes Regarding the Disclosure of Medical Errors. JAMA 2003;289:1001-1007 • Gallagher TH, Garbutt JM, Waterman AD et al. Choosing Your Words Carefully: How Physicians Would Disclose Harmful Medical Errors to Patients. Arch Intern Med 2006;166:1585-1593

25. References • Stewart RM, Corneille MG, Johnston J, et al. Transparent and Open Discussion of Errors Does Not Increase Malpractice Risk in Trauma Patients. Ann Surg 2006;243:645-651 • Witman AB, Park DM, Hardin SB. How Do Patients Want Physicians to Handle Mistakes? A Survey of Internal Medicine Patients in an Academic Setting. Arch Intern Med 1996;156:abstract • Mazor KM, Simon SR, Yood RA, et al. Health Plan Members’ Views About Disclosure of Medical Errors. Ann Intern Med 2004;140:409-418 • Gallagher TH, Studdert D, Levinson W. Disclosing Harmful Medical Errors to Patients. NEJM 2007;356:2713-0 • Brazeau C, Disclosing the Truth About a Medical Error. AAFP 1999;60:

26. References • Lazare A. Apology in Medical Practice. JAMA 2006;296:1401-1404 • Malaty W, Crane S. How Might Acknowledging a Medical Error Promote Patient Safety? Journal of Family Practice 55:775-780 • Berlin L. Will Saying “I’m Sorry” Prevent a Malpractice Lawsuit? ARJ 2006;187:10-15