Disclosing Medical ErrorDisclosing Medical Error

Ethan Cumbler M.D.Assistant Professor of Medicine

Hospitalist SectionUniversity of Colorado Hospital

2007

To Err Is HumanTo Err Is Human

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

We Currently Don’t We Currently Don’t Disclose CompletelyDisclose Completely

The estimated disclosure rate is The estimated disclosure rate is approximately 30%-50% across a number approximately 30%-50% across a number of surveys in Europe and America.of surveys in Europe and America.

In one study of house staff, 50% did not In one study of house staff, 50% did not discuss a serious clinical error with discuss a serious clinical error with medical colleagues, and only 25% medical colleagues, and only 25% disclosed them to the patient or the disclosed them to the patient or the patient’s family.patient’s family.

Why Don’t We Disclose?Why Don’t We Disclose?

Desire to avoid conflictDesire to avoid conflict

Desire to avoid shameDesire to avoid shame

Preservation of our self imagePreservation of our self image

Desire not to lose the trust of the patientDesire not to lose the trust of the patient– Particularly if the event did not result in Particularly if the event did not result in

harmharm

Fear of increasing chance of litigationFear of increasing chance of litigation

We don’t know how to do it well.We don’t know how to do it well.

What Are the Consequences?What Are the Consequences?

Patients who discover error causing an Patients who discover error causing an adverse event later are likely to lose trust.adverse event later are likely to lose trust.

May be more likely to pursue legal actionMay be more likely to pursue legal action

Secrecy interferes with the patient-Secrecy interferes with the patient-physician bond.physician bond.

A culture of non-disclosure prevents open A culture of non-disclosure prevents open discussion of errors, which impairs the discussion of errors, which impairs the ability of the system to improve.ability of the system to improve.

What does the evidence show?What does the evidence show?

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

Colorado Has One Of The Strongest Colorado Has One Of The Strongest Legal Protections For ApologiesLegal Protections For Apologies

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

Errors Occur FrequentlyErrors Occur FrequentlyMany you never find out aboutMany you never find out about

A large percentage are discovered before A large percentage are discovered before the error actually reaches the patient.the error actually reaches the patient.

The majority of those that do reach the The majority of those that do reach the patient do not result in significant harm.patient do not result in significant harm.

A small fraction are preventable and will A small fraction are preventable and will result in adverse events. result in adverse events.

You need to determine how you will You need to determine how you will approach disclosure for all forms of error.approach disclosure for all forms of error.

Would You Disclose?Would You Disclose?

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

CASE EXAMPLECASE EXAMPLE

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

CASE STUDYCASE STUDY

Would you tell the patient about the error?Would you tell the patient about the error?

How would you tell her?How would you tell her?

How would you assign responsibility How would you assign responsibility during this conversation?during this conversation?

Australian Open Disclosure ProjectAustralian Open Disclosure ProjectKey FindingsKey Findings

Patients’ desire to be informed of patient safety issues Patients’ desire to be informed of patient safety issues that have affected themthat have affected themRecognition of the distress they have experiencedRecognition of the distress they have experiencedA sincere and compassionate expression of regretA sincere and compassionate expression of regretA simple and factual explanation of what occurredA simple and factual explanation of what occurredAn explanation of what can be done to redress the harm An explanation of what can be done to redress the harm donedoneNote--there may be desires that patients do not Note--there may be desires that patients do not acknowledge such as the desire to see a responsible acknowledge such as the desire to see a responsible party suffer.party suffer.

What Are The Components What Are The Components of An Apology?of An Apology?

Acknowledgement of the offenseAcknowledgement of the offense

Explanation (note: this is not the same as Explanation (note: this is not the same as excuse)excuse)

Expression of remorse, shame, humilityExpression of remorse, shame, humility

ReparationReparation

How do you accomplish this?How do you accomplish this?

PreparationPreparation

SettingSetting

ParticipantsParticipants

ContentContent

Body LanguageBody Language

PreparationPreparation

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

SettingSetting

The setting should be one that conveys The setting should be one that conveys calm.calm.

Participants should be at the same level, Participants should be at the same level, preferably sitting.preferably sitting.

Avoid interruptions.Avoid interruptions.

ParticipantsParticipants

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

ContentContent

One of the goals of disclosure is to be open and One of the goals of disclosure is to be open and avoid the perception by the patient of a cover-avoid the perception by the patient of a cover-up.up.

This perception can be created by the “pseudo-This perception can be created by the “pseudo-disclosure” where the adverse event is disclosure” where the adverse event is discussed but the fact that a medical error discussed but the fact that a medical error contributed to the adverse event is avoided.contributed to the adverse event is avoided.

Avoid becoming defensive.Avoid becoming defensive.

Keep it simple.Keep it simple.

ContentContent

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

ContentContent

Offer concrete actions that will be taken to Offer concrete actions that will be taken to rectify the situation (you will need risk rectify the situation (you will need risk management to assist with any financial management to assist with any financial promises).promises).

Discuss how this event will create change Discuss how this event will create change in your actions or in the system.in your actions or in the system.

Body LanguageBody Language

Patient and physician at the same levelPatient and physician at the same level

Open body posture (not crossing arms or Open body posture (not crossing arms or legs)legs)

Leaning forwardLeaning forward

Avoiding expressions of psychomotor Avoiding expressions of psychomotor agitation (tapping feet).agitation (tapping feet).

Unconscious mimicry of body positionUnconscious mimicry of body position

Eye contactEye contact

Why do Apologies FailWhy do Apologies Fail

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

Case StudyCase Study

REMOVED FOR PEER REVIEW REMOVED FOR PEER REVIEW CONFIDENTIALITYCONFIDENTIALITY

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From Their Mistakes? JAMA 1991;265:2089-2094From Their Mistakes? JAMA 1991;265:2089-20942.2. Gallagher TH, Waterman AD, Garbutt JM, et al. US and Canadian Gallagher TH, Waterman AD, Garbutt JM, et al. US and Canadian

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4.4. Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and Physicians’ Attitudes Regarding the Disclosure of Patients’ and Physicians’ Attitudes Regarding the Disclosure of Medical Errors. JAMA 2003;289:1001-1007Medical Errors. JAMA 2003;289:1001-1007

5.5. Gallagher TH, Garbutt JM, Waterman AD et al. Choosing Your Gallagher TH, Garbutt JM, Waterman AD et al. Choosing Your Words Carefully: How Physicians Would Disclose Harmful Words Carefully: How Physicians Would Disclose Harmful Medical Errors to Patients. Arch Intern Med 2006;166:1585-1593Medical Errors to Patients. Arch Intern Med 2006;166:1585-1593

ReferencesReferences6.6. Stewart RM, Corneille MG, Johnston J, et al. Transparent and Stewart RM, Corneille MG, Johnston J, et al. Transparent and

Open Discussion of Errors Does Not Increase Malpractice Risk in Open Discussion of Errors Does Not Increase Malpractice Risk in Trauma Patients. Ann Surg 2006;243:645-651Trauma Patients. Ann Surg 2006;243:645-651

7.7. Witman AB, Park DM, Hardin SB. How Do Patients Want Witman AB, Park DM, Hardin SB. How Do Patients Want Physicians to Handle Mistakes? A Survey of Internal Medicine Physicians to Handle Mistakes? A Survey of Internal Medicine Patients in an Academic Setting. Arch Intern Med Patients in an Academic Setting. Arch Intern Med 1996;156:abstract1996;156:abstract

8.8. Mazor KM, Simon SR, Yood RA, et al. Health Plan Members’ Mazor KM, Simon SR, Yood RA, et al. Health Plan Members’ Views About Disclosure of Medical Errors. Ann Intern Med Views About Disclosure of Medical Errors. Ann Intern Med 2004;140:409-4182004;140:409-418

9.9. Gallagher TH, Studdert D, Levinson W. Disclosing Harmful Gallagher TH, Studdert D, Levinson W. Disclosing Harmful Medical Errors to Patients. NEJM 2007;356:2713-0Medical Errors to Patients. NEJM 2007;356:2713-0

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ReferencesReferences

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12.12. Malaty W, Crane S. How Might Acknowledging a Medical Error Malaty W, Crane S. How Might Acknowledging a Medical Error Promote Patient Safety? Journal of Family Practice 55:775-780Promote Patient Safety? Journal of Family Practice 55:775-780

13.13. Berlin L. Will Saying “I’m Sorry” Prevent a Malpractice Lawsuit? Berlin L. Will Saying “I’m Sorry” Prevent a Malpractice Lawsuit? ARJ 2006;187:10-15ARJ 2006;187:10-15