Ethical encounter with errors of laboratory and colleagues Nazafarin Ghasemzadeh Medical Ethics and History of Medicine Research Center Tehran University of Medical Sciences

Objectives Definition of medical error Reviewing the incidence of error Ethical encounter with error of colleagues and laboratory The necessity of error disclosure Barriers of error disclosure Learning an effective method of disclosing medical error to patients

Case A patient’s breast biopsy was confused with someone else’s sample by the histopathologist the patient had undergone an unnecessary mastectomy. believing her to be at serious risk of premature death The mistake was subsequently suspected by a consultant oncologist who then contacted the consultant histopathologist and asked him to review the slides. He did so and found that they showed normal tissue without any evidence of malignancy. The patient’s GP was informed of this and, after discussion, it was decided that the whole situation should be explained to the patient at the hospital by the surgeon who had operated her, together with two nurses to provide support. Telling patients that they have undergone unnecessary distress and a superfluous operation is clearly difficult. patient said that “it was easier to accept the mastectomy when I thought I had cancer because I believed that it was necessary to save my life and I actually felt worse once I knew that it has all been a mistake and unnecessary.

To Err Is Human Therefore, the occurrence of error in medicine and health care services is inevitable. However errors are preventable & their occurrence can be reduced.

Unexpected medical Complication Unexpected Complication: Complication associated with medical practice which can't be anticipated. Adverse event: an injury caused by medical management rather than the patient’s underlying disease; = harm, injury, complication. Medical Error: Unexpected medical events which are preventable. Negligence or professional misconduct: Negative consequences which are caused by intentional or irresponsible practice of medical staff.

Definition of M.E There are various definitions for M.E American medical institute: the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim “a commission or an omission which has the potential to harm the patient & that would have been judged wrong by skilled and knowledgeable peers at the time it occurred, independent of whether there were any negative consequences.”

Errors and Adverse Events Medical Error Non-Preventable AE Negligent AE Potential AE Near Misses Schematic of definitions Not all adverse event are a medical error and many medical errors do not result in harm thankfully Adverse Events (complications) 8

Medical Errors & Adverse Events Non-preventable Medical Errors AE Near Miss Preventable AE

Incidence of M.E Report of American medical institute (1999): M.E Causes about 44000 – 98000 deaths annually in American hospitals causes serious injury to more than one million patients is the 8th cause of death in American hospitals And costs 29 billion dollars Frequency of deaths caused by M.E is higher than death caused by motor vehicle accidents (43458), breast cancer  (42297), or AIDS (16516) Findings of the study(2000-2004): each year about 83000 preventable deaths are caused by M.E occur in American hospital

National American medical institute From every 500 hospitalized patients one is killed because of M.E v.s the possibility of being killed in airplane accidents in one in every 8 million flights. M.E causes 37.6 billion dollars of cost for American health system, 17 billion dollars of which is caused by preventable M.E.

In Canadian hospitals In every 1000 admission 7.3% unexpected medical events occur – 36.9% of which is preventable. Among preventable events 9% leads to patient death.

Australia 16% of patients experience unexpected medical events- half of which is preventable

IRAN In our country there is no statistics or information on the rate of occurrence of M.E

Types of M.E Diagnostic error Treatment errors One of the health care centers which have a significant role in the occurrence of error is medical diagnostic laboratories. (10%-15%)

Laboratory errors which include errors prior to testing, during the test, and after testing are mainly related to human and instrument errors and system design flaws and they can lead to diagnostic and treatment errors and consequently cause emotional, physical and financial damage to the patients.

Common Causes of M.E Ignorance Inexperience Faulty judgment Hesitation Fatigue Job overload Breaks in concentration Faulty communication Failure to monitor closely System flaws

Complexity of medical knowledge- probabilistic science Uncertainty of clinical prognosis Time limitation in decision- making Need for decision- making in spite of uncertain &inadequate knowledge Tension causing factors Multiplicity of duties Specific characteristics of each patient Individual characteristics of physician (e.g. inexperience, ….)

Professional commitment in occurrence of error Commitment to quality of service providing. Reduction in occurrence of errors (error reporting system& assessment of error management committee) Commitment to responsibility: Compensation (treatment, professional liability insurance) Commitment to honesty: Error disclosure

Error disclosure Respect for autonomy The right to be informed about the results of medical practice Increasing patient trust Informed consent for treatment of harm caused by M.E The right to receive compensation

Occurrence of M.E is not necessarily unethical however not disclosing M.E is considered unethical. Not disclosing information is considered as deception & can reduce trust to medical community. It also considers nondisclosure of error as threatening professionalism and potential risk for patients. Being informed by a source other than the responsible physician.

Ethical management of Lab error based on principles of autonomy, beneficence, nonmaleficence and justice disclosure of error to patient and health system is considered as one of absolute rights of patients and as a requirement to trust medical profession in community. Besides it considers error disclosure as a measure in prevention and decrease of future error . Creating a culture supportive of error reporting is the starting point in reducing future medical errors. Since errors can be expected, systems must be designed to prevent and absorb them.

Barriers of error disclosure uncertain if “event is an error” has “No useful purpose , point” increased patients’ pain and suffering decreased patients’ confidence in MD & system patients will avoid future care difficult to admit , confess “no one taught us how” Expectations: Medical profession should be infallible , perfect

Fear Loss of reputation, status Limiting professional advancement Loss of authority Litigation ( legal action ) Uncertainty: What do the patients want?

The Essentials of Disclosure Why disclose? What types of events should be disclosed? What should be said? Who should disclose? To whom ? When and where should the disclosure take place? And how should it be done?

Why Patient Has Right to Know about the Condition and Make Health Care Decisions Improves Doctor/Patient Relationship Rebuilds Trust Quality of Care Professional Code of Ethics Standards on Patient Safety and Error Reduction May Be Required by Hospital Staff, By-Laws, Medical Group Policies and Procedures, Health Plans, and Health Care Organizations

Who Health Care Provider Involved in the Unanticipated Outcome Provider With Responsibility for Ongoing Care Person With Ability to Answer Questions Persons Involved in Disclosure Discussion May Need Assistance in Preparing, Coordinating or Conducting Discussion, Depending Upon: · Communication Skills · Rapport with Patient and Family · Language Barriers

What Acknowledge that the event occurred Give the facts, in order, simply Take responsibility and apologize Commit to finding out why Explain what impact the event will have on the patient now and in the future Describe steps being taken to mitigate the effects of the injury Describe steps being taken to prevent a recurrence

When As soon as practicable after immediate Health Care Needs Addressed Consider patient’s physical and emotional readiness Ideally within 24 hours after the event is recognized Make sure the proper people are present Ongoing communication may be required as more information is available Follow up may be required Patient’s permission needed to discuss care with family

Where Consider privacy and health needs In a quiet and private area Have water and tissues

To whom and which error M.E resulting in no injury Patients do not understand if physician do not disclose Patients understand if physician do not disclose M.E resulting in trivial and treatable injury M.E resulting in severe and incurable injury

How Express Empathy Communicate Only “Known Facts” Avoid Speculation and Blame Solicit and Respond to Patient’s/Family’s Feelings and Questions Respond to Patient’s Complaints Respond to Patient’s Questions About Remedies and Refer Settlement Demands Verify Patient’s/Family’s Understanding of Outcome and Prognosis Plan for Follow-up Care and More Discussions and Communicate the Plan Maintain “open body language”

Practical approach to disclosure of error to patients When error occurs notify your medical insurer. Seek assistance from those who can help you in error disclosure. Take the lead in disclosure. Don't wait for them to ask. Describe the event using non-technical language. Address all questions &concerns of the patient. Express regret and also apologize. Ensure the patient that you will do your best to compensate for the error. Plan for patient care, compensation and prevention of the recurrence of error &also inform the patient about it. Offer to meet patient's family. Document all discussions & disclosure in medical record. Be prepared for patient's strong emotional expression. Take responsibility for the consequences of your error but don’t blame your self. Systematic approach

Ethical encounter with colleague’s error Identification of the error Discussion with the person who commits the error: educating the prior physician presents an opportunity to improve the quality of care received by other patients that should not be overlooked. Could say “I believe I have discovered an error in your diagnosis of a patient that I would want to know about if it were my error.” Disclosure of error to patient and health system respecting the colleague, keeping patient’s trust, and patient’s confidentiality.

Finally to encourage physicians to report error to the error management and patient safety committees by winning physicians’ trust and supporting them. This will enable health system to develop a database of medical errors in the country and to employ them in training health professionals and also use them in error prevention plans to improve health care quality and patient safety.

Thank you for your attention