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

3. 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

4. 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.

5. 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.

6. 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.

7. 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.”

8. 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

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

10. Incidence of M.E Report of American medical institute (1999): M.E
Causes about – 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( ): each year about preventable deaths are caused by M.E occur in American hospital

11. 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.

12. 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.

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

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

15. 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%)

16. 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.

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

18. 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, ….)

19. 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

20. 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

21. 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.

22. 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.

23. 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

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

25. 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?

26. 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

27. 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

28. 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

29. 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

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

31. 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

32. 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”

33. 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

34. 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.

35. 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.

36. Thank you for your attention