Clinical Ethics in Anesthesiology. A Case-Based Textbook

5. Practice issues

42. Disclosure of medical errors in anesthesiology practice

Karen Souter

The Case

A 45-year-old woman presents for laparoscopic cholecystectomy. She is healthy apart from symptoms related to her cholelithiasis. As is normal practice in this institution, the antibiotics to be administered by the anesthesiologist are hanging on the IV pole on the patient’s stretcher. The anesthesiologist notices the antibiotic that has been sent is cefazolin, despite the fact that the patient’s allergy to cefazolin is clearly documented in the chart. He asks the nurse to replace the cefazolin with an alternative antibiotic. As he is about to take the patient to the operating room, one of his colleagues interrupts him to ask if he will take late call that night. A brief discussion ensues. He is now late bringing the patient into the operating room and the surgeon is making his impatience obvious. The anesthesiologist induces anesthesia and starts the antibiotic infusion.

Fifteen minutes later he notices a rash covering the patient’s body. The airway pressures have increased and the patient is wheezing. The blood pressure falls precipitously. To his dismay he sees that, in his haste to get the patient anesthetized he failed to confirm that the antibiotic had been replaced and he has accidentally administered the cefazolin. He diagnoses acute anaphylaxis and initiates treatment. The patient responds and her condition stabilizes, surgery is abandoned and the patient is admitted to the ICU for further care.

“To err is human; to forgive, divine” Alexander Pope 1688–1744.

A competent anesthesiologist would instantly recognize the classic signs of anaphylaxis. Once diagnosed, prompt treatment of anaphylaxis usually results in a complete recovery.

In contrast to the medical management of this error, disclosure of the error resulting in the anaphylactic reaction is not straightforward; layers of hospital policies, legal precedents, ethical codes and personal biases complicate the correct course of action. A thorough understanding of the issues involved in disclosure of medical errors is important to every anesthesiologist.

Ethical principles involved in disclosure of medical errors

If this incident had happened prior to the modern era, it would be easy to imagine the patient being told that she had experienced a “complication” related to her anesthetic, and perhaps very little else. This reflects the paternalist approach by physicians that dominated medicine until the last half of the twentieth century, and summed up by Oliver Wendell Holmes, the dean of Harvard Medical school from 1847–1853. “The patient has no more right to the truth than he has to all the medicine in the physician’s saddlebag”.1 Many physicians believed it was right to deny the patient the truth for a number of seemingly good reasons.

Modern medical ethics emphasizes four guiding principles; respect for patient autonomy, beneficence, nonmaleficence, and justice. Autonomy refers to the right of an individual to make decisions about one’s life and body without coercion by others. When applied to the disclosure of medical errors, autonomy refers to the patient’s right to possess all the available information about their health necessary to making decisions. In our case, the patient required admission to the intensive care unit, escalation of medical care, and investigation of the anaphylactic reaction. She also needed to have her surgery rescheduled. The patient must understand all the facts related to the case in order to be able to consent to extra treatment. Respect for patient autonomy therefore requires the open and timely disclosure of all the facts, including an admission that the wrong antibiotic was delivered.

The American Medical Association (AMA) Code of Medical Ethics is clear about the ethical duty of physicians to disclose errors:

It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients.… Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care. .….. Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.2

Likewise, the General Medical Council of the UK has stated that doctors should:

…offer an apology and explain fully and promptly to the patient what has happened, and the likely short-term and long-term effects.3

In 2009, the National Health Service of the UK announced a new “Being Open” framework as the best practice guide for healthcare staff concerning communication with patients, their families and their caregivers following harm.4

National policies and standards for disclosure of medical errors

In 1999, The Head of the Clinical Risk Unit at the University College London reported that an estimated 40 000 patients die annually in Britain due to medical errors.5 Shortly thereafter in the US, the Institute of Medicine published a landmark report “To Err is Human” making the startling revelation that medical errors accounted for an estimated 44 000 to 98 000 preventable deaths annually.6 This report heralded a significant re-structuring of US healthcare systems aimed at improving patient safety. In 2001 the Joint Commission for Accreditation of Health Care Organizations (JCAHO) in the US issued the first nationwide disclosure standard that required patients to be informed about all outcomes of care, including “unanticipated outcomes.” Since then, guidelines for disclosure have increasingly been used by institutions as well as pay-for-performance programs to promote safer patient care.

A systems-based approach to medical error

It is apparent that a number of problems within the system may have contributed to the error described in our case. These include the delivery of the wrong antibiotic to the patient’s bedside, the distraction by a colleague, and the failure of the anesthesiologist to identify the drug prior to administration. There is also a small chance that the anaphylactic response was due to another drug administered within the same timeframe as the cefazolin. Without investigation of the error, the flaws in the system or the true nature of the patient’s allergy may not be completely revealed. A common response by patients who are the victims of medical errors is a desire that the same thing doesn’t happen again to someone else. The premise of the policies put in place by the quality and safety organizations is that, by encouraging reporting, a greater openness and understanding of medical errors will develop and measures to prevent them can be determined. Hospitals have much in common with the airline and nuclear power industries which are also complex systems in which individuals are rarely solely responsible for serious errors.

In our case, the anesthesiologist clearly has an ethical duty to disclose the error to the patient. The implementation of patient safety and quality policies reinforces this duty. Disclosure respects the patient’s autonomy to be fully informed about their medical care. From a systems perspective, the disclosure of errors allows healthcare systems to identify and eliminate system errors, thereby improving safety for all patients. The ethical principle of justice requires that patients be treated equally, thus patients are entitled to the truth regardless of the views of their physicians or the policies of the institution in which they receive care.

Barriers to effective error disclosure

Studies show significant discrepancies between what physicians say they would do and what they actually do when it comes to reporting medical errors and disclosing them to patients.7 Patients report both concerns that their doctors have withheld the truth concerning medical errors, and dissatisfaction with the way in which errors are disclosed.8

There are many barriers to effective error disclosure. To begin with, which errors need to be disclosed? When ethical standards and policies are examined closely, they are not as clear as they might be. The AMA code of ethics refers to “significant” events and JCAHO to “unanticipated outcomes.” Neither of these terms is well defined.

Fear of litigation is a major reason why physicians have avoided open error disclosure.9 In the US, JCAHO recognizes that this “wall of silence” attributable to the medical liability system impedes the course of open disclosure and error reporting, and that these conceptions (or in many cases misconceptions) will not easily be solved without re-structuring the legal system.10 Evidence that error disclosure may decrease the incidence of litigation and liability costs is largely unknown or ignored by doctors.11 Physicians in the US greatly overestimate the percentage of adverse events that result in lawsuits. Medical malpractice lawsuits represent a prolonged period of emotional trauma, and perhaps even permanent harm to one’s reputation and livelihood, and physicians are likely to attempt to avoid them.

Advocates of patient safety have called for removal of blame and shame from the discussion of medical errors, recognizing that most medical errors are the result of a systems failure involving multiple events with the physician often being the last “nail in the coffin.” Patients on the other hand often want someone to blame and surveys show that the public want to see doctors punished for errors.12

In our scenario it is clear that a systems error caused the wrong antibiotic to be delivered to the patient and also that the interruption by a colleague distracted the anesthesiologist at a time when he needed full concentration. However, it is the anesthesiologist who must face the patient and her family, apologize and rightly or wrongly be blamed for the error.

The introduction of apology laws in many of the US has helped physicians by providing a safe harbor from admission in court for expressions of sorrow and apologies made after a medical error.12

A lack or perceived lack of institutional support can prevent physicians from embracing full error disclosure. In a well-publicized case, an anesthesiologist was actively discouraged from any contact with his patient after she had suffered an adverse reaction. The institution forbade contact on the grounds that this would increase the risk of litigation. Eventually, the anesthesiologist was able to communicate with his patient and much of the emotional pain, guilt, and misunderstanding on both sides were reconciled.13

Ethical considerations in apologizing and telling the truth

It is difficult for physicians to acknowledge their mistakes when the duty to “first do no harm” (nonmaleficence) is a basic tenant upon which medical training is based. A medical error violates this professional norm. The emotional impact for the physician dealing with the guilt and shame of causing a medical error is considerable and physicians will often avoid seeking help because of this.

When physicians disclose an error, feelings of guilt are often alleviated, and this may call into question the physician’s motives for apologizing. Is the physician apologizing for an error out of concern for telling the truth, or is he motivated to seek forgiveness or absolution from his own feelings of guilt and shame? Berlinger and Wu have used the term “cheap grace” to describe the situation when a physician expects forgiveness for an error which harms a patient without first disclosing, apologizing for and making amends for his mistakes.14 A similar criticism has been leveled at apology laws, where the apology may be made to “make the doctor look good in the eyes of a jury”.12

Placing the patient’s interest foremost and being truthful respects patient autonomy and upholds the ethical principles of beneficence and nonmaleficence. Beneficence results when the physician puts aside his own fear of personal harm and provides the patient with an honest explanation. Such an account helps the patient understand what has happened and allows him or her to engage in further treatment decisions fully informed. In a similar way, the principle of nonmaleficence is upheld when the doctor spares the patient harm, both physically and emotionally, that could result from not knowing about the error. The doctor also spares other patients harm if an erroneous system is identified and corrected as a result of proper error reporting.

In the end, however, the physician must understand and accept that he or she may not receive the patient’s absolution from blame. Some patients and families may never be able to forgive the injury, or want any contact with those responsible for harming them.

Should the physician disclose medical errors that do not cause harm?

In the case of an obvious medical error that has caused harm, disclosure and apology on the part of the physician is the right thing to do, even though physicians may struggle to achieve this. In the case where an error has not harmed a patient the correct course of action is much less clear. Let us consider an alternative case scenario. This time the anesthesiologist notices a rash spreading up the arm, but nothing else happens and by the end of the case the rash has disappeared. What is the correct course of action for the anesthesiologist?

There are ethical arguments both for disclosing this error to the patient and for not disclosing it. These can be approached from a consequence-based perspective, or from a deontological or duty-based perspective.

In the alternative scenario the patient would have no knowledge that she received the wrong antibiotic. In a consequence-based approach, there is little reason for a patient to ask her anesthesiologist “did you give me cefazolin?” and in the absence of this question, the anesthesiologist is not guilty of lying to the patient. Voluntary disclosure of the error by the anesthesiologist could conceivably be harmful if the patient suffers emotionally from knowing that she had been placed at risk. Alternatively, one could argue that the patient may not be truly allergic to cefazolin and this serendipitous event in which she did not suffer a major reaction should trigger re-evaluation of her supposed “allergy.” In this case it would be right to inform the patient and suggest further investigations. Finally, if the event were not disclosed to the patient, she may later notice that she was charged for cefazolin on her medical bill and question this. The discovery that some facts related to her case had been withheld could result in loss of confidence in the healthcare system.

The deontological, or duty-based approach is based on the works of Emmanual Kant. His main thesis was that the moral worth of an act is not related to the outcome, but whether or not it is done from a sense of duty or obligation.15 A duty-based argument would determine that the consequences are irrelevant and the patient should be told the truth regardless of the outcome. In the case of a near miss or an error with no adverse outcomes, the patient still should be informed.

The correct procedure in the case of near misses and errors with no harm is yet to be defined in the policies and practices of institutional risk management departments. Currently, most would investigate these errors to help better understand systems issues, but may not disclose all the information to the patient.

Key points

• Adherence to established ethical principles and the strong arguments in favor of open, transparent medical error disclosure are hindered by physicians’ fears and mistrust of the legal system.

• Raising awareness amongst anesthesiologists of the ethical arguments involved in error disclosure, as well as the provision of strong institutional support and training in error disclosure, will help to improve error disclosure practices and enhance patient safety.

• The correct ethical path for physicians involved in medical errors that do not cause harm and particularly the case where an anesthesiologist delivers the wrong drug without obvious adverse effects can be debated from different ethical stand points. Currently, there is no generalized consensus as to the correct procedure in these cases.

References

1 Oliver Wendell Holmes, addressing the graduating class of Bellevue Hospital Medical College, New York, March 2, 1871.

2 American Medical Association. (1994). Code of Medical Ethics: Opinion 8.12. Council on Ethical and Judicial Affairs. Chicago, IL.

3* General Medical Council, GB. (2006). Good medical practice. London; GMC.

4* Being Open; Communicating with Patients, Their Families, and Carers Following a Patient Safety Incident. National Patient Safety Agency, London UK. November 19, 2009. Accessible on line at:http://www.nrls.npsa.nhs.uk/rsources/?entryid45=65077.

5* Blundering Hospitals ‘Kill 40,000 a year’. The Times, London. August 14, 2004. http://thetimesonline.co.uk/tol/news/uk/article468980ece.

6* Koln, L.T.Corrigan, J.M. and Donaldson, M.S. (1999). To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press.

7* Kaldjian, L.C.Jones, E.W.Wu, B.J.et al. (2007). Disclosing medical errors to patients: attitudes and practices of physicians and trainees. J Gen Intern Med22, 988–96.

8* Gallagher, T.H.Waterman, A.D.Ebers, A.G.et al. (2003). Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA289, 1001–7.

9* Kachalia, A.Shojania, K.G.Hofer, T.P.et al. (2003). Does full disclosure of medical errors affect malpractice liability? The jury is still out. Jt Comm J Qual Saf29, 503–11.

10 Joint Commission on Accreditation of Healthcare Organizations. (2005). Health Care at the Crossroads: Strategies for Improving the Medical Liability System and Preventing Patient Injury.

11* Kraman, S.S. and Hamm, G. (1999). Risk management: extreme honesty may be the best policy. Ann Intern Med131(12), 963–7.

12* Wei, M. (2007). Doctors, apologies, and the law: an analysis and critique of apology laws. J Health Law40(1), 107–9.

13 “Patient and doctor reconcile for the greater good.” (2006). Anesthesia Patients Safety Foundation Newletter, Spring, 21(1),

14* Berlinger, N. and Wu, A.W. (2005). Subtracting insult from injury: addressing cultural expectations in the disclosure of medical error. J Med Ethics31, 106–8.

15* Bernstein, M. and Brown, B. (2004). Doctors’ duty to disclose error: a deontological or Kantian ethical analysis. Can J Neurol Sci, 31, 169–74.

Further reading

Bismark, M.M. (2009). The power of apology. NZ Med J122(1304), 96–106.

Center for Compassion in Health Care. http://www.compassioninhealthcare.org.

Lazare, A. (2004). On Apology. New York: Oxford University Press.

Medical Malpractice: an International Perspective of Tort System Reform. The Hon Justice Michael Kirby AC CMG. http://www.hcourt.gov.au/speeches/kirbyj/kirbyj_med11sep.htm.