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2.1.4 The Missed Result

Philip C. H�bert, MD, PhD, FCFPC

Educational Objectives

  1. To review current standards for interdisciplinary management of patient results
  2. To suggest best management for disclosure of lapses in patient care

Case

A hospital-based obstetrician-gynecologist does a Pap smear on a 48-year-old patient as part of a "well woman check." Shortly after doing the Pap smear and before the report on it came back, the gynecologist leaves the country for an extended period to work overseas. When he returns 12 months later, he sees the patient again for her annual visit in his private office and is surprised to discover that she has an advanced form of cervical cancer. He realizes that last year's Pap report is not in her file. Calling the lab, he is told, to his great dismay, that the smear showed evidence of pre-cancerous cells. Having no replacement for him when he had left a year ago, the hospital had closed the clinic in which he had worked. Unfortunately, no arrangements were made to handle his reports. As a consequence, the Pap smear report for the patient was unseen by anyone, and she was not told about her medical condition nor did she receive treatment for it.

Questions

  1. What ought the clinician to do or say, if anything, to the patient?
  2. How can a clinician reduce the risk of lawsuits in such a situation?
  3. When should a clinician disclose error?
  4. How should a clinician disclose error?

Discussion

Q1. What ought the clinician to do or say, if anything, to the patient?

As humans, no matter how good we are as clinicians, we will make mistakes, sometimes with grievous consequences. For example, a common error is the "missed result." Clinicians may say that such mistakes - resulting in omissions of appropriate timely treatment - happen because they are "too busy" to follow up on all the tests that they order. Sometimes, they may simply forget to follow up on a test report, being distracted by other responsibilities, both professional and personal. The problem is one with individual and systemic professional aspects to it.

Individual and Systemic Issues

Systemic Failure Masquerading as Individual Fault

A key feature of this case is how much responsibility for the "missed result" is to be attributed to the clinician. He may have felt that he had "dropped the ball." Maybe he did, but the fault cannot rest with him alone.

System Organization

When different health care professionals are involved in the care of a patient, it is all too easy for the patient's care to fall between the cracks and for no one person to be responsible. In modern health care, where multiple specialties and professions are almost always involved in the care of a patient and where patients may receive care in various venues, the failure to provide coordinated and comprehensive leadership can have serious repercussions for the patient. Clearly, this situation has a systemic component - communication and information exchange - that, barring superhuman efforts, individual clinicians cannot overcome alone.

Serious and widespread deficiencies in care may be more properly considered as institutional hazards to safe care that can be beyond the capacity of individual clinicians to correct. Obvious deficiencies in the system, however, may call for more urgent corrective action on the part of clinicians.

Individual Responsibility

For example, an individual clinician's responsibility for patient welfare does not end if he or she claims to be only indirectly involved in the care of a patient. If ancillary professionals have some information that bears on the patient's well-being, there is some duty to see that this information is received and acted upon. For example, when significantly new and unexpected findings are seen on an X-ray, there may be liability for radiologists who do not ensure that the findings are acted upon. A radiologist's role, for example, does not end with issuing a timely and accurate report, an editorial in Lancet, relying on a recent policy from the UK's Royal College of Radiologists, indicated

Where there is an unexpected finding which may affect patient management or where the severity of the condition is greater than expected, it is the responsibility of the radiologist to communicate this information to the clinical team either by direct discussion or other means.1

If this is so, why would it not be so for other professions or specialties as well, such as pathologists (who detect cancerous cells in a specimen) or physiotherapists (who detect a weak leg in a person still driving)? The interdisciplinary coordination expectations regarding health care professionals generally, insofar as each provides information essential to the comprehensive assessment of patients, are growing. To meet these expectations, the following recommendation for radiologists2 could apply to any health care professional. He or she

  • must coordinate his or her efforts with those of other health care professionals involved in the care of the patient,
  • must be sensitive to the capacity of the health care system in which he or she works to communicate to a patient and/or the treating team unusual, hazardous findings, and
  • may have a duty to communicate directly with the patient if he or she is unable to contact the most responsible clinician in a timely way - especially if the system he or she is part of is deficient.

Just how far individual responsibility for communication and accurate reporting goes is unclear at this time. Let's just say it is an "evolving duty." It is one that is likely to become more onerous to clinicians as state-of-the-art information technologies make reporting and responding to investigations more reliable and rapid.

Q2. How can a clinician reduce the risk of lawsuits in such a situation?

When the outcome of care is suboptimal, patients or families may be as upset by how an incident is handled as they are by the ill event itself. "Facilitative" communication styles - open-ended questions, leaving time for patients to voice their concerns - used by health professionals can be protective against suits and complaints, no matter what the patient outcomes. Perceived secretiveness, failure to respond promptly, failure to be open and available to patients and families, an inability to admit error and accept some measure of accountability, and failure to exhibit sincere empathy with the patient and family are all attitudes and behaviours that encourage suspicion of the health care professional's trustworthiness and commitment to truthfulness. These suspicions in turn lead to corrosive worry and undermine the possibility of a therapeutic relationship.

By contrast, honesty can reduce the desire for a punitive "sting" directed against erring clinicians. Kraman et al. reported on the experience in an American Veteran's Administration hospital that routinely informs patients and their families of any error and then offers them help in filing legal claims for recompense.3 This proactive policy of error disclosure did lead to a net increase in the number of claims made against the hospital, but many more were local, out-of-court settlements. As a result, this hospital had the eighth lowest total monetary payouts of 36 comparable Veteran's Administration hospitals.

A 2004 study suggested that full disclosure of error reduces, but will not eliminate, a clinician's malpractice risk.4 In this study, legal advice was more likely to be sought by patients or their families in the United States if an error was not disclosed and if it had a life-threatening outcome for the patient.

While error disclosure may be no guarantee against suits and complaints, such disclosure has other uses. Clinicians experience great shame when faced with a preventable harmful event in medicine with which they have been involved.a,5 Clinicians typically set high standards of perfection for themselves and, perhaps, fear being censured by their peers. Secrecy around medical error ends up being counterproductive because it impedes learning and can leave the clinician who participated in the poor outcome with a never-ending negative emotional burden of guilt and shame.6 Case reports by clinicians remind us of the tremendous psychological strain that "healers" undergo when they appear to harm the patients they serve.7 Clinicians need to be supported because they, too, suffer when patients are harmed.8 Disclosure of the untoward event can be therapeutic for a clinician and prevent the destructive effects of duplicity on one's self-esteem as a health care professional.


a��"Shame is so devastating because it goes right to the core of a person's identity, making them feel exposed, inferior, degraded; it leads to avoidance, silence."5

Q3. When should a clinician disclose error?
  • The greater the impact or harm an adverse event has or may have upon a patient, the greater is the obligation to disclose the event to the patient and/or the family.
  • By corollary, "non-significant events" do not require disclosure. However, just what "significant" means may depend on individual or subjective factors that need to be taken into account by clinicians when deciding whether they ought to disclose an unanticipated outcome to the patient.
  • When in doubt, it is better for clinicians and institutions to err on the side of disclosure than non-disclosure.

As a general rule, acknowledgement and discussion of the unexpected event should be undertaken by a trusted clinician known to the patient/family. It should take place as soon as possible after it has been identified and when the patient is stable and able to understand and appreciate the information. Patients deserve information that a "reasonable person" would want to know. As one lawyer has astutely written, if patients are owed information about what a procedure or investigation might show before it is done, then they have a right to information about what transpired after the procedure took place.9(p. 170-172) Ethically, patients are owed information by the principles of autonomy (the respect due to them as persons), of beneficence (for the purpose of informed choice) and of justice (to seek restitution or recompense where appropriate).10 There are now provincial and regulatory statutes mandating the disclosure of error and adverse events to patients by health care providers.11

Q4. How should a clinician disclose error?
  • Establishing a rapport with the patient is the first step.12 Be empathetic. For instance, you might say "I am sorry to see that you are still feeling so tired." Don't beat around the bush, and don't wait for the patient to ask. For example, if you were the gynecologist in the case described, you could say "I have something difficult to tell you: the abnormalities were also there the last time we did a Pap smear on you."
  • Once rapport has been established, provide information and offer something like this: "Would it be helpful for me to explain what I think happened ... ?"
  • Avoid defensiveness.
  • Provide a narrative account.
  • Remember, it is not helpful to lay blame on others or yourself.
  • Don't speculate: if you don't know, find out. For example, say "Here's what I know now ... "
  • Empathize with/normalize the patient's feelings. Use reflective listening. Try saying "I know this must be hard for you ... "
  • Apologize for the event and be accountable for your part in its occurrence, its satisfactory management and prevention.

The following language should be avoided when discussing "error":

  • "I dropped the ball..."
  • "I sure made a mess out of things today."
  • "Yes, I know it is not your fault ... it is all my own."
  • "I made a mistake, and now you will have to have surgery."
  • "The events are entirely my own fault ..."

All such language may be self-implicating and makes a rush judgment about what is likely a complex event. Any attribution of individual responsibility ought to await the considered reflection of a "root cause analysis."13 Not all mistakes in medicine are negligent, only those ones that a "reasonably competent" doctor would not make.b

Apology acts in many provinces should make empathetic responses by clinicians (e.g., "This must be very difficult for you. I wish things had turned out differently.") less legally risky because they would not be admissions of liability and cannot be used in a court of law against the practitioner (the footnote below refers to the proposed Ontario Apology Act).c

Further Discussion of Case

The gynecologist must be honest with the patient about the missed lab report and what the abnormal result and the delay in dealing with it likely meant. A lawsuit might result, but, quite frankly, this should be the furthest thing from his mind. His mind should be turned to the question "How can I ensure this patient gets the best care possible without further delays?" It is doubly bad to compound the original mistake by attempting to conceal it. If the patient is not told and finds out later, this might result in anger over a perceived cover-up.

A case akin to this one did come to trial.14 The first trial judge was tough. The "standard of care" for following up on an abnormal test result as in this case, he opined, does not involve "medical skill or expertise." Thus, this oversight could not be a case of "error of judgment...". Having an appropriate system in place fell within the ambit of [the gynecologist's] personal professional responsibility." The judge found no direct hospital liability, ruling that the failure was all the physician's.

A higher Appeals Court thought that this standard was "too high" in requiring the doctor to "ensure" such a system was in place. Instead, the standard should be "a duty upon the physician to see to it that there is a reasonably effective 'follow-up' system in place" as well as "a responsibility on hospitals to see to it that adequate procedures are in place to 'ensure' (but not guarantee) patient safety." "Where a patient in a hospital is treated by more than one specialty, the hospital owes a duty to ensure that proper coordination occurs and that the treatment program it offers operates as a unified and cohesive whole." The court found liability to be shared by the gynecologist and the hospital.


b��"We must not condemn as negligence that which is only a misadventure." This quotation from Lord Denning is quoted in Reference 9 (p. 212).

c��By a 2009 amendment to the Ontario Evidence Act, statements of apology for harmful acts cannot be used against the individual involved. In this Act, "apology" means "an expression of sympathy or regret, a statement that one is sorry or any other words or actions indicating contrition or commiseration, whether or not the words or actions admit or imply an admission of fault in connection with the matter to which the words or actions relate." The proposed act, which will almost certainly be passed in 2009 and is similar to existent provincial legislation elsewhere, goes on to state, "an apology made by or on behalf of a person in connection with any matter (a) does not constitute an express or implied admission of fault or liability by the person in connection with that matter, (b) does not constitute [a confirmation of a cause of action or acknowledgment of a claim] in relation to that matter ... etc."

Conclusion

Lapses in patient care may arise out of failures in interdisciplinary care. To prevent such lapses requires greater attention to multidisciplinary and systems management of patient data and results. Where lapses do occur, appropriate disclosure practices can minimize medico-legal proceedings.

References

  1. Garvey CJ, Connolly S. Radiology reporting - where does the radiologist's duty end? Lancet 2006 Feb. 4; 367: 443-445.
  2. Berlin L. Using an automated coding and review process to communicate critical radiologic findings: one way to skin a cat. American Journal of Roentgenology 2005; 185: 840-843.
  3. Kraman S, Hamm G. Risk management: extreme honesty may be the best policy. Annals of Internal Medicine 1999; 131: 963-967.
  4. Mazor KM, Simon SR, Gurwitz JH. Communicating with patients about medical errors: a review of the literature. Archives of Internal Medicine 2004; 164: 1690-1697.
  5. Davidoff F. Shame: the elephant in the room. BMJ 2002; 324: 623-624.
  6. Hilfiker D. Facing our mistakes. New England Journal of Medicine 1984; 310: 118-122.
  7. McMurray J. Caring for Mr. Gray. Journal of General Internal Medicine 2000; 15: 144-146.
  8. Wu A. Medical error: the second victim. BMJ 2000; 320: 726-727.
  9. Picard E, Robertson G. Legal liability of doctors and hospitals in Canada. 3rd ed. Toronto: Carswell Thomson Canada Ltd.; 1996.
  10. Hébert PC. Doing right: a practical guide to ethics for physicians and medical trainees. 2nd ed. Toronto: Oxford University Press; 2009: 177-181.
  11. Canadian Patient Safety Institute. Canadian disclosure guidelines. Ottawa; 2008. Available from: www.patientsafetyinstitute.ca
  12. Gallagher TH, Denham CR, Leape LL, Amori G, Levinson W. Disclosing unanticipated outcomes to patients: the art and practice. Journal of Patient Safety 2007; 3: 158-165.
  13. Davies JM, Hébert PC, Hoffman C. The Canadian Patient Safety Dictionary. Ottawa: Royal College of Physicians and Surgeons of Canada; 2003.
  14. Braun v. Vaughan, Manitoba Court of Appeal [2000] M.J. No. 63.