Originally published March 2015
Unanticipated clinical outcomes and patient safety incidents in hospital-based pediatric care settings are frequent1 and can be broadly categorized as either medical or surgical. The majority of related CMPA medico-legal cases closed between 2008 and 2012 concerned care in emergency departments. In this group, inadequate assessments were the most frequent issue. In surgical cases, intra-operative injuries were most frequent.
Unanticipated outcomes in the emergency department
Although the reasons were often multifactorial, the failure to appreciate the severity of a child’s condition was the final common pathway in many cases. Deficiencies in the phases of diagnosis commonly led to premature discharges from emergency departments (EDs) and included failures to:
read the previous medical records (including nursing notes)
obtain collateral history from the parents, especially related to teenagers
perform a complete physical examination (including taking, evaluating and re-evaluating vital signs)
perform an appropriate test or procedure, or review test results
correctly interpret diagnostic tests
communicate effectively with healthcare team members
observe and monitor a child as appropriate
refer to a specialist as appropriate
reassess a patient before discharge
admit a patient to hospital as appropriate
Often, the diagnosis of diseases is delayed because an illness has not yet evolved significantly enough to allow it to be recognized or to at least prompt the physician to investigate further. One of the greatest difficulties ED physicians face is identifying children with dangerous medical conditions early in the course of their illnesses and distinguishing these children from the far greater number with less serious conditions. Accordingly, allegations of misdiagnosis or delayed diagnosis are frequent. While the care provided early in the course of illness could have been appropriate, it may, in the absence of careful documentation, appear negligent in hindsight.
Case example: Deficient assessment
A 13-year-old boy presents with abdominal pain. The pediatrician’s entry in the medical record describes a constant squeezing periumbilical pain with nausea and vomiting. Note is made of the absence of urinary symptoms, of a normal bowel movement the day prior, and of the absence of sick contacts or travel. The physical examination documents mild periumbilical tenderness, a soft abdomen and no peritoneal signs, negative Murphy’s sign, no tenderness at McBurney’s point, no costovertebral angle tenderness, and normal bowel sounds. The record of the history and the physical examination do not mention inquiry about, or an examination of, the boy’s testicles. Gastroenteritis is diagnosed.
Following improvement after a trial of PO fluids, the boy is discharged with instructions to return if his pain becomes constant or moves to the right lower quadrant. The patient returns 36 hours later with an 11-hour history of right testicular pain. Testicular torsion is diagnosed and a necrotic testicle is surgically removed.
A legal action is initiated alleging that the physician’s failure to evaluate the boy’s testicles at the time of the initial visit resulted in the delayed diagnosis of torsion and thus the loss of the testicle. At discovery, the pediatrician argues the torsion was not present at the time of the initial visit. He states, as per his usual practice, he had likely performed a brief genitourinary exam, but had simply not documented it. The parents and child deny the performance of a genital examination. A peer expert states all young males should have a genitourinary exam when presenting with abdominal pain. A settlement is paid by the CMPA on behalf of the member pediatrician.
Despite the pediatrician’s claim to the contrary in the case above, the medical record reinforced the family’s assertion that a testicular examination had not been done. The record supported that a differential diagnosis of appendicitis and pyelonephritis had been considered, but did not confirm that testicular torsion had been considered.
The documentation of a well-organized and logical process of care, including an adequate history and pertinent physical examination aimed at ruling out important differential diagnoses, is important in demonstrating a child was treated according to the relevant standard of care. Depending on the case, documenting a child is fully immunized or other reassuring aspects of the presentation such as the findings of moist mucous membranes or a normal level of activity, and pertinent negatives such as a normal fontanelle, or a normal genital examination, can be as important as documenting abnormal findings. Doing so speaks to the thoroughness of an assessment, helps peer experts assess the quality of care provided, and may be crucial in establishing the presence, absence, or even likeliness of a condition at the time of the assessment. Documenting a differential diagnosis will help demonstrate an erroneous diagnosis was the result of an exercise of judgment and not of negligent care.
Cases involving intraoperative injuries are often deemed by peer experts to be non-negligent because they result from recognized inherent risks of the procedure. However, parents of children harmed during surgery often allege not having been informed of those possibilities during the consent process, resulting in the claim that they would not have agreed to the proposed surgery had they been properly informed of those risks.
Case example: Lack of informed consent
An 11-year-old obese child undergoes an appendectomy. The anesthesiologist advises the parents that he will perform a paravertebral block for post-op analgesia, but does not discuss the risks of this procedure. A lumbar paravertebral block is performed and post-operatively the child suffers profound respiratory depression and hemodynamic instability. On investigation, it is discovered that the child suffered an L2-L4 ischemic injury to the spinal cord as a complication of the block. The child is left with chronic permanent neurological deficits and neurogenic pain.
On review of the care, the peer experts question the necessity of the block, suggesting it was unnecessary and excessive in this case. The anesthesiologist acknowledges not having discussed the possibility of neurological complications with the parents. The CMPA pays a settlement to the patient on behalf of the member anesthesiologist.
It is a physician’s duty to obtain informed consent. This applies to all treatment, whether it is surgical or medical, and includes the initiation of medication.
In obtaining informed consent, physicians should discuss the following:
the nature of the proposed treatment
its chances of success
alternative treatments available, including non-treatment and its potential consequences
the material and special risks* associated with the proposed and alternative treatments
any questions the patient may have
Simply asking a patient to sign a consent form does not constitute informed consent. Consent requires a discussion customized to the patient in their individual circumstances, which culminates in a mutual agreement to proceed with a given treatment.
The consent discussion should be documented in a consultation letter, a clinic note, or in a progress note. The purpose is to convince the reader of the medical record that a consent conversation took place. As such, it is not necessary to document every issue discussed. Rather, provision of a general statement to that effect, with additional specific details about the conversation itself (e.g. questions answered, a specific or unusual concern, or an anecdote raised by the patient during the conversation) should suffice.
Providing competent care and obtaining informed consent, both supported by the medical record, are important to patient safety and increase trust between physicians and children’s parents. Before undertaking a procedure or discharging patients, consider the following actions:
Discuss pertinent negative or reassuring findings with the patient or parents and document the discussion.
Formulate and document a pertinent differential diagnosis.
Document your reassessments and their timing.
Conduct a thorough consent discussion including an opportunity for questions, and not merely to seek acquiescence of the plan.
Discuss the benefits and risks of the proposed course of treatment, and discuss other therapeutic options.
Ensure the medical record reflects the occurrence of that consent discussion, and avoid relying solely on a signed generic consent form.
Provide and document appropriate discharge instructions.
* Material risks — Material risks are the risks that a reasonable person, in the same circumstances, would want to know before consenting to an investigation or treatment. This would include complications that occur commonly, and also complications that occur rarely but could have significant consequences for that patient.
Special risks — Special risks are those which are infrequent or unlikely but which, should they materialize in a particular patient, given their individual circumstances, could have a significant effect on them even though such a risk may not be significant for other patients with different circumstances.
Matlow, A.G., Baker, G.R., Flintoft, V., Cochrane, D., Coffey, M., Cohen, E., et al., “Adverse events among children in Canadian hospitals: the Canadian Paediatric Adverse Events Study,” Canadian Medical Association Journal (Sept. 18, 2012) Vol.184 No.13, E709-18