Failure to obtain informed consent

July 3, 2019

Presentation

A boy was born in a small medical center and evaluated one day later by a pediatrician. The results of the newborn exam were essentially normal, though the patient was noted to be “a little jaundiced.” The pediatrician ordered phototherapy. 

 

Physician action

The pediatrician went to the mother’s hospital room that morning to discuss the patient’s exam. However, the mother was not present, so the pediatrician left the room and returned to the nursery. He was scheduled to perform circumcisions on several infants.   

According to the notes, circumcision surgery was performed on the patient. However, the procedure was not ordered in the record by the pediatrician until later in the day. The surgical checklist included an item for indicating the presence of a consent form, which was left unchecked. Documentation of the circumcision included items to check, “patient ID” and “consent,” which were apparently marked with an “x” by the pediatrician.

The pediatrician documented that the circumcision was completed without complication. Later that day, the pediatrician reviewed the patient’s record and could not find a consent form. However, he found a note that the mother did not want her son circumcised. The pediatrician concluded that he was looking at the wrong chart before and during the circumcision.   

The pediatrician went to the mother’s room to explain that the child had been mistakenly circumcised. The mother explained that it was part of their family’s strict wishes that the patient not be circumcised. The physician apologized for the error and did not charge for his pediatric services.

  

Allegations

A was lawsuit filed against the pediatrician, alleging negligence in performing a procedure without consent. Because there were no medical expenses associated with this claim, damages were based on disfigurement from the unwanted circumcision.

  

Legal implications

Multiple pediatricians reviewed this case and stated that they believed the pediatrician deviated from standard of care. There was clear documentation of the parents’ wishes to avoid circumcision and no signed consent form.

 

Disposition

This case was settled on behalf of the pediatrician.

 

Risk management considerations

The Texas Civil Practice and Remedies Code provides the basis of informed consent:

“In a suit against a physician or health care provider involving a health care liability claim that is based on the failure of the physician or health care provider to disclose or adequately disclose the risks and hazards involved in the medical care or surgical procedure rendered by the physician or health care provider, the only theory on which recovery may be obtained is that of negligence in failing to disclose the risks or hazards that could have influenced a reasonable person in making a decision to give or withhold consent.” (1)

Within the patient’s chart, the consultants identified several opportunities when the pediatrician could have either obtained informed consent from the parents or noted refusal of circumcision. These opportunities were:  

  • When the pediatrician initially went to inquire about circumcision with the mother that morning;
  • when the pre-procedure packet was assembled and consent was marked as not present; and 
  • before the procedure, when both the consent and patient identity were confirmed erroneously in the circumcision report.

Conflicting pre-formatted information was noted throughout the patient’s record. The pre-surgical packet reflected that consent was not obtained for the procedure, contradicting a preprinted order that stated the consent was signed and on the front on the chart. 

In this case, it appeared the checklist on the circumcision record was not used; but it was marked that the patient’s identity and consent had been confirmed and obtained. 

The best risk management approach is not to rely on previous checklists, but to perform pre-surgical verification in real time, checking for critical information such as patient identity and consent. This double check maximizes the safety of your patients, and the defensibility of a claim. 

To avoid an allegation of failure to obtain informed consent, physicians should educate patients about known complications and alternative forms of treatment, document these efforts, and obtain a signed informed consent. This case demonstrated a failure of the physician to follow protocols to ensure that appropriate consent was obtained. While forms and checklists were in place to facilitate this process, they were not properly employed.

 

Source

  1. Subchapter C. Informed Consent; Sec. 74.101. Theory of Recovery. Civil Practice and Remedies Code, Title 4. Liability in Tort, Chapter 74. Medical liability, Subchapter A. General provisions. Available at http://www.statutes.legis.state.tx.us/Docs/CP/htm/CP.74.htm. Accessed August 4, 2017.
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