Safety of care
ENT practice — Mitigating the risks of procedural complications
Originally published December 2015
In keeping with the surgical specialties, otolaryngologists are more likely to be named in a legal action when compared with the overall CMPA membership. This may be due to the types of procedures these ear, nose, and throat (ENT) specialists perform — delicate procedures on the head and neck that can sometimes permanently damage nerve function, even in the best of hands. It may also be influenced by the often episodic nature of the care they provide.
As they specialize in the diagnosis and management of disorders of the ear, nose, throat, and related structures of the head and neck in patients of all ages, otolaryngologists are often referred to as ear, nose, and throat (ENT) specialists. They perform many types of procedures, using a variety of tools and techniques including endoscopic and laser approaches.
What the CMPA’s cases indicated
A review of the CMPA’s cases that closed in the last five years and involved ENT specialists indicated that in the vast majority the experts did not criticize the physicians’ care. Yet, the review also showed that there continues to be two key areas in which medical-legal risk can be reduced for patients and ENT specialists — in the prevention of intra-operative events and in the prompt recognition of complications.
Two areas for risk reduction are the prevention of avoidable intraoperative events and prompt recognition of complications.
In the reviewed cases, patient age groups were fairly equally distributed, with the largest being patients aged 50–60 years. Less than 14% of patients were under 18 years of age.
The top three procedures associated with these cases were nasal surgery, sinus surgery, and tonsillectomy.
In close to half the cases, patient physical outcomes were permanent and involved functional impairment (e.g. motor nerve palsy, hearing loss) or affected the patient’s physical appearance.
Most of these patient outcomes were the result of complications from a procedure, which is the biggest issue in CMPA cases for ENT specialists. Many of these complications were considered known risks, and therefore not the result of sub-standard care. The care in these cases was not criticized by experts when the complications (both those that occur commonly and those that occur rarely but have significant consequences for patients) were appropriately explained to the patient during the consent discussion.
Top seven clinical issues with medical-legal risks for ENT specialists based on CMPA cases
- injury resulting from a procedure, e.g. nerve damage
- patient dissatisfaction with a functional or cosmetic outcome
- incomplete consent discussion with respect to the risks of a procedure
- inadequate diagnostic assessment
- poor physician-patient communication
- inadequate follow-up of diagnostic test results
- equipment or resource issues
These same risks are shared by the other surgical specialties.
Considerations before a procedure
Not verifying all relevant patient information before a procedure contributed to poor clinical outcomes in a number of cases. This included not reviewing pre-operative imaging, not performing additional tests to accurately assess the potential for a suboptimal outcome, and not revisiting the patient’s history for information on previous surgeries or recent health developments.
A few cases of patients receiving the wrong procedure were associated with not verifying patient identifiers in the documentation or not checking this information with the patient. These situations also involved other lapses in safety procedures, such as the care team not adequately following the surgical safety checklist.
Case example: A patient undergoes the wrong procedure
An ENT surgeon performs an uneventful septoplasty on a middle-aged woman. On waking, she begins questioning staff as to why she has bandages on her nose. A nurse checks the patient’s file and quickly discovers that she underwent the wrong procedure — she had consented to the excision of a vocal cord lesion.
The nurse reviews the patient’s file and it becomes apparent that the surgeon’s office booked the patient for the wrong procedure. Further review also reveals that before the surgery the surgeon did not verify the procedure with the patient or review the medical record, no members of the care team identified the discrepancy between the consent form and booking sheet, and the surgeon did not recognize anything amiss during the procedure as the patient had a deviated septum.
The surgeon speaks to the patient, explains what happened, and apologizes. Ultimately, a shared settlement is paid to the patient by the CMPA, on behalf of the member surgeon, and by the hospital for inadequate safety protocols. The ENT surgeon implements changes to his office practice to ensure that similar booking errors do not happen again and the hospital makes changes to its safety protocols.
Equipment issues (malfunction or unavailability) were associated with intra-operative injury in a few cases. As these cases involved system factors or other healthcare providers, settlements were often shared with an institution or manufacturer. Nonetheless, these events could have been avoided with pre-operative safety protocols to verify equipment.
The following expert opinions from CMPA cases involving ENT specialists encapsulate the key issues in the pre-operative period:
- Consider whether additional tests or consultations are necessary.
- Discuss the procedure with patients to obtain their informed consent and to establish the expected clinical outcomes.
- Confirm that equipment has been appropriately tested, and is available and in working order.
- Ensure the institution or clinic implements a surgical safety checklist that includes:
- verification of the patient’s identity, the planned procedure, and operative site
- confirmation of site marking, when appropriate
- verification of all relevant patient information in the medical record
Considerations after a procedure
Inadequate follow-up of patients after a procedure was also a key area of concern for experts in the reviewed CMPA cases. Criticism centred on physicians failing to adequately and in a timely manner follow-up patients (i.e. see them pre-discharge) when difficulties had been encountered in surgery. This included not informing other healthcare providers of what to look out for in the immediate post-operative period, and not disclosing the difficulties to patients or providing them with appropriately detailed discharge instructions. Standardized or late operative reports made the defense of care challenging in some of these cases.
The inadequate assessment of patients who reported symptoms after a procedure was another common issue in this period, as was not expediting referrals in cases with potential injury. This was especially problematic in cases where experts found that earlier treatment could have led to a better outcome for the patient.
Case example: A patient’s spinal accessory nerve injury goes undiagnosed for several months
An ENT surgeon excising a large suspected neuroma on the neck encounters an underlying adherent mass, believed to be lymph node. This mass ruptures as it is removed. Specimens from both masses are sent to pathology. The patient is discharged later that day with instructions to see his family physician for suture removal and follow-up, with the assumption that he would be referred back to the surgeon if concerns arise.
The next day the patient attends the emergency department complaining of facial numbness. He is reassured that what he is experiencing is normal healing, and he is discharged after his dressings are changed. A few weeks later, when speaking over the phone with the surgeon’s office about the pathology results, which show benign nerve tissue, he again mentions his numbness, and is again assured that follow-up is not needed.
A few months later, the patient’s family physician refers him to a neurologist after a physiotherapist identifies some shoulder dysfunction. The neurologist diagnoses a spinal accessory nerve injury and the patient undergoes graft repair of the transected nerve six months after the original procedure.
Experts conclude that the surgeon’s post-operative follow-up of this patient was inadequate, especially in light of the fact that both specimens were consistent with nerve tissue. Experts state that earlier repair (in the first few months after injury) might have improved recovery. The patient now has limited shoulder function. The CMPA pays a settlement to the patient on behalf of the member ENT surgeon.
The following opinions from the experts in the CMPA cases summarize the key issues with post-operative care:
- Communicate all information relevant to the patient’s recovery during transfers of care.
- Complete the operative report in a timely manner and include details of the technique, anatomical findings, difficulties encountered during the procedure, and confirmation of sponge and instrument counts.
- Inform patients of any difficulties or complications encountered in surgery, any unplanned procedures performed, and possible post-operative complications.
- Review pathology findings to ensure they correspond with the clinical impression and arrange appropriate follow-up to investigate any discrepancy.
- Thoroughly investigate any post-procedural complaints by patients.
- Carefully document the care provided including any advice given to the patient on post-operative care and follow-up.
While many suboptimal outcomes reflect inherent risks of a procedure, others can be avoided with appropriate planning and safety protocols. In many cases, diligent follow-up of actual or possible complications improves outcomes. These principles of vigilance and clear communication can extend to all aspects of ENT practice to improve care and reduce the risk of medical-legal difficulties.