In 2018-2019, more than 137,000 hip and knee arthoplasty surgeries were performed in Canada,1 and in the past 5 years the proportion of patients undergoing these surgeries within medically recommended wait times decreased from 78% to 72%.2 As orthopaedic surgeons strive to provide high-quality care and are challenged by wait lists, some experience medico-legal complaints.
Among the CMPA cases closed in the past 5 years (2015-2019) involving a named orthopaedic surgeon, over one-third involved lower extremity joint surgery. The medico-legal cases highlight that even routine elective joint surgeries can pose serious risks to patients and contribute to medico-legal complaints.
Healthcare-related harm
The CMPA analyzed 262 medico-legal cases (civil legal, medical regulatory authority [College], hospital), closed between 2015 and 2019 from across Canada, regarding elective surgeries of the hip, knee, ankle, or foot. An orthopaedic surgeon was named in nearly all of the cases; a resident, fellow, or family physician was named in the remainder (<10 cases). Significantly, 76% of the cases (198/262) involved healthcare-related harm to a patient, such as prolonged post-operative pain.
CMPA medical-legal cases involving
elective lower extremity joint surgery,
closed 2015-2019 (N=262)
Hip 86 cases
Knee 122 cases
Ankle 20 cases
Foot 34 cases
Among the 198 cases with healthcare-related harm, the most common elective procedures were the implantation of a prosthetic hip or knee joint. The most common elective procedures on the ankle or foot were fixations or repairs, such as a bunionectomy or an osteotomy. In about half of the patients who experienced healthcare-related harm (109/198, 55%), peer experts3 concluded that the surgeon did not meet the standard of care. In others, they deemed harm an inherent risk, meaning it was a known risk of undergoing the procedure under ideal conditions.
A frequent criticism of orthopaedic surgeons in the CMPA cases was not clearly describing the specific risks of surgery, such as a leg length discrepancy, during the informed consent process.
Wrong-side surgery and team communication
A notable source of harm, affecting 12 patients in different institutions between 2008 and 2016,4 was surgery performed on the wrong hip, knee, ankle, or foot. All cases were civil legal actions or threats that ended in a settlement. A prominent theme was a breakdown in the exchange of information within the surgical teams. In 10 of the wrong-side surgeries, a surgeon or trainee correctly identified the surgical site, typically by marking it, but team members prepared the patient for surgery on the opposite limb. A related issue was team coordination of the surgical safety checklist. Some teams completed a single checklist before preparing and draping the patient on the wrong side, with no documented “time out” before the first incision. Distractions also played a role, as in the following scenario.
Case scenario: A patient undergoes surgery on the wrong hip
5
A woman provides informed consent to undergo hemiarthroplasty of the left hip. On the day of surgery, the surgeon meets with the patient pre-operatively to confirm her consent for surgery on the left hip, but does not mark the surgical site. The surgeon is called away and returns to find the patient anesthetized and in the operating room. As the team initiates their routine sign-in, there is a power outage; they pause until the generator turns on. As the sign-in resumes, they pause again for a nurse to ask the surgeon about another patient. Several team members then position and drape the patient for surgery on the right hip. They conduct a “time out” just before the first incision, and the surgery proceeds.
The patient initiates a legal action against the surgeon for wrong-side surgery. The hospital and the CMPA pay a shared settlement to the patient.
The surgical safety checklist can be an effective tool for fostering team communication and preventing wrong side surgery, if used correctly. It is crucial that surgical team members reach a shared understanding of the correct side in the “briefing” phase (before anesthesia) and in the “time out” phase (before skin incision), with their full attention in each phase. The Canadian Patient Safety Institute offers guidance for implementing the checklist.6
Post-operative complications and situational awareness
Having situational awareness and a high index of suspicion for post-operative complications can help physicians detect problems earlier. Peer expert criticisms in the CMPA cases reviewed reflected gaps in situational awareness in some of the cases. For example, experts noted surgeons not reviewing the patient’s entire medical history (e.g. identifying risk factors for deep vein thrombosis); not performing or documenting a neurological or vascular exam when investigating post-operative symptoms (e.g. associated with an intra-operative injury); and not following up on test results (e.g. showing a displaced fracture post-operatively). As a result, patients experienced missed or delayed diagnoses of post-operative complications. Situational awareness can be more difficult to maintain when relying on healthcare teams for information, as in the following scenario.
Case scenario: An intra-operative injury goes undetected after knee surgery
5
An older man undergoes a total knee arthroplasty by an orthopaedic surgeon. Following surgery, the patient reports numbness and intense pain and exhibits foot drop. A nurse attempts to reach the orthopaedic team and, hours later, finally contacts the surgeon to describe the patient’s condition. The surgeon asks a senior resident to assess the patient on his behalf. On assessment, the resident assumes that the symptoms relate to the patient’s femoral nerve block for pain control; he orders removal of the block and prescribes morphine instead. The surgeon is unaware of this decision.
Two days after surgery, the surgeon assesses the patient for the first time post-operatively. Noting the patient’s stiff leg, he immediately measures compartment pressures and diagnoses compartment syndrome. The patient undergoes urgent decompression surgery, and further testing reveals a vascular injury. Despite surgical repair, the patient is left with persistent neurological impairment and difficulty walking.
The patient initiates a legal action against the orthopaedic surgeon, alleging a delayed diagnosis of the intra-operative injury. Peer experts opine that after learning of the patient’s condition, the surgeon should have taken proactive steps to follow up earlier with the resident and the nurse. The hospital and the CMPA pay a shared settlement to the patient.
The bottom line
To reduce the patient safety risks and medico-legal risks associated with elective joint surgeries, consider the specificity of your informed consent process, your institution’s protocols for preventing wrong-side surgery, and both your and your team’s situational awareness during post-operative care.
The following strategies are consistent with peer expert opinions in the CMPA’s medico-legal cases:
- In the informed consent process, clearly communicate the risks of surgery that a reasonable person in the circumstances of that patient would want to know, and document this communication in the medical record. Include special risks (risks that are rare, but more likely for a given patient because of their comorbidities, for example) and risks that are rare with potentially serious consequences.
- Use multiple team strategies to prevent wrong side surgeries,7,8 such as consistent marking of the surgical site and confirming the mark before preparing and draping the patient. Foster a culture of safety by participating in the full surgical safety checklist 6 and by recognizing the impact of distractions or interruptions in the operating room. Repeat the full checklist if necessary.
- Be mindful of the importance of a timely diagnosis of post-operative complications. Proactively try to identify pre-operative conditions that increase the risks of surgery, and gather information post-operatively to heighten your situational awareness. Adequately supervise and follow up with residents; when signs or symptoms are concerning, attend to the patient yourself.
References
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Canadian Institute for Health Information. CIHI; 2020. Hip and Knee Replacements in Canada, CJRR Annual Statistics Summary, 2018-2019. [cited 2021 Feb 10]
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Canadian Institute for Health Information. CIHI; c1996-2020. Joint Replacement Wait Times [cited 2021 Feb 10]
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Peer experts refer to physicians retained by the parties in a legal action to interpret and provide their opinion on clinical, scientific, or technical issues surrounding the care provided. They are typically of similar training and experience as the physicians whose care they are reviewing.
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While the dataset represents cases that closed between 2015 and 2019, the dates of the surgeries were earlier. The difference in dates reflects the delay from the time a complaint is made until the case closed or it reflects a prolonged duration from the time a complaint is made until the case closed.
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While this case scenario describes an actual medico-legal case at the CMPA, certain facts have been omitted, changed, and added to ensure anonymity for the parties involved.
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Canadian Patient Safety Institute. CPSI. Surgical Safety Checklist: Download [cited 2021 Feb 10]
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Santiesteban L, Hutzler L, Bosco JA 3rd, et al. Wrong-Site Surgery in Orthopaedics: Prevalence, Risk Factors, and Strategies for Prevention. JBJS Rev. 2016 Jan 26 [cited 2021 Feb 10];4(1):01874474-201601000-00003. DOI:10.2106/JBJS.RVW.O.00030
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Healthcare Insurance Reciprocal of Canada. HIROC;2018. Wrong Patient/Site/Procedure [reviewed 2018 Jan;cited 2021 Feb 10]