Adverse Outcomes: A Case Study in Surgical Error and Risk Mitigation Strategies

Pre-Suit Allegation:

The pre-suit attorney demand alleges that the insured operated on the wrong knee, then had the patient’s wife sign an additional consent form for surgery on the incorrect knee. The attorney alleges negligence, gross negligence, fraud, misrepresentation, and violation of the Deceptive Trade Practices Act.

Case Details

A 44 YOM patient (6’, 210 lb) was admitted for knee surgery under the care of a surgeon. The patient was scheduled for a left knee procedure, including a scope, partial medial meniscectomy, an osteochondral autograft transplantation (OATS) procedure, and loose body excision. Prior to surgery, the patient and a witness signed a consent form for the left knee operation, with the surgeon initialing the patient’s left knee.

The operative report states that the circulating nurse, anesthesia staff, and operative staff were completing a time-out procedure as the surgeon entered the operating room. Several contributing factors complicated the defense of this wrong site surgery. The patient was in lithotomy position with the wrong knee draped. The presurgical marking on the patient’s thigh was not visible due to tight draping and was not assessed before the first incision. In addition, there was a change in anesthesia staff at a critical point after the tourniquet was applied to the wrong knee, but prior to the timeout. Further indications of a wrong-site surgery included the lack of shaving and prep and the inability to find the meniscus tear noted on the MRI. However, the surgeon did find the expected crepitus, chondromalacia, and loose bodies.

Upon recognizing the error, staff was concerned about the lack of consent. The surgeon met with the patient’s spouse and claimed he informed her that the procedure had been done on the wrong knee. He then sought consent for the performance of the arthroscopy of the incorrect knee, which was obtained. Following a discussion with the OR director, the patient’s spouse stated she learned that the initial procedure had been done on the wrong knee. Prior to that conversation, she was not aware that the first procedure had been performed on the wrong knee and believed the surgeon was asking to do the “wrong” knee based on an identified need. Only after the completion of the procedure did the surgeon become aware of the error, leading to dismay and chaos in the operating room.

Risk Reduction Strategies

Had robust risk mitigation strategies been in place, such as enhanced time-out procedures and stringent informed consent protocols, this adverse outcome might have been prevented. Here are some strategies that could have mitigated the risk.

1. Enhanced Time-Out Procedures
   Implementing a more rigorous time-out procedure could have prevented the wrong-site surgery. Surgeons and operating room staff should engage in a comprehensive time-out process that includes verification of the correct patient, procedure, site, and laterality. This process should involve all team members, including nurses, anesthesiologists, and surgeons, confirming the correct site verbally and visually.
2. Informed Consent Protocol
   Strengthening informed consent procedures can help ensure that patients fully understand the planned procedure and its risks. Surgeons should engage in thorough discussions with patients and their families, explaining the procedure in detail, including potential complications and alternatives. Patients should be encouraged to ask questions and clarify any concerns before signing the consent form. Surgeons should also confirm the correct site with patients immediately before surgery.
3. Chain of Command Communication
   Establishing clear lines of communication and a robust chain of command can facilitate swift action in the event of an error or complication. Operating room staff should feel empowered to speak up if they notice any discrepancies or concerns during the time-out process or surgery. Surgeons should encourage open communication and create a culture where team members feel comfortable raising issues or asking questions.
4. Double-Checking Presurgical Markings
   Surgeons should personally verify and confirm the presurgical markings on the patient’s body immediately before the procedure begins. This step ensures that the correct site is clearly identified and reduces the risk of operating on the wrong site.
5. Transparent Disclosure Protocol
   Implementing a transparent disclosure protocol can facilitate open and honest communication with patients and their families in the event of adverse outcomes or errors. Surgeons and healthcare providers should be trained in compassionate and effective disclosure techniques, emphasizing empathy, honesty, and accountability. Prompt disclosure of errors allows patients and their families to receive timely information, understand the situation, and participate in decision-making regarding their care. This fosters trust between patients and healthcare providers and may help mitigate potential legal and reputational risks. Additionally, providing support resources such as counseling services or patient advocacy groups can assist patients and their families in coping with the emotional impact of adverse events. By prioritizing transparent disclosure, healthcare organizations can uphold ethical standards and promote patient-centered care.

In addition to these risk mitigation strategies, ongoing staff training and education on patient safety protocols are essential. Regular simulations and drills can help reinforce proper time-out procedures and enhance team communication.

This case of a wrong-site surgery underscores the importance of robust risk mitigation strategies in preventing adverse outcomes. By implementing enhanced time-out procedures, strengthening informed consent protocols, establishing clear lines of communication, double-checking presurgical markings, and prioritizing transparent disclosure, surgical teams can minimize the risk of errors and improve patient safety. Ongoing training and education are crucial to ensuring compliance with these protocols and fostering a culture of safety in the operating room.

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If you have questions on this topic, please email RiskAdvisor@ProAssurance.com or call 844-223-9648.