How surgical time-outs may (or may not) lower litigation risk

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Brianne Goodwin, JD, RNA 66-year-old female was scheduled to undergo computed tomography-guided renal cryotherapy for localized kidney cancer. During a preoperative visit with anesthesia, a note was made in the allergy section of the chart stating: “IV contrast dye.” Preoperative documentation suggested that hydrocortisone should be used before surgery, but no order was written for this.

On the day of surgery, the attending anesthesiologist expressed concern about the severity of the reported allergy, and intended to discuss it with the attending urologic surgeon. On the day of the procedure, the anesthesiologist induced local anesthesia and conscious sedation, and then left the room to oversee another patient requiring induction of general anesthesia, leaving behind his anesthesia resident.

Also by Brianne Goodwin, JD, RN: How patient obesity can impact malpractice litigation

In the OR, the patient was surrounded by the urologist, two urology residents, a medical student, nursing and surgical tech staff, and the anesthesia resident. A surgical “time-out” was conducted, during which a nurse raised concern about the alleged IV contrast allergy. Everyone in the room turned to the anesthesia resident for information. Ultimately, the decision was made to administer the prophylactic hydrocortisone and proceed. The anesthesia attending returned to the room after the time-out, frustrated that he had not been part of it. Further, he had concerns that his resident lacked confidence to speak up and address the allergy concern himself.

The question: Did the surgical “time-out” serve its intended function? Can you identify ways the “time-out” should have been done differently or worked better?

Time-out’s efficacy subject of debate

The elimination of wrong-site surgeries was made a National Patient Safety Goal in 2003 by the Joint Commission and requires compliance with a Universal Protocol consisting of three steps: proper preoperative identification of the patient by three members of the team, marking the operative site, and a final “time-out” just prior to the surgery or procedure regardless of where it is being performed.

Despite the intention of the Universal Protocol, debate swirls around the efficacy of it, particularly the time-out portion, as there is little evidence of its efficacy in preventing wrong-site surgery (bit.ly/AHRQtimeout). In fact, in 2007, a urologist removed a healthy kidney rather than the diseased kidney from a 55-year-old patient and in 2016, a surgeon removed a kidney from the wrong patient altogether.

In the 2007 case, diagnostic imaging was not rechecked to see which kidney had a cancerous mass. In addition, the images were available on a small computer screen in the OR, but were several feet away from the surgeon and could not be seen. Even the most perfectly run time-out may not mitigate a failure to follow basic policy or procedure. In the 2016 case, the kidney was removed from a patient with the same name as the patient who should have had a kidney removed. A time-out hopes to catch errors such as patient misidentification, but will not do so if the team only states patient name, and omits date of birth, medical record number, or other specific patient identifiers.

Adverse events resulting from surgical procedures are more frequently related to errors made before or after the surgery than by technical surgical mistakes during the procedure (bit.ly/WHOchecklist). When one pauses to consider this, it is daunting to think of the number of people involved in preoperative surgical scheduling, booking, and communication with the patient; not to mention postoperative diagnosis and treatment. A breakdown anywhere along the line that leads to an adverse outcome can lead to litigation that would undoubtedly include the surgeon, even if no surgical error was made. After all, how effective is a time-out if the surgical scheduler books the wrong procedure and the team relies on that?

Next: Three opportunities to reduce error risk

 

Three opportunities to reduce error risk

The Surgical Safety Checklist provided by the World Health Organization, and endorsed by the American College of Surgeons, defines three clear opportunities for the surgical team to communicate and reduce the risk for error: before the induction of anesthesia, before the skin incision, and before the patient leaves the operating room (bit.ly/WHOchecklist). In any case where the urologist is not the attending, but called in to consult, for example, to examine the ureters for suspected perforation in a gynecologic case, the three steps required by the Joint Commission should be repeated.

With regard to the WHO Surgical Safety Checklist, a 2015 study reported that in 40% of cases, the required team members were absent at the time-out and over 70% of team members failed to pause and perform safety checks (Patient Saf Surg 2015; 9:26). “Performing a time-out and implementing a checklist in the OR does not mean the patient is safe,” the authors of a 2015 Patient Safety in Surgery review article wrote (Patient Saf Surg 2015; 9:26).

Read: Patient sues after stapler misfire leads to rectal tear

Each team member from start to finish is responsible for safe patient care and protocols associated with their particular role. To further promote surgical safety, surgical teams embodying purpose, goals, leadership, communication, cohesion, and mutual respect can minimize errors (Patient Saf Surg 2015; 9:26). Contrarily, ineffective team communication in the operating room has been described as a “major root cause of errors”(Patient Saf Surg 2015; 9:26).

The take-home: As the surgeon, surgical technique and skill are clearly of great importance, but even with a technically perfect surgery, errors can occur. A time-out may, but cannot be guaranteed, to identify errors or mistakes that have been made preoperatively by others involved in the patient’s care and treatment. The patient’s safety during surgery is the responsibility of many: office staff, schedulers, nursing, central processing personnel, and clinical providers in the OR, to name a few. The time-out is as strong as the weakest link in the chain. Strengthening the chain as a whole promotes patient safety and reduces the risk of an adverse outcome and the potential for litigation.

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