In the coming year, the Risk Management and Patient Safety Department will continue mining data from a variety of sources: CAP closed claims, hotline calls, CAPCares calls, and practice survey data. Our goal is to identify trends, vulnerabilities, and emerging concerns or new issues that impact a physician’s practice. We hope to use the data to drive change, provide education, curb losses, identify new data needs, collaborate with other industry partners, and advance quality outcomes and patient safety initiatives at CAP.
This article will provide a brief summary of findings from the 2017 General Surgery – Laparoscopic Cholecystectomy study.
General Surgery – LapChole Study Summary
The Risk Management (RM) team reviewed 10 years (2006 to 2016) of laparoscopic cholecystectomy closed claims. Between 2012 and 2016, CAP saw a 68 percent increase in the number of lawsuits involving laparoscopic cholecystectomies and a staggering 431 percent increase in the total expenses incurred, meaning the total indemnity (money paid to plaintiffs) plus the costs of legal defense. Additionally, from 2012 to 2016 there was a 39 percent increase in claims closed with an indemnity payment, evidence that lap chole injuries can be very challenging to defend.
In the CAP RM focused review of closed claims with an intraoperative complication, 58 percent of patients suffered an injury to the common bile duct, 24 percent incurred an injury to the right hepatic artery, 16 percent suffered an injury to the hepatic ducts, and in four percent a gallbladder remnant remained.
In the focused review of the closed claims with an indemnity payment, 80 percent of patients required additional more extensive surgery; 18 percent died from sepsis, bleeding, or post-op anoxia; five percent had substantial damage to the liver requiring either partial hepatectomy or liver transplantation; and five percent sustained brain damage resulting in a persistent vegetative state.
To understand the reasons for these statistics, and to make laparoscopic cholecystectomy safer, requires a full understanding of all of the root causes and the contributing factors. The following root causes were identified: Inappropriate patient selection; patient-specific factors (aberrant anatomy, adhesions, and inflammation); misidentification of anatomical structures (cognitive bias and incomplete understanding of the critical view of safety); errors in intraoperative judgment (failure to exercise options such as an intraoperative cholangiogram); failure in technical performance (dissection, use of cautery or clip placement); unsuccessful repair of the biliary injury; and delay in diagnosing the bile duct injury (postoperative instructions on surgical complications that warrant immediate medical attention).
As bile duct injuries become more common in laparoscopic cholecystectomies, it is important to understand how error occurs and develop risk mitigation strategies such as:
- Implement a well-rounded informed consent discussion (risks unique to the patients, alternatives, including risks and benefits of no treatment, and possible conversion to open);
- Use a reliable dissection method that most closely mimics the open procedure and achieves the critical view of safety;
- Know when you are in trouble and exercise options in light of increased technical difficulty or presence of red flags (cholangiogram, time-out, request assistance, convert to open, or discontinue to a later date);
- Recognize confirmation bias – implement checks and safeguards;
- Manage OR production pressures and empower OR staff to “stop the presses” when production pressure compromises patient safety; and
- Provide discharge instructions that include signs and symptoms of a surgical complication that warrants obtaining immediate medical attention.
Moving forward, it is important to direct our efforts to proactively prevent bile duct injury. Strategies for minimizing bile duct injury can be found at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) website (https://www.sages.org/safe-cholecystectomy-program/). The SAGES Safe Cholecystectomy Program has the mission to enhance a universal culture of safety around cholecystectomy. SAGES has developed a six-step program published on its website that surgeons can do now to potentially reduce risk of incurring a biliary injury.
Look for a future CAP RM expanded publication on this subject in 2018.
Ann Whitehead is Vice President, Risk Management and Patient Safety for CAP. Catherine Miller and Steven Blackburn are Senior Risk Management and Patient Safety Specialists for CAP. Questions or comments related to this article should be directed to awhitehead@CAPphysicians.com.