Ms. Goodwin is manager of clinical risk and patient safety at Cambridge Health Alliance, Cambridge, MA.
"Given the costs of defense and the challenge to defend lawsuits involving [retained surgical items], preventing them from occurring at all is the best solution," writes Brianne Goodwin, JD, RN.
Brianne Goodwin, JD, RNRetained surgical items (RSIs) are termed a “never event” by the National Quality Forum, and have been since 2009. In theory, a “never event” is a medical error that should not occur under any circumstances (Int J Acad Med 2016; 2:5-21). However, with regard to RSIs, it’s far from true they never occur.
Since 2014, there have been 400 reports to The Joint Commission on RSIs (bit.ly/RSIreports). The National Institutes of Health estimates approximately 1,500 RSIs each year and a review of government data suggests even higher-4,500 to 6,000 times per year (N Engl J Med 2003; 348:229-35; bit.ly/RSIincidence). While the actual number of RSIs each year is not known, one thing is more certain: A lawsuit involving RSI is very difficult to defend.
A recent news headline likely caught the attention of urologists: A scalpel was discovered in the abdomen of a patient who underwent a radical prostatectomy in 2013. Urologic complications of RSIs have been described in a variety of case reports. One report presented two pediatric cases of gossypiboma associated with urethral stricture following urologic surgery (Int J Surg CaseRep 2013; 4:425-8). In another case, a patient presented with food particles in her urine a few weeks after an abdominal hysterectomy. She was found to have a retained surgical hemostat and sponge, leading to the development of a fistula between the ileum and the dome of the bladder and resulting in fecaluria (Case Rep Urol 2014; 2014:723592). In another, a surgical sponge was left after a partial nephrectomy and found later on computed tomography during a workup for bladder outlet obstruction (Int J Acad Med 2016; 2:5-21).
Also by Brianne Goodwin, JD, RN: How incidental radiology findings can lead to malpractice litigation
A plaintiff’s attorney would likely attack a case of RSI with the legal theory of res ipsa loquitur, meaning, “the thing speaks for itself.” This requires that the attorney show three things: that the harm would not normally occur absent negligence, the harm was caused by an instrumentality within the exclusive control of the defendant, and the plaintiff did not contribute to the harm.
In essence, the argument is the fact that a surgical item has been retained is, in and of itself, proof that malpractice has occurred. Also of importance, in many jurisdictions, the statute of limitations for RSIs may be different than that of medical malpractice. The law in many states offers some protection to the plaintiff who does not discover an RSI for an extended period of time, known as the discovery rule. If the RSI was not discovered, and it could not reasonably have been discovered, the statute of limitations will not begin to run until discovery of the RSI. Thus, one may be able to sue several years later for an RSI that went undiscovered.
Review of one insurer’s closed claims database showed that the average indemnity payout for a claim involving a retained surgical item for hospitals and physicians was approximately $473,000 from 2007 to 2011. For cases involving permanent major damage to a patient, the average claim was $2 million. Another insurer reported individual physician indemnity ranging from $105,000 to $865,000 with a total payout for retained surgical items of $26 million over 4 years (bit.ly/RSIpayout).
In addition, the Centers for Medicare & Medicaid Services has adopted rules that effectively eliminate reimbursement for the costs associated with the RSIs and other “never events” (Int J Acad Med 2016; 2:5-21). Therefore, the hospital or organization must absorb the costs of the surgery and associated hospitalization, adding to the overall economic burden of cases of RSI.
Given the costs of defense and the challenge to defend lawsuits involving RSI, preventing them from occurring at all is the best solution. Despite standards, policies, and procedures for sponge counting, failure to accurately count remains an error today (Jt Comm J Qual Patient Saf 2011; 37:51-8). For this reason, many institutions have begun to use various technology and software to aid in sponge counting and detecting RSIs. Radio-opaque materials and radio-frequency ID systems are being put in place to make counts more reliable. In fact, one Massachusetts insurer has funded the adoption of sponge-counting technology for its 11 hospitals.
RSIs are more likely to occur with emergency surgery, unplanned change in the operation, higher body mass index, and blood loss exceeding 500 mL (N Engl J Med 2003; 348:229-35; Int J Acad Med 2016; 2:5-21). Practices to aid in preventing RSIs from occurring include avoiding change of staff in the middle of procedures and improving communication among the surgical team. Any staff member in the operative suite should feel comfortable and empowered to speak up if there is any concern for an incorrect count or an RSI. Additionally, inspection of surgical instruments before and after use to check for breakage and the potential of device fragments should be routinized. Practices of methodical wound exploration have been recommended by The Joint Commission as well (bit.ly/PreventingRSI).
RSIs, though termed “never events,” continue to occur in health care today. They are associated with significant economic burden and a high likelihood for a civil lawsuit. Moreover, they are very difficult to defend, hence the aforementioned indemnity statistics. Employment of good perioperative practice among doctors, nurses, surgical techs, and all others is fundamental to prevention of these errors, and the use of sponge-counting technology is gaining ground. By making proactive and appropriate efforts around operating room procedures, you may avoid becoming a defendant in a lawsuit involving RSI.
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