Imagine you are a patient suffering serious complications after surgery. If the complications were caused by a doctor who accidentally left part of a surgical tool or a sponge inside your body, no one is required to tell you that. Believe it or not, no doctor, surgeon or nurse is even require to report the surgical error.
Even if the doctor figures out that there is something missing, and a broken off piece of the device is left inside your body, if the doctor does not believe it will create an adverse event, the doctor need not state anything about it. Does that strike you as amazing?
During most surgeries, hundreds of instruments, towels, even robots, are employed. Losing track of the instruments is easy, especially suring laparoscopic procedures when a surgeon watches the placement of very small devices on a video monitor.
True Story: Hide & Seek With Retained Surgical Tools
My Virginia (VA) personal injury law firm partner James C. Lewis recently took a deposition from a very experienced North Carolina (NC) surgeon who uses robotic laparoscopic instruments. The surgeon's patient had major complications after laparoscopic surgery, and the surgeon had to do a second exploratory surgery to determine what was causing the patient's health problems. The surgeon discovered a small piece of a surgical instrument that had broken off inside the patient.
The surgeon admitted what the object was and conceded it must have come loose during the first surgery. However, he also found a nick or perforation that he believed was directly causing the complications the patient was suffering. The patient was hospitalized for many weeks and suffered horribly for months.
The surgeon admitted in his deposition during the medical malpractice suit that the cut area, also known as a perforation, must have been caused during his first surgery. The surgeon eventually concluded that a malfunction in the cutting instrument must have caused the perforation, unbeknownst to him. He knew there had been a malfunction, but did not know it caused the perforation.
After the second surgery, the surgeon turned the small piece of broken-off carbon to the risk management department of the hospital, but never mentioned the discovery anywhere in his second written surgical report (it also did not appear in the original report).
The surgeon testified that he did not put it in his reports because he did not believe there had been any adverse consequence to the patient.
The surgical instrument in question was a robotic laparoscopic device called a “Da Vinci.” This is a state-of-the-art robotic device commonly used by surgeons around the country for many procedures, including hysterectomies.
It appears as though the current policy is simple: trust your surgeon. I do trust my doctors but the status quo asks doctors to self-police. This means voluntarily disclosing the information that may verify their own medical malpractice or at least verify their own violation of the medical standard of care. That could mean trouble, folks. Even turning the surgical tool or item over to risk management doesn't really trigger any special requirements.
Lack of Mandatory Reporting Under Regulations or Governing Standards
We checked with the Virginia State Board of Medicine, to learn what medical regulations or requirements exists with regard to tools or devices left inside patients. What we learned is that the medical board does not require reports of what it formally calls a “retained surgical item,” or RSI. We further found no federal or state regulation governing such reports if the surgeon claims she is unaware of any adverse result.
The Joint Commission on Accreditation of Healthcare Organizations sets many standards for hospitals, and many states implement certain Joint Commission standards for hospitals.
In 2011, the National Quality Forum defined when exactly a retained surgical item incident has occurred — the patient must be out of the operating room with the surgical item left inside of them in order for it to be considered a retained surgical item.
We next spoke with Dr. Verna Gibbs, the creator of nothingleftbehind.org, a website devoted to the issue of retained surgical items.
Gibbs stated that “all hospitals have risk management and quality improvement departments with guidelines that physicians who operate in their facilities must follow, and more directly, that hospital staff must follow.”
She went on to say, “If there is a [retained surgical item] the nurses have to report it to the nurse managers who move it up the chain [of command] because that means there was an incorrect count on the procedure in which the object was originally left in.”
Gibbs was referring to the fact that nurses keep track of things like surgical towels and sponges but not necessarily whether a part breaks off of a surgical tool. They also may or may not formally record if a high-tech surgical instrument completely malfunctions and causes a delay in the surgery unless it involves a replacement part, which should be recorded somewhere in relation to the notes of the operation. Nevertheless, the surgeon may have no duty to report a retained surgical item or instrument left in a patient’s body. Furthermore, placing the burden on the nurses to move the incident “up the chain” of command may be a contributing factor to why these incidents are underreported.
“Do I think there is under-reporting? Yes,” said Gibbs. “Hospitals only [report retained surgical item incidents] if they have to, but that doesn't mean they don't know.”
Gibbs stated that, with this new RSI definition, “it will take a couple of years to percolate through the hospitals and procedure areas which I think will decrease the number of reported events further."
So what should be done? High tech medical and surgical devices are the norm. Do we need federal guidelines?
"I don't think federal laws would help push reporting,” Gibbs said. “It would be yet another report to fill out and send to yet another authority.” She also mentioned that no-pay rules (no reimbursement to hospitals for adverse result surgeries) were “very effective” in getting hospitals to address this important patient safety issue. In other words, Gibbs believes hospitals should police themselves.
She anticipates that the concern for retained surgical items implemented through the no-pay rules will trickle down to individual surgeons. She said this is “why [surgeons] have to engage in preventing this problem.”
My Take
We cannot expect any medical professionals, including doctors and surgeons, to voluntarily turn themselves in when a tool or device breaks or malfunctions without some sort of mandatory written reporting requirement. That requirement need not be a federal or state law, but it must at least be a hospital quality assurance or accreditation standard, such as the one implemented by Medicare or the Joint Commission.
Patients should be entitled to disclosure of any malfunction of a surgical tool or device, replacement of a part, and should always be entitled to information about any RSI. Reporting must not be limited to adverse events. The reporting should be mandatory whether or not the surgeon believes there is any adverse consequence.
PA
About the Editors: The Shapiro, Lewis & Appleton personal injury law firm, which has offices in Virginia (VA) and North Carolina (NC). The attorneys publish articles and edit the Legal Examiner for the Virginia Beach, Norfolk and Northeast North Carolina regions as pro bono service.
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