Wrong-site protocol: A standard of care that can and will be used against you
Safety steps from JCAHO must be implemented immediately
The new protocol for preventing wrong-site surgery is likely to be considered the standard of care immediately and plaintiffs’ attorneys will use it against you in court, says a prominent trial attorney. Risk managers should act quickly to implement the protocol now and not wait for the protocol’s deadline, the attorney adds.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recently approved the Universal Protocol for preventing wrong-site, wrong-procedure and wrong-person surgery — the notorious, tragic cases that haunt every risk manager. Compliance with the Universal Protocol by all accredited organizations that provide surgical services is required beginning July 1, 2004, but you would be wise to act on them much more quickly, says Kathleen Flynn Peterson, JD, a trial attorney with Robins Kaplan in Minneapolis and a board member of the American Trial Lawyers Association, representing those folks you see on the other side of the courtroom.
"I believe it may be sought to be used as evidence of standard practice," she says. "The ultimate decision regarding admissibility will be determined by applicable rules of law and the discretion of the court. Given that the protocol was developed as a consensus of many groups, I believe it can be argued it clearly represents best practice and current standards."
In other words, expect the plaintiff’s attorney to jump up and yell, "They didn’t follow the Universal Protocol!"
Surgeon should mark operative site, take time out to assess
The advice outlined in the Universal Protocol is not groundbreaking, but it now carries the imprimatur of JCAHO and several other prominent organizations, and JCAHO is making it a requirement for accreditation. That creates the unmistakable impression that this protocol is what any good health care provider should do, in effect creating a standard of care, Peterson says. "It certainly can be used by the consumer in litigation to establish what the accepted standards of practice would have been," she says.
The Universal Protocol draws upon and expands a series of existing requirements under the 2003 and 2004 National Patient Safety Goals. It will be applicable to all operative and other invasive procedures. The principal components of the Universal Protocol include: 1) the preoperative verification process; 2) marking of the operative site; 3) taking a time out immediately before starting the procedure; and 4) adaptation of the requirements to nonoperating room settings, including bedside procedures.
The Universal Protocol is the consensus product of a national Summit on Wrong-Site Surgery convened last spring by JCAHO, the American Medical Association, the American Hospital Association, the American College of Physicians, the American College of Surgeons, the American Dental Association and the American Academy of Orthopaedic Surgeons (AAOS). Summit participants included leaders from other medical and surgical specialty organizations, nursing organizations and provider associations, among others. Summit participants concluded that wrong-site, wrong-procedure and wrong-person surgery can be prevented and that the Universal Protocol is needed to help accomplish this goal.
In releasing the protocol, JCAHO president Dennis S. O’Leary, MD, said, "This Universal Protocol asks health care organizations to set a goal of zero tolerance for surgeries on the wrong site or on the wrong person, or the performance of the wrong surgical procedure. These are occurrences, which simply should never happen."
Despite widespread acknowledgment that surgeries on the wrong site or on the wrong person, or the wrong surgical procedure are entirely preventable, JCAHO continues to receive five to eight new reports of wrong site surgery every month from organizations that provide surgical services, O’Leary said.
JCAHO’s protocol follows the lead set by AAOS, which has been working in recent years to eliminate wrong-site surgery, primarily with a campaign urging surgeons to "Sign Your Site."
Liability for wrong-site surgery skyrockets
The incidence of wrong-site surgery claims has held steady over the past two decades, but the average indemnity has gone through the roof, according to an analysis supplied by the Physicians Insurance Association of America in Rockville, MD. There were 44 claims in 1985, of which 34 were paid, with an average indemnity of $38,927. The number of claims held fairly steady over the years, but the average indemnity climbed rapidly, increasing to an average of $144,181 in 2002.
Wrong-site surgery claims are far more likely to result in payment, according to the AAOS and PIAA, with a whopping 84% paid instead of the 30% average in all orthopedic malpractice claims.
A leading proponent of the movement to eliminate wrong-site surgery is S. Terry Canale, MD, chairman of the orthopedic department at the University of Tennessee’s Campbell Clinic in Germantown, TN, where all 30 orthopedic surgeons and 32 residents sign their patients before surgery. He also is a former president of AAOS. Canale says that, though the idea of signing the surgical site is not new, risk managers should not assume that operating room (OR) staff are doing it correctly in their facilities.
"The problem has been that when OR committees got hold of our plan, they said it was a little too rigid and they didn’t want to burden the surgeon because he may go to another hospital," he says. "So they lessened the restrictions by allowing the nursing service to sign the site, or even to let the patient do it. But it’s the surgeons’ responsibility. The further he delegates it down the line, the more the chance for error."
Research has shown that when patients are instructed to sign the site, only about a third do it correctly. Another third does it incorrectly, and the rest don’t do it at all.
25% chance of committing wrong-site surgery
Canale chaired an AAOS task force that found that the problem is more widespread and serious than many believed. Using a database of 37 wrong-site surgery claims from the State Volunteer Mutual Insurance Co. in Tennessee, the AAOS determined that the error was discovered during surgery in 60% of cases and the originally planned procedure was carried out in the correct location while under the same anesthesia. Twenty-six patients had no residual deficit other than cosmetic effects, but others suffered impairment at the operative site, permanent disability, and other effects.
In 18 cases, the doctor and the hospital shared the financial liability. The physician or physician group was solely responsible in nine cases, and 10 other cases remain open.
Using the Tennessee database and extrapolating its numbers to all orthopedic surgeons in the state, the AAOS estimates that an orthopedic surgeon’s chance of performing wrong-site surgery during a 35-year career is one in four.
The Universal Protocol will be seen as the standard of care, but it does not guarantee that wrong-site surgery can’t happen. It can, however, make a difference when it comes time to assess just how badly your hospital may have dropped the ball and how much you should have to pay. And it will affect how JCAHO views your sentinel event.
"If you have to report a wrong-site surgery as a sentinel event and your mechanism didn’t include having the surgeon mark the operative site, I think you’re going to be in even more trouble," Canale says. "If you commit wrong-site surgery, you’re going to pay whether you follow the protocol or not, but I suppose in terms of how much you get punished for that, in terms of damages, maybe it could make a difference if you can show that you were trying to do the right thing and somehow this accident still happened. That’s got to look better than if the plaintiff’s attorney shows that you knew about this protocol and just ignored it."
The Universal Protocol strengthens the advice already offered by JCAHO in its National Patient Safety Goals, says Richard J. Croteau, MD, executive director for strategic initiatives at JCAHO. One advantage will be that surgeons can expect to follow essentially the same protocol at any hospital, with minimal variations. The protocol still allows some variation in exactly how the operative site is marked, but it makes clear that the surgeon should do the marking, which is different from the National Patient Safety Goals. (See additional resources.)
"Another difference over common practice is the specific advice not to mark any nonoperative sites," he says. "That has been one of the biggest variations from organization to organization. Some mark the intended site and some mark the nonoperative site. That variation in itself has led to some confusion and wrong-site errors."
Croteau says risk managers should find that implementing the Universal Protocol can be done at minimal expense and without a great deal of effort. The work will consist almost entirely of educating surgeons and staff about how the new protocol works and why it is important to implement it effectively.
Both Croteau and Canale offer the same bottom line advice to risk managers: The Universal Protocol should be implemented without delay. "Put it in front of the OR committee and say, This is what we have to do,’" Canale says. "JCAHO is saying this isn’t just a good idea anymore, it’s what you have to do."
The new protocol for preventing wrong-site surgery is likely to be considered the standard of care immediately and plaintiffs attorneys will use it against you in court, says a prominent trial attorney. Risk managers should act quickly to implement the protocol now and not wait for the protocols deadline, the attorney adds.
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