Wrong-site surgery: Officials now recommending zero tolerance

They say there’s no reason for one more wrong-site error

Voicing ever stronger concerns that the health care community still is not doing enough to prevent wrong-site surgery, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recently called on all providers to adopt a no-nonsense, zero-tolerance policy toward that grave error. There is no excuse for performing a procedure on the wrong body part, wrong person, or the wrong procedure on the right patient, say leaders from the Joint Commission and virtually every specialty medical organization.

The nearly universal endorsement of steps to prevent wrong-site surgery creates a de facto standard of care for which your organization will be held accountable, they say. But spot checks show that more than a third of providers are not following the required steps, JCAHO reports.

More than 40 organizations now have endorsed a new Universal Protocol to standardize pre-surgery procedures for verifying the correct patient, the correct procedure, and the correct surgical site. The protocol focuses attention on marking the surgical site, involving the patient in the marking process, and taking a final timeout in the operating room to double check information among all members of the surgical team.

In announcing the widespread endorsement of the Universal Protocol, JCAHO president Dennis S. O’Leary, MD, emphasized that wrong-site surgery still is a problem despite years of intense focus by JCAHO and other organizations such as the American College of Surgeons (ACS) in Chicago. Despite issuing Sentinel Event Alerts about wrong-site surgery in 1998, and again in 2001, JCAHO continues to receive five to eight new reports of wrong-site surgery every month, O’Leary reports. The Joint Commission’s new National Patient Safety Goals, which became effective Jan. 1, 2003, include a goal to eliminate wrong-site surgery.

"Despite the know-how that we have to prevent these occurrences, wrong-site, wrong-procedure, and wrong-person surgery remains a significant national problem today," O’Leary says. "We have been addressing wrong-site surgery for five years, but the problem persists. The Joint Commission received over 60 wrong-site surgery reports in 2002, and already we have received over 50 in 2003. And these are only the cases where organizations have voluntarily decided to share the information with us or we have learned about them from the media."

Universal Protocol promises to reduce errors

The answer to the ongoing problem is strict adherence to the Universal Protocol, O’Leary says, and many health care leaders agree. The Universal Protocol grew out of a May 2003 summit convened by JCAHO, in collaboration with the American Medical Association, the American Hospital Association, the American College of Physicians, the ACS, the American Dental Association, and the American Academy of Orthopaedic Surgeons. More than 30 organizations were represented at the summit. Summit participants quickly reached consensus that a Universal Protocol would help to prevent the occurrence of wrong-site, wrong-procedure, and wrong-person surgery, O’Leary says. The participants also agreed that the protocol should be specific, both to eliminate confusion about surgical site marking and to facilitate communication among surgical team members, and that it should provide the flexibility needed for unique surgical situations.

"With physicians, nurses, and other practitioners — as well as health care organizations themselves — standing behind this Universal Protocol, we have a real opportunity to reach our collective goal to eliminate this problem," O’Leary says.

The Universal Protocol officially becomes effective July 1, 2004, for all JCAHO-accredited hospitals, ambulatory care surgery centers, and office-based surgery sites. Compliance may require substantial changes in policy and procedure at some hospitals, he says. Though much of the protocol already has been in place as part of the Patient Safety Goals, O’Leary says recent unannounced JCAHO site visits have revealed that 36% of accredited organizations are not marking the operative site.

Diligence can eliminate errors

The ACS is a major proponent of the protocol, and executive director Thomas R. Russell, MD, FACS, says risk managers should require strict adherence. The protocol is more than just a good idea, he says — it’s an absolute necessity. "Wrong-site, wrong-person, wrong-wrong procedure errors should no longer exist in our hospitals or our ambulatory care centers throughout the United States," he says. "Though this is not a particularly frequent event, we had 60 reported [in 2003], and clearly there were more than that. This protocol should eliminate that problem."

Russell says one of the most important parts of the Universal Protocol is the concept of a time out during which all members of the team, not just the surgeon, pause to discuss whether any concerns or questions remain. "This is an important time when all members of the team can come to an understanding about this procedure and this patient before the anesthetic is administered," he says. "We are most enthusiastic about this. We believe that if hospitals and health care providers adopt this Universal Protocol, we can eliminate this problem."

That prediction is supported by James H. Herndon, MD, president of the Rosemont, IL-based American Academy of Orthopaedic Surgeons, which first promoted the idea that surgeons should sign their names or otherwise mark directly on the correct operative site to avoid wrong-site errors. That practice now is included as part of the Universal Protocol. Herndon says that, unlike some medical errors, wrong-site surgery is 100% preventable. "One more incident of wrong-site surgery is one too many," he says. "If all health care providers commit to following this protocol, wrong-site, wrong-procedure, wrong-person surgery can become obsolete."

Some room for judgment calls

Though the proponents call for strict adherence to the protocol, they also acknowledge that there is some question as to exactly what procedures require use of the protocol at all. Obviously, is it necessary for surgical procedures in a hospital operating room, but what about a procedure performed on an outpatient basis in a physician’s office with no assistants?

JCAHO’s O’Leary says some judgment will be necessary in those situations. But even if the entire Universal Protocol is not necessary for such situations, the practitioner still should follow the intent of the protocol by taking the time to verify the procedure details before proceeding. "Things like marking the site can be appropriate even for simple procedures, and taking the time out to verify that everything is correct can be a useful thing to do," he says. "My experience is that even with an office procedure you usually have some nursing support and being able to use that to play back and verify is helpful, at least in procedures involving some risk."

Russell agrees that "judgment will be necessary because obviously the Universal Protocol will not be appropriate in some procedures performed in a doctor’s office." But he also encourages practitioners to use at least some components of the protocol that might be appropriate. "We’d like to see the protocol used outside the hospital, and even in the hospital it isn’t just for the operating room," he says. "I think the protocol would be appropriate in cath labs and GI labs in hospitals."

Should lower malpractice risk

Proponents of the Universal Protocol say it should lower a hospital’s malpractice risk. Russell says a hospital can cut its wrong-site malpractice risk to zero by following the protocol religiously. "This is malpractice," he says. "It’s hard to defend one of these cases. That’s why they’re generally settled out of court."

O’Leary notes that a provider could increase its malpractice risk by not complying with the Universal Protocol now that it is so universally accepted as the standard of care an effective means for preventing the error. "If a specific injury can be linked to a national requirement and you can make a persuasive case for it, that exposure exists today," he says. "I guess you could say that the Universal Protocol amplifies that risk."

One surgeon who performed wrong-site surgery says the Universal Protocol could have prevented his mistake. Arnold A. Zeal, MD, FACS, chief of neurosurgery at Baptist Health System in Jacksonville, FL, was performing a lumbar disc operation and intended to approach the disk from the right to look for a bone fragment. But instead he approached the disk from the left and could not find the fragment. "I could never understand how this could happen until I had the unfortunate experience of performing wrong-site surgery myself," he says. "Fortunately, there was no real injury to the patient, but the procedure was truly devastating not only to the patient but also to myself. When I started investigating, I found that it was much more common than I ever imagined. I became acutely aware of the need for a protocol to prevent this from happening again, and also how the operative team needs to be involved to prevent these instances."

In his case, Zeal says he never realized he was on the wrong side until the procedure was complete. When he couldn’t find the bone fragment he was looking for, he kept searching and taking X-rays, but the X-rays were side views that don’t indicate which side of the patient they depict. After realizing the problem, Zeal operated on the patient an hour later and removed the fragment from the correct side. "I think the protocol would have totally prevented this. If we had a mark on the appropriate side, if we had a time out, if we had a checklist, I think all of that would have prevented it," he says. "It was not my usual operating room and not my usual operating staff, and nobody raised the issue of which side of the patient I was standing on. That would have been corrected if we had a protocol and the marking."