Published 3/1/2007
Robert L. Brooks, MD

Are you using the Universal Protocol yet?

To prevent rare—but devastating—cases of wrong-site surgery, the Universal Protocol needs to be used universally.

The Universal Protocol—the systematic use of surgical site marking, a preoperative checklist, and a time-out immediately before incision—is effective in preventing the rare but devastating “never event” of wrong-site, wrong-patient, or wrong-procedure surgery. However, it has not yet been universally implemented in American hospitals and ambulatory surgery centers. As a result, wrong-site surgeries (WSS) continue to occur at an unacceptable rate.

This was the consensus reached during a national medical leadership summit meeting held recently in Chicago. Representatives of the American Academy of Orthopaedic Surgeons (AAOS), the American College of Surgeons, the Joint Commission (formerly JCAHO), the Association of Operating Room Nurses, and other patient safety leaders reviewed the WSS experience in America over the past three years.

The Joint Commission received approximately 70 reports of wrong-site surgeries nationally in 2004, 82 reports in 2005, and 75 reports in 2006. In most recent WSS case reports, the Universal Protocol was not used.

We know it works

The AAOS was among the first medical associations to advocate for improved systems to protect patient safety. The AAOS “Sign Your Site” campaign to encourage orthopaedic surgeons to mark the surgical site with their initials was introduced nearly a decade ago. Partly as a result of AAOS experience and with AAOS support, the Joint Commission began requiring all accredited American hospitals to implement a standardized preoperative safety system in 2003.

“The Universal Protocol For Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery” is based on research that demonstrates how to effectively prevent this rare but terrible event. The protocol involves three simple steps: surgical site marking, a preoperative checklist, and a time-out. Military experience with similar “Crew Resource Management” techniques has shown an overall decrease in other operating room errors when surgical teams are collegial, cooperative, and consistently understand expectations.

So why has there not been a more significant decrease in the number of WSS reports to the Joint Commission in the last two years? In fact, because reporting to the Joint Commission is voluntary, most cases may go unreported. Data from the New York State Department of Health, where reporting has been mandatory since 1985, show about 90 cases annually in that state alone.

Even proper use of the Universal Protocol in its current form may not prevent all types of WSS. Possible failure modes include surgery on the wrong patient or site due to an incorrect biopsy, technical errors resulting in an incorrect operation, or not having a correctly sized implant in spite of preoperative planning. There was broad consensus, however, that further refinement of the protocol was less important for the protection of patients than increasing the protocol’s use in all interventional procedures.

You can make it happen

Adoption of the Universal Protocol as the new standard for all operations appears to vary with region, surgical specialty, and facility. Many nonorthopaedic surgical specialty societies have not yet completed evaluations of how the underlying principles of site marking may be best applied in their fields. In addition, the Joint Commission requirement for use of the Universal Protocol does not apply to most ambulatory surgery centers, which often are accredited by other agencies.

Various strategies can be employed to increase the use of the Universal Protocol. AAOS representatives recommended involving surgical subspecialty societies and their state associations. The Joint Commission intends to increase its accreditation of ambulatory surgery centers over the next few years. State officials from New York recommended that more states adopt mandatory use of the protocol, as well as mandatory reporting of all WSS events for better analysis and prevention. Gaining consensus of other accrediting organizations and the medical liability insurers was also proposed.

The AAOS is proud of its history of leadership and advocacy in patient safety. Surgeons and physicians are the best advocates for the care of their patients, and systems such as the Universal Protocol have the potential to prevent not only wrong procedures, but other perioperative problems as well. All AAOS fellows should advocate for consistent use of the Universal Protocol within their medical institutions. In addition, we must support other standardizations of staffing, equipment, and perioperative process to decrease the risks of surgery and reduce the stress of modern operating suites.

Robert L. Brooks, MD, is the chair of the AAOS Patient Safety Committee. He can be reached at rlbrooks@wchsys.org