AAOS Bulletin - December, 2005

The Universal Protocol: A one-year update

Incidents of wrong-site surgery are declining

By David A. Wong, MD, MSc, FRCS(C)

Implementation of the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Patient SurgeryTM has been a mandatory requirement in all hospitals accredited by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) since July 1, 2004. Preliminary data from the first six months of monitoring adverse events via the JCAHO Sentinel Events Program has recently become available.

Indications are that following the Protocol will reduce such seminal events.

The AAOS, by virtue of our longstanding experience with the voluntary Sign Your Site program, was asked by the JCAHO to collaborate on the development of the Universal Protocol and played a key role in defining the particulars of the final methodology.

AAOS, JCAHO and the American College of Surgeons cosponsored a National Summit in May 2002 where work groups composed of representatives from more than 40 medical organizations shaped the Protocol. The final Protocol has three key elements: patient identification, surgical site marking and a time out.

Patient identification

Patient identification was included as a discrete step based on an analysis of data on wrong-site surgery from the

JCAHO Sentinel Events database. On the database, several categories of adverse events were combined under the “wrong-site surgery” category. Somewhat surprisingly, the analysis found that 12 percent of wrong-site surgeries were actually “wrong patient” procedures.

Site marking

Surgical site marking has been the cornerstone of the AAOS Sign Your Site program for almost 10 years. The importance of this step was emphasized when a review of the sentinel events data showed that 59 percent of the incidents reported still involved operations on the wrong side. Another 19 percent involved other “wrong sites,” such as the wrong digit on the correct hand or foot.


The time-out provides an opportunity for the whole team to review and confirm details of patient identification, surgical site marking and the procedure. The sentinel events database showed that 10 percent of the wrong-site surgeries were actually wrong procedures. During the time-out, the procedure is confirmed in three places: on the clinic notes, on the operating room schedule and on the consent form.

The time-out also affords an opportunity to review final details involved in the surgery. This is a similar situation to “running the final checklist” in the aviation industry. The AAOS has developed a preoperative checklist as part of the Sign Your Site program. This document is designed to be used at the time-out because it ensures that particulars such as availability of medical records, imaging studies, X-ray equipment, instrumentation, blood and implants all can be confirmed. The checklist can be downloaded from the Patient Safety section of the AAOS Web site.

Patient safety

Improving patient safety is the aim of both the JCAHO Universal Protocol and the AAOS Sign Your Site program. Until now, the best national data on the effectiveness of similar practices has come from Canada. The “Sign Through Your Initials” is a voluntary program sponsored by the Canadian Orthopedic Association and the country’s national professional liability carrier, the Canadian Medical Protective Association (CMPA). By tracking the number of suits filed and documenting potential suits, CMPA found that these incidents have been reduced by 65 percent over about 10 years.

At recent JCAHO meetings in Orlando and Los Angeles on “Prevention of Sentinel Events,” preliminary data was presented on the results of the first six months following the mandatory introduction of the Universal Protocol. Richard Croteau, MD, executive director of patient safety initiatives at JCAHO, reported that for the first time since the Sentinel Events program was established, incidents of wrong-site surgery had declined. During the first two quarters after implementation of the Universal Protocol, reports fell below the baseline rate of approximately 70 events per year from the previous two years.

Although the JCAHO report is very encouraging news, additional periods of data collection will be required before definite evidence of an effect from the Universal Protocol can be judged. However, moving to such systems-based interventions is an important step forward in fulfilling the AAOS mission of high quality patient care.

David A. Wong, MD, MSc, FRCS(C), is chairman of the AAOS Patient Safety Committee.

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