October 2004 Bulletin

Universal Protocol: Three months into mandatory compliance

Surgeons address concerns about wrong site surgery protocol

By Kathleen Misovic

Three months after mandatory preoperative surgical site marking went into effect, some hospitals are concerned that compliance will be a burden.

The mandatory signing is one of three components of the Joint Commission on Accreditation of Healthcare Organization’s (JCAHO) Universal Protocol for Wrong Site, Wrong Procedure and Wrong Person Surgery. The Universal Protocol went into effect on July 1, 2004, for all organizations accredited by JCAHO.

“Surgeons think that theoretically site marking is a good idea,” said David A. Wong, MD, chair of the AAOS Patient Safety Committee. “But some have concerns about the extra time it takes to do the things mandated in the protocol and patients’ resistance.”

Dr. Wong attempted to overcome some of the resistance to the protocol as one of several guest speakers at an implementation meeting sponsored by JCAHO on August 23 in Rosemont, Ill. Terry Canale, MD, an AAOS past-president and chair of the original AAOS Task Force on Wrong Site Surgery, was also a guest speaker. The meeting was open to physicians, hospital staff, insurance companies and insurance compensation groups, who were free to ask questions and air concerns.

Patient participation is vital

A common concern addressed at the meeting was whether patients could receive sedation prior to verifying the surgery site. The JCAHO Universal Protocol requires that patients are awake and aware to verify the site.

“Some surgeons don’t want to take the time to sign the site and then wait for patients to be fully anesthetized before they can start their surgery,” said Kristin Glavin, AAOS associate general counsel/director of corporate legal affairs, who attended the JCAHO meeting and staffs the AAOS Patient Safety Committee. She explained that many surgeons have been accustomed to entering a surgery room when the patient is already draped, completely sedated and immediately ready for surgery.

Dr. Wong confirmed that JCAHO allows mild sedation if it doesn’t affect the patient’s ability to participate in the site marking.

If the patient is non-speaking, comatose, incompetent or a child, surgeons should rely on the person who has the authority to provide informed consent to verify the site, according to

JCAHO. If the patient can verify the site but refuses to participate, even after the surgeon emphasizes the importance of the patient’s active role, the procedure need not be cancelled. But the surgeon must follow the organization’s policy regarding procedural and documentation requirements in the case of a patient refusal.

“X” doesn’t mark the spot

A second concern addressed at August’s implementation meeting was whether surgeons should use an “X” to mark the surgery site. JCAHO and the AAOS recommend using the surgeon’s initials because an “X” can be ambiguous. Wong cited a case related by a nurse where an “X” caused confusion.

“The surgeon marked the top of a patient’s foot with an X and then the patient crossed her feet before surgery. The marker smeared and she ended up with an X on both feet. If you use your initials, you’ll have a reverse image of them on the incorrect foot if this happens,” Dr. Wong explained.

The time factor was also cited as a concern, especially among surgeons who do outpatient surgery. They noted that their tight schedules could mean delays if they must mark a site just prior to beginning surgery. Dr. Wong suggested that these surgeons simply mark the site during the pre-op office visit while patients are signing their consent papers.

AAOS leads the way to patient safety

Although some orthopaedic surgeons are just becoming familiar with the JCAHO Universal Protocol, many AAOS members have been following similar AAOS recommendations for nearly seven years. In 1997, the AAOS established a Task Force on Wrong Site Surgery that determined an orthopaedic surgeon has a one-in-four chance of performing a wrong site surgery during a 35-year career. Surgical site marking has been a voluntary effort among AAOS members since 1998, when the Academy first adopted its Wrong Site Surgery Advisory Statement and established the “Sign Your Site” program.

Last year, JCAHO decided that reducing or preventing wrong site surgeries should be one of its 10 National Patient Safety Goals. JCAHO held its initial meeting to develop the protocol in May 2003, with the assistance of the AAOS and other national medical associations. Because of its previous work on the topic, the AAOS was instrumental in assisting JCAHO with the protocol, according to Dr. Wong and Ms. Glavin.

“We had the carrot—the evidence that wrong site surgery was a problem, and a way to eliminate it—but we didn’t have the stick,” Ms. Glavin said. “Now the commission has provided the stick.”

Dr. Wong predicted that surgeons would become accustomed to following protocol mandates in the near future.

“When it was a voluntary program, acceptance was more of an issue. We had to rely on people’s goodwill,” he said. “But once the mandate has been in place for a while longer, it won’t be such an encumbrance.”