By David A. Wong, MD, MSc, FRCS(C)
Beginning July 1, 2004, preoperative surgical site marking becomes a mandatory intervention in U.S. hospitals and surgical centers. The procedure is part of the Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) implementation of its “Universal Protocol” to enhance patient safety. With JCAHO's adoption of the elimination of wrong-site, wrong-patient and wrong-procedure surgery as a National Patient Safety Goal, all accredited organizations will be required to use a preoperative verification process and a surgical site marking process. Health care organizations such as critical access hospitals, hospitals, health care networks and office-based surgical practices must implement such procedures to maintain their JCAHO accreditation.
Never before has such a strong, national emphasis been placed on the need for surgical site marking. For the first time, surgical site marking and a preoperative verification process are being recognized as major components of a systems solution to help eliminate the incidence of wrong-site, wrong-patient, wrong-procedure surgery.
The AAOS role
With its ‘Sign Your Site' (SYS) initiative, the AAOS has been a thought leader in surgical site identification for nearly a decade. S. Terry Canale, MD, chaired the initial 1997 AAOS Sign Your Site Task Force formed to evaluate concerns raised by reports of wrong-site surgery. After a review of closed claims data from several professional liability insurance companies, the task force created the first ‘Sign Your Site' program. Surgical site marking has been a voluntary effort within the fellowship since 1998, when the AAOS first adopted its Advisory Statement on Wrong-Site Surgery.
By the 2000 Annual Meeting, an on-site survey revealed that 77 percent of orthopaedic surgeons were aware of the SYS program, and nearly half had begun to institute or promote the program. However, it remained a voluntary effort, and institutions developed different, sometimes conflicting, methods of implementing the program. At least one survey indicated that one in five orthopaedic surgeons will have an occurrence of wrong-site surgery in his or her career.
AAOS public service
advertising campaign highlights
JCAHO also began to track statistics on wrong-site surgeries as part of its Sentinel Events monitoring in hospitals. From January 1995 through September 2003, 278 incidents of wrong site surgery were reported to JCAHO. Thirty five per cent of these involve orthopedic surgery. And JCAHO continues to receive five to eight new reports of wrong-site surgery every month. As of the end of January 2004, wrong-site surgery was the third highest sentinel event, accounting for more than 12 percent of all sentinel events reviewed by the Joint Commission since 1995.
The overall incidence was sufficient that the JCAHO decided to make surgical site identification one of its quality goals beginning in 2003. Further, a summit was convened in May 2003 to develop a “Universal Protocol” to avoid wrong-patient, wrong-procedure and wrong-site surgery. The AAOS, as the only U.S. professional medical association with a formal surgical site marking policy, played a significant role in that summit.
An additional congress was held in December 2003 to introduce the Universal Protocol to the press and more than 100 provider organizations from around the country. AAOS 2003-2004 President James H. Herndon, MD, participated in the press conference announcing the endorsement of the Universal Protocol by more than 40 professional medical organizations. In addition, Dr. Canale, a representative of the Association of periOperative Registered Nurses and I presented a three-hour seminar on implementing the protocol in health care organizations.
In addition to a system of surgical site marking, the Universal Protocol also includes methodology for verifying patient identity and the surgical procedure planned. Final confirmation of all elements of the protocol is performed in a team “time-out” immediately prior to incision.
The AAOS, coordinating with JCAHO, revised its Advisory Statement on Wrong-Site Surgery and added a “Checklist for Safety” and “Recommendations for Management Following Discovery of Wrong-Site Surgery.” These can be found in the Library and Archives section of the AAOS Web site.
Clarification of Elements of the Universal Protocol
A significant benefit of the December 2003 Congress was the opportunity to discuss and clarify issues that had arisen from the original Protocol documents. JCAHO Executive Director for Strategic Initiatives, Richard Croteau, MD, answered questions from the group and was able to define the margins for compliance with the protocol more precisely. Many of the questions revolved around the alternate terminologies “should” and “must.” The use of specific wording was quite deliberate.
The use of “must” and “should” is intended to distinguish between requirements (those steps that must be done) and preferred approaches that should be taken. Where the word “must” is used in JCAHO documents, a definite compliance with the letter of the assertion is expected. In situations of a “should” expression, the JCAHO would allow some leeway in implementation to accommodate the unique characteristics of a particular organization.
For example, the Implementation Guidelines for the Universal Protocol say that “Site marking must be done for any procedure that involves laterality, multiple structures or levels.” However, they also state that “The person performing the procedure should do the site marking.”
Questions and answers about the Protocol
Who marks the surgical site? Although JCAHO says that the surgeon “should” sign the surgical site, the meeting clarified that a “credentialed provider” who is a member of the patient's surgical team for the procedure can perform the initial site marking and confirm with the entire surgical team at the time-out. A “credentialed provider” may include a resident, fellow or licensed physician's assistant.
What site or sites are marked? Only a single site—the actual surgical site—should be marked. This prevents confusion between protocols at various institutions. For example, one operating room nurse related that the normal practice in her hospital was to mark the surgical site with an “X.” At another nearby institution, an “X” was placed on the wrong extremity. Little wonder that the surgeons practicing at both medical centers found the situation confusing.
What type of mark should be made? Using an “X” to mark the site is not recommended for several reasons. As described above, the “X” has been used to mark both the proper site and the wrong site. This is an obvious potential conflict. Further, there was another anecdotal report during the Congress of a patient who had an “X” marked on the dorsum of her foot to indicate the surgical site. Before the ink dried, the patient crossed her feet at the ankles. The tops of both feet touched, so that an “X” appeared on the dorsum of both feet.
This situation can be avoided by using the surgeon's initials as advocated by the AAOS SYS program. In the situation described above, the mark on the wrong extremity would be the mirror image of the writing on the true surgical site.
Does site marking eliminate the use of preoperative sedation? The JCAHO Protocol says that the surgical site “should” be marked with the involvement of the patient and, where appropriate, the family. This does not preclude the use of mild sedatives. Involvement of the patient is one confirmatory step of the Universal Protocol. However, site marking does not have the same weight of consent that would be required for the signing of the surgical consent form, for example.
How can efficient turnovers be maintained, especially at ASCs? There have been several good suggestions to help this situation. Marking the site at the preoperative office visit when surgical consents are signed is probably the most efficient. Indelible ink must be used so that the mark remains visible until the surgery. If marking is done on the day of the procedure, using the “credentialed provider” from the surgical team to do the initial marking may help speed the process.
The AAOS has been a leader in the patient safety movement, not only through its efforts to eliminate wrong-site surgery but also through its advocacy and education campaigns. It is gratifying to see other professional medical organizations and the regulatory agencies add their voices to the call for a safer treatment environment for our patients.