Published 9/1/2009
Dirk H. Alander, MD

The Universal Protocol—Can’t love it or leave it!

By Dirk H. Alander, MD

Let’s put an end to wrong-site surgery

The new Universal Protocol: Understand it? Vilify it! Live with it. All are responses to the enactment of the updated 2009 universal protocol for invasive procedures. What may have gotten lost in the recent upheaval—particularly with regard to healthcare reform—are the continuing safety efforts of the AAOS.

A short history
More than a decade ago, the Academy initiated a “sign-your-site” program to address the incidence of wrong-site surgery. That effort was successful on two fronts: highlighting the problem and decreasing the incidence of wrong-site surgery in orthopaedics.

In 2003, the Joint Commission (JC), formerly the Joint Commission of Hospital Accreditation Organizations, proposed its first “universal protocol.” This protocol was developed as a result of the 2003 Wrong Site Surgery Summit, which involved more than 30 professional groups, including the AAOS.

The protocol was aimed at the problems of wrong-site, wrong-procedure, and wrong-patient surgery. The goal was to create a specific protocol with some consideration for flexibility at the local level that would also facilitate communication among surgical team members.

Unfortunately, the goal of decreasing these problems did not occur as expected. In orthopaedics, the incidence of wrong-site surgery continued to decrease, but surgical misadventure rates actually increased over all surgical and procedural specialties.

The response of the JC was to revise the “Universal Protocol” in 2008 and require its implementation in January 2009. The revised protocol had several problems, most notably the exclusion of the surgical community’s input into the final draft. The top-down approach taken by the JC led to angst not only among the AAOS fellowship but also within a wide range of surgical societies and hospitals.

Confusion and concern
The revised protocol has a significant increase in redundancy, a loss of flexibility in implementation at the local level, and tighter limits on those who can participate in signing the surgical site. The application of repetitive administrative duties and the requirement to run the checklist several times within a short period has led to distractions, confusion, and a lack of engagement of those involved in the process—exactly the opposite of what was intended.

The AAOS leadership and the Patient Safety Committee, along with other surgical specialties, have lobbied for clarifications and revisions of this JC-mandated protocol. Since January, the protocol has been revised twice, and the AAOS is continuing its dialog with the JC.

The universal protocol has been revised to allow residents in teaching programs who are directly involved in the surgery to sign the patient’s surgery site. The JC has also modified the “time out” requirements. A holding area checklist is to be completed prior to the patient’s going to the operating room and a single formal “time out” is to be held prior to the surgical incision.

Although the AAOS has encouraged the JC to look at allowing nurse practitioners and physician assistants to sign the site if they are involved in the surgical procedure, the JC has not changed its stance and does not allow these practitioners to perform this preoperative function.

Don’t gripe…get on with it
As an Academy, the AAOS has supported the continued development of measures that promote safety in the operating room, on the playground, on the athletic field, and in the home. Improved communication skills, which have also been promoted by the AAOS, are a strong starting point for improving surgical safety.

As Academy members, orthopaedic surgeons can and should continue to participate at the local level and to work with hospitals to improve patient outcomes. At the local, regional, and national levels, orthopaedic surgeons need to educate legislators about AAOS efforts to improve patient safety and to identify the obstructions and work for changes in the medical and legal systems to enhance patient safety and improve outcomes.

Let us reinforce our commitment to putting our patients first when providing medical and surgical care. The universal protocol is a step toward minimizing preventable surgical errors. Let’s take the wrong-site, wrong-procedure, and wrong-patient complication out of the operating room.

Dirk H. Alander, MD, associate professor, department of orthopaedic surgery at Saint Louis University, is a member of the AAOS Patient Safety Committee and the Board of Councilors. He can be reached at alanderd@slu.edu