The Case

A patient went to the operating room (OR) for surgery on the lower leg. Per the Universal Protocol, the surgeon marked the proper leg prior to bringing the patient to the OR. The patient was placed in the prone position and anesthesia was administered. A "Time Out" was performed, during which all the team members met and confirmed the procedure. The nurse began to prep the patient's lower leg, but the anesthesiologist felt that something wasn't right. After stabilizing the patient, he checked the chart and discovered that the nurse had scrubbed the wrong extremity. He notified the team members and stopped the procedure. The patient had come just minutes away from having surgery on the wrong leg, but no harm occurred. The correct leg was then prepared, and the patient underwent successful surgery.

The Commentary

Nothing, it is said, is simple. Since 1998, when the Joint Commission issued its first Sentinel Event Alert on wrong-site surgery (1,2), it has amassed over 300 voluntarily submitted reports that describe the performance of surgical procedures on the wrong body site (usually right versus left mistakes) or on the wrong patient, or the performance of the wrong procedure on the "correct" patient.(3) Some of these occurrences have eventually led to patient deaths. How—in the world's most sophisticated operating theaters and in the hands of highly trained surgeons—can such things happen? Or, in this case, almost happen?

On the surface, the problem in this case is that the "Time Out" provision in the Universal Protocol was not properly followed. The Joint Commission's Universal Protocol for the Prevention of Wrong Site, Wrong Procedure, and Wrong Patient Surgery was implemented on July 1, 2004 with the formal endorsement of over 50 surgical specialty societies and other professional organizations.(4) The Protocol describes specific requirements for a pre-operative verification process, the marking of the surgical site, and the conduct of a "Time Out" in the operating room before the surgical procedure actually begins.

The basic purpose of the "Time Out" process is confirmation, but that confirmation, as stipulated in the Universal Protocol, is multi-faceted. The process is designed so that, at its conclusion, all of the surgical, anesthesia and nursing professionals to be involved in the surgical event have unequivocally confirmed the identity of the patient, the procedure to be performed, the surgical site, the positioning of the patient on the operating room table, and, where relevant, the prosthesis to be implanted. To all appearances in this case, this confirmation process was not systematically performed.

The preparation for and performance of surgery are system-dependent processes. This is not—as most medical students and surgical residents are taught—simply an engagement between a doctor and his or her patient. From the time of the decision to perform surgery to transfer of the patient from the operating room to the post-anesthesia recovery room, multiple, seemingly simple processes—involving doctors, nurses, technicians, and other hospital or surgery center staff, as well as technology of various levels of complexity—become part of the patient's experience. In health care, we call these "systems." But in most medical and nursing schools, we do not call these anything, for systems thinking is not taught in these schools. Nor is much taught about the importance of teaming (such as Crew Resource Management principles) and human factors. And the level of enlightenment on these deserts of knowledge is unlikely to expand during post-graduate training, particularly when the teachers and role models lack the relevant training and understanding themselves.

It is no small wonder that many who labor in operating rooms believe that wrong-site surgery is something that happens somewhere else, but certainly never here. Yet every step in this system—every step that brings the patient to and through the operating room—is an opportunity for error. And every human—including every surgeon, anesthesia professional, and technician—is prone to error. Even if these professionals are not steeped in systems thinking, basic awareness of the potential frailties in human performance should breed professional humility.

Good systems do not just happen. They are carefully designed to involve only steps that are absolutely necessary, and to include safeguards that will prevent human error from reaching the patient. Most systems, even simple ones, operating in health care organizations today fall short of this characterization.

The Joint Commission does not operate health care organizations, nor does it design organization systems. But its standards, its national patient safety goals (5), and now its surgery Universal Protocol do provide both general and prescriptive guidance as to how specific organization systems should be designed. Prescriptive guidance is generally reserved for clearly documented, ubiquitous performance problems such as medication errors and wrong-site surgery.

These guideposts, and indeed the accreditation process itself, are intended to help health care organizations and practitioners do their daily work better. For those who recognize Joint Commission accreditation and standards as being inseparable from their daily work, the embracing of the Universal Protocol and other Joint Commission expectations comes quite naturally. For the remainder, these are often viewed as annoying requirements and their validity is frequently called into question. In the latter circumstance, the Universal Protocol is seen as simply another piece of paper.

Good organization systems are designed by and "owned" by organizations themselves. Each step in each process is clearly delineated and understood by all participants, and the roles of each participant are also well defined. There is no ambiguity. Here, the Universal Protocol frames the system expectations, and the organization designs the system(s) to fit its own particular setting and characteristics.

Today, the Universal Protocol and the specific internal systems that are based on it, or are otherwise consistent with it, are "owned" by a growing number of health care organizations and practitioners. These are organizations in which the priority for patient safety is progressively becoming an integral part of their cultures. Indeed, it is the transition to true cultures of safety across all health care organizations that will ultimately determine the impact and success of the Universal Protocol and other efforts to reduce or even eliminate preventable adverse events.

Dennis S. O'Leary, MD President, Joint Commission on Accreditation of Healthcare Organizations

William E. Jacott, MD Special Advisor for Professional Relations, Joint Commission on Accreditation of Healthcare Organizations Emeritus Professor of Family Medicine, University of Minnesota Medical School

References

1. Sentinel event alert. Lessons learned: wrong site surgery. Joint Commission on Accreditation of Healthcare Organizations Web site. August 28, 1998. Available at: [ go to related site ]. Accessed December 16, 2004.

2. Sentinel event alert. A follow-up review of wrong site surgery. Joint Commission on Accreditation of Healthcare Organizations Web site. December 5, 2001. Available at: [ go to related site ]. Accessed December 16, 2004.

3. Chassin MR, Becher EC. The wrong patient. Ann Intern Med. 2002;136:826-33.[ go to PubMed ]

4. Universal protocol for preventing wrong site, wrong procedure, wrong person surgery. Joint Commission on Accreditation of Healthcare Organizations Web site. Available at: [ go to related site ]. Accessed December 16, 2004.

5. 2004 national patient safety goals. Joint Commission on Accreditation of Healthcare Organizations Web site. Accessed December 16, 2004.