HISTORICAL REVIEW OF PATIENT SAFETY AND WRONG-SITE SURGERY PREVENTION

In 1994 the Canadian Orthopaedic Association implemented “Operate Through Your Site.” This was an educational program for their surgeons targeted at reducing wrong-site procedures (WSPs) (Canadian Orthopaedic Association Committee on Practice and Economics, 1994). Leading the way in the United States, the Council on Education of the American Academy of Orthopaedic Surgeons (AAOS) organized a task force in 1997 to research data on wrong-site surgery. The task force’s charge was to determine the prevalence of wrong-site surgery and to develop recommendations for preventing it. Data from the report demonstrated that from 1985 to 1995, 225 orthopaedic wrong-site surgeries and 106 other surgical specialty insurance claims were filed. These wrong-site surgeries averaged payouts of $48,087 to orthopaedic patients and $76,167 to patients in other specialties (Canale, 2005). Outcomes from this initiative resulted in the Advisory Statement on Wrong-Site Surgery, which stated, “The American Academy of Orthopaedic Surgeons (AAOS) believes that a unified effort among surgeons, hospitals and other health care providers to initiate preoperative and other institutional regulations can effectively eliminate wrong-site surgery in the United States” (AAOS, 2008).

The advisory statement spelled out effective methods for eliminating wrong-site surgery (AAOS, 2008):

This advocates strongly for having the patient involved, marking of the surgical site, involvement of the surgical team, and specific organizational policies to mandate the preventive measures. The AAOS did not stop there; they also advised that the surgical team should take a time-out and confirm the patient’s identity, correct procedure and site, equipment, implants and devices, and an additional check of the patient’s medical record and radiologic studies plus addressing discrepancies before starting the procedure. This pause must include all members of the surgical team and leave time to ask questions if necessary. In 1998 the AAOS established the “Sign Your Site” campaign, which issued the advisory statement and created a logo, audiovisual programs, exhibits, and a mail campaign that delivered 20,000 informational flyers to orthopaedic surgeons and operating room committees. The concepts for correct-site surgery were also incorporated into the academy’s surgical skills courses, instructional courses, and their specialty day meetings.

In 1998 The Joint Commission International Center for Patient Safety published Sentinel Event Alert, issue 6—Lessons Learned: Wrong Site Surgery. This publication identified factors that may contribute to increased risk for wrong-site surgery, and it highlighted communication issues as the leading root cause. Three strategies for reducing the risk of wrong-site surgery were suggested (The Joint Commission International Center for Patient Safety, 2008): (1) marking of the operative site, (2) oral verification of the site by the surgical team, and (3) use of a safety checklist to include all aspects of verification.

The 1999 Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System dealt a serious blow to the U.S. health care system. The purpose of the report was to promote safer processes in our health care systems and to bring out into the open those serious concerns often hidden or discussed behind the closed doors of operating rooms and interventional units. This landmark publication, through its staggering numbers of reported patient deaths from preventable medical errors, heightened the awareness of patient safety issues for health care providers, patients, legislators, regulatory agencies, and the media. Media coverage quickly spread the word that the IOM report suggested that between 44,000 and 98,000 patients die in the United States every year as a result of medical errors. This exceeds the deaths attributable to motor vehicle accidents, breast cancer, and acquired immunodeficiency syndrome (AIDS). The report also put a dollar value on the errors, stating that the national cost was estimated at $37.6 billion to $50 billion for adverse events and that between $17 billion and $29 billion was for preventable adverse events (Kohn et al, 2000). One of the issues stated in the report is the lack of standardized nomenclature. The study used a definition for error from Gaba et al (1994): “An error is defined as a failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning).” An adverse event is defined as an injury caused by medical management rather than the underlying condition of the patient. An adverse event attributable to error is a “preventable adverse event” (Brennan et al, 1991). The report is built around a four-tiered approach with recommendations to create health care environments that advocate for the following (Kohn et al, 2000):

The North American Spine Society (NASS) entered the safety campaign in 2001 through design of their SMaX Campaign, which encouraged surgeons to Sign, Mark and X-ray surgical sites (Wong et al, 2001). The x-ray step related to an additional safety check of a radiograph of the spinal level for site verification before beginning procedures on the vertebrae.

In 2001 a second report from the IOM’s Committee on the Quality of Health Care in America was published. Crossing the Quality Chasm: A New Health System for the 21st Century focused on a call to action to redesign the health care delivery system. The movement is directed toward an efficient, cost-effective, quality, and patient-centered system in which the patient is actively involved—a system that promotes an environment that supports patient and professional safety. The report advocated new skills and new approaches with integration of information technology and alignment of payment policies that included addressing quality improvement and outcomes. Six aims for improvement will drive the needed changes in key dimensions of the current health system. These aims establish that health care should have the following characteristics (Committee on Quality of Health Care in America, Institute of Medicine, 2001):

In 2002 the National Quality Forum (NQF) published Serious Reportable Events in Healthcare. This report identified 27 never events—events that were considered preventable and should never happen. Surgery performed on the wrong body part was on the list. Surgery on the wrong patient and the wrong procedure were listed with additional specifications and implementation guidance for each.

In 2003 The Joint Commission held a Wrong Site Surgery Summit. The Joint Commission collaborated with numerous professional associations: the American Hospital Association, the American College of Surgeons, the American Academy of Orthopaedic Surgeons, the Association of periOperative Registered Nurses, the American Medical Association plus more than 20 other organizations. The goal of the summit was to achieve consensus on the adoption of a standard protocol for preventing wrong-site, wrong-procedure, and wrong-person surgery. The result of input, specific recommendations, and consensus on the principles for prevention was the Universal Protocol for preventing wrong-site surgery.

In October 2003 AAOS produced the “Sign-Your-Site: A Checklist for Safety” tool (Canale, 2005). On June 20, 2004, the Patient Safety First Campaign of the Association of periOperative Registered Nurses (AORN) spearheaded its inaugural National “Time Out” Day. The observance was endorsed by the American College of Surgeons, the American Society of Anesthesiologists, the American Society for Healthcare Risk Management, and the American Hospital Association. The purpose of the day was to increase awareness of The Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. Concurrently the AORN’s Correct Site Surgery Tool Kit was rolled out to 40,000 members. In addition, 50,000 copies of the tool kit were sent to chief executive officers and risk managers across the United States to emphasize the importance of standardizing the implementation of the Universal Protocol. The kit contained tools to assist with implementation: an educational CD-ROM, free independent study activity, copy of the Universal Protocol and the Frequently Asked Questions, a plasticized pocket reference guide for implementing The Joint Commission Universal Protocol, and The Joint Commission Speak Up safety initiative patient safety brochure. AORN (2008) continues to hold National Time Out day every year and to provide free resources to reinforce the necessity to implement and monitor the Universal Protocol for prevention of wrong-site procedures and improved care for our patients.

In 2006 The Joint Commission International Center for Patient Safety developed the International Patient Safety Goals. Six goals were created, of which the fourth goal is eliminate wrong-site, wrong-patient, wrong-procedure surgery. The goal includes the criteria to mark the site, conduct a time-out, and use checklists. These requirements are mirrored in the Universal Protocol’s best practices (The Joint Commission International Center for Patient Safety, 2008). In July 2007 the Council on Surgical and Perioperative Safety (CSPS) (2008), a coalition of seven U.S. national organizations that represents the perioperative care team, endorsed as one of its core principles “that all measures will be used to ensure correct patient, correct site, correct procedure surgery, including implementation of the Universal Protocol of The Joint Commission is recommended and support of the Time-Out prior to surgery or initiation of an invasive procedure.” The coalition consists of the following member organizations: the Association of periOperative Registered Nurses, the American College of Surgeons, the American Society of Anesthesiologists, the American Association of Nurse Anesthetists, the Society of PeriAnesthesia Nurses, the Association of Surgical Technologists, and the American Association of Surgical Physician Assistants. Convening this group of practitioners for the select goal of safety in the surgical and interventional areas is groundbreaking, and it is anticipated that the collaborative work will support consensus among the practitioners in our health care system to create, maintain, and monitor processes to prevent WSPs.

In June 2008 the World Health Organization (WHO) held the Second Global Patient Safety Challenge, Safe Surgery Saves Lives. The WHO Surgical Safety Checklist was launched, which will provide to surgical teams across the globe an international tool “to ensure that patients undergo the right operation at the correct body site, with safe anesthesia, established infection prevention measures and effective teamwork for safer care” (WHO, 2008).

STATEMENT OF THE PROBLEM AND IMPACT

The importance of a concerted effort to examine wrong-site procedures and the effects is substantiated by the fact that these are considered preventable adverse events. The NQF includes wrong-site surgery events on its list of serious reportable events, frequently referred to as never events. WSPs include wrong person, wrong side or site, wrong spinal level, wrong organ, wrong implant, wrong nerve block. These WSPs can occur in any area of the hospital or ambulatory setting; they are not limited to the surgical areas. The risks are also present in the procedural areas such as the cardiac catheterization laboratory or interventional radiology, procedures performed on patient units, in ambulatory care facilities, or in the physician’s office, where more complex procedures are being performed routinely. Despite the ambitious efforts of many professional organizations, agencies, individual facilities, and practitioners to eliminate WSPs, the numbers have not declined. For example, The Joint Commission database recorded 88 wrong-site surgeries in 2005, compared with 116 in 2008 (TJC, 2009). WSP is the most frequently reported category of sentinel events, and communication is the number one area of risk (TJC, 2008).

In Pennsylvania all hospitals and ambulatory surgical centers are mandated to report wrong-site surgeries and near misses. From June 2004 through December 2006 there were 427 reports filed—253 near misses and 174 surgical interventions started on the wrong patient, procedure, side, or part. Eighty-three patients’ incorrect procedures were carried out to completion (Clarke et al, 2007). This leaves the following questions: (1) Is reporting improving because secure, anonymous, and mandatory sites to facilitate reporting are provided and the punitive culture is changing, or is the number of cases actually increasing? (2) Are these incidents still being underreported? As we move forward toward a culture of safety in which we examine processes instead of punishing individuals, we have the potential for continued improvement in practice and reporting. However, it is obvious we have not eliminated WSPs.

RISK FACTORS FOR WRONG-SITE SURGERY

Inability to understand the full scope of the problem is not reason for inaction because many of these sentinel events are preventable. In addition, these occurrences are detrimental to the patient, the practitioner, and the organization. The patient initially appears to be the only victim with the possibility of emotional and/or a permanent physical injury or death. However, the practitioners take an oath to do no harm—there is an altruistic facet to their choice of profession, and causing harm to a patient can be devastating to the individual when the error is actually related to process or culture, thus creating another victim. The organization risks loss of trust not only from the patient, his or her family, and the community, but also from the practitioners depending on the culture in which the evaluation of the incident is completed. There are many who fall victim in potentially preventable adverse events.

Identification of risk factors for individual procedures can assist in development of preventive methods and herald particular circumstances or events that increase the potential for a WSP. The Joint Commission (2008) has identified multiple factors in its reviews of WSPs, including multiple surgeons involved in the procedure, multiple procedures being performed, time pressures, unusual patient characteristics, failure to involve the patient in identification of the correct site, poor communication among the perioperative team caring for the patient, and reliance solely on the surgeon for determining the correct site. Other contributing factors that could lead to a WSP include two patients with the same name, emergency procedures, morbid obesity, and unusual patient anatomy.

The American College of Surgeons targeted key high-risk processes from actual root cause analyses that related to WSP. Communication breakdown among team members and with the patient and family ranked highest. Cultural factors such as hierarchy and intimidation were included. The patient preparation process demonstrated issues with incomplete patient assessments, including not checking the medical record, x-ray films, and other reports. The procedure for preparation of the operating room illuminated numerous issues such as unavailable patient information, staffing levels and competency, resident supervision, lack of safety policies and protocols, and distractions, which included the various individuals’ emotional and physical status and environmental influences. The surgical scheduling process was also mentioned (Manuel and Nora, 2004). When considering an electronic medical record system, the scheduler and the practitioners must be alert to inadequacies of the system that could support choosing the wrong patient or the wrong visit and thus transferring the current information to the wrong patient’s chart. Also, all information coming from an outside source in any form needs to have the patient and information validated.

In their research of the literature and numerous databases to investigate prevalence of WSP, Seiden and Barach (2006) discovered many of the previous findings. The categories they chose to use were human factors such as personnel changes, workload, environment, and lack of accountability; patient factors involving sedation, confusion of the patient about his or her procedure; and procedural aspects related to room change for the patient before surgery, patient position changes, wrong site being prepped or draped, and lack of cross-checks. Incorrect specimen labeling has resulted in a procedure on a wrong patient. Removal from the room of patient stickers for labeling specimens must be completed at procedure end to ensure that the next patient’s specimen is not labeled with the previous patient’s information. If the pathology results require additional surgery, the wrong patient may fall victim to a WSP.

A discussion on potential barriers to implementation of the Universal Protocol is important because these barriers increase the possibility of risk. The author and other perioperative directors have seen negative first reactions by staff and surgeons concerning the possibility of increasing the workload and decreasing efficiency, which caused a lack of support. Surgeons were hesitant to move toward a standardized approach and “cookie- cutter” medicine; adaptation to the change in culture was slow. Some staff performed the time-out robotically, and the team performed under an assumption of safety. We also discussed diverse staff competency ranging from novice to expert nurses. This variance in competency and experience could create staff hesitancy to challenge the surgeons to do a time-out or question a possible error. These types of behavior are found throughout the literature, along with organizations that appear to put the cost or return-on-investment benefit before the quality and safety benefits. Each of these carries a level of risk for enabling processes, or lack of, that leave room for error.

Two other important considerations for risk in performance of WSP are (1) the pressure to produce and (2) environmental noise and distractions. The constant pressure for efficiency and decreased turnaround time may influence practitioners to take dangerous shortcuts that increase the potential for error. Just the hectic pace at the start of a procedure can have part of the team moving forward without the proper safety checks, such as the surgeon starting the incision before the time-out. Current operating room and interventional suites are frequently outfitted with music systems intended to provide a tranquil atmosphere, but, depending on the surgeon’s choice of music and the favored genre of the other professionals, this could be a major aggravation or distraction. In addition to the music there are various alarms that cannot be silenced, numerous pagers and telephones that may need answering, suction, and smoke evacuators, all demanding the attention of the circulating nurse and accosting the ears and senses of the team. All of this takes attention away from the patient and the procedure at hand and leaves room for error.

Certain specialties are rising to the top of the risk list in the literature. Orthopaedic surgery appears to have a higher risk of WSP. As stated earlier, the AAOS has a long history of advocating prevention of WSP, which may affect increased reporting. Opportunities for lateralization errors and the higher volume of cases in orthopaedics may relate to the increased risk and percentage of WSP in orthopaedics (Cowell, 1998). An AAOS task force in their review of claims from 22 insurers found orthopaedic procedures accounted for 68% of WSP (Michaels et al, 2007). The Joint Commission (2008) reported 41% of wrong-site surgeries for orthopaedics in 2001. A survey of 1050 hand surgeons resulted in information that 21% admitted to one wrong-site surgery and that an additional 16% reported near misses. Most frequent locations were hand, wrist, and fingers (Meinberg and Stern, 2003).

The number and variety of possible areas of risk demonstrate that potentially every patient may be exposed to a WSP. Would this information not validate for every practitioner the need for preventive measures in every surgical and interventional arena?