Wrong-site surgeries are rare and difficult to study, but they are the most common sentinel event reported to the Joint Commission. Reporting a wrong-site surgery to the Joint Commission is voluntary and confidential, and about half of the states do not require reporting. Some estimates put the national incidence rate — which includes wrong-patient, wrong-procedure, wrong-site and wrong-side surgeries — as high as 40 per week. This estimate includes invasive procedures that occur in many settings within hospitals and ambulatory surgery centers, such as operating rooms, radiology and cardiology departments, and patients' bedsides.
Five hospitals and three ambulatory surgery centers joined a pilot project of the Joint Commission Center for Transforming Healthcare to help manage and prevent wrong-site, wrong-side and wrong-patient surgical procedures: AnMed Health Medical Center in Anderson, S.C.; Center for Health Ambulatory Surgery Center in Peoria, Ill.; Holy Spirit Hospital in Camp Hill, Pa.; La Veta Surgical Center in Orange, Calif.; Lifespan–Rhode Island Hospital in Providence; Mount Sinai Medical Center in New York City; Seven Hills Surgery Center in Henderson, Nev.; and Thomas Jefferson University Hospitals in Philadelphia.
The participating hospitals and surgical centers identified and validated 29 causes of wrong-site surgeries and grouped them into four general categories: (1) scheduling, (2) pre-op/holding, (3) operating room, and (4) organizational culture. Because the eight participating health care organizations represent a variety of settings — small and large, rural and urban, teaching and nonteaching — their differences underscore the importance of managing the risks of wrong-site surgery. Whatever the size or scope of an organization, it can prevent wrong-site surgery by controlling defects in the perioperative process from scheduling to incision.
This project addressed the problem of wrong-site surgery using Robust Process Improvement methods. A proven, systematic and data-driven problem-solving methodology, RPI incorporates tools and methods from Lean Six Sigma and change management. Using RPI, hospital teams measure the magnitude of the problem, pinpoint contributing causes, develop specific solutions targeted to each cause, and thoroughly test the solutions in real-life situations.
Developing Targeted Solutions
Although most of the participating organizations had not had a wrong-site surgery, staff in each setting recognized the risk was there. Many of the causes were identified as risk factors at several of the participating organizations. By examining the three phases of the surgical process (scheduling, pre-op/holding, operating room), along with assessing their organizational culture, the organizations discovered "defects" or factors that contribute to failure. Some of the defects identified by the pilot organizations are described below, along with specific interventions targeted to remedy them.
Scheduling defects include accepting spoken requests for surgical bookings instead of written documents; using unapproved abbreviations, cross-outs and illegible handwriting on booking forms; missing information on forms; and more. Targeted solutions include:
- Confirm the presence and accuracy of primary documents critical to the verification process prior to the day of surgery. At AnMed Health Medical Center, after five weeks of gathering data for the project, staff determined the organization averaged about 15 scheduling defects a day, primarily due to incorrect or missing information on forms. The 578-bed hospital revised its process and set up an electronic scheduling module. Recent measures show less than a 1 percent defect rate for electronically scheduled cases.
- Use a single fax number for primary documentation. Seven Hills Surgery Center uses a scheduling process that is not fully electronic, leaving some margin for error. "Some of the human element still exists in smaller freestanding centers," says Tracy Helmer, R.N., director of nursing. Seven Hills implemented a confirmation process so schedulers now fax back exact wording for a procedure and get final sign-off from the physician's office. "Prior, we could get transcription errors because we hadn't closed that communication loop," says Helmer.
- Build on relationships with physician offices to improve the accuracy of information received and methods used. At Holy Spirit Hospital, scheduling and instructions for many surgeries had been handled by phone, and in many cases there was no written record. "Problems can start in the scheduling office," says Susan McQuade, R.N., associate director of surgical services. "If there's no documentation, it can have a downstream effect in the OR." The hospital revised its scheduling process and implemented higher standards for documents.
Pre-op defects include inconsistent use of site-marking protocol and marks made with non-approved surgical-site markers. Targeted solutions include:
- In the pre-op/holding area, have the surgeon mark as close as possible to the incision site using a single-use surgical skin marker and a consistent mark type. The Center for Health Ambulatory Surgery Center has approximately 100 different providers on its active medical staff, with 50 participating in 80 percent of its cases. Staff at the center, which has many cataract cases, performed an audit and found inconsistencies in surgical-site marking, including how it was done (checkmarks, dots or the word "yes"), where it was done (eyebrows can get in the way for eye surgery) and when it was done (before or after prep or draping, or just before incision). According to Thomas J. Feldman, CEO, standardizing site marking provided an opportunity to "close the gap." "Eliminating variations based on provider preference lends itself to lessening the chance of wrong-site surgery," Feldman observes.
Operating room defects include distractions and rushing during time-out, when the entire operative team stops before surgery begins and verifies patient identity and the correct side or site and procedure. Defects also occur when the time-out is performed without full participation, or if there is an ineffective hand-off communication or briefing process. Targeted solutions include:
- Work with the operating room team to develop a role-based time-out process that works for your organization. Thomas Jefferson University Hospital was the participating organization with the most annual surgeries (38,214) and most ORs (57). "Our OR has high volume and a lot of impetus to move things along," explains Richard Webster, R.N., COO. Webster notes that among the most important changes the hospital made during the project was revamping time-out to support staff who felt rushed at times. "We looked at staffing and — without adding any more full-time equivalents — provided an additional nurse for every two ORs, by modifying the times later shift nurses arrived for providing breaks and lunches," he says. Designated roles for these nurses include providing support for cases getting started and cases closing as well as giving breaks for staff during long surgeries. "[The change] gave our staff the support they felt they needed. And it didn't cost anything extra," Webster says. But the hospital also changed its OR policies to avoid anyone entering the OR during time-out and at other critical points during surgery.
- Perform a standardized time-out process and give every team member an active role to play. At La Veta Surgical Center, the process was perfected to always perform the time-out just before incision — "the most critical moment and everyone is paying attention," points out Maurice Berry, R.N., director of nursing. "One of the biggest challenges is communication and empowering the team to speak up. Focusing on time-out has heightened everyone's awareness," he adds.
- Examine processes for inconsistencies and seek to understand the cause of variation. Staff at the Center for Health Ambulatory Surgery Center eliminated things that had become part of time-out, narrowing its intent and creating a consistent, streamlined process. "We started to confuse time-out with the surgical safety checklist," says Debra M. Lee, clinical educator. Things were being added to time-out, and it was turning the health care team away from listening," she adds. Now time-out at the center is strictly about verifying the right patient, right procedure and right site.
Organizational culture causes include senior leaders who are not actively engaged, staff members who are passive or not empowered to speak up, and policy changes made with inadequate or inconsistent staff education. Targeted solutions include:
- Hold all caregivers and staff accountable for their role in risk-reduction. Use a team approach when teaching all staff how the process should be executed.
Lifespan–Rhode Island Hospital had a highly publicized wrong-site neurosurgical case in 2007. Shortly afterward, the hospital started working with the state health department's director to rectify the situation and improve the process. The hospital revised its procedures, policy and site-marking protocol. But another wrong-site surgery occurred in October 2009.
"Instead of going back and revising our policy to correct the gaps to allow another one to slip through, we went back and drilled down to determine our root causes," says Edward Marcaccio, M.D., medical director of Rhode Island Hospital operating rooms. "Using Robust Performance Improvement tools, we then designed a process that took into account various break points and possible disruption to the process. We made enormous lists and ranked them, from 'most likely to occur' and 'most catastrophic when occurs.' Then we developed prioritizations."
Education was key to leading a cultural change. The hospital closed the OR for a day of education, assembling 1,200 staff and physicians in two hospitals. The chief of surgery led a one-hour didactic session followed by videos to demonstrate new processes. Then, small groups convened in the OR for discussions with leaders trained to model the process. "Buy-in was a critical aspect, and staff as well as hospital leadership participated in the training. After shutting down its operating room for that one day on Nov. 20, 2009, Rhode Island Hospital has not had a wrong-site surgery since. "In terms of changing culture, all the training we've done with leaders and the safety culture and training with staff have been well-received. People are much more likely now to speak up," says Barbara Riley, R.N., senior vice president and chief nursing officer.
Significantly Reducing Surgical Risks
Using RPI tools during the project, the pilot organizations reduced the number of surgical cases with risks by 46 percent in the scheduling area, by 63 percent in pre-op/holding and by 51 percent in the OR. Other hospitals and ambulatory surgery centers that tested the work of the original pilot organizations experienced the same gains. All these participating health care organizations provided guidance on developing a Targeted Solutions Tool™ for Wrong-Site Surgery. Released earlier this year, the TST includes video, implementation guides and checklists, and interactive materials to assess staff learning. The tool also provides data analysis that automatically generates charts and graphs for review. The TST is available free to all Joint Commission–accredited organizations at www.centerfortransforminghealthcare.org.
Cynthia Hedges Greising is a communications specialist at the Health Research & Educational Trust, and Coleen Smith, R.N., is the center project lead, black belt, at the Joint Commission Center for Transforming Healthcare.