The frequency of surgical complications involving a wrong site or wrong patient remains high, even in the era of the Universal Protocol.
The Joint Commission introduced the Universal Protocol to ensure the correct patient, site, and procedure. Although it became effective July 1, 2004, there still exists a lack of data about the true incidence of wrong-patient and wrong-site operations, called “never events,” according to new research reported in the October issue of Archives of Surgery.
To determine the frequency, root causes, and outcomes of these never events, Dr. Philip F. Stahel of Denver Health Medical Center and the University of Colorado School of Medicine, and colleagues performed a retrospective analysis of the Colorado Physician Insurance Company’s (COPIC’s) comprehensive database (Arch. Surg. 2010;145:978-84).
Dr. Stahel and his colleagues screened 27,370 physician self-reported adverse occurrences between Jan. 1, 2002, and June 1, 2008. The researchers initially found 119 wrong-site and 29 wrong-patient procedures, but eliminated cases they could not classify as being a factual wrong site or wrong patient. The final analysis consisted of 107 wrong-site and 25 wrong-patient procedures.
Analysis of root causes found errors in:
- Diagnosis, a root cause for 14 (56.0%) wrong-patient and 13 (12.1%) wrong-site procedures.
- Communication, 25 (100%) wrong-patient and 52 (48.6%) wrong-site procedures.
- Judgment, 2 (8.0%) wrong-patient and 91 (85.0%) wrong-site procedures.
- Treatment, 22 (88.0%) wrong-patient and 9 (92.5%) wrong-site procedures.
In addition, system issues were a root cause in 21 (84.0%) wrong-patient procedures and 78 (72.9%) wrong-site procedures. This category included time-out not being performed in 77 (72%) wrong-site cases.
Wrong-patient cases often were due to a mix-up of patients’ medical records, radiographs, and laboratory or biopsy samples, as well as errors in communication.
Next, the researchers looked at outcomes, namely:
- Death, which occurred in 1 patient (0.9%) secondary to a wrong-site procedure.
- Significant harm, which occurred in 5 (20%) wrong-patient and 38 (35.5%) wrong-site cases.
- Minimal harm or functional impairment, which occurred in 8 (32%) wrong-patient and 65 (60.7%) wrong-site cases.
- No-harm event, which occurred in 9 (36%) wrong-patient and 3 (2.8%) wrong-site cases.
The most frequent specialties involved in wrong-patient procedures were internal medicine (24.0% of cases) as well as family or general practice, pathology, urology, obstetrics-gynecology, and pediatrics (8.0% each). The most frequent specialties involved in wrong-site occurrences were orthopedic surgery (22.4% of cases), general surgery (16.8%), and anesthesiology (12.1%).
Overall, nonsurgical specialties were involved in 14 (48.3%) wrong-patient and 29 (27.1%) wrong-site cases.
“The findings from the present study emphasize a continuing and concerning occurrence of wrong-site and wrong-patient procedures in the current era of the Universal Protocol, leading to frequent patient harm and, rarely, patient death,” the researchers said. “Shockingly, nonsurgical disciplines equally contribute to patient injuries related to wrong-site procedures.”
The researchers believe these findings warrant expansion of the Universal Protocol to nonsurgical specialties.
Limitations of the study include the restricted coverage of the COPIC database to about 6,000 physicians in Colorado; the potential for subjective bias in determining root causes; and the designation of inadequate planning for the procedure, which represents a generic category.
Although compliance with the Universal Protocol is important, “it is not the magic wand of Merlin,” Dr. Marin A. Makary said in an accompanying editorial commentary. Consider the fact that the Universal Protocol has been in place since 2004, yet Dr. Stahel and his colleagues found that preventable errors, or “never events,” exist at alarming rates, Dr. Makary noted.
Further, the number of wrong-site procedures that this study cites more likely reflect the number of errors reported rather than the actual rates of events. So, the number of wrong-site procedures is probably much higher than reflected here, Dr. Makary indicated.
He suggested that a more accurate measurement comes from the complication rates and safety culture scores under the National Surgical Quality Improvement Program, or NSQIP. Safety culture scores reflect the comfort level of hospital employees about speaking up about safety concerns. To improve public reporting and benchmarking, hospitals should be required to publicly report their NSQIP outcomes and culture scores, he said (Arch. Surg. 2010;145:984).
Finally, the Universal Protocol, while important, does not relieve hospital systems from emphasizing individual responsibility in preventing surgical errors, concluded Dr. Makary, who is with the department of surgery at Johns Hopkins University, Baltimore.
Coauthors on the research analysis reported the following conflicts: Dr. Ted J. Clarke is the chief executive officer of COPIC; Dr. Jeffrey Varnell and Dr. Alan Lembitz are employed by COPIC; and Dr. Michael S. Victoroff and Dr. Dennis J. Boyle are consultants for COPIC.