Study: Why are wrong-site surgeries still occurring?
Is Universal Protocol ineffective or underused?
Do you assume that if the Joint Commission's Universal Protocol is followed, wrong-site surgery would always be prevented? A new study conducted by the Agency for Healthcare Research and Quality puts that assumption into question.
Researchers concluded that the Universal Protocol developed in 2003 by the Joint Commission may have prevented only 62% of wrong-site surgery cases.1 The protocol requires preoperative verification of site and patient, marking the surgical site on the patient, and the institution of a "time out" in the operating room.
However, according to Richard J. Croteau, MD, JCAHO's executive director for strategic initiatives, there is a serious flaw in this conclusion. If followed to the letter, he says, the protocol would have prevented virtually all of the cases.
"I went through the cases and in fact, the universal protocol would have prevented all but one of the cases — if it had been followed as it was intended," he says. "The problem was that not all of the steps were followed. All the three steps are necessary. We're not claiming that it will prevent all cases, but if it's done and done consistently, it should prevent the vast majority."
The researchers examined records from 2,826,367 operations between 1985 and 2004 in Massachusetts, and identified 40 cases of wrong-site surgery, a rate of one in 112,995. In the JCAHO's database of wrong-site surgeries, which has 10 times the number of cases in the AHRQ study, almost all were lacking one or more of the steps, says Croteau.
Last year, health care facilities reported 84 incidents of surgeries involving the wrong body part or the wrong patient to the JCAHO. While some states require hospitals to report these incidents, many hospitals across the nation aren't required to account for them publicly.
"While the article did make reference to the fact that not all cases are reported, they then proceeded to treat the numbers as if they represented all the cases that had occurred, when in fact we don't know how many are occurring," says Croteau.
"We are seeing what we believe to be an increase in the rate of reporting, which is why the number of cases appears to be going up every year reported to us," adds Croteau. "That's a pattern that we see with all types of adverse events as we call attention to them, and we've called attention to wrong-site surgery a lot in the past couple years."
The researchers also found significant variation among hospital protocols for site verification, which were analyzed at 28 hospitals. They found an average of 12 redundant checks on the correct surgical site, involving two to four staff members. "Simplification of protocols would improve adherence and efficiency and allow surgical teams to focus their limited time and energy on prevention of more common or harmful errors," write the researchers.
No protocol will prevent all cases, say the researchers, adding that it will ultimately remain the surgeon's responsibility to ensure the correct site of operation in every case.
Noting that only two-thirds of the cases might be preventable under current conditions, the authors suggest implementation of a universal site-verification protocol with a preoperative verification process of patient identity, procedure, site, side, and vertebral level performed by two health care staff members, one of whom should be the surgeon. Any inconsistencies or uncertainties about the proper site should be resolved by the surgeon with confirmation and agreement by the patient and at least one of the inspecting caregivers, recommend the researchers.
However, these recommendations are virtually identical to those in the JCAHO's Universal Protocol, notes Croteau. "They are seemingly dismissing the efficacy of the Universal Protocol, yet they ended up offering the exact same three recommendations," he says.
The problem is that organizations are struggling to get these three steps implemented consistently, Croteau says. "They are finding resistance from physicians on site markings and time out," he says. "More organizations are doing fairly well with implementation in the operating room, but that's not the only place they do invasive procedures. This applies across the board."
Surveyors are reporting that 15% to 20% of organizations are not consistently doing the time out procedure, Croteau reports.
At Carroll Hospital Center in Westminster, MD, the time out policy is followed not only for OR procedures but for invasive procedures done at bedside or any department including radiology. "Initially we experienced some resistance to this practice change, but over the years staff have come to expect it," says Kimberly Lau, RN, risk management coordinator. "The culture has accepted it, and it's part of routine practice."
The time out and site marking are documented on both the pre-op checklist and intraoperative record, and this is audited. "There is also rounding done by team leaders and managers who monitor the process," adds Lau.
At Inova Loudoun Hospital in Leesburg, VA, a Universal Protocol checklist is used. The first section verifies two patient identifiers, that responses match the patient's ID band, that documentation including current H&P is present, and that the informed consent describes the procedure, site, and laterality. The second section verifies site marking as follows:
- Patient/guardian states procedure to be performed and points to the site. (Yes or No)
- Patient/guardian confirms the side for surgery, if applicable. (Yes or No)
- Physician/LIP has marked the site. (Yes or No or exempt by criteria from marking)
- Patient identification verified and site marked according to policy. (Yes or No)
- Signature for pre-procedure verification check.
The third section is for the Time Out procedure:
- Correct procedure (Yes or No)
- Correct side confirmed (Yes or No)
- Site marked and visible to team (Yes or No)
- Special equipment available (Yes or No or N/A)
- Correct implant (Yes or No or N/A)
- Correct position (Yes or No or N/A)
All team members agree that the procedure about to be performed is the correct procedure, is correctly marked, and is on the correct patient. At the bottom of the form, there is space for discrepancy and resolution of the discrepancy.
"We believe we have covered the entire content suggested by JCAHO," says Tootie Lunsford, RN, quality outcomes coordinator. "We do both real-time and concurrent audits to assure compliance to the process."
JCAHO surveyors liked the patient identification form used at Christiana Care Health Services in Wilmington, DE. "They paid a great deal of attention to that aspect of documentation," says Judith A. Townsley, MSN, RN, CPAN, director of clinical operations for perioperative services. "They asked many questions, and if there was not a documented time out, they investigated why and made sure that it was a true emergent procedure."
Universal Protocol compliance for patient procedures done in a non-operating room setting is done with a safe practice behavior monitoring tool which also is used for measuring several National Patient Safety Goals. The tool assists inpatient, outpatient, and perioperative nurse units to assess compliance with safe practice behaviors. "This single measurement tool provides for efficient and effective monitoring," says Terri Lynn Palmer, MPA, manager of clinical information at Christiana Care.
Since a single tool is used for all units and departments to collect monthly data, this results in a simplified review process for the data collector. "The collector reviews documentation in charts for all National Patient Safety Goals at one time," says Palmer.
Data collectors answer the question "Was safe practice behavior performed/not performed?" with no tolerance for partially correct behaviors, says Palmer. Timely results are available to units, so staff can identify actions to improve safe practice behaviors.
A sampling of five charts per unit per month provides a sample size of up to 340 per National Patient Safety Goal, she says. Compliance is also monitored with direct observations from management rounding on units and auditing of safe practice behaviors by performance improvement personnel.
All organizations in the Baptist Memorial Health Care system use a preprocedure verification policy as the guide for compliance to the Universal Protocol.
"All documentation is completed on the invasive procedure record," says Beverly Jordan, vice president and chief nursing officer for Baptist Memorial Health Care. "Audits of these records are conducted weekly and reported monthly through facility performance enhancement committees."
Reference
- Incidence, Patterns and Prevention of Wrong Site Surgery. Arch Surg. 2006;141:353-358.
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