Researchers at the Mayo Clinic in Rochester, MN, have confirmed what many risk managers have noted from their own root cause analyses: Most never events can be traced back to human factors rather than just a root cause.
Most commonly, the researchers found, never events are caused by between four and nine human factors.
They identified 69 never events among 1.5 million invasive procedures performed over five years, and they detailed why each occurred. Using a system created to investigate military plane crashes, they coded the human behaviors involved to identify any environmental, organizational, job, and individual characteristics that led to the never events. They found that 628 human factors contributed to the errors overall, roughly four to nine per event. The study results are published in the journal Surgery. (An abstract and access to the full text of the study are available online at http://tinyurl.com/pj5nweb.)
The never events included performing the wrong procedure (24), performing surgery on the wrong site or wrong side of the body (22), leaving an object in the patient (18), or putting in the wrong implant (5). All of the errors analyzed occurred at Mayo, and none was fatal.
The Mayo Rochester campus rate of never events over the period studied was roughly one in every 22,000 procedures, notes senior author Juliane Bingener, MD, a gastroenterology surgeon at Mayo Clinic. Because of inconsistencies in definitions and reporting requirements, she says, it is hard to find accurate comparison data, but a recent study based upon information in the National Practitioner Data Bank estimated that the rate of such never events in the United States is almost twice that in this report, approximately one in 12,000 procedures.
Nearly two-thirds of the Mayo never events occurred during relatively minor procedures such as anesthetic blocks, line placements, interventional radiology procedures, endoscopy, and other skin and soft tissue procedures.
Despite increasing attention from the medical community, eradicating never events entirely remains elusive, Bingener says. The findings indicate that the never events were not often tied to “cowboy-type” behavior from physicians or staff who disdained safety efforts or casually violated protocols, she notes.
“What it tells you is that multiple things have to happen for an error to happen,” Bingener says. “We need to make sure that the team is vigilant and knows that it is not only OK, but is critical that team members alert each other to potential problems. Speaking up and taking advantage of all the team’s capacity to prevent errors is very important, and adding systems approaches as well.”
For example, to help prevent surgical sponges from being left in patients, Mayo Clinic installed a sponge-counting system with bar code-scanning to track sponges. The hospital also emphasizes use of The Joint Commission’s Universal Protocol, team briefings and huddles before a surgery starts, a pause before the first incision is made, and debriefings using a WHO-recommended safety checklist. (The WHO checklist is available online at http://tinyurl.com/ocofcbv.)
To investigate the never events, the researchers used human factors analysis, a system first developed to investigate military aviation accidents, Bingener explains. They grouped errors into four levels that included dozens of factors:
• “Preconditions for action,” such as poor hand-offs, distractions, overconfidence, stress, mental fatigue, and inadequate communication. This category also includes channeled attention on a single issue. In layman’s terms, that wording means focusing so much on a tree that one cannot see the forest.
• Unsafe actions, such as bending or breaking rules or failing to understand. This category includes perceptual errors such as confirmation bias, in which surgeons or others convinced themselves they were seeing what they thought they should be seeing.
• Oversight and supervisory factors including inadequate supervision, staffing deficiencies, and planning problems, for example.
• Organizational influences such as problems with organizational culture or operational processes.
In addition to systems approaches and efforts to improve communication, attention should be paid to cognitive capacity, such as team composition, technology interfaces, time pressures, and individual fatigue, the researchers say.
Researchers at the Mayo Clinic have confirmed that most never events can be traced back to multiple human factors rather than just one root cause.
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