Wrong-site, wrong-patient surgeries persist

Without cultural change, timeouts, checklists less effective

Despite significant attention to wrong-site and wrong-patient procedures, including The Joint Commission's "Universal Protocol" and checklists developed at prestigious institutions, a new study reports "a persisting high frequency of surgical 'never events.'"1

The study looked at 27,370 physician self-reported adverse occurrences between Jan. 1, 2002, and June 1, 2008, derived from the database of the Colorado Physician Insurance Company. During that time, a total of 25 wrong-patient and 107 wrong-site surgeries were identified. Significant harm was noted in five of the wrong-patient procedures and in 38 of the wrong-site procedures.

The root causes were identified as follows:

  • errors in communication: 100%;
  • errors in judgment: 85%;
  • failure to perform a "timeout": 72%;
  • errors in diagnosis: 56%.

"The rationale for this study was that we wanted to see how many of these events were occurring five years after the introduction of the Universal Protocol," says Philip F. Stahel, MD, FACS, a visiting associate professor at the University of Colorado School of Medicine in Denver and lead author. "We assumed it should go down to near zero, and unfortunately that was not the case at all."

Stahel is not willing to say that these data mean the Universal Protocol does not work. "One issue is that we are looking at reporting and not true occurrence; there may be increased awareness and reporting," he notes.

Martin A. Makary, MD, MPH, an associate professor of surgery at Johns Hopkins University and author of an accompanying editorial, agreed. "... We should ... avoid the trap that these are rates of events, when in fact they are rates of reporting," he wrote. "These data actually describe an increase in reports not events."2

However, he also wrote the following: "The authors would likely agree with me that the real rate of wrong-site surgery is higher than their article reports. The reason is that non-anonymous, self-reported data understate the true incidence of any event."

That seems to be borne out by a recent experience Stahel recalls. During a recent lecture on avoiding wrong-site surgery, he asked attendees if any of them had witnessed or seen a wrong-site surgery. He did not get many responses, but afterward a surgeon came up to him and said that he did have one, but that he was ashamed to admit it.

"The thing that struck him most at the time of the timeout was there were nine providers and none raised concerns when he was about to operate on the wrong leg," notes Stahel.

The timeout, Stahel, continues, is safe "as long as we truly adhere to it." He notes, for example, that in some cases, the timeout had been applied but the surgeon amputated that wrong limb because he or she assumed the marking had been rubbed out. "Incorrect marking is still one of the pitfalls," he observes.

What about checklists such as those developed by Peter Pronovost while at Johns Hopkins or the World Health Organization? "I do believe in the role of checklists, but I do not believe they can completely solve the communication breakdown; we have to be accountable for our actions," Strahel says. "It sounds so simple, but it's not. If you replace clinical judgment and responsibility, it can stop providers from being critical of their thinking."

The system, he continues, "cannot keep us safe if we look at these tools as procedures that ensure we will no longer have wrong-site surgery. They do not fully replace the culture of patient safety we're trying to inculcate."

Addressing the causes

Since communication errors were present in 100% of the events, ensuring appropriate communication is clearly a critical goal. "You have to differentiate between verbal and written communication," notes Stahel. "I'm a strong believer in read-backs; pilots, for example, never take off without a read-back to the tower. I witness communication breakdowns almost every day, but 90% of them don't not lead to harm. I may be talking to another doctor about a patient, for example, and then realize we're talking about two different patients." (Stahel says he's currently involved in a study on the implementation of read-backs.)

What about the "critical thinking" he referred to earlier, and his assertion in the paper that providers who do use timeouts and checklists are sometimes not "mentally involved?"

"People hate additional administrative work; they hate new forms, they hate additional procedures implemented by administration, so I know there's huge resistance and reluctance among surgeons to use the Universal Protocol — they think it's useless," Stahel notes. Even if you do believe in these procedures, he adds, you can fail to be fully mentally involved.

How does he address this problem? "What I do is every 10 times or so, I abort the timeout and start from zero," he shares. "I say, 'Wait guys, you're not paying attention; let's re-do it.' Interestingly enough, after the second time everybody's listening to you."

As for completely moving to a culture of patient safety and accountability, "That's the hardest — if I could answer it I should be nominated for the Nobel," says Stahel.

He has, however, given it a lot of thought. "You can't change behaviors without a carrot-and-stick approach, so you need incentives to do a good job," says Stahel. One way to do that is to turn the tables on the standard approach and identify "always events" — i.e., always operate on the correct side and correct patient, always give antibiotics within 60 minutes of surgery, always wash your hands before and after seeing patients. "If you do these in 100% of your cases in a year, the incentive could be a 20% bonus," Stahel suggests. "The stick could be your bonus vanishes or your privileges are suspended for a couple of days. That's probably the only way we can make it effective."

"I think one lesson that's been learned in attempts to change culture is that certain things work well and others fail every time," wrote Makary. "For example, central mandates in isolation fail every time. Peer-to-peer behavior change or education from respected peers has a big impact. Part of that may be because surgery is a unique culture where surgeons, by and large, learn from other surgeons."

When doctors speak through training, he wrote, they speak the language of data. "When they see the data on the subject, it connects with them," he wrote. "Now there is good data to support a checklist and other similar tools." In addition, he said, effective cultural change includes having nurses and techs feel comfortable speaking up when they see a safety concern. Culture change won't work, he concludes, "where the environment remains intimidating."

[For more information, contact:

Philip F. Stahel, MD, PhD, Visiting Associate Professor, University of Colorado School of Medicine, Denver. Phone: (303) 653-6463. E-mail: philip.stahel@dhha.org.]

References

  1. Stahel PF, Sabel AL, Victoroff MS, Varnell J., et al. Wrong-Site and Wrong-Patient Procedures in the Universal Protocol Era. Arch Surg 2010;145(10):978-984.
  2. Makary, MA. The Hazard of More Reporting in Quality Measurement (Invited Critique.) Arch Surg2010;145(10):984.