Reality check on surgical checklists

Hospital surgical checklists have taken off since their introduction more than a decade ago. Borrowed from the aviation industry and popularized by surgeon and New Yorker writer Dr. Atul Gawande, checklists have been hailed globally as a huge leap forward for patient safety.

But now, with several countries and U.S. states moving to mandate their use, some safety pioneers say it's time to step back and check in with checklists. “It's not a magic bullet,” said Dr. Peter Pronovost, senior vice president for patient safety and quality at the Johns Hopkins University School of Medicine in Baltimore and also a pioneer in the use of clinical checklists. While checklists offer vast potential to improve outcomes, broad implementation without proper training and coordination with staff who will use them could possibly have the opposite effect, he said.

The reassessment comes in the wake of a study reported last week in the New England Journal of Medicine that found surgical safety checklists implemented in more than 100 hospitals in Ontario, Canada, failed to reduce complications or deaths. The Ontario Ministry of Health and Long-Term Care required its hospitals to incorporate safety checklists by July 2010.

Thousands of hospitals across the globe have updated their standard operating procedures to include checklists designed to help clinicians prevent surgical errors, reduce infection rates and lower readmissions. More than 30 countries have either adopted or considered requiring use of the World Health Organization's surgical safety checklist, the organization reports. In 2011, Nevada became the first U.S. state to require medical facilities to adopt patient safety checklists to improve health outcomes.

But safety advocates worry that hasty implementation through government regulation, though well-intentioned, may not generate intended results. “Regulation is too slow to keep up with the changes in evidence-based practices,” Pronovost said. “I fear that regulating (checklists) may actually anchor you into bad practices.”

What's missing in government requirements are hospital-specific customizations needed to make checklists work for specific settings. In an accompanying editorial in the NEJM, Dr. Lucian Leape, adjunct professor of health policy with the Harvard School of Public Health in Boston and a leading advocate on patient safety, wrote, “What should be mandated, and nationally funded, are large-scale state and systemwide collaborations to motivate, train, and support local efforts to implement checklists.”

Stanford University, for example, enhanced the WHO-issued surgical safety checklist in 2008 by including more specific instructions for anesthesiologists, nurses and surgeons. Officials also added a verbally dictated timeout between procedures and a post-surgery discussion for team members. “After the checklist was implemented, mortality declined,” a hospital spokesperson said.

While working on a quality-improvement program with hospitals in Michigan, Pronovost encouraged participants to modify the Johns Hopkins' checklist to ensure the final product addressed their systems' specific needs. “Now every one of them thinks that their checklist is the best,” he said, “and it is, for their culture.”

One of the major challenges, and what may have gone wrong in Canada, is that regulators failed to get all the key players committed to the process. “Just checking boxes is not applying the checklist in the way it is meant to be applied,” said Dr. Don Goldmann, chief medical and scientific officer at the Institute for Healthcare Improvement.

Government mandates also don't provide what Goldmann called the “courageous leadership” needed for a checklist program to succeed. For instance, after hospital leaders in Washington state failed to explain the rationale behind checklists, surgical staff grew frustrated with them and some eventually abandoned their use, despite the hospitalwide mandate, according to a study of five hospitals.

Pronovost suggests it's time to move away from paper checklists, at least as currently configured and consider them as just one component of what will help reduce harm. He is now investigating how to design safety into the technological processes used in operating rooms.

Follow Sabriya Rice on Twitter: @MHsrice