January 20, 2009 The WHO Surgical Safety Checklist Delivers the Outcomes
This has been quite a week for long-awaited studies! The report on the investigation of the Minnesota nursery fire has been released. The NTSB has released its preliminary report on several of the medical helicopter crashes. But you’ll have to wait for future columns for our comments on those because this week’s most significant study was the report in the New England Journal of Medicine on the outcomes from implementation of the WHO Surgical Safety Checklist (Hayes 2009).
Our July 1, 2008 Patient Safety Tip of the Week “WHO’s New Surgical Safety Checklist” described the tool and provided the link to download the checklist tool and instructions how to use it. We also discussed checklist design and use in our September 23, 2008 Patient Safety Tip of the Week “Checklists and Wrong Site Surgery”.
The New England Journal study was a prospective preintervention/postintervention study that looked at mortality rates and major complication rates after non-cardiac surgery. It involved hospitals in eight different countries, allowing the investigators to assess the utility of the checklist in both “wealthy” and “poor” countries. The intervention, of course, was introduction and use of the WHO Surgical Safety Checklist. Mortality at 30-days post-op decreased from 1.5% before introduction of the checklist to 0.8% after. Rate of any complication decreased from 11% to 7%. Both these outcomes were highly statistically significant. That’s a relative risk reduction of approximately 36% for mortality and major morbidity! Of important specific surgery complications, both surgical site infections and unplanned reoperations decreased significantly. Improvements were seen at all participating sites.
Looking at 6 sample processes on the checklist, all 6 were completed in 34% of cases prior to implementation of the checklist and improved to 57% after. So the striking improvement in outcomes occurred even without complete adherence to all items on the checklist.
The biggest debate seems to be whether the striking improvement is attributable to use of the checklist per se or to the change in “culture” that accompanied use of the checklist. To that debate we say “who cares?”. If merely using a checklist results in such powerful improvement in the culture of safety and promotion of better communication and teamwork, use it!!!
The most important issue will be the sustainability of the improvements. We have all seen numerous quality improvement projects that have lost their luster several months after initially encouraging results. The authors do acknowledge the possibility of a Hawthorne effect being partially responsible for the striking results. Time will tell if the results are sustainable.
Other issues pertain to the study design. It was not a randomized controlled trial. Rather, it was your typical before/after type of prospective study. Significant practical issues make a randomized controlled trial unfeasible.
In our previous tip of the week “Checklists and Wrong Site Surgery” we described even more comprehensive checklists that have been developed for specific surgical settings and demonstrated comparable striking outcome improvements. Use of a 28-item structured checklist (Verdaasdonk 2008) addressing problems with laparoscopic equipment resulted in a 53% reduction of incidents related to such equipment. The Verdaasdonk article also discusses human factors considerations in the design of checklists and references an excellent guidance from the UK Civil Aviation Authority on the proper design, presentation and use of checklists.
One important point to remember is that developing checklists is not enough. You need to educate all staff in their importance and implementation and must audit the use of and adherence to the checklists you develop. The audit should be done for anything you develop a checklist for, not just a safe surgery checklist.
Checklists are some of the most valuable tools we have available in quality improvement and patient safety. They are simple and save time in the long run. Even the 28-item laparoscopic checklist in the Verdaasdonk article took only an average of 3.3 minutes to complete. They are also the least expensive of all tools. All the items in the WHO Surgical Safety Checklist have negligible financial costs. The WHO study did not publish the likely financial savings resulting from the improvements but they would obviously be substantial. The ROI on checklists is incredibly high, both in human terms and financial terms.
And, speaking of checklists, don’t forget that Joint Commission’s 2009 National Patient Safety Goals (see our July 2008 What’s New in the Patient Safety World column “Joint Commission 2009 National Patient Safety Goals”) have a requirement for use of a checklist during the pre-procedure verification process. The checklist can be paper or electronic or even on a wall-mounted white board and needs to include elements such as the H&P, anesthesia assessment, completed informed consent, appropriate diagnostic and imaging reports or images, and any required implants, devices, special equipment or blood products that will be needed.
So checklists are here to stay. But one word of caution: don’t let your checklists become so complicated that they become cumbersome. Then they won’t be used. You’ll recall that the WHO Surgical Safety Checklist actually consists of 3 separate checklists, each having 7 or fewer items on them. Keep it simple!
Update: Institute for Healthcare Improvement (IHI) is also sponsoring a new campaign “the WHO Surgical Safety Checklist Sprint” to get as many hospitals as possible using the checklist. Their website offers most of the downloads available on the WHO website plus some additional useful resources. They include a video of the presentation that Atul Gawande, M.D. did at the IHI 20th Annual National Forum on Quality Improvement in Health Care in Nashville this past December.
Haynes AB, Weiser TG, Berry WR, et al. for the Safe Surgery Saves Lives Study Group. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. N Engl J Med. Online First January 14, 2009 (DOI: 10.1056/NEJMsa0810119), in Print January 29, 2009
WHO Surgical Safety Checklist
WHO Safe Surgery Saves Lives website (includes also an implementation manual and videos on how to use the checklist and how not to use it)
Verdaasdonk EG, Stassen LP, Hoffman WF, van der Elst M, Dankelman J. Can a structured checklist prevent problems with laparoscopic equipment. Surgical Edoscopy 2008; 22: 2238-2243 (accessed online 9/22/2008) http://www.springerlink.com/content/1845j684574501v2/
Civil Aviation Authority (UK). CAP 676: Guidance on the Design, Presentation and Use
of Emergency and Abnormal Checklists. January 2006.
Joint Commission. 2009 National Patient Safety Goals.
Institute for Healthcare Improvement (IHI.org). “WHO Surgical Safety Checklist Sprint”