The eTalk threads on PRESENT Podiatry are always interesting, but I found a recent thread about Wrong Site Surgery to be particularly important. As such, we are republishing a past Practice Perfect blog that is topical to the conversation. Join in the conversation. We want to hear your thoughts and experiences.

Jarrod Shapiro, DPM
Practice Perfect Editor
Assistant Professor,
Dept. of Podiatric Medicine,
Surgery & Biomechanics
College of Podiatric Medicine
Western University of
Health Sciences,
St, Pomona, CA

Surgical Checklists: Doing It Better

In a prior Practice Perfect, I made mention of the World Health Organization’s Surgical Safety Checklist. After instituting the Safe Surgery Saves Lives checklist in my hospital and watching how it worked, I wanted to discuss this topic in more detail, and hopefully convince the podiatric community to spearhead the use of this system in your own hospitals. To prevent information overload – and breakdown – I'm going to split the discussion into 2 parts. Part 1 below is my attempt to convince you of the importance of this issue. In Part 2, we’ll discuss recent strong work that is revolutionizing our concept of the time out and minimizing patient complications. For those interested in a more detailed discussion of this topic, I refer you to Dr Atul Gawande’s riveting book The Checklist Manifesto.

Perspective on Surgical Complications

First, let’s put the situation in perspective. Currently there are more than 230 million surgeries performed worldwide, which is more than the number of childbirths.¹ However, with all these surgeries comes a dark side: surgery is not always safe. In fact, there are approximately seven million disabling complications and 1 million deaths per year internationally as a result of surgery,¹ and half of all surgical complications are avoidable.^2,3 In the early 1990’s, a study of 30,195 random charts from New York hospitals found that of 2.6 million charts reviewed for the year 1984, there were 98,609 adverse events, or about 4%.⁴ Of these complications 48% were associated in some way with a surgical procedure.⁵ In Australia, a 28 hospital 14000 record review was performed in 2002, which found a 21.9% adverse event rate for surgical admissions.³ Due to these and other studies, we’ve seen national drives to reduce wrong site surgery and prescription errors. However, it remains clear that surgical complication rates can still improve.

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Taking a Page from the Airlines

In 1935, the US Army had tasked three airplane manufacturers (one of them Boeing) to present airplanes for military use. Boeing’s plane, the 299, was thought to have the best chance of winning the contract. Then it came time to fly the plane. The 299, flown by the Army’s chief test pilot, took off for the sky. About 300 feet in the air the plane suddenly banked hard, tipped its wing, and crashed, killing two members of the crew, including its pilot. The ensuing investigation determined the cause of the crash was “pilot error” due to the complexity of the airplane. It was “too much plane for one man.” Instead of scrapping the 299 program, the Army did in fact buy 12 planes, but with an additional modification: the use of a checklist at multiple points during the flight. After institution of these checklists, the 299 program flew 1.8 million miles without an incident!.⁶ The 299 was renamed the B-17 Flying Fortress and played a key role in the air campaign during WWII. Today, we see this system of checklists in use throughout the aviation industry.

Medicine: Too Much “Airplane” For One Person

Like the B-17 Flying Fortress, medicine and surgery are simply too complex. Why is it that in the 21st Century, with our modern technologies, incredibly high levels of training for physicians, nurses, and support staff, we still have so many complications? Are physicians doing something wrong?

Not convinced? Between June 2004 – December 2006, the Pennsylvania Patient Safety Advisory found 427 reports with some aspect of wrong site surgery. Of these, almost 20% actually completed a wrong site surgery.⁷ Now, this didn’t occur two decades ago in the early 1990’s. This study was published only three years ago – AFTER the Universal Protocol for Wrong Site Surgery became effective.⁸

Medicine and surgery are very complex undertakings, with multiple often highly routine steps, involving high volumes of patients being seen in very short time periods. The problem really boils down to breaks in memory and attention. Not being machines, humans are prone to lapses in memory, and more commonly, attention, that may result in significant complications. We need a better way to prevent complications among our surgical patients, and this way already exists and has been in use for almost 80 years: checklists.

Checklists in Medicine

One problem that has been quite amenable to the use of checklists is the issue of catheter-related blood stream infections. We’re talking here about PICC lines – something most of us have some interaction with, especially those involved in wound care. There are an estimated 80,000 catheter-related blood stream infections per year and up to 28,000 deaths in the ICU from this problem.⁹ To combat this epidemic, the Michigan Health Alliance Keystone ICU Project was undertaken and reported on in 2006.¹⁰ They studied whether a series of interventions (a standardized catheter insertion protocol with a checklist to ensure adherence) would decrease the number of infections. This study involved 103 ICUs with 375,757 catheter-days and examined the number of infections per 1000 catheter-days. Remarkably, their median infection rate went from 2.7/1000 catheter-days (prechecklist) to 0/1000 catheter-days with a 66% overall reduction of infections at 18 months! Their overall rate dropped from 4% to 0% with an estimated 1500 lives and $200 million saved. Clearly the use of a checklist greatly improved patient safety. But what about surgery?

Checklists in Surgery

Early this year, January 2010, a landmark article was published in The New England Journal of Medicine that demonstrated the efficacy of a surgical checklist in reducing intraoperative complications.¹¹ Sponsored by the WHO, this study examined a 19 step surgical checklist performed at 3 different points during a procedure. The study included patients age > 16 years undergoing noncardiac surgery at 8 pilot hospitals internationally (with various socioeconomic locations), including 3733 pre-intervention patients and 3955 post-intervention procedures. They followed patients until hospital discharge or 30 days, looking for any major complication or death.

For the sake of brevity I’ll boil down the results. The researchers found a 36% decrease in “any complication,” 45% decrease in surgical site infections, 25% decrease in returns to the OR, and 47% decrease in surgery-related mortality. All values were statistically significant. These remarkable results were thought to be due to several issues. First, fewer mistakes were made. Second, the effective use of the checklist lead to changes in surgical team behaviors. Third, institutional policies, such as when to administer antibiotics, changed, thereby reducing delays.¹¹ Again, the use of a checklist significantly reduced surgical complications.

Nonsense… Or Is It?

So am I just wasting my breath on this subject? Isn’t it enough that we do our surgical time out? No - it’s not. The evidence shows clearly that a simple time out is not effective enough in reducing the potential for surgical complications. We’ve seen thus far that initiation of checklists successfully and significantly reduces airplane complications, PICC line infections, and surgical complications. It has additionally been shown that checklists improve adherence to clinical pathways for treatment of ST segment elevation myocardial infarction and stroke¹² and improves OR efficiency by reducing unexpected delays by 31%.¹³

You're Already using Many Checklists

Oh yeah. By the way, we’re already using them in podiatry! Don’t think so? Ever use a wound care documentation form? This is simply another checklist to avoid errors and supply clear documentation. How about point-and-click EMR programs? This is simply a computerized version of a checklist. Ever admit a patient to the hospital with a premade admission form? Yup – another checklist. They’re all over the place!

What Do I Do Now?

Whether you like it or not, checklists are here to stay and are likely to become the industry standard. In fact, as of February 2010 the Surgical Safety Checklist is becoming mandated in England and Wales (14). So for those interested in bringing this checklist to their hospital (and decreasing the risk of surgical complications), the question becomes “what do I do now?”
Here are some suggestions:

Perform multiple trials before going “live.”
Modify the checklist as necessary. The WHO’s checklist is made to be changed to fit the specific hospital situation.
Keep it simple. The tendency is to enlarge the checklist to incorporate more steps. Fight the urge and focus on the key steps of the procedure.
Create an atmosphere of acceptance. One doctor cannot implement this program alone. Hospital administration must be supportive. Educate all potential players (nurses, doctors, scrub techs, CRNA’s, etc).
Empower all levels of participants. Teach staff that it is permissible to voice concerns without feeling there will be repercussions from an angry doctor. Emphasize “no fault” reporting. A nonputative environment will foster the teamwork necessary for success.
Track results/progress when possible.
Appoint someone to “champion” the checklist, preferably a surgeon.
Observe the performance of the checklist once widely instituted and re-educate as necessary.
Go to www.safesurg.org which has all the tools necessary to get started.

Remember, it’s not about egos. Recognize that medicine and surgery are highly complex undertakings with the potential for significant error, and no one is 100% consistent. We can all have attention and memory lapses. That's excusable. What’s inexcusable is when a mistake in the presence of ego leads to a poor patient outcome. Welcome to the world of checklists, coming to hospital near you!

Keep writing in with your thoughts and comments. Better yet, post them in our eTalk forum.
Best wishes.

Jarrod Shapiro, DPM
PRESENT Practice Perfect Editor
[email protected]

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REFERENCES:

Weiser, et al. The Lancet 2008; 372: 139–144
Gawande, et al. Surgery 1999; 126: 66-75
Kable, et al. Int J for Qual Health Care 2002; 14(4): 269-276
Brennan, et al. NEJM Feb 1991; 324: 370-376
Leape, et al. NEJM Feb 1991; 324: 377 - 384
Shamel. How the Pilot’s Checklist Came About. Updated 7/5/2009.
www.atchistory.org/History/checklst.htm
PA PSRS Patient Safety Advisory June 2007; 4(2): 29 -45
Facts About the Universal Protocol. Dec 2009.
O’Grady, et al. MMWR Recomm Rep 2002; 51 (RR-10): 1-29.
Pronovost et al. NEJM 2006; 355 (26): 2725 – 2732.
Haynes et al. NEJM 2009;360:491-9.
Wolff, et al. Medical Journal of Australia 2004; 181: 428-431
Nundy, et al. Arch Surg 2008; 143(11): 1068 – 1072
Vats, et al. BMJ 2010;340:b5433