end wrong-site surgeries

Surgeon initials the site

Patient confirms with a checkmark

Nurse and anesthesia add crosscheck marks

Tattoo comes off in seconds but all marks stay

How often? 40 times a week in the U.S.

Physicians operate at the wrong site, on the wrong patient, or perform the wrong procedure at least 40 times a week in the U.S.1In 2019 Mark Chassin, President of The Joint Commission, stated: “The best estimates are that 40 wrong-site surgeries [WSS] occur in the United States every week, and it’s the most common sentinel event reported to the Joint Commission” https://www.centerfortransforminghealthcare.org/why-work-with-us/video-resources/reducing-the-risk-of-wrong-site-surgery/. Chassin notes that inasmuch as most hospitals are not required to report WSS or near misses to the Join Commission, he and others believe 40 times a week for WSS is actually a low estimate. After the Joint Commission failed to eliminate WSS, Chassin was quoted in the Washington Post saying, “I’d argue [solving WSS] really is rocket science.” See Sandra G. Boodman, “The Pain of Wrong Site Surgery” The Washington Post, June 20, 2011, https://www.washingtonpost.com/national/the-pain-of-wrong-site-surgery/2011/06/07/AGK3uLdH_story.html. The bad news is that many analysts actually consider this estimate to be low. Mark Chassin, the President and CEO of The Joint Commission believes “there may be as many as fifty wrong-site surgeries per week in the United States.”2https://www.healthaffairs.org/doi/10.1377/hlthaff.2013.0809, cited in the Minnesota Department of Health. Adverse health events in Minnesota: ninth annual public report [Internet]. Saint Paul (MN) : The Department ; 2013 Jan [cited 2013 Aug 19 ].  Over the years, wrong-site surgeries have remained one of the top 3 errors hospitals report to the Joint Commission.3Linda Groah, CEO/Executive Director, Association of PeriOperative Registered Nurses, “Moving the Needle to Zero Wrong-Site Surgeries,” The Joint Commission, June 2019, https://www.jointcommission.org/resources/news-and-multimedia/blogs/leading-hospital-improvement/2019/06/moving-the-needle-to-zero-wrongsite-surgeries/.

Patients die as a result

U.S. malpractice claims reveal wrong-site surgeries are associated with 6% of patients dying and 32.9% suffering permanent injury.”4Mehtsun WT, Ibrahim AM, Diener-West M, Pronovost PJ, and Makary MA. “Surgical never events in the United States” Surgery. 2013;153:465-72. Also noted in Becker’s ASC Review, “10 Things to Know About Wrong-Site Surgery.” August 12, 2015. So these errors are serious. Malpractice insurers consider all wrong-site surgeries indefensible and they pay claims automatically. One of these errors can cost a hospital up to $3M in penalties, malpractice payments, and associated costs to repair the damage.

 “We consider wrong-site malpractice cases as indefensible. I think using the Surgi-Sign would eliminate the risk of these wrong-site errors.

— Sean E. Capplis, Esq.

Even the best surgeons make mistakes

Too many people—including surgeons and other clinicians—assume wrong-site surgeries only happen to bad surgeons at tiny, rural hospitals. Data proves this is not the case. These errors occur throughout the world and are seen at famous, well-respected hospitals. Despite concerted efforts over the last 30 years to eliminate wrong-site surgeries, the bottom line is that human error can happen to anyone, even to the very best surgeons.

How does it happen?

 

Marking the wrong place

Many factors contribute to wrong-site errors. One of the most common mistakes stem from pre-operative surgical markings—or the lack thereof in many cases. A surgeon may mark the wrong site or mark only the patient’s right or left hand to indicate the side of the procedure. Unfortunately, in the OR these marks are frequently hidden by surgical drapes. And when the marks are hidden the surgeon and or team most often choose where to prep and operate based on memory.

Marking variability

Marking variability also plays a large role in wrong-site surgical errors. Surgeons use a variety of marks including small, scribbled initials, letters, a smiley face, or even a flower to mark the site. In a busy operating room, having to remember how each surgeon marks their patients, where they mark, or whether an ‘X’ means cut here or don’t cut on this side is a recipe for disaster.

How do OR room delays contribute?

“Time is money.” Operating rooms are challenged every day to maximize efficiency and get the cases done. Operating room schedules are adjusted minute by minute as surgeries can unexpectedly take longer, or cases are cancelled, or emergency cases “bump” the scheduled cases.

As surgeries have become more specialized, the instrumentation, X-ray imaging, patient positioning, and even the operating rooms have become specialized for particular surgical sites. Many rooms have become uniquely “sided,” and the Universal Protocol and Time Out procedures are an attempt to deal with these changes.

Unfortunately, operating room staff are constantly adjusting to these sided changes. Add to this fatigue, staff breaks, shift changes, a lack of familiarity with the surgeons’ varied markings, and combine that with the desperate need not to be the person blamed for causing a delay, mistakes are inevitable.

The best solution is the easiest solution: the Surgi-Sign

We started with a simple, inexpensive technology that was quick and intuitively easy to use and we “error proofed” the process of surgical site identification by adding easily identifiable, consistent crosscheck marks. The result was the Surgi-Sign Marking System, a specially formulated temporary tattoo that fits easily into the fast paced operating room environment.

Standardized Markings

The Surgi-Sign goes on the skin at the operative site before the patient enters the operating room. The fill-in-the-box technology standardizes the markings so that everyone knows where and how the patient is marked.

Confirmation before incision

The unique checkmark boxes for the patient, nurse, and anesthesiologist ensure that everyone agrees the correct site has been identified and marked. It also ensures that everyone is actively involved in identifying the correct operative site. For the first time ever an “empty box” visually alerts everyone that a step has been missed and they need to reassess the situation before an error occurs.

Better Time-Outs

The Surgi-Sign is the first and only temporary tattoo that can be applied in 20 seconds, and more importantly, wiped away in 10 seconds while still preserving the surgeon’s initials and team checkmarks on the skin in the surgical field. Now Time Out procedures are performed by actually seeing standardized marks on the skin in the surgical field.

“A wrong-site surgery is the most feared complication any of us would want to encounter. In order to prevent this, the Surgi-Sign is a no brainer.”

— Dr. Kathryn Dalton, DO General and Breast Surgeon

“I would think every hospital wants a product like this. This is what the hospital wants, this is what the surgeons want, and obviously it’s what the patients want.”

— Dr. James Boyle, MD Orthopedic Surgeon

DOESN’T DISRUPT WORKFLOW: Temporary tattoo applies in 10 seconds, and comes off just as fast with gauze and water or an alcohol wipe.

THE MARKS REMAIN VISIBLE: Even though the tattoo disappears, the surgeon’s initials, date, and check marks all remain visible on the patient’s skin in the procedural site — and you’re ready for the Time Out.

true team work

“When you prep and drape that patient, you can see that’s the area that the surgeon and patient identified as the correct site.”            — Nancy Spirko, RN, MSN, CNOR

This is what your Time Out will look like every time

No more marking variability. Time-outs based on visible markings—not memory.

Everyone participates — even the patient. Finally a mechanism for halting a procedure if something doesn’t look right.