No one knows exactly how often a surgeon cuts into the wrong body part, but wrong-sided surgery happens more often than you think, affecting hundreds of patients a year, sometimes with horrific consequences. In one widely publicized Florida case a few years ago, a series of mistakes by the OR team resulted in a doctor amputating the wrong leg. Hundreds more cases likely go unreported. A study in the Archives of Surgery (osmag.net/Tv8kUC) that says wrong-site surgery is underestimated by a factor of 20 or more estimates that there are 1,300 to 2,700 wrong-site procedures annually in the United States. A recent study in the JAMA Surgery (osmag.net/s9WSHq) suggests that it's about 1 in every 100,000 procedures. Wrong-site surgery is clearly closer to an everyday event than a "never event." And for that, we have inadequate site marking at least partially to blame. Either it's not being done or it's not being done as it should.
The Joint Commission has a set of guidelines for surgical facilities to follow to prevent wrong-site surgery: verify the surgical procedure to be performed, mark the surgical site in advance and take a "time out" immediately before starting the operation, during which team members verify that they've got the right patient and that they've marked the surgical site. It's been 11 years since the Joint Commission implemented its Universal Protocol designed to eliminate — or at least vastly reduce — never events. But improvement has been slow and disappointing, say experts.
A recent Outpatient Surgery Magazine survey of more than 550 readers may shed some light as to why. We asked about one of the 3 key components of the protocol — site marking. The response was eye-opening and maybe a little disconcerting. Specificity, standardization and 100% compliance are the protocol's intended pillars, but in practice, many providers appear to be viewing its provisions as suggestions, not edicts.
ACCORDING TO PROTOCOL?
The Joint Commission's Universal Protocol explicitly spells out the who, what, when, where and why of surgical site marking, the best defense you have against wrong-site surgery. But our survey of more than 550 surgical facility leaders shows not everyone is complying with the recommendations.
Who in your facility is/are responsible for marking surgical sites?
- Operating surgeon 80.6%
- Pre-op nurse 2.5%
- OR nurse 0.7%
- Anesthesia provider 0.2%
- Other or a combination of people 16.0%
Which type of mark do you use to identify surgical sites?
- Surgeon's initials 56.1%
- It varies, depending on the surgeon 10.7%
- "Yes" 9.6%
- "X" 4.3%
- A line representing the proposed incision 4.0%
- Dots 1.4%
- Other 13.9%
Are your marking methods and marks standardized for all cases?
- Yes 85.5%
- No 14.5%
Do patients actively participate in your site-marking process?
- Yes 95.7%
- No 4.4%
SOURCE: Outpatient Surgery Magazine Reader Survey, June 2015, n=556
For example, we asked: "Are your marking methods and marks standardized for all cases?" They aren't, 15% of our respondents admit. We asked: "What type of mark do you use to identify surgical sites?" The results were mixed: 56% say the surgeon initials the site and 10% say whoever's doing the marking (more on that later) writes the word yes. Those answers are the only 2 universally accepted practices. Rather than representing the proposed incision with an unambiguous site marking of the surgeon's initials or yes, many surgical facilities may still be using X's, dots, lines, arrows, smiley faces or whatever else comes to mind.
"Variability in the marking process leads to ambiguity for the surgical team and risk for the patient," says patient safety expert Spence Byrum, the CEO and co-founder of HRS Consulting. "Consistent, replicable processes and procedures are the most reliable defensive tools for the team that cares enough to do a quality time out. We owe our patients nothing less."
Of our survey respondents, 11% acknowledge that the marks made in their facilities vary, depending on the surgeon.
"Typically, it's the surgeon's initials, but occasionally it's a line," says one administrator. "We use an 'X,' yes or the patient's initials," says another. That kind of variety, experts say, is a recipe for trouble. "We don't do 'X' because there could be confusion as to whether 'X' means not this site or yes, this site," another facility leader correctly points out.
Do arrows, dots or patient initials, which might be made by anyone, downplay the essential nature of the surgeon's understanding and acknowledgement? The mark you use, says the protocol, must be "unambiguous" and "used consistently throughout the organization."
Studies show that among the most common factors contributing to wrong-site surgery are lack of standardization, lack of clear policies and failure to clearly identify responsibilities.
The protocol is clear: The responsibility for marking the surgical site belongs to the "independent practitioner who is ultimately accountable for the procedure and (who) will be present when the procedure is performed." In "limited circumstances," it continues, responsibility "may be delegated to some medical residents, physician assistants or advanced practice registered nurses."
One gets the feeling that there's considerably more delegating going on than the authors envisioned. In fact, more than 3% of our survey respondents say either the pre-op nurse or the OR nurse is responsible for marking surgical sites at their facilities. Another 16% say the ultimate responsibility belongs either to a combination of people or to someone else entirely.
"The pre-op nurse verifies the site with the patient while the patient marks the site," says a hospital administrator, who adds, "most of our physicians will also make their own site markings." The "technician" puts an 'X' next to the surgical site, says another administrator. Several say that either the surgeon or a "designee" does the job. Having a "designee" mark your sites might be technically permissible, but it certainly isn't preferable.
Nor should it be necessary, say others. "Don't let the surgeon ever delegate this responsibility," says Kathy Bedger, MS, RN, vice president and chief nursing officer of Penn Highlands Clearfield (Pa.). There can be no delegation at St. John Macomb-Oakland Hospital, Oakland Center in Madison Heights, Mich., says Pamela Borello-Barnett, RN, BS, CNOR, clinical nurse manager of surgical services. "Only the surgeon marks the site."
Concerned about pushback? "Give the policy to every new surgeon and have them sign off that they received it," suggests Rita Young, BScN(H), RN, unit manager at Queen Elizabeth II Hospital in Grande Prairie, Alberta, Canada. Remember what's at stake, "adhere to your policy and do not back down," adds Marc Chudow, RN, charge nurse at the University of South Florida Morsani ASC in Tampa, Fla.
It may help to remind surgeons that if something goes wrong, "ultimately, the licensed independent practitioner is accountable for the procedure," says the protocol, "even when delegating site marking." That's true in your hierarchy and it's likely to be true in court, as well.
"Educate, encourage, enforce," says Brandy Miller, MHA, MSN, RN, CNOR, director of The Surgery Center in Fort Wayne, Ind.
ON YOUR MARK
- Mark the site with a marker that is sufficiently permanent to remain visible after completion of the skin prep. Keep a large bin of one-time-use markers in the pre-op area. To help preserve the site marking, you might want to dab the prep solution where the surgeon has marked.
- In addition to the prep, be mindful of the drapes. Position the mark so that it's visible after the patient is prepped and draped.
- Make the mark at or near the incision site. Do not mark any non-operative site(s) unless necessary for some other aspect of care. Adhesive site markers should not be used as the sole means of marking the site.
- Don't rely on patient reporting. Always visualize the mark in pre-op and compare it to the orders and consent. The surgeon may have been to the bedside but failed to mark or mark properly.
- Communicate with staff and surgeons. Explain the why of site marking, and give them real-life examples of wrong-site surgeries.
- Make sure the time out is done consistently throughout the facility. Observe staff and surgeons in the OR and procedure rooms to ensure site marking, and then during the time out to confirm that all remain consistent with your policy and process. Final verification of the site mark should take place during the time out.
- Have everyone participate in the process. The surgeon, surgical team, nursing staff and patient should all be actively involved and concur with the site marking.
- Talk to the patient about site marking during the pre-op visit. Marking should take place with the patient involved, awake and aware, if possible.
- Promise to remove the ink after the case. Hand sanitizer contains a good amount of alcohol, which works to thin and erase the ink from a marking pen.
- If you have to remove hair from the surgical site, clip the site before you mark it.
SOURCE: Outpatient Surgery Magazine Reader Survey, Reader Survey, June 2015, n=556
Many readers say that the best way to make sure surgeons take full responsibility is to make a hard-and-fast rule that unmarked patients don't enter the OR.
"Our compliance with site marking improved dramatically when we implemented a policy that patients would not leave the holding room until the site mark was complete," says Mary Wilson, BSN, RN, CNOR, clinical preceptor/educator at WVU Hospitals in Morgantown, W.Va. "We rarely have to remind surgeons to mark, now that it will delay their OR start time."
Same goes for the Pennsylvania Eye & Ear Surgery Center in Wyomissing, Pa., where if unmarked patients somehow make it into the OR, surgeons "must break scrub, then mark, then rescrub," says Clinical Director Vanessa Tobias, RN.
Implementing such a policy can be "difficult at first," adds another facility leader, acknowledging that it might lead to some late starts, "but now it is routine for the surgeons to come early to mark the site."
Involving the patient
A large majority of respondents say that per protocol, they always involve the patient in the site-marking process, if possible. Still, a surprising 1 in 20 say they don't. Why not?
The Veterans Health Administration, expanding on the Universal Protocol, recommends asking patients during the verification process to not only state their names and Social Security numbers, but also to point at and touch the parts of their bodies where the procedure should take place. The idea is to eliminate potential ambiguity. The "2nd finger on my right hand" may not mean the same thing to a patient and a provider.
Furthermore, if there happen to be 2 patients named Bob Miller and 2 named Maria Garcia in your facility on a given day, it's a reassuring safeguard to have all 4 parties confirm why they're there.
What about those rare patients who refuse to be marked? Most say they've never seen it happen. But when it does, "we discuss with the patient the risk of not marking the site," says Dawn Vocke, MSN, MBA, RN, CNOR, director of surgical services at UPMC St. Margaret in Pittsburgh, Pa., adding that the surgeon is always given the option to cancel the case. If the surgeon decides to go ahead, the patient's refusal is documented and an alternative, such as placing a wristband on the side of the procedure, is initiated. Several readers mention armbands, wristbands and stickers as preferred alternatives if patients refuse marks.
But several others, recognizing the chronic danger of operating on unmarked patients, say that when a patient refuses to be marked, they refuse to cut. What do you tell those patients? "You, my friend, may go home," offers one physician, "and pretend you had surgery."