Despite clear guidance, not every OR practices proper surgical site marking, an essential step in preventing wrong-site surgery. Here's a Q-and-A to test your knowledge.
Q. Is there a standard for site marking?
A. The Joint Commission's Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, which took effect in 2004, has been endorsed by 51 professional associations (www.jointcommission.org/patientsafety/universalprotocol). Marking the operative site is one of the safety strategy's three steps, along with a pre-op verification process and a time out before the procedure begins.
"The Joint Commission sought a consensus that all organizations could buy into and, to their credit, they succeeded," says John Clarke, MD, a professor of surgery at Drexel University in Philadelphia and the clinical director of the Pennsylvania Patient Safety Reporting System.
Q. Which procedures should be marked?
A. According to an updated Universal Protocol, which takes effect on January 1, 2009, "For all procedures involving incision or percutaneous puncture or insertion, the intended procedure site is marked. The marking takes into consideration laterality, the surface (flexor, extensor), the level (spine), or specific digit or lesion to be treated."
This recommendation covers all invasive procedures, whether they take place inside or outside of the OR, says Peter Angood, MD, vice president and chief patient safety officer for the Joint Commission.
The updated Universal Protocol originated from feedback voiced at a Joint Commission wrong-site surgery summit in 2007, says Dr. Angood, which examined the protocol after three years of clinical experience.
Q. Whose responsibility is site marking?
A. This question highlights perhaps the most significant clarification in the updated protocol. "The procedure site is marked by a licensed independent practitioner or other provider who is privileged by the organization to perform the intended surgical or nonsurgical invasive procedure," it reads. "This individual will be involved directly in the procedure and will be present at the time the procedure is performed."
"There was a strong sentiment at the summit that the person doing the procedure must mark the site, period," says Dr. Angood. The update rules out marking by pre-op and OR nurses, who might not be present for the surgery and won't be executing it. But "the language was constructed to provide a little bit of latitude for organizational or institutional responsibility," he says, and would include, for example, the chief resident in a training program.
The protocol also recommends that "the procedure site is initially marked before the patient is moved to the location where the procedure will be performed and takes place with the patient involved, awake and aware, if possible." Don't neglect patients' active participation in marking, says Dr. Clarke, since they'll likely be asleep during the final site confirmation. "The mark," he notes, "is the patient's voice during the time out."
Q. Where should the mark be made?
A. As close to the incision site as possible, says the Universal Protocol, which warns against marking anywhere else unless it is directly relevant to the case. Modern surgery means fewer and smaller incisions, though, a contingency the protocol also addresses. "For minimal access procedures that intend to treat a lateralized internal organ, whether percutaneous or through a natural orifice, the intended side is indicated by a mark at or near the insertion site, and remains visible after completion of the skin prep and sterile draping," it says.
Visibility and verification are key here, says Dr. Clarke. "If you have the mark covered when it comes time to [operate], it's not doing any help," he says. "There's no advantage to marking at the site if you're not going to be referring to the site at the time of laterality in the procedure."
Q. What constitutes an effective mark?
A. The Universal Protocol recommends that surgeons mark sites with their initials, and possibly with a line signifying the intended incision, using ink that is "sufficiently permanent to remain visible after completion of the skin prep and sterile draping." It adds, "The method of marking the site and the type of mark is unambiguous and is used consistently throughout the organization."
While various authorities have backed the use of the word "yes" in marking, the updated protocol does not mention this option. "Utilizing initials provides the most consistency in the process," says Dr. Angood. "It puts a certain degree of responsibility on the person performing the procedure."
The use of an "X," however, is still widely considered an ambiguous mark that should be avoided. And while the Universal Protocol does not rule out stickers, tattoos or other marking accessories, "adhesive site markers are not to be used as the sole means of marking the site," it says.
Q. Do marking alternatives exist for difficult or sensitive sites?
A. The Universal Protocol notes that some sites, such as broken skin, mucosal surfaces, the perineum and the skin of premature infants on whom ink may leave a permanent mark may be "technically or anatomically impossible or impractical to mark." Dr. Angood says some patients refuse to be marked due to their uncertainty about its purpose, about a mark's longevity, about potential allergies or about cosmetically unappealing results.
In these cases, says the protocol, "a temporary, unique wrist band on the side of the procedure" along with a second site identifier may be used as an alternative. "Wrist bands are an easy practice that most institutions are comfortable with," says Dr. Angood. Above all, he says, "we're looking for consistency of process across the institution."
Q. Must the marker be sterile?
A. "Sterility is not an issue as far as we can tell," says Dr. Clarke. If the site is marked before the skin is prepped and draped, and the mark remains visible afterwards, then the skin has been sterilized.
Further, permanent ink is not aqueous in its base, but alcohol- or acetone-based. "My understanding is that the solvents used to dissolve ink pigments are incompatible with bacterial survival," he concludes. (The December issue of his agency's Pennsylvania Patient Safety Advisory is scheduled to examine the question in depth. The quarterly publication is available at www.psa.state.pa.us.)
Researchers at the University of Alberta in Edmonton, Canada, recently announced similar findings on the issue. They contaminated the tips of a sterile, one-use surgical marking pen and an ordinary "Sharpie"-brand permanent marker with four types of bacteria, then recapped them for 24 hours. Testing showed the one-use pen's tip was still contaminated, but the Sharpie's was not on account of its alcohol-based ink. Such a pen may be reused, as long as its casing is swabbed with alcohol between patients, they said. (The researchers presented their findings at the Interscience Conference on Antimicrobial Agents and Chemotherapy/Infectious Diseases Society of America conference in Washington, D.C., in October.)
Q. How can I support correct marking?
A. No OR is immune to medical errors. Adopting and enforcing redundant safeguards, however, can prevent them. Dr. Clarke says that there are two reasons why sites might end up mismarked. First, surgical personnel have incorrect information; or second, a misperception is lent credence by the blind acceptance that the surgeon is right or the patient is wrong.
"Verify information," he says. "Multiple checks by multiple people of multiple documents, a paper trail that people can review and sign off on throughout the process, even before the patient shows up for surgery." Dr. Clarke recommends that your scheduling software be configured with a required field that details the side or situation of upcoming cases, and that all personnel who come in contact with the case documents be empowered to seek clarification if they feel it's needed.
"The rules are the rules," he says. "People can follow the rules with or without thinking."