Wrong-site surgery may be uncommon in ophthalmology, but as J. Robert Rosenthal, MD, said, “If there’s one wrong-site surgery, that’s one too many.” When the Academy issued its Patient Safety Bulletin on the topic, it acknowledged that these errors occur “on a rare basis” in ophthalmology, but also noted that “the consequences could be visually devastating, and thus, measures should be taken to eliminate” their possibility.1
New Protocol for All
With agreement that wrong-site surgery (WSS) is 100 percent preventable, hospitals are taking a major step this year toward eliminating the problem via implementing a new universal protocol that is designed to standardize presurgical procedures to ensure the correct surgical site.2
The protocol, created by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), has been endorsed by the Academy and more than 40 other major professional societies. Beginning July 1, all Joint Commission–accredited hospitals, ambulatory care surgery centers and office-based surgery sites will have to comply.
Caption: As of July 1, JCAHO surgery sites must comply with the new protocol.
The protocol grew out of a consensus conference convened by JCAHO in Chicago in May 2003. The conference concluded that the prevention of WSS must include 1) a commitment and effort by everyone on the surgical team and 2) multiple, redundant procedures, including preoperative verification measures, site marking and taking a preoperative time-out to verify the correct patient, site and operation.
Physician acceptance of the protocol is crucial, but Dr. Rosenthal believes that the new guidelines will be widely accepted by ophthalmologic surgeons. “I don’t think anyone can argue with them,” said Dr. Rosenthal, vice president for medical affairs at the New York Eye and Ear Infirmary.
Many hospitals already have guidelines designed to reduce WSS. At the Wilmer Ophthalmological Institute, rigorous protocols have existed since 1995, and they are updated periodically. “Teamwork and communication are crucial, from preop preparation to the OR,” said Victoria Navarro, RN, MSN, MAS, Wilmer’s director of nursing and chairwoman of the patient care task force of the American Association of Eye and Ear Hospitals.
At Duke University Eye Center, “We’ve had a comprehensive protocol in place,” said Paul P. Lee, MD, JD, professor of ophthalmology. “There are checks and double checks all the way through in order to minimize the risk of wrong-site surgery. The JCAHO approach has highlighted the importance of the process and also resulted in some changes, such as having the surgeon or assistant surgeon initial above the surgical eye instead of just confirming a prior mark.”
For years, many institutions have advised their surgeons to place a mark adjacent to the operative eye, although there needs to be a clear understanding of what the mark means.
The 2004 JCAHO National Patient Safety Goals recommend that each facility adopt a consistent mark throughout the organization, noting the “use of X is discouraged because its meaning may be ambiguous: Does X mean operate here or do not operate here? A line indicating the intended site of incision, the surgeon’s initials and the word yes are all acceptable ways to mark the site.”2
In a high-volume OR, it may not always be practical for the surgeon to take time to mark the site. “We’ve always had a system in which the marking has been done in a very quiet, unhurried atmosphere by a nurse at the time of the intake,” said Dr. Rosenthal.
Nevertheless, the new JCAHO protocol recommends, “The person performing the procedure should do the site marking,” although it uses the word “should,” not the more definitive “must.”
Check and Recheck
Confirming the operative eye should start at the earliest possible point, beginning in the doctor’s office when the original paperwork is prepared, and it should continue until the moment of surgery.
Richard L. Abbott, MD, professor of ophthalmology at the University of California, San Francisco, strongly recommends that the patient’s medical chart and records be present in the OR. “They should be checked and rechecked, ensuring that the proper patient is about to undergo the proper procedure,” said Dr. Abbott, who’s also Academy secretary of Quality of Care and Knowledge Base Development.
When the surgical team discusses the impending operation, it’s important to use the term “correct eye” or “operative eye,” rather than “right eye,” to minimize any confusion. “On the informed consent forms, we also don’t accept abbreviations, such as R or L, or OD or OS,” said Ms. Navarro. “We accept only ‘Right’ or ‘Left.’ It has to be spelled out.”
Involve the Patient
Many institutions engage the patient (or, when appropriate, the family) in confirming the operative eye and surgical procedure, and comparing his or her responses with the doctor’s orders, the consent form and other documents. “I don’t think it’s mandatory to involve the patient in this process,” said Dr. Abbott, “but it’s another helpful step.”
If patients are anxious on the day of the surgery, however, they may become confused and answer questions incorrectly. “The surgeon knows what he or she plans to do, but occasionally the patient isn’t clear,” said Dr. Rosenthal. “I’ve seen situations where the patient got to the OR and said, ‘No, it’s the other eye that needs the operation.’”
Dr. Abbott advised, “If the patient’s response indicates any confusion or misunderstanding, the facts need to be double-checked to make sure everything is being done properly.”
Just prior to the incision, the surgeon must review the informed consent form and the patient’s ophthalmic history and exam to confirm the operative eye a final time. In many surgical centers, most standardized pre- and postop orders and informed consents are preprinted in order to avoid any mix-up attributed to illegible handwriting, said Ms. Navarro.
Take a Time-Out
Many hospitals have instituted time-outs in the OR. “The time-out has worked very well for us,” said Dr. Lee. “The patient’s identity is confirmed, the surgical site is checked, the proper marking is verified, the type of procedure itself is double-checked and the consent forms are reviewed. With the entire team involved, it takes less than 30 seconds.”
Dr. Rosenthal noted, “The time-out is really the last barrier to making a mistake, where everyone in the OR stops before any substantive part of the procedure occurs. But unfortunately, not everyone takes it seriously, including some doctors. It’s very important that somebody in the team initiates it. Someone has to say, ‘We have to have a time-out now.’ If a time-out doesn’t occur in the OR, it’s everyone’s fault.”
While a time-out may be thought of as the last defense, it’s not completely fail-safe. Dr. Rosenthal recalls an NYEEI case in which the anesthetic block was injected in the wrong eye despite a seemingly successful time-out. “I spoke with the surgeon afterward,” Dr. Rosenthal recalled, “and he said, ‘My mind wandered.’ So there’s a human element in this situation, even when everyone appears to be paying attention.”
When the Worst Happens
When a WSS occurs, “The surgeon should act in the best interests of the patient, inform the patient and family, request their written consent, if [the patient is] not already sedated, to proceed to the correct site, and record the event in the medical chart,” the Academy stated.1 The problem needs to be “reported to the appropriate risk management staff and/or legal counsel, if appropriate.”
For instance, said Ms. Navarro, when a sentinel event occurs at Wilmer, key individuals involved in risk management conduct a root cause analysis of what went wrong, examining every step along the way.
This process can be awkward, given the possibility of exposing oneself to action by regulatory bodies and the legal system. In 2001, the Florida Board of Medicine adopted penalties for doctors and organizations for a WSS incident, including fines (up to $10,000), five hours of risk management education, 50 hours of community service and a one-hour lecture to the medical community on the topic.
Even though the prevention of WWS is a team effort, “There’s no question that the physician is still the captain of the ship, and has the ultimate responsibility to make sure things are done properly,” said Dr. Rosenthal.
1 The Academy’s Patient Safety Bulletin can be found at www.aao.org by clicking “Clinical Information.” Under “Quality of Care,” choose “Enhanced Patient Safety,” then to “Eliminating Wrong-Site Surgery.”
2 Both the universal protocol and the patient safety guidelines can be found on the JCAHO Web site (www.jcaho.org).