A 44-year-old truck driver presented at a local ophthalmic ambulatory surgery center (ASC) for bilateral LASIK correction of hyperopia. Originally scheduled to have the second procedure of the day, the man was moved up when the first patient canceled. Staff members addressed him multiple times by the name of the patient who had canceled, but the man didn’t correct them. (He was apparently too anxious about the upcoming procedure to notice.) The surgeon was subsequently given the first patient’s medical records, which were used to verify the laser settings.
The error was discovered the next day, when the patient reported significant visual difficulties. To correct this mistake, the patient ultimately required clear lens extraction with toric intraocular lens insertion, followed by bilateral LASIK retreatment for residual refractive error—all performed free of charge by the surgeon and ASC.
This real-life case, from the archives of the Ophthalmic Mutual Insurance Company (OMIC),1 is an example of what medical professionals call “wrong” or “never” events—events that should never occur but do because of process-related mistakes and failures. “A wrong event could be operating on the wrong eye, implanting a wrong lens, or even operating on the wrong patient,” says Linda Harrison, PhD, vice president of risk management at OMIC. “There are many iterations of wrong events.”
And as the truck driver’s case illustrates, wrong events can be costly and consequential.
“Most third-party payers will not reimburse for expenses related to addressing a wrong event,” Harrison says. “In the example, several more procedures were required, which added to costs and exposed the patient to additional risk from the surgery and anesthesia. In addition, the event delayed the patient’s achieving the desired visual outcome.”
Start with Patient Screening
Preventing wrong events begins with always performing a thorough patient screening, which may or may not include a full physical examination by the patient’s family doctor or another specialist. Nicole Fram, MD, medical director of Specialty Surgery Center in Beverly Hills, California, and managing partner at Advanced Vision Care in Los Angeles, often bases that decision on the complexity of the case.
“For a patient that has a history of diabetes but is not insulin dependent … that’s a patient I would say I can clear for surgery for a routine cataract [as long as] I take a proper history and I look at basic vitals,” she says. “They don't necessarily need a history and physical from their doctor, although we still get history and physical from their primary MDs.”
For more complex cases that take at least an hour, Dr. Fram says, she always seeks medical clearance from the patient’s primary care provider and/or specialist.
“If it’s either a pseudoexfoliation or an advanced brunescent cataract in someone who is older, say above the age of 90, the likelihood of getting into zanulopathy and issues is higher,” she says. Similarly, for vitrectomy cases, she will seek a consultation with the specialist caring for patients with a history of stroke and other cardiovascular events, who may be taking blood thinners such as Lovenox (Sanofi) or heparin, that may need to be stopped prior to surgery.
“Every case is unique, so depending on the complexity of the case is how I determine whether or not I need a preoperative clearance from a cardiologist, primary care doctor, or [can rely on] my own training as a medical doctor,” she says.
Do’s and Don’ts to Prevent Wrong Events
Do say something when you see something. “It’s important to create an atmosphere in the operating room where everyone feels empowered to speak up when they see something that is going wrong or they think is about to go wrong,” says Linda Harrison, PhD, vice president of risk management at OMIC. “You might have staff who feel, because they aren’t physicians, they shouldn’t speak up about something that is beyond their scope. Everyone needs to feel they’re empowered to speak up. The consequences of not creating that atmosphere is that no one will speak up and we don’t want that.”
Don’t consider informed consent just a form. “One of the most important things is the quality of the communication between the physician and the patient,” says Harrison. “Honest, straightforward communication forms the basis of a trusting physician-patient relationship. Remember that informed consent is not the form that the patient signs but rather the discussion between the physician and the patient. In some states, such as Pennsylvania, the law mandates that only the physician obtain informed consent.
Don’t sacrifice safety for efficiency. “You’re only as efficient as you are safe,” says Nicole Fram, MD. “So many surgeons say, ‘Let's just do this fast and get them out. Everything will be fine. I have to get into the next room.’ You have to give your team the time to be safe. If you end up having a complication because of giving too much anesthesia or the patient moves, now your case is taking two hours. How efficient are you then?”
Don’t take shortcuts. “Due to a high level of expertise and repeated good outcomes, surgeons and OR teams sometimes create workarounds or skip steps in safety protocols,” Harrison says. “The abbreviated protocol seems fine until an error occurs that could have been prevented by that one step that was skipped. And that error could result in a devastating outcome for the patient.”
Do learn from your mistakes. “Use complications and wrong events as learning experiences,” Harrison says. “Focus on what you can learn versus punitive measures.”
Perform Preprocedure Checks
Most medical personnel know to follow the Joint Commission’s Universal Protocol, which lays out the steps that must be taken before proceeding with any surgical procedure. From the time the patient checks in until the actual procedure begins, these steps include verifying the correct procedure, for the correct patient, at the correct site. They also require verifying the availability of such documents as signed consent forms, as well as matching the items to be used for the operation (e.g., the correct IOLs, stents, etc.) and marking the correct procedure site.
The Universal Protocol also recommends that a standardized time-out must immediately precede surgery. This time-out must include all active participants, including the surgeon, anesthesia providers, circulating nurse, and lead technicians. All team members must agree on the accuracy of the patient’s identity, the surgical site, and the procedure to be performed.
“From the beginning, when the patient first comes in, before they're even put on the bed, we start the process,” says Victor Gonzalez, MD, medical director of Gulf Coast Eye Institute in McAllen, Texas. “Our front desk staff ask the patient who they are, what is their birthday, why are they here, and so on. We look at the paperwork and make sure that makes sense before they even get passed to the back.”
These questions and tasks are repeated twice in the preoperative area: once when the patient arrives and again when they are placed on the bed and sedated. The process is repeated yet again once the patient is brought into the operating room, Dr. Gonzalez says.
Take Time for Time-Outs
Dr. Fram outlines a similarly comprehensive approach that includes marking the eye(s), checking the patient’s identity against their wristband, and taking multiple time-outs to check the information needed to proceed.
“There are probably about five or six time-outs that I do for each eye. Now that may be excessive, but it’s extremely important, especially when you’re doing high volume,” she says. “I know some colleagues that do 50 cases a day, and you need to be hyper-focused on that time-out procedure.”
Harrison stresses the need for all personnel to maintain focus during these processes.
“Mindfulness is key,” she says. “When these surgical safety checklists fail, it may be because people are not fully focused and paying attention.” Indeed, Harrison advises double checking everything from paperwork to images. “It’s not sufficient to see that there are scans up on the light box and say, ‘yes, we have the scans.’ What if they were left over from the last procedure? That shouldn't happen, but what if it does?” she says.
Keep an Eye Out
Another important aspect to preventing errors is preoperative and intraoperative monitoring. Once they arrive in the preoperative waiting area, Dr. Fram says, patients are connected to heart monitoring machines to assess for any arrhythmias or atrial fibrillation patterns. This is especially necessary for patients that skew to the older side and often have preexisting conditions.
“You’re still dealing with a patient population that could potentially have a cardiac event,” she says, adding that if an atrial fibrillation pattern or other type of arrhythmia becomes apparent, they will postpone the procedure. “We've been able to save lives because we’ve picked up on something that wasn’t necessarily in their history. They were stable, but it was one of those things that’s like serendipity. We were in the right place at the right time.”
During the procedure, the anesthesiologist, the nurse anesthetist, or a nurse must monitor the patient’s vitals to ensure their pulse, oxygenation and blood pressure remain normal. “The surgeon is very focused on the procedure, but the bottom line is that the buck stops with the surgeon,” Dr. Gonzalez says. “The surgeon needs to make sure that he has the appropriate support to properly keep an eye on the patient.”
Above All, Communicate
Ultimately, all these steps make up the overarching most important aspects of managing risk in the ASC: communication.
“We’ll probably never eliminate all human errors, but we can minimize the probability that they will occur,” Harrison says. “One of the key tools is good communication: with the patient, the surgical team, and what is communicated through the medical record.” OASC
References
1. Bucsi R, Menke AM. Patient mix-up in the laser suite. OMIC Digest (Fall 2003). Accessed March 16, 2023. https://www.omic.com/patient-mix-up-in-the-laser-suite
