It started as a routine, noncomplicated cataract surgery. The patient, a man in his 60s, was healthy. He had complete medical clearance, with no history of coronary or respiratory disease. But just a few minutes into the procedure, the man began experiencing a sudden arrhythmia and stopped breathing.
“It's one of those situations where the patient did poorly, even though there was really low risk from a risk standpoint, but those types of things can always surprise you,” says Victor Gonzalez, MD, medical director of Gulf Coast Eye Institute in McAllen, Texas, who specializes in retinal surgery and treatment of macular degeneration, and diabetic retinopathy.
To be sure, code blues and other life-threatening or sight-threatening emergencies are extremely rare during ophthalmic surgery. But they do happen, and the consequences can be costly to both patients and ASCs.
“In spite of all the safety precautions that are in place, emergencies, complications, and wrong events still occur,” says Linda Harrison, PhD, vice president of risk management at the Ophthalmic Mutual Insurance Company (OMIC). “Some complications cannot be anticipated, and sometimes they can't be avoided. Outcomes are significantly impacted by how well the surgeon and operating room staff handle such complications.”
Many state and federal regulations stipulate how ambulatory surgical centers of all types, not just ophthalmic ASCs, manage medical preoperative, postoperative, and intraoperative emergencies. These include regulations mandating procedures for patient transfers to hospitals for care beyond the capability of the ASC; for keeping on hand crash carts equipped with supplies and devices like automated external defibrillators, suction machines, bag valve masks (Ambu bags), and intubation catheters; and for stocking emergency medications for adult and children. They also mandate the presence in the ASC of trained personnel who are certified to administer CPR and basic life support measures.
Drills Are Vital to Mounting an Effective Response
But ASCs can and should go even further, says Dr. Gonzalez, who advocates the development of protocols and regularly scheduled drills based on each ASC’s primary patient population and specialties.
“By all means, follow and make sure you comply with all applicable state and federal regulations, but you also need to make protocols that are specific for the type of patients and the situations you can potentially be in,” he says. “No one knows your patients and the situations you can get into better than you and your team.”
Nicole Fram, MD, medical director of Specialty Surgery Center in Beverly Hills, California, and managing partner at Advanced Vision Care in Los Angeles, agrees.
“The director of nursing has ongoing safety meetings with our staff, and coordinates these with the anesthesia department, so that if there is a case where a patient becomes unstable or a code occurs, the nurses know how to respond [and] there’s someone in charge of running the code or running the assessment with the anesthesiologist,” Dr. Fram says. “We start life-support measures and then call 911. Once the paramedics arrive they take over care and transport to hospital. We must report this through an incident report and through our MAC quality metrics and governing board.
“There's only been a few events over the last 15 years in the eye center that I can recall, and they were all transferred in an appropriate manner from our center, and recovered after surgery,” Dr. Fram adds.
Dr. Gonzalez says his ASC keeps and updates written protocols that spell out how its clinicians should respond to any given emergency. They also run emergency response drills based on a different scenario every month.
“For example, this month we're going to review pediatric emergencies,” he says. “If the patient gets hyperthermia, do we have the medication on hand and know how to use it? We [go through] who’s going to go get the ice, who’s going to call EMS.” Next month’s drill might focus on respiratory collapse after a retrobulbar hemorrhage, he says, so the team knows who’s going to do the Ambu bag, who’s going to call 9-1-1, and who’s going to intubate the patient.
“We may practice a scenario where we’re doing a vitrectomy on a diabetic and the patient codes in the middle of the procedure. How do we keep the eyes stable? We can't wait until the eye is completely stabilized before we start ventilating,” he says.
It’s one thing is to have a written emergency response protocol, but it’s entirely another to put it into actual play.
“Some people ask, ‘Why do you do something different every month?’ Because things can happen that are out of our control, and you need to be ready,“ Dr. Gonzalez says. Just as pilots regularly run drills in which they respond to events such as engine failures and cockpit fires, ASC surgeons and staff must instinctively know what to do, how to do it, and who must do each task when there is simply no time to pull out a handbook and look up proper procedures.
Another less-obvious reason that ASCs should hold regularly scheduled drills is to ensure that all staff—particularly recent hires—know their responsibilities when an emergency occurs and understand how to carry them out. Like any other healthcare organization, ASCs experience staff turnover. Ensuring that new staff members know how to react in an emergency situation is vital.
“We repeat drills to make sure that new members of the team understand their role,” says Dr. Gonzalez. “The objective of everything we do is to make sure that we protect the patient and make sure that in a timely fashion we triage the patient if need be. It's like a fire drill. You hope you never have to use it, but everybody needs to know their responsibility.”
Anesthesia-Related Complications Are Rare, but Costly
A recent study of anesthesia claims filed with the Ophthalmic Mutual Insurance Company (OMIC) found that although anesthesia-related lawsuits are extremely rare, settlements resulting from these cases are significant and costly.1
Conducted by retina specialist Michael Morley, MD; anesthesiologist Karen Nanji, MD; and OMIC patient safety manager Anne M. Menke, RN, PhD, the study found just 50 anesthesia-related lawsuits filed against OMIC insureds between 2008 and 2018. The researchers found that cataract surgery and retina procedures accounted for 36 of these cases, while laser (five), lid/oculofacial (five), pterygium (three), and strabismus procedures (one) accounted for the remainder. Retrobulbar and peribulbar anesthesia were used in 16 cases each, followed by local infiltration around the lids and facial nerve (six), topical anesthesia (five), and general anesthesia (five). In two cases, the exact type of anesthesia was unknown but not general.
Globe perforation was cited as the most frequent injury, occurring in 17 cases. Six of the globe perforation lawsuits were settled, with an average payment of $271,000 (range $20,000 to $585,000). Patient death was the second-most-common consequence (13 cases). All but one patient who died had preexisting comorbidities, such as diabetes, atherosclerotic cardiovascular disease, congestive heart failure, or pulmonary edema. All patients who died had been classified ASA Physical Status III, and had procedures performed in an ASC. Five of these cases resulted in payments averaging $73,500 (range $20,000 to $160,000).
Retrobulbar hemorrhage was the third-most-frequent complication, occurring in seven cases. Four of these claims were settled for an average of $92,000 (range $29,999 to $200,000); anticoagulant/antiplatelet medications were being taken at the time of the surgery by three of these seven plaintiffs. Four cases involved optic nerve injury, while vascular occlusion, pain, and movement during surgery resulting in injury each accounted for two cases, and there was one case each involving numbness, diplopia, and tooth loss during intubation.
The authors concluded that many anesthesia-related injuries could have been prevented. They recommended careful patient screening for conditions such as ischemic heart disease, congestive heart failure, cerebrovascular disease, diabetes, renal disease, COPD, sleep apnea, obesity, hemophilia, and hypertension, as well as screening for the use of anticoagulant/antiplatelet medications.
- Morley M, Menke AM, and Nanji KC. Ocular anesthesia-related closed claims from Ophthalmic Mutual Insurance Company, 2008-2018. Ophthalmology. 2020; 127(7):852-858. https://www.aaojournal.org/article/S0161-6420(19)32371-1/fulltext
Fighting Complacency
Protocols and drills help guard against complacency, which some might argue constitutes one of the greatest threats to patient safety in the ASC. “It's extremely important to respect the fact that yes, things virtually always go well, but you need to be ready for the times when they don’t go as planned,” Dr. Fram says. “Just because they’re infrequent doesn’t mean you don’t need to be alert.”
Indeed, she once witnessed a globe perforation, which she said involved an expert surgeon who was operating on a “high myope.”
“We still don’t know how it happened, but it was so devastating that the surgeon changed their technique to sub-tenons from that point on,” she says, adding that, as a result, she strictly follows and regularly reviews her ASC’s emergency protocols to help fight complacency.
“The complex cases I perform can take longer and often require a retrobulbar or sub-tenon block. Many of these patients have comorbid conditions—such as sleep apnea, for example—and are at an increased risk of respiratory complications with anesthesia,” she says. “Fortunately, the communication between the anesthesiologist and my team is so good that the anesthesiologist and I will look at each other in this setting and say, ‘you know what? No propofol for this patient. I’m going to do a sub-tenon block instead.’ That’s because I respect the fact that with too much sedation, something [bad] could happen such as respiratory distress. I never want to be the surgeon who says, ‘oh, it should be fine.’ I want to be sure and value patient safety first.”
Dr. Gonzalez agrees. “People get very comfortable, and heaven forbid they get too comfortable, and there's turnover in staff, and now the emergency happens and no one knows what they're supposed to be doing,” Dr. Gonzalez says. “This is why the leadership in our surgical center has commanded us that, even though we’re not required to have these drills the way we do on a monthly basis, we do it, anyway. The way you battle complacency is preparation.”
About that cataract patient who developed the arrhythmia and stopped breathing? Thanks in part to adherence to their protocols and regular drills, Dr. Gonzalez said he and his team were able to stabilize and transfer the patient to the hospital, where he made a full recovery. ■