Karen Jeng-Miller, MD, MPH
Mass Eye and Ear, Harvard Medical School
Archana Seethala, MD
Assistant Professor of Ophthalmology
Vitreoretinal Surgery, Boston Medical Center
The 767th New England Ophthalmological Society (NEOS) meeting was filled with interesting talks, beginning with discussions on the diagnosis and management of dry eye and ocular surface disease and moving into an afternoon session centered on ethics and risk management in the field of ophthalmology.
The highlight of the day was the discussion from guest of honor and B. Thomas Hutchinson lecturer Dr. George A. Williams. Dr. Williams traveled from Associated Retinal Consultants/Oakland University William Beaumont School of Medicine, where he is the Chair of the Department of Ophthalmology, to give a series of talks focusing on the intricacies of malpractice in ophthalmology. He is the next president of the American Academy of Ophthalmology.
He began his discussions with an intimate lunch seminar on malpractice exposure in clinical trials. A prominent theme through his case presentations was for researchers to ensure there is stringent IRB approval from a reputable IRB agency, especially when dealing with private and independent IRBs.
He then turned his attention to a wider audience by presenting Ophthalmic Mutual Insurance Company’s (OMIC) top cataract claims. OMIC is unique as it is the only single specialty carrier in ophthalmology. As a result, the organization has an “inside view” into the specialty and has been historically successful in the majority of its claims.
He had several examples of claims filed. One example was a patient with anoxic brain damage secondary to cardiac arrest during cataract surgery likely due to poor judgment for surgical clearance. Another was a patient who developed bilateral central retinal vein occlusions due to femtosecond-assisted cataract surgery, who was later found to have an undiagnosed hypercoagulability disorder. The take home message from the majority of these cases was that practitioners often can do all of “the right things,” and bad outcomes can still happen; as a result, insurance plays an essential role in practice.
Dr. Williams’ next presentation was The Hutchinson Lecture centered on retina malpractice through 30 years of OMIC claims. This was a highly informative presentation that discussed the patient-physician dynamic in cases of diagnostic errors, lawsuits focusing mainly on ROP and intravitreal injections, and learned lessons from these cases. He began by honoring Dr. Hutchinson, who we were lucky enough to have in the audience, along with Dr. Bruce Spivey and Dr. Dunbar Hoskins, for their leadership in OMIC, and their instrumental role in developing the company to where it is now.
Historically, in the 1980s, many ophthalmologists around the country could not obtain insurance coverage at any price. This was a medical malpractice crisis. As a result, through Dr. Spivey’s visionary idea, Dr. Hoskin’s leadership, and the continuing input of Dr. Hutchinson, an insurance company for ophthalmologists, which we now know as OMIC emerged and flourished.
Dr. Williams then turned his attention to the role of the patient in diagnostic errors. He began by detailing types of decision making processes between a patient and the physician: (1) The historically “grand rounds” type decision making of a passive silent patient listening and complying to a physician’s recommendation of what needs to be done for treatment; (2) The “consultation” type decision in which the patient participates in the discussion regarding the diagnosis and treatment plan; (3) The “negotiation” type decision in which the patient collaborates as an equal on the diagnosis and treatment.
He discussed the signs, causes, and consequences of disengagement in patients. One example of a sign of disengagement is silence and flight in which there is non-adherence to treatment, no-show to appointments, avoiding payments, and a lack of participation in the decision making process. Dr. Williams advises that if we recognize these signs, we should try and reconnect with the patient to better understand his or her perspective.
We should discuss with the patient the reasons why treatment is appropriate, unearth any misunderstandings or financial problems, determine any time constrains for the patient, and send communication regarding missed appointments. Another example of a disengaged patient is the violent patient who makes angry phone calls, demands reimbursement, and even threatens litigation. In this case, Dr. Williams recommends once again reconnecting with the patient – determine the source of the problem and to try and educate the patient.
Importantly, practitioners should have a low threshold to reach out for help and consult the risk management sector of his or her insurance company. The causes of disengagement in these patients include cognitive issues (e.g. poor health literacy, poor memory of patient-physician discussions and instructions), a lack of trust in the patient-physician relationship, and patient depression, the most significant predictor of patient disengagement. Disengagement can result in consequences such as delayed diagnoses or treatments, poorer outcomes, wasted health resources, and malpractice lawsuits.
Though these situations are never pleasant, there are always lessons to be learned from them. A review of past OMIC cases revealed that diagnostic errors are the most frequent cause of malpractice lawsuits (they account for 14% of claims, 34% of the payments). Interestingly, a factor analysis for below standard-of-care claims indicated that 100% of these cases of diagnostic errors could be attributed to the physician, not the patient. The lesson from this statistic is that physicians need to communicate more effectively with patients.
Dr. Williams next turned his attention to retinopathy of prematurity. ROP lawsuits are rare (0.6% of claims); however, in the cases when claims are involved, they are usually of very high severity and every expensive. Although these cases are unfortunate, they allowed OMIC to identify key issues that occurred in cases of ROP mismanagement.
The first issue was a lack of physician competence combined with a failure to practice using the latest developments in a rapidly changing field. In response, OMIC instituted a specific ROP underwriting that required practitioners to pass the FocusROP exam, a rigorous and intensive ROP examination.
Another example was a systems issue in which infants were lost to follow up, either while inpatient or transitioning exams from the NICU to the ophthalmology office. This prompted the creation of a safety net system, which changed the landscape of ROP screening and care in the country. This safety net requires triple tracking in the hospital via the ophthalmologist, hospital ROP coordinator, and the ophthalmology office ROP coordinator. Upon discharge, follow up orders must indicate both the interval and date of the follow up exam (e.g. Follow up in 2 weeks on January 2, 2018). Once home, infants are under a double tracking system via the ophthalmologist and office ROP coordinator.
Intravitreal injections were the next topic of discussion. Injections have revolutionized the treatment of vitreoretinal disorders and are one of the most frequently used interventions in our field. Cases involving intravitreal injections total less than 1% of claims and are usually low in severity, with the most common complication being infection. To clarify, Dr. Williams mentioned that the suits surrounding infections after injections are not necessarily due to the endophthalmitis itself, but often due to mismanagement or delay in treatment after the infection occurred (e.g. patient called complaining about vision loss and was not seen in a timely manner).
To manage issues that may arise with intravitreal injections, Dr. Williams recommends carefully explaining and documenting discussions of all the treatment options and the reasons for the chosen therapy, explaining realistic and expected visual outcome and duration of treatment, and carefully explaining the use of off label medications.
Lastly, the discussion centered on wrong events in retina. One case study involved injecting the wrong gas concentration during a vitrectomy, that was given to the physician by an improperly trained staff member. This prompts the need for various safety mechanisms, including an additional time out before gas dilution, agreement between the staff member and physician on the gas concentration, read-back of the gas concentration by the staff member to the physician, and finally proper supervision and confirmation by the physician during the process of dilution. In conclusion, Dr. Williams emphasized the need for an ophthalmology-specific checklist and the importance of time-outs in surgical procedures.
Dr. Williams concluded his series of talks for the day on issues in informed consent with case study examples. The most prominent themes were best practices in informed consent, namely answering patient questions and appropriately documenting discussions, communicating appropriately with patients, especially if other providers are the first line of communication with your patients, and educating patients properly about their conditions.
In conclusion, Dr. Williams’ offered some final words of advice: the patient always comes first and communication is paramount. To emphasize this point, he fittingly quoted George Bernard Shaw, who said, “The single biggest problem in communication is the illusion that it has taken place.”
It was a true honor to meet Dr. Williams and we will surely carry his wise words of advice through our careers.