Risk Management

Endophthalmitis and Tass: Claims Results and Lessons

By Anne M. Menke, RN, PhD

Anne Menke is OMIC’s Risk Manager.

Digest, Spring 2006

To see the charts mentioned in this article, choose this PDF link: Endophthalmitis and Tass Claims Spring 2006

Uncomplicated cataract surgery was performed on an elderly woman. At the end of the procedure, the ophthalmologist was informed by the nurse that the sterilization indicator on the instruments had not changed. It was feared that the instruments had been washed but not sterilized. The physician and ASC medical director decided not to inform the patient of the potential problem, opting instead to increase the frequency of topical antibiotics. No signs of infection were noted at the first postoperative visit, but two days later, endophthalmitis developed. Ten days after surgery, the two physicians informed the patient and her family that the same strain of pseudomonas aeruginosa had grown in the eye and the ultrasonic bath water at the ASC, leading them to conclude that problems with sterilization were the likely cause of her endophthalmitis and phthisical eye. The patient’s lawsuit was settled on behalf of the ASC for $650,000.

Poor outcomes such as this make infectious endophthalmitis one of the most feared complications of ophthalmic surgery. Recently, a type of inflammatory response known as TASS, or Toxic Anterior Segment Syndrome, has garnered attention and prompted calls to OMIC’s Risk Management Hotline. While not all adverse events can be prevented, there is much ophthalmologists can do to reduce the incidence of endophthalmitis and TASS. In its review of OMIC’s claims experience and the lessons learned from it, this article offers risk management guidance on more effective prevention, recognition, and response to these sight-threatening conditions.

Since OMIC’s inception in 1987, endophthalmitis has accounted for 6% of claims frequency (150 claims out of 2,559 total) and 5% of claims severity ($3,345,964 in paid indemnity out of $63,191,199 total). Of these 150 cases, 25 remain open; of the 125 closed cases, only 8 were taken to trial, and in all but one, the jury returned a defense verdict. A poll of the jury after the sole plaintiff verdict of $735,000 revealed that the award was in response to the defendant group’s practice of locking up medical records on weekends, thus preventing access to key patient information needed to assess the plaintiff’s condition. Since the practice’s name did not appear on the jury’s form, a settlement on its behalf was effected for the amount of the verdict, and the plaintiff award against the ophthalmologist was vacated.

More than three-quarters (78%) of OMIC’s endophthalmitis cases have closed without an indemnity payment. The percentage of cases that have settled (22%) and the median settlement amount ($75,000) are comparable to OMIC’s overall data. Despite the severity of the outcome for the patient, endophthalmitis settlements have ranged from $9,000 to $735,000 compared to a low of $500 and a high of $1.8 million for all settlements. Reflecting the relative novelty of TASS, allegations in all but 3 of the 150 claims involve an infectious rather than an inflammatory process.

Given the estimated 2 million cataract procedures performed annually in the United States, one might anticipate that cataract surgery would account for 61% of all endophthalmitis cases. Surprisingly, however, only 23% of cataract- related endophthalmitis cases resulted in an indemnity payment.

During the informed consent process for cataract surgery, ophthalmologists routinely disclose this rare complication, and most actively try to prevent its occurrence by treating preexisting conditions such as blepharitis, preparing the eye with povidone iodine, and administering antibiotics. Assuming cataract surgery was indicated in the first place and the endophthalmitis was promptly recognized and treated, experts view this complication as a tragic maloccurrence rather than malpractice. On the other hand, cases of endophthalmitis resulting from trauma are rare (5%), but they result in settlement 57% of the time. Clearly, ophthalmologists who do not administer antibiotics and/or carefully monitor the eye for signs of endophthalmitis after trauma are not supported by defense or plaintiff experts.

Analysis of Risk Issues

It is helpful to analyze the risk issues associated with substandard care by dividing them into four categories. “Clinical” issues include debates in the ophthalmic community on the standard of care and the natural history of the disease or condition. “Systems” issues involve complicated processes of care, such as medications (research, manufacture, distribution, ordering, etc.), equipment, and follow-up and telephone screening methods. Finally, the acts, omissions, and decisions of individual physicians and patients also impact care out- comes. Table 2 indicates the type and frequency of risk issues in OMIC’s endophthalmitis and TASS cases.

Amid ongoing debate of evidence- based guidelines for prevention of endophthalmitis, it is noteworthy that antibiotic administration was not a key issue in any case; nor was patient noncompliance a significant factor. Ophthalmologists have a leadership role to play in addressing the many systems issues that adversely impact care outcomes. In their capacity as users, surgical directors, board members, and owners, they can review equipment maintenance and infection control measures in hospitals and ASCs, focusing particular attention on issues such as flash sterilization, re-use of single-use items, and the ordering, preparation, and use of ophthalmic products, devices, and medications.

Screening Patient Complaints

The two primary issues in OMIC’s endophthalmitis cases—telephone care and the diagnostic process— indicate the need to carefully screen patients who present with ophthalmic complaints, especially postoperatively, and to educate them about which symptoms to report. Each of these identified risks is squarely within physician control and thus can be modified. This issue’s Closed Claim Study illustrates the perils of inadequate screening and failed coordination of care; the Risk Management Hotline advises physicians on how to disclose and investigate sterilization problems or clusters of cases, and prevent TASS. “Telephone Screening of Ophthalmic Problems” provides screening protocols and contact forms for both staff and physicians taking after-hours calls and can be found at www.omic.com.

“A Witty (WIT-D) Approach to Avoiding Mistakes” proposes an easy-to-remember and effective strategy for improving the diagnostic process. Establish a prioritized differential diagnosis in order to rule out the worst case scenario; determine the information you need to obtain during the history and examination, or through studies, to rule that in or out; tell the patient and other healthcare providers to ensure that you are notified of all signs and symptoms that could help establish the diagnosis and determine the treatment plan; and document your decision-making process and follow-up plan.

Endophthalmitis or TASS?

Failure to rule out endophthalmitis has resulted in harm to patients and significant liability exposure for OMIC policyholders. Emerging research indicates that the ophthalmologist should also include inflammatory reactions such as TASS in the differential diagnosis. Indeed, mistaking one for the other could lead not only to a delay in treatment

but may worsen the outcome. Table 3 summarizes some of the distinguishing features. Although this table may be helpful, it can still be difficult or impossible at times to distinguish between endophthalmitis and TASS. For more information see, “Endophthalmitis and TASS: Prevention, Diagnosis, Investigation, Response” at www.omic.com.

1. Carolyn Buppert, “A Witty (WIT-D) Approach to Avoiding Mistakes,” Gold Street 4(6), 2002. See “Risk Management Issues in Failure to Diagnose Cases: A Focus on Traumatic Eye Injuries.”

2. Table compiled from information in Mamalis, Nick et al. “Review/Update: Toxic Anterior Segment Syndrome.” J Cataract Refract Surg Vol 32, February 2006:324-333; Ronge, Laura J. “Toxic Anterior Segment Syndrome: While Sterile Isn’t Clean Enough.” EyeNet, November/December 2002:17-18; and Davis, Brandon L, and Mamalis, Nick. “Averting TASS: Analyzing the Cause of Sterile Postoperative Endophthalmitis Provides Valuable Clues for its Prevention.” Cataract & Refractive Surgery Today, February 2003:25-27.