Iris Trauma During Intraocular Surgery May Trigger Lawsuit

By E. Randy Craven, MD

Argus, July, 1996

Patients occasionally experience pupil disfigurement or pain during pupillary contraction as a result of iris trauma during intraocular surgery. Preoperatively, you may be able to predict which patients are most vulnerable to iris damage: older people with a flaccid iris stroma and small pupil. Prior to surgery, however, you should inform all patients that a potential but infrequent complication of intraocular surgery is trauma to the iris (pupil), which may result in pain, disfigurement or visual impairment.

Two OMIC cases demonstrate the importance of this informed consent discussion. In one case, the patient underwent phacoemulsification with a posterior chamber intraocular lens implant. An iris tear occurred during surgery and was repaired with a suture. During postoperative examinations, the patient complained of glare and sun sensitivity, but the surgeon allegedly ignored the complaints. The patient believed these problems were related to the torn iris and claimed the ophthalmologist never informed her prior to surgery of this possible complication. She left this ophthalmologist’s care and was seen by another ophthalmologist. A few years later, a YAG laser capsulotomy finally relieved her glare problems. A lawsuit against the first ophthalmologist was settled without an indemnity payment to the patient.

In another case, the patient underwent an extracapsular cataract extraction with a posterior chamber intraocular lens implant. During surgery, the patient had an incomplete block and experienced a great deal of pain, especially at the conclusion of the procedure when the surgeon injected an antibiotic and a steroid. The iris prolapsed a few weeks after surgery and remained disfigured, not adjusting to light as it normally would. The ophthalmologist continued to see the patient a few times postoperatively, but he soon closed his practice and moved to another city. He failed to contact the patient to discuss the transfer of his care to a local ophthalmologist, even though the patient was scheduled for additional visits.

In a lawsuit against the ophthalmologist, the patient alleged that the disfigurement of the iris was related to the surgical pain he experienced and that he had not been informed about the risk of this type of disfigurement. This case settled with a small indemnity payment to the patient.

Both cases illustrate the importance of informing a patient about the possibility of pain, disfigurement, or impaired vision from iris trauma during intraocular surgery, and of properly handling patients who experience a surgery-related complication. You can take technical measures to help avoid iris prolapse, but when a patient’s preoperative cosmetic or visual expectations are not met because of iris trauma, it is important to demonstrate compassion and concern. If a lawsuit arises, show that you discussed this complication with the patient prior to surgery.

Postcataract Inflammation – Uveitis or Endophthalmitis?

By Byron H. Demorest, MD, and Jerome W. Bettman Sr., MD

Argus, January 1997

Abnormal Postoperative Inflammation is Endophthalmitis Until Proven Otherwise

Endophthalmitis has been and probably always will be the most serious risk for patients undergoing cataract surgery. Although all preop cataract patients are routinely informed of the known risks of surgery, including endophthalmitis, patients still may sue their ophthalmologist if they lose vision from an unexpected infection. Patients usually are warned of infection and possible loss of the eye, but they often do not recall this information.

The 1995 Endophthalmitis Vitrectomy study developed diagnostic and therapeutic recommendations that are helpful for risk management. Pain, redness and loss of vision were identified as the most significant symptoms of endophthalmitis, although the study noted that a surprising 25% of patients with endophthalmitis did not complain of much pain. Loss of vision, on the other hand, is extremely significant, particularly when the patient notes a decrease in vision from the day before. Other factors to consider include the presence of a corneal infiltrate, an absent red retinal reflex, and vision reduced to light perception.

These signs and symptoms must be contrasted with the normal sterile inflammatory reaction following cataract surgery that in some cases may produce a severe uveitis. Some eyes react more violently to retained lens material than others. A postoperative intraocular hemorrhage may also confuse the issue. When a patient is seen with a postoperative inflammatory response, it is wise to consider seeing the patient again within eight to 12 hours after increasing topical steroids. Some types of endophthalmitis may improve slightly with steroids, although usually not to the same extent as a postoperative inflammatory reaction. Additionally, although some cells may be seen in the anterior chamber with uveitis, there are usually far more cells and debris in the anterior and posterior chambers with an endophthalmitis.

A great risk to the patient is an endophthalmitis that develops over the weekend. Often the patient is reluctant to call or “bother” the surgeon, and sometimes another ophthalmologist is covering for the weekend. The on-call physician may not see the patient or, if seen, may not have all the relevant records regarding the patient’s prior postop exams. This can be a tragic situation. In one OMIC case where the covering ophthalmologist was taking weekend call for his group, he saw a three-day postop cataract patient on Sunday afternoon. Although he performed a thorough examination, he did not have access to Friday’s record of the patient’s first-day postop exam, which indicated VA 20/200. [For security reasons, this group locked up patient records over the weekend.] By Sunday, when the patient was seen by the covering physician, vision had decreased to hand motion. He diagnosed suture inflammation and told the patient to call back if the pain got worse. The next morning when the patient returned, there was an overwhelming endophthalmitis with eventual loss of the eye. The plaintiff’s expert witness testified at trial that if the covering physician had had access to the chart with the Friday exam findings he would have noted the decrease in vision and been better able to diagnose the endophthalmitis. The plaintiff was awarded a large indemnity. OMIC has been able to successfully defend other endophthalmitis cases even when there was significant vision loss but only when the endophthalmitis was recognized early and treated appropriately, albeit unsuccessfully.

Proven treatment recommendations for endophthalmitis include obtaining aqueous and vitreous samples for culturing on blood agar, chocolate agar, and liquid thioglycollate. When a late infection is seen, Sabouraud’s agar should be used for fungus. Gram staining with microscopic examination of both anterior chamber and vitreous specimens is advisable. Once the vitreous tap has been taken, Vancomycin plus Amikacin should be injected intravitreally. Systemic antibiotics are now felt to be of no or minimal value.

Chronic endophthalmitis with a late onset may be caused by proprionobacterium acne, which often proliferates within the capsular bag. Such infections can be deceptive as they may become quiescent after steroid therapy, only to recur.

In summary, whenever a patient has an ocular inflammatory response following cataract surgery, the ophthalmologist should suspect endophthalmitis and treat it as such until proven otherwise. Proper treatment is good risk management and may save the patient’s eye.

Risk Management Lessons from a Review of 168 Cataract Surgery Claims

By Dean C. Brick, MD

Digest, Summer 1997

One of the advantages of being a single-specialty insurer is the ability to collect and analyze data on a large number of professional liability claims related to one specialty, one subspecialty, or even one procedure and to use this data to develop risk management programs specific to certain subspecialties or procedures.

In an attempt to develop risk reduction strategies for cataract surgery, I reviewed 168 closed claims involving cataract procedures reported to OMIC from its inception to March 31, 1997. Cataract procedures represented 33% of the 515 OMIC claims closed during this 10-year period (Fig.1). Of these 168 claims, 37 (22%) were closed with an indemnity payment made on the behalf of the insured. Although these 37 cases made up only 7% of all OMIC claims, indemnity payments on their behalf totaled more than $3 million, representing 24% of the total indemnity paid by OMIC during this period.

These numbers indicate that cataract surgery is a very risky procedure for the general ophthalmologist and risk reduction strategies are needed. By tabulating the most common clinical events leading to claims, strategies can be developed to help decrease the frequency and severity of claims in connection with cataract surgery.

Surgical Complications

One way to reduce risk is to identify or anticipate incidents and complications that increase the risk of a suit and employ activities designed to prevent or decrease that risk. To determine if a surgical complication is a good indicator of increased risk, I measured the incidence of surgical complications for all closed cataract claims, tabulating only those claims with sufficient clinical data to determine if a surgical complication had occurred. The most common surgical complications found were ruptured posterior capsule, vitreous loss, retained lens material, iris damage, and choroidal hemorrhage. Surprisingly, the data showed that a surgical complication was recognized at the time of surgery in less than 50% of cases. This emphasizes the importance of performing timely and accurate dictation of the operative report. Surgeons are usually careful to dictate complete reports following surgeries in which a complication has occurred; however, in cases in which there is no surgical complication, the surgeon may relax and make the operative report less complete and thus more prone to attack by a plaintiff’s lawyer. Worse still, the operative report may not be dictated until some time later after a complication has been recognized. Such reports usually sound defensive and self-justifying and are difficult to defend. Therefore, the absence of a complication during surgery should be of little reassurance to the wary surgeon, who must always use good risk management techniques to decrease the likelihood of a claim.

Poor Visual Outcome

Poor visual outcome is another clinical area that might be indicative of increased risk. Again, only those cases in which the final best corrected visual acuity was available were reviewed. Not surprisingly, I found that the largest group of claims resulting in indemnity payments had poor visual outcomes, but the second largest group had good or excellent visual results (Fig. 2). Thus, a good visual result does not negate the risk of a liability suit, and the wary surgeon must continue to use risk-reducing activities even in uncomplicated cases with good visual results. Figure 3 demonstrates visual outcomes in claims where no indemnity payment was made on behalf of the insured.

As expected, the largest group consisted of claims with a good visual result. The beleaguered surgeon may find some relief in the fact that the second largest group consisted of claims with very poor visual results, demonstrating that even with a poor visual result, a claim may be defended if the surgeon has followed some risk reducing strategies. These strategies can be found by examining certain groups of claims.

Claims were grouped by the complication that resulted in the decreased vision or subjective complaints of the patient and that most often prompted the patient to file a liability claim (Fig. 4). Often, there was a series of complications that in the end resulted in the claim; for example, the patient suffered a ruptured posterior capsule with vitreous loss, had an anterior vitrectomy, and developed endophthalmitis followed by a retinal detachment and phthisis. In this instance, the case would be classified under endophthalmitis as it was the infection that ultimately led to the loss of vision and the claim.

IOLs Account for Largest Number of Claims

The largest group of identifiable claims involved intraocular lenses (Fig. 5). This group included cases in which it was alleged that the wrong power, wrong size, or wrong type of IOL was used, that a defective IOL was used, or that the IOL became decentered or dislocated postoperatively. Since the FDA has approved all lenses commonly in use, it is generally easy to defend the use of an alleged defective IOL. In both instances where this was alleged, a closed loop A/C IOL had been used and both cases closed without an indemnity payment. Decentration of an IOL is also a well documented occurrence and is listed in most consent forms. It is very defensible, and all cases of this type closed without payment. Allegations of the wrong size or type of IOL also were defensible provided there was documentation explaining why the surgeon chose that IOL and a record that the eye had been measured to determine the correct size. This was obviously most important with A/C IOLs but also significant if a P/C IOL was placed in the sulcus instead of the bag.

This leaves two major problem areas with respect to intraocular lenses: insertion of the wrong power IOL and subluxation of the IOL. The single largest group of claims related to the IOL involved insertion of the wrong power IOL. Events leading up to the use of the wrong power IOL varied and included use of the SRK I formula for ametropia; the circulating nurse handing the surgeon the wrong IOL; incorrectly labeled IOLs and/or confusion over the manufacturer’s number for the IOL; and incorrect biometry or keratometry. These mistakes can be prevented by following modern IOL formulas, employing a few experienced technicians, and using a preoperative checklist. One ophthalmologist suggests having a checklist of the IOL choices for each patient taped to the side of the phaco machine for a final check before insertion. It is likely that most juries will find that the surgeon is ultimately responsible for the correct IOL being inserted, and the surgeon should be prepared to recognize and correct any mistake made by nurses or technicians. Despite the fact that most of these patients had excellent visual results, it is this group for whom the bulk of indemnity was paid. These payments tended to be smaller than payments to other patients with IOL-related problems, however, averaging $28,000 for wrong power IOL cases compared with $87,500 for cases of subluxed IOLs.

Cases in the latter group all involved a secondary surgery and frequently additional complications such as retinal detachment. These claims can be particularly hard to defend if the dislocation occurs soon after surgery. It usually comes down to careful scrutiny of the operative report: if it is well documented that complications during surgery were recognized and treated appropriately and that the correct type of IOL was used and checked after insertion to see if it was secure, the case may be defensible. Thus, if the surgeon elects to use a P/C IOL in the face of a ruptured capsule (which may well be the best choice for the patient), the surgeon should make sure that the procedure, recognition of complications, and their treatment is documented in the operative report. With this type of documentation an expert usually can be found to defend the surgeon’s choice of IOL.

Endophthalmitis Claims are the Most Costly

While complications related to the IOL were the most common cause of claims, they ranked third in terms of total indemnity paid. Claims related to endophthalmitis composed the group with the largest amount of indemnity paid by OMIC and also the largest percentage of claims in any group resulting in an indemnity payment. These findings are interesting because endophthalmitis, a known complication of cataract surgery, is almost uniformly mentioned in consent forms for cataract surgery and should be defensible. The key to any defense is the ability to obtain expert defense testimony, and that is where most claims of endophthalmitis fall short. The most common problem areas involve delayed diagnosis or failure to use consultants soon enough. Although the use of prophylactic antibiotics preoperatively, intraoperatively, and postoperatively is frequently debated, this issue seldom arose during the claims reviewed here. Far more common was the fact that while unusual inflammation was documented postoperatively in the chart, it was not aggressively treated or evaluated. Such cases would have been more defensible if the surgeon had seen the patient more often once the increased inflammation was noted and used consultants to confirm the diagnosis and management plan.

While there is no standard of care for the use of prophylactic antibiotics in cataract surgery, the surgeon’s method of patient preparation should include documentation of whatever means he or she employs to help prevent endophthalmitis; for example, use of povidone iodine, draping of the lid margins, pre- or post-operative antibiotics, etc. After surgery, if unusual or severe inflammation is observed and documented, the patient should be examined at frequent intervals even if that means seeing the patient off-hours or on weekends. Clinical findings should be documented at each visit to justify the physician’s plan of treatment. Finally, if there is any doubt about the possibility of infection, a second opinion should be obtained to help reassure the patient. A second opinion also makes it easier to later defend a claim and obtain expert witness support should the need arise.

Retinal Complications of Cataract Surgery

Claims related to retinal complications of cataract surgery were the second most common type of claim (Fig. 4), ranking second in both total indemnity payments and average indemnity payment ($72,000 for retinal versus $177,000 for endophthalmitis). Seventeen of these claims were related to retinal detachment subsequent to cataract surgery; however, claims settled with an indemnity payment usually followed a surgery complicated by rupture of the posterior capsule, subluxation of the nucleus, and retinal detachment. These cases also were associated with high average indemnity payments. Cases associated with cystoid macular edema (CME) and age-related macular degeneration (ARMD) uniformly closed without any indemnity payments.

During my analysis, it was evident that the outcome of retinal claims frequently hinged on how the complication was managed during surgery and how soon the patient was referred to a specialist. In instances where there were allegations of delayed diagnosis of retinal detachment following surgery, earlier evaluation and referral to a specialist might have prevented the claim or made it more defensible. Surgeons who are not experienced and trained to perform deep vitrectomy or retrieve nuclear fragments deep in the vitreous are better off completing the anterior part of the procedure and referring the patient quickly to a specialist. Although the optimal timing for referral may not be established, it is prudent to refer the patient sooner rather than later.

Corneal Complications Occur Infrequently

Claims related to corneal complications of cataract surgery are relatively infrequent among OMIC insureds (Fig. 4), which is surprising considering that the population undergoing cataract extraction frequently has underlying corneal disease (guttata). This dichotomy probably reflects the fact that preexistent corneal disease is easily visible preoperatively and the potential for corneal edema is discussed with the patient preoperatively. It also supports the fact that claims usually result from unexpected adverse outcomes and that patients who are well educated and informed about the possibility of an adverse outcome prior to surgery are less likely to sue. Other claims related to the cornea followed corneal burns from phacoemulsification (2), descemet’s detachment (1), and corneal erosions after cataract extraction (1). The two cases associated with indemnity payments involved other complications, a dislocated IOL in one case and a wrong power IOL in the other. Risks associated with corneal complications may be reduced through the use of proper informed consent and documentation of preoperative findings and special precautions taken during surgery to protect the cornea. It is also important to maintain adequate flow during phacoemulsification to cool the tip and prevent corneal burns.

Claims related to the iris were notable only because of the relative frequency with which they occurred (Fig. 4). Most cataract surgeons view the iris merely as an obstruction to surgery; however, most of these claims resulted from distortion of the iris and demonstrate the cosmetic and functional importance of the iris even among older patients. Although these claims are usually settled without payment, good surgical technique and thorough patient preparation in cases where it is likely the iris will be distorted might prevent them in the first place.

Finally, there was a large group of miscellaneous claims (Fig. 6). Most of these claims occurred only once or twice; however, a few occurred more frequently. Needle perforations of the globe during anesthesia or postoperative injections occurred four times, emphasizing the need for care when using small bore sharp needles to give injections around the eye. Glaucoma-induced visual field loss occurred in five cases, three of which resulted in indemnity payments. These claims involved postoperative complications that could have been prevented by more aggressive management of the associated glaucoma and the appropriate use of consultants earlier in the case. Claims involving expulsive hemorrhages during surgery occurred six times and also were usually defensible. Recognition of the complication and its treatment need to be documented along with prompt referral to a specialist. Suture irritation was a surprisingly common claim that has disappeared in recent years with single or sutureless technique.

General Risk Reduction Strategies

While every case reviewed was unique and its outcome depended on a number of individual variables, there were some recurring problems that could have been prevented or mitigated by employing the following risk reduction strategies.

1. Document complete preoperative exam, including indications for surgery. (Obviates claims of unnecessary surgery.)
2. Use informed consent specific to cataract surgery. Additional documentation of any findings increasing the risk of surgery is also very useful (e.g., diabetes).
3. Dictate a complete operative report immediately following surgery, including:
   • Steps taken to prevent infection.
   • Recognition of any complications intraoperatively.
   • Surgeon’s response to any recognized complications.
   • If a different IOL is implanted than anticipated, the reason for choosing that IOL and how the size was determined.
4. Follow-up exams should have adequate clinical data and be scheduled as frequently as needed.
   • Frequency should be increased if complications occurred during surgery or are documented postoperatively.
   • Patient complaints of flashes, floaters, pain, etc., should be investigated thoroughly during the postoperative period.
5. Never make any changes or additions to the past record after a complication is recognized. This type of alteration can make a defensible claim indefensible.
6. Use consultants early if there are significant complications that may result in a claim.

Specific Risk Reduction Strategies

These should be used in addition to general strategies.

1. Related to IOL usage:
   • Employ one or two technicians who are well trained to perform keratometry and biometry.
   • Review the scans and keratometry data when choosing the IOL.
   • Use one or two styles of IOLs regularly to prevent confusion about IOL constants or model numbers.
   • Use a third generation formula for IOL selection.
   • Keep a list of IOL choices for that day’s patients on the side of the phaco machine and check it just prior to insertion.
   • Use a checklist preoperatively to document data, informed consent, and any pre-op and post-op instructions that were given to the patient. (Contact OMIC’s Risk Management Department for a sample checklist, which also serves as a cataract surgery face sheet.)
2. Related to endophthalmitis:
   • Document any specific preventative measures taken.
   • If infection is possible, increase the frequency of observation.
   • Document findings carefully in chart with the plan.
   • Use consultants early if inflammation is excessive.
3. Related to retinal complications:
   • Do not operate beyond your experience or training in removing subluxed nuclear remnants.
   • Use consultants early.
4. Related to miscellaneous complications:
   • Be careful if using sharp small bore needles for periocular injections. Pre-dulled needles are preferable.
   • Monitor postoperative pressures closely and treat aggressively if indicated.

Figure 1:

Figure 2:

Figure 3:

Figure 4::

Figure 5::

Figure 6::

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.

Wrong Eye, Wrong IOL, Wrong Patient

By Paul Weber, JD

OMIC Vice President of Risk Management/Legal

Digest, Summer 2008

To view the graphs referred to in this article, go to http://www.omic.com/new/digest/Digest%20Summer%209-12-08.pdf

To err is human, but in medicine, errors can have life and death consequences. nearly a decade after it was published, a 1999 headline from an institute of Medicine report on medical errors is still quoted: “98,000 Americans Dead every Year from Medical errors.” the IOM report, To Err is Human, Building a Safer Health System, shone the media spotlight on the problem of medical errors and raised aware- ness of the shortcomings of the American health care system. Less publicized was a 2000 follow-up article by PBS health correspondent Susan Dentzer in Effective Clinical Practice (vol. 3, no. 6, American College of Physicians). In her article, “Media Mistakes in Coverage of the Institute of Medicine’s Error Report,” Ms. Dentzer notes that “all too frequently, errors in health care were the result of systems problems rather than of individual acts of malfeasance. in other words, to err really is human; at the same time, health care, like any other system in which we operate, is devised by and composed of humans. As a result, like any system that aims to minimize or eliminate error, health care must be designed to compensate for our inevitable human shortcomings.”

All ophthalmologists have heard horror stories of wrong sided, wrong patient, wrong procedure, or wrong IOL cases. Most of us probably haven’t read the iOM report, but we are all aware of the need to reduce systemic errors in health care delivery and improve patient safety. the American Academy of Ophthalmology has made a strong commitment to this problem, and in 2001, published “eliminating Wrong site surgery” and “Minimizing Wrong iOL Placement.” Both documents were revised in 2005 and are on the AAO web site. in addition, two related patient safety documents may also be found on the AAO web site, “suggestions for a Checklist to Verify the Operative eye” and “suggested Multiple iOL Verification Procedures in the Operating Room for Minimizing Wrong IOL Placement.” these documents were first developed by the AAO’s Quality of Care secretariat in collaboration with the American society of Ophthalmic Registered nurses and American Association of eye and ear hospitals and were revised in 2005.

Universal Protocol for Wrong Events

In 2003, the Academy and 50 other professional health care organizations endorsed the Joint Commission’s “universal Protocol for Preventing Wrong site, Wrong Procedure, and Wrong Person surgery.”TM   There are four principal components to the universal Protocol:

1. Completing a preoperative verification process;

2. Marking the operative site;

3. taking a time-out immediately before starting the procedure; and

4. Adapting these requirements to non-operating room settings.

Wrong sided cases continue to occur, however, despite the best efforts of the Academy, the Joint Commission, and others. Current data seems to indicate that wrong site surgery is stubbornly defying solutions to eradicate it. (see Joint Commission and OMIC data, Graphs 1 and 2.)

In 2007, the Joint Commission received 5 to 8 new reports a month of wrong site cases nationally, and recently, wrong site surgery became the most frequently reported sentinel event in the commission’s database (nearly 550 events reported since 1996). (Go to www.jointcommission.org.)

The Joint Commission convened a Wrong Site Surgery Summit in 2007. the organizations represented at the summit, including the Academy, agreed that the universal Protocol is effective if properly implemented and consistently followed. Ophthalmic data support this conclusion. John W. Simon, MD, et al, concluded in a study for the American Ophthalmological society that the universal Protocol would have prevented 85% of the wrong incidents he analyzed had it been implemented (“surgical Confusions in Ophthalmology,” Arch Ophthalmol. 2007; 125(11): 1515-22).

Florida Medical Board Imposes Sanctions Against Violators

State medical boards have also responded to the problem. in Florida, the Board of Medicine requires that:

1. A very detailed mandatory “time- out” needs to occur in all surgeries (surgery is defined as an incision or curettage of tissue) in all settings, including the physician’s office; and

2. All licensed facilities and physicians in their own practice must report wrong site/wrong patient incidents.

Penalties for violating these wrong site regulations and/or the time-out rule include fines, community service, and compulsory CME.

Florida recorded 33 ophthalmic wrong sided incidents between 2002 and 2006. half of these incidents were related to iOLs. Ninety-two percent of the doctors were fined, all had to pay the cost of the investigations, and all but one had to perform community service. Additionally, these disciplinary actions were reported to the national Practitioner Data Bank and to states where the physicians had inactive licenses. One ophthalmologist faced penalties and sanctions in a state in which he had not practiced since residency, 20 years prior to the incident. Earlier this year, the Florida Board of Medicine surveyed other states to find out what they’re doing about the wrong sided iOL problem. none of the 10 states that responded (AL, ID, MD, NV, NM, NY, OK, TN, WV, and WY) has a separate state statute or medical board rule that addresses wrong site cases. Only new York tracks these incidents, and no new York ophthal- mologist has been sanctioned for a wrong site case in the past 5 years.

Cataract Surgery, IOLs Involved in Most Wrong Cases

With cataract surgery by far the most commonly performed ophthalmic procedure in this country (1.8 million annually), it’s not surprising that most wrong sided cases relate to cataract, and most involve problems with iOLs. indeed, over 80% of wrong sided eye cases reported to OMiC over the course of 20 years have resulted from wrong iOL implantation, wrong power, or wrong measurement (see Graph 3). in 1997, Dean Brick, MD, then chairman of OMiC’s Risk Management Committee, found that 25% of cataract claims involved an iOL. he recommended the following loss prevention strategies, which remain relevant today:

• employ one or two technicians who are well trained to perform keratometry and biometry.

• Review the scans and keratometry data when choosing the iOL.

• use one or two styles of iOLs regularly to prevent confusion about constants or model numbers.

• use a third generation formula for iOL selection.

• Keep a list of iOL choices for that day’s patients on the side of the phaco machine and check it just prior to insertion.

• use a checklist preoperatively to document data, informed consent, and any preop and postop instructions given to the patient.

Zero Tolerance by Joint Commission

At this time, Florida appears to be the only state to strictly penalize wrong site cases. the state’s position is in keeping with the following statement from the Joint Commission’s 2007 Wrong site surgery summit: “there should be ‘zero tolerance’ for failure to follow the universal Protocol as a short term goal and there should be ‘zero tolerance’ for occurrence of these events.”

In the move toward “zero tolerance,” the Joint Commission is changing the universal Protocol to provide more flexibility to hospitals, AsC’s, and health care providers in its implementation. in addition, there will be more details on implementing the ”who, what, when, and how” of the pre-procedure verification process, marking the procedure site, and the time-out. these guidelines are on the Joint Commission’s web site at www.jointcommission.org/Patientsafety/ universalProtocol.

OMIC participates in the AAO’s drive to eliminate wrong site, wrong IOL, and wrong patient surgery. this year’s OMIC Forum at the Annual Meeting in Atlanta will focus on these “never events.” We will review OMiC’s claims and lawsuits, discuss the faulty systems and processes that led to them, discuss state board actions, and review the Joint Commission’s latest Universal Protocol. the panel will include James B. Sprague, MD, a member of OMIC’s Risk Management Committee, and William J. Knauer III, MD, chairman of OMIC’s Marketing Committee. Dr. Simon will discuss his findings and Peter Angood, MD, vice president and chief patient safety officer of the Joint Commission, will review the Universal Protocol. the OMIC Forum will be held Sunday, Nov. 9, at 1:00 pm in the Georgia World Congress Center. Pre-registration is not required, but participants must complete an attendance form on-site to receive CME credit and an OMIC premium discount.