State Medical Board Equates Wrong Powered IOL implant with Wrong Site Surgery
By Ryan Bucsi, OMIC Senior Litigation Analyst
ALLEGATION
Misreading of intraocular lens power calculation, resulting in incorrect lens implantation andaneedfora second surgery.
DISPOSITION
Case was settled between the insured and the state board of medicine. The patient did not pursue a claim.
Case Summary
An OMIC insured performed an uncomplicated cataract surgery however on postoperative day one, the patient’s vision was 20/200 OD with a significant hyperopic refractive error that corrected to 20/20. the insured realized that the power of the posterior chamber lens implant had been inadvertently switched with the corresponding power for an anterior chamber lens, resulting in an implant difference of 3.5 diopters. he informed the patient of the error and presented options for treatment, such as wearing glasses, a contact lens, or undergoing an iOL exchange. the patient chose the iOL exchange procedure, which was uncomplicated, and eventually the patient’s uncorrected vision was 20/25 OD.
Analysis
Soon after, the insured received and responded to a letter of investigation from the state medical board. Without contacting OMIC, the insured acknowledged the error that led to the implantation of the wrong iOL. the medical board examiner retained an ophthalmology expert, who opined that the implantation of the incorrect powered iOL was beneath the standard of care. Following this expert’s review, the examiner presented the insured with a settlement proposal, which included a fine, reimbursement of costs of the investigation, a letter of concern from the board, continuing education units, and community service. upon receiving this proposal, the insured reported the matter to OMIC. the case was referred to an attorney, who advised that the insured had put himself at a disadvantage by directly responding to the medical board and not making his response through an attorney. since the board had already conducted an investigation and proposed sanctions, it was significantly more difficult to handle the matter.
OMIC counsel retained two experts who disagreed with the original opinion that the implantation of a wrong powered iOL was beneath the standard of care. While the medical board’s expert did not change his opinion that the insured had violated the standard of care, he disagreed with the board’s finding that wrong powered intraocular lens insertion was tantamount to wrong site surgery and warranted the same fines and penalties. this expert believed that a letter of concern would be sufficient in this case, especially since the insured had taken steps in his practice to ensure that such an error would not recur. the medical board disagreed with its own retained expert and continued to view wrong powered iOL insertion as the equivalent of wrong site surgery.
Risk Management Principles
The insured ophthalmologist should be commended for working with the patient to avoid a claim. Once the error was recognized on postoperative day one, he candidly discussed the error with the patient and the treatment options to address the error. With the insured’s assistance, the patient was able to make a well educated decision on how to proceed. in the event of a medical error, it is wise to withhold billing for the errant surgery and to perform any follow-up procedures at no out-of-pocket cost to the patient. these steps may decrease the likelihood of a patient pursuing a claim or litigation.
As this case illustrates, however, state medical boards have become proactive in response to concerns of patient safety and may take action even if the patient involved is satisfied with the care. Medical board investigations are now often triggered by mandatory reports from surgery centers and hospitals. Once an insured becomes aware that a wrong site surgery or incorrect power iOL insertion has occurred, the incident should be reported to OMIC’s Claims Department or confidential Risk Management hotline at (800) 562-6642, option 2 for Claims or option 4 for Risk Management.
OMIC is collaborating with the American Academy of Ophthalmology and other ophthalmic organizations on a campaign to prevent wrong patient, wrong surgery, and wrong iOL insertion. the Lead and Hotline articles in this Digest provide further insight in to this area of concern.
Twenty Years of Insuring Refractive Surgery
By Anne M. Menke, RN, PhD,
OMIC Risk Manager
Digest, Fall 2008
To view the graphs and tables referred to in this article, go to http://www.omic.com/new/digest/Digest%20Fall%2012-12-08.pdf
For over 20 years, since its founding in 1987, OMIC has insured ophthalmologists who perform refractive surgery procedures while monitoring a key measure of patient safety and satisfaction: professional liability claims (written notices or demands for money or services, including letters, lawsuits, and arbitration proceedings). this spring, we conducted a review of our refractive surgery claims experience to determine if additional measures are needed to ensure that our policy- holders continue to reduce patient safety risks and minimize their—and the company’s—malpractice exposure. this article reports on the frequency and severity of refractive claims and analyzes the issues driving them. this issue’s Hotline article presents risk management recommendations.
Frequency of Refractive Surgery Claims
The first refractive claim—for negligent RK—was reported to OMIC in 1989. Claims were infrequent until 1999, four years after OMIC approved coverage for PRK and three after it added LASIK. As of May 2008, OMIC had a cumulative total of 289 refractive claims, of which 58 are still open and under evaluation. Refractive surgery is now the third most frequent area for claims against OMIC insureds, following cataract surgery and general ophthalmology. LASIK claims in particular, and refractive claims overall, represent a significant percent of total open claims (10.41% and 12.31% respectively), although the percentage is lower among total closed claims. LASIK makes up 85% of all open and closed refractive claims, and the number of LASIK claims reported to OMiC has recently increased. When evaluated by the year in which care occurred, however, LASIK incidents peaked in 2000 and have been dropping ever since.
Severity of Refractive Surgery Claims
While a frequency study shows how often a particular type of claim is filed, a severity analysis looks at how often an indemnity payment must be made in order to close the claim and the magnitude of the payment. Compared to OMiC’s overall claims data, refractive claims close more often with an indemnity payment and have higher average and median settlement amounts.
As expected, the majority of the 64 indemnities paid by OMiC for refractive claims were for LASIK and most were under $100,000 (see Table 1). PRK claims occur less frequently, but have a higher average and median payment and more often require an indemnity payment to close. in 2006 and 2007, there was a sharp increase in the average amount and number of refractive settlements, 50% of which involved ectasia; 2008 showed a marked decline (see Table 2).
Causes of Refractive Claims
In our analysis, we divide the cause of claims into four groups: clinical, provider, patient, and systems. two of these— provider and patient—are self-evident. Clinical issues are areas of controversy or of limits in knowledge or diagnostic/ treatment modalities. systems issues cannot be attributed to a single individual; instead these are processes in which many individuals and entities are involved. A much-studied example is medication: the process spans from research and product development, labeling, packaging, distribution, ordering, dispensing, and administering.
Clinical issues predominate in refractive surgery claims, accounting for half of the identified problems in both LASIK and PRK; systems, provider, and patient issues follow (see graphs on page 5). the primary systems issues, in decreasing order of frequency, are equipment, informed consent, and comanagement for LASIK claims; these same three figure in PRK cases as well. Provider problems in LASIK claims center on documentation, failure to perform the preoperative assessment, and knowledge/skill deficits. Ophthalmologists were criticized for treatment decisions and lack of knowledge/skill in PRK. Patient issues were not a significant factor in LASIK, but they slightly outnumbered provider allegations in PRK.
Clinical Issues
Preoperative care was the focus in 83 of 196, or 42%, of LAsiK claims. the primary preoperative clinical issue was the preop assessment (a factor in 71 of 83, or 86%, of claims). in particular, plaintiffs alleged contraindications to refractive surgery, especially clinical and topographical signs of forme fruste keratoconus, pellucid marginal degeneration, and other corneal problems (see Table 3). Other preop issues include candidacy for retreatment, monovision trials and candidacy, and the interval between retreatments. Only 8 of 39, or 20%, of the allegations focused on preop care in PRK claims; preoperative assessment and choice of procedure were the main issues. the Hotline article discusses preoperative assessment in more detail.
Two aspects of care accounted for the majority of the 101 intraoperative LASIK allegations, namely, flap creation (49) and identification of the patient, procedure, and laser settings (18). Corneal injury, decentration, equipment malfunction, anesthesia complications, double carding, ablation zone size, sterilization breakdowns, and power failure accounted for the rest, in decreasing order of frequency. the allegations in PRK intraoperative claims were decentered ablation, wrong nomogram, and wrong procedure.
Not surprisingly, corneal complications led to 72 of 91, or 79%, of postoperative LASIK claims, with negligent diagnosis and treatment of post-LASIK ectasia and inflammation/infection the top allegations (see Table 3). non-corneal issues included retinal complications, dissatisfaction with monovision, diplopia, glaucoma, depression, and pain. in PRK, postoperative problems accounted for 70% of the clinical issues; of these, cornea-related issues predominated (63%), including (in decreasing order) haze, ectasia, central island, abrasion, infiltrate, scarring, and sPK. Other allegations focused on glare, ghosting, night driving, diplopia, headache, and ptosis.
Systems Issues
Ophthalmology is heavily dependent upon medical devices, and equipment issues account for 30% (48 of 159) of LASIK claims involving systems issues. this was particularly true when there were problems with flap creation. informed consent was a close second at 28%. issues included failure to address ocular and medical comorbidities, the timing of the consent discussion, the surgeon’s role in the consent process, the FDA status of the device, flap complications, and monovision.
Comanagement allegations were found in 23% of claims, most often criticism of the surgeon’s role in the preoperative assessment, informed consent process, and postoperative care. Misidentification of the patient, procedure, or laser settings occurred in 18 cases, accounting for 11% of systems issues.
Claims of false advertising and fraud are becoming more common- place and occurred in 3% of claims. Financial issues, such as refunds, procedure-related costs, and collection efforts, as well as sterilization issues occurred in a few claims. half of the 18 systems issues claims for PRK were due to consent, followed by equipment, comanagement, and advertising.
Provider Issues
The most common provider issue in LASIK claims involved documentation; lack of documentation was the problem 85% of the time. Failure to perform needed tests and evaluations was alleged in 21% of claims. Missing elements in descending order included the preoperative assessment, refraction, topography, pachymetry, and mono- vision trials. Physicians were deemed to lack knowledge and skill in 16% of claims, specifically in topography interpretation, inadequate microker- atome suction, ablation profile, and poor centration. they showed poor judgment when deciding to retreat, performing bilateral procedures the same day, and choosing appropriate flap thickness (11%). Remaining issues, each accounting for 3% of allegations, included poor communication, practice issues (employee, on-call partner, near- ing retirement), personality issues, treatment choices (for abrasion, dry eye, and the use of rigid gas permeable contact lenses with free flaps), and failure to diagnose the cause of decreased and fluctuating visual acuity. Provider issues were the least frequent allegation in PRK; 3 cases involved treatment choices and 2 the physician’s knowledge/skill.
Patient Issues
Defense expert witnesses did not feel patients played a significant role in the outcome of LASIK procedures, pointing to issues in only 25 claims. noncompliance occurred in 9 and personality issues in 8. unsubstantiated complaints and self-inflicted injury (head movement, rubbing, scratching) were found in 4 cases each. As with LASIK, noncompliance was the most frequent patient issue in PRK claims (4 out of 7), followed by individual healing patterns, and self-inflicted injury.
Go to the Hotline article for recommendations on how to reduce the risks associated with refractive surgery.
Why are Dilating Drops in the News?
A medication used routinely by ophthalmol- ogists—dilating drops—was the subject of a recent ruling in the Massachusetts Supreme Court, which in turn occasioned an ASCRS Member Alert. The court opined that if a physician does not warn of the possible side effects of a medication or treatment, he can be held liable not only to his patient but to all those “forseeably put at risk for a failure to warn.”
While this case was triggered by a motor vehicle accident, OMIC has also dealt with mal- practice allegations involving falls after dilation. Indeed, we recently settled such a case, and were already editing articles on risks related to dilating drops for this issue of the Digest (see Closed Claim Study and Risk Management Hotline) when we were contacted by policyholders in response to the ASCRS Alert. It is important to reiterate OMIC’s long-standing recommendations on an ophthalmologist’s duty to warn patients about the effects of dilating drops.
We first suggested such a practice in 1992, when former OMIC committee member Richard A. Deutsche, MD, advised ophthalmologists to “Discuss Potential Side Effects of Eye Drops” in the AAO’s Argus, and we provided a sample consent document for dilating drops in 2002.
At the 2007 AAO Annual Meeting, the OMIC Forum on “Medication Safety and Liability” focused attention on two other high-risk medica- tions that play a role in ophthalmic liability: anticoagulants and steroids. Policyholders who were not able to attend the forum may order a complimentary copy of the CD by calling Linda Nakamura at (800) 562-6642, ext. 652. Insureds are also encouraged to consult “Hemorrhage Associated with Ophthalmic Procedures” and our sample consent form for triamcinolone acetonide (KenalogTM), both available at www.omic.com.
Message from the Chairman (discussed frequency and types of errors)
Wrong site/wrong IOL surgery
errors continue to plague our profession despite a concerted effort by OMiC to educate insureds and others about the circumstances that lead to such errors and provide risk management recom- mendations to help prevent them.
A recent retrospective study of 42 OMiC claims and 64 new York state cases by John W. simon, MD, et al, published in Archives of Ophthalmology (vol. 125, no.11) addressed the effectiveness of the universal Protocol as a prevention tool. According to the study, even if the protocol were perfectly implemented, 15% of errors would remain. Recent events in Florida, where ophthalmologists have incurred substantial fines and penalties imposed by the state medical board, and the persistence of wrong site/wrong iOL errors has galvanized OMiC and its sponsor, the American Academy of Ophthalmology, to examine what can be done to eliminate these errors.
First, the problem must be put in perspective. Wrong site and wrong iOL errors are very low in frequency, indicating that proper safeguard systems are currently in place and working fairly well. in our 21 years of existence, approximately 4,679 lawsuits, claims, and incidents have been reported to OMiC. Only about 220, or 5%, have been related to “wrong” events. since 1997, the percentage of insureds who have reported a wrong site or wrong iOL matter to OMiC has stayed relatively constant at a median annual average of about 0.5%.
however infrequent, these types of errors have drawn the attention of the public and state and federal policymakers, resulting in fines and licensing sanctions against physicians and non-payment of services by Medicare and other payors. the AAO, OMiC, and other ophthalmic societies are taking a two-prong approach to the problem—education and prevention—via the Academy Practice improvement task Force and a three-year Academy Campaign to eliminate Wrong site/Wrong iOL surgery.
the first charge of the Practice improvement task Force, a group of seven ophthalmologists representing the AAO, ABO, AuPO, and OMiC, is to develop an online CMe activity that will allow ophthalmologists to compare their own practice to those that follow evidence-based performance measures and protocols proven to reduce errors. simple-to-use checklists will help participants adopt the protocols in their own office. Anonymous data collection of pre- and post- education practice activities will enable the task force to evaluate the effectiveness of the practice improvement activity on care outcomes.
the campaign to eradicate “Wrong site surgery and Wrong iOL implantation” in the u.s. within three years is another cooperative group effort of ophthalmologists and is led by Gary s. schwartz, MD. the group will review suggestions drawn from evidence-based medicine to help surgical teams evaluate and improve their own safety systems to eliminate all sources of wrong site or wrong iOL errors, whether operating in an office, hospital, or ambulatory surgery center.
At the state level, the Florida society of Ophthalmology is working with OMiC and the Academy to educate FsO members on wrong site/ wrong iOL surgery prevention. Florida is “ground zero” when it comes to the regulatory impact of system errors, and ophthalmologists in particular have borne the brunt of fines and licensure sanctions. the reason lies principally with the reporting requirements of AsCs and hospitals to the Florida medical board when a wrong site or wrong iOL error occurs in the operating room. the FsO is partnering with the Florida Board of Medicine to develop a statewide regulatory/ disciplinary process to handle and correct the systems that produce such violations.
With the leadership and participation of so many prominent ophthalmic organizations, we hope to make the persistent problem of wrong site/wrong iOL a “never” event.
Joe R. McFarlane Jr., MD, JD OMIC Chairman of the Board
Premium IOLs Come of Age
By Hans Bruhn, MHS OMIC
Senior Risk Management Specialist
Digest, Winter 2009
Patient satisfaction can be difficult to obtain and easy to lose. Despite the initial level of deference and trust a patient usually brings to the physician-patient relationship, that trust can be lost due to miscommunication about the diagnosis or treatment goals. Out-of-pocket expenses, especially if they are significant, can increase patient expectations and set the stage for dissatisfaction or malpractice lawsuits. A current case in point is intraocular lenses (IOLs), judging by the number of calls on this issue to OMIC’s Risk Management Hotline.
Prior to World War II, ophthalmologists and their patients had few lens choices following cataract surgery. The only way to replace the focusing power of the lens once it was removed was with a thick cataract glass (remember the coke bottle glasses that elderly people wore years ago?). Today, cataract patients are fortunate because ophthalmologists can replace the natural lens with an artificial, clear, plastic lens implant.
The use of lens implants became common practice in cataract surgery in the 1970s, but the discovery of these lenses actually occurred years earlier in the late 1940s. Howard Ridley was an ophthalmologist in the Royal Air Force treating former fighter pilots who had sustained eye injuries during the war when bullets striking the plastic canopy of their aircraft caused small shards of plastic to fly into their eyes. Dr. Ridley realized that the polymethylmethacrylate (PMMA) acrylic from the aircraft canopy was made of an inert material that was compatible with eye tissue. In 1949, he replaced a cataractous natural lens with the first artificial plastic lens.
Fast forward sixty years to the wide selection of IOLs now available to ophthalmologists and patients. Ophthalmologists can recommend lenses based on a patient’s individual postoperative vision goals, and patients willing to pay extra can upgrade to “premium” IOLs for even better visual results. But, as with any commodity, availability of a “premium” product has its downside. In the case of premium IOLs, patients may have unrealistic expectations and because patients are personally responsible for the added cost, they may insist upon guaranteed results. Management of expectations is thus critical to satisfaction when helping a patient choose the right IOL.
The choices are numerous. In addition to the standard monofocal lens, patients now have the option of a “multifocal” intraocular lens (the first one was approved by the FDA in 1997). “Multifocals” provide both near and far vision. unfortunately, not all patients are eligible for “multifocals.” Some patients who are fitted with “multifocals” may still need glasses or contact lenses for certain activities, such as those requiring near and extremely crisp, clear vision. In general, however, fewer need glasses and contacts when fitted with “multifocals” than they would with monofocals. Clinical studies have found that cataract patients who choose “multifocals” over monofocals express greater satisfaction and improved quality of life following surgery.
In addition to these benefits, each of today’s available “multifocal” IOLs (ReStor, ReZoom, and Crystalens) have specific limitations that need to be communicated to the patient to reduce the potential for disappointment and dissatisfaction. To appreciate the need to move cautiously with premium IOLs, we’ll examine OMIC’s claims experience with cataract surgery.
Claims Experience Involving IOLs
Issues that surface with patients who undergo cataract surgery with placement of IOLs include the typical complaints of incorrect lens power, size, type, and position. Another source of claims are complications of surgery that were not handled promptly by the surgeon or referred on to a specialist in a timely manner; these include vitreous loss, retained and dropped lens material, stripped descement’s membrane and other corneal problems, and choroidal hemorrhage.
As indicated in Graph 1, cataract surgery claims continue to be the most frequent type of claim against OMIC insureds. The high rate of cataract- related claims reflects the large number of cataract procedures performed each year in the United States. (Claims involving the use of IOLs in cataract surgery are included in the overall cataract column, but claims involving the use of IOLs in refractive surgery are fairly new and few have been reported so far.) While the average indemnity for cataract claims over the past five years ($113,000) is less than the average indemnity for all types of ophthalmology claims ($145,000), the aggregate indemnity for cataract claims is significant given their high volume.
OMIC did experience a decrease in the number of cataract claims between 2005 and 2008 from 27% of all claims to 20% (see Graph 2). Whether this decline will continue during the current economic downturn remains to be seen. We are seeing an uptick in the number of small general ophthalmology claims, possibly the result of patients seeking financial compensation during hard economic times.
In order to decrease the risk of a claim and the amount of settlement or judgment if a claim is filed, the following risk management strategies are recommended for ophthalmologists who do IOL placement.
Manage Patient Expectations
Management of patient expectations with regard to cataract and refractive lens exchange surgeries begins with proper patient selection. Plaintiff attorneys and experts are quick to point out if the patient was a questionable candidate for surgery or if better alternatives existed for the patient’s particular needs.
Know and follow the indications for surgery in the American Academy of Ophthalmology’s “Preferred Practice Pattern on Cataract in the Adult Eye.” Determine the role of the cataract in the patient’s vision loss. Ask about near and distant vision under varied lighting conditions for activities that the patient views as important. Document the functional impairment using the patient’s own words. Consider using a vision-specific questionnaire designed to help ascertain the impact of the cataract on activities of daily living, such as the Activities of Daily Vision Scale (ADVS)1 or the Visual Function Index (VF-14).2
Identify whether there are other possible causes of the patient’s visual problems besides cataracts. Evaluate the patient for medical comorbidities and medications that can influence the choice of anesthesia or affect the outcome of surgery (e.g., Flomax, anticoagulants).
Provide Thorough Informed Consent
In addition to a well documented medical record, a thorough and memorialized informed consent process will enable OMIC to mount a strong defense against a claim. Consent should be given in advance of surgery with time allowed for the patient to review this information and ask questions. Include a thorough discussion of the risks, benefits, alternatives, and complications of surgery and anesthesia. It is important to document the indications for surgery (e.g., for cataract surgery with premium IOLs, the need for near and distance VA and the impact of cataracts on the patient’s daily life). Also disclose and document the impact of ocular and medical comorbidities on the outcome (e.g., removing a cataract will not cure other eye conditions such as glaucoma or AMD).
Your discussion with the patient should address the options for near vision and astigmatism reduction. If the IOL was recently approved, explain that there is a lack of information about long-term outcomes and the possibility of unforeseen complications. Patients should not feel pressured to choose a more expensive IOL option. Explain your rationale for recommending a particular IOL and provide information about it, including labeling information that a reasonable person would want to know.
More importantly, clarify that no guarantees can be made about postoperative visual acuity. Explain that the selection of the proper implant is based upon sophisticated equipment and computer formulas, but is not an exact science, and if the refractive result is considerably different than expected, there may be a need for glasses or contacts, additional refractive surgery, or lens repositioning or replacement. Also explain what will happen if the selected IOL cannot be placed due to problems that may arise during surgery. If the patient is at increased risk for a particular complication, disclose and document that (e.g., infection in a diabetic patient). More information on the informed consent process for cataract and refractive lens exchange surgeries can be found at www.omic.com.
Handle Patient Complaints
Even patients with uncomplicated surgery may present with complaints after surgery. unwanted visual images, residual refractive errors such as astigmatism, and overall poor quality vision may be cause for complaint. Manage these situations by being empathetic and reassuring to the patient. Emphasize that it may take time to adjust to visual changes and that you will be available to the patient throughout this process. If complaints persist, discuss the matter with OMIC’s Risk Management Department.
Monitor Advertising
The ophthalmologist should personally review how IOL implants are being marketed to patients in the practice’s advertising to ensure that patients are receiving “balanced” information on their risks and benefits. This will also help manage patient expectations before the patient presents in your office. OMIC’s Risk Management Department will be happy to assist you in reviewing your advertising.
1. Mangione CM, Phillips RS, Seddon JM, et al. “Development of the ‘Activities of Daily Vision Scale.’ A Measure of Visual Functional Status.” Med Care 1992; 30: 1111-26.
2. Steinberg EP, Tielsch JM, Schein OD, et al. “The VF-14. An Index of Functional Impairment in Patients with Cataract.” Arch Ophthalmol 1994; 112:630-8.
