Anthony Agadzi, MD,
Anne M. Menke, RN, PhD,
Richard L. Abbott, MD
Contents
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Introduction |
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The Elements of Medical Malpractice |
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Preoperative Considerations |
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Intraoperative Considerations |
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Postoperative Considerations |
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Conclusion |
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CHAPTER HIGHLIGHTS |
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Introduction
Year after year, cataract surgery accounts for the greatest number of medical malpractice lawsuits against ophthalmologists reported to OMIC, the Ophthalmic Mutual Insurance Company.[1] An analysis of 168 cataract surgery claims over a 10-year span revealed that they represented 33% of the claims, and 24% of the total indemnity paid by OMIC.[2] This chapter will focus on actions surgeons can take before, during, and after surgery to further the two goals of healthcare risk management, namely, promoting the patient's safety and reducing the physician's liability exposure.
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The elements of medical malpractice
In a lawsuit for medical malpractice, or professional negligence, the patient is known as the plaintiff and the physician becomes the defendant. To successfully sue a physician for malpractice, the plaintiff must prove the existence of four elements: duty, a duty of care owed as the result of a physician–patient relationship; negligence, a breach in the duty caused by the defendant's negligent act or omission, with negligence defined as a deviation from the standard of care that is determined by expert witness testimony; causation, a direct link between the defendant's negligent act or omission and an injury suffered by the plaintiff; and damages, pain and suffering, disability and disfigurement, past and future medical bills, lost wages, wrongful death, etc.
During the preoperative-assessment period and informed-consent process for surgery, ophthalmologists weigh up the likely benefit of the procedure for their patients and help them understand the potential risks involved. Despite these educational efforts, patients who experience an unanticipated outcome – a maloccurrence – too often forget that they were forewarned about complications and instead assume that someone was negligent in their care. It is often difficult to persuade patients and other physicians alike that an unanticipated outcome may or may not be the result of error or negligence, and that not all errors are the result of medical malpractice. Indeed, often the investigation of unanticipated outcomes and allegations of negligence reveals that what initially appeared to be malpractice was instead the result of either the disease process itself, or a foreseeable or unpreventable complication of risky, even life- or vision-saving treatment.
An example may help clarify this distinction between malpractice and a maloccurrence. Rupture of the posterior capsule is a well-known complication of cataract surgery. The surgeon is not necessarily negligent if this occurs during the procedure. With this or any other complication, what might be deemed below the standard of care would be the ophthalmologist's failure to:
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explain the potential complication and the likelihood of its occurrence to the patient as part of the informed-consent process |
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recognize and address the complication in a timely manner |
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inform the patient and document that the complication occurred |
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give adequate discharge instructions. These include information about diet, activity, wound care, and the follow-up appointment; how to contact the surgeon; what symptoms to report (“call my office right away if you experience red eye, blurry vision, pain, flashing lights, many floaters, or sensitivity to light”); and the potential consequences of not informing the physician (“these symptoms could indicate a serious infection or a retinal detachment, which if not treated promptly, could lead to vision loss and even blindness”) |
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refer the patient to a sub-specialist for care in a timely manner if the situation warrants more advanced management. |
While a lawsuit may be prompted by a specific event, such as a complication, the entire process of care is scrutizined when patients sue physicians for medical malpractice. Experts pore over the medical records in order to evaluate the decision to perform surgery, the preoperative assessment, the choice of anesthesia, surgical approach, intraocular lens (IOL) choice, the quality and timing of the consent, the technical skills of the surgeon, the perioperative monitoring, recognition and management of complications, and postoperative care. Each of these aspects of care will be discussed in turn.
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Preoperative considerations
It is hard to defend a cataract surgery lawsuit if the procedure was not indicated in the first place. The plaintiff attorney may allege that the patient's cataract did not interfere with activities of daily living, the cataracts were not the cause of the visual difficulties, or that removal of the cataract would not improve visual acuity in the presence of other ophthalmic conditions, such as diabetic retinopathy or age-related macular degeneration. If both eyes are impacted by cataracts, the plaintiff may allege that the wrong eye was operated on first. Finally, in the case of a (functionally) monocular patient, the plaintiff may claim that the risks of the surgery were simply too great. Depending on source and criteria for selection, rates of inappropriateness of cataract surgery range from 1.7[3] to 37%.[4] These criteria typically include indicators of visual and functional impairment, which may be correctable by glasses or visual aids, situations in which patients cannot undergo surgery because of pre-existing comorbidities, or where underlying ocular conditions imply either a marginal benefit to surgery or clearcut contrandications.
Indications for cataract surgery
According to the American Academy of Ophthalmology's Preferred Practice Pattern on Cataract in the Adult Eye, “the primary indication for surgery is visual function that no longer meets the patient's needs and for which cataract surgery provides a reasonable likelihood of improved vision.”[5] Cataract removal is also indicated when the lens opacity inhibits optimal management of posterior segment disease or the lens causes inflammation, angle closure, or medically unmanageable open-angle glaucoma. Notably, preoperative visual acuity is a poor predictor of postoperative functional improvement – and a poor defense of the decision to operate if the cataract does not interfere with the quality of the patient's life. Accordingly, assessment of a patient's near and distance vision under various contrast and lighting situations is highly important.[5] As a risk-management measure, documentation about functional impairment, ideally in the patient's own words or from a visual function questionnaire, should be included in the medical record.[6,][7] The same indications extend to (functionally) monocular patients, but because such patients are dependent upon the eye being considered for cataract surgery, they represent a higher medico-legal risk. Thus, the ophthalmologist should carefully weigh the need for surgery and the type of anesthesia, and is obliged to explicitly inform the patient of the definitive risk of total blindness. Documentation of the decision-making and consent process must be especially complete in such cases.
Preoperative ophthalmic evaluation
In additional to measurements of functional vision, the preoperative ophthalmic evaluation should include assessment and clear documentation of the patient's visual status, acuity and refraction, external and slit-lamp examination including motility and alignment, pupillary function, intraocular pressure and dilated vitreo-retinal exam (or B-scan of posterior segment where poor visualization is present) at the very minimum. Similarly, contrast-sensitivity, glare-testing and potential acuity testing may be other adjunctive parameters on which to gauge and legally justify readiness for cataract surgery. Other tools like specular microscopy may also be useful in predicting poorer outcomes from otherwise routine cataract surgery in eyes with pre-existing endothelial disease. When performed and adequately documented, discussions with a patient about how the results of preoperative ophthalmic testing may influence final outcomes may help mitigate unrealistic patient expectations and prevent undue litigation.
Second-eye surgery considerations
The indications for second-eye surgery are generally along similar lines of first-eye surgery if cataract surgery in the fellow eye is expected to provide similar visual acuities in both eyes.[5] The necessity of second-eye cataract surgery is well established, and rarely challenged in court. In a British study looking at stereoacuity for instance, the number of patients meeting driving standards increased from 52% after first-eye surgery to 86% after second-eye surgery.[8] More recently, the second cross-sectional Blue Mountains Eye Study group demonstrated that a moderate-to-severe unilateral visual impairment caused by eye diseases such as cataract had a measurable impact on health-related quality of life, further underscoring the need for eventual bilateral surgery.[9] This has also been recently corroborated by the Los Angeles Latino Eye cross-sectional population-based study.[10] The importance of visual impairment – of which cataract remains a leading cause – in limiting functional quality of life and the legal ramifications therein should not be underestimated in any discussion of risk management. Visual impairment has been shown to be an important risk factor for falls and hip fractures,[11] and first-eye cataract surgery was shown to independently decrease the rate of falling and fracture over a 12-month period in a randomized controlled trial.[12] Visually significant cataract has also been implicated in a higher likelihood of motor-vehicle accidents.[13,][14]
From a medical malpractice perspective, the highest risk for second eye surgery is the interval between procedures. The timing is dictated by several factors, including patient preference and surgical readiness, final visual acuity, medical and refractive stability of the first operated eye, anisometropia and the degree of the need for binocularity, especially as reflected in successful performance of activities of daily living such as driving. The shortest interval between procedures is, of course, simultaneous bilateral cataract surgery. While several reviews of simultaneous bilateral cataract extraction have shown no bilateral complications that resulted in visual loss,[15–18] most ophthalmologists do not operate on both eyes on the same day because of the potential for bilateral visual impairment, and the lost opportunity to adjust surgical plans for the second eye in the event of unanticipated findings or complications in the first. Interest in this scheduling option is growing, nonetheless, particularly in healthcare systems where patients have long waiting times for surgery.[5] At this point in time, at least in the United States, simultaneous bilateral cataract extraction is still considered exceptional, reserved for those patients in whom the risks of anesthesia, co-morbidities, or special travel or other living arrangements preclude the possibility of consecutive surgeries. Even if second-eye surgery is planned from the start, the ophthalmologist must obtain and document informed consent each time. Any additional information about risk gained during the first procedure (e.g., weak zonules or iris instability), must be explained to the patient and documented. The surgeon may either ask the patient to sign a separate consent form, or add the date and signature on a separate line on the first form.
In summary, careful patient selection lies at the forefront of risk management in cataract surgery. The single most important criterion for surgery and outcome measurement is the restoration of vision to meet a patient's functional needs and expectations. Given the potential for improvement in not only visual, but also physical, emotional and mental well-being as a result of cataract surgery, it is important that patient selection involves careful documentation of visual acuity and functional disability as pertains to activities of daily living, as this is the standard against which allegations of malpractice will be measured.
Preoperative medical assessment
The primary purpose of the preoperative evaluation is to determine if the chosen procedure and anesthesia are safe and appropriate for the patient, and to help anticipate potential complications related to ophthalmic or medical co-morbidities. If a patient experiences an unanticipated outcome, he or she might allege that the assessment was negligent or failed to detect pre-existing medical conditions. While ophthalmologists are medical doctors, as specialists they generally limit their care and treatment to ophthalmic conditions. Accordingly, most ophthalmologists do not perform the preoperative history and physical examination themselves. Instead, they regularly refer the patient to the primary care physician for medical clearance. Ophthalmologists who perform their own preoperative medical assessment should ensure that their history and physical examination skills are up-to-date.
Preoperative assessment for cataract surgery must take into account consideration of past medical, social, family, medication, and allergic history. Extensive medical work-ups with EKG, complete blood counts and serum electrolytes do not appear to decrease perioperative morbidity and mortality, and are thus not routinely performed.[19] Systemic health issues uncovered during the preoperative evaluation may, however, influence an ophthalmologist's decision making regarding anesthetic and surgical technique, thus influencing final visual outcome. Such preoperative concerns should be discussed with the patient as well as primary care physician and anesthesiologist; where indicated, additional testing, such as cardiopulmonary risk assessment, should be undertaken. The ophthalmologist should clarify with the primary care physician who will be responsible for ordering and reviewing results of preoperative testing, communicating them to the patient and healthcare team, and arranging for any necessary follow-up care.
Particular attention should be paid to patient medication history, especially over-the-counter, anti-coagulant, anti-platelet, and alpha-adrenergic antagonist therapies. Patients should be asked about current and remote use of these medications (especially the latter). There appears to be little evidence favoring the discontinuation of anti-platelet and anti-coagulant medications in the setting of routine cataract surgery.[20] Indeed, cerebrovascular accidents related to inadequate anticoagulation are felt to be the greater threat to patient safety. Surgery on anticoagulated patients must, nonetheless, be carefully managed. First, the surgeon should certainly disclose to the patient the potential for intraoperative bleeding (especially in the setting of retrobulbar anesthesia). Second, careful attention should be paid to the choice of anesthetic route. Finally, the entire surgical team, including the patient, should be instructed to monitor for signs of intra- and postoperative bleeding. From the risk management standpoint, careful documentation of the mutual decision to either continue or temporarily suspend anti-coagulation, as well as choice of alternative anesthetic route employed if any, is imperative.
The use of systemic alpha-adrenergic antagonists for benign prostatic hypertrophy, hypertension, and urinary retention – even years before surgery – has recently been associated with a newly described small-pupil floppy iris syndrome which may increase the risk of complications during cataract surgery.[21,][22] During preoperative review and informed consent, a discussion of the possibility of these complications must be documented, equipment to manage them made available, and appropriate surgical technique utilized to minimize risk of a poor outcome.
Informed consent
Surgeons are familiar with the duty to obtain the patient's informed consent before invasive and risky procedures. The patient's consent must be both voluntary and informed, and obtained when the patient is able to participate in the decision-making process in a meaningful way, in advance of surgery. Too often equated with the consent form, informed consent is instead a process which begins as an oral agreement between the ophthalmologist and the patient that is reached after a discussion. The discussion includes the condition, recommended treatment or procedure, and the risks, complications, benefits, and alternatives, as well as the consequences of refusing the recommended treatment or procedure.
Lack of informed consent is rarely the main focus of malpractice lawsuits. Exceptions include when the surgeon performs a procedure that is different from the one planned, or adds one without discussing it with the patient (limbal-relaxing incision during cataract surgery). Jurors readily imagine the difficulty patients feel when trying to make a healthcare decision based upon a layperson's knowledge. This easy identification with patients may explain the attention both plaintiff attorneys and jurors pay to the issue of informed consent. Allegations in lawsuits include failure to warn the patient of a particular complication for which the patient was at increased risk, coerced consent obtained the day of surgery, consent from a patient incapacitated by preoperative medication, or lack of consent for experimental treatment. Lack of documentation of the consent discussion inevitably leads to a credibility battle whose outcome will depend upon subjective factors rather than medical facts.
In general, the duty to obtain informed consent cannot be delegated: the healthcare provider performing the diagnostic procedure or surgery must obtain it. In cases of co-managed care, it is common for the plaintiff attorney and expert to criticize the surgeon for failing to perform his own independent determination of the patient's candidacy and personally conduct the informed consent discussion. Surgeons who co-manage can further decrease the risk of allegations of lack of informed consent by asking the patient to sign a specific consent for the co-management. If the patient has any known risk factors that increase the likelihood of complications, side effects, or poor outcome, the ophthalmologist should discuss these with the patient and document the disclosure discussion. Finally, the informed consent discussion should take place when the patient is awake and aware, free from the effects of any medication that could interfere with the patient's ability to participate in the decision-making process.
The informed consent discussion should always be documented, ideally in two ways. First, the surgeon should include a brief note about the discussion in the medical record. If the discussion took place in a language other than English, document the language used, and the name and relationship of any translator. Specific questions or concerns raised by the patient should be documented, along with the answers. In addition to documenting that the discussion took place, patients should sign a procedure-specific consent form, and be given a copy for review with family or legal guardian. Records and copies of educational materials distributed to patients should be kept readily available.
For elective surgeries, the discussion should take place before the day of the surgery whenever possible. Some patients who had surgery the same day as the informed-consent discussion have later sued for lack of informed consent, arguing that they were coerced into having the procedure and did not have time to weigh the risks and benefits. If the patient cannot be seen until the day of surgery due to time and distance constraints, taking the extra time for discussion will help facilitate patient understanding and ensure that the consent for surgery is not coercive. An extra step for the informed consent includes obtaining information about the patient's medical and ocular health from the referring physician or directly from the patient by telephone or questionnaire. Another strategy is to send the patient an unsigned copy of the procedure-specific form along with other educational information, and to ask the patient to review the materials well in advance of surgery. On the day of surgery, before any medication is administered, the ophthalmologist should conduct the final preoperative assessment and personally obtain the patient's oral consent as well as signature on the consent document.
Anesthesia issues
In 2006, OMIC completed a study of its anesthesia claims experience.[23] Out of 2474 claims during this 18-year period, only 78 (or 3%) were related to anesthesia and sedation.[23]While the frequency of anesthesia claims is low, both the percentage of claims resulting in payments (34%) and the severity of the indemnity awards ($150,000 median payment) were higher than OMIC's overall claims averages (21% and $75,000).[23] Complications of orbital injection anesthesia accounted for the overwhelming majority of anesthesia/sedation-related claims against OMIC insureds (69 claims), while general and topical anesthesia accounted for only five and four claims, respectively.[23] Sedation was an issue in five of the 69 orbital cases.[23] Retrobulbar anesthesia was administered in 49 cases, peribulbar in 16, and O'Brien block in one.[23] Of note is the fact that there were no claims resulting from sub-Tenon's blocks.[23] The injury to the plaintiff was felt to be the result of physician negligence in 13 of the 22 cases that resulted in an indemnity payment.[23] Some incidents of negligence pertained to inadequate control of eye pain, movement, anxiety and level of sedation, as well as negligent administration of orbital injection.
The following guidelines for risk management and anesthesia are critical:
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Document the choice of anesthesia, and decision-making process as discussed with the patient, anesthesia provider, and primary physician, where needed |
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Document the patient's informed consent for both the surgical procedure and type of anesthesia, even if administered by an anesthesia provider |
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Respect scope of practice, licensure, and competency when providing, delegating, and supervising anesthesia and sedation. Ophthalmologists are usually held vicariously liable for care rendered by their employees, such as nurses and technicians. As a general rule, however, they are not held liable for the negligent acts of anesthesiologists, or certified registered nurse anesthetists even if – for billing and regulatory purposes – they are deemed to be their “supervisors”, unless the ophthalmologist directly controls the actions of the anesthesia provider |
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Communicate pertinent ocular biometrics or co-morbidity (e.g., long myopic eye, staphyloma, etc.) which may affect the technique of anesthetic administration. |
Intraocular lens calculation and selection issues
Following cataract extraction, a patient's final visual acuity expectation depends largely on the type and method of IOL implantation. Any discussion of informed consent, in addition to stating the inability to guarantee a perfect visual outcome, must, therefore, accurately document specific visual goals for both near and distance vision. Issues relevant to lens type include choice of either distance or near acuity with monofocal lenses, dominant eye and depth perception issues in monovision scenarios, or the possibility of unpredictable visual side effects in multifocal lens implants. An additional discussion on the occurrence of temporary anisometropia between the consecutive cataract surgeries, as well as the likelihood of residual refractive error and options for its management, are critical determinants in preventing unnecessary malpractice claims.
According to multiple medico-legal sources, errors related to IOL power miscalculations, size or type, defectiveness, dislocation, or decentration, comprise up to one-third of all cataract-related legal claims.[24,][25] Such claims were frequently defensible if there was appropriate documentation and explanation for why a surgeon picked a particular IOL power or type. Further risk-reduction strategies include accurate, repeatable, bilateral ocular biometric measurements derived from precisely calibrated instruments, and performed by well-trained technicians. The use of appropriate lens formulae, as well as appropriate labeling and intraoperative verification of IOL types is critical.
In recent years, in addition to regular monofocal lenses for either distance or near vision, several new “multifocal” intraocular lenses with the ability to provide an expanded range of near-to-distance vision have been developed to more adequately simulate the pre-presbyopic eye. These lenses may not be appropriate for patients with unrealistic personal expectations or strict professional visual acuity requirements (e.g., pilots) as even the most accurate biometry and uncomplicated surgery in the hands of the most adept surgeon, may not guarantee a perfect visual outcome. Since patients often pay more for multifocal lens options, such inflexible expectations can lead to dissatisfaction and ultimately litigation in the event of a suboptimal visual outcome. This may especially be the case in the setting of misleading advertising on the part of the ophthalmologist who “guarantees” spectacle-free near, intermediate and distance acuity. The following points should be documented as part of the informed consent pertaining to patient selection for multifocal lens implantation:
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Discuss presbyopia and alternatives for near vision following cataract surgery with every patient, whether or not you offer “multifocal” IOLs. If you do not offer these IOLs, the discussion can be brief. If patients desire an IOL you do not offer, encourage them to seek care elsewhere. |
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Elicit and document information about professional and leisure activities that may influence IOL choice (e.g., accountants and knitters may prefer near vision). |
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Discuss side effects associated with multifocal IOLs such as nighttime glare, haloes, or imperfect near or intermediate acuity results and their potential effect on activities of daily living, night driving, or other low-light situations. |
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Discuss the possibility of placing a monofocal lens in the event that a multifocal lens cannot be implanted because of an intraoperative complication. |
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Discuss the possibility for subsequent IOL exchange in the event of extreme side effects, or symptom intolerance which persists after a reasonable “neuro-adaptive” period. |
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Discuss management options and financial implications for both the IOL and any residual refractive error. |
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Inform patients having refractive lens exchange of the “off-label” status of IOLs, which are only approved for implantation during cataract surgery. |
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Intraoperative considerations
Identification of the patient and surgical site
Perhaps no other type of medical error has received more attention than instances where the wrong procedure has been performed. OMIC has had a total of 42 of these “wrong” allegations, which are usually considered by plaintiff attorneys and juries to be completely preventable.[1] The vast majority (26) involved claims of wrong power IOLs, followed by surgery on the wrong eye (10), block on the wrong eye (2), wrong procedure (2), and wrong patient (2).[1] Fully 36% of these cases resulted in indemnity payments totaling $573,515.[1] Surprisingly, in many instances, the patient never filed a lawsuit. Patients who are promptly told the truth, offered an apology, and granted a waiver of the fees associated with the procedure tend to be more forgiving.
Recommendations for preventing site errors include a preoperative verification process, marking the operative site and a “time out” immediately before starting the procedure. The “time out” involves the patient and the entire surgical team and frequently includes a checklist to verify the identity of the patient, correct site and side, procedure, patient position, and any implants, or special equipment. The verification process should be enforced prior to administration of anesthesia as well as before the operative procedure.
Surgical sterile preparation
Once in the operating suite, appropriate sterile instrumentation, preparation and draping of the patient, operating surfaces and equipment is imperative to reducing the risk of intraoperative complications and for facilitating a proper surgical outcome. In a recent review of risk issues in endophthalmitis by OMIC, at least nine out of 32 systems-related errors pertained to failure to sterilize, contaminated ultrasonic baths and equipment malfunction.[26] Appropriate labeling of all medications, injections and liquids used during surgery and on the sterile field is also essential to avoid any complications or intraocular toxicities.
Intraoperative communication
Due to the ambulatory nature of most cataract surgery performed today, of utmost importance to risk management is communication between surgeon, anesthesiologist, patient and any ancillary staff members present in the operating room during an encountered complication. Since the cataract patient is frequently awake and relatively lucid during surgery, anxiety management on the part of the surgeon is a key element to patient cooperation during a difficult case, and tactful verbalization of operating room directives to counter a complicated situation can help prevent patient misunderstanding and undue litigation. At times, it may be necessary to conduct a post-procedure “debriefing” to collect necessary information and ensure adequate documentation.
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Postoperative considerations
Documentation
Accurate and immediate documentation of the operative report is an imperative risk reduction strategy following routine and complicated cataract surgery, both in the form of a dictated report and a brief entry in the medical record conveying information needed for care in the post-anesthesia care unit. A careful and detailed, customized operative report may be more easily defensible than that created by a standardized template which may omit critical information. Any information gained after the report is dictated should be entered into the record as a correctly labeled and dated addendum. A complete cataract operative report should include indications for surgery, informed consent documentation, record of infection prophylaxis, anesthesia method, surgical technique, recognition of and response to complications or unusual occurrences, as well as the rationale for and type and serial number of IOL used. Unusual occurrences, such as equipment malfunction, should be noted in the medical record in a factual manner without speculation or blame. In addition, the physician should notify the facility risk manager and follow the established protocol for completing an incident report which may contain information that should not be included in the medical record. Incident reports should not be referred to or included in the medical record, and should not be photocopied.
Surgical complications
Corneal complications such as phacoemulsification burns, Descemet's detachments, endothelial decompensation or epithelial erosions, are recognized complications of cataract surgery. Legal claims associated with these complications may be reduced by appropriate informed consent, careful documentation of pre-existing pathology such as endothelial guttae, and precautionary phacoemulsification technique. The latter includes maintenance of adequate irrigation and flow around instrument tips, nuclear-chop techniques to minimize ultrasonic power and time, and appropriate use of ophthalmic visco-dispersive materials.
Despite the common opinion that the iris is merely an obstruction to anterior segment surgery, many claims result from the cosmetic effect of post-surgical iris trauma and distortion;[2]this possibility should be mentioned in any informed consent discussion. Preoperative conditions such as alpha-adrenergic antagonist use or poor dilation are often predisposing factors to iris trauma and need to be taken into account so that appropriate techniques can be anticipated and employed to minimize such scenarios.
Vitreoretinal complications are not only the second most common legal claim, but also the second highest in amount of indemnity paid.[2] Specific issues include those related to retinal detachment, choroidal effusion, exacerbations of age-related macular degeneration, as well as ruptured posterior capsule with dropped or retained lens fragments. Anterior segment surgeons not experienced or trained to perform deep vitrectomy should abstain from retrieving nuclear fragments in the vitreous as such heroic efforts may paradoxically lead to further complications. Instead such patients should promptly be referred to vitreoretinal specialists for follow-up care.
Other miscellaneous complications including intraocular pressure exacerbations in the context of glaucoma emphasize the need for meticulous management of ocular comorbidities, including early referral for sub-specialty care where indicated. Large settlements have resulted from failure to perform and document examinations of the optic nerve, to obtain informed consent for prolonged courses of steroids, and to monitor for steroid-induced side effects.[1]
Endophthalmitis and toxic anterior segment syndrome
Infectious endophthalmitis is one of the most feared complications of ophthalmic surgery. Recently, a type of inflammatory response known as TASS, or toxic anterior segment syndrome, has also garnered attention. Since OMIC's inception in 1987, endophthalmitis has accounted for 0.6% of claims frequency (150 claims out of 2559 total) and 5% of claims severity ($3,345,964 paid indemnity out of $63,191,199 total).[1,][26] Of the 150 endophthalmitis cases, more than three-quarters (78%) of OMIC's endophthalmitis cases have closed without an indemnity payment.[26] The percentage of cases that have settled (22%) and the median settlement amount ($75,000) are comparable to OMIC's overall data.[26] Despite the severity of the outcome for the patient, endophthalmitis settlements have ranged from $9000 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 three of the 150 claims involve an infectious rather than an inflammatory process.[26]
Given the estimated 2 million cataract procedures performed annually in the United States, it is hardly surprising that cataract surgery would account for 61% of all endophthalmitis cases.[26] Less expected, however, is that only 23% of cataract-related endophthalmitis cases resulted in an indemnity payment.[26] During the informed consent process for cataract surgery, ophthalmologists routinely disclose this rare complication, and most actively try to prevent its occurrence by treating pre-existing conditions such as blepharitis, preparing the eye with povidone iodine, and administering antibiotics. Indeed, assuming cataract surgery was indicated in the first place and the endophthalmitis was promptly recognized and treated, expert witnesses view this complication as a tragic maloccurrence rather than malpractice.
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.[26] Instead, systems issues and physician-driven processes predominate.[26] While not all adverse events can be prevented, there is much ophthalmologists can do to reduce the incidence of endophthalmitis and TASS. 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. Failure to rule out endophthalmitis has resulted in harm to patients and significant liability exposure. Emerging research indicates that the ophthalmologist should also include inflammatory reactions such as TASS and postoperative uveitis in the differential diagnosis. Indeed, mistaking one for the other could lead not only to a delay in treatment but may worsen the outcome. Finally, the prompt use of retinal consultants with early suspicion of endophthalmitis can prevent liability associated with delay in diagnosis and treatment of this dreaded complication.
In the event of an endophthalmitis or TASS outbreak at a surgical facility, an effective response depends upon careful coordination and cooperation among the facility, surgeon, and patient. The facility should contact all affected surgeons, and document the notification efforts. Ophthalmologists in turn need to call all patients operated on that day or during that period, and notify them of the events, screen for symptoms, and educate them about when and why to contact the physician. As in any disclosure discussion, the physician should avoid speculation or blame. Documentation of outreach efforts must be made in the affected patient's medical records. Close follow-up and patient reassurance during such at-risk periods is critical. Particular attention must be given to patients whose surgery falls right before weekends or holidays as provision must be made for on-call coverage.
Given an outbreak, a surgical facility needs to sequester all involved materials, interview staff, and evaluate equipment, devices, solutions, medications, and the sterilization process. All aspects of the investigation should be carefully documented. The investigation will help locate the responsible organism or toxic agent, ascertain liability, and determine what steps to take to remedy any identified problems. Faced with a cluster of either endophthalmitis or TASS cases, both the surgical facility and the individual surgeon will need to decide whether or not it is safe to proceed with other scheduled ophthalmic cases at that location. Ophthalmologists who have an ownership interest in an ambulatory surgical facility may also be involved in these deliberations, and should act as patient advocates promoting quality care. Patient safety should be the driving factor, and all parties must feel confident that the causative factors have been identified and addressed.
Disclosure discussion
After a detailed informed consent discussion, most patients can understand and accept a single complication, if they have a good working relationship with the surgeon. For this reason, surgeons who co-manage would be well-advised to perform the postoperative care of all patients who experience significant problems. Certain complications, moreover, predispose patients to subsequent ones. If patients are not promptly informed of complications as they occur, and warned that they are also at higher risk of experiencing other problems, they may lose faith in the ophthalmologist and seek out second opinions and legal advice. The best course of action is to invite the patient to be a member of the healthcare team assigned the responsibility of monitoring for, and reporting, symptoms suggestive of complications. Telephone screening protocols that prompt staff members and physicians alike to ask for past surgical history can also reduce the risk of a malpractice suit.[27]
Discharge instructions, patient follow-up and compliance
After cataract surgery, clear, written instruction for appropriate postoperative care must be reviewed with the patient and accompanying family members or surrogates, and appropriate follow-up arranged. While a wide range of postoperative follow-up intervals exists, practitioners should ensure adequate timing to allow for diagnosis of common postoperative complications, such as endophthalmitis, especially within the first postoperative week. In the event of a complicated cataract surgery, more frequent follow-up may be necessary, along with appropriate documentation in the chart of any unusual findings, and the use of outside consultants.
While patient compliance with postoperative antibiotic regimens and follow-up appointments is critical in facilitating improved outcomes, it is not always possible. Where non-compliance and patient attrition become an issue, it is the practitioner's responsibility to document such behavior as well as any attempts made to resolve this problem, such as records of correspondence. When the practitioner is unable to continue providing care, a documentation of referral or transfer of care is essential to reduce the risk of liability resulting from a poor outcome.
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Conclusion
The ultimate goal of risk management in cataract surgery is to maximize safety and satisfactory visual outcome for the patient, while minimizing the ophthalmologist's liability exposure. This can be achieved by implementing current treatment recommendations (e.g., Preferred Practice Patterns), and careful documentation at each stage of the preoperative, intraoperative and postoperative care of the ophthalmic patient as detailed in this chapter. Finally, clear, consistent, and accurate communication with the patient about the treatment plan, risks, expectations, and complications helps foster an effective physician–patient relationship. Taken together, these risk reduction measures may prevent even the worst outcome from translating into a medical malpractice lawsuit.
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