Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

plication. If several choices of how to deal with the problem were considered, they should all be outlined and the reasons for choosing the one used clearly explained. Plaintiff’s expert witnesses are often critical of the defendant physician’s treatment of a complication, and a scanty operative note allows them to fill in the missing data in a way that is most beneficial to their client. If there are no holes in the operative report, they may quibble with the method chosen, but are on much weaker ground if it was a reasonable option because the physician who was there and faced with having to make a real-time decision will often receive deference from a jury that can understand that hindsight makes everything clearer.

Postoperative instructions to patients should always be written and should be in a form that patients can clearly understand. This includes using languages other than English when appropriate. In particular, the patient must understand how to reach the physician at any time in the event serious problems develop before or between scheduled visits. If sample drugs are used, they should be clearly labeled with dosage and frequency directions. If the patient is to be comanaged, the plan for the transfer of care must be clearly understood by all parties. In particular, it is critical that the comanager have sufficient training, experience, and licensure to carry out the delegated duties.

Considerations Specific to Cataract Surgery

Endophthalmitis

The complication of endophthalmitis following cataract surgery is fortunately quite rare but unfortunately quite devastating in terms of return of useful visual function. The low incidence is somewhat surprising considering recent studies that demonstrate the frequency of bacterial contamination of the anterior chamber during cataract surgery. The incidence ranges from 1/1,000 to 1/3,000 and seems to be the same in most series worldwide. Because the frequency of endophthalmitis is so low, there are few well-controlled prospective studies of the risk factors involved in its development.

The questions of whether to use preoperative prophylactic antibiotics and which one to use have no clear answer that can be supported by well-designed studies. There are new studies every year, some of which seem to show that the actual choice of a specific antibiotic is not critical. It is known that preoperative administration of antibiotics does lower the level of the bacterial flora of the conjunctiva, but it is not clear how this relates to the incidence of postoperative infection, because many of the bacteria that cause infections are not typically found in the normal conjunctival flora. Povidone iodine 5% applied topically during the preparation is thought to offer some protection. Despite lack of strong evidence of efficacy, most ophthalmologists in the United States do pretreat with topical antibiotics because of concerns regarding potential increased liability in the event an infection develops in an untreated patient.

There are other issues that should be considered preoperatively as well. Lids and lashes should be well prepped and draped, and diseases such as blepharitis, meibomianitis, and lacrimal outflow obstruction should be adequately treated before elective cataract surgery is performed.

Intraoperative and postoperative treatment with antibiotics is also common and accepted as the standard of care by most ophthalmologists. Drops, injections, collagen shields, and intracameral and subconjunctival routes of administration have all been used, but personal preference, rather than scientific evidence, seems to be the main driver in determining the route.

The duration of postoperative treatment varies considerably, and there are no good studies available to answer the question of exactly how long antibiotic drops should be continued. Topical treatment is often continued until the frequency of topical steroids is reduced. There is also a feeling that the incidence of postoperative infection may be higher in patients who have suffered complications such as capsular rupture or vitreous loss, so these patients should be followed up especially carefully postoperatively.

Self-sealing clear corneal incisions are popular now because of better surgical exposure, less astigmatism, compatibility with topical anesthesia, and brighter red reflex. There is some evidence in the literature (but also some to the contrary) to indicate that the frequency of postoperative endophthalmitis is higher when a clear corneal approach is used. This may be due to inadequate wound closure, which allows bacteria to enter the eye with rubbing or blinking. To avoid this issue, a meticulous watertight seal of the corneal wound is critical, and sutures or cyanoacrylate adhesive should be used if there is any concern at all about the integrity of the wound.

Successful treatment of infection when it occurs depends on prompt diagnosis and early aggressive intervention. It is surprising how frequently the defense of cases with postoperative infection hinges on how and when the treating physician was first notified by the patient that there was a problem. Frequently these calls occur outside of normal office hours and are not documented contemporaneously (or even at all). Patients may not remember exactly what they told the physician and visa versa, and a poor visual result may further impair their recall when a legal case is brought. If there is a timely entry in the chart, in almost every instance the physician’s testimony will be believed if there is a conflict between the physician and the patient as to what actually transpired. All ophthalmologists need a system of making sure every conversation, in or out of the office, is promptly documented in the patient’s chart. The information should include the important details of the discussion, the time the actual conversation took place, and the time it was entered into the patient record. There are many systems available that allow this to be done relatively easily using either paper or electronic health records. The operating surgeon should also make sure that all physicians providing coverage or comanaging the patient follow these same guidelines.

In addition to documenting all contacts with postoperative patients, it is also critical that those patients who complain of loss of vision, pain, or other atypical findings be seen promptly. How promptly is always the issue. Although there is no clear answer, it is better to err by seeing them sooner rather than later. If there is any doubt

whatsoever in the ophthalmologist’s mind, the patient should be seen the same day as the call rather than waiting until the next day. Office staff should have a protocol in place that ensures that all postoperative patients get immediate appointments if they call the office with unusual postoperative complaints. Covering ophthalmologists and any comanagement partners should treat the patients under the same protocol.

A recent case emphasizes the importance of this process and how lack of documentation and coordination with covering physicians can make a very defensible case, one that must be settled. An elderly man, after adequate work up and a good informed consent that included a warning about the danger of loss of vision, underwent cataract surgery that was complicated by capsular rupture and vitreous loss, which were appropriately documented and treated. The patient was examined the next day and was doing well, but later the same day the covering physician (the surgeon’s partner) was called and remembered being told only that the patient had a scratchy eye. She directed the patient to continue to take his drops and added acetaminophen and told him to come to the office for follow up the following day. When he did so, a severe bacterial endophthalmitis was diagnosed. Despite vigorous treatment, the patient lost the eye and filed suit.

You might be wondering what the issue here is: endophthalmitis is a known complication that can lead to loss of the eye despite proper treatment. However, the situation was complicated by the fact that the covering physician never documented her conversation with the patient and his wife in the chart until almost 3 months after the event. She remembered the caller denying vision changes, redness, or pain and simply relating a foreign body sensation, and this is what was eventually entered in the chart. With no significant complaints and taking into account that the patient had been seen earlier that day, the covering ophthalmologist felt comfortable waiting to see the patient until the following day.

The patient and his wife were adamant that the physician was told of pain and other more significant problems, and the covering physician was just as adamant that she had not been told any of this. Neither party had a written record of the conversation, but only the ophthalmologist has the obligation to have such a record. Interestingly, both the plaintiff and defense experts agreed that the treatment was below the standard of care if the patient’s version of what occurred was correct. They also agreed that it was not substandard care if the ophthalmologist’s recollection of the conversation was accurate. The result was a standoff, forcing the company to settle a case that certainly could have been defended. The physician now has an entry in the National Practitioner Data Bank and a large settlement on her record because of a situation that could easily have been avoided if standard risk management protocol had been followed.

Patients whose postoperative clinical course falls outside the normal pattern should be considered to possibly have endophthalmitis until that diagnosis has been ruled out. Appropriate referral and consultation are indicated sooner rather than later, and a vitreoretinal surgeon comfortable with diagnosis and treatment of this condition is a valuable partner. This avoids the “if only you had come in sooner, we might have been able to save your eye” discussion, which can poison the well when this complication arises.

Elective Refractive Surgical Procedures Involving

Lens Extraction

With improvements in surgical techniques and lens implant technology, clear lens extraction with lens implantation (refractive lens exchange) as a technique for improving uncorrected visual acuity has increased in popularity. This is now being performed not only for patients with high myopia and hyperopia but also for those with more moderate refractive errors and even for simple presbyopia. Patients undergoing this type of surgery with implantation of monofocal, multifocal, astigmatic, and accommodating lenses present unique problems for the ophthalmologist.

As you might expect, patients who are paying significant sums out of pocket to be able to see without their glasses or contacts are quite demanding and have very high expectations. For this reason, patient selection is of critical importance. Those with preexisting pathology, such as corneal disease or retinal issues that would likely preclude a good visual result, make very poor surgical candidates. Patients who cannot comprehend the risks and have unreasonable (as opposed to high) expectations should be approached with caution. Very carefully documented informed consent is a must, with potential complications receiving the same attention as the proposed benefits of the procedure. Care should be taken not to guarantee results or exaggerate the likely visual outcome. Physicians should also not misrepresent their own experience with these procedures or the track record of the lens that will be used. In particular, it is important to be certain that the lens chosen will actually perform as advertised. In some states, in addition to malpractice cases being pursued by disgruntled patients, consumer fraud actions for false and misleading advertising have been filed in which patients have charged that the information given them as part of the advertising and marketing of the practice and the informed consent were misleading.

From a purely risk management point of view, an ophthalmologist who cannot reliably perform a reproducible, complication-free cataract extraction should probably not perform elective refractive surgery involving lens extraction. If the posterior capsule breaks and vitreous is lost, it is less likely that the postoperative visual result will match preoperative expectations. Those performing this type of refractive surgery should have ready access to and sufficient training and experience with other corneal refractive surgery techniques that are often required to “touch up” the final product.

In addition to the surgical skills required for these procedures, other issues must be addressed long before the trip to the operating room. The most important is accurate data collection. Without proper care in this area, technically successful surgery will not deliver the desired visual result. In a process that requires multiple measurements, the opportunity for measurement-induced error is high. These errors may be additive in their effect on the final vision obtained. For this reason, the preoperative refraction, anterior chamber depth, keratometry, and axial length must be determined with great precision using good technology and the findings accurately recorded. Errors in transcription occur much more frequently than you might imagine.

Appropriate formulas for calculating the lens power should be used with particular attention to eyes that are either very long or very short. Data should be

reviewed well before the trip to the operating room, and findings that do not make sense clinically should not be used until the issues have been resolved. Five minutes spent in checking and double-checking data preoperatively can save hours of pain, expense, and aggravation postoperatively. Preoperative consultation with experienced colleagues may also be quite helpful in dealing with more difficult or unusual cases.

Off-Label Use of Pharmacologic Agents

General Considerations

The Food and Drug Administration (FDA) is the agency that is responsible for approving new drugs for the treatment of disease. After assessing the safety and efficacy of a particular pharmaceutical agent, it requires the manufacturer to create a “label” that describes the dosage, frequency, route of administration, and other parameters to be used when the drug is administered to treat that particular condition. Once a drug has been approved for one condition, the FDA does not regulate its use for other diseases or purposes, considering that the “practice of medicine” is best left to the physician’s discretion. A major exception to this rule is that scheduled narcotics can be used for only those indications that have been approved.

Ophthalmologists are using more and more pharmacologic agents “off label” during cataract surgery, and certain rules should be followed to limit liability. The FDA protocol indicates that “if physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.” More details are available on the FDA’s website (www.fda.gov).

If a drug is used off label, it is important to be certain that its use will improve the safety or outcome of the procedure, that it has been carefully studied for the specific clinical situation, and that the risk/benefit ratio is clearly favorable. Use of drugs with only marginal utility and “fad of the month” choices should be scrupulously avoided because their use will be very difficult to defend if there is a problem. Similarly, if there are two drugs of equal efficacy and one is approved and the other is off label, use of the approved drug is always the safest choice.

Most cataract surgeons do not get a specific informed consent document signed by the patient when they plan to use medications off label during a case. Although obtaining such a form is not absolutely necessary and certainly not the standard of care, it may be wise to do so, especially if the use of the particular medication is not widespread. OMIC has a sample consent form on its website that can be used as a template with modifications as needed. Regardless of whether a specific form is signed, the informed consent process should be followed, and the patient should be told the reasons why the agent is being used.

Specific Drugs Used Off-Label During Cataract Surgery

Intracameral lidocaine (1% nonpreserved) has been used for many years if sensation begins to return during the surgical procedure. It is generally believed to be safe and effective, although there is some evidence that its routine use does not increase overall patient comfort. If a capsular dye to stain the anterior lens capsule is necessary, it is recommended that the on-label trypan blue ophthalmic solution 0.06% be used instead of the off-label older agent indocyanine green, which is more difficult to formulate for intracameral use.

Intracameral steroids and antibiotics are not generally used during routine cataract surgery by most ophthalmologists. There is no evidence that they have significant intraocular toxicity when properly formulated and administered. There is also no good evidence that they actually reduce the evidence of endophthalmitis or intraocular inflammation.

Anticoagulation and Cataract Surgery

Before the advent of small incision cataract surgery, it was generally thought that aspirin, nonsteroidal antiinflammatory agents, and Coumadin® should be discontinued prior to cataract surgery to minimize the risk of bleeding. Although objective peer-reviewed data are lacking, the trend now is not to discontinue these agents prior to small incision surgery, particularly when topical anesthesia is used. It is thought that, for many patients, the systemic risk from stopping the drugs (stroke or thrombus formation) may be greater than the risk of bleeding during the procedure. Although there is not an absolute contraindication to the use of retrobulbar or peribulbar anesthesia techniques in patients maintained on anticoagulants, caution should be used and the increased risk of bleeding explained to the patient. Subtenon anesthesia is generally safe, but the frequency of subconjunctival hemorrhage is probably higher. All patients taking Coumadin® should have an international normalized ratio (INR) performed close to the surgery date to be certain that the value is not well above the desired therapeutic range.

If the surgeon believes that the surgery should not be done with the patient taking Coumadin®, it is important that the decision be made in conjunction with the patient’s primary care physician or internist. Those physicians may agree to discontinue the drug if the risk is thought to be acceptable. However, ophthalmologists should never discontinue the drug on their own, as a complication that develops following that unilateral decision will likely result in a nondefensible situation. If discontinuing anticoagulation is not possible, the patient can be converted to intravenous heparin anticoagulation over several days and weaned from the Coumadin®. The heparin can then be briefly discontinued to allow the surgery to take place and then restarted along with the Coumadin® and continued until a stable INR is reached.

Second Eye, Monocular Patients and Same-Day Bilateral

Cataract Surgery

The indications for removing a cataract from the second eye are no different from those for the initial surgery: the presence of a cataract that impairs visual function and the anticipated benefits of surgery exceed the risk. The time interval between surgeries is variable but should be sufficient to be certain that there are no complications in the first eye. In particular, it is important to verify that there is not a “power surprise” error that could translate as well to the second eye. For this reason, it is reasonable to quickly refract and not just pinhole patients during the follow-up office visits to make sure that all is well. Because the incidence of endophthalmitis peaks between 4 and 6 days after surgery, most ophthalmologists wait at least 1 to 2 weeks before operating on the second eye. Rushing the surgery can leave the ophthalmologist in a difficult position if complications occur.

Functionally monocular patients should have the same indications for surgery as any other patient, but in reality this is usually not the case. A serious complication in a monocular patient can lead to a lot of second guessing, soul searching, and hindsight analysis on the part of both the patient and the operating surgeon. Additional attention to candid informed consent is critical to be certain that the patient fully understands the potential downside risks (including total loss of vision) of the surgery as well as the benefits. Memories fade when complications occur, and complete documentation of the process is critical. It is prudent to take a cautious approach when offering advice in this situation.

Most surgeons do not perform bilateral cataract surgery on the same day because of the concern of bilateral simultaneous complications. There are reports of bilateral endophthalmitis in this situation. There may be instances when same-day surgery is in the best interest of the patient. For some individuals with advanced bilateral cataracts who require general anesthesia for surgery or those with significant health issues a single session may be most prudent. The reasons for taking this approach should be documented in the informed consent. Under these very unusual circumstances, the second eye should be prepped and draped after the first case is completed, a second set of instruments should be used, and special precautions should be taken to be certain that the correct implant is placed in each eye.

Cataract Surgery in the Presence of Ocular

and Systemic Diseases

Improvements in surgical techniques and advances in pharmacologic agents now make cataract surgery appropriate for many patients who would have been inoperable in the past. Special attention to preoperative and postoperative management is often required. Patients with significant systemic health issues should receive proper

clearance from their physicians before surgery is performed. Issues such as hypertension, cardiac status, and diabetes should be stable before elective surgical procedures are performed. If a laboratory test or x-ray is ordered as part of the preoperative routine, it must be reviewed and the proper action taken if the result is abnormal. “Failure to diagnose” cases in which obviously serious pathology such as lung cancer is ignored because no one looked at the preoperative x-ray results are becoming more frequent and often result in sizeable judgments against the ophthalmologist even in the absence of any ophthalmology-related complication.

Diseases such as glaucoma should be under good medical control before elective surgery is scheduled, and postoperative pressure management needs to be particularly aggressive to avoid further damage. Realistic expectations in the face of comorbid ocular conditions are essential, and the limits these conditions may place on postoperative acuity must be carefully explained and documented or the diminished vision postcataract surgery will be blamed on the surgery, not the underlying pathology.

Patients with chronic uveitis should probably be treated preoperatively with steroids and/or immunosuppressive agents topically and/or systemically before elective cataract surgery is performed. Aggressive postoperative treatment is also usually required, and a flare up of the inflammatory process should be anticipated and the patient monitored accordingly. These patients often have capsular and zonular changes related to chronic steroid administration, and the planning for surgery should take these potential issues into account. Ophthalmologists should rarely if ever administer immunosuppressive agents without the assistance of an internist familiar with their use and complications.

Patients with prostate disease need to be quizzed particularly carefully preoperatively to learn whether they have taken Flomax or similar agents that may make cataract surgery extremely difficult because of their effect on the iris tissue (“floppy iris syndrome”). Surgeons unprepared to deal with this issue will find themselves struggling to catch up in the middle of the case. At the present time, the literature suggests that stopping the medication does not mitigate the problem, and various treatment options have been described. Most importantly from a liability point of view, this issue has been so well documented that an ophthalmologist who fails to inform the patient of a potential problem or fails to prepare in advance for the additional risks of surgery may have difficulty prevailing if litigation ensues.

General Considerations for the Adoption of New Technology

Ophthalmologists must keep current on the development of new technologies, surgical techniques, and pharmacologic advancements. Review of relevant scientific journals and attendance at continuing education seminars, meetings, and grand rounds at academic centers are ways this can be done. “Innovations” often appear with such rapidity that careful evaluation of their efficacy is difficult because true evidence-based research is lacking. This is particularly troublesome in the new technology area where the marketing division is often way ahead of any reasonable

concrete evidence of superiority over currently available products. Many “breakthroughs” have been consigned to the waste can within a very short period of time. A healthy skepticism regarding some of the claims made for these products is important, because the ophthalmologist, not the company, is stuck with the result if the device does not perform as promised. This is of particular concern in the area of new lens implants, which are often promoted as a simple cure for almost every problem. It is often useful to check the European literature to see if lenses, which are often released earlier there, are still being used when they finally are approved for use in the United States. If the answer is no, beware, because “FDA approved” is not necessarily a synonym for “better.”

Anesthetic Issues in Cataract Surgery

Improvements in anesthetic techniques have increased the options available for cataract surgeons, offering increased flexibility and safety. This increase means that they must become more adept and comfortable with a variety of choices, turning what was once a more or less routine decision into one that should be closely tailored to both the specific needs of the patient and the preference of the surgeon. Although topical anesthesia has increased in popularity recently, there is no correct answer in most instances to the question of which of the available techniques is “best.” Different ophthalmologists will choose different methods for similar patients and yet obtain very satisfactory results. Each technique has advantages and disadvantages, and a detailed discussion of this topic is beyond the scope of this chapter (see Chapter 10).

It is important, however, during the preoperative examination to assess which technique might be best for that particular patient. Considerations include the type of surgical incision being considered, the level of anxiety of the patient and his or her ability to cooperate, the anticipated length and complexity of the procedure, and the level of experience and anxiety of the operating surgeon. Those who are relatively inexperienced or might take longer to complete the procedure might want to consider techniques that produce both prolonged anesthesia as well as akinesia. A totally uncooperative patient might do best with general anesthesia if the patient’s health permits this choice. Whatever technique is chosen, it is important that the surgeon be comfortable with it and that it be discussed in advance with the patients so they will know what to expect and what is expected of them. Surgeons who administer the agents themselves should obtain the informed consent.

If the task is being delegated to an anesthesia professional, it is usually the responsibility of that individual to obtain the informed consent. When the injection has been delegated to another provider, such as an anesthesiologist, nurse anesthetist, or resident physician, the issue of the level of competence to perform the delegated task often arises. It is important that the operating surgeon be certain that those providers administering the injection are adequately trained. If there are any unusual anatomic issues, such as a shallow orbit, staphyloma, or extremely long axial length, the surgeon must communicate that information to the individual giving the

injection, particularly if that person is not an ophthalmologist and would not be expected to be aware of this unusual condition. Including this information in the preoperative admission note is an easy way to accomplish this.

The situation discussed above led to a very large settlement in a case I reviewed several years ago. A young monocular patient with 20/40 acuity was scheduled for cataract surgery under local anesthesia. Because the patient had a condition that would make communication during surgery difficult, it was thought that topical anesthesia would be contraindicated. A nurse anesthetist (CRNA) administered the local using a peribulbar technique and perforated the eye, and the vision was lost. Ordinarily this would be more of an issue for the CRNA (who was experienced in administering local injections for eye surgery) than for the ophthalmologist. However in this instance, the patient had a shallow orbit and an axial length of close to 30 mm. Neither of these issues was conveyed to the CRNA, and it was thought by experts that both issues should have been because they were unusual and not likely to be detectable by a CRNA based on his training and experience. The case resulted in a large settlement for the plaintiff.

If an anesthetic soaked pledget is used as part of the preoperative routine, it is important that there be a protocol in place to ensure that it is removed before the surgery commences. This would seem to be a trivial issue, but legal action accusing ophthalmologists of negligence based on a retained pledget discovered weeks to months postoperatively is not nearly as unusual as one might think. Usually these end with no significant damages against the operating surgeon or facility, but the time and dollars spent to defend the incident can reach surprising levels.

Conclusion

If you are like me, you probably assumed that most cases of medical malpractice related to cataract surgery are the result of technical incompetence: an unskilled ophthalmologist “botching” a cataract operation and paying the price. Actually, I have learned, and OMIC data confirm, that cases based on allegations of inadequate technical skill are the exception rather than the rule. The majority of claims and suits I have seen involve instances of either poor judgment or process errors (or both) rather than inferior technical ability.

Why is this so? To some degree, it can be attributed to the high skill level of the typical practicing ophthalmologist. More important, however, is the fact that it is much less difficult to explain complications of a complex surgical procedure (which most patients and juries understand are often unavoidable) than it is to justify placement of a wrong power lens or transcription errors or other issues that most patients feel are easily avoided and should “never” occur. These process errors are not medical in nature and are more easily understood by patients (and juries), and no amount of rationalization can explain them away.

Averting these problems clearly trumps having to deal with them. Prevention centers on preparation, and preparation in large part hinges on having proper policies and