Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

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procedures in place to anticipate and avoid those problems that by their nature can be avoided. Whether the issue is as complex as careful preplanning for difficult surgical cases or as simple as checking the preoperative test results to avoid missing out-of- control diabetes, time and effort spent in this fashion always pays a large dividend. Ophthalmologists who have ever been forced to deal with a claim or suit or even the threat of one will confirm this without hesitation. There is an old adage that “Judgment comes from experience and experience comes from bad judgment.” Risk management is simply a way of getting the experience needed for good judgment by learning from the bad judgment and misfortunes of others rather than having to make all the mistakes for yourself. No pain, all gain—now that is the way to go.

Subconjunctival injections of gentamycin and cefazolin were given, as well as corticosteroids. The patient was seen on postoperative day 1 and was comfortable. The graft was clear and the wound intact, with normal intraocular pressure and vision of 20/200. An appointment was made for the following week, and she was instructed to call the office if there were any signs of increased pain, visual loss, redness, or any other untoward situation.

The next morning the patient called and reported that her eye was more uncomfortable and she felt her vision was not as good. She was seen that morning, approximately 48 hours after the corneal transplant, at which time the wound was secure, the cornea slightly hazy, with many cells in the anterior chamber and a 3+ flare. These findings at this postoperative period are indicative of possible endophthalmitis, and she was referred to the retina service for evaluation and care.

Subsequently, the retina specialist saw the patient that day and diagnosed bacterial endophthalmitis. She was admitted to the hospital and treated for this surgical complication. Unfortunately, the organism recovered was a streptococcal bacterium and the patient did poorly. The final visual acuity in the operated eye was hand motions, despite intensive appropriate care by the retina specialist for bacterial endophthalmitis. The patient sued the corneal surgeon for the surgical complication and poor outcome. As the patient could not obtain an expert witness to testify that there had been malpractice on the part of the corneal surgeon, the suit was dropped.

Comments

There were several reasons that the suit could not be carried forward, which exemplify the appropriate postoperative care for a patient with a corneal transplantation:

1.The patient had been told to call the office at the first sign of any untoward situation, such as increased pain, loss of vision, ocular discharge, or increased redness.

2.The patient was appropriately seen the same morning that she called. It is important for surgeons to instruct the office personnel answering the telephone that patients who have had a corneal transplant be seen immediately, soon after surgery. These patients may be subject to elevated pressure, endophthalmitis, intraocular hemorrhage, or other complications within the first few days of surgery and therefore must be considered emergency patients. The office personnel answering the telephone must know to ask the specific question about whether the patient has had recent surgery.

3.The corneal transplant patient with endophthalmitis was seen promptly when she called and then appropriately referred to an ophthalmologist who specialized in the treatment of endophthalmitis. In some centers, the anterior segment surgeon treats endophthalmitis, but in others this is left to the vitreoretinal specialists. In areas where vitreoretinal specialists are not readily available, the ophthalmologist

who is suspicious of endophthalmitis should initiate treatment if the patient cannot be seen that day by a vitreoretinal specialist.

There are three important lessons to be learned from this patient with endophthalmitis. First, appropriate postoperative instructions must be given to the patient to call at the first sign of something unusual occurring. Second, instructions must also be given to the office personnel to make sure that, upon answering the telephone, the patient is seen as an emergency and not delayed for a day or several days for the convenience of the ophthalmologist. Finally, appropriate referral to the proper physician who is able to see the patient and treat the endophthalmitis as an emergency must be available for the patient. Documentation by the ophthalmologist is imperative throughout these steps. In the case of this patient, the poor visual outcome was unavoidable, as the infection was due to a streptococcal organism. The standard of care was observed, although the outcome was very unsatisfying.

There are other emergent situations that can occur with a patient who has had a corneal transplant. One is a call from a patient, even weeks, months, or years after the surgery, concerning decreased vision. These patients may be subject to graft rejection and also must be considered as emergency patients. They must be seen within the next 24 hours to initiate therapy if this is graft rejection or to reassure the patient that it is not graft rejection.

Another emergent situation is the patient who has had a herpes simplex virus infection. The answering service or the personnel who answer the phone during the day must ask the patient who calls with a complaint if he or she is a herpes simplex virus patient as well. Patients who call with a nonspecific red eye may have their examination delayed if it is merely a conjunctivitis, but if there is a history of herpes the patient must be seen immediately to rule out a new outbreak of dendritic keratitis or stromal keratitis.

Case 2

Suture Removal

A patient who had a corneal transplant 1 year prior was seen by another ophthalmologist (not the corneal surgeon) for a foreign body sensation in the grafted left eye. Sutures were still in place, and the vision was 20/40− in the right eye and 20/30− in the operated left eye. The cornea was clear, but there was some pooling of fluorescein indicating a flat area inferiorly. Computed tomography (CT) was not performed. The sutures were buried and intact. Three sutures inferiorly were removed to alleviate the foreign body sensation from what was thought to be a dellen effect. The knot of the 5:00 o’clock suture was resistant, and, after cutting the suture and removing it with a jeweler’s forceps, a small 2:00 o’clock wound dehiscence of the graft host interface occurred. There was no aqueous leakage with the Seidel test. Five days later the vision

had dropped to counting fingers at 3 feet, and there was 10D astigmatism present, which had not been present prior to suture removal.

The ophthalmologist had informed the patient of the need for suture removal to hopefully alleviate the foreign body sensation. The physician did not get written consent for this procedure, nor was there a note on the chart indicating a risk/benefit discussion for suture removal. There was no documented discussion of alternate treatment. Although the vision could be improved with a contact lens, the patient was very unhappy with the visual result and a lawsuit ensued.

Comments

This patient, who presented with foreign body sensation after corneal transplantation, had had excellent vision, with a clear cornea. Although the sutures were intact, the treating ophthalmologist felt that a dellen effect inferiorly might be the cause of the foreign body sensation. Generally speaking, corneal surgeons do not obtain written consent for suture removal after corneal transplantation, but because the ophthalmologist treating the patient was not the corneal surgeon, it would have been wise to obtain a written consent for this procedure. Lacking a written consent, documented discussion of the risk/benefit relationship of removing the sutures would be appropriate. Generally speaking, where vision is excellent after corneal transplantation, it is not wise to remove three adjacent sutures, as this may cause significant astigmatism. In this case, with the small wound dehiscence, although Seidel negative, the wound dehiscence and suture removal were responsible for the development of a significant amount of astigmatism. The standard of care would require a physician to discuss with the patient the possibility that suture removal could cause increased astigmatism, although the main reason to remove sutures is to eliminate astigmatism.

The lesson here is that if one is not the corneal surgeon, it is preferable to use alternative means to treat a foreign body sensation short of suture removal unless the suture is loose or exposed. Three adjacent sutures should not be removed with excellent vision. Discussion of the risk/benefit relationship for removing these sutures should have been documented.

Case 3

Choroidal Hemorrhage After Surgery

A 75-year-old patient with a history of Fuchs’ dystrophy and previous cataract extraction with an anterior chamber lens implant was scheduled for corneal transplantation and intraocular lens exchange in the left eye because of corneal edema. The patient’s vision had been decreasing in the eye to be grafted and also was

significantly reduced in the right eye. An anterior vitrectomy was performed in preparation for a sutured posterior chamber lens. During surgery the patient suffered an expulsive choroidal hemorrhage, and an evisceration had to be done. The patient claimed that the surgeon had not informed him before the procedure that bleeding and hemorrhaging were additional risks of the procedure, even though he had told the physician he had an artificial heart valve and was taking Coumadin for a heart condition. The informed consent form, however, did include the possibility of infection, hemorrhage, and loss of vision as potential complications with this operation.

The question arose as to whether this patient on Coumadin had an increased risk of choroidal hemorrhage or whether the age of the patient and the complicated nature of the surgery (corneal transplantation, intraocular lens exchange, and anterior vitrectomy) were the causes of the hemorrhage. One concern was the fact that a discussion between the surgeon and the patient relating to the increased risk of continued bleeding with patients on Coumadin was not explicitly documented on the chart, nor was there any documentation that a conversation had taken place between the surgeon and the patient’s cardiologist, although such an encounter had occurred. The surgeon felt that the surgery could be performed safely with the patient on Coumadin and, additionally, that taking the patient off Coumadin represented an increased and unwarranted cardiac risk.

One potential expert witness for the defense felt that replacing the anterior intraocular lens with a posterior sutured intraocular lens prolonged the surgery and therefore increased the risk of a suprachoroidal hemorrhage, although he concurred that this was the appropriate surgery for this case. Coumadin did not increase the risk but would make controlling a hemorrhage more problematic. A documented discussion would have been helpful for the surgeon, but, despite this, the case was dismissed for cause.

In two other corneal transplant surgeries, intraoperative and postoperative bleeding relating to suprachoroidal hemorrhages were the reasons the patients initiated litigation. Although these hemorrhages are rare, they do occur, particularly in long procedures such as penetrating keratoplasty, where the eye is open for an extended period of time.

In one case, nausea and vomiting occurred after the corneal transplant, and the patient alleged she was not handled appropriately. There was no postoperative visit on day 1, but the patient was seen on the second day after surgery. The standard of care is generally a 24-hour visit after a penetrating keratoplasty. Even if that visit had occurred, in the case of a postoperative suprachoroidal hemorrhage, most surgeons would not have intervened surgically for at least several more days unless the intraocular pressure was significantly elevated. When the patient was seen on the second postoperative day and the choroidal hemorrhage recognized, observation only was indicated, which was the appropriate treatment, considering that the pressure was not elevated.

In another case related to a suprachoroidal hemorrhage, while under general anesthesia during a corneal transplant procedure, the patient’s entire body spasmed as if awakening. This occurred after only 2 of 16 sutures had been placed in the donor button, causing expulsion of the intraocular contents coincidental with a choroidal hemorrhage. Unfortunately, the anesthesia chart did not mention the patient awakening or lightening.

The surgeon’s operative report, however, references the complication, a suprachoroidal hemorrhage, but does not indicate that this resulted from the patient awakening during the general anesthesia administered for the corneal transplant.

This intraoperative incident should have been mentioned in the anesthesia record and would have made it easier for the corneal surgeon to be dismissed from the case or be subject to minor liability. It is very important for surgeons who, in many cases, work under general anesthesia to make sure that the anesthetist intubates the patient and keeps the patient under deep enough anesthesia to complete the corneal transplant. The anesthetist in this case was responsible for the surgical complication.

Eye Banks and Litigation

There has been at least one major lawsuit involving an eye bank donation of corneal tissue. The eye bank had removed the tissue without obtaining the family’s consent. To make matters worse, the family had consented to an autopsy but had particularly mentioned not to remove the eyes. A corneal surgeon in another state had received one of the corneas and had performed a corneal transplant. He was sued, along with the eye bank, but was eventually dropped from the suit when it was realized that it was the eye bank’s responsibility to obtain permission for use of the corneas and not the responsibility of the corneal transplant surgeon.

Several other suits along these lines have been initiated, but the ophthalmic surgeon generally has been released. With over 1 million corneal transplants having been performed in the United States over the past 40 years, these suits are extremely rare, and the corneal surgeon should not be concerned about being involved. The Eye Bank Association of America, which has very strict guidelines for corneal donations and consents, monitors eye banks very strictly and requires appropriate education and training for member eye banks in their efforts to obtain appropriate legal consent.

The Emergency Room and Litigation

The emergency room is a prime area for the genesis of lawsuits. Generally, ophthalmologists do not like to be called out of their busy offices or homes to see patients in the emergency room. Therefore, they often prescribe over the telephone. In addition, patients with ocular inflammation, decrease in vision, and pain frequently present themselves to the emergency room or accident ward first rather than being seen in the ophthalmologist’s office.

Telephone consults by ophthalmologists and treatment in emergency rooms by nonophthalmologists both have the potential to lead to faulty diagnosis and inaccurate treatment, producing unnecessary discomfort, pain, and possibly loss of vision. There are several specific areas of concern from emergency room care that are illustrated by lawsuits that have occurred in these situations.

Case 1

A patient called the insured ophthalmologist, complaining of irritation in the right eye. The ophthalmologist instructed the patient to go to the local emergency room, where she was seen with symptoms of conjunctival irritation, a small amount of purulent discharge, but a clear cornea. The pupil was slightly constricted. The emergency room physician called the ophthalmologist for consultation, and it was decided, over the phone, that since the cornea appeared to be clear, the patient had a corneal abrasion as opposed to a corneal ulcer. The patient was sent home with antibiotics, a prescription for pain medication, and a patched eye.

Later in the day, the patient’s mother phoned the ophthalmologist and reported that the pain medication prescribed in the emergency room had worn off and the patient could no longer tolerate the patch. The ophthalmologist prescribed Demerol, and the patient was told to make an appointment in the office the following day. At that examination, a corneal ulcer was diagnosed, and she was immediately referred to a corneal specialist and admitted to the hospital. Aggressive antibiotics were administered, but the Pseudomonas infection, which was diagnosed, led to severe central corneal scarring and ultimately resulted in a corneal transplant. Eventually, the patient did recover good vision after the corneal transplant, but a lawsuit ensued, resulting in a judgment against the ophthalmologist.

Comments

There are several facts that mitigate against the ophthalmologist. First, the emergency room physician, who was not an ophthalmologist, did not use a slit lamp in the examination. The ophthalmologist who sends a patient to be seen in an emergency room should make sure that the emergency room physician has access to a slit lamp and is familiar with slit-lamp examination. Just instilling fluorescein in the eye and using a Woods’ light, as is often done in smaller emergency rooms where a slit lamp is not available, is not appropriate for diagnosing ocular inflammation. The ophthalmologist who referred this patient to the emergency room should have known that and should have seen the patient himself or made sure the physician in the emergency room had access to the proper diagnostic materials.

When pain occurred later in the day, the ophthalmologist prescribed Demerol by phone. It is essential that any emergency room physician, intern, resident, or consulting ophthalmologist treating an emergency room patient be thorough and complete in her or his evaluation before ordering medication. In addition, the ophthalmologist should have seen the patient if pain had persisted. The eye patch that the emergency room physician had applied was contraindicated in this case of a bacterial ulcer.1

It is now clear that contact lens abrasions should never be patched as part of the treatment, even if antibiotics are used. Contact lens corneal abrasions are notorious for initiating Pseudomonas infection in the cornea. In this situation, when the patient was

seen on day 1, there was just a corneal abrasion from the contact lens and no sign of infection. Patching overnight, despite the use of erythromycin ointment, allowed the Pseudomonas organisms to multiply in a warm culture-like setting beneath the patch.

It is not the ophthalmologist who is usually to blame for patching these contact lens abrasions or any abrasion but rather the emergency room physician, who is not cognizant of the fact that abrasions should not be patched and should be treated with frequent antibiotics. These patients with contact lens abrasions should be seen the next day to make sure their abrasions have healed. The patients should be told that if the eye is worse, they should call back immediately.

Another aspect of infections related to contact lenses made headlines around the world in 2006. Up until that year, fungal corneal infections were generally very uncommon in contact lens users. Initially there was an outbreak of fungal corneal infections in Singapore, which then appeared in the United States.2,3 To have so many corneal infections (over 100) in a 1-year period was highly unusual. This outbreak of fungal keratitis has been traced to a contact lens solution manufactured by Bausch & Lomb—Renu with Moisture Lock. Not all of these infections were in patients who used the Bausch & Lomb solution, but a great majority of the infections were traced to patients who did use it. It is not clear why this particular commercial solution has been so prominent in fungal infections with contact lens use, but it is obvious that there is some process going on that allows fungal infection to occur despite the use of this supposedly antiinfective contact lens solution. No organisms have been found in it, but the ability of the solution to prevent fungal infections is obviously decreased. Numerous lawsuits are now underway, and these have been moved into class action suits because of the large numbers involved. The manufacturer rather than the ophthalmologist is the target of these suits.

A similar situation developed 25 years ago with the organism Acanthamoeba, when patients who cleaned their contact lenses with salt solution made with distilled water and salt tablets succumbed to an outbreak of an Acanthamoeba infection. There had never been corneal infections caused by Acanthamoeba before 1980. The use of distilled water to make salt solutions was found to be the culprit in these contact lens infections, as Acanthamoeba is ubiquitous in most water solutions, even distilled water. Certainly not all Acanthamoeba infections can be traced to distilled water and salt tablets, but a great majority of them were so traced, and when this practice was stopped the number of infections due to Acanthamoeba with contact lens use significantly diminished.

Case 2

A 22-year-old man was seen in the emergency room following an accident at work, during which a foreign body struck his right eye. A full-thickness corneoscleral laceration and small hyphema were seen during the slit-lamp evaluation. No foreign body was found in the anterior chamber, which was deep, and there was no sign of aqueous leakage. The patient was given topical antibiotics, a patch was applied, and