Cataract Surgery Interval
Ophthalmologists are at times asked by patients who live far from the hospital or surgery center, or those with significant medical co-morbidities, to perform cataract surgery on the same or consecutive days.
See OMIC’s risk management recommendation guide below.
Cataract Interval Recommendations
Debunking the Exploding Cataract: Why You Shouldn’t Sell Surgery
By Michael R. Redmond, MD
[Argus, March, 1992]
A patient presents to the ophthalmologist’s office with a cataract and 20/40 Snellen visual acuity. Visual acuity with medium glare is recorded as 20/100. Cataract surgery is performed and goes well, but the patient develops a retinal detachment soon after surgery. Complications ensue and the final visual acuity is light perception. The patient sues the cataract surgeon on the basis that the surgery was unnecessary in the first place.
A young father, himself postop twice for strabismus surgery, has his son in the pediatric ophthalmologist’s office for the child’s strabismus follow-up. Allegedly, the ophthalmologist initiates a discussion and tells the father that he, the father, needs additional strabismus surgery and that it can be done simply and without problems. Postoperative restrictions develop, corneal exposure with keratitis ensues and the father endures additional surgeries without total relief. He sues the ophthalmologist alleging, among other things, lack of informed consent.
Were the surgeries marketed too vigorously? Expectations set too high? Were the surgeries themselves trivialized, potential complications minimized or not even discussed? Were the patients “solicited” for surgery?
In today’s medical milieu, the ophthalmologist must avoid any hint of pressure on the patient or the family to undergo an elective procedure. Physicians are required to inform patients about the therapeutic (surgical) alternatives available and the urgency or elective nature of a procedure, but they must avoid “selling” their services. If a patient is pressured to undergo an elective procedure and a less than satisfactory result occurs, the patient is much more likely to become angry and initiate a malpractice action. Under these circumstances, the patient is unlikely to admit to recalling discussions of risks and alternatives, but will likely remember assurances, trivializations and encouragement to undergo surgery.
Documentation and informed consent are two cornerstones of risk prevention and management. An ophthalmologist can never do too much in these areas but can easily, all too often, do too little. Because what an ophthalmologist does every day may become routine, the multiple complaints the patient expresses (e.g., headlight glare, inability to read, people not knowing whether or not the strabismus patient is looking at them) are not always recorded adequately in the chart. If the records do not substantiate the ophthalmologist’s claims, a jury is likely to doubt his or her credibility and may begin to suspect a lapse not only in charting but also in professional judgment and/or ethics. The ophthalmologist should also record anything of importance, i.e., test results, consultations and family members present.
Informed consent must include an understanding between the patient and the physician, not simply discussion and signing a piece of paper. The proper relationship and rapport between patient and physician can thus be established.
Ethically, an ophthalmologist should never pressure or cajole a patient to have an elective procedure. Such pressure could turn into a malpractice liability. Communicate, document and inform but never “sell.” After all, cataracts really do not explode.
Clarification of Roles During the Informed Consent Process
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2005
Recently, OMIC revised its sample consent form for cataract surgery, partly in response to the new “multifocal IOLs” and partly to better prepare patients for the procedure and defend ophthalmologists against allegations of lack of informed consent. Soon after the form revision was announced in our E-Bulletin and the AAO Express, policyholders began calling with questions about the roles they, their office staff, and the ASC play in the informed consent process.
Q I just reviewed OMIC’s new cataract consent form. Do you really expect me to review all six pages with each of my patients?
A The short answer is no. A more complete response should help clarify the phases of the informed consent process and the roles played by various members of the health care team. As the surgeon, you have a legal duty to obtain the patient’s informed consent, which is best understood as an oral agreement you reach with the patient after the informed consent discussion. This face-to-face talk addresses the ophthalmic condition and the risks, benefits, and alternatives—including no treatment—of the proposed procedure. The discussion must always take place before the patient signs any consent form, while the patient is awake and aware, and free from the effects of any medication that could interfere with his or her ability to participate in the decision-making process. The form itself serves to document and verify that the informed consent discussion with you took place. Neither the form nor any video or teaching aids can substitute for the face-to-face talk with the surgeon.
Q Do I have to mention all known risks during my discussion?
A No. The standard discussion most ophthalmologists conduct is rarely as detailed as a procedure-specific consent document and usually consists of a summary of this information. You do, however, need to address any particular concerns of the patient as well as any condition that puts the patient at increased risk, and then write a brief note in the medical record. To help educate the patient and provide more details about the surgery, OMIC recommends that you give patients a copy of the procedure-specific consent form. Some practices ask the patient to read it before the preoperative meeting with the surgeon; others have a staff member go over it with the patient afterwards.
Q Can my staff members witness the patient’s signature even if they were not present during the discussion?
A Yes, since what is being witnessed is the patient’s signature. While they cannot obtain the patient’s informed consent, staff members play an invaluable role in patient education. As a risk management measure, staff members should ask patients what procedure will be done and why before asking them to sign the form. If the patient does not appear to understand, staff members should inform you so that you can discuss the procedure again and clear up any confusion or misunderstanding. Staff members can then document that you discussed the procedure again with the patient and that the patient appeared to understand and signed the consent.
Q Can I just use the consent form at the hospital or ambulatory surgery center (ASC)?
A No, since that form’s primary purpose is to document that the ASC or hospital has fulfilled its own, separate legal duties. The ASC or hospital cannot obtain the patient’s informed consent for the procedure you are performing; only the ophthalmologist can do that. Hospitals and ASCs must verify, however, that the surgeon obtained informed consent before allowing the procedure or surgery to take place. ASCs and hospitals also have a separate duty to obtain what is known as general consent for the care and treatment provided at their facility by their employees and other providers, e.g., the anesthetist. There is no discussion of specific risks or benefits of the ophthalmic procedure when obtaining this general consent. ASCs and hospitals often use a single form both to verify that the surgeon obtained informed consent and to obtain general consent for care rendered at their facility. The patient is usually given this form to sign by a facility employee during the registration or admission process. To protect themselves against allegations of lack of informed consent, therefore, ophthalmologists should have the patient sign the procedure-specific consent form in their office and place it in the patient’s medical record.
Endophthalmitis/TASS Investigation Protocol
Please see attached.
Delayed Diagnosis of Endophthalmitis Following Cataract Surgery
Digest, Winter, 1994
ALLEGATION Insured ophthalmologist allegedly delayed diagnosis of endophthalmitis following cataract surgery.
DISPOSITION Case was settled for $50,000.
Background
Claims against ophthalmologists frequently arise from cataract treatment. Improper performance of surgery is the most common allegation related to the treatment of cataracts followed by failure to recognize and treat a complication of surgery. Careful postoperative evaluation and documentation is crucial for successful defense of these claims.
Case Summary
The patient was an elderly male who presented to the insured’s office for decreased vision in the right eye. V.A. was 20/80 OD with correction. The patient was scheduled for a cataract extraction OD with insertion of a posterior chamber IOL. Surgery proceeded without complication although toward the end of the procedure the ophthalmologist noticed a rent in the inferior posterior capsule. Maxitrol and Pilocarpine drops were instilled.
The patient was doing well on the first day post-op. The record for this visit noted that the vitreous had moved forward to occupy 3/4 of the anterior chamber. The patient was continued on Maxitrol TID and scheduled for another visit in six days. There was no record of visual acuity or a fundus examination on this date. On the third day post-op, the patient called the insured’s office complaining of a very severe sharp pain in the right eye. No record was made of the call. The following day, the patient came to the office complaining of increased discomfort and decreased vision. V.A. was 20/200 OD. 2+ cells and a cloudy vitreous were noted. No fundus examination was documented. The patient was scheduled for another exam the next day by which time the cells had increased to 3+ and were described as being deposited on the posterior cornea. The insured documented a “faint red reflex.” No visual acuity or fundus examination was recorded. When the patient was seen on the sixth day, the record noted that a vitreous tap had been scheduled for the following day. But again, there was no description of an examination or findings to explain why the tap had been scheduled. The insured attempted the vitreous tap but was unable to aspirate despite trying several size needles. Findings in the record noted substantial membranes within the vitreous cavity.
Eight days after the initial surgery, the patient was referred to a retinal-vitreal specialist who diagnosed an endophthalmitis that already had created permanent and extensive damage to the retina.
A culture indicated a bacterial strain sensitive to multiple antibiotics. Although the retinal specialist was able to preserve the eye’s structure, the infection had caused functional loss of the retina. One year after the cataract surgery, the patient’s vision was count fingers at two feet OD.
Outcome
This case presented documentation issues that made it difficult to defend. The insured’s medical record was replete with questionably substandard examinations, inconsistencies and incomplete descriptions of findings. Notes were in the form of computer billing printouts and did not follow chronologically. The insured was criticized by defense experts for not doing a more thorough examination when he noticed the vitreous had moved to occupy 3/4 of the anterior chamber, and in the presence of cloudy vitreous and a “faint red reflex.” Furthermore, the ophthalmologist failed to record visual acuities and to explain why he decided to “proceed with vitreous tap.” When the vitreous tap was unsuccessful, the insured was criticized for not referring the patient immediately to a retinal specialist and for not administering a proper dose of antibiotics in the meantime. Another 24 hours elapsed before the patient was seen by the retinal specialist. Earlier intervention with antibiotic therapy may have saved the eye.
Risk Management Principlesand Commentary
When a claim arises related to a post-op complication, the experts reviewing the case have only the patient’s record to assist them in evaluating whether treatment of the patient was reasonable. An ophthalmologist often will be given the benefit of the doubt by a reviewer if there has been documentation of the reasoning behind certain judgments at critical decision points. Careful documentation alone may not be enough to overcome claims of a delayed diagnosis; however, patently inadequate documentation is likely to raise doubts about whether the treatment met the applicable standard of care.
