Reduce Your Risk of a Refractive Surgery Claim
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2008
The refractive surgery claims study featured in this Digest points to actions ophthalmologists can take to improve the safety of these procedures and reduce the likelihood of a malpractice claim. Document any actions you take in the patient’s medical record.
Q OMIC’s refractive surgery underwriting requirements state that the “surgeon must perform and document an independent evaluation of the patient’s eligibility for surgery, including performing a slit lamp exam and reviewing topography, pachymetry, pupil size, and discuss monovision option for presbyopic patients” and “personally obtain informed consent.” Is OMIC opposed to comanagement?
A No, but we have learned from our claims experience that comanaged care has risks that must be reduced. experts for the plaintiff regularly scrutinize how much care is delegated to non-ophthalmologists, whether such delegated care is properly supervised, and if the patient freely consented to the arrangement. We recommend that you develop and implement written protocols for comanagement (see “Comanagement of Ophthalmic Patients” at http://www.omic.com). Clarify in the protocol the role of the surgeon in preoperative and postoperative care and consent. Release the patient to the care of the non-surgeon only when deemed stable, and especially continue to see the patient if there have been complications. Request that comanagers send you reports on all visits, and review, date, and sign the reports before they are filed in the medical record. OMIC’s position on the role of the surgeon reflects that of the American Academy of Ophthalmology (AAO) and the American society of Cataract and Refractive surgery (ASCRS). In joint clinical statements, these organizations have clarified that the “ultimate responsibility for obtaining accurate preoperative assessment and the patient’s informed consent to refractive surgery rests with the ophthalmologist who performs the surgery.”[1] Referencing case law, Medicare regulations, actions by the Office of the inspector General, and ethical standards, their analysis notes that the law imposes duties on surgeons who do not provide the postoperative care. Ophthalmologists who do not meet this obligation could be accused of patient abandonment and risk “liability for patient injury, including injury resulting from the acts or omissions of others to whom the provision of postoperative care is inappropriately delegated, or for inadequate patient informed consent, or both.”[2]
Q What has OMIC learned that can help me improve the quality of my preoperative care?
A Patients who present to ophthalmologists have often already decided that they want refractive surgery, and know that they have myopia, hyperopia, and astigmatism, the conditions refractive surgery is designed to treat. Rather than focusing on indications for surgery, therefore, the preoperative assessment aims to ensure that the patient is a good candidate and to fully advise him or her of the expected risks, benefits, and alternatives. First, avoid if possible meeting the patient for the first time on the day of surgery. If you cannot avoid this, obtain and review the patient’s medical record, especially the topography, before the day of surgery. Send the patient a copy of the consent form to review, and ensure that the consent is not signed until after you conduct the informed consent discussion.
During the preoperative evaluation, rule out ocular and medical contraindications to refractive surgery, initially and before each retreatment. In particular, ensure that there are no topographical or clinical signs of forme fruste keratoconus or ectasia. Assess and disclose the impact of ocular and/or medical comorbidities that are not absolute contraindications but that may influence the visual outcome (e.g., glaucoma, diabetes, stable autoimmune disease, dry eyes). Verify refractive stability and the cause of decreased visual acuity (i.e., regression vs. ectasia), especially before performing repeat surgery. Ask the patient to help identify work and leisure activities that could be impacted by the refractive outcome, such as night driving, piloting a plane, working as an accountant, and knitting. Consider providing the patient with the new AAO guide “Is LASIK for Me?” available at www.aao.org. Ascertain the patient’s goal for surgery and ability to handle disappointment (“how will you feel if you still need to wear glasses at work after surgery?”).
Q What actions should I consider at the surgery center?
A Verify that equipment is regularly maintained, and check for proper functioning of equipment before procedures. Implement the recommendations of the AAO Prevention of Medical Error Task Force so that the correct patient, procedure, eye, and laser settings are assured. If there is a flap complication, refund the patient’s fees and stay in regular phone contact while the cornea heals.
1. AAO/ASCRS Clinical Statement. “Appropriate Management of the Refractive Surgery Patient” (Issued August 2004, Revised January 2008). Available at www.aao.org.
2. AAO/ASCRS Clinical Statement. “Ophthalmic Postoperative Care (OPC)” February 2000. Available at www.aao.org.
Botox and Filler Recommendations
Cosmetic botulinum toxin and/or filler injections are frequently administered in ophthalmology practices. Sometimes, ophthalmologists are asked to provide them at a spa or “botulinum toxin and/or filler party” at a private home. The recommendations in Botox and Fillers are designed to promote patient safety and reduce the physician’s liability exposure.
Warn Patients about Side Effects of Dilating Drops
Anne M. Menke, RN, PhD OMIC Risk Manager
Dilating drops are used on countless patients daily during diagnostic examinations and surgical procedures. They are essential in order to obtain an adequate view of the retina and fundus. Indeed, failure to perform a thorough examination of the eye could lead to significant patient harm such as delay in diagnosis or failure to diagnose, as well as surgical complications due to poor visibility. However necessary, drops have also precipitated lawsuits, as discussed in this issue’s Closed Claim Study. These claims are usually based upon the ophthalmologist’s failure to warn of the risks of ambulating and driving following the insertion of dilating drops. While the Closed Claim Study discussed fall prevention, this article will focus on driving issues.
Q Do I need to obtain the patient’s informed consent before administering dilating drops?
A Having been taught that informed consent is not required for simple procedures whose risks are commonly considered to be remote—drawing a blood sample or taking a chest x-ray are the usual examples—an ophthalmologist might conclude that dilating drops fall into this category. It is important to remember, however, that the legal doctrine of informed consent is based not upon what an ophthalmologist feels should be disclosed but rather upon what a “reasonable person” would want to know prior to undergoing a procedure or taking a new medication. A quick review of the ocular and systemic side effects might lead this hypothetical reasonable person to feel informed consent is needed. Dilating drops cause vision to be blurred for a period of 4 to 8 hours and induce photophobia, lack of accommodation, glare, and decreased contrast threshold and high-contrast visual acuity. For elderly patients whose vision and mobility are already compromised, these visual changes can be dangerous. Dilating drops can also provoke allergic reactions, angle closure attacks, and systemic reactions such as increased blood pressure, arrhythmias, tachycardia, dizziness, and increased sweating. A jury might reasonably conclude that informed consent should be obtained.
Q What specifically do I need to tell the patient? Can I delegate this duty to my staff who administer the drops?
A The patient needs to understand that the drops will cause blurry vision for 4 to 8 hours, and that he or she should wear sunglasses and avoid driving and operating machinery until the effects wear off. Staff may be assigned the task of warning patients and offering sunglasses.
Q Do I need to have the patient sign a consent form?
A Not necessarily. Document the offer of sunglasses (or reminder to wear them) and the warning about side effects, especially the possible impact on walking, driving, and operating machinery. It is helpful to advise new patients as they are making their appointment that their eyes will be dilated. The first time patients’ eyes are dilated, ask them to sign a form acknowledging that they have been apprised of the risks (see OMIC’s sample consent form at www.omic.com).
Q Do my staff members need to warn the patient each time?
A Yes. To remind them to do so and to expedite the documentation process, you may want to use a chart stamp (see sample following this article and under risk management recommendations for dilating drops at www.omic.com). Consider placing a sign in your waiting room reminding patients whose eyes are dilated not to drive, to wear sunglasses, and to let the staff know if they need assistance walking while their eyes are dilated.
Q Some of my patients feel safe driving home, even right after their appointment. Others tell me that no one is available to drive them to the office for their regular retina appoint- ments. Should I refuse to dilate the eye if a patient insists on driving?
A Not necessarily. Use your medical judgment, taking into consideration such factors as the patient’s pre-dilation visual acuity and driving ability, driving conditions, the reason for the patient’s visit, and how urgently you need to diagnose and/or treat the presenting condition. Involve the patient in the decision-making process and document the discussion. Patients who need to be dilated but will be driving themselves can be offered morning appointments and encouraged to stay in the waiting room until the effects of the drops have worn off. If in doubt, err on the side of patient safety. In general, lawsuits against physicians have been dismissed if the physician warned the patient and documented the warning.
Identify and Manage Preoperative Causes of Wrong IOL Placement
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Summer 2008
Every ophthalmologist has heard stories of the wrong eye being enucleated or the wrong procedure being performed. the Joint Commission’s Universal Protocol (UP)—preoperative verification, site marking, and time-out— was developed to prevent such cases. While the UP is capable of catching 85% of “wrong” errors in ophthalmic procedures performed in hospitals and surgery centers, it does not address the cause of wrong IOLs, the most frequent type of surgical confusion in ophthalmology.[1] As John Simon’s study shows, 25% of IOL mistakes originate in the physician’s office.
Q When I examined my cataract surgery patient at his first postoperative visit, his refractive outcome (+3 D) was not what I had expected. I reviewed the medical record and discovered that I had implanted the wrong IOL. I informed the patient of the error, apologized, offered to refund the cost of the procedure, and disclosed the treatment options. What else should I do?
B Your honest and compassionate discussion with the patient will go a long way to helping him through the postoperative period. studies show that in addition to a truthful account- ing and an apology, patients also want to know that you will take steps to protect others from the same outcome.[2] One method proposed by patient safety experts is to inform your patient that you will conduct an event analysis that exposes not only the error that occurred in this instance, but potential mistakes in the sequence of care that could culminate in choosing or implanting the wrong IOL in another patient.
Q I already know what happened! My new technician made a mistake during the A scan. Should I fire her?
A While firing an employee involved in an error that harmed a patient is an understandable initial reaction, it does not address your role in training her, may send your staff the wrong message, and could lead to the loss of your best ally in preventing future errors. Your technician no doubt feels as badly as you do about this outcome. Rather than allowing her to shoulder the entire blame and punishing her, you can show staff that you take ultimate responsibility for the care provided in your office, as well as for hiring, training, and supervising them. Indeed, you can show them how to use mistakes as a learning opportunity. Call a meeting and explain that wrong IOLs are the most frequent type of error and cause of malpractice claims in cataract surgery. Ask for their assistance in reviewing office practices. Ask the technician to be part of the effort to analyze the event. Invite her to tell her story, and then explain how you dealt with the patient. You and your technician will thus demonstrate your commitment to the patient, the staff, and to improving the quality of your care.
Q What are the next steps in the event analysis?
A Ask your staff to map out the entire office-based sequence of events involved in choosing and ordering an IOL. You might want to have two teams, one that focuses on the clinical process (A scan and choice of IOL) and one that studies the administrative sequence of events (transferring the physician’s order to the ASC or hospital, informed consent, etc.). Experts suggest establishing two timelines: one for how the process is actually done and one for how it should be done.[3] Once the team is sure that all of the steps are noted, it brainstorms on how this part of the sequence can go wrong, thus beginning the “hazard analysis” part of the review, which also includes determining the effect, severity (impact on the patient), probability, and detectability of the “failure.” The hazard analysis helps the team determine which errors in care constitute critical failures and these become the focus of your efforts to design a safer process.
Q Has anyone analyzed “wrong IOLs” this way?
A I have not seen a formal failure mode and effects analysis, but there are several studies of wrong IOLs. Dr. Simon’s article on surgical confusion cited earlier explains some common causes, and the AAO/ASORN and American Association of Eye and Ear Hospitals have identified ways to prevent wrong IOL. In addition to ensuring adequate training of personnel and calibration of equipment, the AAO/ASORN/ASEEH report suggests that you instruct your staff to test both eyes and then compare the results of each eye to itself and to the other eye (in the same eye, the difference between the two scans should be ≤ 0.2mm, while between eyes it should not exceed 0.3mm unless the patient is known to have anisometropia).[4] Verify the results of the IOL Calculation Report and the formula used to pick the IOL yourself, and take a copy to the OR. Assign two staff members to compare the results to the preop orders sent to the ASC.
Wavefront Addendum
SAVE THIS FORM TO YOUR COMPUTER BY USING THE DOWNLOAD BUTTON. A PREVIEW IS DISPLAYED BELOW.
PLACE LETTERHEAD HERE AND REMOVE NOTE.
CHANGE FONT SIZE FOR LARGE PRINT
NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
Version 02/08/05
(Courtesy of David A. Wallace, MD, a practicing ophthalmologist in Santa Monica, CA.)
Addendum or Insertion:
“Wavefront”-Guided Laser Vision Correction Surgery
Indications and Alternatives
“Standard” or “conventional” laser vision correction surgery refers to correction of spherical (near- or farsightedness) and cylindrical (astigmatic) refractive errors of the eye. Such treatment is rendered based upon measurements of the refraction, using lenses combined within an instrument called a phoropter.
“Wavefront”-guided treatment is based upon an imaging system called wavefront (aberrometer) measurement of the whole eye. In August of 2002, Alcon/Autonomous received FDA approval for use of its laser system (the LADARVision laser) in performing “Custom Cornea” treatments, guided by aberrometer (LADARWave) measurements; in June, 2004, the approval criteria were expanded. In May of 2003, Visx received similar approval for its “CustomVue” treatments using their WaveScan aberrometer and S4 laser, with approval for hyperopia with astigmatism in December, 2004.
Wavefront measurement is relatively new to the eye care profession, having evolved around imaging and manufacturing applications in the fields of astronomy, aerospace engineering, and photography. Wavefront measurement is able to detect subtle imperfections in an optical system that contribute to imperfect focus of an image. “Sphere” and “cylinder” are referred to as “low-order aberrations,” while other optical factors comprise the “higher-order aberrations.” Higher-order aberrations include spherical aberration, coma, trefoil, and others. Most people are not at all familiar with these terms. Unfortunately, it is not easy to graphically or pictorially represent the influence that higher-order aberrations have on human vision.
It is recognized that a minority of patients treated with conventional laser treatment describe some visual difficulties after their treatment, including glare, haloes around lights, diminished comfort at night, and ghosting of images (among other things). Data presented to the FDA suggests that a significant amount of these adverse visual consequences may be reduced by wavefront-guided treatment. The data also suggest that with wavefront-guided treatment a higher percentage of patients achieve better visual acuity, and a lower percentage have complaints, even in reduced illumination. The research was performed in very tightly-controlled circumstances on a relatively small number of patients (several hundred) by a small group of surgeons (less than 10). These results have not yet been reproduced or confirmed in large-scale studies on thousands of patients treated by larger numbers of surgeons in diverse settings more typical of the public domain.
Candidates for Wavefront-Guided Vision Correction
At present, the range of prescriptions treatable by wavefront-guided systems is narrower than the range of treatments approved for conventional treatment. Alcon’s LADARVision system is approved only for nearsightedness up to -8.00 diopters sphere, with -0.50D to -4.00D of astigmatism. The Visx Star S4 & WaveScan WaveFront System is approved for up to -6.00 D of myopia, with or without astigmatism up to -3.0 diopters, and for hyperopia with or without astigmatism up to +3.00D MRSE, with cylinder up to +2.00D.
Possible Advantages and Benefits of Wavefront-Guided Vision Correction
The advantages of wavefront-guided treatment may include:
• A higher percentage of patients are reported to achieve better visual acuity (“20/20” and “20/15”) after wavefront ablation treatment than with conventional therapy. There is no guarantee that you will achieve these results.
• A lower percentage of patients report glare, halo, or discomfort with night vision after treatment.
• The process eliminates some of the subjective component of the refraction measurement process (the “Which is better, one or two?” part).
Possible Disadvantages and Risks of Wavefront-Guided Laser Vision Correction
There are some potential disadvantages to wavefront-guided treatment. These include (but are not limited to):
• Wavefront-guided treatment removes more tissue (typically 18 – 30% more) than conventional treatment.
• Currently, it is only possible to treat for “full distance correction” as a target, so it is not appropriate for those desiring monovision.
• Wavefront treatment is currently more expensive than conventional treatment, and the supposed benefit is intangible, as it cannot always be measured.
• Wavefront measurements of the eye, like refraction measurements, can fluctuate somewhat from hour to hour, day to day, or week to week.
Wavefront or Conventional Treatment?
As with any elective surgery decision, you are well-advised to make your decision based upon multiple factors. Speak to your surgeon; do your research; consult the websites of the laser manufacturers and the FDA; and satisfy your own curiosity before making a determination.
Patient’s Statement of Acceptance and Understanding
I have read and understand the above information about wavefront-guided vision correction surgery and wish to have this type of vision correction surgery on my _____ (indicate right or left) eye.
____________________________ __________________
Patient signature Date
____________________________ __________________
Witness signature Date
Revised 2/2005
