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.
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.
Coverage for Use of Premium IOLs
By Kimberly Wittchow
OMIC Legal Counsel
Digest, Winter 2009
While use of premium intraocular lens implants (IOLs) does not directly impact your policy coverage with OMIC, you should be aware of the policy provisions and underwriting requirements related to the use of IOLs and how they might vary for premium IOLs. There are two scenarios in which premium IOLs might be employed. The first is refractive lens exchange (RLE) surgery and the second is cataract surgery.
Refractive Lens Exchange
OMIC uses the term refractive lens exchange for refractive surgery in which IOLs (premium or otherwise) are used to replace a patient’s natural lens in order to improve vision when visually significant cataracts are not present. All refractive surgery is excluded under the policy unless specifically added back on by endorsement.
If you seek coverage for refractive lens exchange, you must fill out a supplemental questionnaire and submit it to the underwriting Department for review. In applying, you agree to abide by OMIC’s general refractive surgery and specific RLE requirements.
If approved, an endorsement will be placed on your policy, adding coverage back for this procedure at full policy limits. (No additional premium is required.) This endorsement specifies that RLE is covered, but only when performed within OMIC’s underwriting requirements or any exceptions to the requirements granted in writing by OMIC. If you seek an exception to the requirements, you may do so in writing to your underwriter by completing the Exception Request Form. OMIC discourages exceptions except in extenuating circumstances and only grants exceptions on a patient- specific basis. Do not schedule surgery until your exception is granted.
RLE Underwriting Requirements
To see all of the refractive surgery and RLE-specific underwriting requirements, see the Guide to Refractive Surgery Requirements. These requirements, along with the RLE supplemental application, address patient selection criteria, informed consent, operative procedures, postoperative care, and advertising.
One specific requirement to note is that RLE must take place in a hospital or outpatient surgical facility approved for cataract surgery and full sterile technique must be followed. RLE may not be performed in a physician’s office, laser refractive center, or other facility that does not meet the standard for sterile conditions required for accreditation.
Other requirements specific to RLE are: (1) there must be an interval of at least a week between primary procedures, (2) all patients must undergo a retinal exam pre- and postoperatively and be advised of the increased risk of retinal detachment, and (3) patient selection guidelines for myopia and hyperopia (treatment of emmetropic patients is not covered) must be followed (see box).
The use of premium versus standard IOLs in RLE procedures does not make a difference as far as coverage is concerned, as long as, in using them, no underwriting requirements are violated. You are, though, required to address the specific IOL to be used in the informed consent process and explain its indications, risks, benefits, alternatives, and complications, as well as its off-label use for RLE.
Cataract Surgery
If the patient has selected the use of premium IOLs in cataract treatment, no special underwriting is required. Remember that a procedure is considered refractive surgery if the lens is completely clear or there are visible cataract changes that aren’t visually significant and not associated with patient complaints about vision. Cataract surgery is automatically covered under the policy (under surgery class 3). As long as the use of premium IOLs is within OMIC’s general policy requirements, no endorsement is required.
You should also note that the policy excludes coverage of clinical research or trials that are not conducted under and in accordance with an American IRB-approved protocol. Make sure that any premium IOL clinical trials you are involved in meet these standards in order to ensure coverage under your OMIC policy.
RLE UNDERWRITING REQUIREMENTS
Myopia. Patients must be presbyopic, age 40 or older, and have at least 6 diopters and not more than 15 diopters of myopia.
Hyperopia. Axial length must be at least 20 mm, and uncorrected visual acuity must be 20/40 or worse. Patients age 40 and older must be presbyopic and have at least 1 diopter and not more than 15 diopters of hyperopia. Patients under age 40 must have at least 4 diopters and not more than 15 diopters of hyperopia.
Charges of Abandonment by Noncompliant Patient
Digest, Spring, 1992
ALLEGATION Insured ophthalmologist was charged with abandonment by a patient after terminating care due to poor compliance with treatment.
DISPOSITION Insured wrote off the patient’s bill. No payment was made by the insurance carrier (OMIC).
Background
One of the most difficult things a physician sometimes must do is to terminate the doctor/patient relationship. The decision to terminate a relationship is not only an emotional one but can have medical and legal ramifications as well.
Case Summary
The patient was a 30-year-old female who underwent a radial keratotomy of the left eye by another physician. Postoperatively, the eye resulted in a marked overcorrection with a hyperopia in excess of +12. The patient did not want to wear glasses or contact lenses to correct the problem and was referred to the OMIC insured for evaluation. To help correct the problem, the insured performed a procedure whereby he sutured the radial keratotomy incisions to help stabilize the wound. A detailed informed consent was obtained. Although there was noted improvement in the visual acuity, the patient continued to complain of monocular diplopia, fluctuating vision and photophobia. However, the patient failed to keep several post-op appointments despite letters and telephone calls from the insured stressing the need for follow-up. She was also noncompliant about taking prescribed medication.
The patient elected to see a corneal specialist and the insured transferred the medical record to the specialist and advised the patient that he wished to discontinue serving as her ophthalmologist. The patient threatened legal action if the insured stopped seeing her.
Outcome
The OMIC insured wrote off her bill and the patient did not take legal action. OMIC closed the claim without making any payment. The insured ophthalmologist did several things that were instrumental in minimizing the chance of a lawsuit. First, he discussed the procedure and all possible risks, complications and alternative treatments available to the patient. He obtained a detailed consent form and made no guarantees as to the outcome of the surgery. After the procedure, the insured thoroughly documented in the chart when the patient failed to comply with treatment and followed up with several letters expressing concern and disappointment that she had not kept her appointments. The insured also communicated the need for follow up so that the medications could be adjusted and the cornea monitored for continued healing, and he mentioned the adverse consequences of continued noncompliance. Furthermore, the insured wrote to the patient to advise that he was discontinuing his service as her ophthalmologist and to suggest that she select an ophthalmologist who could continue to care for her. Finally, he wrote off the remainder of the patient’s bill without suggesting there was any improper care or liability.
Risk Management Principles and Commentary
Although there is no guarantee that every ophthalmologist who terminates the doctor/patient relationship will have the same result as this insured, there are some guidelines to follow which may protect one against a claim of abandonment.
- Discuss the procedure with the patient thoroughly and document the risks, complications and alternative methods of treatment;
- Document in detail the patient’s noncompliance with treatment and failure to keep follow-up appointments;
- Write or telephone the patient communicating your concern and the consequences of noncompliance and document that communication;
- Suggest that the patient obtain a second opinion;
- Write to the patient noting the reasons why you are terminating the relationship and recommending that the patient obtain another ophthalmologist for continued care.
A note of caution: In this situation, the patient had already sought the care of a corneal specialist and had requested the ophthalmologist forward the medical records to the specialist. Also, the patient’s condition was not critical. Terminating the relationship did not carry any risk to the patient, which may not be the case in other situations. However, in the absence of a critical condition requiring continued medical attention, terminating a doctor-patient relationship may become necessary in some instances.
