Browsing articles from "November, 2012"

Maintaining an Effective Informed Consent Process

Anne M. Menke, RN, PhD, OMIC Risk Manager

Digest, Summer 2011

In nearly all PIOL claims we reviewed, ophthalmologists had lengthy informed consent discussions with patients and asked them to sign detailed procedurespecific forms before surgery; yet, patients alleged lack of informed consent. What happened? Almost inevitably, a breakdown in physician-patient communication occurred after surgery when patients experienced side effects or complications, or did not quickly achieve spectacle independence or the quality of vision they wanted— and for which they paid thousands of dollars out of their own pockets.

Q What information was missing from the initial informed consent discussion in the PIOL claims?

A Ophthalmologists can do a better job of identifying, evaluating, disclosing, and documenting the presence of systemic or ocular comorbidities that could impact the quality of the visual outcome: “As you know, you are a glaucoma suspect. My review of the visual field and OCT results show no signs of active disease, so I feel you are an appropriate candidate for a PIOL. You may be at increased risk, however, for optic nerve damage and vision loss if your intraocular pressure rises during or after surgery, or if you develop swelling and need to be on steroid eye drops for a prolonged period of time. Are you willing to go forward knowing you could have this problem?”

Eye surgeons can also educate patients about areas of clinical uncertainty: “Not all ophthalmologists agree that patients with a monofocal IOL in one eye are good candidates for a premium IOL in the other eye, so I want to talk to you about the drawbacks for you of implanting this type of IOL.”

Q Why do you recommend relating postoperative problems with the consent the patient signed before surgery?

A Although patients hear and read information about potential complications, they tend to emphasize the benefits, minimize the risks, and assume that these problems will not happen to them. When they face disappointing outcomes, some patients may fear that something they did caused it. Others may decide the surgeon was at fault, probably in agreeing to implant the premium IOL rather than insisting on a monofocal one, or in not preventing or better managing the complication. Ophthalmologists can help patients by “normalizing” the outcome: far from being a surprise, perioperative complications are expected in a certain number of cases, despite the best efforts of patients and surgeons alike, and that is why they are discussed before every surgery. When physicians listen to patients’ concerns with empathy rather than defensiveness, they promote emotional healing and strengthen the physician/patient relationship.

Q Should I discuss the extra charges as part of informed consent?

A Unmet expectations and confusion over what services were covered by the extra charges led to dissatisfaction in a number of cases. One patient called her ophthalmologist when she received a bill for toric IOLs from the ASC. Trying to be helpful, a staff member at the practice explained that the ASC orders and provides the IOL. Convinced that the ophthalmologist had double-billed her, she filed a claim alleging fraud (it was dismissed). ASCs already receive $105 for the IOL as part of the surgical fee, so a recent AAO Coding Bulletin on PIOLs advises them to collect the extra fee for the PIOL, both to clarify the billing process for the patient and to avoid the appearance of splitting fees with the surgeon.[1] Ophthalmologists may prevent billing surprises by providing patients with an itemized account of the professional services they will provide and clearly indicating whether the fee covers any additional surgery needed to optimize the quality and precision of the visual outcome. ASCs would be well-advised to provide details about their fees as well as part of the admission process.

Q At what point should I consider refunding the extra amount the patient has paid for a PIOL?

A Some patients may ask for a refund as soon as a problem arises, others may not bring it up at all. If you were not able to implant a PIOL, consider refunding the extra fee right away. If after doing everything you can to improve the refractive outcome and address any complications, the patient still is not satisfied, consider a refund then. Whether or not to offer a refund is a business decision and not an admission of liability. OMIC risk management staff are here to assist you. Call the confidential Hotline at (800) 562-6642, ext. 641.

1. Vicchrilli S. “Coding for Premium IOLs.” AAOE Coding Bulletin. American Association of Ophthalmic Executives, October 2011, www.aao.org.

Surgical Experience: Acquisition and Disclosure

Hotline, Surgery Issues // No Comments

Anne M. Menke, RN, PhD, OMIC Risk Manager

Digest, Spring 2012

Policyholders often call the OMIC Risk Management Hotline to discuss the risks associated with new techniques and technology. They wonder how much training is required and if and how they should talk to patients about their training and experience. The Closed Claim Study in this issue demonstrates that seeking such advice is prudent, as the physician’s level of expertise may become the focus of a malpractice lawsuit.

Q How much experience is needed in order to present oneself as qualified?

A There is no clear-cut answer, but the surgeon will be held to the standard of a reasonably prudent eye surgeon. While physicians are expected to be lifelong learners and continue to hone their skills, the acquisition of new knowledge and skills requires careful preparation. Certainly, any training required or recommended by an equipment manufacturer should be completed, as well as the review of pertinent peerreviewed literature. If the technique or technology is significantly different than that of the surgeon’s experience, additional formal training may well be needed, such as skill transfer classes or practice on cadaver or animal eyes, followed by observation of experienced surgeons and surgical assisting. Once the physician feels ready to treat patients, it would be prudent to ask a senior colleague to serve as proctor (this may even be required in order to obtain privileges at a hospital or ASC). The proctor, an impartial observer with documented training and experience in the skill in question, provides an objective evaluation and is able to attest that the surgeon has demonstrated competency. Finally, the ophthalmologist must feel that he or she is ready to perform the new skill.

Q I have been asked to proctor another ophthalmologist. Are there precautions I should take?

A Yes. First, ensure that you are licensed in the state where the proctoring will take place and have been granted privileges at the facility. Clarify with the credentialing department whether your role will be limited to observing and reporting or whether you are expected to intervene if there is a patient safety risk, and share that information with the physician being evaluated. In addition, ask if proctoring is considered a confidential peer review activity. Confirm that you and the physician whom you will be proctoring have professional liability insurance at adequate limits for the procedure. Ask the surgeon to inform the patient that you will be observing the surgery. Be candid and objective in your evaluation.

Q I just purchased a femtosecond cataract laser. I completed my training from the manufacturer and have been proctored. Do I have a legal duty to tell my patients how many procedures I have done using the laser?

A There is only a small body of case law governing voluntary disclosure of experience during the informed consent discussion, but one of the most famous cases highlights the risks of not discussing experience. A neurosurgeon disclosed the risks of death, stroke, and blindness to a patient who had a basilar aneurysm, stated he had done the procedure to treat it several times, and quoted a mortality rate of 2%. The patient had no prior neurological impairment but was an incomplete quadriplegic after the procedure. During the trial, the surgeon admitted that he had done only two cases, making it seem as if he had inflated his experience. Experts testified, moreover, that he had underestimated the risk: the mortality rate ranged from a low of 11% with very experienced surgeons to a high of 20 to 30% for those surgeons with limited experience. The jury awarded the plaintiff $6.2 million. On appeal, the Wisconsin State Supreme Court ruled that a reasonable person facing the need for an operation to treat a basilar aneurysm would have wanted to know that the neurosurgeon had little experience in the surgery and that the mortality and morbidity rates differed based on experience. In addition to mandating the disclosure, the court felt that the surgeon should have discussed the option of referral to a tertiary care center. In his analysis of the decision, OMIC Vice President Paul Weber noted that there is no clear rule on when the surgeon should talk about comparative risk and that such comparative risk data might not be available. He encouraged ophthalmologists to see the procedure from the patient’s perspective. If, as a patient, the eye surgeon would want to know the level of expertise and experience of the surgeon, he or she should disclose experience (see “Trends in the Duty of Informed Consent” at www.omic.com).

Q What if a patient asks me about how many procedures I have done?

A Here the legal answer is clear. Physicians do have a duty to answer truthfully when asked about their experience and results. When discussing results, it is important to distinguish results from clinical trials or studies from personal experience or that of the entire practice. Overstating one’s results may seem relatively harmless, but it has been construed as false advertising or fraud and has led to settlements of otherwise defensible care.