Risk Management

Surgical Experience: Acquisition and Disclosure

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.