HEALTH NOTES Byron Y. Newman, O.D.
Assessment of patient understanding
ow does a doctor know when enough has been said about a certain procedure or prescription being recommended? Perhaps even dilation? Patients participating in choices about their health care need to be fully informed, and it’s their legal and ethical right to direct what happens to their bodies. The ethical duty of the doctor to involve patients in their health care is termed “Informed Consent” (IC), according to “Ethics in Medicine” by the University of Washington School of Medicine (depts.washington.edu/bioethx/topics/consent.html). The most important goal of IC is that the patient has an opportunity to be an informed participant in health care decisions. It is generally accepted that complete IC includes a discussion of the following elements: ● The nature of the decision or procedure ● Reasonable alternatives to the proposed intervention ● The relevant risks, benefits, and uncertainties related to each alternative ● The acceptance by the patient Basic consent entails letting patients know what should be done and then asking them if that will be alright. Basic consent is appropriate, for example, when using dilation drops and, for this consent to be valid, the patient must be considered competent to make the decision and the consent must be voluntary. The American Medical Association (AMA) suggests, “To protect yourself in litigation, in addition to carrying
adequate liability insurance, it is important that the communication process itself be documented, which can serve as evidence in a court of law that the process indeed took place” (www. ama-assn.org/ama/pub/category/4608. html). What stimulated this Health Note was a case that occurred in Southern California where a patient, upon leaving the office of an optometrist, fell on the sidewalk and was injured. The patient sued the optometrist with a claim of liability for personal injury. The question came up in an e-mail to peerreview committee members from Mark Condell, O.D., optometry director for an insurance company for vision care, who queried: “How many of you use Informed Consents in your office?” Dr. Condell then added, “Elements of an informed consent include: 1. Discussion of the risks, benefits, and alternatives to any procedure 2. Acknowledgement that all information is understood and all questions have been answered to the patient’s satisfaction 3. Consent obtained for the proposed procedure.” He recommended the Web site for an ophthalmology insurance company (insuring MDs and ODs who work for ophthalmologists), Ophthalmic Mutual Insurance Company (OMIC), which listed items that need an IC Form (www. omic.com/resources/risk_man/forms.cfm). These forms are available on the Web site for viewing, to copy for use, or to modify and then use. They are specific about each procedure, such as (of interest to ODs):
1529-1839/08/$ -see front matter © 2008 American Optometric Association. All rights reserved. doi:10.1016/j.optm.2007.11.007
Byron Y. Newman, O.D.
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Punctal plugs Dilating eye drops Off-label use of a drug or device Refusal of recommended medical or treatment procedure 5. Consent for comanagement after eye surgery 6. Consent for all types of eye surgery OMIC also describes what it calls “Risk Management Principles.” “Failure to provide for a patient’s safety has been the basis of many ‘slip and fall’ suits. Oftentimes, a slip and fall claim will cross over both a physician’s general liability and professional liability coverage, depending on whether the treatment rendered to the patient contributed to or caused the incident in question. Responsibility for patient safety does not begin and end in the exam chair, but extends to the entire
4 premises, regardless of whether the doctor owns or controls the property outside the office.” OMIC continues, “Visual impairment following dilation raises questions of patient safety and establishes a duty on the part of the caregiver to provide for the patient’s safe transport out of the office. Settlements and judgments involving patient falls post-dilation can range from a few thousand to tens of thousands of dollars, particularly if the doctor or office staff is found to be negligent in supervising an elderly or visually impaired patient. Providing a safe environment for the patient should be a priority in all practices. Conduct periodic audits of the office premises and safety policies. Develop written procedures establishing safety guidelines and practices to be followed by office staff. A routine checklist or mechanism to record that a patient has been warned of potential glare problems and instructed to wear sunglasses can serve to protect the doctor and staff from failure to warn allegations.” In reviewing 1 case, OMIC reported a situation where a 72-year-old male patient was dilated, went outside after an examination, stepped off a curb and fell, resulting in a hip fracture. The patient alleged that the insured ophthalmologist was negligent in not providing him with sunglasses or advising him to wear sunglasses after the dilation. He stated that when he left the doctor’s office his eyes were unprotected and blinded by the sun’s glare, which impaired his vision so that he
Health Notes did not see the step down from the curb. The plaintiff’s expert opined that it was below the standard of care to allow the patient to leave without providing sunglass protection before the effects of dilation have dissipated. The insured countered that the technicians in his office, who instill dilating drops routinely, warn patients that the drops can cause blurry vision and heightened sensitivity to light, and they keep sunshades at the front desk for patients who request them. However, there was no written office policy or procedure in place regarding this issue. Although the office administrator maintained that she offered the patient sunglasses, there was no documentation to support this, and neither the insured nor other office staff could remember specifically warning the patient of the potential problems associated with dilation. “Furthermore,” it is stated in the analysis of the case, “the OMIC Publication Archives advises physicians who administer dilating drops to instruct patients to wear sunglasses and avoid driving or operating dangerous machinery afterwards. In light of this, the defense team and insured both decided it would be difficult to defend the case and settled on behalf of the insured ophthalmic group.” As an historical event, IC is relatively new, according to the AMA Web site. “The first case defining informed consent appeared in the late 1950s. Earlier consent cases were based in the tort of battery. Though battery
claims occasionally occur when treatment is provided without consent, most consent cases generally center around whether the consent was informed, i.e. whether the patient was given sufficient information to make a decision regarding his or her body and health care. Because informed consent claims are based on negligence, they generally are covered by liability insurance.” The AMA continues, “In the communications process, you, as the physician providing or performing the treatment and/or procedure (not a delegated representative) should disclose and discuss with your patient: 1. The patient’s diagnosis, if known; 2. The nature and purpose of a proposed treatment or procedure; 3. The risks and benefits of a proposed treatment or procedure; 4. Alternatives (regardless of the cost or the extent to which the treatment options are covered by health insurance; 5. The risks and benefits of the alternative treatment or procedure, and 6. The risks and benefits of not receiving or undergoing a treatment or procedure; and 7. In turn, your patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure so that he or she can make an informed decision to proceed or to refuse a particular course of medical intervention.” Enough said!