LEGAL MATTERS
Informed Consent Process in Ambulatory Surgery Review state laws and AHRQ materials before creating your policy BY NESKO RADOVIC AND SANDRA JONES, CASC
Editor’s note: This is part one of a two-part column. Look for the second part in the November–December 2019 issue of ASC Focus.
Informed con- sent, a funda- mental patient right, is the process where-
in the physician provides the patient with the necessary information to make a fully informed decision about the course of recommended care. Informed consent is a process, not a piece of paper. Treating the consent process as just a piece of paper or as another item to check off the to-do list can lead to mistakes and patient and physician dissatisfaction. It could also expose healthcare providers to potential malpractice liability. Lack of informed consent remains the most common secondary claim in physician medical malpractice actions. The long-standing legal standard for informed consent was first artic- ulated in a famous New York case, Schloendorff versus Society of N.Y. Hospital, in which a surgeon failed to obtain consent for a hysterectomy. The case was decided on the theory of bat- tery, reserved for situations where the doctor performs an operation to which the patient has not consented. In con- trast, when the patient consents to certain treatment and an undisclosed inherent complication occurs, the lack of informed consent will constitute negligence (see Cobbs versus Grant, 1972). In short, the physician has a legal duty to disclose to the patient all material information (Arato ver-
sus Avedon, 1993). When the planned procedure involves a known risk of death or serious bodily injury, a doc- tor, at a minimum, has a duty to dis- close the potential risks of harm and to explain in lay terms the complications that might occur. If a physician does not make the minimal disclosure, he or she could be liable for all injuries sus- tained by the patient during the treat- ment whether it satisfied the standard of care or not.
Consents in a surgery center include
1) the physician’s procedure consent, 2) the facility’s consent to proceed with ordered treatment, and, if anesthe- sia will be administered, 3) the anesthe- sia consent. Anytime a physician examines or treats a patient, informed consent must be obtained. It is the communication between the patient and the surgeon when the patient learns and understands
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the reasons for the procedure, its risks and benefits and alternative treatment options. It is also when the patient has questions answered and agrees to the procedure. The patient’s signature on a consent form is not informed con- sent. The patient should not be asked to sign a consent form at the admis- sions desk nor should a consent form be presented prior to the patient having a conversation with the provider. The signature on the consent form sim- ply evidences that the informed con- sent process occurred. Best practice would be to include both a signed con- sent form and a surgeon’s note in the patient’s medical record describing the process of informed consent. The ASC staff should also consider state law and whether physician assistants can facili- tate the process by providing informa- tion to the patient. State law on this issue varies greatly.
The advice and opinions expressed in this column are those of the authors and do not represent official Ambulatory Surgery Center Association policy or opinion.
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