QUESTION:
We are currently updating our informed consent forms. Can you remind us of what information should be included on these forms

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
Informed consent is critical to providing quality care, so I commend your efforts to review your forms. In almost every state, the treating provider is responsible for explaining to the patient ˗ in such a way that the patient can understand ˗ (1) the item or service that will be provided, (2) the benefits and risks associated with that care, and (3) any alternatives. In some states, failure to obtain a patient’s informed consent may render the treating provider liable for any injury that results from the rendered care, so be sure to check your state law!

Under the Medicare Conditions of Participation, the medical record must contain documentation of the patient’s informed consent for certain treatments and procedures. The Medicare Conditions of Participation Guidelines offer a detailed explanation of what a properly executed informed consent form should look like. When revising your informed consent forms, be sure that they have at least the following elements:

• The name of the facility where the care is going to take place;
• The name of the procedure or treatment for which consent is being given;
• A statement that the procedure or treatment, including the anticipated benefits and material risks, and alternative treatments, was explained to the patient or the patient’s legal representative;
• The signature of the patient or their legal representative; and
• The date and time the informed consent form is signed by the patient or their legal representative.

CMS also states that a well-designed informed consent form may also include:

• The name of the provider who conducted the informed consent discussion;
• Date, time, and signature of the person witnessing the patient or their legal representative signing the consent form;
• An indication or listing of the benefits and material risks of the procedure or treatment discussed; and
• A statement that physicians and providers who are not physicians, other than the treating provider, including residents, will be involved in the care of the patient and will perform important parts of the procedure or treatment, as allowed under state law and regulations, in accordance with the clinical privileges granted and/or scope of practice.

If in doubt, reach out to Mary Paterni to review whether your informed consent forms comply with state and federal law.