QUESTION:
We are working on updating our informed consent forms.  Can you remind us what an informed consent form should include?

ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
Informed consent is essential to providing high-quality, ethical care, so I commend your efforts to review and improve your forms.  In nearly every state, the treating provider is responsible for ensuring the patient understands:  (1) the item or service being provided; (2) the associated benefits and risks; and (3) any reasonable alternatives.  This explanation must be delivered in a manner the patient can understand.  In some states, failure to obtain informed consent may expose the provider to liability if the patient is harmed by the treatment – so it’s important to review your specific state laws.

Under the Medicare Conditions of Participation, the patient’s medical record must include documentation of informed consent for procedures that require it – either under federal or state law or by your facility’s medical staff policies.  The Medicare Conditions of Participation Guidelines offer a detailed explanation of what a properly executed informed consent form should look like.  At a minimum, your consent forms should include:

• 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 recommends including the following elements to strengthen your informed consent documentation:

• The name of the practitioner 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 non-physician practitioners, other than the operating practitioner, 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 you have a quick question about this, e-mail Mary Paterni at mpaterni@hortyspringer.com.