Amended CoP regulations concern informed consent

Required elements highlighted

Except as specified for emergency situations, all inpatient and outpatient medical records must contain a properly executed informed consent form prior to a patient receiving any type of treatment that requires informed consent.

The Centers for Medicare & Medicaid Services (CMS) recently amended the Conditions of Participation (CoP) regulations for hospitals to clarify the requirements for informed consent processes and forms, notes Stephen Frew, JD, a risk management specialist and web site publisher (

An informed consent form, in order to be properly executed, must be consistent with hospital policies as well as applicable state and federal law or regulation, Frew points out.

A properly executed informed consent form, he says, contains the following minimum elements:

  • Name of the hospital where the medical procedure or treatment is to take place.
  • Name of the specific procedure or treatment for which consent is being given.
  • Name of the responsible practitioner who is performing the procedure or administering the medical treatment.
  • Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient's legal representative.

Material risks, Frew explains, could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but a high degree of severity. Hospitals are free to delegate to the responsible practitioner the determination of which material risks, benefits, and alternatives will be discussed with the patient, he adds.

  • Signature of the patient or the patient's legal representative.
  • Date and time the informed consent form is signed by the patient or the patient's legal representative.

If there is applicable state law governing the content of the informed consent form, the hospital's form must comply with those requirements, Frew notes.

A well-designed informed consent form, he adds, might include the following additional information:

  • Name of the practitioner who conducted the informed consent discussion with the patient or the patient's representative.
  • Date, time, and signature of the person witnessing the patient or the patient's legal representative signing the consent form.
  • Indication or listing of the material risks of the procedure or treatment discussed with the patient or the patient's representative.
  • Statement, if applicable, that physicians other than the operating practitioner will be performing important tasks related to the surgery, in accordance with the hospital's policies.
  • Statement, if applicable, that qualified medical practitioners who are not physicians who will perform important parts of the surgery or administration of anesthesia will be performing only tasks that are within their scope of practice.

The full text of the regulation is available on Frew's web site.