CMS SOM App. A, Tag A-0466

§482.24(c)(4)(v) - Properly executed informed consent forms for procedures and treatments

specified by the medical staff, or by Federal or State law if applicable, to require written

patient consent.

Interpretive Guidelines §482.24(c)(4)(v)

Informed consent is discussed in three locations in the CMS Hospital CoPs. See also the

guidelines for 42 CFR 482.13(b)(2) pertaining to patients' rights, and the guidelines for 42 CFR

482.51(b)(2), pertaining to surgical services.

The medical record must contain a document recording the patient’s informed consent for those

procedures and treatments that have been specified as requiring informed consent. Medical staff

policies should address which procedures and treatments require written informed consent.

There may also be applicable Federal or State law requiring informed consent. The informed

consent form contained in the medical record should provide evidence that it was properly

executed.

Informed Consent Forms

A properly executed informed consent form should reflect the patient consent process. Except as

specified for emergency situations in the hospital’s informed consent policies, all inpatient and

outpatient medical records must contain a properly executed informed consent form prior to

conducting any procedure or other type of treatment that requires informed consent. 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. A properly executed informed

consent form contains the following minimum elements:

• Name of the hospital where the procedure or other type of medical treatment is to take

place;

• Name of the specific procedure, or other type of medical 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 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 high

degree of severity. Hospitals are free to delegate to the responsible practitioner, who uses

the available clinical evidence as informed by the practitioner’s professional judgment,

the determination of which material risks, benefits and alternatives will be discussed with

the patient.)

• Signature of the patient or the patient’s legal representative; and

• 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, then the

hospital’s form must comply with those requirements.

A well-designed informed consent form might also 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 that were

discussed with the patient or the patient’s representative;

• Statement, if applicable, that physicians other than the operating practitioner, including

but not limited to residents, will be performing important tasks related to the surgery, in

accordance with the hospital’s policies and, in the case of residents, based on their skill

set and under the supervision of the responsible practitioner.

• 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, as determined under State

law and regulation, and for which they have been granted privileges by the hospital.

Survey Procedures §482.24(c)(4)(v)

• Verify that the hospital has assured that the medical staff has specified which procedures

and treatments require written patient consent.

• Verify that the hospital’s standard informed consent form contains the elements listed

above as the minimum elements of a properly executed informed consent.

• Compare the hospital’s standard informed consent form to the hospital’s policies on

informed consent, to verify that the form is consistent with the policies. If there is

applicable State law, verify that the form is consistent with the requirements of that law.

• Review a minimum of six random medical records of patients who have, are undergoing,

or are about to under a procedure or treatment that requires informed consent. Verify that

each medical record contains informed consent forms.

• Verify that each completed informed consent form contains the information for each of

the elements listed above as the minimum elements of a properly executed informed

consent, as well as any additional elements required by State law and/or the hospital’s

policy.