Informed Consent

by Laura A. Dixon, BS, JD, RN, Director, Department of Patient Safety, Western Region
(This article originally appeared in The Doctors Advocate, published by The Doctors Company)

In April of 2007, the Centers for Medicare and Medicaid Services (CMS) issued new interpretive guidelines for informed-consent documentation in patients' medical records. Although the requirements apply primarily to facilities, the changes also affect individual providers. CMS now requires hospitals to assure that the practitioner responsible for surgery obtains informed consent in a manner consistent with the hospital's policy.

According to 42 CFR 482.24(c)(2)(v), the statutory authority for regulation of health care facilities accredited by Medicare and Medicaid, all inpatient and outpatient medical records must contain a properly executed and completed written informed-consent form for all procedures and treatments specified by the hospital's medical staff or by state or federal laws or regulations. Any physician with privileges at such facilities must follow the requirements on informed consent for all patients, not just Medicare and Medicaid patients.

Required Contents of Informed Consent
In response to the above regulation, the CMS developed interpretive guidelines, or instructions, to assist its surveyors on how to apply the regulations. Included in the guidelines is the following definition of informed consent: "The patient or patient representative is given (in a language or means of communication he/she understands) the information, explanations, consequences, and options needed in order to consent to a procedure or treatment."1

1. The following is a list of items that must be included on each consent form
2. Name of the patient and, when appropriate, the patient's representative
3. Name of the hospital where the procedure or other type of medical treatment is to take place
4. Name of the specific procedure, or other type of medical treatment, for which consent is being given
5. Name of the responsible practitioner who is performing the procedure or administering the medical treatment
6. 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
7. Signature of the patient or the patient's legal representative
8. Date and time the informed-consent form was signed by the patient or the patient's legal representative

The CMS guidelines also provide additional information that should be considered for a well designed informed-consent form. They include:

1. Name of the practitioner who conducted the informed-consent discussion with the patient or the patient's representative
2. Date, time, and signature of the person witnessing the patient or the patient's legal representative signing the consent form
3. Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or the patient's representative
4. 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
5. Statement, if applicable, that qualified medical practitioners who are not physicians but 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

Patient Safety Implications and Recommendations
Overall, the CMS requirements enhance patient safety by promoting open and thorough communication between the patient and physician, and they also reinforce the axiom that "informed consent is a process and not just a form." Through the new requirements, a patient or legal representative must be given sufficient information to make an informed decision whether or not to consent to a procedure or treatment. Such information would be considered material if a reasonable patient would not have consented to the procedure or made the same decision had he or she received that information. The more informed patients are about a procedure, the more likely they are to understand their condition and become more involved in their health care.

Impact on the Provider
The physician must provide the patient or legal representative with information about the planned procedure and its risks. The physician should use plain, simple language and avoid "medicalese" or medical terminology.

In addition to listing the common risks of the procedure, the physician should consider adding any risks that are applicable to a particular type of patient. For example, the physician might consider informing a diabetic patient with heart disease of the heightened risks of delayed healing or the possibility of a heart attack with completion of the procedure.

The primary surgeon should provide the patient or legal representative with information about the procedure to be performed and an explanation of each team member's role. The responsibility to make sure that the patient is fully informed should not be delegated to a clinical staff member. However, clinical staff can assist the surgeon in verifying that all of the patient's questions have been answered. The discussion should begin in the clinic, with time for questions and answers, and then it should be repeated prior to the procedure to reinforce what was discussed.

Some states require a separate written consent for the use of general, spinal/epidural, or regional anesthesia. Given the particular risks and complications specific to anesthesia, a separate consent is effective in demonstrating that all of the required elements were included in the discussion and that the consent obtained from the patient was indeed informed. However, CMS does not require a separate consent form for anesthesia, but it is essential that the physician is aware of the specific state requirements for a separate consent form. For physicians who provide services at an accredited ambulatory surgical center, The Doctors Company recommends that each physician review and update the informed-consent forms utilized by the surgical center to ensure that the requirements are met.

Finally, to ensure the patient's understanding of the procedure and its common risks, the physician should have the patient read a section--such as the section on risks and complications--directly back from the consent form, and then have the patient provide an explanation of another section--such as a description of the planned procedure--in his or her own words. This serves two purposes: to verify the patient's literacy status and to provide insight into the patient's overall understanding and comprehension of what was discussed.

Summary
Although CMS oversight and regulation traditionally impact hospitals, individual physicians are also affected and regulated by the requirements when providing services to patients in such facilities. Awareness and proper documentation will enhance patient interaction and promote patient safety.