Informed Consent is still an issue on the healthcare agenda. It appears we are still not doing it properly. Consent is a process, not a form. It also continues to be a source of malpractice liability, because the legal requirements continue to lack complete clarity. And, done poorly, it contributes to a climate of public mistrust in healthcare professionals. The Centers for Medicare and Medicaid Services (CMS) periodically issues clarifications of its expectations for informed consent.

Consent may be express or implied. Express consent is an oral or written authority by the patient to render the proposed treatment. Consent may be implied by the patient in a particular case - a patient who voluntarily submits to treatment under circumstances that indicate awareness of planned treatment without the express consent - for instance, when the patient signs for admission into the hospital. Consent for routine blood work and x-rays are considered implied.

Informed consent provides a cause of action if a patient is not adequately informed of the nature and consequences of a particular medical procedure, process, or treatment prior to giving consent to that treatment. In May 2004, CMS issued new rules that significantly expanded the scope of informed consent that must be obtained by hospitals prior to surgical procedures. CMS guidelines state that the patient or his/her representative has the right to make informed decisions regarding care. These rights include the right to be informed of his/her health status, to be involved in care planning and treatment, and to be able to request or refuse treatment. The patient may also delegate these rights to another person.

Hospitals must establish processes to assure that each patient or his/her representative is given information on the patient's health status, diagnosis, and prognosis. Hospitals must utilize an informed consent process that assures patients are given the information and disclosures needed to make an informed decision about whether to consent to a procedure, intervention, or type of care that requires consent. Informed decisions related to care planning also extend to discharge planning. Hospitals must establish policies and procedures that:

• Assure a patient's right to request or refuse treatment, and how this right will be exercised.
• Include the patient's right to delegate to a representative.
• Address the patient's right to have information on his medical status, diagnosis and prognosis and how patients will receive this information.
• How the patient will be involved in his/her care planning and treatment.
• Addressing the patient's refusal of treatment.
• How the patient's request for treatment will be handled - which includes the circumstances under which a patient request for treatment can be denied.
• Comply with state laws/regulations governing patient rights

CMS expects that a properly executed informed consent form for a procedure be in the patient's chart before surgery, except in emergencies. The practitioner must obtain informed consent from the patient in a manner consistent with the hospital's policy.

CMS expects the potential short- and long-term risks and benefits, as well as their likelihood be included in informed consent. The facility's informed consent policy should describe:

• Who may obtain the patient's informed consent.
• Which procedures require informed consent.
• The circumstances under which surgery is considered an emergency, and may be undertaken without informed consent.
• The circumstances when a patient's representative may give informed consent.
• The content of the informed consent form and instructions for completing it.
• The process used to obtain informed consent, including how it is to be documented in the record.
• Mechanisms that ensure that the informed consent form is properly executed and is in the patient's chart before surgery.
• How the consent forms obtained outside the hospital will be incorporated in the patient's chart.

Hospital medical staff bylaws should address which procedures and treatments have been specified as requiring informed consent.

Resources

Bryant, S & Sagin, T. (2007, June 25). CMS and informed consent: Is your institution getting it right? [Interactive audioconference]. Marblehead, MA: HCPro.

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