Patients or their representatives have the right to participate in the development of the patients’ plans of care. This includes providing informed consent for medical and surgical interventions. First, though, each patient and representative must receive adequate information in a manner they can understand.

The primary purpose of the informed consent process in an acute care hospital is to ensure that each patient, or each patient’s representative, is provided with the information necessary to enable him/her/them to evaluate a proposed procedure or surgery before agreeing to the procedure or surgery. In other words, informed consent should be a process, not a form.

The Accreditation Commission for Health Care (ACHC) Acute Care Hospital Accreditation Standards Manual addresses aspects of informed consent in multiple standards.

Learn These Important Details

Question: When is consent required?

Answer: The hospital must define which procedures and treatments require a written consent and which circumstances are considered an emergency for which informed consent is not required. Consents are also required for investigational or experimental drugs; participation in any unusual, experimental, or research projects and organ procurement; or in situations consent is required for a care decision.

Question: Who can obtain informed consent?

Answer: The practitioner who is performing the procedure/surgery is responsible for ensuring a completed informed consent form is obtained prior to the procedure/surgery. Hospital policy must describe the informed consent process and who may obtain the consent. Anesthesia policies must define the categories of practitioners eligible to obtain informed consent for anesthesia. If the anesthesia consent is integrated into the surgical consent, the practitioner responsible for administration of anesthesia must participate in the informed consent process and discussion of the planned anesthesia care.

Question: When should the informed consent process take place?

Answer: Informed consent may be obtained outside the hospital prior to the procedure/surgery, based on hospital policy or state law. If the informed consent is obtained outside the organization, there must be a defined process to ensure the consent is entered into the medical record prior to the procedure/surgery. Regardless of the location in which the consent is obtained, it must be completed and entered into the medical record before the procedure/surgery begins.

Question: What needs to be addressed in the informed consent discussion?

Answer: The following elements should be addressed at a minimum during the informed consent discussion:

• Short- and longer-term risks and benefits of the proposed procedure/surgery.
• Description of the proposed procedure/surgery and anesthesia to be used.
• Indications for the proposed procedure/surgery.
• Material risks and benefits related to the procedure/surgery and anesthesia, including the likelihood of each.
• Treatment alternatives.
• Probable consequences of declining recommendations or alternative therapies.
• The name of the practitioners who will conduct the procedure/surgery and who will administer anesthesia.
• Whether other qualified practitioners will perform important tasks.
• When anesthesia is provided, a discussion by an individual acting within their scope of practice with the patient or representative about the anesthesia plan of care, risks, benefits, and alternatives to anesthesia.

Question: What elements must be on an informed consent form?

Answer: The consent form must, at minimum, contain the following details:

• Name of the patient.
• Name of the hospital where the procedure will take place.
• Name of the specific procedure or other type of medical treatment, including  anesthesia.
• Name of practitioners performing the procedure and administering anesthesia.
• Statement that the procedure, anticipated benefits, material risks, and alternative therapies were explained to the patient/representative.
• Signature of the patient or patient representative.
• Patient’s or representative’s signature with date and time the consent is obtained.
• The consent form may also include:
  • Name of the practitioner who conducted the informed consent discussion.
  • Date, time, and signature of the person witnessing the patient/representative signing the form.
  • Indications or listing of material risks.
  • Statement that other qualified practitioners may be performing important tasks.

Question: What elements should be in the informed consent policy?

Answer: Your organization’s consent policy should contain, but not be limited to, the following elements:

• Procedures and treatments that require a written informed consent and circumstances that would be considered an emergency for which an informed consent would not be required.
• Who may obtain the patient’s informed consent.
• Circumstances in which a patient’s representative, rather than the patient, may give informed consent for a procedure/surgery.
• The content of the informed consent form and instructions for completing it.
• The process to be used to obtain informed consent, including how informed consent should be documented in the medical record.
• Mechanisms that ensure the informed consent form is properly executed and is in the patient’s medical record before surgery.
• If the informed consent form is obtained outside of the hospital, how the properly executed informed consent form is incorporated into the patient’s medical record prior to the procedure/surgery.

If there are additional requirements under state law for informed consent, the hospital must comply with those requirements

Remember that the witness who signs the consent form is not witnessing the understanding of the information provided by the physician. The witness signs only to verify that the patient or patient’s representative was the person signing the form.

Question: Who is legally allowed to sign the consent form?

Answer: The patient or surrogate designated by the patient in accordance with state law may provide informed consent. For anyone who has been declared “incompetent” under applicable state laws, the person who has been appointed under state law to act on the patient’s behalf may provide informed consent.

• Reminders:
  • Information should be provided in a language that is fully understood by the patient or patient representative.
  • An interpreter should be provided when the need for one is identified, and provision of interpreter services should be documented in the medical record.
  • Consent must be written in simple sentences at the fourth grade comprehension level.

Take Time to Understand the Standards

Review the following standards related to informed consent for detailed information.

• Standard 03.00.14 Multiple hospital systems: unique circumstances.
• Standard 10.00.03 Retention of medical records.
• Standard 10.01.16 Informed consent.
• Standard 14.00.04 Informed consent requirements.
• Standard 15.01.02 Notice and promotion of patients’ rights.
• Standard 15.01.04 Participation in decision making.
• Standard 15.01.05 Advanced directives.
• Standard 18.00.04 Required policies.
• Standard 25.01.28 Investigational drugs.
• Standard 30.00.09 Standards of practice.
• Standard 30.00.11 Surgical informed consent.

Maintain Compliance

When a Surveyor Visits

While conducting a survey, an ACHC Surveyor will ask for documentation of hospital policies and procedures that explain the informed consent process and the elements required to be present on the consent form. The Surveyor will also assess:

• Medical records to review informed consents for procedural and surgical cases to verify all elements are present on the surgical and anesthesia consent based on hospital policy and state law.
• Relevant policies and procedures.
• Interview responses of staff to validate their practice reflects policy and to observe how the informed consent process is executed.

Tips for Compliance

• Develop hospital policies and procedures for the informed consent process and the elements required to be in the consent.
• Educate all providers and staff on the informed consent process and documentation requirements.
• Ensure the patient consent form is completed with all required elements and that the consent is available in the patient medical record before the initiation of the procedure/surgery.
• Develop strategies to monitor the informed consent process and to ensure all requirements related to informed consent are met.

Here to Help

ACHC is more than an accreditor. We are your partners. For more information, or to obtain a copy of the ACHC Acute Care Hospital Accreditation Standards Manual, contact your Account Advisor, email [email protected], or call (855) 937-2242.