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 and other aspects of their care. First, though, each patient and representative must receive adequate information in a manner they can understand.

The primary purpose of the informed consent process for a critical access hospital is to ensure that the 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 or other care practices that require consent. In other words, informed consent should be a process, not a form.

The Accreditation Commission for Health Care (ACHC) Critical Access 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 form and which circumstances are considered an emergency for which informed consent is not required. Consents are also required for investigational or experimental drugs; for participation in any unusual, experimental, or research projects and organ procurement; in situations consent is required for a care decision; and for the use of siderails in conjunction with swing beds.

Question: Who can obtain informed consent?

Answer: A recommendation would be that hospital policy defines the informed consent process, including 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: While there are no specific requirements regarding the timing of consent, an informed consent must be readily available and reviewed during the timeout process, therefore it must be in the medical record before the procedure/surgery.

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:

• Nature and purpose of the procedure/surgery.
• Risks and consequences of the procedure/surgery.
• Risks and prognosis if no treatment is rendered.
• Probability of success for proposed procedure/surgery.
• Alternative methods of treatment (if any) and their associated risks and benefits.
• 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.
• Other physicians who may be performing important tasks related to the surgery.
• Other qualified medical practitioners, as permitted by state law, who will be performing important parts of the surgery or the types of tasks they will be assisting with.

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

Answer: The informed 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 and anesthesia.
• Name of practitioners performing the procedure/surgery and administering anesthesia.
• Signature of the patient or patient representative.
• Date and time the consent is obtained.
• Statement that the procedure was explained to the patient/representative.
• Signature of the professional person witnessing the consent.
• Name and signature of person who explained the procedure to the patient/patient representative.

Question: Who can obtain consent for delivery of anesthesia to a patient?

Answer: Hospital policy must define the categories of practitioners that are able to obtain informed consent for the delivery of anesthesia. Informed consent requires a discussion of the risks, benefits, and alternatives to anesthesia. Therefore, it is critical that an individual acting within their scope of practice participate in the discussion with the patient and/or representative regarding the anesthesia plan of care, risks, benefits, and alternatives. The medical record must contain documentation of the patient consent for anesthesia. This may be accomplished through a separate written informed consent for the administration of anesthesia or may be integrated into the surgical informed consent given that the practitioner responsible for the administration of anesthesia has participated in the informed consent process and discussion of the planned anesthesia care.

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 or surgeries that require informed consent.
• Other care practices that require informed consent
• 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 there are additional requirements under state law for informed consent, the hospital must comply with those requirements.

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 their consent.

• Reminders:
  • Information should be provided in a language that is fully understood by the patient or patient representative.
  • Information must be presented in a language or means the patient/representative can understand. If an interpreter is needed, one should be used.

Take Time to Understand the Standards

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

• Standard 01.001 Compliance with federal laws and regulations.
• Standard 05.00.18 Multiple hospital systems: unique circumstances.
• Standard 06.10.02 Notice of Patient Rights.
• Standard 06.10.04 Participation in decision making.
• Standard 06.10.05 Advance directives.
• Standard 07.00.04 Record content requirements.
• Standard 07.01.00 Record Protection.
• Standard 08.00.04 Policies and procedures.
• Standard 08.00.06 Informed consent.
• Standard 08.03.05 Anesthesia policies.
• Standard 10.00.03 Designated requestors.
• Standard 11.01.05 Right to request, refuse and/or discontinue treatment.
• Standard 11.11.01 Quality of care.

Maintain Compliance

When a Surveyor Visits

While conducting a survey, an ACHC Surveyor will ask for documentation of hospital policies and procedures that explains 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.
• Interviews with 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 partner. For more information, or to obtain a copy of the ACHC Critical Access Hospital Accreditation Standards Manual, contact your Account Advisor, email [email protected], or call (855) 937-2242.