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Informed Consent Is More Than Just a Signature

By Michelle Nolander, M.S.N., R.N., CNOR

Informed consent has been a hot topic for decades. Who can obtain it? When should it be obtained? What needs to be addressed in the informed consent discussion? What elements should be in the informed consent policy? Who is legally permitted to sign the consent form?

In her article titled Whose Decision Is It? Teaching Students and Physicians About Informed Consent and published by the Association of American Medical Colleges in 2017, Kim Krisberg examines the importance of informed consent. “Evidence is limited on the specific links between informed consent and patient outcomes, though research has found that effective patient-provider communication is associated with better outcomes for both doctor and patient,” Krisberg writes.

In 2013, the Agency for Healthcare Research and Quality said research shows only 9 percent of more than 1,000 outpatient encounters studied contained all of the elements of informed decision-making. The agency noted that the most frequent oversight was the physician not assessing the patient’s understanding of the information. This results in a patient who cannot fully recall what they have consented to.

The primary purpose of the informed consent process in an ambulatory surgery center (ASC) is to ensure that the patient, or the patient’s representative, is provided with the information necessary to enable him/her/they to evaluate a proposed surgery before agreeing to the surgery. In other words, the informed consent should be a process, not a form.

Unraveling the Mystery of Informed Consent

Question: Who can obtain informed consent?

Answer: The provider who is performing the procedure should obtain informed consent, unless otherwise specified by your state laws. Information should be given in a language that is fully understood by the patient or parent/legal guardian. Additionally, if there are other medical providers that will perform important parts of the surgery or administer the anesthesia, that should be indicated on the consent form.

ASC Deemed Standards: 08.00.03 Form and Content of the Medical Record

ASC Non-Deemed Standards: 06.00.02 Informed Consent, 08.00.03 Form and Content of the Healthcare Record

Question: When should the informed consent process take place?

Answer: There is not a prescriptive answer to this question, unless it is a provision in your state law. Informed consent may be obtained in a physician’s office outside the surgery center before the patient’s day of surgery. Nevertheless, the ASC is responsible for ensuring an informed process is in place for each patient and the providers are required to follow the informed consent policy/process as outlined by the ASC. The consent form must be completed and placed in the patient’s medical record before surgery.

ASC Deemed Standards: 11.02.01 Exercise of Rights and Respect for Property and Person

ASC Non-Deemed Standards: 06.00.03 Advance Directives

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:

Planned procedure and the indications for the procedure to be performed.
Risks, benefits, and alternatives to the procedure.
Expected outcome of the procedure.
Allergies and abnormal drug and material reactions.
Provider(s) performing the procedure and administering 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 administering anesthesia, the types of tasks they will be assisting with, and evidence that the practitioners are performing within their scope of practice and granted privileges by the ASC.

ASC Deemed Standards: 11.02.01 Exercise of Rights and Respect for Property and Person

ASC Non-Deemed Standards: 06.00.02 Informed Consent, 08.00.03 Form and Content of the Healthcare Record

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:

Who may obtain the patient’s informed consent.
The circumstances when a patient’s representative, rather than the patient, may give informed consent for surgery.
The content of the informed consent form and instructions for completing it.
The process used to obtain informed consent, including how informed consent is to 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 process and informed consent form are obtained outside of the ambulatory surgery center, how the properly executed informed consent form is incorporated into the patient’s medical record before surgery.
If there are additional requirements under state law for informed consent, the ASC must comply with those requirements.
Consent specific to recordings, films, or other images of patients for internal use.

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

ASC Deemed Standards: 11.02.01 Exercise of Rights and Respect for Property and Person

ASC Non-Deemed Standards: 06.00.02 Informed Consent

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

Answer: The patient or surrogate designated by the patient in accordance with state law may provide 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 consent.

ASC Deemed Standards: 11.00.06 Advance Directives

ASC Non-Deemed Standards: 06.00.03 Advance Directives

Remember, as repeated throughout this article, to know your state laws! Laws greatly differ from state to state, and it is important for you to know, understand, and follow the laws outlined in your state.

Resources

Code of Federal Regulations: eCFR :: 42 CFR 416.50 Condition for coverage - Patient rights [§416.50 (e)(1)(iii), §416.50 (e)(2), §416.50 (e)(3)]

AAMC article: Whose Decision Is It? Teaching Students and Physicians About Informed Consent | AAMC

The Agency for Healthcare Research and Quality: Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices (updated 2013). Original Report: Obtaining Informed Consent From Patients: Brief Update Review - Making Health Care Safer II - NCBI Bookshelf (nih.gov)

Here to Help

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Some content presented in “Did You Know?” may consist of timely or topical articles deemed to be of interest to the provider community. These are presented for informational purposes as a service to our readers. The views, opinions, and positions expressed by the authors are theirs alone and do not necessarily reflect the views, opinions, or positions of ACHC, its related entities, or any employee thereof.

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