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Three Steps to Informed Consent

By Angela Fitzsimmons

“Informed consent” is the name given to the idea that a patient has a legal and ethical right to direct what happens to his/her body. The specific term appears in only a limited number of AAAHC Standards* relating to anesthesia, surgical services, dental services, behavioral health services, research activities, and radiation oncology services, but it is the philosophical basis for placing patient rights and responsibilities as the first chapter of the AAAHC Accreditation Handbook.

The goal of informed consent is that the patient has the opportunity to be an active participant in his/her health care decisions. The inherent imbalance of power in the provider-patient relationship can make this goal difficult to achieve. Patients may feel vulnerable and reluctant to ask about a proposed procedure or course of treatment. Or, they may lack the needed vocabulary or basic process knowledge to formulate clarifying questions to help them understand. In short, patients don’t know what they don’t know and that places the burden of obtaining meaningful informed consent squarely on the shoulders of health care providers.

Because providers sit on the up side of this power imbalance, they may be unaware of the patient’s hesitation to press for explanation or express anxiety. This means that a patient-centered approach to communication is essential in order to achieve true informed consent. Explaining the nature of the proposed treatment or procedure, the relevant associated risks, and any alternative options along with the attendant risks of these is only the first (and perhaps the simplest) step in a three-step process.

Communication means shared understanding

Step two of the process is transforming information into communication. The provider must take the initiative to confirm that the patient (or his or her representative) has moved from the basic level of knowledge – information – to the level of comprehension at which meaning is attached to knowledge.

How do you do this? It may help both sides if the issue is framed as a decision-making partnership. The provider will be providing information and sharing a specific recommendation. The patient must then have ample opportunity to participate in the decision to proceed. A consent form included among a stack of papers to sign does not address the intent of informed consent. In fact, it might signal a problematic lack of patient-centeredness; a “we’re-going-through-the motions-because-we must” approach that reduces the patient’s agency and results in a response that could be seen as coerced.

Prior to seeking that signature (step three), providers must ensure that the consent is voluntary and intentional. Ask questions. Has your patient understood the information well enough to restate it? For example, could she explain to a family member what she consenting to in basic terms?

Informed consent in action

When an accreditation survey takes place, informed consent is usually confirmed through documentation. Here are some questions that we’ve received from organizations seeking accreditation with regard to issues of consent.

Q: For a surgical procedure, can a single consent form cover both the anesthesia and the procedure?

A: The issue is voluntary, informed patient consent. If the provider(s) have fully communicated the options, risks, recommended course of action, and assessed the patient’s understanding and willingness to proceed, it is acceptable to use a single consent document.

In cases where the anesthesia provider and the surgeon are individually discussing their roles with the patient, it is more usual to see separate forms. In settings where a surgeon is supervising anesthesia provided by a CRNA, a single consent form is more common.

Q: Can documentation that the proposed procedure was discussed with the patient or the patient’s parents/guardian, and that they consented to the procedure be included in the medical notes without a separate form?

A: Some states require a written consent, many do not. However, beginning in 2016, AAAHC Standard 10.H is quite specific on this:

10.H   Informed consent for the proposed procedure is obtained.

  1. There is documentation that the necessity of the proposed procedure or surgery, as well as alternative treatment techniques, have been discussed with the patient.
  2. The organization obtains written informed consent from the patient or the patient’s representative before the procedure or surgery is performed.

Written informed consent has always been required in Medicare-certified ASCs, and the Standard now requires it in other surgical/procedural settings as well. To apply 10.H.2 in primary care settings in 2016, surveyors will ask for the organization’s policies or guidelines regarding when written vs. verbal consents are required, assess the rationale of those guidelines, and then confirm compliance through the review of clinical records. The intent is that in primary care settings, some procedures such as cryotherapy of warts, removal of skin tags, etc. are sufficiently benign that they will not require separate written, signed consents. In this case, a note in the clinical record is sufficient.

*Standards cited refer to the identifiers in the 2016 edition of the Accreditation Handbook for Ambulatory Health Care.

About the author

Angela FitzSimmons is Director, Marketing and Communications for AAAHC and its family of companies. Since 2011, she has focused on bringing best practices to life by developing educational resources for AAAHC-accredited organizations based on the Standards.



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