Informed consent is a patient right
“Informed consent is a communication process that provides patients, or their representatives as allowed by Oregon law, the opportunity to make informed decisions regarding their care.” — Asante Policy 400-RISK-RISK-0007
As many know, Asante has received nonconformities from DNV for our consent process — specifically, ensuring that all elements are included on the consent form.
The list of required elements may seem overwhelming but they are critical not only for documentation but to ensure the patient understands the risk-and-benefit conversation they have with their provider. Finalizing the paper document gives the patient an opportunity to ask questions or seek clarification.
These parts of the form are commonly missed.
As a reminder, consent forms must contain all these elements:
- Name of patient and, when appropriate, patient’s legal representative.
- Name of hospital.
- Name of specific procedure(s) or treatment(s).
- Name of the responsible practitioner performing the procedure(s) or administering the medical treatment.
- Signature of the patient or legal representative.
- Signature of the witness* (must be a professional person, described below).
- Date and time the consent form is signed by the patient or the patient’s legal representative.
- Statement that the procedure or treatment — including the anticipated benefits, material risks and alternatives — was explained to the patient or the patient’s legal representative.
- If the procedure or treatment (including the anticipated benefits, material risks and alternatives) was not explained to the patient or the patient’s legal representative, explain why it would have been materially detrimental to the patient to do so, giving due consideration to the appropriate standards of practice of reasonable health care practitioners in the same or a similar community under the same or similar circumstances.
- Name of the person who explained the procedure(s) or treatment(s) to the patient or patient’s legal representative.
- The manner in which care will be provided in the event that complications occur that require health services beyond what the hospital has the capability to provide.
- The written informed consent form for surgery has requirements in addition to the other written informed consent requirements:
- Description of the proposed surgical procedure(s) including the anesthesia to be used.
- Name of the practitioner(s) performing the procedure(s) or important components of the procedure(s), as well as the name(s) and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner. (Significant surgical tasks include opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices and altering tissues.)
- Name of person who explained the procedure to the patient or patient’s legal representative. The properly executed surgical informed consent form will be incorporated into the patient’s medical record prior to surgery except in the case of an emergency. See Appendix A in the consent policy for flow diagram on entering the informed consent form into the patient’s medical record.
* A witness is someone other than the provider who observes the patient (or, when applicable, the patient’s legal representative) sign the informed consent form. The witness must be an Asante employee, contractor or medical staff member who is licensed by the state of Oregon or who is a medical assistant. The witness must sign the informed consent form to document that he or she was the witness. If a professional person other than the provider is not available to observe the patient’s or patient’s legal representative’s signature.
We acknowledge that consents can feel burdensome, but it is critical that we advocate for our patients by documenting all necessary consent information.
For more details, please take time for some light reading of the policy to refresh on the roles and responsibilities of the consent process.
If you need answers for a personal work matter, please contact the author or department directly instead of leaving a comment.
Modern consent processes are moving from informed consent to knowledgeable consent. Knowledgeable consent highlights the person receiving services or a procedure knows (understands the why and how) rather than capturing a statement of agreement to having a procedure done. A key component of knowledgeable consent is encouraging the person about to receive a service or procedure to ask questions so that the service or procedure is understood to the receiving person’s satisfaction. An example statement for knowledgeable consent is, “I encouraged the patient to ask questions to assure that s/he fully understood the procedure and potential consequences, and answered her/his questions to her/his satisfaction.”