Clinical Care

What you need to know about the new informed consent policy

New CMS rules require witnesses to patient signatures.

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Do you have old photocopied consents in your file drawers on your unit or in your department? Throw those old consents in the recycle bin. We’ve got new informed consent policy, which may prompt some questions. Let’s see if I can answer them for you.

What is informed consent? It is a consent to surgery, anesthesia, medical treatment or other type of procedure. It’s also a communication process that allows patients or their representatives, as allowed by Oregon law, to make informed decisions regarding their care. We have had a new informed consent in place since late August.

Patients have the right to be informed of their health status diagnosis, and prognosis, to be involved in their care planning and treatment, and to be able to request or refuse treatment.

Each patient or, when applicable, the patient’s representative, should receive adequate, understandable information to ensure they can make informed decisions. During the registration process, the patient will be provided the Condition of Services Rendered Form (400-PATR-0028E), which is the agreement to routine hospital services, diagnostic procedures and medical treatment.

Informed consent forms provide written acknowledgement by the patient or representative that the informed consent process occurred.

Here is something new and important: The new consent requires a witness signature. A witness is someone other than the provider who observes the patient or legal representative sign the informed consent form. The witness must be one of the following:

  • An Asante employee
  • A contractor
  • A medical staff member who is licensed by the state of Oregon or who is a medical assistant

The witness must sign and print their name legibly on the informed consent form to document that they witnessed the patient’s acknowledgement. If a professional other than the provider is not available to observe the patient’s or legal representative’s signature (this is rare), the provider may sign as the witness.

Why is a witness signature required?

A witness signature is required by the Centers for Medicare & Medicaid Services.

What is the witness verifying?

  • The name of patient and, when appropriate, patient’s legal representative
  • The name of hospital
  • The specific procedure(s) or treatment(s) provided
  • The name of the responsible practitioner who is performing the procedure(s) or administering the medical treatment
  • Signature of the patient or legal representative

Related policies

  • The informed consent policy can be found here.
  • The preparing a patient for surgery policy can be found here.
Tags: CMS, informed consent, Melissa Bellm, new forms, procedures, signatures
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If you have a question, please contact the author or relevant department directly.

1 Comment. Leave new

  • Question. Is the best practice to have the patient sign at the time and place of procedure? for instance in the hospital while checking in for said procedure and or surgery?

    Reply

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