Informed Discussion and Informed Consent Documentation
Except in an emergency, an informed discussion and properly signed, dated and timed consent form must be obtained from the patient (or patient’s representative) and included in the patient’s medical record prior to the patient undergoing the following procedures:
- Any surgical procedure performed under general anesthesia, spinal anesthesia or major regional anesthesia or moderate or deep sedation
- Amniocentesis diagnostic procedure
- A diagnostic procedure which involves the intravenous or intraductal injection of a contrast material
Exception:
- An emergency exists.
- The patient requests no informed discussion.
- At the time of the informed consent process, a new or additional procedure was unforeseen or not known to be needed and the patient consented to allow the performing/ordering physician to make the decision concerning the new or additional procedure.
- Informed discussion and informed consent documentation is delegated to hospital staff that performs diagnostic procedures involving intravenous (IV) injection of contrast material. In this situation, the hospital staff that performs the procedure provides information pertinent to the procedure and any questions hospital staff is unable to address are referred to the performing/ordering physician.
- For minors, if child abuse is suspected. However, if the minor is 16 years of age or older and refuses to consent to examination for child abuse, the minor may not be examined.
- The physician providing or performing the treatment and/or procedure conducts the informed discussion with the patient.
- During the informed discussion, the physician should allow the patient the opportunity to ask questions and receive answers about the proposed treatment and/or procedure. This will assist the patient in deciding either to proceed or refuse the proposed treatment and/or procedure.
- Informed consent is obtained by the physician performing certain procedures, medical treatment or diagnostic tests.
- The physician should obtain documentation of the patient’s understanding of the informed discussion by assisting the patient in completing the appropriate informed consent for their planned care, treatment or service. (The name of the physician who explained the information to the patient must be noted on the consent.)
- Ensure all sections of the consent are completed prior to obtaining the patient’s signature.
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