Department(s): Hospital Wide

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Effective Date:

Policy Title: Informed Consent

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Review Dates:

POLICY:

It is the policy of ______Hospital that the patient must be given the opportunity to give an "informed consent" prior to the performance of high risk procedures that place the patient at risk, diagnostic or therapeutic procedures, or situations when it is deemed advisable to have formal documentation of the patient's consent for treatment. Informed consent is the process by which the patient’s physician or other appropriate licensed independent practitioner provides the patient with information regarding the high risk procedure(s) or treatment(s) planned so that an informed decision by the patient can be made. Informed consent is necessary for complex procedures, not for simple and common procedures (i.e., the procedure is known to carry a low associated risk). Written verification of the informed consent must be on the patient's chart prior to initiation of the above stated procedures.

PROCEDURE:

1. Information provided to the patient includes, but may not be limited to:

  • The risks, drawbacks, complications and expected benefits or effects of the procedure and associated anesthesia
  • The nature of the treatment
  • The risks, drawbacks, complications and expected benefits or effects of such treatment
  • Potential problems related to recuperation
  • Any alternatives to the procedure and their risks and benefits
  • The likelihood of success
  • Possible result of non-treatment
  • That the patient understands the information
  • That the patient has been verbally informed about the anesthesia or procedure
  • That the patient has had the opportunity to ask questions
  • If any limitations in the confidentiality of patient information is discovered from or about the patient, the information will be documented in the progress notes

2. Obtaining Informed Consent:

  • It is the treating physician's responsibility to obtain the informed consent.
  • Hospital personnel cannot be involved in providing information that is necessary for informed consent - only the physician and/or anesthesiologist can provide the information.
  • Informed consent form is prepared by the attending physician or operating physician and is discussed with the patient by the physician.

3. Documentation in the medical record includes:

  • Notation that a discussion was held with the patient
  • That the informed consent was obtained
  • Patient signature of informed consent and receipt of a copy
  • Physician or other approved LIP signature (individual providing information regarding care, treatment or procedure to the patient)
  • Signature of the individual witnessing the signature of the patient and the date of the witnessed patient signature

4. Role of the Hospital in the Informed Consent Process:

  • Identification of professional status of any other individuals responsible performing treatments and procedures such as opening, closing, dissecting, etc.
  • Disclosure about any professional relationship the responsible physician, healthcare practitioner, the hospital staff or the hospital has to another healthcare provider or institution, that might suggest a conflict of interest, and
  • Any relationship to educational institutions involved in the case of the patient, or
  • Any business relationships between individuals treating the patient or between the organization and any other healthcare, service or educational institutions involved in the case of the patient.

5. Duration of Informed Consent:

  • Remains in force until the patient revokes the consent
  • Circumstances have changed which affect the nature of the risks of the procedure, and/or the alternatives to the procedure for which information was provided and consent was received