The age-old discussion of “informed consent” and “the consent form” never ceases. A procedure or treatment is scheduled and there is an order to obtain the patient’s consent. The nurse takes the consent form to the patient for signature and the patient inquires, “What am I signing? I have not spoken to the doctor yet.” A common allegation in malpractice lawsuits is the failure to obtain the patient’s consent for treatment. It goes beyond just getting the patient to sign a piece of paper.
The cornerstone of the informed consent process is the discussion between the physician and the patient. A patient has the right to consent (or not) to any recommended medical procedure or treatment. The patient also has the right to enough information to give an informed and meaningful consent. Before proceeding, the patient should be informed about the proposed procedure or treatment; the risks, benefits, and alternatives; and the risks and benefits of any alternative treatments. This informed consent discussion, as well as any written materials and videos, must be provided in a language that the patient understands. The discussion should include enough information so that the patient has a clear understanding and can make an informed decision whether or not to undergo the proposed procedure or treatment. Include a copy of the written materials, drawings, photographs, and names of videos reviewed with the patient in the medical record as part of your informed consent discussion documentation.
The patient also has the right to refuse the proposed procedure or treatment. In this case, the physician should ensure that the patient understands the risks and consequences that may result from the decision to refuse, or failure to pursue, a recommended medical procedure. This documentation must be thoroughly noted in the medical record, as above.
Patient refusal and documentation also applies to a physician’s recommendation that a patient see a specialist. The patient should be informed of the reasons for the recommendation and the possible consequences if the patient fails to obtain a specialist’s advice.
Another example of refusal occurs when there is a patient emergency in the office that triggers a need for EMS transport. If the patient refuses to utilize the EMS transport, the healthcare provider should explain to the patient and family, regardless of the distance, that the ambulance service is the safest vehicle transportation. If the patient opts to go by private vehicle, document the informed refusal discussion in the medical record.
In litigated cases, jury instructions related to informed refusal include: “A (physician) must explain the risks of refusing a procedure in language that a patient can understand. The patient should be given as much information as (they) need to make an informed decision, including any risk that a reasonable person would consider important in deciding not to have the said procedure/treatment. The patient must be told about any risk of death or serious injury or significant potential complications that may occur if the procedure/treatment is refused. A physician is not required to explain minor risks that are not likely to occur.” (CACI No. 534)
Tips for Patient Discussion
- Provide enough information so the patient can make an educated decision whether, or not, to agree to the proposed procedure or treatment.
- Provide the information in the language the patient understands. Provide written materials, drawings, videos to assist in discussion.
- Evaluate the patient’s understanding through teach-back methods; ask open-ended questions, allow time for patient questions.
- Identify an alternative treatment plan.
- Obtain the patient’s signature, if possible, if the patient refuses the procedure or treatment. (Perhaps have a witness present when a patient refuses treatment.)
- Document your discussion: diagnosis, proposed procedure/treatment, prognosis, risks and benefits of treatment and alternative treatments, and the consequences of refusing treatment. Whether your patient is refusing a surgical procedure, a medical treatment, referral for follow up, or other situation, document the discussion (risks, benefits, alternatives, and consequences) in the medical record.
Deborah Kichler is a Senior Risk Management and Patient Safety Specialist for CAP. Questions or comments related to this article should be directed to dkichler@CAPphysicians.com.