Recent court decision impacting informed consent process

 

By Andy Norton, MD, SVP and Chief Medical Officer

 

The Pennsylvania Supreme Court’s recent decision in the Shinal v. Toms case significantly impacts the informed consent process in Pennsylvania. The case involved an allegation that the operating surgeon failed to obtain informed consent for a neurosurgical procedure. As part of his defense, the surgeon presented testimony that his physician assistant also provided information about the procedure to the patient during the informed consent process.

 

The Supreme Court ruled that the duty to obtain a patient’s informed consent is a nondelegable duty owed by the physician conducting the surgery or treatment. In addition, the Court held that a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patient’s informed consent. The physician must personally disclose to the patient the risks, benefits, likelihood of success, and alternatives to the proposed procedure or treatment in order to obtain the patient’s informed consent.

 

In reaching its decision, the Court relied on the language contained in the Pennsylvania MCARE statute provisions related to informed consent. The statute provides that except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient’s authorized representative prior to conducting the following procedures:

  1. performing surgery, including the related administration of anesthesia
  2. administering radiation or chemotherapy
  3. administering a blood transfusion
  4. inserting a surgical device or appliance
  5. administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner.

The requirements imposed by the Court in the Shinal decision are effective immediately. Information provided to a patient by qualified providers other than the physician who is performing the procedure or conducting the treatment will not be admissible in a lawsuit to establish that informed consent was obtained.

 

Practice implications for providers:

(Note — The following guidance is based on currently available information. This situation is fluid and this guidance may be updated if additional information becomes available)

 

  • The provider performing the procedure must personally obtain the patient’s informed consent.
    • The attending surgeon/proceduralist performing the surgery must obtain informed consent. Obtaining informed consent for the surgery cannot be delegated to a fellow, resident, nurse practitioner or physician assistant.
    • The attending anesthesiologist must obtain informed consent for anesthesia and obtaining informed consent cannot be delegated to a fellow, resident or nurse anesthetist.
    • The fellow, resident, nurse practitioner or physician assistant who is personally performing a procedure (such as insertion of a chest tube or central line) may obtain the patient’s informed consent for that procedure.
    • The fellow, resident, nurse practitioner or physician assistant who orders the administration of a blood transfusion to a patient may obtain the patient’s informed consent for the blood transfusion.
    • The attending physician ordering a PICC line to be inserted by a member of the PICC team must have the informed consent discussion with the patient and document consent via the CPOE order (this is currently embedded in the Siemens CPOE PICC order).  The PICC team RN may finalize the consent document. Obtaining informed consent for PICC line placement in procedural areas (non PICC team insertions) such as Interventional Radiology, is the responsibility of the practitioner inserting the PICC line.
  • The informed consent process must include a description of the procedure, disclosure of the risks and benefits of the procedure or treatment, the likelihood of success, and alternatives. The provider performing the procedure or treatment must personally answer any questions the patient requires in order to feel informed and willing to consent. There must be direct communication between the provider performing the procedure and the patient during the informed consent process, with a face-to-face exchange of information except in circumstances where the individual providing consent on behalf of the patient is not available for a face-to-face discussion.
  • With respect to informed consent forms, the best practice is for the provider performing the procedure to sign the form and have the patient sign the form at the time informed consent is obtained (i.e., at the time of the direct communication between the provider and the patient). The provider should also document a contemporaneous note in the medical record describing the information provided and the discussion between the provider and the patient. If the patient is at particular risk for a complication based on his/her/their condition or circumstances, this should be discussed with the patient and documented in the medical record.

 

If you have any questions about the informed consent process, please feel free to contact your facility’s Patient Safety Specialist or the Main Line Health legal department.

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