A 30-year-old male presents for shoulder arthroscopy under general anesthesia. Prior to induction, an interscalene block is performed without a nerve stimulator, and 25 ml of 0.5 percent bupivacaine with epinephrine is administered. The patient is not informed of any possible complications from the block. Surgery is performed uneventfully and the patient is discharged. Six days later, the patient complains of significant postoperative pain. A neurological examination is consistent with injury to the brachial plexus. Four months later, a neurological examination is unchanged. A settlement is reached against the anesthesiologist for $300,000 based on lack of informed consent.¹

What Is Informed Consent?
nformed consent requires an active communication between doctor and patient wherein the physician educates the patient, explaining the nature and purpose of the proposed procedure or treatment along with the attendant risks and benefits. The physician should describe alternative techniques that are available, including a description of the risks and benefits of the alternatives. The desired outcome is that the patient will have sufficient knowledge to make an educated decision whether or not to undergo the proposed therapeutic intervention.

This communication process is both an ethical obligation of the practice of medicine and a legal requirement spelled out in statutes and case law in all 50 states.² Today’s patients present armed with information garnered from the Internet and their friends and relatives and are ready for dialogue. Many doctors provide them with the information necessary for informed decision-making but do not adequately document the discussion. These physicians may find themselves vulnerable when a patient experiences an unexpected outcome and litigation ensues.

Legal Implications
Most consent cases are based on allegations of negligence of the physician in disclosing sufficient information for the patient to make an informed decision regarding health care. Cases based on negligence are covered by liability insurance whereas cases based in battery are not.²

The type and nature of information that must be disclosed to the patient during an informed consent discussion varies from state to state. Most states have adopted the “reasonable patient” standard, which requires a physician to disclose information that a reasonable patient under similar circumstances would want to know to make an informed decision.³ Under this standard, the physician would only need to disclose those risks that are deemed “material.” Material risks are those that “a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.”⁴ In common parlance, material risks are those that may not be severe but occur more commonly (e.g., nausea, vomiting, oral/dental damage, sore throat) as well as those that are rare but of major consequence (e.g., death, paralysis, recall).

How Should Consent Be Documented?
The Joint Commission on Accreditation of Healthcare Organizations requires documentation of all of the elements of informed consent “in a form, progress notes or elsewhere in the record” (Standard RI.2.4.0). There are three predominant schools of thought among anesthesiologists and professional liability carriers with regard to documentation.

Handwritten Note: Proponents of a handwritten note detailing the specifics of the discussion held with each individual patient advocate that a precise description of the risks of the particular anesthetic technique(s) unique to that patient provides the best evidence that the discussion did indeed take place and was tailored for that patient. In a busy operating suite, the time necessary to hand-write a note for each patient may be unacceptable. Many of the risks are similar for all patients, and it may be inefficient to rewrite the basic text of common risks for each patient.

Separate Anesthesia Consent Form: Proponents of a separate, written anesthesia consent form argue that the common risks can be clearly detailed on a separate form, and patient-specific risks can be written in longhand, thus decreasing the time necessary for documentation. Opponents state that patients seldom read or understand preprinted consent forms and that a separate anesthesia consent form only adds an additional layer of paperwork. Opponents also worry that the form itself might be inappropriately substituted for the informed consent process.

Reliance on Surgical Consent
Many anesthesiology practices rely on a sentence in the surgical consent document that may state something such as “anesthesia is required for the procedure, and there are associated risks ….” This approach is flawed from many viewpoints. Oftentimes the procedural consent is signed in the surgeon’s office during the patient’s preoperative visit, and the patient has yet to meet an anesthesiologist. The surgeon is not trained to formulate an anesthesia care plan or to discuss the risks, benefits and alternatives — that is the role of the anesthesiologist! In some areas of the country, surgeons refuse, for liability reasons, to have a sentence or paragraph relating to anesthesia risks in “their” consent document.

There has been a rapid growth in nonsurgical procedures that require anesthesia. Many centers provide an anesthesia team each day to care for patients who are young, claustrophobic or developmentally delayed who require imaging studies or therapeutic procedures. Using a surgical consent for these procedures is inappropriate. Absent a preprinted anesthesia consent form, the anesthesiologist has no alternative but to provide a handwritten documentation of the informed consent discussion in the patient’s record.

Anesthesiologists have long been engaged in the battle to be recognized as skilled professionals whose scope of practice is far different from that of our surgical colleagues. Delivery of safe anesthesia care is a challenging process that requires engaging our patients as partners in their care to ensure the best outcome. As professionals we must take our own “time out” to ensure that our patients understand the anesthesia care plan we develop together, answer their questions and document our discussion in detail. It is time for us to acknowledge that anesthesia care is a separate but critical part of the patient’s procedural care and to treat the informed consent process as an integral part of that care.

There is an old adage that is frequently taught in anesthesiology residency training programs: “If you didn’t write it down, it didn’t happen.” Adopting a well-thought-out, separate written consent document for anesthesia care is one way to ensure that our professional discussion is documented appropriately.

References:
1. ASA Closed Claims Database <www.asaclosedclaims.org>. Accessed on March 26, 2006.
2. American Medical Association. (Legal Issues) Informed Consent <www.ama-assn.org/ama/pub/category/print/4608.html>. Accessed on March 25, 2006.
3. American Society of Anesthesiologists. Informed Consent. Available in: Manual for Anesthesia Department Organization and Management; 2005:1-18.
4. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.1972).

Colleen E. O’Leary, M.D., is Associate Professor and Interim Chair, Department of Anesthesiology, Medical Director of Perioperative Services, Adjunct Associate Professor, Department of Cardiovascular Perfusion, College of Health Professions, State University of New York Upstate Medical University, Syracuse, New York.