any anesthesiologists are aware that there has been some controversy regarding surgical informed consent in the famous “Interpretive Guidelines” (IGs). The IGs constitute the 307-page Appendix A to the State Operations Manual, and they are Medicare’s detailed instructions to hospital surveyors — including those from the Joint Commission on Accreditation of Healthcare Organizations — for determining whether a hospital satisfies the Conditions of Participation for hospitals appearing in the Medicare regulations. The entire Appendix is available at <www.ASAhq.org/Washington/Medicare Interpretive Guidelines.htm>.

The IGs for Anesthesia Services (Regulations §482.52(b), p. 278 of Appendix A) do not say anything about informed consent except that the anesthesiology department’s policies must address “patient consent.” The treatment of informed consent under Surgical Services (§482.51(b) (2) p. 270), however, is quite detailed. Interpreting Regulations §482.51(b) (2) p. 270), the IGs provide:

A properly executed informed consent form contains at least the following:

• Name of patient, and when appropriate, patient’s legal guardian;

• Name of hospital;

• Name of procedure(s);

• Name of practitioner(s) performing the procedure(s) or important aspects of the procedure(s) as well as the name(s) and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner. (Significant surgical tasks include opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues);

• Risks;

• Alternative procedures and treatments;

• Signature of patient or legal guardian;

• Date and time consent is obtained;

• Statement that procedure was explained to patient or guardian;

• Signature of professional person witnessing the consent; and

• Name/signature of person who explained the procedure to the patient or guardian.

Nothing in this list — which is, of course, directed toward surgeons — answers explicitly the question of whether there should be separate written hospital, surgical or anesthesia informed consent forms. The narrative instructions to the hospital surveyors give some guidance in the following language:

The responsible practitioner must disclose to the patient information necessary to enable the patient to evaluate a proposed medical or surgical procedure before submitting to it. Informed consent requires that a patient have a full understanding of that to which he or she has consented. An authorization from a patient who does not understand what he/she is consenting to is not informed consent.

The issue is whether the patient is or is not sufficiently informed about the procedure. The signature is virtually meaningless if the patient subsequently denies having understood the purpose or nature of the form. How is the adequacy of the information best assured? There is a presumption that “the responsible practitioner,” i.e., the surgeon, is the best person to discuss the risk and benefits and alternatives to the procedure proposed with the patient. Information printed on a consent form or summarized by a nurse or even a resident may not seem as important to a patient as the surgeon’s personal attention and interest in the patient’s understanding.

This is even truer in the case of the information regarding anesthesia. Do you trust the surgeon – or the surgical nurse, or for that matter, a nurse anesthetist or anesthesiologist assistant whose role may not be clear to the patient – to ensure that the patient understands the alternative types of anesthesia and the risks and advantages of each as well as why you believe that general anesthesia might be preferable to regional for this patient? Will that other party be able to elicit and answer the patient’s questions?

Again, the current IGs do not contain any requirements regarding the form of documentation of patient consent. We are aware that the Anesthesia Services section is being modified to include guidance on informed consent that will be similar to the requirements for surgery, and the new section could possibly be specific on separate written anesthesia informed consent.

The main reason why all four lawyers on the ASA staff firmly believe that anesthesiologists should always personally obtain and document in a separate, distinct form their patients’ informed consent to the anesthesia service is based on managing legal risk.¹ We do not know of any malpractice trial whose outcome turned on the lack of separate, written anesthesia consent, but we want you to appreciate that a jury would not be sympathetic to you if it looked as though you had not personally discussed the risks of anesthesia with the injured patient. This is the courtroom scenario that we would like to help you avoid:

Plaintiff’s Lawyer: Mr. Patient, did anyone ever tell you that you might have significant postoperative pain related to the anesthetic?

Plaintiff: No.

Plaintiff’s Lawyer: Mr. Patient, would you have consented to the interscalene block if anyone had told you that you might experience this ongoing pain?

Plaintiff: No.

Plaintiff’s Lawyer: I show you Exhibit 5A, a form headed “Surgical Consent” with your name filled in the blank at the top. Have you ever seen this form before?”

Plaintiff: No.

Plaintiff’s Lawyer: I draw your attention to the bottom of the second page, where you’ll see what looks like your own signature. Do you remember signing this form?”

Plaintiff: No. There were so many pieces of paper that people just stuck in front of me and told me to sign.

Plaintiff’s Lawyer: Look at page one, Mr. Patient. Do you remember reading the paragraph about anesthesia? And do you see where it says that you had the opportunity to have your questions about anesthesia answered?

Plaintiff: I never saw anything about anesthesia, and I never got to ask any questions about it.

Plaintiff’s Lawyer: Not even just before you went into the operating room? Didn’t the defendant, Dr. Anesthesiologist, come and talk to you right outside the O.R. about the type of anesthesia you were going to have and what its risks were? Didn’t she ask you if you had any questions even then?

Plaintiff: No. I don’t remember anything like that.

If instead the anesthesiologist had discussed the anesthetic alternatives and their risks and benefits with the patient before meeting him in the holding area, documented that discussion on a specific anesthesia informed consent form and contemporaneously obtained the patient’s and witness’ signatures, the patient’s disavowals would probably seem less credible. Indeed there could well have been a chance to establish the type of personal rapport that would have kept the anesthesiologist out of the lawsuit.

The informed consent process and its documentation, performed by the anesthesiologist, also would have complied with the IG requirements for surgical consent. Those requirements are likely to be extended to anesthesiology this year. Remember that the “responsible practitioner” must make sure that the patient has a full understanding before signing any authorization forms or giving consent. Anesthesia language on a surgical consent form that may well be handed to a patient by a nurse or ward clerk, with no explanation whatsoever, will not dependably do the job. That is true even if the surgical form is supplemented by the attending anesthesiologist’s attestation that he/she or another member of the care team discussed the anesthesia with the patient immediately before induction.

Although there is no empirical evidence that the IG-style informed consent process and separate anesthesia consent form lead to improved patient care, lawyers believe that they offer better protection to their clients. They also are required by an increasing number of state statutes.

The committees on Practice Management, Economics, and Quality Management and Departmental Administration have asked me to repeat that they welcome questions from their ASA colleagues where the combined knowledge of the committee members can be tapped.


Reference:
1. Bierstein K. Informed consent is more than a signature. ASA Newsl. 2002; 66(12): 28-30.

Karin Bierstein, J.D., M.P.H., works with members and committees on regulatory matters that affect practice management, quality management and departmental administration, and Medicare/ Medicaid issues.