December 17, 2011

Anesthesia-Specific Consent

Texas has revised its statute on medical informed consent, 25 Texas Administrative Code, Chapter 601, effective January 16, 2012.  The new rules, adopted by the Texas Medical Disclosure Panel, require physicians to inform patients of the risks of anesthesia and/or perioperative pain management and to obtain their signed consent for these procedures.  Section 601.2 contains a list of specific risks that a physician or health care provider must disclose “fully.”  Section 601.9 sets forth a complete anesthesia consent form that should be implemented by Texas anesthesiologists, and that may serve as a model for practices in states that do not have their own statutes prescribing the content of the form.

The form above is quite similar to the model published by a well-known anesthesia professional liability insurer, Preferred Physicians Medical Risk Retention Group, Inc. in Issue 16 (2006) of its risk management newsletter, “Anesthesia & the Law.”  Other forms in actual use are reprinted in ASA’s Manual for Anesthesia Department Organization and Management.  Most forms, it should be noted, contain the names of the anesthesiologist, resident and CRNA as applicable.  The Texas model does not.  The Medicare Conditions of Participation-Interpretive Guidelines state (§482.24(c)(2)(v)) that:

An informed consent form, in order to be properly executed, must be consistent with hospital policies as well as applicable State and Federal law or regulation. A properly executed informed consent form contains the following minimum elements:

• Name of the hospital where the procedure or other type of medical treatment is to take place;
• Name of the specific procedure, or other type of medical treatment for which consent is being given;
• Name of the responsible practitioner who is performing the procedure or administering the medical treatment;
• Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient’s legal representative; (Material risks could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but high degree of severity. Hospitals are free to delegate to the responsible practitioner, who uses the available clinical evidence as informed by the practitioner’s professional judgment, the determination of which material risks, benefits and alternatives will be discussed with the patient.)
• Signature of the patient or the patient’s legal representative; and
• Date and time the informed consent form is signed by the patient or the patient’s legal representative.

If there is applicable State law governing the content of the informed consent form, then the hospital’s form must comply with those requirements.

A well-designed informed consent form might also include the following additional information:

• Name of the practitioner who conducted the informed consent discussion with the patient or the patient’s representative.
• Date, time, and signature of the person witnessing the patient or the patient’s legal representative signing the consent form.
• Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or the patient’s representative;
• Statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies and, in the case of residents, based on their skill set and under the supervision of the responsible practitioner.
• Statement, if applicable, that qualified medical practitioners who are not physicians who will perform important parts of the surgery or administration of anesthesia will be performing only tasks that are within their scope of practice, as determined under State law and regulation, and for which they have been granted privileges by the hospital.

We caution that any anesthesiologist considering adopting or updating an informed consent form should realize that state statutes or common law may require that the form contain specific facts or language.  A sizable number of states have informed consent statutes on the books, and one may vary a good deal from another.  A seemingly comprehensive, succinct and easily understood document in use a few hundred miles away may not provide your own group with sufficient protection in the unlikely event of malpractice litigation where consent is in issue.  A model form should only be adapted into your own practice if it is consistent with the statutes and regulations of the state where you practice.  Fortunately there are readily available sources for this information:  (1) your malpractice carrier, (2) your hospital’s legal department and (3) your state medical society.

The topic of anesthesia informed consent is by no means new or unfamiliar.  It is, however, dynamic, as shown by the work of the Texas Panel and legislature.  It is also more interesting than matters of mere technical compliance.  As recently as last July, two prominent anesthesiologists, Roger A. Moore, MD and Kevin K. Tremper, PhD, MD, revived the debate over whether anesthesiologists should use separate consent forms in Separate Anesthesia Consent: Pro/Con.   ASA Newsletter 2011; 75(7): 50-55.  Dr. Moore took the position that:

Documentation of the consent process is best provided by a detailed separate anesthesia informed consent document in conjunction with a handwritten note in the medical record. A separate anesthesia informed consent document is important for the purposes of ensuring proper documentation of the consent process, of promoting a minimum standard of professionalism in anesthesiology and of decreasing the potential for undermining an anesthesiologist’s credibility during a medical malpractice case.

Dr. Tremper, on the other hand, noted that there was virtually no reported litigation over the quality of the documentation of anesthesia consent, and questioned whether separate forms for anesthesia were of use to anyone:

Studies have documented that most patients do not remember or understand the consents they sign, especially in current practice where the vast majority of patients come in the morning of surgery and unfortunately meet us for the first time just prior to entering the operating room.  Although I think a good discussion is appropriate, I seriously doubt that having the patient sign a long list of bad outcomes (which looks more like a car leasing form than a medical record), immediately followed by 2 mg of midazolam to calm them and provide amnesia, will help the patient in any way.

The debate over the need for separate anesthesia consent has been continuing for years.   See, e.g., the set of four articles on this subject in the July 2006 issue of the ASA Newsletter.  The controversy relates only to the form in which consent is documented, of course:  it is a given that professional ethics and the principle of patient autonomy require that the patient be fully informed in fact of the risks of the procedure, and of the alternatives.  A more nuanced question is: how much information is appropriate?  Without reviewing any of the voluminous literature on the philosophical and ethical considerations, we will simply note that the patient-centric nature of healthcare reform is going to keep us thinking about all of our communications with patients.

As always, we are interested in your views and comments.

With best wishes,

Tony Mira
President and CEO