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ASA NEWSLETTER
 
 
December 2002
Volume 66
Number 12

Practice Management


Informed Consent Is More than a Signature


Karin Bierstein, J.D.
Assistant Director of Governmental Affairs (Regulatory)



Coding Correction

On page 28 of the November NEWSLETTER, in Table 3 of the “Practice Management” column, the 2003 ASA Base Unit Value for code 00542 was mistakenly printed as “5.” The correct Base Unit Value for code 00542 is 15. We apologize for any inconvenience.

The updated table can be found at: <http://www.ASAhq.org/Newsletters/2002/11_02/pracMgmt.html>.


Should anesthesiologists obtain a patient’s “informed consent” themselves, or should they rely on the hospital staff or surgeons to collect patient signatures on consent forms? This question has resurfaced recently in several contexts, including the 2002 meeting of the Committee on Quality Management and Departmental Administration in Orlando, Florida. The committee is preparing to publish the 2003 edition of the Manual for Anesthesia Department Organization and Management (MADOM). Previous editions have contained a discussion of informed consent that includes a recommendation for separate anesthesia consent forms as well as sample forms. The appropriateness of that recommendation is the topic of this month’s column.


The Separate, Specific Anesthesia Informed Consent Form – PRO


The patient’s signature on a consent form provides written evidence that the patient has been informed of the risks of the recommended procedure and of alternative options and that he or she has consented to undergo the procedure based on that information.

A signed consent form is not indispensable unless required by a particular state’s statutes — it merely documents the informed consent process. This is very similar to the function that documentation serves in establishing compliance with Medicare billing rules. It provides evidence that physicians did what they claim to have done, but it does not substitute for the communication with patients (or for the immediate availability of medically directing anesthesiologists).

The informed consent process involves educating patients or their representatives in case the patient is unable to give valid consent. If consent has not been given or if the scope of the consent given has been exceeded, e.g., by the performance of additional procedures, then the patient may bring a lawsuit for battery (the traditional law school definition for battery is an “unwanted touching.”) Far more commonly, a medical malpractice lawsuit will include a claim based on the inadequacy of the information provided regarding the risks of the procedure.

What information will be adequate, then? In most states, the courts have adopted the “reasonable patient” standard and require the physician to disclose any information that a reasonable patient under similar circumstances would want to know in order to make an informed decision. For example, a physician who recommended radiation therapy for a lung cancer patient told her that the radiation was a “midplane dose” but did not inform her that the treatment involved a 1-percent to 2-percent risk of permanent injury to the spinal cord. In that litigation, the Tennessee supreme court explicitly adopted the “objective” reasonable patient standard and rejected the minority view that considers whether, subjectively, the individual patient would have consented to the procedure if fully informed of the risks.

For the “reasonable” anesthesia patient, material information will probably include alternative anesthesia procedures and the major risks and benefits of each. If moderate sedation is planned, the possibility of conversion to a general anesthetic should be disclosed. The anesthesiologist who will be supervising nurse anesthetists, anesthesiologist assistants or residents providing the care should inform the patient of that fact. The laws and court decisions governing the nature of the information to be discussed with the patient and the specific form of documentation of the patient’s consent vary from state to state.

Do you wish to rely on the surgeon or the hospital staff to provide all of the above information in a standard consent form?
Even if the form were to list every conceivable risk, which does not seem practical, the patient may ask questions to which the surgeon or hospital staff cannot give an accurate answer. In a Pennsylvania appellate court case, an esophageal cancer patient who suffered permanent lung damage attributed to a leak at the surgical site had asked the surgeon about his clinical experience. The surgeon failed to reveal that this was only the fifth time he was performing the procedure in five years. Although there is no duty to inform all patients about one’s qualifications, the fact that this patient had asked made the information material and relevant.

There is no one-size-fits-all set of information that can be reduced to a single preprinted form, which is why the form should document that all material risks have been disclosed but state clearly that the printed list is not exhaustive. Because the form is secondary to the actual informed consent process, it would make sense to obtain the patient’s signature on a specific anesthesia consent form following the oral educational session and discussion with the patient. The form should indicate that the patient had been given a satisfactory opportunity to ask questions. The anesthesiologist’s own signature would document that he or she had explained the necessary information.

Beyond the legal protection conferred through a thorough informed consent process, many experts emphasize the relationship benefits. Patients who have had a talk with the anesthesiologist that leaves them feeling properly informed are less likely to bring a lawsuit even if the outcome of the procedure is not what they expected. Having had face-to-face contact may also help a patient’s understanding of why he or she has received a bill from the anesthesiologist.

Practice tip:
Some practices have created videotapes explaining anesthesia techniques and risks. Again, the anesthesiologist should see whether the patient has any questions or needs additional information, but a videotape or other educational tool may shorten the process and at the same time give the patient a better understanding.

Exceptions: Consent need not be obtained if there is a true emergency. There also is an exception for “therapeutic privilege,” a concept that would protect the physician who reasonably believes that disclosure would prevent the patient from making a rational decision or would cause psychological damage to the patient. Finally, if the patient states that he or she does not want information on the risks of anesthesia, there is no need for it to be provided. The anesthesiologist should carefully and contemporaneously document the circumstances if informed consent is not obtained.


Using a Specific Anesthesia Consent Form — CON


The argument against using a separate and specific anesthesia consent form boils down to this: some anesthesiologists are unclear on the difference between a signature on a form and true informed consent. When they refer to “informed consent,” they mean a piece of paper in the patient record. Lawyers working with these anesthesiologists believe that it is safer to have no anesthesia consent form if that is what it takes to make their clients personally discuss the risks of anesthesia with their patients.

Admittedly, the informed consent discussion takes time and may seem burdensome. An anesthesiologist’s individual experience may suggest that the discussion makes no difference.

Where it does make a difference, however, the difference can be huge. Both the courts and patients themselves are increasingly insistent on patients’ rights to informed participation in their medical care. Although legal claims based on negligence in sufficiently informing the patient of the risks are almost always appended to a claim of medical malpractice, in one recent California case, lack of informed consent was the sole basis for a $6 million verdict. A 5-year-old patient had suffered bilateral thalamic infarctions during a cranial tumor resection and became mute, incontinent and blind. These were indeed risks of the procedure, and the patient’s parents did not challenge the neurosurgeon’s technical performance. Rather, they sued because the neurosurgeon had not mentioned the specific risks of stroke or blindness and because he had not advised them of the alternative of a subtotal resection. Nine out of 12 jurors felt that the parents would have sought a second opinion if they had been fully informed and that they would then have chosen the less aggressive alternative, even though it could not have been curative.

Last month, the ASA Washington Office received a long, articulate and detailed letter from a patient who was extremely unhappy with the lack of information provided regarding his anesthesia care in a major teaching hospital. The otolaryngologist had indicated to the patient that he would receive a local anesthetic for a routine intranasal surgery that would take just half an hour. Apparently the patient had a morbid “fear of general anesthetic specifically and unconsciousness in general” but did in fact lose consciousness. Discussion with the anesthesiologist occurred in the operating room and was limited to a statement regarding “one cocktail now and one in about a minute.” There was no mention of a general anesthetic, its risks or the possibility of postoperative nausea and vomiting, which were severe and shocking. The letter stated that had the patient been informed that general anesthesia would be administered, he would have declined the procedure altogether.

This letter presents only one side of the picture, and one hopes that the anesthesiologist and that practitioner’s entire department were less abrupt and cavalier than is alleged, preoperatively and postoperatively, about the patient’s and family’s concerns. Nevertheless, the patient perceives that he did not receive material information, and he remains very angry with the anesthesiologist and the hospital. A lawsuit may yet result, even though there appear to be no lasting physical effects of the anesthetic.

This is precisely what the anesthesia informed consent process and the discipline imposed by its documentation are intended to prevent.

Source Material:

• Ashe v. Radiation Oncology Associates, 9 S.W.3d 119 (Tenn. 1999).

• Duttry v. Patterson, No. 199 MDA 1999, 1999 PA Super 250; 741 A.2d 199 (Pa. Super. Ct. 1999).

• Professional Liability Newsletter Vol. 32, No. 4 (July-August 2002).



Practice Management Conference Scheduled
January 31-February 2, 2003 — San Antonio, Texas
The complete program and registration materials for the annual ASA Conference on Practice Management are available on the ASA Web site <www.ASAhq.org> under the “What’s New” section on the homepage. New survey data on creative scheduling, Health Insurance Portability and Accountability Act compliance, the best setting for a pain medicine practice and information on negotiating hospital stipends are among the many interesting subjects that will be presented. The Committee on Practice Management warmly encourages you to attend.

Please note that Jody Locke, who will speak on “The Net Collections Fallacy and Other Performance Metric Myths,” is a vice-president with Anesthesia Business Consultants, LLC. His previous affiliation was listed erroneously in the program brochure.



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