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Archived Content
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Before discussing the substantive issues the model forms were designed to address, it is important to
understand the concept of informed consent and the legal theories upon which the law is based. It is
equally important to remember that while this paper discusses the general rules applicable in most states,
the law may differ from state to state. Consequently, the law of informed consent in your state may be
different than what is stated herein. The model consent forms are sufficiently generic to be acceptable in
most jurisdictions. Readers are cautioned to thoroughly investigate their respective state laws that pertain
to informed consent or consult with legal counsel before attempting to implement the forms or draft
policies and procedures dealing with consent issues.
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was said, even if the evidence indicates that a meeting between provider and patient took place. The fact
that a meeting took place does not necessarily mean there was a meeting of the minds.
As a result, some providers argue that consent forms have no value because there is no way to adequately
prove that informed consent was obtained. This position should be resisted because it is incorrect and
legally problematic. Healthcare professionals must merge the concepts of communication and evidence
of consent so that when a challenge arises about an individual case the consent form itself will create a
strong presumption that informed consent was obtained.
The model consent forms incorporate substantial details of anesthesia techniques, risks and other elements
of informed consent so a strong presumption is established on its face. This does not mean they cannot or
will not go unchallenged. However, if the provider follows the guidelines in this document, it should help
in the event a dispute arises.
Court decisions have generally determined what needs to be discussed with the patient to effectively
satisfy the patient’s right of self-determination and the informed consent doctrine. Generally, a well-
designed consent form will merge most of the communication and evidence factors. Consequently,
standardized forms should contain the following elements needed for a patient to make an intelligent
decision regarding recommended procedures: 1) diagnosis, 2) nature and purpose of the treatment, 3)
risks and consequences of the particular procedure, 4) probability of success, 5) alternative treatment, and
6) prognosis if the proposed treatment is not given.
Regulatory agencies or state statutes may require additional information or more details. For example,
the Joint Commission on Accreditation of Healthcare Organizations calls for the above information, as
well as the date, patient's identity, names of the individuals who will perform the procedure, specific
authorization for anesthesia, and disposition of any tissues removed.2
The model consent forms in this document contain most of the required information discussed above
including specifics about the risks, expected results, and techniques used in each anesthesia procedure.
Anesthesia consent forms differ from surgical consent forms in that they do not contain the diagnosis, or
the surgical or diagnostic procedures. However, in the first paragraph on the model consent form the
patient acknowledges that the surgical consent process occurred and that he/she understands the reason
for anesthesia. This acknowledgment by the patient is included to protect all parties and assure that
appropriate informed consent took place.
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Obtaining Informed Consent from Impaired Patients
For the consent to be valid the patient must be able to understand the nature and risk of the proposed
treatment, as well as alternatives to it. Among the circumstances that can diminish or impair a patient’s
capacity to understand are: 1) the inability to speak or understand English, 2) the patient’s physical
condition adversely affects his/her capacity to decide, 3) senility or another mental or emotional
condition adversely affects the patient's capacity to comprehend, and 4) medication, alcohol or drugs
prevent comprehension. The patient must also have reached legal majority, which usually is 18 years old.
Anesthesia professionals who realize that the patient is either a minor or lacks capacity to consent should
obtain consent from a substitute who can legally provide it on behalf of the patient. Many states have
statutes that list in order of priority those who may consent for another. The following are commonly
accepted substitutes.
A parent (usually only one is necessary) for a minor child.
A husband or wife for a spouse.
A guardian for a ward.
Any adult standing in loco parentis (place of the parent) for a minor. (Often defined in state
statutes or case law; example, the principal of a boarding school.)
These are common rules as defined by law; however, there are other parties who also may provide
substitute consent in limited circumstances.
The doctrine of therapeutic privilege is an exception to the law of informed consent that grants physicians
the privilege of withholding information in instances where disclosure would likely harm the patient
either emotionally or physically. No legal authority has been found that extends the privilege to
nonphysicians. Therapeutic privilege should rarely be used and should only be exercised very
judiciously. It is recommended that the provider consult legal counsel in situations where he/she feels the
privilege might need to be exercised. There are many cases where the privilege is abused, usually by
withholding information because of fear that the patient might choose to forego the procedure if the risks
were known. In the event a provider should elect to use the privilege, a detailed note should be placed in
the patient’s medical record outlining all the relevant facts and circumstances regarding why the provider
reached the decision.4 (P. 71)
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Preanesthetic Evaluation Integral to Informed Consent Process
The process of informed consent is becoming more problematic because of the increase of same-day
surgery and the use of other nontraditional locations such as ambulatory surgical centers, physicians’
offices and clinics. As a result of this phenomenon, patients often arrive for surgery a short time before
the procedure is scheduled to begin. Consequently, providers frequently do not have enough time to
spend with their patients. When patients are medicated prior to obtaining consent, there is a risk that they
will lack the capacity to make an informed decision. These administrative barriers must be overcome so
that anesthesia professionals can satisfactorily fulfill their responsibilities. Adequate preanesthetic
evaluation is not only the quality standard of care, but the legal standard as well. The court, in LeBeuf v.
Atkins,5 said that, “The preanesthetic evaluation is integral to the informed consent process and the
provision of quality anesthetic care. The information elicited from such an evaluation concerning the
patient’s history might influence the requisite disclosure.”
In order to adequately meet the requirements of informed consent, anesthesia professionals should arrange
for a patient to arrive in ample time to conduct a preanesthetic visit with the patient or their substitute.
Regardless of the detail of the anesthesia consent form, the anesthesia professional should explain the
form and procedure to the patient or the substitute. The patient should not simply be given the form and
asked to read and sign it. In Brown v. Dahl,6 the court addressed this issue and reinforced the accepted
procedure when it said, “The requirement of obtaining an informed consent is not fulfilled by having the
patient sign a consent form unless the proper information has been provided to the patient. The health
care provider must supply the information, not just respond to questions.”
The degree of specificity regarding risks has always been an issue. In Lindquist v. Ayerst Laboratories,
Inc.,7 the court said, “The anesthesia provider is not required to inform the patient of every conceivable
risk, but only significant risks.” The model consent forms include all significant risks; however, space
constraints preclude adding all information that might be desirable in order to answer most questions a
patient might ask. A frequently asked question is, “What are the chances of dying or sustaining a serious
anesthesia complication?” In order to relieve anxiety and maintain good patient rapport, it is generally
wise to attempt to answer such a question by quoting statistics and emphasizing the improved safety of
anesthesia due to newer technology and monitoring techniques. Estimates of anesthesia mortality rates
vary according to which study is quoted. According to E. C. Pierce8 and Richard Keenan9, reports
published between 1954 and 1985 established mortality rates at somewhere between 1 per 1,56010 to
about 1 per 10,000 anesthetics administered. Recent studies11, 8, 12 have shown a dramatic reduction in
anesthesia mortality rates, with ranges between 1 per 185,000 and 1 per 280,000.
Besides the risks, the provider must mention the details listed in the above section on “Merging
Communication and Evidence.” In Sauro v. Shea,13 the court said, “The health care provider must
disclose the alternatives to and relative merits of proposed procedures or anesthetics. The comparative
risks between types of anesthetics must be disclosed as part of an informed consent. The health care
provider's belief that a patient already knows the risks of a proposed procedure is inadequate; valid
disclosure must be tailored to the immediate case.”
Once the consent process has been completed, an additional precaution can be taken by writing a brief
progress report or other note in the patient’s record stating that the provider met with the patient and/or
substitute, and informed consent was obtained. The note should include the time, date, and name of
persons present. This note, plus the signed and witnessed form, will create a strong legal presumption
that valid informed consent was obtained.
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Provider, not Hospital, must Obtain Informed Consent
The responsibility for obtaining a patient’s consent rests with the person who provides the actual
diagnostic, medical or surgical care. The specialist or consultant, not the referring physician, has the
obligation to obtain the patient’s consent to treatment.4 (P. 646) Case law generally holds that in the area of
consent it is not the hospital’s duty, and therefore hospitals (or other, institutions) cannot be held
responsible for obtaining a patient’s authorization for treatment.14 The only exception is when the
hospital knows that a physician has not obtained a patient’s consent.15 This general rule is based on the
fact that the surgeon or specialist carrying out the procedure is usually the person who has the most
knowledge of what is to be done and the risks and other details associated with the selected procedure.
The individual who obtains informed consent is responsible for informing the patient about other
individuals who will have access to the information about the patient. The hospital is responsible for
ensuring that the patient’s healthcare information is protected.16
Although this rule appears clear on its face, the use of the team concept can cause confusion. In the
anesthesia setting, it is recommended that the person who will be commencing and carrying out most
elements of the procedure, such as decisions about routes, agents, etc., should obtain the consent. Since
both nurse anesthetists and anesthesiologists are viewed as being specialists and qualified anesthesia
professionals, either can conduct the consent process. Institutions should avoid a situation where one
team member conducts the consent process, and it is that member’s last contact with the patient. This is a
risky practice that could raise allegations of misrepresentation as well as negligence in the event of an
adverse outcome. The patient may not understand that multiple parties will be providing anesthesia care,
or the patient might decide to go through with the procedure based on the confidence he/she has in the
person who conducted the consent process.
These model forms have not been copyrighted and healthcare professionals and institutions are welcome
to use all or parts of them in their own settings at no cost. We advise potential users to consult local legal
counsel before adapting the forms and to seek permission from the appropriate “forms” committee or
administrator of the hospital or institution in which you plan to use them. The AANA does not warrant
the forms as being free of legal defects, and providers who elect to use them do so at their own risk.
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Model Form without Transfusion Language
It has been explained to me that all forms of anesthesia involve some risks and no guarantees or promises
can be made concerning the results of my procedure or treatment. Although rare, unexpected severe
complications with anesthesia can occur and include the remote possibility of infection, bleeding, drug
reactions, blood clots, loss of sensation, loss of limb function, paralysis, stroke, brain damage, heart
attack or death. I understand that these risks apply to all forms of anesthesia and that additional or
specific risks have been identified below as they may apply to a specific type of anesthesia. I understand
that the type(s) of anesthesia service checked below will be used for my procedure and that the anesthetic
technique to be used is determined by many factors including my physical condition, the type of
procedure my doctor is to do, my doctor’s preference, and my own preference. It has been explained to
me that sometimes an anesthesia technique which involves the use of local anesthetics, with or without
sedation, may not succeed completely and therefore another technique may have to be used including
general anesthesia.
□ General Anesthesia Expected Result Total unconscious state, possible placement of a tube
into the windpipe
Technique Drug injected into the bloodstream, breathed into the
lungs, or administered by other routes
Risks Mouth or throat pain, hoarseness, injury to mouth or
teeth, awareness under anesthesia, injury to blood
vessels, aspiration, pneumonia
□ Spinal or Epidural Expected Result Temporary decrease or loss of feeling and/or
Analgesia/ movement to lower part of body
□ With sedation Technique Drug injected through a needle/catheter placed either
□ Without sedation directly into the spinal canal immediately outside the
spinal canal
Risks Headache, backache, buzzing in the ears, convulsions,
infection, persistent weakness, numbness, residual
pain, injury to blood vessels, "total spinal"
□ Major / Minor Nerve Expected Result Temporary loss of feeling and/or movement of a
Block specific limb or area of the body
□ With sedation Technique Drug injected near nerves providing loss of sensation
□ Without sedation to the area of the operation
Risks Infection, convulsions, weakness, persistent
numbness, residual pain, injury to blood vessels
□ Intravenous Regional Expected Result Temporary loss of feeling and/or movement of a limb
Anesthesia
Technique Drug injected into veins of arm or leg while using a
□ With sedation
tourniquet
□ Without sedation
Risks Infection, convulsions, persistent numbness, residual
pain, injury to blood vessels
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□ Monitored Anesthesia Expected Result Reduced anxiety and pain, partial or total amnesia
Care (with sedation) Technique Drug injected into the bloodstream, breathed into the
lungs, or by other routes producing a semi-conscious
state
Risks An unconscious state, depressed breathing, injury to
blood vessels
□ Monitored Anesthesia Expected Result Measurement of vital signs, availability of anesthesia
Care (without sedation) provider for further intervention
Technique None
Risks Increased awareness, anxiety and/or discomfort
I hereby consent to the anesthesia service checked above and authorize that it be administered by
________________________________________or his/her associates, all of whom are credentialed to
provide anesthesia services at this healthcare facility. I also consent to an alternative type of anesthesia, if
necessary, as deemed appropriate by them. I expressly desire the following considerations be observed (or
write “none”):
_____________________________________________________________________________________
I certify and acknowledge that I have read this form or had it read to me; that I understand the risks,
alternatives and expected results of the anesthesia service; and that I had ample time to ask questions and
to consider my decision.
_______________________ ____________________
Substitute’s Signature Relationship to Patient
_______________________ ____________________
Witness Developed by the
American Association of
Nurse Anesthetists -
1991
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Model Form with Transfusion Language
It has been explained to me that all forms of anesthesia involve some risks and no guarantees or promises
can be made concerning the results of my procedure or treatment. Although rare, unexpected severe
complications with anesthesia can occur and include the remote possibility of infection, bleeding, drug
reactions, blood clots, loss of sensation, loss of limb function, paralysis, stroke, brain damage, heart
attack or death. I understand that these risks apply to all forms of anesthesia and that additional or
specific risks have been identified below as they may apply to a specific type of anesthesia. I understand
that the type(s) of anesthesia service checked below will be used for my procedure and that the anesthetic
technique to be used is determined by many factors including my physical condition, the type of
procedure my doctor is to do, my doctor’s preference, and my own preference. It has been explained to
me that sometimes an anesthesia technique which involves the use of local anesthetics, with or without
sedation, may not succeed completely and therefore another technique may have to be used including
general anesthesia.
□ General Anesthesia Expected Result Total unconscious state, possible placement of a tube
into the windpipe
Technique Drug injected into the bloodstream, breathed into the
lungs, or administered by other routes
Risks Mouth or throat pain, hoarseness, injury to mouth or
teeth, awareness under anesthesia, injury to blood
vessels, aspiration, pneumonia
□ Spinal or Epidural Expected Result Temporary decrease or loss of feeling and/or
Analgesia/ movement to lower part of body
Anesthesia Technique Drug injected through a needle/catheter placed either
□ With sedation directly into the spinal canal immediately outside the
□ Without sedation spinal canal
Risks Headache, backache, buzzing in the ears, convulsions,
infection, persistent weakness, numbness, residual
pain, injury to blood vessels, "total spinal"
□ Major / Minor Nerve Expected Result Temporary loss of feeling and/or movement of a
Block specific limb or area of the body
□ With sedation Technique Drug injected near nerves providing loss of sensation
□ Without sedation to the area of the operation
Risks Infection, convulsions, weakness, persistent
numbness, residual pain, injury to blood vessels
□ Intravenous Regional Expected Result Temporary loss of feeling and/or movement of a limb
Anesthesia
Technique Drug injected into veins of arm or leg while using a
□ With sedation
tourniquet
□ Without sedation
Risks Infection, convulsions, persistent numbness, residual
pain, injury to blood vessels
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□ Monitored Anesthesia Expected Result Reduced anxiety and pain, partial or total amnesia
Care (with sedation) Technique Drug injected into the bloodstream, breathed into the
lungs, or administered by other routes producing a
semi-conscious state
Risks An unconscious state, depressed breathing, injury to
blood vessels
□ Monitored Anesthesia Expected Result Measurement of vital signs, availability of anesthesia
Care (without sedation) provider for further intervention
Technique None
Risks Increased awareness, anxiety and/or discomfort
I hereby consent to the anesthesia service checked above and authorize that it be administered by
________________________________________________ or his/her associates, all of whom are
credentialed to provide anesthesia services at this healthcare facility. I also consent to an alternative type
of anesthesia, if necessary, as deemed appropriate by them. I expressly desire the following
considerations be observed (or write “none”):
_____________________________________________________________________________________
BLOOD TRANSFUSIONS
The likelihood of needing a blood transfusion for this procedure is: □ Highly unlikely □ Possible □ Probable
I understand that there are potential risks from blood transfusions, though rare, and that some of these include
transfusion reaction, hepatitis, and AIDS (Acquired Immune Deficiency Syndrome). Initial in appropriate box:
□ I give consent to receive blood or blood products as determined by my anesthetist and doctor to be necessary for
my well-being.
□ I give consent to receive blood or blood products only as an emergency life-saving measure.
□ I do not want to receive blood or blood products under any circumstance.
I certify and acknowledge that I have read this form or had it read to me; that I understand the risks,
alternatives and expected results of the anesthesia service; and that I had ample time to ask questions and
to consider my decision.
_______________________ ____________________
Substitute’s Signature Relationship to Patient
_______________________ ____________________
Witness Developed by the
American Association of
Nurse Anesthetists -
1991
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References
1. 211 N.Y. at 126, 105 N.E. at 93 (1914).
2. Comprehensive Accreditation Manual for Hospitals 2004. Chicago, Ill: Joint Commission on
Accreditation of Healthcare Organizations.
3. 464 F.2d 772, (D.C. Cir. 1972).
4. Rozovsky FA. Consent to Treatment, A Practical Guide. Boston, Mass: Little Brown &
Company, 1984.
5. 22 Wash. App. 877, 594 P.2d 923 (1979).
6. 41 Wash. App. 565, 705 P.2d 781 (1985).
7. 227 Kan. 308, 607 P.2d 1339.
8. Pierce EC. Anesthesia risk modification: Reducing the incidence of mishaps. Wellcome Trends in
Anesthesiology. 1989;7:3-10.
9. Keenan RL. Anesthesia disasters: Incidence, causes and preventability. Seminars in Anesthesia.
1986;5:175-179.
10. Beecher HK, Todd DP. A study of the deaths associated with anesthesia and surgery. Ann Surg.
1954;140:2.
11. Lunn JN. Perioperative mortality: Lessons from the confidential enquiry into perioperative deaths
in three NHS regions. Lancet. 1987;2:1384-1385.
12. Pierce EC. Anesthesiologists' malpractice premiums declining. Anesthesia Patient Safety
Foundation Newsletter. March 1989:2.
13. 257 Pa. Super. 87, 390 A.2d 259 (1978).
14. 588 S.W.2d 134 (Mo. Ct. App. 1979).
15. 19 N.Y.2d 407, 280 N.Y.S.2d 373, 227 N.E.2d 296 (1967).
16. Health Insurance Portability and Privacy Act, 1996. Public Law 104 – 191.
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