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Informed Consent Form Process & Documentation

Blog_SurgicalInformedConset_InformedConsentSignDrPatient_260x200px.jpgObtaining the informed consent of the patient is required in all states before an invasive procedure that carries a material risk of harm is performed. This is a non-delegable duty of the practitioner who is going to perform the procedure; this means that the practitioner is ultimately responsible for the validity of the consent and cannot avoid liability by claiming that it was someone else’s responsibility.

However, obtaining informed consent should not be construed to be an obstacle. Obtaining informed consent can be a mechanism for reconciling the expectations of all parties involved. It is important for the surgeon to understand and appreciate the expectations of the patient and reconcile them with the possible outcomes of the procedure. It is a recipe for disaster when a patient goes into a surgical episode of care with unrealistic expectations.

Overview of Claims and Liability Issues

In a review of 58,518 surgery-related malpractice payment using the National Practitioner Data Bank, Orosco and coauthors reported that 2.29% alleged "failure or lack of informed consent". Even though it is a rare occurrence, improved informed content processes can reduce this risk. It is also true that informed consent cases are originally brought in tandem with a medical malpractice case. When the patient cannot prove that negligence occurred, only the informed consent claim remains. Accordingly, the number of verdicts for lack of informed consent may include several claims in which there was no negligence – only a bad outcome. A proper discussion of risks, benefits and alternatives can reduce the incidence of verdicts and settlements in cases where the surgeon did nothing wrong.

To obtain the patient’s informed consent, the practitioner must advise the patient of the risks and benefits of the proposed procedure as well as the alternatives. Cases are almost never brought because the practitioner did not explain the benefits of the procedure, and only a few are brought because the practitioner did not discuss the alternatives to the procedure. The majority of medical malpractice cases related to informed consent involve the failure to discuss one or more of risks of the procedure that subsequently occurred.

As noted, the risks that need to be addressed are generally those that carry a material risk of harm. It is in defining which risks are “material” that many problems are encountered. There are two schools of thought on this issue:

  • The reasonable practitioner. The test is: “What would a reasonable practitioner disclose under the same or similar circumstances?”
  • The reasonable patient. The test is: “Of what risks would a reasonable patient want to be aware before consenting to the procedure?”  

The application of these tests varies by state, and some states use both tests.

Informed Consent Forms & Process

website_author_west.jpgIt is important to remember that consent is not a form; it is a process. The form merely memorializes the process. The process includes all discussions, informational hand-out materials, videos that the patient watched, and the form that the patient signed. Complete documentation of the entire process is highly recommended.

Consent forms often contain a great deal of standard (boilerplate) information such as that noted above that is often taken for granted. There is usually a good reason for the standard language, and surgeons should be careful to retain it when modifying the form.

Any procedure carries a risk that the surgery may need to be more extensive than the surgeon originally anticipated. This is a risk of which the patient should be aware. This means that the surgeon can deal with unforeseen complications without getting additional consent, but it does not mean that the surgeon is free to do whatever he or she feels is necessary. Any extension of the surgery needs to be reasonably related to the procedure for which consent was originally granted.

Best Practices for Obtaining Informed Consent

The American College of Surgeons’ Statements on Principles as revised April 12, 2016 addressed the issue of informed consent, which is considered a standard of ethical surgical practice, not just a legal requirement. The statement, in part, stipulates the following:

“Surgeons must fully inform every patient about his or her illness and the proposed treatment. The information must be presented fairly, clearly, accurately, and compassionately. The surgeon should listen carefully to understand the patient’s feelings and wishes and should answer all questions as accurately as possible. The informed consent discussion conducted by the surgeon should include:

  • The nature of the illness and the natural consequences of no treatment.
  • The nature of the proposed operation, including the estimated risks of mortality and morbidity.
  • The more commonly known complications, which should be described and discussed. The patient should understand the risks as well as the benefits of the proposed operation. The discussion should include a description of what to expect during the hospitalization and posthospital convalescence.
  • Alternative forms of treatment, including nonoperative techniques.
  • A discussion of the different types of qualified medical providers who will participate in their operation and their respective roles.”

The AMA also has a stand on the discussion of alternatives in the informed consent process. It states:

“The patient’s right of self-decision can be effectively exercised only if the patient possesses enough information to enable an informed choice. The patient should make his or her own determination about treatment. The physician’s obligation is to present the medical facts accurately to the patient or to the individual responsible for the patient’s care and to make recommendations for management in accordance with good medical practice. The physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice. Informed consent is a basic policy in both ethics and law that physicians must honor, unless the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent. In special circumstances, it may be appropriate to postpone disclosure of information (see Opinion 8.122, “Withholding Information from Patients”).

“Physicians should sensitively and respectfully disclose all relevant medical information to patients. The quantity and specificity of this information should be tailored to meet the preferences and needs of individual patients. Physicians need not communicate all information at one time, but should assess the amount of information that patients are capable of receiving at a given time and present the remainder when appropriate.”

American Medical Association, Opinion 8.08 - Informed Consent (July 2012).

Informed Consent Documentation

Since liability may arise out of the failure to discuss a specific risk or the failure to document that a specific risk existed, it is important to be able to show which risks were discussed. There are various levels of proof available to show that a risk was discussed.

  1. The lowest level is for the practitioner to testify that a risk was discussed with the patient without documenting anything other than a signature on a standard consent form. 
  2. The next level is for the practitioner to document in progress notes that he or she discussed the risks, benefits and alternative treatments with the patient without specifying what was discussed. 
  3. A higher level of proof is for the practitioner to sign a consent form that states that the risks, benefits and alternatives were discussed with the patient. 
  4. The highest level of proof is to list the risks that were discussed on a consent form, have the surgeon and the patient sign it, keep one copy, and give the patient a copy.

website_author_savrin.jpgThe surgeon needs to document informed consent prior to surgery. In addition to the routine form, a personalized informed consent statement for each case places the surgeon in the best possible position to ensure that each patient was given appropriate informed consent. Consider the following example of a surgeon’s statement for surgery for a carotid endarterectomy:

I explained the diagnosis of carotid stenosis with transient ischemia attacks to Mr. Smith and his family. I advised them of the indications for surgery and discussed with them the various forms of operative and non-operative therapy. I also discussed the expectations, risks and possible complications of each, including but not limited to: artery damage, vein damage, nerve damage, paresis, paralysis, paranesthesia, anesthesia, voice change, voice fatigue, vocal cord paralysis, difficulty chewing, difficulty swallowing, recurrent stenosis, infection, hemorrhage, TIA, CVA, myocardial infarction and death.

They understand these risks; their questions have been answered. Mr. Smith requests we proceed with surgery as the most desirable method of managing his condition.

I have agreed to perform the procedure. He is aware that other personnel may participate in his care, including but not limited to other physicians, physicians in training, and nurses.

Summary

Surgeons should not bemoan the fact that informed consent may be required before performing a procedure. Rather, informed consent should be embraced as a way to protect against liability in the event of a bad outcome that can occur in the absence of negligence.

Learn more for CME: 

These concepts are discussed in extensive detail in the course Surgery: Risks with Informed Consent.

 

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Categories: Medical-Legal Issues, Surgery

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