EXECUTIVE SUMMARY

The informed consent process must be maintained as a valid and effective part of patient care. There is substantial risk in allowing it to become routine.

  • Documentation is important but it is not the primary goal of the informed consent process.
  • Electronic records can inadvertently degrade the process.
  • Time pressures are the biggest challenge for physicians trying to inform patients.

Informed consent is a fundamental part of the healthcare process. Risk managers know the risks that can come with failing to adequately educate patients and document their consent. But the procedure is so common and performed so often that there is potential for it to become routine and less thorough.

Risk managers should constantly guard against that kind of relaxation of the informed consent process. That means emphasizing to clinicians what can happen when they let their guard down.

It is important to differentiate between the informed consent exchange with the patient and the documentation of that discussion, says David Feldman, MD, chief medical officer with The Doctors Company, a medical malpractice insurer in Napa, CA. Documentation of the informed consent process is important and necessary, but it is not the primary goal, he says. “People often conflate the two, and it is important to keep them in perspective,” Feldman says.

The actual conversation with patients and families sometimes can be hurried and less than ideal in terms of content and a good back-and-forth with the patient, Feldman says. That is usually because of time constraints rather than the clinician thinking a more effective discussion is not necessary.

However, the time constraints can combine with a sense of routine so that clinicians do not recognize that their informed consent process has deteriorated, Feldman says.

“In the practice of medicine in 2019, time is a battle. With all the distractions and time pressures from electronic medical records [EMRs], and vanishing resources in the face of more complicated patients in a hospital environment, it creates time pressures for clinicians to spend the appropriate amount of time discussing the risks and benefits,” Feldman says. “That becomes tricky when it’s a procedure that the clinician does a lot of, but for the patient it’s their entire world. The one operation that is routine for the surgeon may be a very big deal for the patient.”

Most physicians are better at obtaining informed consent than they were 20 years ago, but the time constraints threaten to undermine that progress, Feldman says.

Can Be Key in Litigation

Informed consent is central to almost every case in which medical negligence is alleged, notes Peter Kolbert, senior vice president for claims with Healthcare Risk Advisors in New York City, which provides insurance and risk management advisory services. (For more on the foundation of informed consent law, see the story in this issue.)

“We do worry about cookbook processes where papers are presented to people and someone has to sign that consent has been done. It’s a process, not a piece of paper,” Kolbert says. “At the same time, it is in the self-preservation interests of every physician to adequately document it. If everything goes right, only clinicians read that document. But who reads it if something goes wrong? A lot of lawyers.”

He agrees that the chief culprit in insufficient informed consent is the time pressure clinicians feel. “They are being asked to do more in the same amount of time, and the EMR has created some obstacles. Checkboxes and the lack of free narrative create a document that eliminates or removes free thought and the ability to write a narrative that includes the history and their thoughts about the patient,” Kolbert says. “Informed consent can be a victim of that push to fill in the EMR.”

Clinicians are keenly aware of the documentation needs for credentialing, accreditation, and the many aspects of patient care requiring records, Kolbert says, so much so that completing all the paperwork and checking all the boxes in the EMR can inadvertently draw focus away from what that documentation is supposed to represent.

Even if there was a truly meaningful informed consent discussion, it sometimes is not adequately reflected in the notes, Kolbert says. “I think every physician has the best intention and does discuss the procedure, but we need more than just a signature on a consent form. We need a narrative note written by the physician that they have had a conversation,” he says. “The danger becomes that it is not a process, that we’re just looking for a signature on a piece of paper. For the surgeon, it’s Wednesday and just another appendectomy, but for the patient, it’s the one time in their life they’re going in to have an appendectomy and maybe the only time they have any surgery.”

Patients Claim No Discussion

The danger comes when there is an adverse outcome and the patient claims, perhaps in good faith and perhaps not, that the conversation did not take place, Kolbert says. A simple signature and checkbox in the EMR is not much of a defense in that situation, but a good narrative note can be, he says.

“We’ve seen this in many lawsuits — not withstanding what actually happened — that the patient asserts no one explained anything to them. ‘I was in the waiting room, someone presented a consent form to me and I signed it,’” Kolbert says. “The benefit of the narrative note is that it is a time capsule one can refer to later on to demonstrate that a conversation was held. Fingers were put on a keyboard or a pen was put to paper at that point in time, indicating a conversation occurred.”

Fortunately, Kolbert says, EMRs are beginning to catch up with what physicians need to document. Modern EMRs allow and encourage physicians to include a narrative about the informed consent process, rather than relying so much on drop-down menus and checkboxes, he says.

Kolbert notes that malpractice claims often allege both insufficient informed consent and a technical error in how the procedure was performed. A thoughtful note about the informed consent process can defend against both claims, he says.

“Quite often the defense to the technical charge that something was done in error can be advanced with a note saying the physician discussed the possibility of this and it is a known risk,” Kolbert says. “The good narrative note can support them in both the consent claim and the technical performance claim.”

Audit Charts for Compliance

Time pressures may continue getting worse, Feldman and Kolbert both say. Risk managers may find it difficult to know how well their clinicians are performing the informed consent process and documenting it without actually witnessing it, which is impractical even to sample, Feldman says. However, a random audit of charts to look for adequate narratives may be possible.

Kolbert notes that research has shown an enormous disparity between what patients are told before a procedure and what they remember. That is good reason to take any allegation in a lawsuit of insufficient informed consent with a grain of salt, he says.

“It is still good practice to remind staff to never take this for granted, to emphasize that this is very important,” he says. “Remind staff that although this is what they do every day, it’s not for patients and they have to take their time, slow down, and explain this material in a meaningful way.”

Clinicians also should be reminded that a signed consent form is not a perfect defense, Feldman says. In virtually every lawsuit alleging the patient did not receive appropriate informed consent, there is a form with the patient’s signature saying otherwise, he says. Not all those cases are dismissed or won by the defendant, Feldman notes.

Kolbert points out that when a patient has been injured and claims not to have given informed consent, U.S. law does not require the plaintiff to say “If had I known the risks, I would have refused.” Instead, they rely on “If a reasonable a person would have known, a reasonable person would have refused.” The difference is significant, Kolbert says.

“The plaintiff does not have to prove that he or she would have refused, but that a reasonable person in that situation would have refused,” he says. “That can be a lower bar than proving that individual would have made a different decision.”

State Laws Vary

Informed consent law is state-specific, so physicians must understand the particular requirements of their own states, says Amy S. Flanary-Smith, JD, special counsel with Parker Poe in Columbia, SC. The legal obligation to obtain informed consent falls on the physicians, even though hospitals usually maintain the documentation because they need it to receive payment and to meet the Medicare Conditions of Participation, she notes.

State statutes on informed consent typically outline categories of information that must be conveyed, Flanary-Smith explains. They include the professional standard of what other physicians would disclose, and then the standard of what the patient would want to know. Some states use a modified version of the second, requiring disclosure of what a reasonable patient would want to know.

“We have seen movement toward physicians taking the informed consent more seriously, with many surgeons completing the informed consent process before the patient comes to the hospital,” she says. “If the informed consent process were to become a matter of just handing the patient a document to sign, without a true exchange of information, that would be a problem. Fortunately, that is not something we encounter very often.”

Readability and understanding of printed information can be a concern, Flanary-Smith says. Physicians should be certain that a patient can read and comprehend the information, obtaining translation to another language when necessary and explaining terms in a way the patient can understand, she says. The same concerns can occur with verbal conversations, so it is important to ensure that the patient understands and is not just listening politely, she adds.

Some physicians are using video presentations of the potential risks associated with a particular procedure in addition to the personal conversation, Feldman notes. He used such videos when he practiced as a plastic surgeon.

Kolbert notes that the videos can be linked to the patient record and even shown to the jury if there is a claim involving informed consent. “We need to take informed consent to the modern age,” Kolbert says.

SOURCES

  • David Feldman, MD, Chief Medical Officer, The Doctors Company, Napa, CA. Phone: (800) 421-2368.
  • Amy S. Flanary-Smith, JD, Special Counsel, Parker Poe, Columbia, SC. Phone: (803) 253-6853. Email: amyflanarysmith@parkerpoe.com.
  • Peter Kolbert, Senior Vice President for Claims, Healthcare Risk Advisors, New York City. Phone: (800) 869-0751.