EXECUTIVE SUMMARY

Obtaining patients’ informed consent is the physician’s responsibility, but the process is more than just a signature on a page.

  • Surgery center staff are witnesses who confirm the informed consent form has been signed.
  • Typically, the informed consent process communicates the time the patient will spend in recovery, potential adverse events, and what types of activities patients can handle as they recover.
  • When patients do not have mental competence and consent capacity, then a legal guardian or a person with durable power of attorney must sign an informed consent form on their behalf.

Surgeons know that obtaining acceptable informed consent from patients requires more than asking for a signature at the bottom of a form. What they might misunderstand is what the role is for the nurse and other healthcare providers (other than physicians) in the informed consent process.

“Sometimes, there is confusion [among] the public, attorneys, and other healthcare providers as to what is the role of the surgery center nurse or staff member with regard to informed consent,” says William A. Miller, JD, partner and chair of Higgs Fletcher & Mack LLP in San Diego. “They are generally not required by law to obtain informed consent. That is the role of the physician.”

Generally, it is the physician’s responsibility to diagnose, determine a treatment plan, and make recommendations to patients about the treatment plan. Physicians should ensure patients are fully educated about the procedures to be performed, along with risks and benefits. “The role of the surgery center staff is more of a witness when the informed consent form is signed at the surgery center,” Miller says.

Another issue is the notion that informed consent is synonymous with the informed consent form. Instead, providers should focus on the informed consent process, not just the signature.

“People tend to focus on the form that needs to be signed rather than on the process itself,” says Debra Stinchcomb, MBA, BSN, RN, CASC, senior consultant for Progressive Surgical Solutions in Fayetteville, AR, and former president of the Arkansas Ambulatory Surgery Association. “It’s important for patients to understand exactly what they’re having done. Informed consent should start with the surgeon in his or her office. Explain why the person needs surgery, any alternatives available vs. surgery, and any risks and benefits that the surgery is going to bring.”

Informed consent in the surgeon’s office also might include the physical therapist informing the patient of necessary therapy after surgery or information from other providers.

The informed consent process typically covers the time the patient will spend in recovery, potential adverse events, and what types of activities patients can handle as they recover. Patients should receive this information before they schedule the procedure. Then, on the day of surgery, the surgery center needs to ensure the patient has been fully informed, Stinchcomb says. “That’s where the consent form comes in, but the entire process is not just the form,” she adds.

Physicians and others might provide an informed consent form, but it is important that ASCs create their own facility consent form in which the procedure is described. This form should include a statement that reads, “I have been given information about my diagnosis about this procedure and any risks, benefits, and alternatives,” Stinchcomb notes.

Surgery centers can run into legal problems when patients believe the informed consent process was inadequate in some aspect. For example, one case involved a plaintiff who claimed brain damage post-surgery and wanted $15 million in damages, Miller says.

“The patient claimed to have consented to only a certain type of procedure being performed and further claimed the patient would not have gone through with surgery if the particular procedure was not performed,” he explains. “The physician contended the issue had been discussed with the patient preoperatively, and there was no agreement the surgery would proceed only if the particular procedure was performed.” The physician contended the particular procedure could be performed, but only if the physician concluded it was clinically necessary, Miller adds.

Conditional consent also could look like this hypothetical example: A patient visits an orthopedist and says, “My knee really hurts, and I’m willing to undergo knee surgery, but will only agree to have a knee replacement procedure.” In response, the doctor says, “OK, I think you are an appropriate candidate for total knee replacement.” But then right after starting the procedure, the doctor said, “I don’t think the knee looks that bad, so I’ll only debride the cartilage.”

In this scenario, Miller says the patient could sue the doctor, claiming that the patient’s consent was conditioned on the surgeon performing the total knee replacement procedure, not anything less than that. “The patient might say, ‘Had I known you would only do something less than total knee replacement, I wouldn’t have had surgery and anesthesia. Now, when I need a total knee replacement surgery in the future, I’ll have to go through a second surgery with all of its risks,’” Miller explains.

In other cases, patients might sue surgery centers claiming that the informed consent process was inadequate because they did not receive enough information, Miller offers. “If a patient wasn’t given enough information, then the claim generally is a claim for negligence. “If, on the other hand, I consented to procedure A, and you proceeded to procedure B, and you never obtained my consent in the first place for procedure B, then that’s a battery claim.”

For example, there could be a medical battery claim if a patient consented to surgery on his right knee but the surgeon performed surgery on the left knee. Typically, ASCs direct a pre-op nurse or someone in the registration area to handle informed consent and ask patients to sign the form.

However, there are some circumstances when the person handling the consent form should stop the process. For instance, if the person handling the consent form believes the patient has cognitive issues, the process should not continue. “Whoever notices that the patient is confused should notify nursing staff, the medical director, and surgeon,” Stinchcomb advises.

When patients do not exhibit mental competence or consent capacity, then a legal guardian or a person with durable power of attorney must sign an informed consent form on their behalf, Miller says. Since ASC procedures are elective surgeries, there is no emergency issue at stake. A delay until a medical guardian is available would be the answer.

“Make sure you have the right person making those decisions,” Stinchcomb cautions. “I have had some cases where people call us and say, ‘We had someone transfer from the skilled nursing facility, and we don’t have a medical power of attorney, so what can we do?’ I say, ‘You have to send them back and wait until you have [permission from] a power of attorney or a court-appointed guardian.’”

It is inconvenient to postpone surgery, but sometimes this is the prudent choice. ASCs should cancel a case where the patient’s decision-making capacity is questioned and there is no patient representative authorized to sign an informed consent form on the patient’s behalf, Miller recommends.

“You’re better off canceling the case than having the case go forward and risking an unfortunate complication and the question of whether the person had the competency to provide informed consent,” Miller explains. “Someone suing would say, ‘This is not an emergent procedure; it’s elective, and there would have been no harm to see if that person was competent.’”

Surgery centers also should pay attention to language barriers that might affect the patient’s informed consent. “At the physician’s office, if patients say they don’t speak English, and the doctor doesn’t have a translator, then how could the physician obtain a meaningful informed consent?” Miller asks. “Patients could have a family member translate, but most states require you to have a translation service available for the patient.”

If there is a complication during surgery, and the ASC and surgeon relied on a patient’s family member to translate, then it raises questions about the adequacy of the informed consent process.

“Who does a jury believe — a family member, who after the fact says they were not informed of all of these risks, or the nurse, who says they clearly understood it and communicated to me they understood it?” Miller says.

There are medical translation services available that could handle any language and dialect. Since these are elective procedures and not emergency situations, the surgeon should delay the case until a translator is available, Miller adds. Surgery centers must provide quality care in their work and also should provide optimal informed consent. “In my experience of 29 years of doing healthcare law, I know that ambulatory surgery centers are doing the best they can for their patients, and they want to provide excellent care,” Miller says. “Informed consent is one way to help minimize the perception that you don’t provide thorough care. It minimizes the risk of being sued.”