ASCs can ensure best practices in the informed consent process through knowing state laws and ensuring patients fully understand the procedure, along with its risks and expected outcomes.
Patients need to know what is required, which takes more than just signing a consent form, says Debra Stinchcomb, MBA, BSN, RN, CASC, who offers a few tips for improving the informed consent process:
• Witnesses. The person who signs the informed consent document as a witness is documenting that the patient or guardian signed the form, not providing informed consent.
“It’s the surgeon’s responsibility to provide informed consent. The witness only verifies that the signature is that individual’s,” Stinchcomb explains. “If there are any questions from patients, the entire process needs to stop, and the surgeon needs to come out and answer the questions.” The surgery needs to wait until the surgeon can answer the patient’s last-minute questions. Usually, patients are well-informed by the time they make it to the day of surgery. But ASC staff should know that any confusion on the patient’s part is a red flag to stop the process. “Make sure you get those questions answered before moving forward,” Stinchcomb adds.
• Guardianship. Stinchcomb says some states have passed laws that allow an emancipated minor who is not of the legal age of 18 to still sign consent for themselves. More often, there are cases of elderly patients who become confused periodically, and a family member needs to have a medical power of attorney and documentation, showing that family member can make medical decisions for the patient, Stinchcomb explains.
• Time limits. In some states, procedures are time-limited, meaning the procedure cannot be performed for a set number of hours after the patient has signed the informed consent form. An example of this would be tubal ligation or sterilization in which a patient has to wait 24 hours after signing consent, Stinchcomb says. “States that have time limits on procedures really want people to think about it,” she notes.
• Readability. Informed consent forms should be written in language patients can understand easily with one exception: “When it comes to the actual procedure, that should be written in medical jargon,” Stinchcomb says. “The main reason for that is due to the time-out in the operating room where everyone stops to make sure they’re doing the right procedure on the right patient. They’ll need to compare the consent form with what they’re doing.”
If the consent form describes the surgery one way, and the actual name for the procedure is something different, it might cause confusion or hold up the process.
• Language. When patients are not fluent in English, the informed consent process needs to include language interpretation, either with a professional fluent in the patient’s language or with the help of an interpretation hotline. When necessary, consent forms also should be in the patient’s language.
ASCs are responsible for ensuring patients can read and understand post-op instructions, consent forms, and other relevant information, Stinchcomb says.
• Documentation and storage. “The informed consent form should be kept within the medical record and retained for as long as that state requires a site to retain medical records,” Stinchcomb says. “In some states, that might be seven years; in others it’s 10 or 15. You should understand your state’s regulations.”