Using informed consent forms vs. progress notes
While not required, forms ensure accuracy
If it’s not documented, it didn’t happen. That applies to informed consent as well as all other activities associated with same-day surgery. Even though obtaining informed consent is a responsibility of the surgeon, all same-day surgery managers should make sure the consent is documented in a manner that clearly meets accreditation, state, and federal guidelines, says Jean S. Clark, RHIA, director of health information services at CareAlliance Health Services in Charleston, SC.
Although there is no requirement that a separate form be used to document informed consent, the best way to ensure documentation is to use a form, she says. "Relying on physicians to document the informed consent in the progress notes doesn’t work," Clark says. "We’ve conducted chart reviews to see if it happens on a regular basis, and it doesn’t."
About three years ago, Clark’s hospital gathered the variety of informed consent forms that were being used throughout the facility and pared the number to three forms. "We have a surgical consent that includes anesthesia and blood transfusion consents, a surgical and anesthesia consent that does not include blood transfusion, and a consent form for medical patients receiving blood," Clark says. "We’ve chosen not to include specifics about the risk of surgical procedures on the form because we wanted to keep the form to one page to make it easy for the patient to read." The form includes language that indicates the physician explained the risks, benefits, and options for treatment, she says.
Informed consent forms that contain a description of risks for specific procedures are the direction taken by Hanover (PA) Hospital. "We have one general consent form and 40 specific consent forms that have been developed at the physicians’ requests," says Pamela Owens, RHIA, director of health information management at the facility. (To see Informed Consent for Stone Manipulation, click here.) "Our hospital attorney designed a template that includes the terms and language we needed, then we add the risks and complications that are specific to the procedure," she explains. The surgeons who perform the procedure for which the consent form is designed are involved in the review and approval of the final form, Owens adds.
Although there are no requirements for a form or for signatures on the form, both Owens’ and Clark’s facilities require a signature from the patient, a witness, and the physician. "Our legal counsel recommends that the signatures be obtained as further proof that risks, complications, and options were explained," Owens says.
Clark says physicians at her facility have to sign the informed consent form before they go into the operating room. "The patient signs the form during the admitting process on the day of surgery after the admitting nurse has verified that the physician discussed risks and options," she says. "If the patient says the surgeon did not discuss these things, the physician is called to the admitting area and asked to talk with the patient."
Because Owens’ facility offers specific procedure forms as well as a general informed consent form, packets are sent to the physicians’ offices so the forms can be completed prior to the day of surgery and sent over to the same-day surgery program. "If a form is not completed at the physician’s office, we have the patient sign the general consent form during the admission process," she says.
There are some instances that require going ahead with a procedure even though the patient has not signed the informed consent, Clark says. "If the patient is not alert, not able to communicate, or not competent to give informed consent, we’ll contact family members or guardians by telephone," she explains. "If we have to rely upon a verbal consent, we have two RNs on the line talking with the family member.
"Two RNs are necessary since the family member giving the consent will not be signing the form. The second RN is an extra witness to the consent in case questions are asked about the validity of the consent later," Clark says. Both RNs sign the consent form as witnesses, she adds.
Although most people complain about extra paperwork, there have been no complaints about informed consent forms, Clark says. "The forms have made it easier for the physicians," she says. "It is one less piece of documentation that they have to remember to include in their progress notes, and we can be sure the medical record is complete." (For more information, see "Have your patients truly given informed consent?" Same-Day Surgery, April 2001, p. 45.)
Sources
For more about informed consent, contact:
• Pamela Owens, RHIA, Director of Health Information Management, Hanover Hospital, 300 Highland Ave., Hanover, PA 17331. Telephone: (717) 633-2050. Fax: (717) 633-2265.
• Jean Clark RHIA, Director of Health Information Services, CareAlliance Health Service, 316 Calhoun St., Charleston, SC 29401. Telephone: (843) 724-2291.
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