What to include in informed consent

When performing informed consent, there are several critical elements for hospitals, including a list of the procedures that your facility has compiled that require informed consent, says Sue Dill Calloway, RN, Esq., BSN, MSN, JD, a nurse attorney and medical legal consultant in Columbus, OH. Calloway recently presented an audio conference on "Informed Consent 2010: The Latest in CMS and Joint Commission Consent Requirements" for AHC Media.

This list is a requirement of the Centers for Medicare and Medicaid Services (CMS) and The Joint Commission. "You have to have a list of procedures that you do in the hospital, and you have to say 'yes' or 'no,'" Calloway says. "Make sure that all of the procedures that your physicians and your licensed independent practitioners are credentialed and privileged for are on that list."

CMS says that signed informed consent forms are needed for all hospital surgeries except in emergencies, she says. It "doesn't matter whether they're inpatients or outpatients," Calloway says.

Calloway supports individualized consent forms for each procedure, although she acknowledges that such forms take a lot of time and effort and they must be kept updated. "But I really think it's worth it, having been a defense attorney," she says.

CMS surveyors are told to confirm that the policy discusses state law and that the state law requirements are included on the consent form. They also are told to pull six medical records from the hospital. They also are told to ensure the consent forms have the minimal or mandatory elements, she says. Those elements are:

  • The name of the facility. When a patient is having elective surgery and is receiving the consent form in a doctor's office, the doctor doesn't always think to put the name of the hospital on the form, Calloway says. "That's one of the two that the doctors miss," she says.
  • The procedure.
  • Description of the surgery, plus risks and benefits.

The description of the surgery should include the anesthesia to be used, Calloway says. You have the option of spelling out the risks, benefits, and alternatives, or simply saying on the form, "The risks and benefits and alternatives have been discussed with me," she says.

"And of course, having been a defense lawyer, I would really like to say `the risks include but are not limited to,' and that you specifically name the reasonably known risks," Calloway says.

  • The practitioner.
  • Who is going to perform the surgery.

The Centers for Medicare and Medicaid Services (CMS) requires that you list whoever is doing important parts of the surgery, even if the surgeon is in the OR supervising the entire time, Calloway says. Patients must be informed about staff who are assisting, such as the RN first assistant, surgical physician assistant, or surgical resident, she says. However, you aren't required to list the names of the assistants, Calloway says.

She says that one teaching hospital says in its consent form, "We are a teaching hospital, and as such we have surgical residents on most of our cases and they do help us with important parts of the surgery including helping make the decision, helping close up the incision," etc.

List all potential physicians

Be careful, Calloway warns. "If you're in a group where you cover for each other like gastroenterologists..., just say, 'Anyone in our group could be doing the procedure including A, B, and C.' Or 'Dr. A is going to be doing it, but often, the way that we're set up, any of the [doctors] can fill in, and so you have permission for Dr. B, C, and D,'" she says. If you have one doctor listed, and another doctor performs the procedure, "you don't have any informed consent," she says.

  • Signature/date/time. The time is the second element that physicians often miss, Calloway says. Representatives from CMS and The Joint Commission want everything timed: "every time of every order, time of every consult report, a time of everything in the progress note," she says.
  • The state law requirements.

Recommendations for surgery centers

For ambulatory surgery centers, CMS officials say that a well-designed informed consent process would most likely include a discussion of the following:

  • a description of the proposed surgery, including the anesthesia to be used;
  • the indications for the proposed surgery;
  • treatment alternatives, including the attendant material risks and benefits;
  • who will conduct the surgery and administer the anesthesia;
  • whether physicians other than the operating practitioner will be performing important tasks related to the surgery. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices, and placing invasive lines;
  • whether, as permitted by state law, qualified medical practitioners who are not physicians will perform important parts of the surgery or administer the anesthesia, and if so, the types of tasks each type of practitioner will carry out; and that such practitioners will be performing only tasks within their scope of practice for which they have been granted privileges.

Don't forget the implants

In addition, informed consent documentation should include details of the implant, legal sources say.

One option is to list the specific type and size of implement, such as 450 cc Mentor silicone implant, says Patricia S. Calhoun, JD, associate at Buchanan Ingersoll & Rooney in Tampa, FL.

"The physician should have already thoroughly discussed this information with the patient, but by putting it in writing, the [ambulatory surgery center] can have some additional assurance that the patient is truly informed," Calhoun says.

However, the physician might not know ahead of time exactly what size implant will be used, which would mean that the consent would have to include a list of the options or a range of possible options, she says. In addition, the facility might not have that information in advance and would have to wait for the physician to provide the information before the consent is signed, which could cause delays, Calhoun says.

"And there is the problem about what happens when the physician no longer wants to use the proposed size or style, based upon his or her surgical findings," she says. "Surgery is an art, not just a science, and decisions made based on the findings during surgery are well within the standard of care"

Managers will have to weigh the options and determine if adding that information to the consent improves their outcomes and/or the quality of care, Calhoun says.