Has the patient given informed consent?
Surgery staff is last line of defense
The patient is ready for surgery, or so the surgeon says. However, the circulating nurse says the patient is asking about the risks of the surgery and appears to be confused about what procedure is being done. Now the nurse is questioning whether this patient gave informed consent.
That's been a dilemma for nurses for a very long time," says Ramona Conner, RN, MSN, CNOR, perioperative nursing specialist at the Center for Nursing Practice at the Association of periOperative Registered Nurses (AORN). The perioperative nurse is responsible for ensuring informed consent has been obtained and that it's appropriately signed and on the patient's record prior to surgery, Conner says. The circulating RN is the last guardian, the last one to check it," she says.
So how should this situation be handled to maximize patient safety and minimize the risk to the facility and the surgeon? If necessary, the nurse should delay administering of preoperative meds (if ordered) until the physician is located to answer any issues or unresolved questions the patient still has, says Waldene K. Drake, RN, MBA, vice president of risk management and patient safety at Cooperative of American Physicians — Mutual Protection Trust (CAP-MPT) in Los Angeles. Your policy on informed consent should discuss the right of the nurse/ supervisor to delay surgery and preoperative medications when a patient has verbalized concerns, Drake says.
The repercussions of not doing so can be severe. The Physician Insurers Association of America says that 15% of all surgical claims involve allegations of failure to obtain informed consent or failure to clarify elements of informed consent.
In 41% of all closed claims that include those allegations, the patients receive payments, the association says.
However, it's a significant liability for surgery center or hospital staff members who aren't surgeons to try to provide the informed consent discussion, says Anne M. Menke, RN, PhD, risk manager at the Ophthalmic Mutual Insurance Co. in San Francisco. In some states, it's illegal, because they're practicing medicine," Menke says. They're increasing their liability if they try to explain what's going to be happening and why." Instead, the staff should be making certain that the patient understands what's being done and has had a discussion with the surgeon, she says.
Informed consent cannot be delegated to anyone else by the surgeon, she says. Everyone has role in helping educate the patient about his condition and the proposed treatment of medication or surgery, but only the surgeon has the knowledge requirement to obtain an informed consent," she says. Menke points to a recent malpractice lawsuit in which a $3 million verdict was obtained by a patient who, among other claims, said there was no personal discussion of the eye procedure with the surgeons, although the patient did sign an informed consent.1 Some facilities put language into their medical staff bylaws that require surgeons to obtain informed consent in their offices prior to surgery. While the surgeon should discuss the benefits and risks of the procedure, the facility should have a separate consent form that the patient signs giving consent to be treated at the facility, sources say. The facility consent should state that the patient has met with the surgeon and discussed the need for and the potential risks of the surgery, sources say.
Often patients have been informed about the risks and benefits of the procedure in the surgeon's office, but they might not have absorbed all of the information given to them and they might not have understood what they were told, Conner says. Sometimes they feel more comfortable asking an RN until they really clearly understand," she says.
Surgery programs face special difficulties
Some surgery programs face the additional challenge of serving patients who live a long distance away and can't be seen until the day of surgery.
Those patients can be sent the informed consent document ahead to time to read and ask questions, Menke says. The morning of surgery, before patients are sedated, the surgeon personally should obtain the patient's informed consent, she says. However, some patients who had an informed consent discussion on the day of surgery have later sued and argued that they were forced to have the procedure and didn't have time to consider the benefits and risks, Menke warns.
It's important for physicians to convey that they are genuinely concerned about their patients, says Lewis A. Lefko, partner with Haynes and Boone, a Dallas-based law firm. That's why I prefer informed consent between physician and patient take place in physician's office, rather than when a patient is being rolled into OR," he says. Surgery centers and hospitals are pretty intimidating."
Keep in mind that informed consent can't be obtained from a patient who is sedated, Menke says. However, if the patient simply has dilated eyes, a family member or staff member may read the consent form to the patient, and then the patient can sign it. That person's name and relationship to the patient should be documented on the form, Menke says.
Additionally, when a patient's surgery unexpectedly changes after the case has started, a modified informed consent may need to be obtained from a relative who has been informed of the situation, sources say. In such a situation, the informed consent should be separately documented.
Before grabbing any type of informed consent form to copy, know who developed it and who commented on it, Lefko suggests. Several states, such as Texas, have medical disclosure panels that develop such forms, he says. [English and Spanish copies of the Texas informed consent form are available with the on-line edition of the December issue of Healthcare Risk Management. If you're accessing your on-line account for the first time, go to www.reliasmedia.com. Click on the Activate Your Subscription" tab in the left-hand column. Then follow the easy steps under Account Activation." If you already have an on-line subscription, go to www.reliasmedia.com. Select the tab labeled Subscriber Direct Connect to Online Newsletters. Please select an archive." Choose Healthcare Risk Management," and then click Sign on" from the left-hand column to log in. Once you're signed in, select 2006" and then select the December 2006 issue. For assistance, contact customer service at firstname.lastname@example.org or (800) 688-2421.]
You can fill those in, but the form doesn't keep you from having discussion," Lefko emphasizes. Also, keep in mind that different physicians may use different techniques, such as laparoscopic vs. an open approach, so the risks may be different, Drake says.
The form can help prepare patients for potential complications, Menke says. That's also an important piece of informed consent: Patients are important members of the health care team," she says. If they are better informed, they are better able to make their surgery go as good as possible."
1. New York jury issues $3 million verdict in medical malpractice case. LexisNexis Mealey's Personal Injury Report Aug. 10, 2006; 3. Accessed at www.mealeys.com/free%20views/per.htm#_New_York_Jury> citing Gropack v. Eric D. Donnenfeld, MD.