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Informed consent nightmares
Legal experts offer advice
Sue Dill Calloway, RN, Esq., BSN, MSN, JD, a nurse attorney and medical legal consultant in Columbus, OH,has had considerable experience in dealing with informed consent. Calloway recently presented an audio conference on "Informed Consent 2010: The Latest in CMS and Joint Commission Consent Requirements" for AHC Media, publisher of Medical Ethics Advisor.
Calloway has experienced her own issues with informed consent. When she tore her anterior cruciate ligament and went in for surgery, the registration clerk handed her a consent form and said, "Here you need to sign this that the risks, benefits, likelihood of achieving the results have all been discussed." "And I looked at her and I said, 'I'm extremely embarrassed because I'm a nurse, I teach this stuff, but you know I haven't talked to the doctor about the risks and benefits and alternatives,'" Calloway says. "And being very unsympathetic she looked at me and she said, 'Look, lady, if you don't sign this, you're not having surgery today.'"
Calloway's husband and mother had woken at 4 a.m. to take her to the hospital and were waiting with her, so she signed it. "If the surveyor had come to me and said, 'Oh, how was that informed consent process?' and I just repeated what happened, they would actually cite the hospital," Calloway says. "That registration person has now violated this requirement."
The reason? Informed consent is a process, not a piece of paper, Calloway says, "and when she knew that process had not been accomplished, just saying 'sign this form or you're not having it' is violating the standards." The Joint Commission and the Centers for Medicare and Medicaid Services (CMS) are emphasizing that informed consent is a process, she says.
Don't wait for a lawsuit to be filed before you develop a thorough informed consent process, Calloway warns. When she was doing medical malpractice legal work, she had three examples of what she considered to be the best informed consent. "I found out that they had all been sued before for informed consent, and that's when they got great informed consent," Calloway says.
Consider these suggestions:
Establish policies on intraoperative consents.
Ambulatory surgery programs should have policies about how intraoperative consents are obtained and who may grant such consent, says Patricia S. Calhoun, JD, associate at Buchanan Ingersoll & Rooney in Tampa, FL.
"Emergencies are different, but ASCs frequently run into the argument that they could have stopped and asked the patient," Calhoun says. "Because elective surgery can always be rescheduled, I think juries are less likely to understand going forward with a decision like this [different type of breast implant] from someone not authorized to grant consent in an elective surgery."
Policies must address right to refuse treatment.
Ensure your policies and procedures address the right to request or refuse treatment, Calloway says. "...I need to know what all the risks and alternatives are so I can make an informed decision, so that's part of the informed consent process," she says.
Have the consent on the chart before surgery.
CMS requires providers to have a consent form in the chart before patients go to surgery, except for emergencies, Calloway says. "You've got to have a policy to make sure it happens, so they should have had a process when that person knew I hadn't been given any information, that should have told her what to do," she says. The form must be signed before administration of medications/anesthetics.
If the consent form is signed outside the facility, then you have to include in your policy how you're going to get it into the chart, Calloway says. "Make this easy," she advises. "They can fax it in; they can e-mail it in; the patient can bring it with them; the doctor can bring it with him."
Ensure thorough documentation.
From a medical malpractice perspective, the best defense is good documentation, say sources.
Calhoun says, "Documentation that the patient stated they had no questions, that they understood the risks and benefits, that they understood or that their physician had answered all their questions, are all helpful when the patient alleges that they did not give informed consent, because the basis of that allegation is that the patient just signed the paper."
The physician also should document the same information or even more, she says. "In addition, careful documentation any time a consent is changed in the pre-op holding room is very important," Calhoun says. "In particular, documentation about the patient's level of awareness and the timing of any medications can be key."
Anesthesia providers sometimes administer a small amount of medication for anxiety, but the exact time that medication is administered is frequently missed, she says. "Pre-op nursing can document that sedation was given per anesthesia and note the time, just in case the anesthesia provider doesn't," Calhoun says.
Beware of electronic medical records.
Problems with electronic medical record documentation is increasing in frequency, Calhoun says.
"In order to make the charting easier and more complete, many facilities use a template," she says. "I've seen it be wonderful, but I've also found that complacency causes a template to end up with some really goofy results."
Staff might check the wrong boxes or forget to check the right boxes, Calhoun says. The end result can be a poor medical record, she says. "I'd recommend that facilities pull a sample number of the template records every quarter or so, and share the results with the staff," Calhoun says.
Follow guidance from national organizations.
Several national organizations have developed informed consent guidance, including The American Congress of Obstetricians and Gynecologists (www.acog.org/from_home/publications/ethics/co439.pdf), the American Association of Nurse Attorneys (www.aana.com/practicedocuments.aspx), and the American College of Surgeons (www.facs.org/fellows_info/statements/stonprin.html), Calloway says.
"So whatever area you're in, always be familiar with your organization's, because if you follow those you can use them in the court room, and if you don't follow them they can be used against you," she says.