Is EP Legally Required to Obtain Patient’s Consent?
Consent to an intervention or treatment is generally implied when a patient comes to the ED, but there are some exceptions to this, according to Andrew H. Koslow, MD, JD, an assistant clinical professor of emergency medicine at Tufts University School of Medicine in Boston, MA, and an emergency physician (EP) at Steward Good Samaritan Medical Center in Brockton, MA.
“As for which procedures EPs need to do the complete informed consent process, there are some general guidelines, but not all EPs agree in this area,” he adds.
Koslow says that EDs should obtain consent for procedures that have considerable risks, and procedures that the average patient wouldn’t expect to happen during the ED visit, such as conscious sedation.
For the procedures for which EDs do obtain informed consent, EPs need to be very careful they are disclosing the proper information, he adds.
“We see a lot of boilerplate forms, which lack key elements of informed consent, and are often difficult to understand,” says Koslow. “We often see just the form on the chart, sometimes not completely filled out, without any discussion of alternatives or other key elements of informed consent.”
While some EPs have patients sign a consent form for procedures, others just document the discussion in the chart.
“The value of the patient’s signature is very much debated. There are a lot of people who believe there is no value in the signature itself. What is really important is what was discussed with the patient,” says Alfred Sacchetti, MD, FACEP, chief of emergency services at Our Lady of Lourdes Medical Center in Camden, NJ, and assistant clinical professor of emergency medicine at Thomas Jefferson University in Philadelphia, PA.
If a bad outcome occurs, the patient can easily claim that he or she was in too much pain or too nervous to understand the form he or she was signing. Sacchetti says a note stating, “I discussed this with the patient and the patient agrees we are going to proceed,” is more legally protective for EPs.
“If you say in the chart, ‘We had a conversation and they understood what I was saying,’ that is a whole lot different than just having them sign a piece of paper,” he says.
Sacchetti is aware of a case involving a pneumonia patient, in which the EP obtained informed refusal for admission to the hospital. The patient signed the standard forms, but when the patient returned in respiratory failure, the family claimed that they didn’t understand that the pneumonia could get worse and the patient could end up on the ventilator and die.
“In that case, the EP’s only note was, ‘Patient signed out AMA [against medical advice],’ with the signed form. There was nothing to show that a conversation occurred, or what that conversation included,” says Sacchetti. Here are practices that could reduce liability risks for EPs:
• Document that the patient or his or her surrogate was able to repeat back or explain the key concepts involved, ideally in the presence of witnesses.
This might dissuade a plaintiff’s attorney from pursuing an informed consent claim, says Koslow.
• Know state requirements for what the EP is legally obligated to disclose to the patient.
“Various courts have weighed in on this. It is generally accepted that you need to talk about alternatives, including doing nothing at all,” says Koslow.
Koslow points to a 2012 Wisconsin case1 involving a man who came to an ED with neurologic symptoms and was diagnosed with Bell’s palsy, was discharged, and returned with a major stroke days later, with a nearly completely occluded carotid artery.
“The court decided that the physician needed to tell the patient about the possibility of having a stroke, and that tests such as a carotid ultrasound were available — even though the physician didn’t think the patient was having a stroke,” he says.
This caused a lot of controversy, and Wisconsin lawmakers are currently trying to nullify the court’s decision, he notes. While an extreme case, Koslow says it illustrates the point that state requirements vary for informed consent.
• Have a way to document the patient’s partial refusal of care.
While most EDs have an AMA form, these are typically meant for patients leaving the ED altogether, as opposed to refusing just one aspect of their care.
For instance, a patient might refuse a lumbar puncture, but doesn’t want to leave the ED. “EPs are often not sure how to handle that situation, especially the documentation of it,” Koslow says. “Most EPs don’t have a good premade form for that.”
This means that EPs will either have to cross out statements and add addendums on the AMA form or document from scratch.
“That is a very vulnerable area,” says Koslow. “If the patient who didn’t want the lumbar puncture actually had a subarachnoid hemorrhage or meningitis and they didn’t sign an AMA form, then what could the EP have done instead? Often, they don’t have much to rely on.”
• Be specific about risks.
For example, instead of stating that risks of infection were discussed with the patient, the EP might document that the patient was informed of the risk of a specific type of infection.
Be clear that risk of death is a possibility, if that is the case, but that alone may not be sufficient if loss of function and other serious risks exist, Koslow says.
“Include all the bad things that could happen,” advises Sacchetti. “There’s been cases where the patient said, ‘The doctor told me I could have died, but I didn’t realize I could be severely handicapped.’”
• Learn why patients are refusing care and attempt to address their concerns.
“I’m a big believer in using quotes whenever possible,” says Koslow. “Really paint the picture so that when someone is reading the chart two years later, they can get a sense of the circumstances and the patient’s reasons for not wanting something.”
For instance, if pain is the reason for a patient refusing a lumbar puncture, the EP should document if additional anesthesia was offered, or that the process was explained more carefully.
“When the patient talks about their reasons for refusal, you often find out it’s based on a misconception that you can clear up. Once you do that, the whole potential legal issue goes away,” says Koslow.
It may be that the patient can’t afford to take off work or needs someone to care for a pet or family member. “Anytime a patient is refusing a potentially life-altering test, procedure, or hospital admission, find out why,” says Sacchetti. “The more descriptive you are, the better.”
A number of Sacchetti’s ED patients have refused a CT scan because of the cost, for instance. “If they tell me, ‘It’s too much money, and this bill is already going to be too expensive,’ my comment is, ‘You need the test, we’ll figure out a way to pay for it,’” he says.
If the EP makes every effort to address the patient’s concern, but the patient still refuses care, the EP looks like a good, compassionate provider.
“A plaintiff’s attorney is going to be reading that chart and thinking about what kind of person will possibly be there on the witness stand,” Koslow says. “If you come off like a compassionate person wanting to do the right thing for the patient, that is hard for them to overcome.”
• Show that the patient had the capacity to understand what you told him or her.
“Document that the patient was competent to understand the conversation,” Sacchetti says. “You can’t get informed refusal from someone so intoxicated that they can’t even hold a conversation.”
The EP has to be aware of all factors that could interfere with the patient’s judgment, adds Koslow. “If you have sepsis or hypoxia, or have just received a large dose of pain medicine, these are all things that can make you less able to understand what’s been told to you and make an informed decision,” he says.
Often, the patient’s reasons for not wanting to do something are strong evidence of their being able to make a rational decision.
“If the patient states that he or she read in a legitimate source that the procedure has a high complication rate and you document that, you’ve gone a long way toward protecting yourself,” Koslow says.
1. Jandre v. Physicians Insurance Co. of Wisconsin, 330 Wis 2d 50, 792 NW2d 558 (Wis Ct App 2010).
For more information, contact:
- Andrew Koslow, MD, JD, Department of Emergency Medicine, Steward Good Samaritan Medical Center, Brockton, MA. Phone: (508) 427-3034. E-mail: Andrew.Koslow@steward.org.
- Alfred Sacchetti, MD, FACEP, Chief, Emergency Services, Our Lady of Lourdes Medical Center, Camden, NJ. Phone: (856) 757-3803. E-mail: email@example.com.