A 63-year-old woman with a history of smoking and previous coronary disease with diffuse abdominal pain underwent a CT scan, which revealed no abnormalities. Still, the patient’s pain persisted throughout her ED visit, unabated by medication.

At the end of the shift, the EP discussed admitting the patient. However, the patient refused, citing the need to care for her pets. After a long discussion, the patient signed an against medical advice (AMA) form, and left the ED. Later, the EP learned that the patient had been admitted to another hospital several days after her first ED visit with an acute abdomen and ischemic colitis. The patient sued the EP, alleging failure to diagnose an acute abdomen, failure to timely refer for surgical consultation, and that breach of the standard of care led to the adverse outcome.

“The patient asserted that she was not aware of how serious her condition could be,” says Alan Lembitz, MD, CEO at COPIC, a Denver-based medical professional liability insurance provider. Two factors resulted in the case’s dismissal: excellent documentation in the ED chart explaining the EP’s medical decision-making and the signed informed refusal form. “Experts also supported that the ED physician did all he could do with a competent adult patient,” Lembitz adds.

There is no question that AMA or informed refusal forms can be strong legal defenses when competent adults make decisions that result in adverse outcomes. However, not all forms are equally protective. Often, says Lembitz, “AMA forms seem to be binary — ‘my way or the highway.’” The forms do not state in clear language the recommended action, the risks of not complying with that recommendation, or any reasonable alternatives. Also problematic: The capacity discussion generally occurs in the record, not on the form.

By contrast, informed refusal is a process that honors a competent adult’s shared decision-making. It documents the preferred course the EP suggests.

“But when that is not chosen by the patient, a next reasonable alternative can be chosen,” Lembitz notes. An ED’s informed refusal forms should address the following:

  • Is the ED patient competent to make such a decision? “Although courts have found that intoxication can impair a patient’s competence and ability to refuse medical treatment, a patient who is intoxicated does not automatically lack the competence or capacity to make medical decisions,” Lembitz notes. Similarly, patients with psychiatric complaints can be difficult to assess but do not necessarily lack capacity to make an informed decision.
  • Does the patient have the health literacy to understand his or her decision?
  • Does the patient understand the diagnosis and the reason for treatment?
  • Is the patient aware of alternatives?
  • Can the patient communicate his or her choices?
  • Is there an understanding of the effects of the patient’s refusal?

According to Lembitz, the use of a properly executed AMA/informed refusal form can create protection from future liability in three ways: clearly demonstrating that the patient understands the EP’s medical decision-making, creating the affirmative defense of “assumption of risk,” and establishing a record of evidence of the patient’s refusal of care. “The physician record needs to document that an adult with functioning decision-making capacity was presented with the risks, benefits, and alternatives and chose to refuse the recommendations,” Lembitz says. Involving family members can offer additional legal protection. “They can either help sway the patient into the recommendations, or they can support that the patient was informed, and chose poorly,” Lembitz notes.

A recent ED misdiagnosis claim highlights the risks of patients refusing admission without appropriate documentation. The case involved a man presenting with back and neck pain. “The patient was told that admission and observation was advised,” says John Davenport, MD, JD, physician risk manager of a California-based HMO. The patient and family asked if he could be discharged home instead. The EP agreed, on the condition that the patient follow up with his primary care physician in 12 hours. “The patient went home and died of a myocardial infarction. The family sued based on informed refusal,” Davenport says.

There was no documentation that the family had been informed and refused admission. The case went to trial, resulting in a verdict for the plaintiff. Notably, family members testified that had they known the risk their dad and husband faced in going home, they would have consented to admission.

“The ER doctor testified that he had warned them, but the family denied it,” Davenport adds.

Patients with decision-making capacity have the legal right to choose to discontinue medical care, even if such a decision is against the EP’s advice. “It is well supported in the literature that patients who leave against medical advice are at higher risk for bad outcomes,” warns Renée Bernard, JD, vice president of patient safety at The Mutual Risk Retention Group in Walnut Creek, CA. To manage the risk that comes with this situation, Bernard suggests EPs take two steps:

  • Confirm that the patient can make the decision with sufficient understanding of the risks, benefits, and alternatives. “Where capacity is not clear, the provider may engage psychiatry for assistance in determining capacity,” Bernard offers;
  • Ensure a safe discharge plan to the extent possible. For example, it is advisable to assist with transportation or other resources if it makes the discharge plan safer, rather than refrain from assisting due to concern about the AMA decision. “The same as informed consent is a discussion and agreement between patient and provider,” Bernard says.

In California, there is a required hospital form intended to evidence such a discussion. Regardless of whether the patient agrees to sign the form, it must be offered. Further, regardless of whether the patient signs, the form has to be scanned into the patient medical record.

“But this is not enough. The provider should absolutely, always document the discussion,” Bernard cautions, noting that quotes should be charted where relevant. “Patients leave for many reasons. It is important to attempt to address the patient’s concerns to the extent possible.” This might include dissatisfaction with wait time, anxiety, drug withdrawal, or other factors.

Involving an ED nurse in the discussion is always a good idea. “This is not only to enhance the discussion and understanding of the situation, but also to evidence these efforts,” Bernard notes.

Whether defending against lack of informed consent allegations or lack of informed refusal allegations, a single form is not the “be all and end all,” Bernard says. “But it’s important to complete one where required by regulations or hospital policy.”

Even if all the appropriate documentation is in place, it does not stop the patient who left AMA, or their family, from suing the EP. Possible allegations include failure to diagnose, failure to treat, and/or wrongful death.

“The defense to such allegations begins with proving that the patient assumed the risk after having an informed refusal of care discussion,” Bernard says. For a successful defense, Bernard recommends one “show that all that could be done for a safe discharge, given the patient’s decision, was done.”