Does a Clinical Decision Aid Constitute the Legal Standard of Care?
By Stacey Kusterbeck
A plaintiff attorney can argue that failing to follow a clinical pathway (computer-generated or not) indicates the emergency physician (EP) violated the duty of care. “However, a clinical pathway is always a suggestion, based on experiences. Each physician must determine in each case whether the pathway recommended is appropriate,” says Victor Moldovan, JD, a healthcare partner in Holland & Knight’s Atlanta office.
A computer-generated recommendation should not be adopted without the appropriate medical staff review and analysis, just like any other clinical pathway. “Hospitals using recommended pathways will typically use a process to vet the pathways to ensure they are appropriate,” Moldovan observes.
An EP cannot avoid medical decision-making simply because there is a recommended course of action. “The fact that the EP may have deviated from a pathway does not mean the physician violated the duty of care,” Moldovan explains.
The reverse also is true. Just because an EP followed a pathway does not inoculate him or her from a malpractice lawsuit. “If an outcome is negative, an attorney can argue that the physician violated the duty of care because the physician followed the recommendation when the patient’s condition required an alternative path,” Moldovan adds.
Each EP should undertake the appropriate medical approach to evaluating a patient, regardless of any recommended course of action. The medical record should support using the recommended path or justify another course of action.
Moldovan says the medical record should include the physician’s medical assessment (a physical and medical history, including all known co-morbidities, medications, and other standard information). Clinicians also should provide support for whatever medical decisions are made (whether this follows the decision aid recommendations, or whether the EP chose another approach because of the patient’s condition). “The medical record requirements are the same for all ED patients,” Moldovan says.
The ED chart should reflect the patient’s information and the decisions the EP made based on that information. “It’s not required that a physician address explicitly a decision to follow or not follow a recommendation/pathway, as long as the record reflects the information showing the assessment and the course of action,” Moldovan adds.
Plaintiffs can argue that failure to follow the recommendation of the decision aid creates a prima facie case of malpractice, according to Kenneth N. Rashbaum, JD, a partner at New York City-based Barton LLP. This is because the definition of malpractice is a deviation from the legal standard of care. The defense has to counter the assertion that the decision aid constitutes the legal standard of care. “That could be difficult to argue, since the hospital should have vetted the decision aid before going live with it. Therefore, the plaintiff could argue that they wouldn’t have used it if they didn’t want it to be considered a standard of care,” Rashbaum offers.
The plaintiff will argue the decision aid represents a standard of care. If the EP did something different, the plaintiff will argue the EP departed from the standard of care. “The only questions that should be sent to the jury are causation and damages. It’s a frighteningly simple argument that may persuade many judges,” Rashbaum says.
To counter this, the defense can argue “the decision aid has neither eyes nor hands nor instruments on the patient. The clinician does, and so can exercise clinical judgment in a patient with a unique set of symptoms, history, or complaints that the algorithm may not have found when it scraped the database of medical records,” Rashbaum offers.
For example, the decision aid may not be able to determine when an off-label use of a medication is clinically indicated. Should ED providers document the fact they were aware of the decision aid recommendation? Rashbaum cautions such documentation would open the door for voluminous discovery requests about how the algorithm was developed. “This would be a budget-busting use of litigation, legal, and expert fees and resources,” Rashbaum says.
The issue also could distract the jury from the facts of what happened. “It could also open the door to an argument that the clinician didn’t use clinical judgment and just relied upon ‘the machine,’ to the detriment of the ED patient,” Rashbaum warns.
Each emergency physician should undertake the appropriate medical approach to evaluating a patient, regardless of any recommended course of action. The medical record should support using the recommended path or justify another course of action.
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