ED Patient Didn’t Meet tPA Criteria? Leave No Room for Doubt in Chart
A woman in her 40s was rushed to the ED after suddenly developing vertigo, nausea, and vomiting. “Nursing performed an EKG and wheeled the patient to a bed, because she could not walk unassisted, to await the ED doc,” says Gary Mims, JD, a partner at Sickels, Frei and Mims in Fairfax, VA, who represented the plaintiff.
The EP ordered a CT due to “left facial weakness,” which was negative, but did not assess gait. The patient was diagnosed with a possible inner ear problem and discharged from the ED.
“The patient’s husband wheeled the patient to his car, and assisted her into their home. The next morning, the patient awoke ‘locked-in,’ and was rushed to the ED,” Mims says.
An interventional radiologist performed an emergency thrombectomy in the basilar artery on the patient.
“She was transferred to a hospital with a terrific rehabilitation center, still locked-in, where she stayed for over three months,” Mims says.
After extensive rehabilitation, the patient learned to walk using a walker, but has dysphagia and significant restrictions in her executive functioning. The malpractice case settled for an undisclosed amount. Notably, the first time the patient came to the ED, it was well within an hour of the onset of symptoms.
“She was discharged within 4.5 hours of the onset of symptoms,” says Mims. “She had no contraindications to IV tPA [tissue plasminogen activator].”
Mims says that in his opinion, the patient’s bad outcome could have been avoided if the EP had done two things:
- tested the patient’s gait upon arrival and again before discharge;
- alerted the stroke team.
“This was a certified primary stroke center,” Mims notes. “By simply calling a stroke code, the ED doc would have been off the hook.”
Jennifer L’Hommedieu Stankus, MD, JD, FACEP, an attending EP at Madigan Army Medical Center and founder of Gig Harbor, WA-based Comprehensive Medical-Legal Consultants, says all EDs should create “code stroke” packets that include inclusion and exclusion criteria for tPA. Particularly important is this documentation: The “last time seen normal” time, and whether symptoms are improving rapidly.
“This patient needed an MRI following the CT scan for a complete work-up. From a legal standpoint, this case is indefensible,” says Stankus.
The problem in the above case is that the EP was not, apparently, even considering stroke.
“This is a very common error,” Stankus says. “Vertigo and gait ataxia should make you think stroke as well.”
“Get the stroke team or consultant involved early and on board with the decision of whether to administer this medication,” Stankus urges.
Devastating Neurologic Outcomes
EPs are much more likely to be sued for not administering tPA to stroke patients than for administering the drug.1
“Most of the litigation in this area stems not from hemorrhagic conversion of an acute ischemic stroke after administering tPA, but rather from the loss of chance of an improved outcome,” Stankus notes, adding that catastrophic payouts “are associated most strongly with devastating neurologic outcomes. So get this one right.” This means EPs must:
- take the time to complete the chart properly;
- meet time deadlines for consulting the stroke team or neurologist;
- document the conversation with the family carefully.
“This is a high area of risk, which can be mitigated to a great extent by these important actions,” Stankus says.
Mims says the ED chart should be so clear that anyone reading it would realize the EP was doing his or her best to determine the patient’s eligibility for tPA.
“Experts for plaintiffs formulate their opinions based on the chart,” he emphasizes.
When Last Known Well?
“Failure to give tPA” malpractice cases often hinge on the “last known well” time.
“The window for IV tPA is generally considered to be 4.5 hours from the time last known well,” Mims says. “If that time cannot be determined, tPA is not an option.”
A patient with sudden onset of headache who presents with an unsteady gait should be asked when the first symptom began.
“If the patient reports a sudden, severe headache at the grocery store, she should be asked at what time, then followed by, ‘Were you OK before the headache?’” Mims says. If the answer is, “I was dizzy for a couple of hours,” or “I vomited,” it’s possible the clock began before the debilitating headache.
“If the patient presents with confusion, the history must be defended. In that case, the physician must chart why the confused patient was reliable,” Mims says, noting it could be that paramedics interviewed family members, who supported the patient’s time line. “Better yet, if family or friends are available, they should be interviewed, and that should be recorded in the chart.”
In some cases, tPA isn’t given because the EP determined the condition was the result of a transient ischemic attack. The ED chart must support this.
“Saying ‘Patient well,’ ‘Feels better,’ or ‘Wants to go home’ doesn’t cut it,” Mims warns.
A documented repeat neurological exam is what’s needed.
“The chart should clearly document that the symptoms that brought the patient to the ED resolved, and that there were no new or other neurologic deficits at the time of discharge,” Mims says.
- Liang BA, Zivin JA. Empirical characteristics of litigation involving tissue plasminogen activator and ischemic stroke. Ann Emerg Med 2008;52:160-164.
- Gary Mims, JD, Sickels, Frei and Mims, Fairfax, VA. Phone: (703) 925-0500. Fax: (703) 925-0501. Email: [email protected].
- Jennifer L’Hommedieu Stankus, MD, JD, FACEP, Comprehensive Medical-Legal Consultants, Gig Harbor, WA. Phone: (253) 820-9343. Email: [email protected].
All EDs should create 'code stroke' packets that include inclusion and exclusion criteria for tissue plasminogen activator, with a particular focus on documentation.
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